The Leading Difference

Annmarie Ison, Vice President and Head of Service at Elekta, share her remarkable career focusing on life-saving medical technology. Annmarie reflects on her initial aspiration to be a doctor, her pivot to physics, and the serendipitous turn that led her to a startup revolutionizing radiation oncology. With a personal touch, she shares insights from her childhood fascination with science, her transition from aerospace to the dynamic world of Silicon Valley startups, and her commitment to improving patient care through technology. The conversation not only showcases Annmarie's technical expertise but also her deep passion for making a tangible difference in people's lives. Guest links: https://www.elekta.com/ | https://www.elekta.com/products/oncology-informatics/elekta-one/ Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 029 - Annmarie Ison [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Annmarie Ison. Annmarie serves as the Vice President and Head of Service at Elekta. With over 25 years of experience as a software development professional, Annmarie specializes in product development and software architecture for information management systems and radiation therapy delivery devices, specializing in software, inter connectivity, machine functionality, and clinical workflow. She is highly effective and directing all aspects of the software development life cycle. And is passionate about new technology, customer relations, and products that have the potential to enhance the standard of care in oncology. [00:01:37] Welcome to the show, and thank you so much for being here. [00:01:41] Annmarie Ison: Oh, thanks for having me, Lindsey. I'm really excited to be here and chat with you and see where this goes. [00:01:49] Lindsey Dinneen: Absolutely. Well, I would love, if you wouldn't mind starting by telling us just a little bit about yourself and maybe your current role. [00:01:58] Annmarie Ison: So my current role is Head of Service for the software products at Elekta. And these products support radiation therapy and medical oncology and for clinics to deliver therapy, both chemo and radiation therapy, in a more efficient, safe, and effective manner. I actually for many years was in engineering and this role in service is fairly new to me. It's only been about a year that I've been in this role. I sometimes wonder how I got here, but I think it really comes from the fact that I love interacting with customers. [00:02:42] I started with the company as a startup, and there were only about 20, 25 people when I joined. And so you did a little bit of everything. And one of the things that got me really excited was working with our customers, talking to them, finding out what they need, why they need it, what they're doing. And also occasionally having those uncomfortable conversations on why things aren't working and how we can make 'em better and how we can fix stuff. And so I think over the years I've done different, as I said, different roles. [00:03:22] I did some product management and went back to engineering again, and then recently took on this challenge of service because, yeah, I just love interacting with the customer for good and for bad, and I really want to help them be better, help us be better by helping them be better and do their jobs in a easier way so that they can focus more time on the patients and less time on the stuff that they have to do. The computer systems are everywhere. We all have to use 'em, right? We have email and we have everything. And I don't want our software products to be burdensome to them. I want them to be easy and streamlined and make their life easier, and again, so that they can make the patient's lives easier. [00:04:19] Lindsey Dinneen: I love that. Oh, thank you so much for sharing a little bit about yeah, your story and how you ended up in this new role. This sounds like a wonderful blend because you have this, I can already tell, this heart for other people making a difference. And then you have that combined with your love of people and your enjoyment with working with them and that's not always easy. So I love the fact that you're able to combine some of those passions. And I'm curious, how did you start getting involved with the company at the beginning, when it was first a startup? How did that all come out? [00:04:58] Annmarie Ison: That was really just by happenstance. I'm gonna go back even further and say, as a child, as a kid, nine, 10 years old, I loved science. I was always into science. I had experiments. I had a chemistry set in my bedroom. But I always just assumed that I would be a doctor. And I, it wasn't, this is gonna sound really weird. It wasn't that I wanted to be a doctor. I just assumed that's what one did. If you were good in science, you became a doctor. That's, that was the only path, and I really never gave my career choice-- it wasn't a choice, actually. It was the only path. [00:05:40] I never really gave it much thought until I got to college and of course I was pre-med and I started meeting my new classmates and talking with them about what, why they wanted to be a doctor, why they were drawn to the practice of medicine. And I realized really quickly that I wasn't, that wasn't me. That isn't what I wanted to do. I didn't have that-- I didn't aspire to practice medicine. And so I kind of pivoted and I went away from that completely and I studied physics. And I focused on physics. And to me, I picked physics because to me it's foundational. And plus, physicists have the best toys. We get to play with all sorts of cool things. [00:06:26] But to me it was foundational and it really helps you understand a lot of other disciplines, and at the same time I was into mathematics and other staff and-- this was many years ago, for those younger folks listening-- computer science as a degree, as we know it today, didn't actually exist back then, or at least not at a lot of universities, and certainly not the small liberal arts college that I went to. And the, but the courses around computer science were taught outta both the physics and mathematics departments, and so I was really fortunate to have these great professors who were, I consider on the forefront, at least to me, they were on the forefront of figuring out how to use computers, and I'll really say PCs, as a tool to connect the physical world and the digital world, and use it to do the things that computers are really good at and let humans do what humans are good at. [00:07:35] And, you could focus on the physical situation and the data collection and data analysis was all done by the tools that we take advantage of or take for granted today. Excel and things like that didn't exist back then. It's a long time ago. So anyway, it, kind of pivoted away from that, from healthcare and being a doctor altogether and focused on physics, went to graduate school. And when I left graduate school, I really wanted to do exciting things like pay rent and eat. [00:08:09] So I found myself in aerospace and it was really interesting. I, I also found myself in Silicon Valley. I met my husband who grew up there, so that's where we wound up, and in aerospace I had, like I said, it was a cool job. I liked it. I was working on satellites. I, GPS was kind of a new thing then. It was really just coming into its own. And I even got to work bit on the space shuttle, so I, I was very excited. I was happy to stay in that role, but unfortunately the job moved out of the Bay Area and I had found myself going what do I wanna do with my life now? [00:08:58] But there were so many exciting things happening in Silicon Valley at the time that I I mean, it looked, it felt like there was a startup on every corner or really in every garage, right? And I just really, by happenstance, found this startup. And during my discussions with 'em, I met the principals and they shared their vision with me and it just resonated. They were working to change the face and the trajectory of radiation oncology, and when they explained their vision, I saw it, and I also saw a path to get to that vision. [00:09:48] Even more so, I felt like I saw how I could bring everything that I had done up to this point-- my physics background because there's a lot of physics in radiation oncology, my safety background for man's space flight, and my desire to do good and help people from when I was a little girl thinking about being a doctor-- I was able to bring all of that together into this one job. And I'm gonna say I was hooked and I haven't looked back. I've been doing, I've been with the company aiming for that vision really for the last 29 years. And I'm still striving for that vision because it really was a visionary that we're not quite there yet. There were paradigm shifts along the way, and we hit those and helped change how things are done and really form a market, but we're still striving. We're still striving to do better. [00:10:48] Lindsey Dinneen: Yeah. Yeah. Thank you. Thank you for sharing about that background. I love how, I just love when a pathway isn't, isn't as straight as we necessarily think it's gonna be. It's kind of funny how, you said looking back, it was almost like this expectation of, I'll be a doctor. And then you were able to, yeah, to take your interest in science, but your interest in lots of other things as well, and then form this career path that's probably looked unexpected, but seems to have wound you up in a place that you feel at home? [00:11:23] Annmarie Ison: Yeah totally. I do feel at home and sometimes I wanna go back to that nine, 10 year old self and go, "see, see, there isn't one path, there are options." There are so many different people and disciplines and viewpoints and technologies that are all needed to change healthcare, to advance the standard of care and the standard of practice. And you can make that difference by bringing your own set of skills, your own viewpoints, your own passion, and by just being you. And I hope that people hear that and realize that there isn't one path. [00:12:06] Lindsey Dinneen: Yes. . Thank you. I am completely in agreement with you, but I also just appreciate that, that you shared that particular advice because I think you're absolutely right. There are always multiple avenues to a dream and what might work for one person might be a different path for someone else. Well, so are there any moments that stand out in particular as just having this moment of realization that you are where you're supposed to be, like you're in this field, you're at this company, you're doing this particular work. Just any, anything that stands out in particular as, "Yes I am, I am in the right place at the right time." [00:12:51] Annmarie Ison: Oh goodness. I mean there, it's been a long career. So there are so many things that I'm proud of, but there's a moment that sticks in my head from many years ago. Maybe about two or three years after I joined the company, there was a new forum, a new technique in radiation therapy that was trying to become --I'm gonna just call it mainstream or standard clinical practice-- but there was a challenge there that the amount of data that was involved in preparing the patients for the treatment was huge. Hundreds, thousands of pieces of data that the medical physics team had to check and recheck and do measurements on. And it took a lot of effort and we were working with some of our customers to tried to streamline that process and provide them the confidence. Some of these checks, again, people can do those checks, but computers can do those checks really fast. And so we were working with a number of customers and there was one night, and like I said, it sticks in my head. I was in a, can I say I was in a bar in Saddlebrook, New Jersey of all places? [00:14:06] Lindsey Dinneen: Of course. [00:14:07] Annmarie Ison: You're up in New Jersey, so maybe that's why it sticks out. But where I was talking with a colleague, a customer, and we were gonna give a seminar the next day, and he had just, he was putting his slides together and going over them with me, and he had told us that he was able to get this effort that took him like 30 to 40 hours down to about an hour, and we were like, "Wow, that's awesome. That's fantastic." And we were really excited about that. But it was the thing that he said next that really stuck with me. And there's two points on it. The first is he said, "And now we don't have to choose. If the clinical indication requires this kind of treatment, we can offer it." [00:14:54] And that just hit me and I was like, "Wow, we moved the needle. Right? We really moved the needle." And I just, I was really excited about that statement, but it also hit me in a slightly different way. It reminded me that in all the rush to, in the day-to-day responsibilities of getting these features to the market, and who has to sign what paper, and what form has to be done, and what project plan has to be completed, and all those things that I actually didn't think about the patient. I'd forgotten about the patient. [00:15:35] And really since that day-- I actually felt bad about myself when he said it. I was frustrated and angry at myself for not thinking, not keeping that patient and that set of patients in mind-- that really since then, every day I think about the millions of patients that are impacted by the products that we work on. And I also think about each individual patient. When I'm never sure about, "Is this the right thing we should do? Are we working on the right thing? Is it good enough?" I think about the patient, the individual who could be anyone. It could be your brother, your sister, your spouse, your next door neighbor, child as well as I think about that vast set of patients that can be impacted. [00:16:24] And it helps recenter me and refocus me to make sure that I know I'm doing the right thing. And it's just stuck with me all those years. I'm a little bit of a broken record at work when I say, "Two and a half million patients, two and a half million patients," , or I say, "What about the patient? What about the patient?" But, I think in the end, it serves us well to do that, to always keep that in mind. [00:16:52] Lindsey Dinneen: Yes, absolutely. And, thank you so much for sharing that story. That's powerful. And so I know that women's health and advocacy for femtech, whatnot, that's something that you are interested in and passionate about. And I was wondering if you could share just a little bit about maybe your experience. [00:17:13] [00:17:14] Annmarie Ison: Yeah, so I think that access to care is really the key thing. And, whether it's women's health-- which I think is a huge issue of getting access to care-- but it can be anyone really. As I mentioned in the previous discussion about bringing these advanced techniques to the clinical setting, there are areas of the world that, that don't have the resources. And the resources could be basics like electricity and access to power and things like that. But also, the resources of skills. Right? [00:17:56] As I mentioned, medical physics is a big part of radiation therapy and if you don't have really skilled medical physicists around, it can be difficult to use these really advanced techniques that can, provide better care, fewer side effects, shorter treatment times. Again, when if you're looking at someone who has to travel a long way to get to care, you don't want them to have to come back every day for 25 or so days. If you can shorten that down into a week or so, which we can with some of these really advanced techniques. [00:18:35] But again, you need those resources, you need those expertise, and I think that's where I. The digital world comes into play again. And if anything, the pandemic taught us that we can do so much remotely. I can be, and we have this already today, can have medical physicists from some of the leading clinics in the world, here in the United States as well as in Europe, looking at and supporting countries that don't have that same baseline of resources and technical expertise. [00:19:10] And I think, women's health comes into play there a lot in that there are many indications in that are managed by radiation therapy. So I think, again, being able to offer these advanced techniques, shorter timelines, hopefully higher cure rates, or at least control rates, to these emerging markets, and expand access to care is really important to me. And I feel that's the direction that we have to go with in the, in healthcare in general. Access to care is the key. [00:19:47] Lindsey Dinneen: Yeah. Yeah. Thank you for speaking to that and elaborating a little bit on, on that, and I, I, I appreciate the fact that that you and your company in particular are aware of those issues and are thinking through them and talking about them and, that's how change is gonna happen. So, it's always exciting to see that. [00:20:08] Annmarie Ison: Yes. [00:20:09] Lindsey Dinneen: Yeah, absolutely. So, pivoting the conversation, just for fun. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It could be within your industry, but it doesn't have to be. What would you choose to teach about and why? [00:20:30] Annmarie Ison: Oh my goodness. I think fundamentally I have a hard time with this question because I don't consider myself a master of anything. I always consider myself an intermediate, because as I learn, I realize how much more I don't understand about them. But for the million dollars, and I'll take it, I think it would have to be something around cooking. I love to cook, but I wouldn't want to talk about technique, mastering a specific chopping technique or sauteing technique or whatever. But I think I'd call it "collaborative cooking." I have so many friends who are intimidated by cooking and, "Oh, I don't know how to cook. I don't have a recipe." But I just can't think of anything more fun than to work as a team, bring everyone's different perspectives and skillsets and passions, if you wanna use that word, together, to bring a nice meal on the table and if things go wrong, well, that's part of the experience. [00:21:38] I also think that if you don't cook and you can still be a part of the team. My, my family does this, my family and friends, we do this all the time. Someone, we have three or four people in the kitchen, all cooking together. Someone made the menu, someone else has picked the wine, someone setting the table. Hopefully someone's pouring the wine too, but we all come together and it makes everything less, like I said, intimidating. You don't, you shouldn't be intimidated by cooking. It's fun and there's nothing better than enjoying a nice meal prepared by all of us together. [00:22:16] And that's my feeling about a team also is when you have a team working with food, like I said, dinner, it's no one's thing. It's everybody's thing. We all came together to make it so it's no longer, "I cooked this." It's, " We cooked this, we did this, and we made this wonderful evening or afternoon or whenever it is." You're enjoying it. So that would be my theme of the masterclass, if I could. [00:22:50] Lindsey Dinneen: I love that. Oh, I love that. [00:22:52] Annmarie Ison: Yeah, just, cooking with my nieces and nephews is always fun, and everyone coming together to enjoy and celebrate. [00:23:01] Lindsey Dinneen: Yes. . Yes, that is very exciting. And hopefully, like you said, the, the teamwork component of it will be joyful as all the families get together . [00:23:11] Annmarie Ison: It can also be, I call it, "passionate." It can be . It can also be passionate at times, like... [00:23:19] Lindsey Dinneen: I love it. [00:23:20] Annmarie Ison: ...someone can feel strongly about the temperature that cookie should be cooked at. I don't know. [00:23:25] Lindsey Dinneen: Yeah, that's right. And we're all working together towards a common goal, so gotta figure it out. . Amazing. Amazing. How do you wish to be remembered after you leave this world? [00:23:38] Annmarie Ison: This question, I'm gonna have a hard time with answering without getting very emotional. My husband passed away a few years ago, and he was in medical devices as well. We actually have a very similar background, he was a physicist, went into medical devices and we actually talked about this when we knew the end was nearing. And his answer was, "I want to be remembered that I helped." And I can't think of a better answer. I would love to be remembered that way, that I helped in some way, in all sorts of ways, that I helped my family and friends in times when they needed help, whatever that was, might be cooking something for them. But also that I helped forward this vision that the founders of the company had that I helped clinicians help their patients, and that I had some small impact on the standard of care and the direction of oncology. Yeah, that's the way I would like to be remembered, that there was some help. I can't think of anything better than that. [00:24:51] Lindsey Dinneen: Yeah. That's beautiful. That's a wonderful thing to aspire to. Thank you for sharing those stories, really appreciate it. And last but not least, what is one thing that makes you smile every time you see or think about it? [00:25:07] Annmarie Ison: Oh man. I feel like I should say something honorable like my family and friends and things like that, but they would all know that I was lying if I said that. They know the answer. The answer is pandas. [00:25:25] Lindsey Dinneen: Yes. [00:25:27] Annmarie Ison: I love pandas. As a little girl, I had a stuffed panda instead of a teddy bear, and I became a bit obsessed, and I consider myself now a recovering panda- holic. I had a rough week when the pandas left The National Zoo. It was very emotional for me, but I still lean towards pandas. I can't help but smile and laugh when I see them, and if you were to look under my desk on my early morning teams calls, chances are that I'm wearing my big fuzzy panda slippers while I'm taking those morning meetings. [00:26:09] Lindsey Dinneen: Oh. [00:26:09] Annmarie Ison: You dunno that, but I've got my big fuzzy panda slippers on most days. [00:26:15] Lindsey Dinneen: I love it! Thank you so much for sharing that. That just makes me smile. I love pandas, oh my word, and I just, every time I see those videos of those care takers trying wrangle the babies, oh my goodness. I love it. [00:26:34] Annmarie Ison: I, I, if I wasn't doing what I was doing and helping people this way, I, that's my dream job. [00:26:40] Lindsey Dinneen: Yeah. I have often said my retirement gig is gonna be a animal caretaking in some way. Oh my word. Well, this has been such a pleasure to speak with you today, Annmarie. I really appreciate you sharing a little bit about yourself and your background, how you came into this industry, and just your heart and passion for people, and making a difference. I really commend you and I just I thank you. Thank you for everything that you're doing to change lives for a better world. [00:27:10] Annmarie Ison: Oh, thank you. Thank you for having me. And I've actually listened to a number of your podcasts, so I feel honored to be a part of the group that you've talked to. And thanks. Thanks for inviting me here. I really enjoyed it. [00:27:24] Lindsey Dinneen: Thank you so much and thank you so much also to all of our listeners, and if you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two and we'll catch you next time. [00:27:39] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development. ​

Essa Abdool-Karim, an emerging companies lawyer specializing in medical technology, shares his intriguing journey from sports and entertainment law to finance law, before finding his passion in MedTech legal affairs. He discusses the vital role of contracts, liability considerations, and the complexities of navigating regulatory landscapes, especially when expanding into international markets. Essa offers invaluable insights into the importance of strategic investor relationships and the distinction between "smart money" and "dumb money." His optimistic outlook and dedication to facilitating breakthroughs in MedTech make this a must-listen for aspiring and established entrepreneurs. Guest links: https://www.linkedin.com/in/essa-abdool-karim/ Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 028 - Essa Abdool-Karim [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey and I am so excited to introduce my guest today, Essa Abdool-Karim. Essa is an emerging companies lawyer who helps his clients build their businesses. This can be through raising capital, producing the correct contracts or structures, navigating regulatory hurdles, or purchasing new businesses that will either expand or open a new market for their current businesses. [00:01:17] Essa, welcome to the show and thank you so much for being here. [00:01:21] Essa Abdool-Karim: Thank you for having me. [00:01:23] Lindsey Dinneen: Absolutely. I'd love if you wouldn't mind starting off by telling us a little bit about yourself and your background. [00:01:30] Essa Abdool-Karim: Yeah. So a little bit about myself. I am an emerging company's lawyer, some would say a venture capital lawyer as well. I, I have sort of like a general practice, but my emphasis are in several technology companies, but I have a special interest in medical technology companies, representing them from their early sort of incubation stages all the way up into hopefully one day, some IPO or other form of exit. And a lot of my practice is helping sort of build that out and almost acting as fractional general counsel to a lot of the activities that they do. [00:02:03] Lindsey Dinneen: Excellent. And then would you mind telling us a little bit about your background, maybe how you got into this field and specialty in the first place? [00:02:11] Essa Abdool-Karim: Yeah, my journey is quite interesting actually. It is not, it's not a straight line by any means, right? So, I actually started as a, so after I finished law school, I went and worked for sports and entertainment law firm where I was representing athletes, entertainers, at sort of international tribunals and contracts sort of negotiations, mediations. There was contract drafting as well. So it was really cool. It was a lot of fun and I don't know what possessed me to say, "Hey, I want to go leave this and go to the exciting world of finance." [00:02:41] So I ended up in the the finance industry. I worked for an broker dealer in Montreal. So I did sort of a quasi-legal role there. But at some point I just missed private practice. So I left, ended up starting my own shop and then joining up with the firm I'm currently with. And yeah, so as I was developing my practice, I realized that I loved working with startup companies and growth companies or companies in a growth stage. I found it to be very exciting. [00:03:11] How the medical technology thing sort of happened. It sort of lined up with my interest and I had one client that sort of reached out to me that was sort of a larger, they had a more established medical technology company than they all also had an early stage medical technology company. They had a couple. And it sort of through that, I really sort of delved into the world of medical technology and all of the legal issues that these companies typically face, both in local markets and international markets. Prior to that, however, I've always been interested in the space. I just didn't know exactly what the space was or meant. Right? So yeah, that's that's a bit of background about me and sort of how I ended up where I'm now. [00:03:51] Lindsey Dinneen: Yeah. And so out of curiosity, did you growing up think, "oh my goodness. One day I'm gonna be a lawyer?" Like, was this always a goal and interest of yours or has that evolved over time? [00:04:03] Essa Abdool-Karim: Yeah, weird. It's kind of weird how that happened. Law has always been sort of something of interest to me and from a very young age. And it is something that I've often entertained. I did wanna do something a little bit different, but it was like, "oh, it would be nice to be like a marine biologist. What do they do? It'd be nice to be an astronomer, but I do just look at the stars all day?" I'm not sure, right, what that sort of entails. So I was like, "okay, I understand what lawyers do, I think for the most part. So I'll just do that". So, yeah, how that happened. [00:04:32] Lindsey Dinneen: Okay, . Okay. So, so first was just sort of, okay, I have an idea of what you do, but then, I mean, that's a huge commitment in terms of education and time and all sorts of things. So, how has becoming a lawyer and then going from sort of industry to industry, how has that been a compelling thing in your life in terms of career trajectory as you've gone from one industry to another? [00:05:00] Essa Abdool-Karim: Yeah, Yeah, Yeah it's been interesting. I kind of like it personally just because when I first started, and even a little bit right now, I'm sort of industry agnostic. I wouldn't have been where I am today, if not for the journey that I've had. I kind of done everything that I wanted to do. Like prior to law school, I taught, I was a teacher because it was always like, maybe I should become a teacher. Then I went to law school, wanted to work in sports entertainment. I think every entry class has about 30% of the students want to enter into that. I was very fortunate that I ended up in there. So, and then I went, I've always wanted to try the world of finance. I tried that, got to see what that was about. It was interesting. Not interesting enough for me to stay, but interesting, so. [00:05:43] Lindsey Dinneen: Sure. [00:05:43] Essa Abdool-Karim: So it was, it's good. It's been a very good journey in that regard. And I'm just happy that I ended up dealing with medical technology as one of my major verticals. So that's been, it's been really cool and I've been very fortuitous to have that experience, and it's exciting. I enjoy the pace of it. [00:06:01] Lindsey Dinneen: Yeah, for sure. So with medical device companies in particular, I imagine that each industry, and of course each company has different focus points in terms of legal considerations, but MedTech is a very heavily regulated industry, so what are some of the top considerations that you help-- especially very young startups, maybe it's their very first invention or product-- what are some of the considerations that you always help them to think through from a legal perspective? [00:06:35] Essa Abdool-Karim: It's a loaded question and I don't wanna, don't wanna. No, it's a very loaded question. It's a good question though. I don't wanna give you the lawyerly answer and say it depends but in, in a way it does, but I think the essentials are, there's, there's a few. [00:06:50] So, you know, contracts are very important. Obviously having the right contracts in place is, there's a very good starting point, especially with your founders. You, everyone sort of starts your relationship thinking, oh, this is sort of like a "kumbaya kind a moment. We're all gonna be fine. Everything's gonna work out." But the reality is, you know, I'm not paid to think about the kumbaya moments. I'm paid to think about, you know, what's the worst that can possibly happen and how do we account for that, unfortunately, right? So that's one thing that's very important. Understanding where everyone's responsibilities are, outlining that in a document is a very good starting point. [00:07:22] The other critical starting point I would say is liability, particularly in the medical technology industry. It's a highly regulated industry. There's a lot of money flowing around, and with that, there's a ton of risk. So, as an example for Canadian companies they will be receiving any sort of regulatory approvals that you need to receive from the relevant Canadian authorities. And once you obtain that, you have it, you're in the market, but more often than not, you're looking to expand to the United States, as an example. [00:07:54] Now there are a number of considerations when you're having to do that. There's obviously FDA regulations that you have to worry about, certain sort of disclosures that are required to be made. And this isn't even going into the intellectual property element of patents and other sort of important intellectual property issues. But just both focusing right now on the corporate side. When, and I'll speak from a Canadian perspective and I'll transition into the US, but when a Canadian looks at the US the, they're, the biggest thing they're afraid of is getting sued and understandably so. The United States is the most litigious society on earth in the entire world. I think I saw a statistic where it said there's a lawsuit literally every second. And. [00:08:38] Lindsey Dinneen: Oh my word. [00:08:39] Essa Abdool-Karim: Yeah, so it's understandable. There's a high risk, high reward because the United States is such a large market, and there's so much promise here, people want to enter into it, but they wanna be very careful when entering into it. And I typically advise them the relevant corporate structure to enter in to this market for it. Now there's a distinction, right? There's the early stage elements where we're dealing with startups, making sure the contract correct contracts are in place. There is a basic corporate structure in place. And you're working towards some sort of intellectual property ownership because that's critically important, particularly in this field, although I'm not an intellectual property lawyer. [00:09:17] I do, I shouldn't say-- I'm not a patent lawyer. I do some intellectual property work. I'm not a patent lawyer specifically. You know, I'm familiarized with trademarks, copyrights, but patents that are very sort of technical area of law. But it's critically important to have your eye on the prize and want to work towards that. So I do liaise with patent agents, patent attorneys and other relevant legal minds. So that's all part of the process. [00:09:45] I think building your vision very early, understanding how you want to get there and where you want to go is all critical and part of the process. In my experience, patents take a very long time relatively to secure, but I think that's the end goal. And even with that, there's time limit after you obtain it to, to file for it in other countries. So it becomes a global thing as well. But yeah, so at the early stage you wanna work primarily on the structuring, get the right team together, make sure that everyone has the right documents in place. Could be employment agreements, could be independent contractor agreements. [00:10:15] It depends on how you wanna structure your company, how much appetite you have for it, what's your relationship with the employees or independent contracts ought to be. anD even the boring stuff like share classes, understanding how those work. And then there's raising money, and that's a big one because everybody needs money to operate their company, and to get it off the ground. So those are some of the early stage considerations. When you're sort of like at a growth stage, what you're looking at is market entry, how to enter into foreign markets, which obviously I help my clients with as well. [00:10:48] Lindsey Dinneen: Yeah, so lots of considerations. So we can just barely scratch the surface, and folks should hire you if they need additional supports. [00:10:56] Essa Abdool-Karim: For sure. [00:10:58] Lindsey Dinneen: You know, it's so interesting. Thank you for sharing some of those considerations and bringing to light some things that you might not think of initially, especially like you mentioned, it, it does feel very exciting when you start a company and you have all of these like celebratory moments, 'cause everything is exciting and a big deal. And then like you said, but you have to think it is your job to think about what could go wrong though, and then prepare for that. So I am curious though, that sparked a question for you personally in your own life, how are you able to separate or negotiate the fact that a lot of what you need to do is look for worst case scenario, when probably you wouldn't wanna do that in your personal life all of the time. So I'm curious how that works where it's like your work is so heavily focused on being proactive in a preventive way, however, at the same time, for you personally, how do you balance that? [00:12:00] Essa Abdool-Karim: Yeah. Yeah, it's interesting. It's a good question too because we have... listen, I'll be honest with you, lawyers are pessimistic by nature, right? I think generally speaking, we just think of the worst case scenario. I'm not like that personally. I'm an optimist. I'm a cautious optimist, a realistic optimist, whatever you wanna call it, right? My philosophy is always hope for the best, but prepare for the worst. I think it's critically important to do that. I do that in my personal life. I do it in my professional life. And just because you're thinking of the worst case scenario, it doesn't mean it's gonna happen, right? You just have to calculate for it. My job is to make sure we don't get to that point, right? But you have to account for it nonetheless. [00:12:39] Lindsey Dinneen: Yeah. So, so you are able to keep the perspective of we're doing this as a, as something to be prepared for as a preventative and not get to that point, so therefore it can be a little bit more optimistic and a little less... [00:12:54] Essa Abdool-Karim: Yeah, and it's so difficult. It's so difficult too, to be honest with you, just because so much of my job is, you know, thinking about that stuff, [00:13:04] Lindsey Dinneen: Yeah. [00:13:04] Essa Abdool-Karim: It's very easy to get down on yourself outside of work. So you need to be really good at sort of detaching. And I have a good support system in place. I think that's very important. I didn't marry a lawyer. I know a lot of people that do, like lawyers marry other lawyers. So I think the fact that I'm not married to one probably helps. [00:13:21] Lindsey Dinneen: Yeah. [00:13:23] Essa Abdool-Karim: I know me if I was married to one, we just bought talk shop when I got home. So, and I know a lot of lawyers that are married to other lawyers and it works for them. I think they probably make it a point to probably detach and they probably understand each other in, in that sort of capacity. But I'm married to an accountant, so very different world and I think is beneficial for me. [00:13:45] Lindsey Dinneen: Yeah, that makes a lot of sense. . Yeah. So with the medtech industry specifically-- when you do get to work with those clients, what are some of the things that stand out to you as being particularly noteworthy or enjoyable? What in particular do you like about this industry? [00:14:04] Essa Abdool-Karim: Oh, I love how brilliant everyone is. Everyone is so smart, so much smarter than I am. Like it's It's amazing. [00:14:11] Lindsey Dinneen: Yeah, [00:14:12] Essa Abdool-Karim: It's [00:14:12] Lindsey Dinneen: I get that. [00:14:13] Essa Abdool-Karim: It's really cool. It, there's so many smart people in this industry. Watching, not only watching, but also being in that room with people who are trying to solve a problem makes such a massive difference because I feel it pulls myself up as well. I really have to be on my A game. And because of that, it's just so enjoyable working with them. So yeah, definitely. It's definitely the intelligence. That's one thing. [00:14:37] Another sort of element is-- and I went to law school with this intention-- I always wanted to be able to provide for my family, but I always wanted to do good. I wanted to be able to sleep at night and knowing that I was doing good. And, when I'm servicing medical technology companies, I know, yeah, obviously you have to care about the bottom line. That's, that's part of the business side of it. But a lot of the founders I met their intentions aren't just the bottom line. [00:14:59] Their intentions are, we wanna change the world for better and we want to make the world a better place. We want to make it easier for, for everyone who's going through this particular difficulty and we want to make their life easier. And I think that's remarkable. So one of the greatest pleasures I have is I'm trying to help 'em achieve that goal and I'm trying to help them realize that success and that is really cool for me. [00:15:22] Lindsey Dinneen: Yeah. Yeah, absolutely. Yeah. Thank you for sharing that. I think those two things are-- I agree with both of them. I really enjoy both those elements. I also really like-- I don't know what your experience has been-- but one thing that I very much enjoy about the industry is how friendly people tend to be, and they tend to be just very welcoming. And us about you, tell us, you know, it is, it's just a very inclusive place for the most part. And I hope it will continue down that pathway because [00:15:47] Essa Abdool-Karim: I think, yeah, I for sure. I think the people I've met are very receptive, and that's, and I think that's really cool. Typically, and I'll be honest with you, in some industries there's almost, I wanna call it a fraternity, where they try to keep people out. But I haven't found that in the medical technology industry. I found that people are very receptive, very open, and I think the worldview actually is a little bit different from other industries in that sense. There's very human side to this that I think everyone appreciates. And I think that's really cool. [00:16:18] Lindsey Dinneen: Yeah. Yeah, absolutely. And so, are there any moments along your lawyerly journey where you had this realization, maybe you were helping a client, or it could really could be anything, where you just had this thought of, wow, this is why I do what I do. [00:16:38] Essa Abdool-Karim: Yeah, that's a very good question. There's a really basic one I had recently a couple of months ago. So I drafted up an independent contractor agreement for a client and things didn't work out. Independent contractor got upset. They parted ways. Independent contractor comes back threatening to sue. Client goes, "Hey, look at the contracts. You can't do that." And I was like, "yeah I drafted that. So this is what I do. Okay, cool. So there's purpose to my job and the work I do." So that was, so that was good. That was a full circle moment. That was really cool. [00:17:16] Lindsey Dinneen: Yeah, exactly. Seeing it in real time, the protections that you've put in place, actually helping your clients, which of course you want them to, but if they're not tested... there you go. [00:17:27] Essa Abdool-Karim: For sure. And when, and one of the other, one of the other things I think that was really cool recently was one of my clients launched in in another jurisdiction. And I helped set that up and knowing that, and I've seen testimonies about the product and the treatments that the clients were receiving, and to be a part of that is really something special. [00:17:44] Lindsey Dinneen: Yes. Yes. Absolutely agree. Absolutely. Yeah. And so, coming down the line, what are some of your things that you're looking forward to with with your firm, with your clients, or, you know, continuing to expand? What are some things to look forward to? [00:18:00] Essa Abdool-Karim: Yeah, it's it's an exciting time for me just because I'm expanding my, my practice a little bit in the sense that I'm really digging into sort of medical technology community, even to an extent the health tech community. So it's exciting for me because I'm moving in that direction. And I'm really doubling down on helping my clients open up their companies into international markets. So that's been really exciting. We do quite a bit of work in the Middle East, for example. But I. The United States for a lot of people is a big, a big market. So expansion here is very important, and even for US clients, expanding outwards is still really good for simply diversifying your portfolio. And there's many companies that do this. [00:18:40] The Canadian market is really good for that as well because we do have a robust economy. We do have a good set of regulations in place. Market entry is a little bit difficult because of the regulations, but we have a very sophisticated consumer market and a very good infrastructure, which is the appeal of Canada, which is something I didn't realize until earlier this year, I, in my mind it was, why come to Canada when you can go to the US, right? And it still very much is the case. And if you just look at the consumer market, ours is smaller naturally. The US has, I think, the second largest consumer market in the world behind China. So, makes sense why companies would wanna open up in the US over Canada. But for us, companies that are already established here, I think it's a very good move for them to establish themselves in Canada, just because there is a very sophisticated user base and consumer base for the products that you would launch there. [00:19:30] Lindsey Dinneen: Yeah, so continuing to expand even more into helping those clients as they look towards more global reach essentially. And yeah, continuing to build up that medtech portfolio. That sounds good. [00:19:44] Essa Abdool-Karim: Yeah. Yeah. And it's a lot of fun, again, just because of the people you meet. Super, super exciting. I mean, there's been. There's been there's so many anecdotal stories. There's a saying amongst lawyers, we'll do everything for you. Just give us the book rights, right? Waive-- your story is so phenomenal-- just waive your book rights, so when, you know, at the end of my career, I can put it in my book and tell people about it, sort of thing, right? Because we do a lot of that and... [00:20:08] Lindsey Dinneen: Right. [00:20:09] Essa Abdool-Karim: Some of the stories we see are truly sort of remarkable. And a lot what we do, it's kind of sad, but funny at the same time because like my, one of my mentors says, and one of the principal lawyers in my firm, he says, "Listen, they're either gonna get us on the way in or the way out. You know, one way or another, you're gonna need us. Either when you're starting the company, you're gonna hire us or you're gonna make a mistake down the line and you're gonna need us down the line." And unfortunately, I've seen the latter situation where down the line things have gotten really bad. And have you had just spent a little money upfront, this wouldn't have cost you a million dollars later on. And that has, and it has happened. I've seen it happen firsthand and it's super unfortunate. [00:20:47] Lindsey Dinneen: Yeah, so in general, I it, I'm not putting words into your mouth, but it sounds like one of the first things if you establish your own company is to consult with a lawyer. [00:20:57] Essa Abdool-Karim: I think so. I think I, I think as far as... and obviously I have my bias here, but you know... [00:21:03] Lindsey Dinneen: Sure. [00:21:03] Essa Abdool-Karim: Again, I've seen, I've, I've seen companies, that started barely anything, right? And they built into this thing that they never thought they'd be, like this massive company. And not to say that they never wanted to reach that point, or they never wanted to get to that point, but it grew into something that they never thought, even dreamed possible, right, in a very good way. The problems, the foundational documents and the relationships they had with maybe vendors or licensees, weren't the best in nature. And then I have to come in and I'm doing crisis management at this point. I'm either managing their litigation or if I'm not managing their litigation, I'm trying to diffuse the situation so it doesn't get worse, could be through mediations and out of court discussions, right? Even though I'm not a litigator, I do this sort of litigation management. All that to say in long-winded way of answering your question is, yes, please consult a lawyer as early as you possibly can, as early as you can afford it. [00:22:00] You want to be able to resolve issues before they get to court, generally, right? When you're not the offensive side, but even when you are suing, right? Because obviously if you have a patent interest in something or someone's infringing on your patents or you know, maybe there's a commercial disagreement. Even if you are the party suing, you have to be very careful when going to court. And the reason for that is you cannot tell who the judge is gonna be and how they're gonna view things. It's always, you always throw the ball up in the air. [00:22:29] You know, even we as lawyers, we can do as much case law research as we want. We can look at the legislation as hard as we want. We can really scrutinize it. We can go into the wording, we can make our arguments, but we cannot guarantee that things will end up in your favor even if you have a really strong case. Because when you go into court, anything can happen. From witnesses to, to, to the judge's opinion, maybe their own personal experience in something, you don't know. So even in that situation, it often is better to settle outside of court or have some sort of discussion. But yeah, it's it's an important sort of strategy to note that dispute resolution is a critical part of any legitimate litigation strategy, in my view, at least. [00:23:14] Lindsey Dinneen: Yeah. Yeah, that makes a lot of sense. I absolutely see the value, of course, in that. And then, and like you said if you end up sort of inviting in non-controllable human elements into the mix, if you do end up.... yeah. Yeah. Okay. Yeah. All right. [00:23:32] Essa Abdool-Karim: it's not I think. I think if a lawyer tells you, "This is a slam dunk," you should be very cautious. Yes. I think that's a big, I don't like, maybe it's a red flag. It's definitely like an orange flag. Not even a yellow. It's like an orange flag, right? So you definitely wanna watch out for that because a lawyer's telling you, "oh, this is a slam dunk. This is not a problem." I like, okay, are like, "are you a psychic? Do you know the judge person?" Like, you know what-- there's a lot of things that can go wrong. [00:24:01] And by the way, it's all very expensive to go to court. It is very expensive. And this bothers me 'cause even lawyers are expensive, right? I know this. It's unfortunate because access justice is something very important to me. But the problem is there's a big paywall behind it. So, and it's one of the things a lot of early stage companies struggle with. So how can you get legitimate and valid legal advice when you can't afford it? [00:24:23] So there's actually two ways I have in my mind and I guess I share with you right now. And perhaps your listeners will find value in it. One of them is obviously to join some sort of incubator or accelerator. Those are always good, because the network you can build in them. Even, so one of the other thing is, and perhaps if you'd like, we can talk about investing right after this, you'd be able to connect with, you know, could be venture capitalists, could be angels, but what's important, you open up sort of a new network for yourself in a myriad of different ways. So that's the first element. [00:24:55] The second element, and I posted on this on LinkedIn a couple months ago. It's, you can have an advisor committee where you give maybe one or 2% of your equity or whatever the advisor wants. But you can bring a lawyer onto that advisor committee for equity. That way you're not actually paying liquidable cash for that advice, but you're actually bringing them in to advise you on how to set things up while giving maybe one or 2% of your company away, which maybe a lot, maybe a little, depending on how valuable the lawyer is, but it's a good way to save upfront cost. [00:25:28] Lindsey Dinneen: Those are great suggestions. Thank you for that. That's great advice. And then you mentioned the investing side. Do you wanna talk a little bit more about that too? [00:25:35] Essa Abdool-Karim: Yeah, absolutely. So financing is a difficult thing, right? Because you're very sort of, subservient to the markets in a sense, right? And we're in a little bit of a down market right now, but people are still raising capital. I know people are, that completed about a $50, $60 million raise like about four or five months ago. So, I mean, money is still being moved. [00:25:53] But the sort of important thing here is, and I cannot emphasize this enough, there is an important distinction between smart money and dumb money. And what I mean by that is, it's sounds crazy, but anyone can go out and get money. I, you know, you can go and you get in front of the right person and they'll just give you, they'll write a check for a 300,000, $400,000, whatever, right? The problem is you don't want to just take cash. I mean, you can. But it's not gonna open up a network if that person doesn't have the network that you need. [00:26:24] The smarter way to go about it is to make sure to get it, bring in an investor that can actually open up a network for you, because at some point they might want a board seat and those shouldn't be given away just to anyone. It has to be very strategic. And one of the important things I find is that if you have a very good investor, someone who actually has a market behind them. And since we're talking about the medical technology space, we want someone in that invests into medical technology companies that understands the vertical. Because when they come in they likely already have an ecosystem that you can use. [00:26:57] They might, I don't wanna say have a relationship with the regulators, but they might be familiar with the regulators and maybe familiar with certain professionals that they can introduce you to. They may have in their own portfolio connections to distributors. That could be huge, that could be more valuable than the million dollars they just gave you because it might open up a $10 million market for you, just by virtue of the fact that you got introduced to distributor because of this person's reputation. So you have to scrutinize your investors as much as they scrutinize you. [00:27:24] And I know that's difficult sometimes because obviously there's a huge power dynamic between early stage companies, even growth companies, growth stage companies, and an investor when you're literally might be on fumes and your runway is at its the very end, maybe like a month or two away from giving out. So it's very difficult to sort of stand there and tell them like, "look, you need to open this and this door for me, you to bring me in." Very difficult to put yourself in that position, but that's the position you ideally wanna be in. Connect with someone who can open, open market for you. And I think that's one of the most important things about bringing investors in, [00:28:01] Lindsey Dinneen: Yes. Thank you. That's really great advice and that's the first time I've heard that particular advice, so I really appreciate you sharing that. [00:28:08] Essa Abdool-Karim: You are welcome. [00:28:10] Lindsey Dinneen: Yeah, I think I, that brings a lot of value to when people are looking for those resources. And like you said, maybe the million dollars, I mean, it is cash, it's gonna be useful, but might not be, as you said in the long term, as impactful to your business as those relationships in this context can be. So something to really think about, and take seriously. [00:28:31] Essa Abdool-Karim: It can be very difficult sometimes to remove those investors that have invested into the company that you don't want anymore. And they're just taking up a spot in your cap table... [00:28:42] Lindsey Dinneen: Yeah. [00:28:42] Essa Abdool-Karim: ...with not one really bringing anything. And that's very difficult. And this is one of those other issues, is if you don't have something in writing that allows for you to both parties to sort of set the step away amicably, they'll be stuck on there. [00:28:57] Lindsey Dinneen: Yeah. [00:28:58] Essa Abdool-Karim: And that's happened and I've had sort of like these business divorces that I deal with, which is not fun, but it is sort of part of the game as well. But there are strategies you can employ at a high level without breaking any laws that will help remedy that. But again, situation by situation [00:29:17] Lindsey Dinneen: Absolutely. So you have shared lots of great advice, but I would just say when I summarize it in my mind, one of the biggest things is talk to a lawyer early and often. [00:29:28] Essa Abdool-Karim: Yeah. [00:29:28] Lindsey Dinneen: Yeah, there you go. There you go. Amazing. [00:29:34] Essa Abdool-Karim: Play the long game. You know, make a friend, be like, "Hey listen, you'd make a great lawyer one day" and just kind of push them to law school. Yeah, just push them into law school. [00:29:43] Lindsey Dinneen: And maybe, maybe offer to contribute to the law school tuition a little, just you know. [00:29:48] Essa Abdool-Karim: I just believe in you so much [00:29:53] Lindsey Dinneen: That's amazing. I love it. Pivoting a little bit, just for fun. Imagine you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your field, but it doesn't have to be at all. What would you choose to teach and why? [00:30:10] Essa Abdool-Karim: I think I'd want to teach people how to motivate themselves. I have a background in coaching, coaching sports. So I've always found it and no matter what sort of industry I've been in, what position I've been in I find great value, in, in being able to motivate others. I think it's very important and I find great satisfaction in it. And it's really, it feels really good when you, when you see people becoming successful, perhaps not, I don't wanna say as a result of it, your advice, but partly as a result of your advice or your encouragement. So I would probably put together some sort of masterclass on how to get out of bed in the morning, how to set your goals, how to set your visions, and how to execute on those visions. [00:30:54] Lindsey Dinneen: Yeah, that's a great masterclass and one that I'm sure a lot of people would sign up for, because it's so important. I recently actually listened to just a snippet-- I need to go back and listen to the whole thing-- but of a TED talk where the woman was talking about how we often treat confidence as a" nice to have" instead of a "must have." And what a difference it makes when you do treat it as a must have. And anyway, that I thought of that immediately when you were talking about the motivation and sometimes you need a coach to kind of come alongside you and help with that and say, "Yeah, no, you can do this. Let's figure out how we're gonna do this together." [00:31:31] Essa Abdool-Karim: Yeah, Lindsey, it takes, honestly, it's, it can just be one person, just one person that says, I" believe you can do this." It makes an entire, huge difference. And I don't think some people maybe do realize this, others don't realize how big that can be. [00:31:46] Lindsey Dinneen: Yeah. Yep. Absolutely. And I just kept thinking though, , is a very, that was a very good point and a serious one, but the first thought that popped into my mind was like, "Okay, who do I know that I can tell, ' Yes, I think you'd make an excellent lawyer.'" Oh man. [00:32:03] Essa Abdool-Karim: You're always giving, Lindsey. It's really good. I like the way you.... [00:32:05] Lindsey Dinneen: Yeah. So giving. [00:32:07] Essa Abdool-Karim: Helping propel everyone forward. It's really good. [00:32:11] Lindsey Dinneen: Yeah, exactly. Exactly. Oh my word. Oh my goodness. Okay. Yeah. So how do you wish to be remembered after you leave this world? [00:32:21] Essa Abdool-Karim: Yeah, it's a good question. You know, I deal with some incredible entrepreneurs that at this point in their careers, they're not even thinking about, you know, exits or companies. They're thinking about legacy and they want to be sort of remembered as luminaries and experts, not just experts in the field, but people who sort of change the world. So for myself, I do eventually want to get to the point where I can change the world. I don't know what that's gonna look like or how it's gonna happen, but I want some sort of positive lasting influence in the world that I played a part doing. Now interestingly mentioned like how do I want to be remembered? I don't necessarily have to be remembered for doing it. But I want to know to myself that I was a part of it. [00:33:02] Lindsey Dinneen: Yeah. Absolutely. Yeah. And then final question, what is something that makes you smile every time you see or think about it? [00:33:15] Essa Abdool-Karim: My life. Just... [00:33:19] Lindsey Dinneen: Yes! [00:33:20] Essa Abdool-Karim: You know, retrospect really is 2020. And it's this crazy, life is just crazy thing, right? You know, we go through so many difficulties and everybody does. You just can't see it, right? We all go through these difficulties, these ups and downs, these mountains and valleys, these peaks and valleys, and no, not everybody sort

Meet Alexander Ballatori and Shane Shahrestani, two innovative minds revolutionizing the medtech industry with their groundbreaking company, StrokeDX. Their story is not just about technological innovation; it's a tale of resilience, determination, and a deep-rooted desire to enhance stroke care. Amidst financial hurdles and skepticism, their commitment to transforming stroke diagnosis and treatment shines through. Their episode is a must-listen for anyone intrigued by the confluence of medical technology, entrepreneurial spirit, and the profound impact of personal experiences in shaping healthcare solutions.   Guest links: https://www.linkedin.com/in/shane-shahrestani/ | https://www.linkedin.com/in/alex-ballatori/ Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 027 - Alexander Ballatori & Shane Shahrestani [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guests today, Alex Ballatori and Shane Sharasani. They are the creators and innovators extraordinaire behind StrokeDX, and I'm so excited just to talk with them, find out more about the innovation and see where they're going from here. So thank you all so much for being here. [00:01:11] Alexander Ballatori: Yeah. Thank you so much for having us. We're really excited to be here. [00:01:15] Lindsey Dinneen: Excellent. Excellent. I'd love if you two wouldn't mind starting off by just sharing a little bit about yourself, your background and, well, let's stop there. Let's do that first. [00:01:26] Alexander Ballatori: Great. I'll go ahead. So, I'm Alex. I'm originally from upstate New York, from Rochester, so very grateful to be in sunny California at the moment. Now that we're entering the winter period. But I went to the University of Rochester to study biology and chemistry. I was really interested in medtech and medicine in general. And I want to take some time before deciding what type of graduate degree I was going to pursue as well as learn a bit more about the startup ecosystem. So I ended up living in San Francisco for a few years. I really got to see a lot with respect to medtech in general, predominantly in the orthopedic in the pediatric health space, and then I ended up choosing to go to medical school where I met Shane is my first roommate in medical school and we hit it off right away started. [00:02:07] This is our 2nd business together and yeah very passionate about stroke. Stroke has impacted my family numerous times and when I saw this creative solution that Shane developed during his PhD and also just given my long lasting interest in medtech, it was a no brainer to start this company with him, but I'll let him kind of take over from there, give him some background, and then we can dive into more about our story as a company. [00:02:32] Shane Shahrestani: Thanks, Alex. Yeah, so my name is Shane Sharasani. I grew up in sunny Southern California, very different from Rochester. And I was at UCLA for undergrad. I studied neuroscience and then I did my MD PhD, my MD at USC and my PhD at Caltech. And the way they designed that is you do 2 years of med school, you do the full PhD and you come back and you finish med school. So in the first 2 years, I saw the effect that stroke had on patients. And when I went into my PhD, I wanted to develop technology that can solve that problem. Namely, having timely access to stroke care diagnosis that you receive faster treatment because time is brain. So that's where this idea came about. [00:03:13] We pivoted this tech from the aerospace industry and developed this tech for stroke detection. And when it came time to spinning out of Caltech, there was no other partner that I wanted on this other than Alex. He's my best friend and also my first roommate, as he said. So it made sense to work together and we work very well together. So since then, it's been a exciting journey since the end of 2020 when we spun out and filled with highs and lows. And we're happy to be here today on this podcast. Thank you. [00:03:46] Lindsey Dinneen: Yes, of course. Again, thank you all so much for being here. And it's just fun to hear how you guys got connected in the first place, and the fact that, you know, this roommate, which could be so hit or miss, let's be honest. And it just turned into this fantastic friendship and now business partnership. So I love hearing those kinds of background stories. So, you know, Alex, you mentioned having a personal connection to stroke, and perhaps Shane, you do as well, but I would love if you would share a little bit about your, your own experience and kind of what really motivated you all to tackle this issue and to try to make a difference in this arena. [00:04:26] Alexander Ballatori: Yeah, so, I mean, it started really close to home with my grandfather, actually, as well as a couple other uncles and great uncles, unfortunately. And, you know, my, so both my family, both my parents are clinicians by training. And so, when I saw them, and I saw the care that they received, my, my family was always, my, both my parents were very strong advocates for anyone in my family that became ill. And when I saw my family members go through stroke care, I saw that even if you have the best advocate at one of the best hospitals, there's still so many inefficiencies in the care that we can deliver. [00:05:00] And then going to medical school and seeing it firsthand when we are now. I was functioning as the provider at that point, there's just so, it's just so many issues. And despite all the advancements we've made from surgical technique and therapeutics, we haven't put a dent in stroke outcomes in multiple decades. So, you know, when we, when I first saw what this technology could do, the chain had developed at the price point that it can, also at the safety level and in the amount of time that it can deliver this information, I saw all of those problems from at my, within my family and within my medical training. That could be solved just with this simple, elegant, low cost solution. [00:05:42] Lindsey Dinneen: Yeah, that's incredible. And Shane, do you have anything to add to your own experience with stroke and what motivated you to develop this? [00:05:51] Shane Shahrestani: Yeah, of course. So I briefly touched upon the fact that I went to the PhD, I already had some experience with stroke in terms of dealing with patients in medical school and really looking at the inefficiencies there. Why are we ordering so many CTs? There has to be a better way to monitor at the bedside. And why do we not have that? Right? And now I work as a neurosurgery resident and those problems still exist. So many patients every day have to be sent back to the scanner just because something changed about their exam, and we have no idea what happened until we send them down to this big, bulky, expensive machine that requires transport. It uses radiation and there have to be better ways to solve these problems and provide the information at a point of care at a efficient cost to the patient in the hospital system. [00:06:41] Lindsey Dinneen: Yeah. And so I would love if you both or one would share a little bit about the technology itself, kind of where you are in process with approvals and all that fun regulatory excitement and just, you know, what do you envision for your company as it grows? [00:07:01] Shane Shahrestani: So from a tech perspective, there are sensors that they use in aerospace to look for cracks in airplane wings. And we have methods for non destructive detection. That's what they call it: "non destructive testing and detection" that we use every day in other fields. So what we did is, we took this technology and we optimized it for the human body, specifically for the brain and by doing so you can create a non invasive handheld, small, cheap, portable, non radiating technology that you can use anywhere to quickly assess objectively how the brain is doing in terms of its cerebrovascular health, right? [00:07:52] And the idea is it works a lot like a metal detector, right? And in stroke, you can either have too much blood in the hemorrhage or too little. And in ischemic stroke, where you're literally stopping blood flow. And if you have a metal detector that's tuned for the human body and for blood, then you can quickly assess how is the blood flow changing and what are we going to do about it? So that's the technology, and I'll pass it over to Alex to talk about the rest. [00:08:17] Alexander Ballatori: Yeah, so absolutely. So given that this technology can differentiate, localize, as well as produce an image of where the lesion is, and in stroke, again, there's two types of stroke. You need to know what type of stroke they're having. And then once they have the stroke can progress over time. So back in 2020 and 2021, when Shane was first validating this technology with an NIH funded grant awarded to Caltech and USC, we saw that it could provide all of that critical information in a very compact form and in a very low cost form. [00:08:48] So once we published that information in Nature Scientific Reports, we went out and started the company. We went out and started to raise money. And one of the, one of the things that we knew is that our basis, the basic form of our technology the common baseline principle, how it works could impact the entire stroke continuum. Right? So the stroke space has a lot of problems. So, for example, 1 out of 6 stroke patients in an ambulance goes to the wrong hospital because we can't evaluate their brain. Often stroke patients are just found down. Right? [00:09:20] So as an EMS personnel, all you want to do is get them to the closest hospital. But unfortunately, not all hospitals can manage stroke patients. So, one out of six times they're wrong, and that leads to hours in their delays in care. And like Shane said, time is brain. Every minute that passes, you lose a million neurons irreversibly. So, that's the first problem. It's kind of like the EMS. [00:09:38] Then in the emergency department, it still takes quite a while to rule in stroke, because we rely on CT scans. And there's also just a whole slew of things that have to happen for a patient in that process of getting admitted to the hospital. So stroke on average takes over two hours to diagnose from the initial symptom onset. So that's kind of the pre hospital, early hospital problem within stroke care. [00:10:01] The other big problem in stroke care is we don't have any way of monitoring patients at the bedside with a disease that's rapidly progressing. And so currently we just send patients back down to CT, on average four times for admission. And so 80%, unfortunately, these repeat scans are negative. Nothing had changed in the brain, but we require objective information to manage these patients appropriately. So we keep sending them back. [00:10:26] The other problem not to get too into the weeds with this is that most stroke patients are above the age of 65. They are enrolled in Medicare and the Medicare bundled payment system. Ever since it came out, hospitals have been losing money across the board route on stroke care, and a big contributing factors are inability to monitor and image the brain in a timely manner. So that problem also goes into the neuro rehab setting where hospitals are now pressured to push patients into neurorehab where they're getting paid, you know, per diem. And also can kind of close the DRG. [00:10:56] So you can kind of look at the stroke continuum as two problems. The early hospital, pre hospital, and then the inpatient inability to monitor this rapidly progressing disease. We have built an automated device for that second space, the inpatient and neurorehab space. Which is an automated, lightweight device that takes our sensor and has two mechanical arms that move it around the patient's head in a completely automated fashion, removing the human element to the path and the scanning path. [00:11:23] And so what that enables us to do is it enables us to put this device-- it sits right at the head of the bed-- all you have to do as a user is set them up in it, which takes less than a minute. You press go on a tablet and it scans everything and tells you all the information that's happening right at the point of care. It also enables us to leave it on and monitor patients over time, which is going to be a game changer in inpatient stroke care, where currently it takes quite a while to get patients to CT. [00:11:48] And again, 80 percent of the time it was a negative scan. So it's a completely inefficient process. That's actually we estimate to be over a 6 billion in efficiency in the U. S. alone. So we're first pursuing that, but not to say that we're not interested in the pre hospital space. We still are very interested in prehospital stroke ruling and so a lot of our diluted first round of our first round of funding, which was just about a year ago, we came to our 1 year mark, like 4 or 5 days ago, is spending a lot of time on improving our sensors capabilities, which we've improved about 3 X from what it was back in 2021. [00:12:21] So ultimately we are pursuing the inpatient space first, because there's a very clear problem for us to solve that we can solve, but it's not to say that we're not going to go for the outpatient space at a later date. We are still very actively pursuing it because our technology will be the one to solve that problem as well. [00:12:39] Lindsey Dinneen: I love it. And I love how bold and confident y'all are in your ability to do this because it's exciting to see that there are such amazing innovations and there's progress in this space. So thank you for doing the work to make that happen. I know that's going to impact so many people's lives. And also, I want to say congratulations because y'all are winning so many awards. I was looking at your LinkedIn pages and it was so fun to see, you know, post after post. So tell me a little bit about some of your recent wins, if you'd love to share that. You've been part of the MedTech Innovator Accelerator cohort for a year ish now. So yeah, just tell me about your experience and what you're celebrating. [00:13:25] Alexander Ballatori: Yeah. I mean, it's been an incredible process. MedTech Innovator is by far the most significant thing we have participated in since forming our company. The doors that were completely shut and locked and sealed that we could never potentially even knock on are now wide open because of MedTech Innovator. So yes, we've been participating for the past year and it's been a wonderful experience. First, starting off at the the pitch events at UCLA, where we pitched to the judges, where they narrowed it down. They had about 1200 early stage companies. I think a total of 1900 applications in total. And they, after those pitch events, which there were five, they narrowed it down to 61 companies total and about, I think it was 40 early stage companies. [00:14:06] So we enrolled in that program and got assigned to some incredible mentors, got to meet all of these amazing alumni that were either first time founders or seasoned, seasoned founders that have been through a lot. And we just had this complete access to this amazing network of people that we could talk to. And so, you know, it started off with Wilson Sonsini, the Innovator Summit, and the Wilson Sonsini medical device conference where we were picked to be in the top five for the vision award, which is based on the criteria, "would you invest in this company? And would you want to work for them? And do you find them inspirational?" [00:14:38] So we made it into the top five, which we're pretty surprised about, honestly, because it was a cohort wide boat. And then we had 7 minutes to pitch very similar to the finals, which I'll get to in a second. And we won that, and that was the first kind of wave of, you know, just increased interest in us, a lot more visibility for us, and a lot of validation. Our 2022 was a very very trying time for us, which we can talk about later. But anyways, that was the first big win for us. [00:15:05] And then we participated in the cohort and got to know the MTI team and our mentors and go through the value proposition program. It was so helpful for us in so many ways, and it culminated in us making it to the finals at the AdvaMed medtech conference, whereas a similar setup, we had about 7 minutes to pitch, try to explain all of the wonderful things about our technology in just a couple of minutes. After a crowd vote, we ended up winning. And so, it was really special for us because in 2022, as young innovators, you get a lot of doubt, you get a lot of no's, you get a lot of people saying you're crazy. And so to win that was really special. And I want to give Shane a moment to say anything else with respect to that too, but it was just a really sweet moment for us after what we've been through. [00:15:48] Shane Shahrestani: Yeah, a hundred percent. You know, we were two young guys in medical school, no previous business experience, trying to spin out a medtech company while also being in medical school. And the number of times we got said no to, we completely lost track. So to be able to build back up and to make it to a point where we're actually the top startup in medtech in the world was, you know, we didn't even believe it. And also, you know, a couple other things it was, Alex and I just went so much. It was awesome working together as a team over the last year and figuring out all these other problems that came up. And at the same time, at MedTech Innovator, we met so many other people going through similar problems as us. And there are so many amazing cohort companies that we got to meet who are going to change how medicine is provided in the U. S. and globally. So it was an absolute pleasure to work with all of them and to work together to solve so many problems in MedTech Innovator. It's cool. [00:16:47] Lindsey Dinneen: Yeah, that's incredible. I'm so glad that you guys had such a great experience with the cohort. And again, yeah, congratulations for winning the whole thing. That's fabulous. And I think it does speak to the innovation that y'all are bringing to the world and how important it is. And obviously you're getting some really good external validation. I mean you know the value that you're bringing, but it's always nice to have an outside person saying, "yes, we agree," you know, and to that point, I'm really curious about your 2022, because you kind of mentioned that that was a little bit more trying. So if you'd be willing to speak to that, I'd love to hear a little bit about that. [00:17:28] Alexander Ballatori: Yeah, absolutely. So like Shane mentioned, we were both full time in medical school. We were in the hospital for, I don't even want to admit how many hours. I don't think I'm allowed to say how many hours. And you know, trying to form a pitch deck. And, we're both heavy in science and research and we know how to build the presentation typically for the scientific community, right? And so, and again, we're clinicians, like, one of the reasons why I mentioned before, I think, before the recording, one of the reasons why we're so excited to come to this podcast is that this podcast is really about increasing and bringing technology to increase human health and improve human health. [00:18:05] And, you know, one of the things that we were passionate about, and still are very passionate about, is that we want to bring this product to market because we know it's going to help a lot of people. But one of the things that we had to learn is that we needed to pitch a company, right? We needed to pitch a vision and a mission, which we had the vision and the mission. It's gotten much more refined. But we had, that was our, I think our first learning curve, which we give a lot of, we have got to give a shout out to Helen McBride and Julie Schoenfeld from Caltech, as well as our lead investors at Freeflow for helping us with that one. [00:18:33] But it was tough. We were pitching during our lunch breaks and we were pitching on the weekends and we had investors lined up and then unfortunately, the day before the round of funding was supposed to come through, the markets went south and they said, "Hey, we're not investing right now. So sorry." And we were in a good amount of debt. And so, it speaks to one of the value or one of the most important things when starting a company is kind of faith in your mission and faith in your founder. [00:18:57] We were sitting and just looking at each other like, "man, what are we gonna do right now?" Like, we were still fully deep in school studying for our board exams, and we were in debt and we couldn't even build anything. And so, you know, we kept going at it and we really believed in what we could do. And we ended up finding Freeflow Ventures with David Fleck and Kevin Barrett who believed in us and, and saw our vision as well as the individuals at Caltech, and then we ended up finding quite a few other angel investors who are all directors of stroke centers, neuroradiologists, triple board certified neurologists, and you know, experts in clinical trial neuro design. [00:19:34] And they all believed in us. And so we got the money that we needed. And we've been sprinting ever since, which is why we've been able to accomplish so much in the last year. And, you know, now looking back, Shane and I were just talking about this, after we'd won MedTech Innovator finals and we were like, you know, 2022 was really tough, but it put us in a really good position because it forced us to study everything about the market, learn everything about our competitors. And really hone in on where are we going to bring this thing first? Right? Because like I said before, there's an entire continuum of stroke care where the sensor could be applied and we will apply it to all of those areas. [00:20:12] But what did we want to do first? Right? And so I think us having to go through that tough time is one of the reasons why we're so successful in such a short amount of time. So it was a tough time, but we're obviously, I think we're doing much, much better out of it. Now we can, you know, when you look back at it, we're grateful more than anything else. It's taught us a lot and definitely earned our stripes. [00:20:35] Lindsey Dinneen: It sounds like it. Shane, do you have anything to add to that? [00:20:39] Shane Shahrestani: Pressure makes diamonds. I mean, we felt the pressure. We definitely felt the pressure. It's an understatement, but you know, we learned a lot and we were able to thoughtfully revise our pitch decks, our business plans, our engineering plans with all the no's that we were getting and the feedback that we were getting underlying those no's and that's how we were just able to learn and grow. And I think there's something to be said about being young and trying to run a business. I think a lot of people don't necessarily believe in you, especially when you're asking for millions of dollars. So, we learned that we, as Alex said, earned our stripes and proved ourselves and that we were serious and we knew what we were doing. [00:21:27] Lindsey Dinneen: Yeah. And you know, what's so interesting is, when I was looking at both of your LinkedIn profiles and just seeing, I kept thinking, do you guys sleep? Do you have time to sleep? [00:21:40] Alexander Ballatori: We're sponsored by caffeine. That's actually, so Shane and I, before we even started this. We, I don't know, Shane, how many papers we published together and like 30 at least and so many conferences. And it was honestly like that, that the number of nights where we consumed hundreds of milligrams of caffeine, just working together is how we knew we were going to be great business partners. And so, you know, again, we're StrokeDX is sponsored by caffeine. [00:22:06] Lindsey Dinneen: Amazing. Can we get that official so that you actually don't have to pay for your coffee or whatever? Your caffeine of choices. Incredible. So this journey from, and obviously you probably wouldn't consider it a complete pivot or anything, but this journey from clinician to entrepreneur, and everything that entails, you know, obviously, like you said, 2022 was this huge learning curve. What would be some advice that you might have now looking back and being able to say to somebody who might be in a similar situation, maybe what's a one or two pieces of advice that you would say would be beneficial? [00:22:49] Shane Shahrestani: All right. A couple of things. One, find a co founder that you trust with your life, who is your best friend, that you'd rather be awake drinking Monsters at 3am than being asleep. That's very important. Two, every time someone says, no, that's an opportunity to learn and grow. And if you have the resilience and grit to keep your head up when you're being told no and to learn from it and to keep going forward, it will always work out. [00:23:20] Alexander Ballatori: Yeah, that's exactly, literally exactly what I was going to say. You know, someone gave us a good piece of advice. They said, expect to receive 200 no's. And so when you get your 113th, you know, you're barely, you've just barely crossed the halfway mark. Just keep going, because you should expect 200, right? And that was something that, you have to be a little crazy to do this. But also, I think, in addition, like what Shane was saying, you need to have someone that when you hit a low, you know that you can trust the person next to you and you just say, "okay, let's learn from this. Let's refine our approach. Let's , amend our deck and our plan. And let's keep going." Right? [00:23:58] And also, I think really taking the time to understand the market is really-- what you have, first of all, this is before you even get to this point-- you need to understand what you have, how it will be applied. And I think that was actually one of the one of our biggest benefits is that we work in medicine and we understand clinical utility, clinical need and as well as what we've learned that was very easy for us to learn because of we are clinicians is the whole pay/ payer system, right? [00:24:25] And, you know, price points and pricing strategies, it's all kind of coming from a clinical side. And seeing these products that I know how people use them. I've seen them use. I've used them. It just made it a lot easier for us. But yeah, ultimately boils down to having a strong partner. And and not taking things too to heart when people tell you that you're crazy. [00:24:51] Lindsey Dinneen: Yes, indeed. You know, that reminds me, I remember one time somebody saying, " when you hear no it's very rarely no forever. Never going to consider it, the end, close the door, slam it, and lock it." It's usually, "no, not right now." So if you can take that with a grain of salt, if you can take those no's with a grain of salt, eventually, you'll get to either them changing their mind or somebody else saying, no, I agree with you, you're absolutely right. [00:25:22] Alexander Ballatori: Yeah, we got a lot of "not nows." And I think it really boiled down to the fact that our first prototype was handheld. And so we were confident in our decision to go into the inpatient setting. And so now the pendulum has swung the other way. And now that we've validated that our automated device has worked in this translation, translational project of automating this technology has been successful, all of those people that were the not nows are the, "are you raising money now?" questions, which is obviously a great feeling. But yeah, no, definitely. We learned a lot. There were-- also be frank. There are many times where they ask us questions that we studied for weeks afterwards and learned so much from so all those not now is really they shaped us in such a positive way. [00:26:07] Lindsey Dinneen: Yeah, yes, I can imagine. Anything to add to that, Shane? [00:26:13] Shane Shahrestani: No, I totally agree. As Alex was saying, a lot of the previous no's are now reaching out to us. So table turn for sure, but it just takes hard work, great resilience. Got to keep your head up, keep fighting and it works out. [00:26:30] Lindsey Dinneen: Yeah. Yeah. Excellent. Out of curiosity, going back to your childhoods, could you have possibly imagined where you are now, back in the day? I mean, did you always have an interest in medicine? Is this something that sort of developed over time? Did you think you were going to be a business owner? [00:26:50] Shane Shahrestani: So ever since I was in fifth grade, I always loved the brain. I knew I wanted to do something related to the brain and now I am working in neurosurgery, but my deep passion is medtech. That's what I wake up for every day. I look forward to working with Alex and our team and solving complex problems and creating new devices that can save brain. Right? So I knew I'd be somewhere in this field, but I had no idea that I'd be able to work on a product so amazing that can really just change the paradigm and stroke care, which affects so many people every year. So, so, I never thought I'd be a business owner. I knew I'd be in the brain somewhere, but this is super exciting. [00:27:35] Alexander Ballatori: Yeah, and for me, I, so I grew up with two rockstar parents. Both came from nothing from, you know, farms in Italy, but both were very naturally gifted when it came to science and medicine. And so my parents actually met while my dad was completing his PhD at the University of Rochester. My mom was finishing up her MD. And they both saw that they had Italian last names, and then the rest is history. And then I grew up in Rochester, New York, and clouds and snow for the first 22 years of my life. But, I was very, whether it's nature or nurture, I was always very drawn to science and medicine, and both my parents actually were both entrepreneurs as well in the medical space. [00:28:13] So my dad was a pioneer in lipid and bile metabolism in the liver and developed a lot of enzymatic targets and a lot did a lot of the early work in understanding bio reabsorption. And my mom is a surgeon with multiple devices under her belt and actually is pursuing, it just gotten one of her products just got FDA cleared at the moment. They're launching right now. So I grew up in a very unique household where this is kind of dinner conversation, but I didn't know what I wanted to do. I knew I wanted to be in medtech. I knew I wanted to some sort of degree in medicine. [00:28:44] And so I took time off after I graduated and I got a degree in biology and chemistry. And so I kind of went into my time off just trying to explore as much as possible. I got my hands on so many different startups. I also got to learn from kind of the bigger medtech corporate world is getting more in respect to the orthopedic world. And so I knew it was for me, but then I was deciding PhD or MD. And for me, I liked kind of the wide breadth of knowledge that you get from the MD because there's so many problems in medicine that need to be solved. [00:29:16] And one of the things that really sticks with me is that this whole definition of "gold standard" or "standard of care," or "this is the best that we got" that I just don't, I don't like accept fully, maybe that's just kind of how I was raised or what, but I knew that I was going to, I wanted to go to medical school because I knew that there were so, there's so much more I could learn with respect to how we take care of patients that is so behind with respect to where it should be and can be, especially when you look at what's happening at some of these top universities, like a Caltech and USC and at the lab or at the benchtop. [00:29:52] So, of course, the PhD would have kind of pigeonholed me into one very specific area that I couldn't decide what I was super interested in. So to tell to go back to your question, if I, if you ask me 5 years ago, if I would be doing exactly what I'm doing right now. No, there's no way. But given my background, given my experience with stroke and then, you know, working with Shane, it just really harmoniously kind of just worked out very well. [00:30:17] And I'm really looking forward to the next few years and seeing where we can take this and then the next one as well. And the next one after that. Shane and I have a very common, one of, one of the we're I keep saying we're crazy. We kind of are in many ways where when a finish something a little bit, when we finish a task and we like finish our to-do list, the next thing we say is not like, "let's go grab lunch or grab dinner or something." It's "alright, what's next? What do we do next?" Right? And so I know the day... [00:30:40] Shane Shahrestani: I'll call Alex at like 6, 7 p. m. and be like, "Alex, I'm itching to do something. Like, just tell me something to do. What needs to be done?" He's like, "dude, you just worked a 14, 16 hour day. Why do you want more work?" I don't know. I just, it feels wrong. [00:30:56] Alexander Ballatori: I was like, Shane, go to sleep. [00:30:57] Lindsey Dinneen: It's all that caffeine. You've got your system wired, ready to go. Oh my word. Oh, that's incredible. Oh, my goodness. So out of curiosity, are there any moments or maybe one moment or whatnot that kind of stand out to you? It could be through medical school, it doesn't necessarily have to be with StrokeDX, but just a moment that stands out to you as saying, "yes, I know exactly why I'm here. This is it." It's reinforced for you: "I am in the right place at the right time doing the work that I really feel passionate about." [00:31:37] Alexander Ballatori: Yeah, you know, I think there wasn't one specific moment, but more so a process over 2022. And being told no, so so many times. And then finally battling through debt, and thank you so much to our lawyers for being very flexible with us on that. But when we finally got the amount of investors that we needed and the amount of money that we needed, everything, just we were on fire. We were so ready and we had such a strong plan. The moment the money came in, it was we were already starting to send it out the door to our engineers to start paying. And we started working that the same day that the money came in, we had a meeting with our engineers to start working. And I think just that transition point from going from trying to sell the mission to actually executing it was definitely a highlight for us. So I don't think there's one specific moment. But I think it was that kind of transition and seeing all of our incremental improvements in our sensor and seeing this device come to life. It's just been, it's, I think it's almost the whole process is really just validated that this is where I'm supposed to be. [00:32:45] Shane Shahrestani: Yeah, I think to the families of people who had a stroke and explaining to them what a stroke is and the prognosis and what's going to happen to their loved one, and then seeing people unfortunately pass because of stroke, and maybe they live too far from a hospital and their life could have been saved if they came in a little bit sooner, or they didn't know that they were having a stroke and they tried to sleep it off and woke up and couldn't move half their body. Right? And the stories go on and on. You see it in every permutation and every variation. But then, at the end of the day, these are people and their loved ones are in the hospital with them and you're trying to keep them alive and all our odds are against you and it's a function of losing brain cells and that is a function of time and efficiency, right? [00:33:41] So a big why is just so much suffering, sadness, loss can be prevented by creating new technologies that can just make healthcare more efficient for people, right? Faster, cheaper, better diagnostics, better assessment tools, better ways to monitor. And you know, that's another reason why I think Alex and I, you know, share that in common and we just work tirelessly just to create new things to just change the paradigm, change the standard of care, make things better for people. 'Cause that's just where our heart and our passion lies. [00:34:20] Lindsey Dinneen: Yeah. Yeah, absolutely. I'm very glad that you both did not let all the no's deter you. I'm glad you were willing to come back to your why and just keep at it. Yeah, that's, that takes a lot of grit and determination, but glad y'all are doing what you're doing. So, pivoting just for fun, imagine that you were asked to teach a masterclass on anything that you want. You're going to be given a million dollars for this. What would you choose to teach and why? It also doesn't have to be related to your industry at all, although it could be. [00:34:58] Alexander Ballatori: I, so my family and my my, just family events and cooking is, and my Italian heritage, is very important to me. And so I, it's, when I'm not working, I'm cooking or I'm spending, I make wine for fun. It's just it's all the traditions from my family. So I think if I had to teach a class, it would probably be sharing some of my family recipes, and also I love to cook and host all the time. So I like have had cooking classes at my house with friends and every year I make wine. It's always a big event and always have people over it. It's a really simple process. It seems so daunting, but it's quite simple, especially when you do it the old world way. And so, yeah, I guess I guess that would probably be mine. [00:35:45] Shane Shahrestani: First of all, I would go to Alex's masterclass. I'd pay however much he charged. I'd be there. His wine is like the only wine I drink now. If I had to teach a masterclass, so there's two things about me that I don't even know if Alex knows. I can identify the

Laura Yecies, CEO of Bone Health Technologies, shares her journey from a tech and marketing background to leading a company that's revolutionizing the treatment of osteoporosis with Osteoboost, a wearable device using NASA-proven vibration technology. Laura's diverse professional experiences highlights her personal motivation to improve people's lives. Her story illustrates a passionate commitment to developing non-pharmacological treatments and fostering better patient support, emphasizing the significance of technology in advancing healthcare. Guest links: www.bonehealthtech.com Charity supported: Equal Justice Initiative Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 026 - Laura Yecies [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm excited to introduce you to my guests today, Laura Yecies. Laura is the CEO of Bone Health Technologies, makers of Osteoboost, which is the first clinically proven, safe and effective non-pharmacological treatment for low bone density. Osteoboost puts NASA proven vibration in a wearable, comfortable, convenient belt form factor. Laura, thank you so much for being here today. I'm so excited to chat with you. [00:01:23] Laura Yecies: Me too. Really happy to be here. [00:01:25] Lindsey Dinneen: Wonderful. I would love, if you wouldn't mind starting off by telling us a little bit about yourself and your background and maybe what led you to the medtech industry. [00:01:35] Laura Yecies: Sure. My background's in business and tech primarily. I went to college on the east coast and after business school, in 1988, I came to California. I grew up in New York, but my husband was from California and so we decided to give it a shot out here for a little bit. And I started working in tech doing marketing, first in enterprise software, relational databases, and developer tools. And then I moved into consumer softwares, started off at Netscape. And when I was at Netscape, I took on larger roles and responsibilities. I was Vice President of the browser division, managing a group of over 200 engineers, and we were responsible for Netscape 6.1 and 7.0 and the Mozilla spin out. I then led the mail team at Yahoo, when we were sort of the number one email provider. [00:02:30] And then I also worked at a tech startup and spent some time at Checkpoint, which is a large internet security company heading up marketing there as well. And then I was CEO of two different tech startups, Sugar Sink, which is a sink and share company, and that's now owned by J2 Global. And then I became CEO of a small company called Catch. We had a note taking app and we were able to sell that company to Apple and the Catch team became the core part of the Apple Watch team. So that was very exciting. [00:03:03] And after that when I was thinking about what I wanted to do next, I worked on some ideas for my own startup with some colleagues and, some things that happened in my life that really drew my attention to healthcare. And also I grew up in a family of doctors, both my parents, two of my siblings. And then at that point, my two older sons were in medicine, and I'd always been interested in that and had a bit of flexibility because of this exit and decided that, I'm gonna, I'm gonna make a pivot. And so I switched and started looking for roles in the healthcare area. [00:03:40] And everyone sort of wanted me to work in more of the pure software side of healthcare more of the billing and receiving and revenue cycle management and staffing and logistics. And that's interesting and important. But I found that I really wanted to work on something that had directly a health or therapeutic or diagnostic benefit for patients. And so I started consulting. I consulted with companies in the genomics field, MS. And then I was lucky to get my first CEO role at a concussion diagnostic company. And that company, now called NeuroSync had great science. I think they went on to get an FDA clearance for diagnosing concussions. But after a couple years, the board and I had different ideas of what to do. It sometimes happens. [00:04:26] And so I left, I spent a year consulting at Achille Interactive and at Fabric Genomics and a couple of other companies while I was looking for my next CEO role, and I was really excited to have the opportunity, just over three years ago, to join Bone Health Technologies. I knew a marketing consultant that had been there and was connected to the company, and as soon as I saw what they were trying to work on and solve and have, frankly really make a dent in this issue of osteoporosis, I was interested. [00:05:01] I mentioned that my parents were doctors. My dad had been Medical Director of a nursing home, and I worked a couple of summers during college as a nurse's assistant. And people seemed, my recollection was that they were in the nursing home typically for one of two reasons: Alzheimer's, or they broke their hip. And, my grandmother had osteoporosis. I'm a small person. It certainly runs in my family. And so I recognized that it was an important problem, a big problem, an unsolved problem. [00:05:30] And so my really, my only question for the company was, does it work? We had this innovative treatment for osteoporosis and the founders shared the data with me. It was not a sure thing, but I found the data to be very compelling and so I joined and we're three years down the line from that point in time. And one of the most important things that's happened is we finished our pivotal trial and we got the results. Now it takes a while to do a trial for osteoporosis, but we had excellent results from the treatment. [00:06:03] Lindsey Dinneen: Yeah. First of all, thank you so much for telling us a little bit about your background. You have such an incredibly diverse background. So many questions just emerge from that, but I would love to hear about your current device and the way that it works and whatnot. [00:06:18] Laura Yecies: Sure. So it's a wearable treatment. It's a belt that has a vibration pack that you wear over your lumbar spine, specifically at the sacrum. And so we're applying vibration to the hips and lower back, and those are to the key areas that experience fractures from osteoporosis. So hip fractures are very life impacting, deadly for almost 30% of people. Spine fractures, you can imagine, are very painful and debilitating. And so we're focusing vibration, which has been proven to improve bone density on the vulnerable anatomy. And, there's a body of evidence from NASA where they did whole body vibration to try to reduce bone loss for astronauts. [00:07:05] So when astronauts spend time in space, they lose bone. And what they proved was that standing on a whole body vibration platform can improve bone density. But those companies that make these platforms, they have very good products. I'm a believer in the science, but those products haven't gone mainstream. They're people that tend to not comply very well with them, and the good ones are expensive. And so we're aiming to take this proven science-- and by the way, before NASA did the whole body vibration studies, there's a lot of studies in animals and cellular research showing the same thing. There's really a lot of science to support this. [00:07:45] But our device, we aim to solve the ease of use challenge by making it something wearable. And then most importantly, the vibration is applied locally to the vulnerable anatomy. So that's what we do. And what we showed in our pivotal trial is that we reduced bone loss by over 80%. So we measured the lumbar vertebra with a CT scan at baseline in one year. And the patients who were on the active treatment lost about a half a percent of their bone strength. And those on the placebo or sham treatment lost just under 3%. Our patients, we kept them clinically, essentially stable and slow this bone loss so you don't outlive your bones. [00:08:29] Lindsey Dinneen: Wow. That's incredible. I am. . I . I say this a lot and I know it's used as sort of a more tongue in cheek manner, but for real, what a time to be alive. That is so cool how so much innovation is just constantly coming through and the, there's this, people like you are doing this incredible work to bring new devices that are really impacting patients' lives. So that sounds like incredible results. You guys must have been thrilled with those numbers [00:09:03] Laura Yecies: Yes. And this was really our first attempt. We had done a pilot study, but this was our first one year study and we just applied for a grant to do another study with in basically a longer treatment duration, essentially a higher dose of vibration. So from my point of view, this is a great result, but this is like the beginning. [00:09:26] Lindsey Dinneen: Yeah. Yes, which is so exciting too, because it just leaves room for so much more as you continue to go down this path. So that is exciting. And so that's your next step. I'm imagining, is this, next level of treatment and what do you envision the company to, to do or be doing in say, three, five years from now? [00:09:50] Laura Yecies: So in three to five years, my goal is first of all, that we have this device very widely used in the market or with patients. So there's 52 million patients with osteopenia and other 12 million with osteoporosis. Our trial was for patients with osteopenia, and so there are a lot of patients out there who I think would benefit from this device. We also want to start to develop a relationship with those patients. Not just sell them a device, but support them in their overall bone health optimization. So we today have created an OsteoBoost application. So we help patients remember and comply and we remind them and give them encouragement to use the device. We help them get the optimum amount of calcium by tracking that exercise. [00:10:41] And then, our vision is to add community and other elements of optimizing bone health and potentially to have other services. We never wanna get in the way of a patient's relationship with their doctor. So if their personal physician is supporting their treatment of their bone density issues, that's great. But in many cases they're not. And so we wanna have services available for that as well. And it's interesting if you look in the app store or look at a lot of startup activity, there's many companies doing these kinds of solutions for diabetes or cardiovascular disease or asthma or depression, but there's really not much out there for bone health. And yet it's really a key part of staying well and independent and living, living healthily, and it's such a common problem. So we're excited, that we have something unique, yet very much needed and not in a, in a small group it's not a rare thing. It's very common. [00:11:46] Lindsey Dinneen: Yes. Yes, absolutely. And is your plan to sell directly to the consumers or will you be going through, insurance companies, doctors, whatnot, or do have you gotten that far yet? [00:12:00] Laura Yecies: We haven't finalized the details of that. So we're not ready to share them. But but what I will say that I think we are quite certain about is first of all, it is a prescription device, so there will be a doctor involved to write prescription and some of the details, and we will certainly have a way where the personal physician can write that prescription. We may have some other options for patients, but a doctor's involved, which is appropriate because they have a condition that puts them at risk of fractures and other health issues. [00:12:34] But the other thing that I am confident about is that we are going to want to appeal to patients to generate interest. We have seen tremendous inbound interest into the company with not a lot of marketing. I mean, I've done things like this podcast and I speak at conferences, but we have not spent money on advertising or things like that because the product's not on the market yet. And I hear from patients all the time, they are searching for an innovative treatment. They're searching for ways safely to slow their bone loss. I, I'm a member of a number of Facebook groups for osteoporosis and hear how patients talk about this, and so I believe there's tremendous interest by patients and that we wanna tap into that to build the business. [00:13:24] Lindsey Dinneen: Yeah. Yes. And part of the reason I brought it up, the question in the first place was exactly for that reason. I was thinking there's gotta be so many people who are searching for a solution and yours is so innovative and accessible. I'm so excited to see where it leads. Yeah, that's gonna be incredible. And it really struck me, you talked about your background being heavily in marketing back in the day and so obviously those skills are still very present today. So it's fun to see how, elements of things that you've done throughout your life will lead to this success, in this next endeavor. [00:14:01] And I'm actually very curious also. yoU talked about some really amazing positions that you had, and then those led you to have these CEO roles. So I'm curious, how was that transition for you stepping into your first CEO opportunity? Was that exciting, daunting, energizing? How are you feeling in those moments? [00:14:25] Laura Yecies: Those, you captured many of the feelings. So you know, a bit of context. So it was the very end of 2008. And so the world from a financial markets point of view was kind of falling apart. I had led large groups. I had been a general manager, but I'd not been CEO. I had never raised money before, and so I stepped into a company that had been through some trauma. They were supposed to be acquired. The acquisition, the plug got pulled out because of the markets collapsing. The founder had left before I got there. So it was, the company was really in a crisis, I would say. The employees were very afraid for their jobs. We didn't have money and, the financial markets were terrible. It was really challenging to go in and stabilize things and kind of pull the team together and then, build the business in a challenging environment. [00:15:23] Existing investors gave us some runway, but it was limited. They had already kind of been in investing quite a while, and so I had to find outside money, which in 2009 was challenging. But it was exciting. I loved the product that I was working on. I had been a user of it. It was something that was in my wheelhouse of, I had worked quite a bit on productivity tools for workers and business people and consumers. And, and I, we had great technology. So it was exciting. But it was It was intense. But we built that business. When I joined we had essentially zero revenue and we got to essentially in the 20 million run rate in four years. [00:16:07] Lindsey Dinneen: Wow. [00:16:08] Laura Yecies: That was great. [00:16:09] Lindsey Dinneen: Yes. That is great. That is kudos to you and your leadership for being able to step into such a challenging situation and it around. Yeah. [00:16:19] Laura Yecies: You know, one thing I learned then, because we did have all these challenges, but we also had a market where the latent demand and need was growing. It was a rising tide. Just to be specific a bit-- and then I'm gonna give an analogy to bone health technologies. So at that time we had a sink and share solution. We were a little bit more niche, but you could think of it as it was quite similar to a Dropbox or a box.box, what was then box.net, and that was also the time that iPhone sales, laptop, Netbook sales were growing very quickly, and so the need to get your data into the cloud was I mean, you could argue that it was always useful to be able to access your data remotely. And there, there were always kind of some niche solutions like, Go To My PC. [00:17:12] But suddenly, because the environment was changing where people were having these devices the market demand and the market opportunity was growing. Okay, so fast forward, oh, 14 years, 13 years, and osteoporosis and osteopenia is growing. But the other thing that's growing is awareness. And our target demographic, postmenopausal women, I'd say our typical patients are in their sixties. I don't know, what's the joke? Sixties is the new fifties or the new forties. Like these are women who wanna stay active, right? They may be still working if they're not working. They're very involved in the community, they're very involved with their family. They may have, they may be at a point where they've educated their children, they've saved some money, so they have disposable income that they want to take care of their health. And so it's a demographic that spends money on their health. They also are very social and community minded. [00:18:16] Let's imagine a six year old woman with osteopenia and she's going on a hike or a walk with her girlfriends. What are the chances that her female friends also have osteopenia That's probably 80%, right? If similar in age, and so I see this set of patients and who we're going after as being very interested in safe non-pharmacological solutions that are easy to access. You can call it the Amazon effect. They're used to things being convenient and seamless. And they, they want this type of solution to help them stay kind of active and healthy and be in a way preventative of the need for medication. So I see this as in a very different way than Sugar Sink, still a rising tide market. [00:19:08] And oh, by the way, at the same time talking about health concerns related to menopause is suddenly, and as it should be not just socially acceptable. It's a hot topic, right? Oprah, Michelle Obama, Gwyneth Paltrow, they're all talking about menopause symptoms. And by the way, osteopenia is very much a result of menopause. You're losing bone density slowly typically starting your thirties, but in the five years after menopause, there's rapid bone loss, and that's typically when women get into that osteopenia stage. [00:19:44] Lindsey Dinneen: Yeah, absolutely. [00:19:46] Laura Yecies: Oh, by the way the women who are in their sixties today, when they were going through menopause 10 years ago, or 12 years ago, or 15 years ago, they were told no. Hormone replacement therapy unless you're completely miserable because of findings in the Women's Health Initiative. And that pendulum has now swung back to a more moderate position. But today's 60 somethings are less likely to be on HRT or to have even been on HRT, so they're more likely to have bone loss. [00:20:21] Lindsey Dinneen: . Yeah. And. Speaking of this, and you were talking about thankfully, there's much more awareness, there's much more conversation happening about women and menopause and going through symptoms and whatnot. I've just been reading lately how much it is still a struggle despite that for women founders, especially of medtech companies to get the funding that they need. And I'm curious, what was your experience when you were fundraising, what were your challenges? What were your triumphs and maybe even suggestions for other women founders who are gonna be going through this soon too? [00:21:01] Laura Yecies: There's no controlled experiments on these questions, right? So if my fundraise on a difficulty from zero to 10 was a seven. Right? Would it have been easier or harder if I were a man? I really don't know. I know that women, there's less funding going to women, but I have felt that, at least for this company, I don't have any reason to assume that to be the case. If anything. I believe that investors, many of them, they even talk about this, they're looking for founder product or founder market fit. And I'm not the founder of the company. I was brought in as CEO after it started, but I feel like a founder. I operate that way. This is my adopted child. And I love it no less than if... [00:21:56] Lindsey Dinneen: Yeah, of course. [00:21:58] Laura Yecies: ...if I gave birth to it. [00:21:59] Lindsey Dinneen: Right, right. [00:22:00] Laura Yecies: I am a user of our product, right? And I empathize with very deeply and connect with our patients. And I think if a, a 25 year old man were sitting in my shoes trying to raise money, maybe he would've even had a harder time. So I, I know. I don't know. Women's health has been under invested in, I believe it still is under invested in. And why is that? It's very hard to tell. I will also say that devices are a harder field to raise money for, independent of gender. There's more investors investing in digital solutions or pharma than devices for a variety of reasons. The size of the device investor market has shrunk. [00:22:51] And I think that's unfortunate and because I think there are a lot of solutions that are less invasive, less systemically invasive. Osteoporosis or osteopenia is one example. But we see devices for other women's health areas like pelvic prolapse or stress urinary incontinence, or a number of things that are of concern to women, but also things that affect everyone like migraine and these device solutions are very safe. They don't completely replace pharmacological solutions, but I think it's really important to have other options and so I do think it has been challenging, especially in the early stages in that field. [00:23:37] Lindsey Dinneen: Yes, exactly. Yeah. But I thank you for your perspective too. It is, I think quite refreshing to hear from somebody who was a woman who went through this raising capital and actually did have a really good experience, 'cause you hear so many of the opposite, so sometimes it's easy to go, "oh gosh, it's not changing fast enough." But it is so encouraging to hear from somebody who has had a really good experience, so I appreciate your telling me about that. [00:24:03] Laura Yecies: Yeah. And for women's health if most of the investors are men, a good investor should be able to appreciate concerns outside of their personal experience. But I think human nature is such that we tend to connect with problems that we've had. And so the fact that most of the VCs and investors are men makes the whole women's health field, I think, more challenging for fundraising. But we'll see. That's changing too. [00:24:35] Lindsey Dinneen: Yeah. Absolutely. Yeah. . So what are some things that you are excited about, either personally or professionally in the coming, coming couple of years? What are, what's gonna, what's gonna get you up and ready to just tackle the day? [00:24:52] Laura Yecies: Yeah. It kind of goes back to what we were talking about before that most of my career I've spent more on the commercial and marketing and sales side. And since I've been at BHT, we've been very much in sort of science and research mode, which has been very interesting, fascinating. I've enjoyed it, but I'm really looking forward to this next phase where we can get the product on the market. I mean, I hear from patients multiple times per week. "When is this gonna be available?" And I don't like saying "it's not available today." [00:25:27] Lindsey Dinneen: Yeah. . Yeah. [00:25:29] Laura Yecies: I wanna say today, and that feels tantalizingly close. I'm very much looking forward to that. And, first doing it at a small scale, we have a waiting list of patients. And I wanna, kind of put a shout out on that. We will first go to the waiting list. To make the product available and people can sign up at bonehealthtech.com and the front of the line are the patients who, the citizen scientists who participated in our pivotal trial, and they're, we have another trial going on. They're first in line. They have contributed so much and did it really out of a total generosity of spirit. They had minimal compensation. And then of course to get to the next level of, hitting the gas and growing the availability and distribution of the product. I'm imagining, I talked about hiking before and that's because I love to hike and I'm imagining, osteo boosting hiking groups or something like that. I know that sounded corny, but. [00:26:27] Lindsey Dinneen: Oh, I love it. . No, it's fun. And that is so exciting. I am really cheering you on as this next phase comes to reality. That's, yeah. That's incredible. Pivoting just for fun, imagine you were to be offered an opportunity to teach a masterclass on any subject you want. It doesn't have to be in your industry, but it can be, and you'd get a million dollars for doing so. What would you choose to teach and why? [00:27:00] Laura Yecies: I think I would want to teach around marketing and commercialization, sort of product management, and then really the full life cycle of bringing products to market. I've been doing it for 35 years. I hate to say that. Sounds like a long time in various formats. I mean, I've, some of it has leaned heavily on the digital marketing. Some of it has been more B2B sales, business development. So I feel like I've spent a lot of time in that area and I have lessons learned to share. I actually enjoy teaching. I spent some time, when I first came out to the Bay Area, I taught marketing at Santa Clara Business School. I enjoyed it, but I enjoyed working in the marketing field more, and I had young kids, and so between a full-time job and kids, there wasn't also time for teaching. But I would love to get back and do more teaching. And I do executive coaching and I informally coach and that's a very rewarding part of my job. [00:28:07] Lindsey Dinneen: Yeah, absolutely. That sounds like a great masterclass and very needed. So we would sign up for that one. [00:28:13] Laura Yecies: Thank you. [00:28:15] Lindsey Dinneen: And how do you wish to be remembered after you leave this world? [00:28:22] Laura Yecies: Oh I mean, I'm a family first person and I am lucky to have great husband, four kids and today's six grandchildren. And the first thing that goes through my mind when you ask that question is, to have had just a really positive impact on them and the other family members and friends in my life. And then, work-wise if this device or our solution is effective it provoke small changes, but in our field, small changes over time can have big results. And, if we've prevented fractures and help people, I would be really honored to be able to be known for that. [00:29:00] Lindsey Dinneen: Yeah, of course. And final question. What is one thing that makes you smile every time you see or think about it? [00:29:10] Laura Yecies: My grandchildren getting to play with 'em when they want, when they come through the door every Friday. [00:29:16] Lindsey Dinneen: Aw. [00:29:17] Laura Yecies: We have a family dinner almost every Friday night. And I look forward to it all week and when they walk through the door. So that's my mental image and I for sure smile with that one. [00:29:29] Lindsey Dinneen: Oh, I love that . What a great tradition. And I, it's so lovely that all your families, or at least some of your family, is close enough to be able to do that. How fun. [00:29:40] Laura Yecies: Yes, it's really fun. It's fun. And I grew up with that so I'm trying to continue, with the next generation. [00:29:47] Lindsey Dinneen: Yeah. Yes. That's fantastic. Laura, thank you so much for joining us and sharing about yourself, your background, and the incredible work that you and your company are doing. I'm so excited to see it come to market and just really impact lives. Thank you for the work you're doing. [00:30:06] Laura Yecies: Oh, my pleasure. And thanks for the chance to share it with people and for inviting me onto your show. [00:30:11] Lindsey Dinneen: Of course, and we're so honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongfully convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So thank you so much for choosing that charity to support. We just wish you continued success as you work to change lives for a better world. [00:30:40] Laura Yecies: Thank you very much. [00:30:41] Lindsey Dinneen: Thank you, and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:30:55] Ben Trombold: ​ The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Richard "RJ" Kedziora, co-founder of Estenda Solutions, dives into the inspiring world of digital health solutions, where innovative minds are not just developing technology, but also saving and improving lives. RJ shares his journey from early software development days to creating impactful healthcare technologies, highlighting the importance of understanding patient and provider needs. With a focus on people and process management, RJ's story is a testament to the power of technology in making a tangible difference in healthcare through human compassion and the drive to better lives. Guest links: https://www.linkedin.com/in/rjkedziora/ | https://estenda.com/  Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 025 - Richard "RJ" Kedziora [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to welcome as my guest today, Richard "RJ" Kedziora, co-founder of Estenda Solutions, focusing on people and process management which also provides strategic technical direction, guidance, and innovative insights, creating digital health solutions that improve patient outcomes, reduce costs, increase efficiencies, and improve patient provider satisfaction. RJ received an MBA from Westchester University and a BS in Computer Science from Duquesne University, where he received the excellence in computer science award. RJ is a frequent podcast guest, has spoken at numerous technology and healthcare conferences, and has coauthored articles in technology and peer reviewed clinical journals. [00:01:37] Welcome to the Leading Difference, RJ. And RJ, I would love if you would start by telling us just a little bit about yourself and your background. [00:01:46] RJ Kedziora: Yeah, Lindsey, thanks for having me. It's a pleasure. I look forward to our conversation. My background is through software development. Graduated with a computer science degree back in, in the early nineties before web and mobile and internet. So crazy days. And came up through those software development racks. Started out programming, got into requirements analysis, understanding what a solution is about, project management, general management. And then in 2003, with a good friend, we were working with together at a large consulting company in the pharmaceutical space, we went off and started our own company called as Estenda Solutions and remain there today. We just hit our 20th anniversary, which is always crazy when I can talk about decades, but it has definitely been an interesting journey. So my day to day is, I think of it as a digital solution architect. So helping a mix of large companies and small companies, startups develop tools, technologies, algorithms, better ways of looking and dealing, handling data, to make a difference in the lives of people. [00:02:56] Lindsey Dinneen: Wonderful. That's incredible. So 20 years. Congratulations. That's no small task. . So I commend you for that. That's really exciting. I. Yeah. So how did the idea to start your own company come into being? Did you identify a gap basically in the market? [00:03:15] RJ Kedziora: It's something probably even early on as I was graduating from college, always in, in the back of my mind to make a difference, to go off and try something new and really drive what I wanted to do. Even before starting my own company, as I worked in various different roles, I'd be hired by a company, I'd come in with a defined role, and then I'd always just find a niche. They'd be like, "okay, where does this company need help? Where can I make the biggest impact?" [00:03:40] And that's how I went from software development into like more of the analysis and project management , 'cause I quickly realized software development, developing a digital product, it, you know, technology is important and you have to understand how to program and how to test, but it's very much about the people, the process, understanding what they're going through, and realizing those things. It was sort of a natural evolution of like, "okay, I need to strike off on my own and really drive projects and things like that with my talents and capabilities and now our team's talents and capabilities." [00:04:17] We were fortunate in those early stages to have a Congressional grant for the development of a diabetes disease management application for military healthcare. That's how we got our start. So we worked with people like Walter Reed Army Medical Center, the Boston VA, the Indian Health Services, which is responsible for the Native American population here in the United States. Still working with 'em 20 years later, which is crazy that we have 20 year clients-- bunch of other clients that we've been working with, 10, 11, 12 years a across the board. So, it's been enjoyable from that perspective. [00:04:53] And I always talk about, I've developed accounting systems, I've developed inventory management systems. And even a railroad car scheduling system, it's like, "Hey, great. We need to get that railroad from here to here. It's important!" You know, it's essential and the economy's important. But healthcare, there's that sense of giving back, of making a difference. [00:05:16] Lindsey Dinneen: Yes. Absolutely. Yeah, I, that is one of the things that I really enjoy about being in this industry is you're right all of those things matter that you could do with your skills, because obviously you have those skills and can use them in all sorts of capacities but in healthcare and med tech, it's this really great extra layer of feeling like you really are able to impact people's lives directly. And it, it just, it has a different sort of feel to it. [00:05:46] RJ Kedziora: Yeah. And our projects are typically on the R&D side, work, working with the R&Ds, working with academic medical centers, work with PhDs, with doctors, where they'll have an idea. It's like, okay, here's a different way of treating a patient with diabetes. A different way of looking at the data that you can collect around diabetes or other chronic conditions. I, I wear the Aura ring. It's there's a lot of data that's available there now. And so as we develop those solutions, it's one thing for us and the doctors, the PhDs, the corporations we work with to say, "okay, yes, this really works." But they, you know, they have to go to clinical trial. They have to go and do, they work in the real world. So we also have a couple PhDs on staff to help drive those discussions and do the planning around those clinical trials. [00:06:34] And ultimately, in certain situations, things then have to go to the FDA to be approved and validated. These days, there's a new terminology called digital therapeutics that we're getting heavily involved with. It's a relatively new term, probably 2017, 2018 that came around. And if there's probably 300,000 digital health applications out there. Systems, you know, some of which we've helped create over the years. But there isn't extensive clinical evidence that they work. There's some, but not extensive, and I think of it as the difference between, supplements and prescribed medications. And so there's lots of supplements out there. You can go to your CVS, your Rite Aid and pick them off the shelf, and there's some evidence they might work, but the evidence isn't exactly clear. [00:07:25] But then you go to prescribed medications, go through a very extensive, rigorous process of development of clinical trials, and then the FDA or other global regulatory bodies look at these and say, "okay, yes, this does make a difference." And that's the idea of digital therapeutics today is there are lots of digital health applications out there, but now people are taking these digital therapeutic applications: evidence-based, clinically validated, approved by regulatory bodies that can be prescribed by your doctor, by your provider. And more importantly than reimbursed by the insurance company. So making a difference. [00:08:05] You know, and we talk about health, healthcare, and being able to make a difference. There's not enough healthcare professionals out there, particularly in mental health. There's a mental health crisis in the United States. We just can't train enough people fast enough. Digital health is a way to approach that, to scale, to increase access and equity to these systems, to the care and treatment people deserve, and so that's the idea of digital therapeutics. They can get out there, provide this treatment, share the information with your provider, and make a difference. [00:08:38] Lindsey Dinneen: Yeah, absolutely. So what does it look like when somebody comes to you and says, "Hey, I have this idea for this app, for this software, whatever." And then how does it work when they start approaching you, and this is a brand new, never before , you know, project and you step alongside them. How does that work? [00:09:00] RJ Kedziora: Yeah, it is. It is a great question. And we work with a mix of Fortune 50 clients, so big customers, global customers, lots of people, processes, technology. We do happen to be ISO 1345 certified, which quite simply means we have a, well-developed quality management process of how we do software development, very template driven, process driven. It's like, here's how we're going to do it, and then we demonstrate that we do it. We get audited regularly by external third parties, by our clients. [00:09:32] But then we also work with startups who, in some cases don't really understand software and don't understand regulations and what's required to create one of those digital therapeutic applications. So when a customer does come to us in the, in those early stages, it's very exploratory. It starts out with prototyping understanding the problem in the domain space. One of the things that differentiates Estenda from a lot of other companies is we are going to provide the entire development team, software developers, QA from the ground up, educational training, medication training. So if you're working in diabetes or congestive heart failure or lupus, multiple sclerosis, the better the entire team can understand the condition, have empathy for the patient, can understand the provider, the care professional's journey about what they're dealing with and how they can care and treat that patient, the better off they're gonna be. [00:10:27] So it's those early stages of experimenting and playing and we start with, you know, black and white wire frame diagrams and really get those going and gradually build them up. And I think about it as you, you have a problem and you want to get across town as fast as you can from one end to the other, and you can walk. Great. Okay. But it's not very fast. Okay? I have this idea for a car. I can get across town really fast, but it's gonna take a long time to build that car and realize value. So, let's first build a skateboard. Very simple, can do it very quickly, provide value, get feedback, from the stakeholders, from the customers, from the patients, from the doctors, the nurses, whoever we're developing that application for. [00:11:15] And so you figure out the unknowns, you know, so what, aren't we sure? What areas are showing promise? So we build that skateboard and then it becomes a scooter with a handlebar, you know, okay, I'm getting across town faster. It's not the ultimate goal. But I can get there. And then you can build a simple motor on it,, and then you build a body around it and you progress gradually until you get to that car. But along the way, you're adding value very quickly, which is important. [00:11:47] Lindsey Dinneen: Absolutely. Yeah, that sounds like a really good process to work through. And I love your illustration. That's such a great way of capturing the essence of the process and the way that you go through all of that. So, I'm curious, have you always had an interest in and passion for computers, technology, software development, or is this something that evolved over time? [00:12:08] RJ Kedziora: Yeah, I was very fortunate. My parents were able to buy an IBM PC Junior when I was in probably seventh grade in the mid eighties. I went to a local parochial school. They had a computer lab, you know, as one computer in the classroom. But, for the eighties, that was phenomenal. And so I knew going into college that I wanted to do software development. A good friend had a Commodore 64, which is typically a gaming, and so I'd be over there and it's like, "okay, games are fun, but what can we make the computer do?" You know? So I was very early driven by what can I do and the possibilities of digital everything. [00:12:49] College, I really thought I was gonna go and get the PhD in artificial intelligence. Very much enamored with that idea. Ultimately as I got ready to graduate, I got offered a job and was like, huh, money and so that, that turned my, you know, immediate trajectory there. You know, I did start working in programming kind of thing, but always followed AI and things and applied those ideas and principles and what AI is, has evolved a lot over the years. We've developed some AI systems in the past, but you know, now when you look at them, they're really like rules engines, and think things of that nature. And they were considered AI at the time, but nowadays it's like, "okay, that really wasn't AI." [00:13:36] But you know, the idea is, and the principals were there, and one of my senior thesis projects was genetic algorithms and how do you apply the idea of genetic algorithms to solving computer problems? And that was at the early stages of the internet kind of thing, just as a browser were coming out. So that made research interesting 'cause you could even at that early stage reach out globally to people and seek ideas and thoughts and stuff like that which led me down that road. But fast forward 30 years now and AI is everywhere. It's all that, that the media can talk about these days. Rightfully so. [00:14:15] Lindsey Dinneen: Yeah, and actually that brings up a great question that I had for you, because I did notice on your LinkedIn, you do share a lot of articles about AI, and you're obviously very involved in that. How have those tools helped your work or how has it changed your work or whatnot? How do you feel about all of that? [00:14:33] [00:14:33] RJ Kedziora: It really comes down to data. That's the core of AI. In the past and today, you need data to be able to train the AI systems to do what they're capable of. And it's interesting, our journey as Estenda is, as I've been reflecting on it was one of data scarcity. You know, 20 years ago, getting data was the difficult challenge. In diabetes, it was typically finger sticks, and people would, you know, do it a couple times a day and EMRs were there. They existed. We were lucky working with government organizations that had them, the military, the VA had them. Now it's, you know, fast forward 20 years later, there's an overwhelming amount of data. So early on it was like, how do you make decisions with limited data? Now it's like, okay, how do you use all of this data and pick out the important, salient things to be able to make decisions on and drive recommendations, [00:15:29] And the same thing is true with AI today. As you're developing a system, you need a robust set of data to train the AI systems. The broader data that you have, the better off you're gonna be. Day-to-day. I think today, generative AI, you know, the Chat GPTs, the Bards, what everybody's really, the media is talking about are amazing. You need to know and understand how to use these tools today. And it's not so much where they are today because there are challenges, there are problems, you know, they make up stuff. It's called hallucinations. And so you do have to fact check what they do. It was interesting is I was sharing, we do a monthly all staff meeting kind of thing, and I was sharing my experience with chat GBT and one of the people on the call sort of googled, like, tell me about Estenda. And it made him the president of the organization kind of thing. It was like, he's a great guy, does amazing work us, he's not the person. And it was just one of the odds of that, in that moment, kind thing. It was like, yeah, that's not true. [00:16:34] Lindsey Dinneen: Right. [00:16:34] RJ Kedziora: So you do have to fact check it. But that's today and where we are. And so imagine where we're gonna be 10 years down the road. And Bill Gates said a long time ago, "Humanity overestimate what technology will be capable of in, in the 18 months, two years, underestimate where it's gonna be in 10 years." And I think about Estenda, if the iPhone didn't exist, Facebook didn't, Instagram, Twitter, X, none of these things existed when we started, and here we are a short 20 years later and the world's changing. In terms of AI now it's really an efficiency thing. And it's like, "okay, I need to do some blog posts." And yeah, I can sit there and come up with the blog, post ideas, but it's like "Hey, ChatGPT, gimme 10 ideas for blog posts," you know, and I might not like four of 'em. Okay, "gimme four more." I don't like this. "Gimme four more." [00:17:29] You know, and it's just, it's an efficiency thing. Even in healthcare, that's what we're seeing. So there are, a lot of, I think it's over 400 now, approved, FDA approved AI algorithms very much in the idea in the area of radiology and looking at images. That's by far the biggest use of . Today, if you have those images, you can train systems to recognize certain things, you know, whether it's breast cancer or diabetic retinopathy. You can train systems to recognize what you need to see in those images instead of a person looking at them all the time. So, again, you can scale much more effectively, which is nice. But in, in healthcare it's very much, it's that efficiency question. [00:18:09] Lindsey Dinneen: Yeah. [00:18:10] RJ Kedziora: It's like, okay, I know how to write a prior off letter for this patient, but that takes time. So have ChatGPT write the prior off letter. And then you as the physician, the trained professional, have to look at that and evaluate. And you can't just send it off. You do have to look at it, but you know, EMRs, there's a plethora of data in the EMR. Let the AI systems... [00:18:35] Lindsey Dinneen: Yeah. [00:18:35] RJ Kedziora: ...you know, surface what is important, is a challenge. EMRs is a general idea, are very much around capturing data for billing, not the best, usable experience. If you can use AI that's just listening in the room to then document that encounter, that provider's now not heads down on the computer typing, trying to make sure they get everything in and not looking at the patient and not paying attention to the patient. [00:19:02] Lindsey Dinneen: Right. [00:19:03] RJ Kedziora: It can reverse this kind of thing. It's like, okay, the doctor can now pay attention to the patient and look at that person and really understand their situation better and pick up on those cues of just their body language kind of thing, and not have to worry about typing away at the computer. And then there's a lot of duplication in clinical records. So it's like, let the AI systems get rid of that duplication, make it better. And then just, you know, enhance. And I saw an article, I think I posted about it, the idea of collaborative intelligence, but a lot of people are asking is, AI going to replace Doctors, software programmers, software developers, insert profession X, is AI gonna replace it? And then people are like, "AI is not quite there. AI makes mistakes. It has biases. AI Hallucinates." [00:19:50] I love my doctor, but my father has said over the years, " the doctor that graduates last in his medical school, what do they call him? Doctor!" You know, they're human. That, and that's what it amounts to. It's, they provide a great service, but they're human too. And they might not recognize everything. And so if we work collaboratively with the AI to balance that out we can improve overall care and treatment. So. [00:20:18] Lindsey Dinneen: Yeah, so a lot of potential for it, and I love your idea of using it for some of those more tedious, time consuming tasks and just giving you your first draft because it's not, like you said, it's not gonna replace the human. Let's look through this. But it can help. And if you're using it appropriately, there's a lot of good uses for it too. So, yeah. So, you know, there's a couple of things that I noticed from your LinkedIn profile I'd love to chat with you about. One of the things that stood out to me was in your headline, you mentioned Chief People Officer as being most important. So I would love if you would speak a little bit to that and why you feel that way. [00:21:00] RJ Kedziora: I can do a lot, but I can't do everything. So I, the people that work for us are very important. I can make an impact. A team can make a much bigger impact. A company can make an even a bigger impact. So that is, that's why they are important. I talk about family first a lot. And, we provide fully paid healthcare benefits for you and your family. You want to have that sense of safety, want people to feel that they can take risks, and do their best work kind of thing. And the better they feel, that emotional safety, that the better off we're gonna be as an organization. They'll be able to provide more value to that customer, be more productive, 'cause ultimately that's what it amounts to is we need to get software out the door. We have customers and clients that have needs and demands and we have to meet those, but you know, you have to balance that with life. So. [00:22:02] Lindsey Dinneen: Yeah, absolutely. And I love the emphasis on people first, and I'm, I'm wondering if that's something that, is that an ethos that developed over time for you as well as how did your leadership skills evolve? Because going from starting a business to then and then growing it, I mean, it's a whole thing. So, yeah, I'd love to hear a little bit about that. [00:22:24] RJ Kedziora: Yeah, it definitely has grown and evolved o, over the years. It there, there's this concept of being a 10x software developer, one person making the impact of 10 people. And that's somewhat of a myth, but there are people that are more productive than others. And the idea of empathy and understanding that other person's perspective and experience is what's driving to that next level to become that 10x developer. You're not developing for yourself. You're developing for the end user, but we embody it in, we have a professional development process, and the idea of helping others is embedded in that. [00:23:01] You'll see that we do one-on-ones, not as great, as frequently, as I would like. But we try and do those. But as part of our structured plan, we do a self-assessment and we ask everybody that question, "how have you helped other people?" as part of the goal process, "how are you helping others?" But even as you're developing in that day to day when you're writing code, "how is it helping you in the future understand what you're doing? How does it help the tester better test that software? How does it help the support person provide better support?" [00:23:37] So it's really thinking about how you're helping others along the way. And ultimately the whole company is driven by that of working in healthcare. But it starts at that bottom of every person. It's like, "how, what you're doing, helping the next thing?" So we try and constantly reemphasize that when we can. [00:23:54] Lindsey Dinneen: Yeah, that's a great approach. And so, and because that is so much the heart of your company and your people, I'm curious if there's any particular moment that stands out to you as you've gone along this journey, that kind of really reinforced, yes, this is why I am here doing this work. Is there anything that, or a series of moments, just things that really stand out as being a very sure "yes, this is correct" for you? [00:24:20] I [00:24:21] RJ Kedziora: Yeah. It, I would say it's more a series of moments, because as we've developed software and then it's used by the care providers or patients, we've constantly over the years, hear those anecdotal stories of "Hey, I was using your software, what you developed for us, and found this and helped this patient." There's a series of those, but then it even goes up, it bubbles up that we do those clinical trials and we've done five year NIH funded National Institutes of Health funded RO one study. So it's like a five year study to then demonstrate that the software we produced does make an impact kind of thing. [00:25:00] But even more importantly, as we're part of that process, we've had several customers put our names, our developers' names on patents, or as those articles have gone to clinical journals, peer review journals that our software developers and QA, other staff have been authors on those. That, that's just rewarding where, okay, yes, we are helping people, but then our customers are also recognizing how much of a part of this journey we are. You know, if you really know what you wanna do and have it, here's my 10 requirements kind of thing. We're probably not the company for you. Let's explore and create something together. [00:25:38] Lindsey Dinneen: That's really cool. So it's always a collaboration it sounds like with your clients. It's not just a one way or the other, them dictating to you or you dictating to them. It's this, let's figure out the best way for us to work together. [00:25:50] RJ Kedziora: Yeah, it says how do we add value? How are we, you know, we want to contribute. [00:25:56] Lindsey Dinneen: Yeah. That's amazing. Yeah. So, one other kind of random question. Based on your LinkedIn profile, when's your next triathlon? [00:26:04] RJ Kedziora: How much time do you have? [00:26:06] Lindsey Dinneen: Yeah. [00:26:06] RJ Kedziora: I, yeah, that's a whole 'nother podcast. [00:26:08] Lindsey Dinneen: Yeah, sure. [00:26:09] RJ Kedziora: I think I'm, I think I'm, I think I'm done for this year. I live in the Philadelphia area, the temperature's getting, yeah, temperature's getting a little colder and that type of thing. But, you know, take a little rest for a month or two before I get back into training. And, but there are definitely ones I do every year. There's one escape from Cape May, Cape May, New Jersey. You jump off the back of a boat, the ferry, into the ocean and swim to shore. I did escape from Alcatraz two years ago, which is interesting because they take you out in a boat, in, into the. And jump off the boat from Alcatraz and swim to shore. Always interesting kind of thing to, to do those, but it's very much-- it's interesting because my day-to-day at Estenda, my own company, and how I get involved in projects is 'cause I enjoy the challenge of it. [00:27:00] And in triathlon, yes, there, there's a definitely a physical aspect of training and, but it is also very mental to, and that's really what I think drives me in the sport of triathlon. It's like, "okay, I need to get up at 4:30 and go jump on the pool and swim for 45 minutes and then hop on a bike" time and time again. And I thoroughly enjoy it. But yeah, it is that mental challenge. I've done just pure marathons in the past and it's like, "okay, get to the next telephone pole. Get to that next half pot." It's that mental, keep pushing kind of thing is drives me. [00:27:34] Lindsey Dinneen: That's incredible. It just reminds me-- tangent very quickly-- it reminds me, I remember I was running a 10k with my husband and I'm not a runner, I don't claim to be, but I was doing this challenge for myself, and I just remember we, we were getting close and I was so exhausted and, you know, kind of miserable at that point. And he was like, "it's all downhill from here. It's all downhill." And I was like, "it's literally sloping up!" [00:28:00] RJ Kedziora: Yeah, but it's, you know, it's like, yes, for me, try, it's hard. It's difficult kind of thing. but I'm also good enough that I'm not out there it's like, for a a marathon, I can-- in the past it was like 3:20 for a marathon. [00:28:16] Lindsey Dinneen: Wow. [00:28:17] RJ Kedziora: But there are people out there that are five hours, six hours. I think that is so much harder, so much dedication for that individual to be out there for five hours. It's kudos to you for being out there for, you know, it's like, yeah. I'm not saying I, I have an easy time of it by any means, but I'm not out there for five hours and they did it. So I just, I'm astounded by those people and they're not on the couch. And I know I, I look to have a long lifespan and a long healthspan. I want to hit a hundred years, but with a good quality of life. And I have a couple friends that are in, still out doing that 5k at 70 years old, and they're like, "I won my age group! I was the only one in my age group..." but you weren't on the couch! Like you did it! And that's motivation to, to keep going out there as well. So hopefully I'll be that person. [00:29:10] Lindsey Dinneen: I love it. That's brilliant. Excellent. So, pivoting just for fun, but imagine you were to be offered a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? [00:29:29] RJ Kedziora: Oh wow. It would probably be about health. [00:29:34] Lindsey Dinneen: Okay. [00:29:35] RJ Kedziora: Which, which combines sort of everything I do. The triathlon, the training, the fact that I'm in software development in the health field. It brings all of those things together. And just a lot of people don't know what they don't know. And so if I could impart that knowledge on more and more people, I think that would make an impact that would make a difference. So yes, I could teach a software development course on cybersecurity. Interesting.. I could teach one on AI. Yes, interesting. But if it, if you really just focused around the idea of eating better, moving. You don't have to do a triathlon, you don't have to do a 5k. And it's like park a little further away from the supermarket and walk. You're gonna be better off, have that longer lifespan, longer health span. So yeah, it's, if I have that million dollars and it is probably health in in general, which encompasses a lot. But yeah, it would be health. [00:30:37] Lindsey Dinneen: Yeah, absolutely. Yeah. And then, how would you like to be remembered after you leave this world? [00:30:44] RJ Kedziora: Huh. Wow. Then I've made an impact and I've made a difference in, in some small way. I don't have to win the lottery, I don't have to be the billionaire kind of thing, but that, that I've made a small impact and, the lives of the people around me and hopefully a bigger audience through the work that I've done, that our company's done. And yeah, I've made a small difference and made a few people laugh. [00:31:12] Lindsey Dinneen: Yeah. Yeah. I mean, I've already laughed today. So , you're succeeding. Excellent. And then final question, what is one thing that makes you smile every time you see or think about it. [00:31:26] RJ Kedziora: Family, I, that's, you know, wife. I have two daughters, 24 and 21, doing very well. Yeah, any chance I get to see them? Family. [00:31:36] Lindsey Dinneen: Yeah. [00:31:36] RJ Kedziora: And oldest of six. So you get to see them and their family kind of thing. Family's important, yeah. Yeah. [00:31:43] Lindsey Dinneen: Yeah. And you've mentioned that several times: family first and people first. So it's a running theme. . That's great. RJ, this has been so much fun. I really appreciate your time today and just thank you so much for joining us. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational and safe environment. So, thank you so much for picking that, that organization to support and we just wish you continued success as you work to change lives for a better world. [00:32:24] RJ Kedziora: Thank you very much. This was a great interview. Thank you. [00:32:27] Lindsey Dinneen: Excellent, excellent, and thank you so much to our listeners for tuning in and if your feeling is inspired as I am right now, I'd love if you'd share this with a friend or two and we will catch you next time. [00:32:38] Ben Trombold: ​ The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dr. Scott Bertrand, the inventor of the AllCore360 therapy optimization platform, shares his journey, beginning with two significant spinal injuries that led him to question conventional physical therapy methods and ultimately steer his career towards chiropractic care and MedTech innovation. He discusses his invention, which revolutionizes core training by focusing on isometric exercises, benefiting a wide range of individuals, from spinal injury patients to elite athletes. Scott's personal experiences and challenges fuel his passion for MedTech and his desire to impact lives positively. His story is one of perseverance, innovation, and the power of using personal challenges as catalysts for creating solutions that can change the world. Guest links: www.allcore360.com Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 024 - Dr. Scott Bertrand [00:00:00] Lindsey Dinneen: ​ [00:00:05] Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:14] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:20] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:33] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:43] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:47] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:55] Hello, and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm so excited to introduce you to my guest today, Dr. Scott Bertrand. Scott is the inventor of the AllCore360 therapy optimization platform, and currently the chief research officer with AllCore360 America. He is retired after 35 years of caring for the chiropractic needs of a wonderful community in south Atlanta. He is a proud a 101st Airborne veteran and honored member of Mensa, but most importantly he's married to his wonderful wife, Lori, has two incredible children, Stephanie and Luke, who have blessed him forever with five precious grandchildren. Thank you so much for joining us today, Scott. I'm so excited to have you on the show and hear from you. [00:01:40] Dr. Scott Bertrand: I appreciate the opportunity to speak with your audience and to you. [00:01:45] Lindsey Dinneen: Excellent. I would love, if you wouldn't mind starting off by telling me just a little bit about yourself and your background, and let's start there and then we'll get into some of the other fun things. [00:01:58] Dr. Scott Bertrand: Let's go back to where probably my medtech life started. I had two separate spinal injuries that kind of thrust me into the healthcare world. One when I was 19 years old and I had a fracture in my lumbar spine, and when I was 19, I was brought up in a blue collar, middle income family and my parents, you know, believed that medical providers were set next to the Pope. I, it was whatever they said, whatever they did, that's how we looked at it. And I thought, I felt no other way. I had, I'd injured my spine and fortunately I wasn't paralyzed at all, but I was definitely beat up and pretty painful. [00:02:36] But I went into the therapy process at that time just excited to recover. In my mind, the medical doctor would fix me. That's all. I mean, I knew I was broke, but that was his job, and I believed that's what he would do. He goes on and, you know, I'm not putting fingers at anybody. I realize that he was doing the best he could with what he had at the time he had. So I, I'm not, this isn't anything negative, but he refers me to a physical therapist, of course, which he would. I excitedly go to my physical therapist and instantly he requests me to do things that were incredibly uncomfortable, very painful. And I remember kind of leaning back and going, "whoa, wait a minute, that this problem isn't a good thing. This is quite similar to the trauma. Let's probably not do that." But, you know, he kept insisting that I needed to do these movements, and these movements were brutal. [00:03:30] I was 19. I was an athlete. I had been in the 101st Airborne. I was a, I guess you could quote, kind of a tough guy, but, you know, this was incredibly uncomfortable. And I, I finally, after several visits going back and forth with him and complaining that this was obviously not the right approach, he just looks at me and says, "Hey, you know what, Scott, what you need to do is suck it up." And, you know, this really wasn't a suck it up thing. I mean, I know what suck it up is, [00:03:57] Lindsey Dinneen: Yeah. [00:03:58] Dr. Scott Bertrand: That really wasn't it. And I was incredibly disappointed and everything just kind of fell into my like, oh my gosh, maybe they don't know everything. It was kind of a, oh my gosh moment for me, but I ended up going, you know, this isn't gonna work for me. I'm gonna have to, I'm gonna have to quit. [00:04:14] And so I look over at him and he takes a stamp and puts "non-compliant patient" stamp on my file. I remember going, wait a minute, I'm not "non-compliant." There's nobody that wants to get healthier than I do. He released me and that's how I was. That's my name. I'm a noncompliant patient. So I was really frustrated at that time and I thought, this is really not right. I, but what it did do though, is it focused me in healthcare. You know, I'm a young man and I'm not sure what my career is gonna be. I don't know what I want to do in life exactly. But I went, oh my gosh, some missing links here. And I, at least I need to know more about it for my own self, you know, my own health. [00:04:54] So I started pursuing a career in health, and I ended up going into the chiropractic profession because I had injured my spine. And these people seem to be the ones that were the spinal professionals. So I go to school I'm going through this process. I'm learning about the spine and the body, the miracle machine we drive, which these are the first kind of early things that are going off in my mind going, oh my gosh. We're blessed with a miracle and we're just trying to learn how to take care of it. [00:05:23] I'm getting ready to graduate from chiropractic school. I'm at my brother's wedding. I dive off the high dive. I shouldn't have been up there to begin with. I hit somebody in the pool and I break my neck. Okay? It's like, oh my gosh. Here we are again. I'm thrust into this space again. I'm not paralyzed, [00:05:38] Lindsey Dinneen: Oh [00:05:39] Dr. Scott Bertrand: and I say that because I've treated and worked with so many people who are... [00:05:42] Lindsey Dinneen: Yeah. [00:05:43] Dr. Scott Bertrand: That I don't wanna put myself in that basket. I wasn't, but I was, you know, it was a shocking experience to say the least, and incredibly uncomfortable, and it took a long time to heal, but it's been a good eight, nine years since the first trauma, and now I'm almost a chiropractor. I'm graduating from chiropractic school. So I've got a really strong background, at least anatomy and physiology and how the body works, and excitedly. I go off to therapy again, and I look across the table and he asked me to do the same movement again that they recommended 10 years ago. [00:06:13] I'm like "whoa, wait minute. I know that doesn't work. Let's not do that. What else do you have?" " No, that's what we do." And I go, " no." And we went back and forth. And then he said to me, Scott, "you need to suck it up." The second "suck it up" got me to walk out of there and say, "look, there's something massively wrong with how we're treating this. I don't know what it is yet, but there's something wrong and it needs to be corrected." [00:06:36] Medtech is coming up with some innovation that addresses a concern in the medical world that hadn't been addressed that way before. So there's a long process between "I have a problem and I'm trying to figure it out," and "I come up with a solution." I don't wanna underestimate the time that requires. There's a long gap of time in there, but then, okay, now we have a solution. And I guess really, Lindsey, that's kinda where it starts. I invent the AllCore360. That's an interesting conversation if you wanna go into that. But that's what threw me into the MedTech industry. [00:07:10] And that's where I realized that, when you come up with something in MedTech industry, it's not like a better windshield wiper, which Lord knows we might need better windshield wipers, and that's good. But when you're impacting people's lives and the way that we got to do that, and it's a global reach. It's not just like across the street, across the neighborhood. When you can impact a human being, there's a strong possibility you can impact us all. The awareness of knowing that I can help the world was the motivation in everything. That really was, I think, that's what drives everybody in the medtech industry. [00:07:44] It's an innovation that can impact society in a way that it needs, but it can do it on such a grand scale and it's not . I know you have a lot of medtech industry, so I know I'm preaching to the choir, but it's not about money. You'll be rewarded certainly, but you'll spend your money, but I'll never be able to spend the hug from the mother who I took care of their daughter and help her to walk. Not only does, I can never spend that, that just gets interest. That just gets better and better, and then they tell somebody else and it grows and it's, it's a, it's just a wonderful industry to be in. Tough, hard, really hard, but oh my gosh, are the rewards amazing. [00:08:24] Just anybody in that space and is struggling and Lord knows I know how hard that is, please don't give up. It's so worth it. You know, we all say if we could just take care of one person. Back to what I said, if you can take care of one person, you can probably take care of 'em all. And that's, that is pretty exciting. And I've been able to do that. That's where we're at now. I've, you know, it's taken my whole life to get here and decades, but, you know, we're here now and we're really, I'm really proud and I could not be more happy with what the company and our team has been able to do. [00:08:57] Lindsey Dinneen: That was fantastic. I loved hearing it. I love hearing your background and what motivated you to get into this field, so thank you for sharing, especially some of those really personal stories of challenges that you had to overcome, which ended up being the catalyst for. This new stage. So I wouldn't, I certainly wouldn't wish those injuries upon you by any means, but I am, I want to recognize and thank you for taking those kinds of really challenging periods of your life, but using them as catalysts for good. I think that is very commendable and not easy. [00:09:34] Dr. Scott Bertrand: No, and I appreciate you saying that. And I kind of joke, but only a little joke that this kind came to me. This invention came to me after months and months of studying on all the issues I was trying to resolve in that kind of hypnagogic state. You know, that's that dream state. It actually came to me in a dream, and when I realized what it was, I realized that was a gift. I'm giving this gift, and now the job is to share that gift. You know, in medtech it's a lot easier said than done, but that's kind of the next step. And they know we've been able to do that. We finally have and it's been a blessing that I've thoroughly enjoyed. [00:10:14] squadcaster-bf62_2_10-20-2023_140435: Yes. Yes, absolutely. And like I said, thank you so much for sharing about that. And there's so many questions that I have that popped up from it. But I'll start with, I would just love to hear more about your company now and your incredible device and how it works and how it's changing lives. [00:10:32] Dr. Scott Bertrand: Oh, wow. Thank you for even giving me the opportunity to share that because that's unique and that's why, I guess it's an invention. It's not been out there before. So to do this real quickly, the, the design of the device is to train the core. And when I started, the core was an apple core. People didn't know what cores were. We used to call it the trunk, but anyway, it was, it's the core. And so what we're gonna call "the core" is from the base of your skull to your pelvic floor, that tube of muscles that is who you are. We plug arms and legs into it, and if you're an animal of flippers or fins or wings or whatever, but we're all just this tube of muscles that is that core. [00:11:12] And so the design of our, my device is to train that core. And so the, here's how we do it contemporarily. We take the core instead of, you know, really realizing we're a tube, we're a round tube. We call ourselves a box. I'm not sure where we came up with that, but now we say our tube has its front and a back, and a right and a left when tubes don't have front and back and right and left. But for some reason we called ourselves a square and then, and that was our first mistake, but we just all just accepted that like, "okay, um, our eyes are pointing forward, so let's make our box pointing that way." So what we did is we took this square, we decided what the square could do. [00:11:54] The square could bend forward at the waist. It can bend backward at the waist. It can bend to the right at the waist. It can bend to the left at the waist, and we're gonna challenge it that way to make it better. You know, I think what happened was people did that and they got better. There were, it does that kind of works. It wasn't a horrible thought. It was just a, an incomplete thought. So what the AllCore does is it takes this 360 degree machine, it's really a 360 degree machine that can go in any direction. It can bend and twist in any direction, and it takes it and challenges it in every direction. If we took our box example and we bend forward, bend backward, bend right, and bend left, that's four degrees. That's four separate degrees of movement. [00:12:40] We've only left out 356. What about all those other movements we just left out? And I'll tell you where one of the lights went off that I, this is kind of what makes it so unique, I believe. We are, we train the core isotonically, and by isotonically, I mean, we bend and twist and move. So right now, 99% of the people that run down to their local workout gymnasium center, they go in to do their core and they bend in half. Let's call it like a sit-up. They do sit-ups. When I was like 15, we were doing sit-ups, so you know, that's not anything new. Okay. And then they, we got really clever and we started calling our sit-ups "crunches." That's the same thing. A crunch is a sit-up, but we somehow thought that was even better. And then we went we can make a machine to do that. And then we had a crunch machine. But what we have, it's the same concept. It's bending in the middle of our bodies. [00:13:40] This was one of the, oh my gosh moments. They, one of these things that eureka moments, if you will. I walked out of the gym one day and I'm a gym rat. I live there. I, that's what I did. And I realized that . If for some reason I'd never walked into the gym, I would've never done a sit-up in my life. Sit-ups are not things we do. These are not positions we get our bodies into. There's no sport where everybody lays on the ground and bends it half 50 times. I started to go, "why in the world are we working so hard to do this one movement when we never ever do that movement?" [00:14:19] And I thought, "oh my gosh." My next Eureka moment comes in. Now I'm outta chiropractic school and I'm working really hard and I realize we're working with this miracle machine body and I, all of a sudden, I had to start laughing at the way we treat the body 'cause I was reading old medical journals and old history medical journals. I mean, there was a time when they thought smoking cigarettes made you a criminal. I mean, I know that medicine only took what we could take and we believed it and we taught it and we treated it. But what I really realized now, the things we think are true now may not be true in the future, unfortunately, but what I realized, what medical providers and medtech providers really need to do this to me became the bottom line. [00:15:02] We were blessed with this incredible healing miracle machine. To ever think that somehow our brain that read that book knew better than our body did on how to take care of our body was ludicrous. Our body knows how to do everything. We're the best survival machine on the planet. This machine knows how to heal. It knows how to do everything. In fact, it's a lot better if we just stay the heck outta the way. The more we get involved, the more we screw it up. So here's what I think physicians really need to do, and this is what I kind of decided to do at the medtech, is realize what the body does to survive. [00:15:43] Because that's really all it's about. It's about survival. There's no extra parts on the body. I mean, everything on the body has a survival value. And if you want to improve the body, you help the body in its ability to survive. So what I did was I looked at the core, and this is, these are these eureka moments. I looked at the core and I said, "what really is the survival value of the core? Why am, why do I have a core? I mean, what do I do with it that helps me survive?" [00:16:12] It dawned on me almost immediately. The core, as much as we think the core is designed for movement, there's not a lot of survival value to movement. I'll take that back and say, if a rhinoceros was coming after me, I need to step outta the way. So I understand there is a survival, I gotta move, but let's say I didn't move when the rhino hit me. How was I damaged? I was damaged by being bent around the rhino's head. My body went beyond its normal range of motion. So what really is the core designed for? [00:16:48] And here's the key. It's designed to isometrically maintain your posture in the most efficient, safe position possible. Your perfect posture is so perfect. It's almost hard to get damaged where you're in that perfect posture. When you bend to the left and pick up a weight, you took yourself out of the perfect posture and oh my goodness, he blew a disc. You know, you took your posture, got it out of position, and then challenged it. So that's not how you should challenge your posture. You should take your posture, put it in a perfect position, and then isometrically challenge it because that's how we use it: isometrically in the 360 degrees of its potentiality. [00:17:31] It needs to be able to do all those things isometrically, and at the end of the day, the AllCore360 takes your body, your only athletic ability has to have the ability to sit. You know, sometimes you go to the gym, you look across the floor and you go, "oh, that looks like a great exercise, but I know I can't do that." The AllCore, all you gotta do is sit and what that does is that adds everybody on the planet. That's your senior citizens. That's people in wheelchairs, that's people that don't have legs. It addresses so many people in the population. All you have to be able to do is sit and we can make your core better. [00:18:10] At the end of the day, like I said, the core is everything. So what's the survival value of the core? It's not to bend. It's to stop from bending too far, 'cause if you bend too far, something breaks. So what you do is you stop it from bending and you stop it from bending in every direction, and you do that isometrically. That's how you need to challenge the core in the way it was designed to perform. Once you do that, once you develop a very balanced, coordinated strong core, that core can go hit golf balls and baseballs and do anything it wants, but you can't train a core by hitting golf balls and baseballs and all those things. [00:18:49] You train the core the way it's designed to perform. You make it efficient and strong and high endurance and balanced. What you're really doing is taking your God-given miracle machine and making it the best it can be. As opposed to what most of us do is we take this incredible miracle machine and we beat it up until we kill it. So it's a better way to look at it. We really should take care of it. But yeah, so it allows most of the population, and 99.95% of the population treat their core in a balanced, optimal fashion and it only takes 10 minutes, three times a week. [00:19:29] One of the problems with therapy, and one of the problems with fitness is always I don't have the time. I don't have the time. My goodness. 10 minutes. It takes you longer to put your gym shorts on. All you gotta do on this machine for 10 minutes. That's how it works. And because of that, people really -- they're compliant. Back to my non-compliant patient status, if it's only 10 minutes, you can kick people to come and do 10 minutes. [00:19:56] Lindsey Dinneen: Yeah. [00:19:56] Dr. Scott Bertrand: To have someone come in and do an hour and a half, and now they need all kind of other things in their life that they can use for excuses. [00:20:02] Lindsey Dinneen: Right. [00:20:02] Dr. Scott Bertrand: 10 minutes isn't a big commitment for the remarkable, miraculous results it gets for some people. That's kind of how it works. And it's, like I said, it's a it's a blessing, and it started in this spinal cord injury space because what it did for people who only have their cores, I mean, this is what they have. They don't sometimes have arms and legs. This is what they have. So it started in that space, but when those patients and clients started sporting six packs and losing 10 pounds, all of a sudden, everybody wanted it. Everybody wants a six pack, everybody wants to lose 10 pounds. And that's great. [00:20:39] So we definitely are in this spinal cord injury space, this extreme rehab space, this weekend warrior rehab space. But we're also in that elite athlete space. We're at a lot of colleges, university, sporting clubs. They're seeing that, it's much better to prevent injury than always trying to fix it. Doctors go into the world praying that they get to take care of people and they teach 'em how not to get hurt. But really what they do, they get thrown into this world of broken bodies, the people that don't take care of their bodies and they don't listen to you and you never get a chance to teach them even how to take care of it. Right? So it was an opportunity for us to really impact lives. We don't need a lot of time, we just need you to show up and this, and it works that way. [00:21:21] Lindsey Dinneen: Wow, that is incredible. And yeah no, it is incredible, and I love that there are two extremely important case uses for-- more than two-- but I was thinking about it in terms of, like you said, injury prevention, just in general, health, wellbeing, physical optimization, versus also, then you have the Yeah, versus also, then you also have treating, [00:21:47] Dr. Scott Bertrand: Right. [00:21:48] Lindsey Dinneen: Right. Yeah. So I think it's incredible [00:21:51] Dr. Scott Bertrand: That opens up such a big market. [00:21:53] Lindsey Dinneen: It could exactly right because everybody could benefit from this. This is literally something that could impact everybody's life who participates. Holy mackerel. [00:22:02] Dr. Scott Bertrand: And the nice thing was, it's if you knew where there was one or you used one, I. What I get to do every day, although oftentimes it's cry because these stories are so overwhelmingly wonderful, but I get to hear on a daily basis almost about these recovery stories and it's because we weren't doing it right. It's not that-- I mean, I appreciate the fact the AllCore is the, it's my device and our device, and it's doing what we said it would do-- but it's the body. The body-- if you treat the body right, it just does the right things. It just needs someone to kind of just help it a little bit. It's a miracle. We just need to kinda encourage it sometimes, and that's what this really does. [00:22:43] And the, again, because it's the results and the responses are so rapid, people enjoy maintaining the schedule. And the longer you maintain the schedule, the more and more of those results improve. And once you finally develop a balanced core, like I said, I've been an athlete my whole life. But I didn't have a balanced core. I thought I did, but I didn't. And when I developed a balanced core, I was, I'm overwhelmed and I can, I can't tell you how many athletes that are starting to experience those same things. You would think an athlete would come in and get on our device and max it out, you know, show me something that, wow, only an Olympic athlete can do. But I can have an Olympic athlete come in and when they get on the machine, I can say to them straight to their face, "I've got a woman in a wheelchair that can make you look horrible." And that is the honest to goodness truth. What the core actually can do when it's taken care of is an amazing thing. [00:23:43] I wanna make this one really quick story. So I had a beautiful woman come in that was, had been in a wheelchair for decades. And we had to transfer her from her wheelchair to our chair. It's just a matter of lifting her and setting her down here. And I don't wanna sound negative when I say this, but when I lifted her up the first time, she was soft, you know, fluffy, kind of, you know, 'cause she couldn't, she didn't have a lot of muscle tone and Lord knows, how could she? She spent her life in this wheelchair. So I, it didn't surprise me. I would put her in the wheelchair or we put her in the machine. [00:24:19] Lindsey, I will say probably in three months, maybe, when I would reach over to help her, instead of reaching around somebody that was fluffy, I was reaching around somebody that felt like a granite statue. She was solid rock, and I saw that happen and I saw what that did for her life. She could get in and on and off the commode on her own now. She could get in outta the car. These things that make a difference with independence, these things that are so important that we take for granted. [00:24:49] Lindsey Dinneen: Yeah. [00:24:49] Dr. Scott Bertrand: I saw these incredible recoveries and I knew then that I was absolutely on the right path. It wasn't about our six packs and our low back pain. It was about these people that had been almost forgotten and deserved so much, and now they're having an opportunity with hope and getting some great results. So that's the reward of MedTech. That's why, and all your listeners, hang on. It's worth hanging on. It's taken me three decades. I mean, you can't expect to go out and be tampering with people's lives and not expect it to take a long time to get there. People aren't just gonna let you start messing with them until you can prove you're doing the right thing. But it's so, but don't give up. Do the research, keep doing it. And that one person that you help, maybe you'll be a million. [00:25:33] Lindsey Dinneen: Yeah. [00:25:34] Dr. Scott Bertrand: I know that's what's gonna be happening to us. [00:25:37] Lindsey Dinneen: Yeah. Oh, yes. And thank you for that encouragement because I, like you said, it's a long road. So it's helpful to have people on the other side of it going, "Yes, it's possible. It's absolutely it. It'll take time, but you can do it." yeah. So, looking back ?Over your life, I'm just always curious about this, you know, do you think, is there any way that six year old Scott could have possibly had an inkling of what was to come in the future? What your path may have turned out to be? [00:26:09] Dr. Scott Bertrand: I, you know what's funny? I'm so that, that's such an interesting question. I'm writing a book and the book is, you know, it kind of goes through some of my life and I was just doing this the other day and, yeah, there was a six year old Scott that had an occurrence that happened to him that made him stop and think and go, "my God, I'm driving a miracle." and I was only six. And I remember it like it was yesterday, and it stuck with me. Long story short I was, I shouldn't probably be alive, but due to just natural reflexes, I got outta the way of something. And what I had to say, and I realized is I moved on from that potential horrible trauma that my body moved me out of the way. [00:26:50] Scott didn't, little six year old Scott wasn't smart enough. My body pulled me outta the way. And that reflexive action, that right there is what the AllCore relies on. So I don't know if that was the very first little thing, the very, you know, the little spark that said, Hey this machine you're driving is not just a bucket of bolts. You know, this is pretty impressive. And I got to, I still get to see that miracle every day. It's amazing. [00:27:17] Lindsey Dinneen: Yeah. Yes, it is amazing. Yeah, thank you for sharing that story. That's pretty, pretty interesting how that ended up being a, you know, of course, like, like you said, six year old Scott wouldn't have known where that would've led, but hey, It's, it's just, it's cool to see those threads looking back. [00:27:35] Dr. Scott Bertrand: Yeah. That's what they're the little seeds that found some fertile ground somewhere down the road that'll let 'em grow. But they, it's all those little things. And I can go through my life and point out about a dozen of those and that. You know, you go through life with all kinds of paths that present themselves, and you right or left. And where you are today is dependent on all those choices you made. But I can go back and look at so many of those and go, "thank God I turned that way because that allowed me to get here." And [00:28:05] Lindsey Dinneen: Yeah. [00:28:06] Dr. Scott Bertrand: That's almost pure luck. I don't know. So, [00:28:09] Lindsey Dinneen: Or Destiny or both? [00:28:12] Dr. Scott Bertrand: You know, I prefer to say that too. I think we're all put on this world for a reason. I think one of the things I say to people all the time, and the two biggest moments or greatest things in your life is the day you were born and the day you realize why you were born. And that, I realized that day, when it finally came to my mind why I was here that my job on this planet was to make sure that people knew that there was an alternative, and just make sure it happened before I died. You know, I just I remember one time sitting on a couch and all of a sudden realizing that if I don't do this, it might not get done. That was a frightening place, it really, it scared me. I was kind of thinking in my mind that someone else will come up with it, and I was okay if somebody else did. I just knew it needed to happen, but all of a sudden I realized maybe somebody else isn't going to, and I knew it was my job, so. [00:29:09] Lindsey Dinneen: Yeah. Yeah, that, that brings up an interesting point. I mean, my initial thought was that quote from Spider-Man where there's the whole " with great power comes to great responsibility." And, you know, and it's not exactly applicable here, but the idea of when you've been presented with a series of challenges that have led you to a possible solution. Yes, I think there is some sort of feeling of I have this responsibility to, to help because this isn't just about me anymore. This is about the planet. Who else could I impact if I can bring this successfully? And there are, and that's probably something really helpful because, I'm sure as a founder and you know, and you're leading your company, there are days where it's tough and you have to go back to your why of, you know, why are we here? Why are we, you know, going to all this effort and expense and whatnot. [00:30:12] Dr. Scott Bertrand: Right, right, right. You know? Yeah, exactly. It's every company, and I think a lot of people have, we all have dreams, you know, we have dreams, we wanna do this and do that, and dreams and goals, and those things and they all drive us forward, and they're good motivation. But when it goes to a mission, when it goes from a dream to a mission, it's a total different thing. It's a mission is one of those things that you think about it when you go to sleep, but it wakes you up in the morning and starts beating you on the back until you go ahead and get it done. I was almost fearful of if I didn't do it, God was gonna throw me off another roof and break something else. I needed to get this done. [00:30:50] Lindsey Dinneen: Oh no. [00:30:51] Dr. Scott Bertrand: Hit me twice. He told me what to do. He's like, pay attention here, gotta get this together. So, but anyway, I did. It took me a little while, but you hit me in the head a few times. I'll wake up . so, we did, and here we are. [00:31:06] Lindsey Dinneen: I love your honesty. That's fantastic. In the end, you followed that calling or leading or whatever you wanna call it. So go. This is so much fun just to hear all of your stories and whatnot, but I wanna pivot and take it in a slightly different direction completely for fun. If you were given the opportunity to teach a masterclass on anything that you want, it can be within your industry, but it doesn't have to be. You get paid a million dollars for this. What would you choose to teach and why? [00:31:40] Dr. Scott Bertrand: I'd listened to the offer. What I've learned, and I could probably share better than most things would be, how important perseverance is at the end of the day. It's the ability to focus and not give up. It's that day to day responsibilities that lead to the final goal. It's, I just know, like I said before, it's not going to be easy. So if you want something easy, you need to pick something else. I would think I would just explain to people not only how to persevere, and by that I mean sticking to a recipe, maintain your vision and your passion because you are the one who has to protect that vision. And then do everything you can again, I guess, to make it happen. But that it's, you just don't give up. No one said it'd be easy and, you know, you gotta do it again tomorrow. But it's there. It's there. It's there. There is a ladder and the rungs are hard, but one step up is one more than yesterday, and I'll take that. [00:32:40] Lindsey Dinneen: Yeah. That sounds like a fantastic masterclass. So yes. How would you like to be remembered after you leave this world? [00:32:48] Dr. Scott Bertrand: You know, this is a powerful thing that we're doing here with the AllCore360 and to possibly able to be the inventor of a device that can really impact millions upon millions of lives. I don't think there's any legacy anybody could ever ask for that could be greater than that, but I think what's every bit is important and I think in medtech and all these innovative companies, I really know that-- it took me a while to realize this-- but you can't do big projects alone. You can't take on gigantic projects of changing the world by yourself. So you really need to develop a really good team. And I took a little too long to develop that good team. But the legacy I would like to leave, not just for the device and my name, this group took on that mission of changing lives just like I did. And they've invested their energy just like I did. So my legacy needs to include their legacy. They need to be just as proud of changing the world 'cause they have, and I could not have done it without the help. So it's that it's all of us, you know, it's that legacy. You know, two generations from now, their granddaughter needs to say, "daddy, you worked on that, didn't you?" "Yes, I did." And I want them to have that pride. I really do. That'd be a great legacy. I could wouldn't ask for more than that, you know. [00:34:16] Lindsey Dinneen: Yeah. Yeah. That is a great legacy. Absolutely. And final question, what is one thing that makes you smile every time you see or think about it? [00:34:28] Dr. Scott Bertrand: Gosh, there's several of those. You obviously can go to the birth of children and grandchildren. Those are hard to beat, but I, in, in, if not down that line. Yeah. Yeah. I'm a, I'll tell you a really quick story that, and I'll try not make it too long, but it was one of these individuals that had been in a wheelchair and were working with me on the device. And like I said, these things are always so rewarding and I love them so dearly, and I have many memories, but one that I will always smile. The girl's name was Lori, and like I said, I love Lori. [00:34:59] But so, you know, it's hard to explain, but the device is a, it's a challenging device, and so, I could put it at a certain angle and it would be more difficult than maybe the angle you did got on. So we could compete, you know, I could do more than you, or you could do more than me. So I was using the device, obviously myself, and so I had a certain range that I went to that I was proud of. In fact, I, you know, I'm pretty tough. I'm down here. I'm doing a really good job. Here comes this gal on the wheelchair, by the way, the gal I'm talking about that turned into a granite statue. It's that gal. But so we start out, and I am way ahead of her, you know, and I am, I'm way ahead of her. Of course I am. But then like a two weeks later, she's gaining on me and three weeks later she's gaining on me and six weeks later she's on my rear end and I'm going, oh my gosh. I finally had, I stopped one day and I just had to look at her and I said, "Lori, How in the world are you doing this?" Because you know, I knew where I was at and she took her finger and put it in my face and went, "how are you not?" [00:36:07] And I will never quit smiling on that day because she struck me to the ground and basically said, "here I am sitting in a wheelchair and I'm kicking your rear end. What is your excuse?" I mean, she brought me to my knees and I will never forget that. And I'll smile because that showed me power that I've never seen. And I only pray I can be as motivated as she is someday, you know? But I will always smile. It was a wonderful day. [00:36:36] Lindsey Dinneen: That is incredible. I love that story and I also love the fact that that makes you smile that sort of Very much, you know, confrontation. And this is, she's gonna speak her truth to you. And you know, you took that as a good thing, as a challenge to keep, you know, doing what more of what you can do. And I, [00:36:56] Dr. Scott Bertrand: She was right. Yeah, she was right. She hit me right where I live and I thought, you know, I don't think there've been many people on the planet that would

Marina Daineko, a biocompatibility expert with a background in analytical chemistry, shares her journey from a research assistant in physical chemical problems to a prominent figure in the medtech industry. Marina discusses her passion for understanding the regulatory compliance and quality management systems in medical devices, reflecting on her curiosity and desire to make a difference in people's lives. She also shares her commitment to increasing women's representation in the medtech field. Guest links: https://www.linkedin.com/in/marinadaineko | https://www.intrinsicmedicalgroup.com Charity supported: ASPCA Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 023 - Marina Daineko [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:52] Hello, and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I'm excited to introduce you to my guest today, Marina Daineko. Marina, a certified biocompatibility subject matter expert with an MSc in analytical chemistry, shines as a dynamic figure at the intersection of medtech and chemistry. Her knack for seamlessly bridging biocompatibility, regulatory compliance and materials science, sets her apart. Marina's captivating presentations at conferences, including the prestigious Women in Tech Global Conference 2023, underscores her multifaceted expertise in the medtech industry. [00:01:31] Welcome. Thank you so much for joining us. I'm so excited to have you here today. [00:01:36] Marina Daineko: Hello, Lindsey. Nice to meet you. Thank you very much. [00:01:40] Lindsey Dinneen: Yes, absolutely. I was wondering if we could start off by you just sharing a little bit about your background and yourself and how you got into the medtech industry. [00:01:51] Marina Daineko: Oh, yeah, absolutely. Actually, it's very interesting story because I have started with medical device industry, not from the very beginning. But since I was young, I have always had a keen interest in learning more about the properties and different forms of matters and understanding how this undergo changes. So all in all, I fell in love with chemistry while I was in high school, and knew that I need to proceed with chemistry in my adult life. So anything that can be touched, tasted, smelled, seen, or felt is made of chemicals. And I was inspired by this fact and yeah, so I decided to connect my life with it. [00:02:36] And it's interesting because I started my career as a research assistant in the Research Institute for Physical Chemical Problems. And here I had a really scientific background because I published several articles, put my hands into patent work, and so on and so forth. And everything related to non resist photocatalytic lithography and nanoelectronics. So far away from medtech industry. And yeah, but it was interesting for me. And it was sometime after that it was time of self discovery through challenges, because I wanted to do something in my career that is challenging, interesting, and makes a difference in people's lives on a daily basis. [00:03:23] And actually around this time, I found out that my ancestor, Vladimir Galalyev, was a researcher in medicine and published academic papers dedicated to rheumatism and the morphology of allergy. So, I found it interesting and I decided that I might delve into this area, into this domain. So all in all, I started look for opportunities and found out RNC position. And that's why I joined MedTech industry as R&D and my background in chemistry and material of science helped me a lot here. And I'm a curious person, so when I was working as R&D, I also was trying to understand, "Okay, what are the sources of different requirements?" What are these come from, what are all these regulations that some people are talking from time to time. [00:04:20] And as a result, yeah, that was really interesting for me. Okay, I need to understand the source. I need to understand the matter, what I'm doing, why I'm doing. So, and as a result, I started to look into regulatory compliance area and overall, like, quality management system, just understand how the things work and to understand medical devices from different areas, right? Because it can have very different requirements depending on what aspect you're looking from, right? [00:04:51] So I was really fascinated and thankfully I had the chance to, to join biocompatibility and biological evaluation team as R&D also understands the requirements with chemical background in chemistry. So I started to look into biological evaluation to, because it's so interesting for me, look here, it's mixture of science, also medical device, and additionally some investigation, some topics that are not discovered or something like this. So it's really nice. And also next step I decided, okay, I'm pretty aware like what are things with medical devices that contain hardware for instance, but how make this medical device life. Because it's really interesting and fascinating to see how their lives can be changed. [00:05:45] So that's bring me to software in the medical devices. So software and firmware is something that could help to make medical devices live so they can be used in some analysis, predictions, and so on and so forth. And that's why I'm here in the medical device industry, really enjoying what I'm doing and understanding the medical device from different perspectives. [00:06:10] Lindsey Dinneen: Yeah, that's wonderful. Thank you so much for sharing your background too. It's so fun for me to hear about how you go from so many different, yeah, because you're so multi talented, and you're so interested in so many things, and I love hearing that. I love hearing about your background in chemistry and then you went into R&D and now you're doing software and firmware. Oh my goodness, you are a lifelong learner! [00:06:38] Marina Daineko: Yeah, I believe it's very important because we are living in book of world. It means that, there are a lot of changes around us. And additionally, for me, it's really interesting. I'm really fascinated to see is a medical device from different sites. Okay, we have compliance. Compliance means like this requirements, right? We have R&D and product quality and biological relations and those requirements may be applied, and when touching one topic, it's very interesting to see what is beyond this topic. For instance, as I said, okay, R&D requirements, design input, design verification activities, and so on, according to, for instance, ISO 13485 or CFR part 820. But what about regulatory, right? What about FERS? [00:07:27] Moreover, it's also, yeah, one thing that I'm proud right now is that this year I took a very bold choice to become a student one more time and I selected a program that focused on the medical sterilization engineer. So I believe it helps me to understand medical device even deeper because biocompatibility and sterilization are things that lay near each other. So just to deep my knowledge in the sterilization and disinfection areas, I picked this program. So I'm a student again. It's a very nice feeling. [00:08:09] Lindsey Dinneen: Oh good, yeah. I love how you said that, it's a nice feeling. [00:08:15] Marina Daineko: Like back to school, yeah! [00:08:17] Lindsey Dinneen: Yes, that is ,incredible though and it is so Interesting to hear how you just keep developing your skills, and like you said, you're a curious person, so you're going continue to explore different ways and help the industry move forward. So, good for you. [00:08:35] Marina Daineko: New choices for industry, [00:08:36] Lindsey Dinneen: Nice. Nice. Okay. So, I know that you also are an advocate for women in medtech, and I would love if you would share a little bit more about that and your involvement. How did all that get started, and what are you optimistic about with that? [00:08:56] Marina Daineko: Oh yeah, it's great questions. Thank you very much for asking it. So it has started actually recently when I was invited to speak at Women in Tech conference. So I was really excited here because in my experience, I-- all right, some time ago, long, long time ago, I don't remember even how many years it was-- I tried to start a business as a woman and unfortunately, I have got quite a lot of pushbacks with said words, like for instance, "okay, you need to sit down at home and growing up children and I don't know, cooking," and for me it was like a question, "okay, I can do it truly, but I have like other perspective and other ambitions and willing motivation to grow like a professional, like an expert." So for me it's very important to show an example for other people, women said, "okay, we can, surely we can grow up children. Surely we can take care of some other people and cooking and cleaning, like this man." [00:10:09] So it's very important to show an example that I can do it. So everyone can do it. Everyone has own voice and this voice shall be heard. It's very important. So it started quite innocent for me, just invitation to, to talk at the conference, but I was so proud of it. And I shared this news with my colleagues, with my family, friends like with everyone, I believe, and trying to support this. [00:10:39] Moreover, recently I has been nominated for Women in Tech nomination. So, and I'm so excited of it because my presentation, I was talking about Internet of Medical Things actually, and compliance and risk aspects within IoMT. So, my, my talk as a speaker and I was congratulated with this nomination, so I'm so proud to, to show again other people that, "okay, look it start, it has started really innocently, but where I am now." [00:11:13] I'm nominated and I am growing awareness regarding women in tech and asking for collaboration here as a women to join this network because I could see a lot of opportunities with it like to support each other, to help each other to grow together, because when we are sharing our expertise, when we are given advices, when we are providing areas for improvements, it is really also very important, actually, our points of growth here. So I believe it's very valuable network and really could see a lot of improvements while taking part in this Women Tech Network. [00:11:54] Lindsey Dinneen: That's incredible. And first of all, congratulations on that nomination! [00:11:59] Marina Daineko: Thank you. Thank you so much. [00:12:01] Lindsey Dinneen: That's incredible. Yeah, I'm so excited to see where that leads, but in general, I [00:12:06] Marina Daineko: Yeah. [00:12:08] Lindsey Dinneen: Yeah! And you're like, oh my goodness, "yes, me too!" Ha Yeah, but I just I love the fact that, it started off with an ask of you do this talk, and then you just said, "okay, and I'm diving into this too." So, [00:12:25] Marina Daineko: It's exactly how it works with me. [00:12:26] Lindsey Dinneen: Okay. Excellent. Yeah. And, I know from being connected with you on LinkedIn that you are very passionate about helping to spread knowledge about the industry. Yeah, and so you do this Mondays, you do like a coffee chat or coffee talk. Yeah. Can you tell us a little bit more about that? [00:12:50] Marina Daineko: Absolutely. So it's again interesting story because sometime ago, actually I have started to be pretty active on my LinkedIn, like just around the year or so. And how I, why I decided to be active and why, how it's actually started. It started because I felt like I'm so full of expertise, knowledge, advice that I can't just hold them with myself so I need to somehow to share them and I found LinkedIn platform very useful and comfortable for such knowledge sharing because here there is a community of different experts and that's why we can share opinions, advices, comments, because it's also valuable to see from some things from our perspective, right? [00:13:43] And on Mondays, I'm doing like Monday news. And I remember when I'm using actually my own picture. I took this picture when I had a coffee and croissant, like dreaming, "okay, what would I like to read on Mondays?" And for me, it was kind of a digest of important things. And I usually connect in this important available things around biological evaluation, because I could see quite a lot of information regarding compliance, quality management system, risk management clinical evaluation, like really ocean of news and updates and knowledge sharing regarding clinical evaluation. [00:14:24] But for some reasons, I saw that biological evaluation is kind of underestimated, meaning that-- and it's quite, it's not too easy to find some valuable information or clarify something or, to make it transparent and traceable why we need to go like this direction or this direction, and what are updates in the industry and so on so forth. And I know that quite a lot of people are too shy to ask directly or they simply don't know whom to ask, right? Because if you are known as a subject matter expert in this domain, nobody would ask you even if you are right. [00:15:03] So, and it helped me to understand like, okay, maybe I could put myself in this niche and provide some updates like I'm doing here on Mondays, like taking one topic and provide small basic, maybe basic, maybe not too basic things, around this topic. Like for instance, biological evolution, but inside of biological evolution, we have a lot of things to talk. And to be honest, I can talk about a biocompatibility like all days and nights. It can be unstoppable. So, yeah. [00:15:42] Lindsey Dinneen: Okay, so you have lots of things in the works and you're a student still. What is coming up for you? What is next that you're particularly excited about either personally or professionally or whatever you want to talk about. [00:15:55] Excellent [00:15:56] about [00:15:56] marina_1_10-18-2023_190318: My God, I swear a lot of things, to be honest. Yeah. First of all, maybe from professional side, I'm really excited to take part in the MedTech Summit. Flying to the United States, and I'm really excited because there would be a lot of professionals and subject matter experts within the summit like from biological evaluation, as well as regulatory affairs. So I'm very interested to make like connection in real life, not only like online, looking at people's heads and that's it. [00:16:34] Lindsey Dinneen: Right? [00:16:37] Marina Daineko: So, I'm really excited of it. Also I will have panel session about post market surveillance. And it's very interesting, actually, format because it would be different experts here at this panel, like from regulatory, clinical, risk management. And I will represent biological evaluation aspect. So, and we would be talking about post market surveillance for medical devices. It's also hot topic and I'm excited because in such format is it, that would be my first time in such format with other experts, but I find it really valuable because this cross functional team usually, it's like kind of brainstorming, negotiation, discussion. So I expect like a vivid discussion around this topic and again I believe that would be very interesting insights here during this panel. Yeah. [00:17:34] Lindsey Dinneen: Yeah. Yeah. And, speaking to that, when you are involved in these these panel discussions or conversations or things where you might, where like you said, you're going to be surrounded by experts and you have your area of expertise too and whatnot and you're sort of all collaborating, is there ever a moment where, does it ever feel overwhelming when you're just " oh, I don't know enough about this topic?" I'm just curious because I know sometimes we have those moments as humans. We go into this situation that's not 100 percent our realm, and I'm just curious how you handle those moments of " how can I contribute to this conversation?" [00:18:13] Marina Daineko: Yeah, that's a great question because I wouldn't be honest if I say that I don't have such moments. Surely I have and as I'm quite active as a speaker in different conferences. So surely I have such moments in my life. And yeah, so, how I deal, I'm trying to be logical, first of all, and structured. Actually, I'm a super structured person. I have folder and folder, all the reminders and so on. Organized and structured. But, yeah, so I'm trying to think in this way, "Okay, here is the question. How can I decompose it for the parts that I can understand, right?", And I can provide some feedback, insight or advice, for instance, right? Because usually a person who is asking a question, this person usually has some background or circumstances or conditions why this question is asked. So I'm trying to decompose this question if it's still unclear. So I'm trying, I'm asking to ask maybe in a different way. It gives me additional time to think actually, so well, right? [00:19:19] So, and in that for, I would say for 100% cases with this decomposition or, and for instance, asking to reward the question, I can answer it because it gives me time to think the decomposition can gives me the base, " okay, we are talking about XYZ or ABC or what we are talking about, right? What area from what perspective?" So all the things help me to answer, but usually, yeah decomposition and additional time to think helped me each time. [00:19:57] Lindsey Dinneen: Yeah, and thank you for your honesty, because I really love listening to other people's strategies, because I think we all have those moments sometimes, right? [00:20:04] Marina Daineko: Absolutely. It's very nice because I also can understand, okay, what are my weakness? What my, what are my areas for improvement? Maybe I need to dive deeper into this topic. But, I am, I consider myself brave enough to say, I don't know if I really don't know something, right? Not to, not to make a not proper conclusions, for instance, or advices and so on, so forth, because it's very important to, to say such things because we are talking about medical devices. Medical devices are used when people are in need some help. It might be even the question of life and death so it's very important to say if I don't know so I'm saying I don't know, please ask this I need additional time to investigate. So I need to so I need this additional time, right? [00:20:56] And also what is very important for me as again as a woman and as immigrant, right? Not to be shy, but to talk, to speak up because yeah, I can be, I am an expert. And I need to show my expertise to others because others, other people can, for instance, they just simply maybe not aware that I'm expert, right? So it's very important to speak up and to be brave here. [00:21:26] Lindsey Dinneen: Yes, a hundred percent. And I kept thinking about that when you've been telling us about your life and your trajectory and how curious you are. And I was going to say that bravery is such a strong theme. I, it really is though, because it is hard sometimes to be willing to speak up and say, "I don't know, or I let me go back and research or whatever." And so I really, I think that's really powerful what you said, and I appreciate your candor there. And I'm, I am also curious myself, so if, let's say that you are in a sort of mentorship position. What kind of advice would you give somebody, maybe especially a woman or, somebody who is coming from a different background who may not have the same access basically, how would you advise that person to participate and to keep moving forward with their own career, even if they're feeling a little uncertain or they don't fit in. [00:22:30] Marina Daineko: Oh, yeah. No, I love this question. Thank you for asking it. So, I believe that we are living in such a world where hard skills shall be complemented with soft skills. And as far as I could see, listening is very important. Listening and communicating properly. And listening, I believe that listening to others is a part of communication. So, regarding listening, it's very important to listen,: like kind of correctly what I mean on this is for instance, not multitasking when someone is listening to another person, right? Because sometimes we are doing something and listening not attentively. And we, for instance, can mix up topics or don't understand something or just don't miss some part of, conversation. And that's why it's very important to, to listen attentively, really deep really diving into the topic and understanding what is going to be, like, what we are talking about, what is the topic, what is the ask. Maybe something is hidden between rows, so it's very important. [00:23:44] Sometimes we are listening with a goal in mind. What it means? We have we are talking to each other, right? But I have my goal in, into my mind, so it doesn't matter actually what you are talking about. So. I have something and that's it. I don't care. So it doesn't work. It doesn't work actually. So especially for leadership, but not only for leadership, it's just for, for real life. It doesn't work. We need to listen and trying to understand what another person is trying to say here. [00:24:20] And one more, maybe things that I noticed is judging. So when something, when someone is saying something, so we are judging. We are like, okay, there is just black and white and that's it. But fortunately, no, we have different colors, so like rainbow colors, there is no black and white, so we don't, we should, we shall not judge, we need to listen attentively, accurately, and trying to get rid of maybe some negativity when talking to a person, so it's very important because collaborating with different people may be challenging, especially in these cross functional teams because I could see more and more that we are working in remote world. [00:25:08] So I'm from Poland, you're from the United States. Someone is from the United Kingdom, someone from Australia and it's really amazing and I love it. But people are from different cultures. People have different, I don't know, mood, time zones, different things in their private life. So it's very important to switch off this as, as much as possible, this emotional thing and don't judge, just take the information as it is. And actually it helps me also a lot when I'm doing internal audits. So as it's written, I could see, and I could just, yeah, ask for some evidence as it's written not judging here. [00:25:50] And maybe one more topic here I would like to raise, it's about preparing your response. So when, for instance, my colleague is talking to me and I just codes the first sentence, for instance, right? And I'm answering to this sentence, not to whole speech or whole things that this person is trying to say, but to this sentence . Please don't prepare your response and improve your listening skills. I believe that this listening skills, first of all, when we are collaborating with other colleagues from other, I don't know, departments, for instance, like product quality or clinical affairs, regulatory affairs, R&D manufacturing, so it's very good, marketing, some other. So it's very important to listen and to listen to the messages because there are a lot of valuable information. It shall be filtered accordingly and taken into account for, taken for consideration. [00:26:51] And when we have like good listening skills, we can proceed with improving our communication because I believe that communication is just powerful tools that can resolve any, simply any issue, challenge, whatever, if we can communicate effectively so it helps. It helps a lot in professional life, in not only professional , so it's very important to work on this. [00:27:17] But coming back to your question, I believe that any person can entry medical device industry because there are a lot of directions here. This directions depends on people background. So here we need like mechanical engineers to be able to prepare drawings and actually work on new product development or modifications of existing medical devices, for instance, right? Someone with a chemistry, biology background needed for like specific things like biological evaluation, clinical evaluation, right? [00:27:49] But even people without technical background, someone who is like a good communicator is very nice. It's very valuable person in the project because such person can help with communication between different departments, because someone needs to orchestrate all this work for medical device. So don't be afraid, listen carefully, and improve your communication skill. And I believe, yeah, it would help in any industry, including medical devices. [00:28:21] Lindsey Dinneen: Yes, that's great advice and thank you for sharing that. I think you're right that in many aspects, so one of them, [00:28:29] Marina Daineko: Thank [00:28:30] Lindsey Dinneen: I just want to clarify, agree with you, one thing that stood out to me is, you said that it, It is definitely possible for people to come into the medical device industry. And I think you're absolutely right. There are lots of avenues within the industry. So if your background is in engineering, there's plenty of places for you to go, but if your background is in marketing and sales, I mean, people have to know your device exists in purchase it. So all of the roles are are useful. So I think you're absolutely right in finding the area where you fit in. But the industry is really friendly, is what I have, yeah. [00:29:12] Marina Daineko: Absolutely. Because if I can, yeah, add here, for instance, for marketing and sales, so, I love these people because they help me a lot. Why? Because I am doing, for instance, biological evaluation, I need, this is my documentation, I need to explain other people from notified bodies who, for instance,. Can audit this documentation how this medical device works. And what happened here? Look, I need these people from notified bodies or like from like auditors, right? They can have really different background. They can have background in clinical or they may not have this background. They may just have, I don't know, absolutely different background, right? They are not familiar with this specific medical device. [00:30:01] So, and within my biological evolution, I need to explain how this medical device works. And it's known fact that a lot of people can consume the information with their eyes. So it's visual. So it means that the information shall be visualized, and visualization is the best tool to explain some things to people. That's why I love marketing, people from marketing and sales, because they can prepare these great pictures of medical device, how it works, for instance, on YouTube, like video or whatever, right? As well as, yeah, to make it understandable for everyone. It's simple, not with all these tons of words. But usually it, it shall be described as well, right? But visualization as well. So, that's why, yeah, I triggered so much when you mentioned marketing and sales, because yeah, it's really important to explain complex things in pictures. [00:31:02] Lindsey Dinneen: Yes. Indeed. Yes. And I'm glad to have an advocate for that. [00:31:12] Marina Daineko: Absolutely. Yeah. Yeah. [00:31:13] Lindsey Dinneen: Yeah, absolutely. Pivoting the conversation just a little for fun. Imagine you were to be offered a chance to teach a masterclass on any subject that you want to. You would be paid a million dollars to do so. It can be about your industry, but it doesn't have to be. What would you choose to teach and why? [00:31:35] Marina Daineko: As I said, I can talk days and nights about biological evaluation. So maybe it would be the simplest answer because it really, it really works for me. I mean, like I can talk about biocompatibility a lot and I am more than happy to share some insight with people, especially taking into account that this buzz and noise regarding biological evaluation recently, and I could see a lot of people that are coming in this aspect, this domain, I mean, in biological evaluation in medical devices, so I would be more than happy even be paid properly for this. [00:32:18] Lindsey Dinneen: There you go. [00:32:20] Marina Daineko: Yeah. [00:32:22] Lindsey Dinneen: You could put the million dollars to, your research or something fun, so. [00:32:27] Marina Daineko: Yeah. No, absolutely. When I was younger, I had actually a dream to organize a kind of, research center and to have some equipment, to have some databases, and so on for scientists who can, for instance, like scientists, startups, and so on so forth who can actually try, say, ideas on this on this research center. So if you, for instance, I don't know, invented something, you can go to my research center and I, we can first of all, test it and also provide like scientific background if required to help with patents and so on and so forth. So I believe this million dollars can be used for this goal. [00:33:12] Lindsey Dinneen: Ooh, I like it. Okay. Excellent. All right. And how do you wish to be remembered after you leave this world? [00:33:24] Marina Daineko: This is important question and I'm thinking from time to time exactly on it. So, it's very personal for me because it's also a funny story. When I was a student at the university, I was, I have been providing kind of mentorship for people who would like to study chemistry. So, and usually I was working with, mentorship, blaming the fire for chemistry. So showing that chemistry is not just something boring, boring science, but also very interesting and it can be kind of fun. So, I had a case when one boy he needed he needed improve his knowledge for chemistry just for his marks because he intended to, to get in British College. And, we were having the studies with him. I was explaining things and providing real life examples where and how chemistry can be utilized and improved. And in the end, this boy decided to utilize chemistry in his life, so he switched from math as well as physics to chemistry and connected his life with chemistry. [00:34:40] And for me, it was like, "Oh my God, it seems like I changed someone's life." And it was so, so inspiring for me that I decided for myself that I would like to proceed with it, that I like how I can make this connection to show people the beauty of different things, like for instance chemistry to this boy. And yeah, I believe that I'm pretty successful in such things, so I would say that I would like to be remembered as a person who can connect people with beautiful and inspiring things, changing lives in this matter. [00:35:26] Lindsey Dinneen: Ooh, that is a beautiful goal. I love it. That just gave me chills. [00:35:33] you [00:35:34] Marina Daineko: Yeah, no, I feel the same, actually, because for me, this boy, it was like a changing moment for me. Yeah, it's very powerful. Even this even this memory is very powerful for me. [00:35:47] Lindsey Dinneen: Yes. Thank you for sharing that story. It's a fantastic story, and I love that because it's so, that just speaks to you and your willingness to, to help somebody understand something that doesn't come naturally or maybe easily to them. And what a difference you made in that person's life, so, yes, I think that's incredible and a beautiful life goal of yours. [00:36:11] Marina Daineko: Thank Thank you, Lindsey. Oh yeah. To explain like complex things into simple, understandable steps is my favorite entertainment, I would say [00:36:21] Lindsey Dinneen: Ah, okay, I love it, alright. What is one thing that makes you smile every time you see or think about it? [00:36:32] Marina Daineko: Oh, I believe it's my dog. I have pitbull, but she reminds me a cat, mostly, because, yeah, no, really, because, for instance, when I have a door opened to join other room, to go into other room, for instance, but when I close the door she needs to come back immediately. And it makes me smile because it's behavior of a cat and also yeah she's sleeping and she is snoring from time to time and when I have a meeting for instance with my colleagues So I am asked all the time "Marina, please don't sleep." Yeah. So, yeah it's funny and I adore her. I am working with her, actually, I like, I love walking like 10 kilometers or so. She's not happy with this distance, but she has just simply no choice with it. Yeah. So, yeah, no, believe useful for her heart, so that's my, yeah. [00:37:35] Lindsey Dinneen: Mutually beneficial for both of you. [00:37:37] Marina Daineko: Yeah. [00:37:38] Lindsey Dinneen: Yeah. Very good. Oh my goodness. That's fantastic. Yeah. This has been so much fun. Thank you so very much for joining us today. I'm just so thrilled to have you and you're so inspirational. So thank you for doing what you're doing and how you're continuing to learn and evolve with the industry, but evolve your own skills too. Yeah. And we're, [00:38:05] Marina Daineko: Thank you. [00:38:06] Lindsey Dinneen: Of course. And we're so honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thank you for choosing that organization to ,support and we just wish you continued success as you work to change lives for a better world. [00:38:30] Marina Daineko: Thank you. Thank you so much, Lindsey. It was a pleasure. I really enjoyed our conversation, a lot of, love and insight. So thank you very much for invitation and yeah I'm really happy to meet you. [00:38:45] Lindsey Dinneen: You too. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:38:58] [00:38:59] Ben Trombold: The leading difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

In this episode, Ken Hoyme, a semi-retired product security expert, talks in-depth about his 40-year career focusing on safety-critical systems, which spanned across commercial aviation, aerospace, and medical devices, with a particular focus on medical device security. Ken reflects on the personal impact of his work, and also talks about his continued involvement in the field through consulting, teaching, and volunteering post-retirement. He also discusses troubleshooting solutions, his pride for his family, and his passion for pipe organs. Guest links: https://www.linkedin.com/in/kenhoyme/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 022 - Ken Hoyme [00:00:00] Lindsey Dinneen: [00:00:01] Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:08] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:13] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:27] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:37] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:41] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:47] Hello and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I am excited to introduce you to my guest today, Ken Hoyme. Ken is the semi retired former Director of Product security at Boston Scientific. His 40 year career spanned commercial aviation and aerospace and medical devices with specific emphasis on medical device security. In retirement, Ken continues to consult, teach, and volunteer. Welcome, Ken. Thank you so much for joining us today. I'm so excited that you're here. [00:01:20] Ken Hoyme: Thanks, Lindsey I'm happy to be here. [00:01:22] Lindsey Dinneen: Wonderful. If you wouldn't mind just starting off by telling us a little bit about yourself and your background, I would love to hear more about you. [00:01:31] Ken Hoyme: Sure, I'd be happy to. Being semi retired, I have had a career that spans close to 40 years, or actually I think I just passed 40 years about a month ago from when I started working. So I went to grad school, did four years of grad school at the same time my wife was in vet school, so four years of marriage that we were both studying like crazy. I never finished my dissertation on a PhD, so I'm the classic PhD, ADD person. Pretty much my entire career has been spent in safety critical, life critical systems, which has been a fascinating area. You gotta do the right job or people might die. [00:02:08] I started, split 50 /50. My first 18 years was at Honeywell Corporate Research Labs, where I ended up working on various things between integrated circuit projects, but a lot of it was focused on control systems for commercial aircraft, and so building safety critical systems that made the pilot interface to the airplane was fascinating, tough, but interesting problems. [00:02:32] Touched a bit on industrial controls and automotive controls, and then mid career, I got recruited away by former Honeywell folks who had gone to Guidant, medical device company at the time, that was later purchased by Boston Scientific, and where I ended up working initially on cardiac pacemakers and defibrillators and then shifted into remote patient monitoring, and that kind of evolved into more detailed interactions with how security can impact patient safety. [00:03:02] So a large fraction of the last 12, 15 years has been in medical device cybersecurity. Did a brief stint, three and a half years, at a small R&D company doing research on medical device cybersecurity, and then returned to Boston Scientific in 2016 to lead the product security program at Boston Scientific, which is what I was doing when I officially retired. [00:03:25] Lindsey Dinneen: Nice. Okay. So lots of cool twists and turns throughout your career. I wanted to touch on a couple things. The first is, you've actually talked about how one of the running themes was safety and safety critical systems and whatnot. And I'm curious, have you always had an interest or a passion in safety and security. Where did that come from? [00:03:49] Ken Hoyme: Given some of my behavior as a kid, you wouldn't think so. I certainly did my share of foolish things as you grew up. My, my interest in grad school was in computer architecture, kind of a foot between hardware and software, though I was in electrical engineering as a degree. So as I ended up at Honeywell, Honeywell was at that time focused on control systems. And control systems are cyber physical systems, they are computers touching the real world physically. And almost all aspects of cyber physical systems-- which are pervasive and now what's viewed as US critical infrastructure-- there's a safety aspect of whether you're talking about nuclear power plants or oil refining and things that can explode to commercial aviation, automotive. All of those things, if they don't work correctly, the people that are interacting with them that run the risk of being harmed. [00:04:44] So it really was that culture at the original research center of thinking about how you interact with the physical world. And so that really grew that interest. And that was the skill set in doing safety analysis that drew guidance to recruit me because it really was obviously another safety critical environment in cardiac devices. So it was a an early budding interest that was really nurtured by the projects and things that worked on for Honeywell. [00:05:14] Lindsey Dinneen: Yeah, absolutely. And then you obviously continued to grow in your career, you continue to be involved in safety and security. And then you had your stint at Boston Scientific. And I wonder if you could share a little bit more about some of the projects that you worked on that were particularly impactful or just moments that stand out perhaps. [00:05:36] Ken Hoyme: My first project, I knew nothing about things that bled. I had avoided them. In junior high, I had to dissect a frog, I really didn't like it. And so in high school, when you needed to have some science stuff, and I knew I was planning on going toward electrical engineering, I skipped biology and took chemistry and physics. And by working on cyber physical systems, aircraft and automotive and industrial controls, nothing bled, but I also had no pets growing up. [00:06:09] And when I started dating my now wife of 44 years, she had a quarter horse, 4 Shetland ponies, a dog and two cats at a 10 acre hobby farm she had talked her parents into buying so that she could have horses. And as a veterinarian, everything in her life bled, so we really had this difference in backgrounds, but interest in learning from each other. [00:06:35] And so when I first went to Guidant, the company recognized I didn't have that domain knowledge. And so I ended up being put on projects specifically with the goal of rapidly bringing me up to speed. I went to various classes on how the heart works, how you pace it, all the various different things. And I can tell you that the dinner conversation changed considerably as I was starting to learn these things and my wife knew these things. So it was kind of an exhilarating mid career change because of having to learn the domain. [00:07:05] So, because of my safety background, Guidant was working on a new architecture for their pacemakers and defibrillators. And I got put on the redundant safety core, which was a redundant hardware pacemaker and defibrillator. If anything failed in the rest of the device, the hardware would kick in and keep the patient pink. And so I got to work on that, and I ended up with several patents. [00:07:30] And so in 2006 or 7, I believe, my brother in law, my wife's brother, ended up with a viral cardiomyopathy and his ejection fraction was down at 15%. It's normally in a healthy human should be up around 70. He ended up getting a resynchronization defibrillator that I had worked on, as well as being put on the home patient monitor that I had been the lead system engineer in developing. And so that was that first family connection of recognizing that what you're doing is personal. [00:08:04] And a few years back, my now 95 year old mother in law has a pacemaker in her and I have four patents on the technology. So you're recognizing that people that you love and care for are using these things. And the people who get these things are loved and cared for by somebody, so it really becomes a passion of building something that works correctly and is safe. Those kind of things stand out in terms of things that are meaningful. [00:08:29] Lindsey Dinneen: Yeah, of course. Yeah, because when you are able to see the results in real time in real life, by people who you know personally who are affected by it, that's such a full circle moment of just recognizing that what you do isn't confined to this silo. It actually does impact lives. And that's a pretty cool thing to be a part of. [00:08:52] Ken Hoyme: And I crossed over into security. I can recommend the devices that I was involved in developing because I am personally familiar with the level of detail that had been done in terms of securing them. So I don't have fears that my family members or others are going to have hackers going after them, which is a paranoia in the industry. The idea of hacking pacemakers became, as Dr. Kevin said, " sucks the oxygen out of the room." It's theoretically possible, but very difficult to do, compared to devices that might be connected to a hospital network, which are exposed to more. [00:09:24] Lindsey Dinneen: And to that point, if you don't mind sharing a little bit more about how you were able to develop those skills and awareness of the importance of medical device security. I know that you are an expert in this field and there is a lot more education and knowledge these days, but it still seems like something every once in a while that you have to remind people, this is actually a critical thing. Do you mind speaking a bit to that? [00:09:52] Ken Hoyme: I started out as an electrical engineer, but evolved to a systems engineer, particularly working in aviation. I worked on the design of the flight deck of the Boeing 777. And Boeing is the-- at least they used to be, they've lost some of the secret sauce-- but they were the premier system engineering organization in the world. And working on a critical system for an aircraft with the master of system engineering, you start learning the techniques. So my, my evolution into system engineering was very much on the job training, certainly a lot of reading and things that went on at the same time, but it was also interacting with experts. [00:10:31] Similar thing happened when security came along is, I got recruited into Guident because of my safety skills. And then within the first year of being there, Guident was putting a remote patient management system together, which was a bedside monitor for every patient with the radio links to the device links up to a server that would analyze all the data for potential alerts that the physician should know. [00:10:56] The system has more than a million patients on it. So it's a scalable protected health information, all of that. Program Manager on that project understood the importance of the various ilities that sit around system engineering and deal with the development. So he hired in a PhD psychologist to do human centered design and machine interface, he had been dealing with all of those issues. And in the medical device world, user interfaces also touch safety, because if you have confusion and a physician or patient makes a mistake in using something, harm can happen. So it's another branch of safety. And he recognized the security implications of what we were doing and hired in security experts. [00:11:43] And so we had this old grizzled, bearded, absolutely canonical look of a computer geek that had been a chief architect at a company called Secure Computing and had been security. And he was titled our Security Curmudgeon and as Lead System Engineer, I worked with these various groups as we balance the design. And it really was interacting with real experts in this field who had no compunction about correcting me whenever I said anything that was inaccurate. [00:12:15] In that environment, I started absorbing. The methods of doing security and the importance of it and what those kind of, so it really was one of those cool opportunities in your career where you get to a Vulcan mind meld with experts and absorb the information and integrate it with what you know. [00:12:32] Lindsey Dinneen: Yeah, absolutely. And at the time of this recording the FDA has finalized their guidance and I'm curious to know what your thoughts are on that and how you feel it's going to affect everybody moving forward. [00:12:50] Ken Hoyme: It's interesting because both the original pre market guidance and the post market guidance came out relatively quickly. The time between the draft pre market and the issuance of it, I think was just less than a year, which everyone who were involved with guidance has said was light speed for the FDA. And the post market was similar, but they've done a couple of iterations in 2018 and 2022 of drafts. And, was in a meeting earlier today where two of the FDA people who had been working on that were mentioning that in both cases, they got more than 100, 000 comments back to the FDA related to it. [00:13:28] You know, the push by Congress to have it out by October 1st really pushed, I don't think anybody thought that it would be feasible to get it done. And yet they did it. It seems like they have clarified many of the concerns that were still in the 2022 draft, had some clear definitions about things like exploitability. So I think it really will anchor, and everyone is scrambling this week to read it and adapt to what's in there. But, the good news is it's not a giant leap from what they issued in 2022. So it's not going to have everyone doing a 90 or 180 degree turn on what they've already assumed it was heading for. So it's just good to have that out in its definitive form. [00:14:14] Lindsey Dinneen: Yeah, absolutely. And it'll be exciting to see how the industry adapts. [00:14:19] Ken Hoyme: As one example, the Health Sector Coordinating Council had published in 2018, I believe it was, their joint security plan, because the non formal standard, but kind of a guide, particularly helpful for smaller companies for what they need to do, incorporate cybersecurity into their quality system and their development. And a lot has changed, and so we have been working since middle of 2022, this is one of my retirement volunteer efforts that I'm involved in, to bring it up to date. [00:14:54] And there was a real goal for the JSB version 2 to be out by the end of this year. And we were worried about the race condition with the FDA getting their final set pre market guidance out. And so one of the activities now is adapting what we've written in the joint security plan to make sure that it is in sync and in line with the finalized guidance. By getting it out now, we have time over the next couple of months to make whatever changes we need to based on that change. Which will be good, it means when that guide is updated, it will not be anchored in an old guidance, but will properly reflect the new update from the FDA. So it's really great to see them do that. [00:15:38] Lindsey Dinneen: Yeah, absolutely. So circling back to something you mentioned, because I'm curious how you were able to overcome it. You mentioned you hadn't dealt early on in your career with anything blood related and you didn't necessarily want to go after that when you were in college. So how are you able to overcome that and say, "No, this is fine. I'm gonna, I'm gonna make it happen." [00:16:05] Ken Hoyme: Thankfully, I didn't have to personally do any implants. Okay. I didn't have to handle a knife or deal with that and get flashbacks of my frog experience. When I left Honeywell, I thought I was going to retire out of the company. I was in an absolutely great position at the research center. I was invited to the strategic planning sessions for the entire aviation business as a technical expert. Honeywell was bought by Allied Signal, which was quite a culture shift. They were far more prescriptive. You're telling research center, here's what you're going to do rather than asking you to partner with the businesses, determine how to best apply the skills. And the other aspect is because I had become an expert in commercial aviation, I was not learning at the rate that you used to. It's like, you know, a lot of things, you're doing more mentoring than individual personal learning. So when I shifted domains and got hired in because I was a senior fellow at Honeywell, they hired me in at the top technical rank that Guidant had at the time to be competitive. I felt a huge obligation to learn the domain as quick as possible. [00:17:19] I needed to feel like I was providing value. It's just not a good feeling to feel like you're taking a paycheck and not providing something for that. It's just not the way I was raised. And so I really took it on that I needed to learn this domain. And the reality, all kidding aside, is the work in understanding the physiology and the behavior of cardiac devices is really more about electrochemistry and how the muscles work and how arrhythmias occur and how they can be cleared. And so it was more of a learning a new technical domain than really dealing with the bleeding side of it. [00:17:57] Yes, when I was at Honeywell, we had a program where if we were working in the commercial aviation side, we had, it was pre 9/ 11, we had jump seat privileges. So I got to be in the jump seat of aircraft so that you could see how the pilots who use the systems you develop, how they interact with them, just as an experience base. And one of my cool things, just as an aside to talk about, along with the family members using cardiac devices is, I got to jump seat a 777 from Dulles to Frankfort, and that's the aircraft that I did a fundamental invention to enable how the flight deck works. So that was cool to actually see the pilots interact with what you did. [00:18:39] The same thing happened in the cardiac world is you got the opportunity to go and experience implants and see the doctors using and interacting with the devices. Again, part of that system's knowledge of how does the end person, the actual user, use those devices and how do you use that knowledge to get better. So the closest thing you get to bleeding is to watch somebody else do one but I never had to actually directly deal with blood. [00:19:10] Lindsey Dinneen: Okay. That's fair. That's a really good hybrid situation right there. Well, nowadays I understand that you are quote unquote retired, however, you are still quite active. So I would love to hear about your current initiatives and frankly, if you don't mind sharing, why you're still so involved, obviously you care, but I'd love to hear it from your perspective. [00:19:35] Ken Hoyme: So I've always been a bit of a workaholic. I gained a lot of my intellectual stimulation through the people I interact with. When I started a corperate research center, it was 25% PhDs, 50% master. It's a great learning environment because there were brilliant people are all around you. [00:19:52] One of my career advices I've given to the young people is go to a place where you are not the smartest person in the room, surround yourself with people you can learn from. Now you want to have your niche. You want to have something that you feel is your area of expertise that you build, but being or thinking you're the best person in the room isn't necessarily a good learning experience. So, I've always enjoyed interacting with people at various stages in their career. [00:20:20] So when I retired, I don't know how many different serious and semi serious reach outs I had from people asking what I was up to and what I was interested in. It was a dozen or something, but I had been interacting for several years at the company called MedCrypt out of San Diego, a company that focuses on initially tools to help secure medical devices, comes out of the medical device world and tools for software build of materials, things of that nature. And while I'm not a software engineer developing tools, they were also starting to build a service business to work with clients on how to improve their quality system. [00:20:59] When I was at Adventium Labs, that three and a half year stint I did between my two Boston Scientific experiences, along with doing government funded research on medical device security, I also did consulting with companies, and so I had formed a reasonably strong opinion about how you can best organize cybersecurity into a quality management system in a medical device company. And so being able to apply those skills, very lightweight, I've tried to keep my consulting to no more than one day a week so that I still can do some retirement activities. [00:21:36] And Mike Kijewski, who's the CEO of that, I've interacted with him for many years and he had been pursuing me before I retired. So they have some people on staff, two of them are ex FDA. One of their FDA people, Seth Carmody, had written the post market cybersecurity for the FDA and I think he did the first draft of the updated cybersecurity pre market. And then they have another gentleman, Axel Wirth, who I've interacted with for a decade and has written textbooks in the space. And so it was a way to continue where you got to really work with smart people and continue to have that intellectual stimulation that watching TV or picking up whittling doesn't give you. [00:22:16] Lindsey Dinneen: Fair, but those two activities on occasion could be good for your mental health, which we were talking about. So you can have both. You can have both. [00:22:26] Ken Hoyme: So my eldest daughter, when she was going through undergrad, wanted to take a class. She went to Luther College in Iowa, which was a very Scandinavian Norwegian school, and there was a class on Scandinavian whittling. And she really wanted to take it, and she did, but she was going into dental school, and so there was this paranoia about her slicing something important in her hand when she was whittling. She whittled with Kevlar gloves on! [00:22:54] Lindsey Dinneen: Oh! [00:22:55] Ken Hoyme: So there's a certain amount of connection, potentially, between whittling as a hobby and that blood thing that I didn't like, so that hasn't necessarily attracted me retirement hobby. [00:23:04] Lindsey Dinneen: That's a fantastic story. I love that. I wonder, you know, with her whittling skills, did those help her in her dental practice? [00:23:12] Ken Hoyme: She stopped it after undergrad. She also no longer plays the oboe, though she had an oboe scholarship along with her sciences because the finger stretching on the oboe ,she has all of the finger exercises she gets at work and doesn't really think she should be taking the risk of fatiguing it more. And so yeah, being safe in that environment has been important. So I think the thing that actually did the best for her is playing video games. She played things like Mario World, where you're having to constantly in your brain translate going around sphere things and jumping. And that's when you're looking through a mirror and drilling in the back of the mouth, you're constantly doing these translations. And so I'm convinced that all the video games she played growing up really gave her the spatial skills that help, particularly as she took the exams to get in, they do try to assess whether somebody is capable of that before you get into dental school, because you don't want to get in there and start getting into drilling and having somebody who just can't make their brain do that. [00:24:17] Lindsey Dinneen: Thank goodness. [00:24:19] Ken Hoyme: Exactly. [00:24:20] Lindsey Dinneen: That's fantastic. [00:24:21] Ken Hoyme: No wonder why people are afraid of the dentist. Maybe they had one of the bad ones. [00:24:25] Lindsey Dinneen: Right. Yeah, exactly. Oh, my goodness. Oh. [00:24:28] Ken Hoyme: And then I had already alluded to the fact that I'm, I'm doing volunteer work at HSCC on the joint security plan. And then the other thing that I did this last winter, and we'll be repeating this, is I had developed and taught a master's level class in medical device cybersecurity through the University of Minnesota's Technological Leadership Institute. And so after giving it once, they decided to make it a core curriculum for their medical device innovation. So it will be scheduled to be given annually. Things like the FDA keep coming out with new guidances, even while we were giving it last winter, one of the things that would happen each week is, this week, this got replaced. It's kind of this constantly changing environment that happens in this space. [00:25:13] Lindsey Dinneen: It keeps you on your toes and it keeps you learning and growing. I guess that's a great thing. [00:25:18] Ken Hoyme: I can't claim I've been bored. [00:25:22] Lindsey Dinneen: Brilliant. All right. Pivoting just for fun. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? [00:25:37] Ken Hoyme: My first thought might be a master class in how to hide out with somebody's million dollars and not get caught. Being realistic, if I was teaching in my domain, I would probably want to expand out things related to security and safety and how that really is my technical expertise. If I was going to jump out of domain, you know, just something that, might seem off the wall would be a masterclass on the design and physics of the pipe organ. [00:26:09] Lindsey Dinneen: Oh, tell me more. [00:26:12] Ken Hoyme: When I was growing up, I studied the classical organ and sang in choir, was in the all state choir in high school and came out of high school thinking, music major, engineering, music, and I ultimately decided I could do music on an engineer's salary a lot easier than the other way around. And so I had twice been on pipe organ projects at churches I've attended where they brought in and bid and had a pipe organ builder install. So I've been close to that process. When I've been over in Europe, I seek organ recitals. So I've gotten to hear many instruments in Europe that are older than the United States. [00:27:00] And so, yeah, that's always been a passion and fascination of mine because there's such a engineering aspect of that and yet so much of it is musicality. And I've learned a lot interacting and talking with these builders. If I had a million bucks, I would be able to dive deeply into the topic and try to flesh out something that would actually be more comprehensive. [00:27:23] Lindsey Dinneen: Amazing. Okay. So I have to ask you, since you are a pipe organ enthusiast, how do you feel about the fact that there's quite a lot in pop culture of, it's being a vilified instrument, you know, you have the Phantom of the Opera, and there's like a Disney something that has a pipe organ that's a bad character. And how do you feel about the fact that pipe organs are used as villains? [00:27:48] Ken Hoyme: It's always an interesting thing when popular culture adapts something that is so much deeper. As a totally different but slight example, the accordion has always made fun of it. I don't remember how I tripped across it, but there is a very famous organ work by Olivier Messiaen, a French composer, which is-- I think it translates from French to English, "The Epiphany of the Lord." It is a multi-part work related to the Christmas story, and it is incredibly complex, somewhat challenging to listen to, you have to be quite into it. But there is a movement called Du Parmanu, which is, " God Descends and Becomes Us." And it is one of the most bombastic, just these big, huge chords. It's just exciting to hear. [00:28:40] And back 20 years ago, I heard or saw something about a Russian woman who had recorded the entire suite on accordion. And here in the Twin Cities, and it's nationally distributed, but I don't know how many different places, there's a gentleman by the name of Michael Barone who works for Minnesota Public Radio, who for 30 years plus has produced a weekly radio program called Pipe Dreams, all about the pipe organ and that. [00:29:10] So I ended up ordering, because I had a friend who was Russian and was only available on a Russian Amazon kind of equivalent, copies of it and sent a copy to Michael Barone and he actually played an excerpt. I think he did the Du Parmenu section on his radio program. And it's in countries like Russia, the accordion is treated very much differently than in Western countries, where it's more of a polka accompaniment. And so it's different instruments have the different faces, depending on how they're viewed and who's viewing them. So I just tend to look at the mass media view of it as the unwashed heathen. [00:29:48] That said, there is a woman who is bursting onto the scene, she's 26, I think, British, name is Anna Hapwood, and she has been making TikTok videos of her playing the organ, including at the, the Albert Great Hall that they do the BBC proms, and she is popularizing the instrument through her TikTok videos. I think it was CBS Sunday Morning, I saw her interviewed about how she's popularizing the instrument. You never know with the modern media and music distribution, how somebody might reinvigorate interest in something that was viewed as old fashioned before. [00:30:26] Lindsey Dinneen: Yeah, I love that. I love that. And I think it always depends on context. All sorts of instruments, for instance, could be used to be very light hearted and fun or very serious and mysterious. And part of it is just, yeah, are you playing in the major or minor keys? And, all the things that go into it. But anyway, it's just funny because pipe organ, I feel is one of those instruments that is a little polarizing [00:30:50] Ken Hoyme: I understand that. I was warped as a child and the interesting merging there is my father was a serial hobbyist. And when he went into a hobby, he went in 110%. And when I was growing up in my formative years, he was into gardening and breeding his own Asiatic lily types. And we had flowers everywhere and garden clubs would come through and tour the garden. [00:31:23] Then he went cold turkey on it and decided to build him an electronic organ in the basement and he built it from initially a kit and then through other designs that he did. And so I was in fifth or sixth grade with the soldering iron in my hand, helping build this electronic organ. And it was, part of what I view, my dad, his dad died in the Great Depression. He came out of World War II and really had to support his mother and sister, and never really had the money for college-- he would have been a great engineer-- but instead he manipulated my brother and I to both become electrical engineers, and part of it was by these, so part of my interest in organ was also my father's manipulation of getting my brother and I both interested in electrical engineering. [00:32:11] Lindsey Dinneen: Hey, it worked out. I love it. Okay. [00:32:14] Ken Hoyme: My brother has a church organ in his basement, so it took a little heavier with him than it did with me. I enjoy it being played but I don't play it myself anymore [00:32:22] Lindsey Dinneen: Ah, understandable. Well, what is one thing you wish to be remembered for after you leave this world? [00:32:24] Ken Hoyme: Number one would be that I didn't overstay my welcome. I would hope to be remembered that I made lives better, I made lives safer. That attention to detail matter and I worked on things that were significant, that actually had meaning for people's lives. When I moved from Honeywell to Guidant, I said, I used to be worrying on things that if they failed, people might die, 375 people at a time. And then you get into medical devices and now you're working to save their lives, one at a time. I would hope to be remembered that I worked to make a difference and had positive impact on people's lives. [00:33:03] Lindsey Dinneen: Yeah. Of course. Yeah. And then final question, what is one thing that makes you smile every time you see or think about it? [00:33:14] Ken Hoyme: I would have to say my children. Yep. I'm incredibly proud of them. They're both, both professionals, a dentist and an audiologist, they have remarkably snarky sense of humor that I presume they got from their mother. My story on that one was, I was telling my eldest one time, she said something snarky and I said, "Kirsten, you are the queen of snark." And her instant response was, "Yep, broke it, you bought it." But yeah, as you think about what you leave behind in the world, and I'm incredibly proud of them and the things that they've learned. They both secure, use individual passwords on every website and deal with the internet with the sufficient paranoia that they should, so I'm proud of that as well, but yeah. [00:33:57] Lindsey Dinneen: Excellent. Well, It sounds like you raised them right. [00:34:01] Ken Hoyme: They're great kids. They had to live with growing up with their dad being an engineer. [00:34:06] Lindsey Dinneen: Yeah. But it looks like it all worked out beautifully. So I'm very glad to hear all that. Ken, this has been so much fun. I really appreciate you joining me today. It was great to hear about your background and your advice, and I loved especially hearing about some of the little nuances that I wouldn't have gotten to otherwise, like pipe organ interests. So that's fantastic. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thanks so much for choosing that organization to support. And we just wish you continued success as you work to change lives for a better world. [00:34:54] Ken Hoyme: Thanks, Lindsey. I really enjoyed chatting with you. [00:34:57] Lindsey Dinneen: Yeah, same. And thank you so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:35:10] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dr. Kenneth Brown is a private gastroenterologist with a clinical research division at Atrantil. Dr. Brown shares his journey from traditional medicine to a more holistic approach, blending natural therapeutics with traditional methods to treat gastrointestinal issues. He also discusses the advantages of being a generalist, how to care for your microbiome, and the need for more education about the link between gut health, brain health, and overall wellbeing.  Guest links: https://www.linkedin.com/in/kennethbrownmd/ | https://atrantil.com/ Charity supported: ASPCA Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   EPISODE TRANSCRIPT Episode 021 - Kenneth Brown Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome to The Leading Difference Podcast. I'm your host, Lindsey, and I am excited to introduce you to my guest today, Dr. Kenneth Brown. Dr. Brown is a private gastroenterologist with a clinical research division. In his practice, Dr. Brown uses a mix of traditional medicine and natural therapeutics to treat patients suffering from gastrointestinal issues. He hosts the Gut Check Project podcast where he and his team address topics surrounding gut health, healthcare economy, patient safety, nutrition, and more. Thank you so much Dr. Brown for joining me today. I am so excited that you're here and welcome. Dr. Kenneth Brown: Thank you so much, Lindsey. I'm super excited getting to be a guest on The Leading Difference podcast. Awesome. I typically am always asked to do medical stuff, so this is a little bit out of my scope, but very exciting nonetheless. Lindsey Dinneen: Great. No I'm very excited to have you and talk with you, and I would love if you would start by just telling us a little bit about yourself and your background and how you got to where you are today. Dr. Kenneth Brown: Yeah, absolutely. So I'll take you way back. I was in medicals, I basically raised in Omaha, Nebraska. I was in medical school scraping ice off my car and realized one day, "I don't have to do this." And so I immediately drove down to Texas as quickly as I could, did my residency and fellowship, and became a gastroenterologist and still residing in Texas. I seemed to like the warm a little bit more than that scraping ice off cars. So I started my practice about 20 years ago. Initially, I started doing clinical research specifically for the pharmaceutical industry. And I was helping launch some small biotech firms that were developing products. We were doing research for them, and in that time I realized there was this unmet need. In other words, no drug was being developed, or no drug existed for this big space called irritable bowel syndrome. I started to do research for the first drug that was trying to address this when I was in training. IBS, Irritable Bowel Syndrome, was considered more of a psychological diagnosis and literally I was taught that if you do tests on people and everything is normal, then more than likely, it is a psychological thing. We used to think the same thing about ulcer disease. Whenever it was 50 years ago, if you got an ulcer, it was because you were too stressed. You need to back off work, do something like that. Then we found out that it was probably due to a bacteria called Helicobacter, H Pylori. And the person that discovered that got a Nobel Prize. That same massive paradigm shift was starting to take place when I was doing this research about 15 years ago. And that was that a doctor had shown that irritable bowel syndrome is actually caused by bacteria growing where it shouldn't be. And that's called small intestinal bacterial overgrowth. So it's just that bacteria growing where it shouldn't be. And I was doing the clinical trial for them to look at treating people that had irritable bowel with diarrhea and in passing, I was having a conversation with the lead investigator and he said, unfortunately we'll never be able to help the bloated person with constipation because the type of bacteria that is causing it is a very old, ancient type called archaebacteria, and no modern antibiotics affect it." And that was kind of interesting. And and he said, "the issue is that this type of bacteria produces a gas called methane." So I'm writing on my whiteboard in my office, "archaebacteria methane." And I start thinking, I started the story in the very beginning, 'cause I said I was raised in Nebraska and I scraped ice off my car to come down in Nebraska, the prime export would be agriculture. And what they were trying to do is mandate that these ranchers and farmers give different feed products to the cattle to decrease methane production that they're admitting for the Greenhouse Effect. And I looked at that and I just went, "they've been trying to do this in Nebraska for a really long time. What is it that they're giving these cattle and can it be transferable to humans?" And so that sort of started the "aha!" moment of a bloated cow producing methane could be something eventually that might help the millions of people, and I mean millions, like 20% of the US population suffers from some form of irritable bowel syndrome and many more suffer from bloating and have never been diagnosed. So I spent the next several years, me and my research manager, and we were looking at all the data in animals, and then we came across this combination of three large polyphenols, which are the molecules that make vegetables and fruits colorful. And realized that one of the major ones in there is something called Quebracho Colorado that had never been used in a supplement before, but it is used in wine making and beer making and many other things that humans are already consuming. Went through some trouble of trying to get some Quebracho. This is in the like, weird things that happen with entrepreneurs. The only place that it is being developed is Argentina. And I happen to be half Argentinian, so I'm emailing, I'm calling, I'm trying to do anything to get hold of somebody to get me some of this product up just so I can do a clinical trial on it. And nothing was happening, I'm getting no response. And so I actually called a cousin who's a physician in Argentina. She physically drove to the manufacturing facility, walked in an office and said, "there's a doctor in Dallas that's needs your product. He thinks he found a reason to give it to humans." And so that started this whole domino effect. And then eventually I get this shady bag of material sent to my office and I had to spend a lot of money to have analyzed and everything because they're used to working in the agricultural business where they would just send bags of stuff. And so I was able to get this analyzed and all this other stuff, and then we encapsulated it and then put it with a few other things, and then ultimately did two clinical trials and found that it was remarkably successful in this patient population. And, we were able to launch this company called Atrantil. And that was about seven years ago that we were able to actually launch the company. And we have just been learning more and more about the science of all of this. I've been fortunate enough to do this at the exact time where you and I were talking off air about where there seems to be this push for more awareness about nutrition, more awareness about doing things naturally, and not always relying on drugs to do everything. So I feel like I'm very fortunate to be in this great space, learning a ton. And being able to help millions of people at the same time. So that's where we're at now. Lindsey Dinneen: Yeah. I love your story. Thank you for sharing that. There's a few different things that really stood out. First of all, I'm curious, did you always want to be a doctor? Is that something that was always a bit of a goal for you, or what made you decide to go into the medical field? Dr. Kenneth Brown: I don't know how detailed you want to get into this, but I will tell you another quick story since this is, that one's very specific because, when I was in eighth grade, summer of eighth grade, my childhood friend got severely burned when he was on vacation with his mom. Third degree burns, ICU, whole nine yards, both him and his mom. And I get a call, you know, I was in touch with him, this is back before cell phones, so it's landlines. I get a call from him and he goes, "they say that I need to get outta the hospital because, mom needs to stay in here a little bit longer." Like they were in the ICU for a long time, so he had skin grafts and everything. And I said, " just come live with us." And didn't even ask my parents and I just said, "Junior's gonna come live with us." And so he came and ended up spending a year living in our house and I was changing his bandages and all this other stuff. One night, at like 8:00 PM at night, doorbell rings and it's a guy-- introduced himself, his name was Leonard Woods. He said, I'm a physical therapist. I hear you have a young man who could use little help. I'd like to volunteer my services. So he just basically rehabbed and then we all became friends, all of us. And of course I'm watching this guy that comes over and volunteers his time and I for sure am gonna be a physical therapist now. And I'm like in ninth grade, go through high school, always kinda shadowing and then during college doing some internships and stuff. And this guy saves my friend and he's this super cool dude and this is what I'm gonna do. And then he pulled me aside and he just said, "Hey, I know that you think this is what you should do, but I really think your calling is to be a doctor and I think you need to apply for medical school." So I went, "okay." I just, at this point, I'm gonna do something in healthcare, just to help people. And the fact that your hero slash mentor is telling you to not do the job he's doing that he loves, I'm like, "okay, I guess I'll apply to med school." And then I ended up graduating college early, so I got a chance to spend a year, and I worked officially for him and he knew I was going to med school and then he spent that year teaching me how to manage employees, teaching me how to manage patients, how to run a busy clinic. And he just said, " dovetail me so that you can see how the business side of this stuff works." And I was fortunate enough to go to medical school already having some idea of how I would do this and then I thought I would be a surgeon and then quickly realized that's a horrible lifestyle. I think I need to shift gears and was internal medicine. And then found gastroenterology and that fit me like a glove. So a gastroenterologist is an internal medicine trained doctor, so they already have a predisposition for a little bit of intellectual curiosity, but you get to do procedures. So you get to get in and immediately fix or help or prevent various diseases. And so as a gastroenterologist, you basically are treating things from the esophagus to the anus. So I got into fellowship to be a gastroenterologist. I'm loving it. And then that's when I started realizing, "wait a minute, all health begins and ends in the gut." I was seeing all these people, they had gut issues years before they had something else. Everybody would complain that they had something else, and so, when I started private practice, that's how come I was drawn immediately after just a few years, I started the first research division of our company and I did research for about 10 years and it was just this beautiful sequence of events that led up to that point where I'm thinking about a bloated cow. I mean, it took a really nice physical therapist to show up and then physical therapist to tell me to do something different-- possibly more, depending how you look at it-- and me to realize that all health begins and ends in the gut. And I basically continued that with that complete curiosity. And I'm continuing to learn all the time as everyone else is, as we're all learning that the gut is probably the root of disease and health. Lindsey Dinneen: Yeah. Thank you for going to that story. I love hearing the why, what prompted somebody's interest or passion in what they're doing, and it really struck me-- both kind of stories you've shared with me so far about how synergistic from an outsider's perspective your life has been in a few different ways where like, seemingly no connection. So grew up in, in Nebraska and just you didn't like the snow, which I totally relate to by the way, side note. And then drawing from that experience is what helped you translate that into your work more recently. And that, that seems so disjointed, but it actually was this synergistic connection. And then you also have something like, you mentioned the one random place in Argentina and you had the connections, and I just love those stories when what's meant to be comes together in such a way that you could never predict. Dr. Kenneth Brown: For sure. And the other thing about it, you say the story, but I look back and it was months and months of just radio silence. But I knew that we had something there. So it was me asking around, call my mom, "do we have anybody in this part of Argentina?" And so it took that continual pursuit of doing that. It wasn't just, oh, dumb luck. It's there, but it's the knowledge that it's there and it's the knowledge that you have an angle and it's the knowledge to utilize your network to try and get there. The story sounds like it just kind of fell in place, but I think with every entrepreneur that you speak with, there's that classic line, "it only took 10 years to be an overnight success." There's so much more that happens back over here. And I look at this and I realized that some of these decisions that were made-- I don't know if you gave me another shot at this. Do you ever think about this? I mean, you have this incredible dualistic career of being a ballerina and then being in the medtech, entrepreneur space and marketing and it's funny 'cause you love your life and you've got this great situation that you have going, when people say, "would you ever do it again?" I'm like, "no, no way. 'cause I don't know if I would make the right decisions, even though I know what decisions I made. I don't know if I would make the right decision to get exactly where I'm at right now, 'cause I kind of feel like I'm just beginning about where we can go with all this." Lindsey Dinneen: Yeah. But that's the fun part, right? So it is kind of an interesting exercise to look back and think about the "what ifs." And if you were to redo it, would you make the same decisions? I've thought about that many times with different aspects where I chose between two seemingly really good options, but I'm so thankful I went with the one I did because that got me to where I am now. But you know, I was chuckling about your overnight sensation comment and I have thought about that so many times where, agree-- from an outside perspective it always looks different-- but I've always appreciated the quote, something like, "the harder I work, the more luck I have," or something like that, Dr. Kenneth Brown: Exactly. Lindsey Dinneen: I also think there's something to be said-- you talked about drawing on your network and the months of work that it did take. But I do think that there is something to be said to being open to possibilities that you wouldn't ordinarily pursue, or opportunities that you wouldn't ordinarily consider, because sometimes those, again, seemingly random, disconnected moments, somehow do all come together. And it might not be this overnight thing, but... Dr. Kenneth Brown: Have you heard of a book called "Range" by David Epstein? Lindsey Dinneen: Nope, but I'm writing it down. Dr. Kenneth Brown: So the book is called "Range: Why Generalists Triumph In a Specialized World." It's really interesting because it's an analysis-- who's looking like business leaders and things like that, and generalists that learn a little bit-- it's always thought like in medicine it's " jack of all trades, but master of none." So it's that whole thing of jack of all trades, but master of none. And so in my field, you wanna become the most specialized of subspecialists that just, you're the expert. And I think because of my path coming in, there was never this devotion to this one thing immediately or I'm gonna be the experts' expert. I'm a generalist in life and I eventually end up in this space of a specialized world. But I seem to be better off 'cause I was a generalist. And what I mean by that is in his book, what he describes is that when you have lots of life experiences-- if you've been in marketing for a little bit, and then of course you did have that, brief minor in accounting during college, and then you dabbled into sales over here-- and what he showed is that if you are adept at looking at this and you're still passionate about everything, you make the neural connections between these different experiences so you can see a connection between something where others are not. And almost by definition, that's kind of what genius is, where you can continually see things and go, "yes, this idea over here relates to that article that I read five years ago." I see where this happens, and that's how you end up having an electric car company and a rocket company and a whatever that Elon Musk does, right? He's just pooling from all this knowledge and forming something. So I think that is probably the most important thing, and I'm, and I say all this because my massively transformative goal for the rest of my life is to cure something that to me is the, like, the worst thing that can happen, which is robbing you of your memories. So dementia, it's an epidemic and it continues to go on, and I feel like what you lose when you have any type of brain trauma, even minor trauma, CTE, when you have toxins, when you start developing Alzheimer's and things, you lose the dendritic, meaning the connections between the neurons that allow that use of prior knowledge to now be integrated with new knowledge. And so that's why I think it's so important to protect the brain through the gut. Is any of that making sense? I feel like it just went down a rabbit hole. Lindsey Dinneen: No, I love rabbit holes, first of all, so that's great. But also I think that is such a fantastic goal and it's so important and actually very encouraging to hear people working on these kinds of things, and the losing your memories and not being able to recognize people you love but realizing that maybe there are ways to slow that process or reverse or cure, that's a wonderful, hopeful thing. Dr. Kenneth Brown: So that's the thing. Nobody's talking about that, but there's so much evidence out there. So one of my most frustrating things being in this space-- so what's happened since the-- I did, traditionally trained gastroenterologists, and then I'm doing pharmaceutical research and then I figure out that there's this space where maybe natural products can start filling the void, and that has really just shifted me to what I would consider myself more of a functional gastroenterologist. I still do traditional gastroenterology stuff, but I sure would like to find a more natural solution before we just knee-jerk and put you on drugs. And one of my most frustrating things when talking to colleagues is, and I'm not throwing any individual under the bus here, but I start talking about, "oh, did you see this?" For instance, "hey, I just read a great article on the neuromodulatory effects of flavonoids, polyphenols, my world and gut microbiota through the gut brain access and how we can ultimately start healing our brains by having the right microbiome plus flavonoids. So that's an article. Just reviewed it. Super cool. Neat." And discussing that amongst my colleagues would be like there's no data on that. And I went to a meeting recently and I was preparing to give a talk on, if you keep your microbiome young, you'll stay young. And, and it's all about manipulating your microbiome. And there's evidence to show that our supercentenarians, the ones that live past 95 or whatever, they actually have a microbiome, the microbiome is the collection of bacteria in your body, the collection of bacteria primarily in your colon that they have their own genome. You and I have a 99% identical genome, but we could have a 90% different genome in our microbiome, which may be one of the reasons why I age quick and you don't, one of the reasons why I get cancer and you don't, got it? The microbiome, it's the collection of the bacteria in our body. So I was in a meeting, so I'm already preparing for this talk about the microbiome. And so I'm going to Croatia to give it. So I'm like really excited and it's, it's motivating 'cause I'm learning and everything. And I go to a meeting where a professor emeritus is gonna give a talk on probiotics and he gets up and the actual title of the talk was the "Probiotic Guide to the Gastroenterologist in 2023." And he said, "I think we can finally agree to this," and this is his words, "that the data does not support the use of traditional probiotics and we need to move away from this, and this is data. So some people do well in probiotics, but the data really is showing that probably traditional probiotics don't survive the digestive tract." And he said, "but what we really need to start thinking is we need to work on our microbiomes, but unfortunately, there's no data out there." I'm in the audience and I have a folder of about 200 articles and a Mendeley. Mendeley is a journal repository on my computer of like another 300, and I'm like, "no data out there?" And it just got me thinking. I'm like, unless you have a specific desire to go look at something, the data that you're referring to is when a drug rep shows up at your office and gives you a detail piece 'cause that's how we're being reminded that there's new research. Here's the new drug, not are there any new, because this is like bench research that's going on all over the world. Now we live in unprecedented times. I can find an article that hasn't even been translated in English yet, translate it from some postdoc candidate in Thailand doing crazy work on the stuff that I'm working on. And this is a true story. This is exactly what happened, and it's helping me develop more products because I'm like, "Oh, this person did do the heavy lifting already." And it was done 10 years ago and nobody's probably even heard of this. It's out there. It's just, do you have the motivation and the time to go look for things? Right now doctors are super busy and the time that they have is the five minutes they get with the person that brings them lunch. Lindsey Dinneen: Wow. Yeah. So pivoting just slightly. I'm so thankful again that there are people like you doing this research and analyzing this data and helping us live healthier, fuller lives. So first of all, just thank you for that. I am curious if there are any moments that stand out to you throughout your career as really affirming that this was the right career path for you. Dr. Kenneth Brown: Yeah. There was a-- I can't call it "aha moment" or anything. It is a, " you cannot not do this" moment, is what it came down to. So I'm an adult doctor and a woman who quit her job brought her 18 year old, severely autistic son in to see me. And I don't have any particular specialty in autism or anything like that. And what she said to me is, she goes, "I need help, 'cause he's now a young man. He's big and he's strong." And she said, "Nobody will take him. Like nobody will babysit him because he can be aggressive. And he's getting much worse with his autism and things are very rough on me, I had to quit my job. I have to spend all my time with him at home." And I said, "I'm just curious, why here?" Now this is years ago, so it isn't like I was really deep into the functional medicine yet. And she said, "I've noticed one thing. I've noticed that when he eats, he's much more combative, and he's non-verbal so his communication is just really limited." And she said, "There has to be something with his gut if it's doing this." it didn't take very long to realize that he was getting super bloated after he ate and his belly hurt and he couldn't say, "I'm hurt, I'm hurting." And so now we're in my wheelhouse. I started doing some research real quick and it's very evident that people on the autism spectrum disorder can have dysmotility or changes in the motility of their intestines, which can predispose to developing bacterial overgrowth, which is exactly my space now. And so we treated him and we treated him with both an antibiotic and my product and then changes diet. Changed lifestyle, change his diet, just made some changes. No processed foods. Don't open a bag. It's whole foods. I personally, with the way that we grow our crop, I really try and get patients to avoid gluten as well. I think it's very neuroinflammatory. And so she came back three months later and she was crying. And she was so happy. And this young man was calm. He was talking. She's like, "he can eat." She's like, "I haven't seen him like this in 10 years since he was like a little kid." And I'm like, "Okay, this is the n-of-1 that tells you, the brain and gut are connected and you have to keep pursuing that." And so that was oof, I dunno, six, seven years ago or guess well, like shortly after we launched. So I guess about, yeah, I dunno, six years ago or so. Yeah. So when you say that, I always think about that, if that's ever a case. I've heard that many other times since then and I don't think it's just the product or the antibiotics, I think it's the lifestyle change as well. Lindsey Dinneen: Yeah. And how it all comes together to support Oh my word. Wow. Thank you for sharing that story. That is really powerful and I can see why it would be such a moment that would make you say, "yeah, this is what I'm meant to do, this is the impact I can potentially have on changing someone's life." There's nothing quite like that. Dr. Kenneth Brown: Yeah. And then the more that you get into it, it just more reaffirming. So then it just becomes all consuming. You're like, you have to do this. And I think everybody that owns a business or is an entrepreneur-- I'm the visionary. We need an implementer to make things run at the company and all this. So if I had all the time and all the money in the world, it would just be 24/7 trying things out, looking at these natural products. The beauty is we're learning that the modulation of the microbiome, the gut microbiota, the thing that seems to positively affect them the most are these large, stable polyphenols. And it's these large, stable polyphenols that get broken down into smaller phenolic compounds that work in an anti-inflammatory way and can cross the blood brain barrier, which is what I think is happening. Just go ahead and name any neuro-inflammatory disease from anxiety, A D H D, dementia, autism spectrum. There's different neurologic mechanisms primarily excitability and overactivity due to inflammation, creating all of it. So knowing that's the root cause, where does most of the inflammation come from? It actually can start in the gut. So knowing that, how do we stop that inflammation? And then how do we improve the microbiome to produce anti-inflammatory aspects that then heal the brain? And the science is mapping out there. I think the traditional scientists will say that we don't know enough about it. And that's true, 'cause you can't manipulate it in a way that people wanna manipulate it, but, I'm kind of taking that functional approach. Let Mother Nature figure it out. Just give your body what it wants, give it the foundation. Make sure you have a good sleep. Make sure that you socialize. Make sure that you exercise a little and make sure that you eat the right foods and all of it will sort of work itself out If you have your foundation right. Lindsey Dinneen: Yeah. So last year, I had the opportunity to spend a little bit of time in Puerto Rico and there was this beautiful rainforest that we did a hike in. And it was really interesting, our guide was telling us that with the hurricane that they had just a few years back, had destroyed like, I wanna say maybe 80%, it was a very high percentage of the flora and fauna of the rainforest. And when we were there, there was no way we would've known that had she not pointed it out. And it really struck me how resilient living things are. I think about this with humans as well. And when you intentionally try to nurture and cultivate and take care of yourself or other living things, how much we can bounce back from and how much we can heal and regenerate and make new, and I just thought of that when you were talking about the possibilities that if we can heal our gut, maybe we can heal our brain and heal some of these other things that come from, from that inflammation. Dr. Kenneth Brown: Yeah, for sure. So let's use that same analogy with the hurricane, because what we do to our microbiome is a tropical forest. Exactly what you are walking through. There's trillions of bacteria. There's thousands of species. The more diverse it is, the healthier it is. Just like the rainforest you were walking through. Now you take antibiotics, you eat a highly processed diet, you do something to disrupt it. That's equivalent to that hurricane disrupting the rainforest. The difference is we continue to do that and what we try to do is, we try to take control of it and take drugs or take different things to try and say, "oh, I'm gonna heal it with this." So the equivalent would be, when the rainforest was knocked down, somebody comes in and goes, "the rainforest was destroyed, but what I'm gonna do is I'm going to plant anything, name it, corn. I'm gonna plant grass, anything." And so now you have a big lush field of grass. Now on the one side is just grass, and on the other side is a dense tropical forest. The dense tropical forest is the healthier version. We tend to focus on one bacterial species. That's where the science is. It's like, how do we grow more of this? How do we do more of this when it's the diversity that has to happen? They left the rainforest alone and it figured it out. And grew back quickly. The more that they would intervene with that, the slower that process would be. Lindsey Dinneen: Yeah. Thank you for taking my own thoughts and putting it in, into exactly what we're talking about 'cause I appreciate that. Okay, so I am gonna take the conversation slightly differently, so just for fun, imagine you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your industry, could be related to your work, but it doesn't have to be. What would you choose to teach and why? Dr. Kenneth Brown: Oh my goodness, it's gonna be so boring 'cause it's, I mean, the masterclass would be this exact same topic. It's, you can protect your brain through your gut, would be what it is just because there's too much evidence that so little people are talking about it. And would it be a masterclass, 'cause I'm still learning? You'd pay me a million dollars and we would have to share it, 'cause it would be a group learning session. That's what it would be like. Everybody that attends, we all teach each other and share the million. Lindsey Dinneen: There you go. You can use part of it to further your work because you were saying, if you had unlimited resources, how much more could you do? So, we can share the love. Dr. Kenneth Brown: Yeah, I just, immediately was thinking, "my ego would not allow me to accept a million dollars to give a class". I'm like, "oh my gosh." What kind of a, like, there's my PowerPoint. Could never be that good deserving a million. Lindsey Dinneen: Oh, yeah. Like We'll just give it to your organization and I'm sure you could find good ways to use it. I'm sure that would be a worthwhile masterclass to take, and it would be just a good learning experience for everyone. So, good answer. What is the one thing you wish to be remembered for after you leave this world? Dr. Kenneth Brown: I wanna be remembered as a curious and kind person. Lindsey Dinneen: Yeah. I like that. And then final question, what's one thing that makes you smile every time you see or think about it? Dr. Kenneth Brown: Dude, I'm so boring on these questions. Like my knee jerk is like, oh, my family. I want to give something cooler than that. Oh my gosh. I try to practice some mindfulness type things. Have you heard of neurolinguistic programming? NLP? And so you know how there's an anchoring technique so that you can get yourself excited or happy? I will say that my happy memories would be, I took my family to Spain and we went to a Michelin star restaurant and had a chef's tasting menu there. And just thinking about that is my, anchoring to be happy. And then this summer, we went to Portugal and did the exact same thing, except the kids are older and all this other stuff. And so something that makes me smile immediately. Alright, there we go. It doesn't even have to be me. Something that makes me smile immediately is when people are loving and caring and they're breaking bread with each other over a nice Mediterranean meal. Lindsey Dinneen: That is a great answer. Yes. I would have to say that I, I can fully support that. I love both Spain and Portugal, and some of my fondest food memories would have to be there too. So see this. Dr. Kenneth Brown: It's just that feeling of, just openness and enjoying and discussing. There's something primal about breaking bread with other humans in a way that is, I don't know. And of course, it's a chef's tasting menu, so you don't know what's coming. There's that dopamine anticipation, and then it gets put down and it's like nine courses. It's just stuff like that that's awesome. Lindsey Dinneen: Oh, I love it. That's amazing. Thank you so very much for joining me today. This has been such a great conversation, and I learned a lot. I'm very thankful for the work that you do and just all the ways that you finding to help people live their best lives. I just wanna, again, say thank you for your time and as just a small token of that, we're honored to be making a donation on your behalf to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. And we just appreciate again, your time, your efforts, and we just wish you continued success as you work to change lives for a better world. Dr. Kenneth Brown: Thank you so much, Lindsey. Thank you so much for having me on. And I really enjoyed this and I enjoyed our 10 minute off the record banter and I feel like you would be a great guest on the Gut Check Project, my podcast, and we can talk about the ballerina days and all that. Let's do it. Lindsey Dinneen: That sounds amazing. Alright, well, thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love if you'd share this episode with a colleague or two and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Allison London Brown is the CEO of LUMINELLE 360, a company focused on improving women's health through innovative medical technologies. In this episode, she discusses the challenges of fundraising, particularly for startups and women-led organizations, and the importance of personal mission and storytelling in leading a company and securing financial backing. Allison also emphasizes her commitment to changing diagnostic practices for women's health, particularly uterine biopsies, by developing a device through LUMINELLE 360 that enables physicians to perform these procedures more effectively. Guest links: https://www.linkedin.com/in/allisonlondonbrown/ | https://www.luminelle360.com/  Charity supported: Tunnel to Towers Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Production: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 020 - Allison London Brown [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:10] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:39] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:43] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome back to The Leading Difference Podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Allison London Brown. Allison is the CEO of LUMINELLE 360. She is a visionary leader with a passion for changing the lives of patients, providers, and caregivers and inspiring teams to achieve their full potential. She has experience working with startups, venture backed organizations, global partnerships and corporations, as well as associations, NGOs, and global government agencies. Thank you so much for being here. I'm so excited to talk with you. [00:01:28] Allison London Brown: I'm excited to be here. It's, it's great to meet you, Lindsey, and to talk to your audience, and I look forward to it. [00:01:35] Lindsey Dinneen: Wonderful. Well, I'd love if you wouldn't mind starting off by telling us a little bit about yourself and your background. [00:01:43] Allison London Brown: Yeah, so I am currently the co-founder and CEO of a company called Luminelle. And we in essence are a company that's focused in women's health. And we do that using our insights into what happens for women in diagnosis, especially in the office place. And we have a proprietary visualization system that physicians can use in their office. I wouldn't say it's just my job. It's actually a mission for me. [00:02:17] So a little bit about me. I am a recovering scientist. I started in chemistry and engineering, so I still have a little bit of that, I'm a nerd, whatever, and I was with J&J for a lot of years in GE and some really great, amazing companies and was trained in both the medical device and as well as in the consumer and pharma world. So I've had some really spectacular experiences with tremendous people and great physicians and their patients. And, I've been in the women's health industry for a really long time. [00:02:53] And in the company I'm in now, a few years ago, some physicians came to us and started talking about a problem that they were having and I had to say, I really didn't understand or believe it because I've been, again, been doing this for forever, and they were telling me that the difficulties of something as simple as getting a uterine biopsy. What we started looking into is that the failure rate for uterine biopsies is 50%. And that just seems really unacceptable, right? [00:03:29] And so then the more I dug into it, the more I was learning about uterine cancer and how it's the fastest growing mortality rate. And that African American women, if they're diagnosed with uterine cancer, they have a 90% mortality rate. Hispanics have a six times mortality rate. [00:03:50] So, just doesn't make sense, right? What is going on? And really what I discovered was that the way we do endometrial biopsy is they do it blind. So it's like this little straw that goes in to, to try to take a sample and you're not taking the right spot and you're not taking enough tissue. And so we get these really high failure rates. And the reason I'm saying all this about that is it was shocking to me, A: as a woman and B: as a person who felt like I was extremely knowledgeable and had been doing this for forever. So I was honestly shamed, that I didn't realize that this is such a major but small, a simple problem, right? [00:04:40] So we've shifted all of our efforts really into creating this new device that we are going to launch any minute now which is allowing physicians to do very easy sampling. And I will tell people it's the most meaningful thing I've ever done in my career. And again, had great opportunities to work on major launches, but this is, I feel like is kind of that legacy moment, people talk about that legacy moment and I feel like that's this for me. [00:05:10] Lindsey Dinneen: Oh, I love that. Yeah. You talk so much about it being so important and underrepresented and can't believe that there's this gap, and you know, that seems to be coming out more and more. There's so much more awareness, there's chatter, there's emphasis on women's health. However, there's also, it feels like there's still such a barrier to progress. Yeah, and I was wondering if you could touch on that, because obviously you're at the forefront of this. You are the one who is paving the way, but it is tough. [00:05:45] Allison London Brown: Yeah, so people always ask me this question about, oh, as a CEO, my job is 99% of the time I'm raising money. Right? That's what you do when you're in a startup. You're raising money. You can never have enough money. You're always raising money. And so the question inevitably is talking about all of the statistics about how women founders don't get cash and the VCs don't fund us, and blah, blah, blah, blah, blah. [00:06:11] Yes. Okay. So all of that may be true, but I do think that the bigger challenge is not 'cause I'm a woman, but because of the fact that I'm dealing in women's health. And, it's difficult. I've worked in a lot of different male down there care issues, and I have difficulty understanding all of it. And I'm sure that for investors ,who are predominantly male, are also struggling to understand why this is so impactful. I think the other thing is there's been so much legality in the United States around women's health. There's, lawsuits left and right, and so it does make some investors a bit wary. So on a positive side, we are seeing some significant wins when it comes to reimbursement. And so doctors are actually getting paid for their work. I think we're seeing some innovation come. But it's a whole lot too late maybe. I dunno, can I say that? [00:07:15] Lindsey Dinneen: Yeah, that's fine. . Yeah. But now you have a bit of a unique fundraising experience if I ascertained correctly through some of your posts, and one thing that really stood out to me is there was a comment at one point where you said something to the effect of, if you're not comfortable raising money or asking for money or whatnot, then maybe you need to find a different occupation or different job title. Yeah. Yeah. I love the boldness of that. I was wondering if you could elaborate a little bit on that, because obviously, like you said, that's a huge component of what you have to do. [00:07:54] Allison London Brown: Yeah, I mean, I think. The essence of all that anybody does really is we're all storytellers, right? We should all be telling a story. If you want someone to buy into what you're doing, whether it's to write you a check or to join your team, or to stay on your team, we talk about leadership and loyalty and recruiting and all these things, but in essence, all of those things really go down to, you gotta tell a good story. You gotta believe your story. And I don't mean like making up a story, I mean, you're sharing this common experience with somebody, or you're sharing how you've come to something with somebody. [00:08:28] And so I think the challenge is it's easy for some people to ask for a sale, right? I'm selling you a product, I'm selling you a widget, I'm selling you a contract, whatever that is. But when you are raising funds for your company, you're kind of selling yourself. You are saying to an investor, trust me. Trust my team. Trust that I am going to take care of your money. I'm a good steward of your money and that I will not waste your money. And not only that, but that I will give you a good return. [00:09:09] And I think when I talk to a lot of younger, newer entrepreneurs, the idea of selling yourself in a way and then getting the close on the deal, getting that check right? You gotta close the deal for whatever reason is very troubling for some people. And I mean, that's the whole point, "I'm telling you my story so you can understand why am I doing this, why I know I can be successful, why my team can be successful, and write me a check. Show me the money." [00:09:46] Lindsey Dinneen: Yeah. And now you have approached it in, well, my perspective, a little bit of a unique way, and that is that you mentioned at one point that you raise a lot of capital through your own networks and through maybe not just Angel Investors or VCs or whatnot, but that you have been able to draw on your own social network, and so I was wondering if you could share a little bit about that process and if it's still an option, what opportunities still exist for people to invest in your company? [00:10:18] Allison London Brown: Well you're welcome to invest, of course I'm always raising money, so, yes, thank you for asking. So the first part of that question, though it's kind of personal and I think people talk about doing like a friends and family round. That's not what I'm talking about here. The way that I have approached our fundraising, done a lot of Angel Funds, we've done a lot of high net worth individuals. We've been very judicious in our spend. We've been very fortunate. I mean, raised very little money, and have four or five, 10Ks, five patents, we're commercial, we've got contracts. [00:10:55] But we are now at that stage that so many startups find themselves in, which is, I hate this word, but it's the "valley of death" where you finally have got everything ready to go and you run outta cash. A lot of us are in that boat. This has been a horrific year for raising money. So I, earlier in the year really tapped into my network. But I raised actually a little bit over a half a million dollars in two weeks, and most of it was from people in my church and their contacts. [00:11:28] Lindsey Dinneen: Wow. [00:11:29] Allison London Brown: So when I talk about it being personal, when we say this is missional, it is missional on a mental, emotional level, but for us it's also on a spiritual level that we really believe in what we're doing and we believe that kind of, for such a time as this, is why we're doing it. There's a reason why this idea came to us at this time with this group of people, with these physicians, with the technology that's available today. And honestly, that's not lost on a lot of people who know me personally, they understand why we are doing what we're doing. We will not quit. we will do whatever it takes to keep us going. And so in terms of fundraising, yes, we are still fundraising. We have a note that's out. We are opening up a seed round in the first quarter. And we have some very big plans for how we are going to launch this product. Not expensive plans, but big plans. Anybody who's interested, you can find me on LinkedIn. I think I'm on the only last name, London Brown. So easy to find. [00:12:46] Lindsey Dinneen: Amazing. Yeah. I love what you said, and you've now said it a couple of times, of being so mission focused. Like this is not just a job to you, it's not just a company to you. This is a life's work and I love that. And I'm wondering if you can speak a little bit to, you've found this purpose, you've found this goal, and this mission to orient around and then how are you able to, like you said, story tell and express that to people who may not have experience or concern? [00:13:21] Allison London Brown: The organ! They, they don't have a uterus! That's OK. [00:13:25] Lindsey Dinneen: Exactly so, so, right, or people who might think, oh well, "I'm healthy, I'm fine." But that doesn't necessarily mean anything. So I just love to hear how do you share that heart and that passion and really help people care and understand like you do. [00:13:39] Allison London Brown: Yeah, I mean, it does depend on the audience and everybody will say that, " it depends," but it does. I mean, you have to know kind of who you're speaking to and what's gonna matter for them, what's gonna get them to a, yes. Typically when I'm meeting with a group of, especially let's just say older gentlemen, it's easier for people to think about, "oh, have you had a colonoscopy?" Right? "Have you had a skin biopsy?" Have you had, all these different things that we kind of take for granted, right? [00:14:08] These wonderful abilities to do diagnoses, and it's all driven by the ability to see. My business development manager, Jamie Harding, she goes on rant all the time about how sight is one of the most critical things in medicine, and yet here we are doing something blind. And, for a typical biopsy, the failure rate is 2%. So I think for a lot of guys they can get their head around, "oh, can you imagine no anesthesia, and the doctor starts just using some probe, and no camera, and it's just like digging around to try to figure if you have a problem." Okay. [00:14:56] Or, you know, it's hard sometimes, but it's like getting a root canal without anesthesia and he's not looking. I mean, it's, there's a lot of different ways could say this, but at the bottom of this, it's like you gotta be able to see, right? So that's not a hard thing, I think for a lot of them to understand. Many times I'll spend more time talking about the technology, or I'll talk about the dollars, the actual economics of the situation versus the problem itself, because that can be, again, it can be a little bit distressing for some audiences. [00:15:30] But, get 'em in the mindset of what if this was happening to you, and then what if this was your mother or your sister or your daughter or your granddaughter, you know? And she goes in, she has this horrific experience. It's extremely painful. And then. You wait a couple weeks and the doctor says, "oh well, either we didn't find anything or we are not really sure because it was Inconclusive." Inconclusive! That is the word that nobody wants to hear, right? [00:16:05] Lindsey Dinneen: Yeah. Yes. [00:16:06] Allison London Brown: Inconclusive. What does that mean? You can't tell me what's wrong with me. So yeah. [00:16:13] Lindsey Dinneen: Yeah, so part of it definitely is sort of putting it into almost like, like you gave some great examples of putting it into terms where it's like, yeah, "can you imagine if you had a root canal where the dentist wasn't looking at you , and you had no anesthesia, what would that feel like?" That's ridiculous , and there's a solution for that. [00:16:35] Allison London Brown: The other one is, I like this one, is a skin biopsy. You go in, you have something on your arm, you can see it, it's on your arm. Everybody can see it. It looks weird. Your wife has said to you, "you need to go get that thing checked. You need to go get that thing looked at," as we would say in the south. You go into your doctor, the doctor sees it, the doctor gets out a tool, then the doctor turns off the light and then tries to find where it was. I mean, it's kind of that same thing. Things you don't do blind. This is like a whole, like if I had a bazillion dollars, I'd be doing commercials about things you don't do blind, right? [00:17:10] Lindsey Dinneen: Yes. Oh, I love that though. . I'm already starting to think of so many great ideas with that particular... [00:17:17] Allison London Brown: Exactly. [00:17:19] Lindsey Dinneen: You know, looking back, let's say years ago, and I recognize this as a little bit of a, a newer venture, although you've been very involved in med tech and science your whole life, did you always have an interest in science and healthcare from an early age? Is this something that you thought you might ever do or was this sort of a, an evolution over time? [00:17:39] Allison London Brown: I can tell you the exact time where I decided this is what I wanted to do. So in high school, I thought I was gonna be a musician. I actually had a full scholarship in music and piano, voice and drama and really thought, that was my journey. And I took a chemistry class. I had put it off until my senior year. And fell in love with chemistry. I mean, I always liked math and then, at the time there were all these really interesting things going on around genetics and just so many different breakthroughs in medicine and I just felt like that was my path. So I started studying in chemistry. I started looking at the different careers in chemistry. I knew I didn't really wanna be in the lab, I didn't wanna be like a bench top scientist or anything like that. [00:18:37] But medicine was so intriguing, I kind of thought that I was gonna go be a researcher at like NIH or National Cancer Institute or something like that. Some big, huge impact on the world. And, over time, I just, I found myself feeling more and more drawn to really understanding another form of science, which is understanding, "why do people make the decisions they make and why do they buy the way they buy?" Which, you know, behavioral decision making. And so marketing and sales was very intriguing to me. So I think I've I just leveraged a different part of my brain on the commercial side to really figure out how do you get someone, again, you get somebody to that yes. [00:19:26] Lindsey Dinneen: Yeah. So very multi-passionate and multi gifted. Do you still do anything with music, voice, or drama, out of curiosity? [00:19:36] Allison London Brown: I don't do drama anymore. I mean, well, ask my friends-- might tell you I'm dramatic all the time. I don't, I dunno that I am, but don't like drama. Let's just that way. I try to avoid drama in my life. Look, I'm very comfortable in front of an audience, and think all that upbringing of being on the stage, and I had the opportunity to sing at the Grand Ole Opry, so it wasn't a foreign concept to be in front of a large audience. I think that's very helpful. I'm in a band at church and I do that kind of stuff, but I don't have time anymore. I, you know, I'm trying to raise money. Right. I don't have time for that. [00:20:12] Lindsey Dinneen: Right. But I love how that performer background may have helped contribute a little bit to your comfort on stage and giving presentation, being in front of people because that would be a very useful skill that, that, would intimidate some other people sometimes if they're suddenly in this role where, oh my gosh, now I have to be the face of the company, which means I have to do Y, and Z. [00:20:34] Allison London Brown: Yeah. Right. Isn't that like the number one fear I think people have is speak in front of a crowd? [00:20:39] Lindsey Dinneen: Yeah, . So there you go, you already had a little bit of an edge there 'cause you had that comfort, that's amazing. . [00:20:46] Allison London Brown: Yeah, I mean, I think that's helpful, but and I tell people this all the time, again, if you cannot communicate your ideas or your story, then it is gonna be very difficult for anybody to buy in. I may have been a scientist, but again, that training in drama I think helped because a lot of people in science, they have a hard time articulating their ideas at a level that if you're not a PhD, you can't understand it. I am not a PhD. There are many brilliant people around me all the time and I'm like, "can you please dumb it down for me." Like I can't communicate it back to you in a way that makes sense, it's not gonna stick with anybody. [00:21:29] Lindsey Dinneen: Yeah. And speaking of not having time anymore, you are a board member of multiple other organizations. Can you share a little bit about that? And also, do you get a chance to sleep or... [00:21:43] Allison London Brown: Yeah. Yeah, I've actually had to back off some of my work. I've been involved with CED, which is the Council for Entrepreneurial Development here in Raleigh, for a long time. I guess 10 years. And this year I've had to really back off of that work, even though it's a passion of mine to help other entrepreneurs. I do sit on the board of Clayco Therapeutics. I really believe in what they're doing. They're working on a new biologic for necrotizing enterocolitis, and I know that's a big word, right? Basically it's when babies are low birth weight or premature, we talk a lot about like lung development, right? They can't breathe well or whatever. A lot of times their gut doesn't work, so their stomach doesn't work, and there's not a good diagnosis for it at all. And there's also a really not a great therapy for it. There's not like a drug. Some of these kids end up having multiple surgeries, it can lead to slow development, it can cause, just a myriad of other really horrific things for kids. And so they have a product that we believe is gonna be able to literally reset the gut, and allow the children to be able to feed properly. So I mean, these are like itty bitty little babies, right? So it's, I guess, adjacent to the women's health world, but it's, I just think it's a fascinating area of medicine, which is biologics, using natural substances to heal our bodies. [00:23:15] Lindsey Dinneen: Yeah. [00:23:16] Allison London Brown: Not synthetic things. And its a great mission, yes, I do get to sleep. [00:23:20] Lindsey Dinneen: Okay, good. [00:23:22] Allison London Brown: I do get to sleep. But I do try to get involved in things that, A) where I think I can add value. I try to get involved in things where I really know make a difference or help the entrepreneur, and it's something I, I believe in. [00:23:34] Lindsey Dinneen: Yeah. Oh, I love that. Yes. And paying it forward is such a wonderful thing. So what are you looking forward to, as the company continues to move forward, either personally, professionally, what are some things that you're looking forward to? [00:23:48] Allison London Brown: I'm looking forward to a vacation I don't, dunnah know if that's a good thing to say, but I'm looking forward a good, a vacation, that would be nice. We did not do a vacation this year 'cause it's just been one of those years. No, so in terms of the company, I have this vision in my head of having a building and having 20-30 people and 10 to 15 sales reps and just this humming, working, hive of people all focused in the same direction, working and aligned on the same outcomes, and just this community of believers that have come together to really make a difference. So I kind of have this idea of that place where we are all together doing something. And I think that could happen for us this year. So I'm extremely excited about that and giving people jobs, right, and giving people an opportunity to join with us in this mission. So that's exciting for me. [00:24:53] Lindsey Dinneen: Absolutely, are there any moments in particular that stand out to you, that really solidified for you, "yes, this is why I'm here doing what I'm doing"? Because of something that happened that just was such a reinforcement of, "yes, I'm in the right place at the right time." [00:25:13] Allison London Brown: Yes, I have. Two things. The first thing is we were doing research around this new biopsy tool and listening to physicians talk about what they're doing today, how they're doing it today, and hearing. doctor, after doctor say, "what I'm doing today is just fine, not good, not great, just fine." And I thought, "you gotta be kidding me." Like, how is that an acceptable answer? And not trying to diss the doctors, please. That's not at all what I'm trying to say. To me that just sounded like they have acquiesced or they don't feel like anybody's gonna pay attention to them or their plight or their concerns. And so why bother? And it felt very defeatist. Again, for people who-- my friends who know me, like, give me a challenge. Like, just go ahead, tell me, "no." let's see where that goes. So that was one thing. [00:26:20] The second thing is much more personal. And in my prayer time, in my devotional time, in my, crying out to God to ask him is "Is this really real? Is this really gonna happen? I'm running outta money." All those fun things that we think about as entrepreneurs, "what am I supposed to do?" kind of at your wit's end and just having this huge sense of, " yes, move forward. Yes, go forward. Yes, I'm here with you. Yes, I'm in it." And I know that sounds kind of kooky, for people who are not maybe into that kind of thing, but a few years ago I would've said, "that's crazy." But I will tell you, it was extremely meaningful event for me and it stays with me. It keeps us going because I just, I believe in us. I have faith that this is what we're supposed to be doing. [00:27:19] Lindsey Dinneen: Thank you for sharing those stories. Those are both very meaningful and it is encouraging because feeling that belief and that reassurance that "yes, you're in the right place, doing the right thing at the right time" is so important because it's not easy. Nothing about what you're doing is easy , so you have come back to that. [00:27:40] Allison London Brown: Yeah, and I feel extremely blessed that I do have that, because I, a lot of my friends are thinking through what is their purpose? What should I be doing? How blah, blah, blah, it's tough when you are seeking for something that's meaningful, right? And I do believe that we've been given that opportunity. [00:28:00] Lindsey Dinneen: Oh. I love that. I, yeah, absolutely love that. Pivoting just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything that you want. It can be in your industry, does not have to be. What would you choose to teach and why? [00:28:20] Allison London Brown: Yeah. There's a lot of things I think I would like to teach people. It's something my girlfriends and I have been talking about quite a bit lately, which is, as a woman-- and it's probably not a masterclass, it may be more of discussion group-- but it's, how do you move through those different periods of your life physically, emotionally, mentally, all of those things and still be true to yourself. And I think, I look back on my twenties and my thirties and I think "well, wow, was that really who I was? Did I have to evolve through that to get to where I am?" And if there's a way to impart any knowledge to someone to say, here are some skills you can use, here are ways to leverage your brain or deal with hormonal issues, or deal with the fact that you're having to take care of your family or whatever it is. I feel like we chunk it up a lot. We talk about, oh, mothers in the workplace, or we talk about now the big thing is menopause in the workplace, which I think is hilarious. But it's great that we're talking about all these things, but there's not a kind of path, how do you go from being an 18 year old to a 22 year old, to a 30 year old, to a whatever year old, right? So to me it's really sitting down and thinking through how do you go through each stage of your life. That would be one thing that may sound kooky, but... [00:29:50] Lindsey Dinneen: Nope. I would sign up for that Masterclass. No, I love that. And because that's not something that is really talked about and like you said, each stage is different and it brings its own unique sets of excitement and challenges and considerations and you don't really hear enough people saying, "Hey, here's some things to think about. Here's some things to watch out for." So, yep. I'm on board. [00:30:16] Allison London Brown: Yeah, I have a friend that she's in her thirties and she listens to a group of us talk and she's like, "oh, so this is what I have to look forward to." And I'm like, "oh, yes." [00:30:25] Lindsey Dinneen: Yes. Indeed. Indeed. Yeah. So, what do you wish to be remembered for after you leave this world? [00:30:35] Allison London Brown: Well, besides what we're doing here at Luminelle, I certainly would love to have that as a legacy as something that really impacted how, maybe not just how women were diagnosed, but how physicians started thinking about diagnosis differently. But, I guess I would like to be thought of as somebody who liked to have fun and laugh and brought joy to other people. [00:30:56] Lindsey Dinneen: I love that. I love that answer. That's a wonderful thing, . And then final question, what is one thing that makes you smile every time you see or think about it? [00:31:08] Allison London Brown: I probably should say my husband's face. I get points for being a good wife to say that. And it's true. It's true. It's not-- I'm not making it up. It's true. I'm a sucker for I really am a sucker for the movie "Elf." [00:31:23] Lindsey Dinneen: I love that movie. [00:31:26] Allison London Brown: I have three movies I watch every holiday, " Elf," " Scrooged" with Bill Murray and "Die Hard." And I'm not allowed to get those movies out until after Thanksgiving. [00:31:41] Lindsey Dinneen: Oh, So what works for, what works for our family is my husband and I have a tradition of always on Thanksgiving Eve, so to speak, we break bread to get it ready for stuffing so it can, kind of dry out overnight. And we spend the evening watching "Elf," and that's like the start of our holiday season. It's like a really fun tradition, do you think you could get away with that? [00:32:06] Allison London Brown: I don't know, because I will watch it like 500 times during the holidays. [00:32:12] Lindsey Dinneen: Fair enough. [00:32:13] Allison London Brown: I am a sucker for like --not stupid comedy, so I'm not, I don't like slapstick or anything like that, but I just think "Elf" is such, I mean, it's a great story. It's got great songs. It's got Will Ferrell's hilarious. It's got a great ending. It's kind of that. It's, it, I just, and I love James Kahn. Let's just, okay, sorry, but love me some James Conn. I think he's amazing. [00:32:39] Lindsey Dinneen: That is a fabulous answer. Definitely, that goes to the top of the most unique and that is so fun. I'm so glad you enjoyed that. Oh, my word, Allison, this has been such a fun conversation. I'm really inspired by what you're doing and by your focus on mission and impact and the way that you are working so diligently, even when it's tough and it's gonna be tough to share your story, to bring this to market, to change lives. [00:33:10] And we are so excited to be making a donation on your behalf Today to the Tunnel to Towers Foundation, which since 9/11 has been helping America's heroes by providing mortgage-free Homes to Gold Star and fallen first responder families with young children, and by building specially adapted smart homes for catastrophic injured veterans and first responders. They are also committed to eradicating veteran homelessness and helping America to never forget September 11th, 2001. So, thank you so much for choosing that organization to support. And we just really appreciate your time. [00:33:47] Allison London Brown: Thank you. I really appreciate it. And I hope that if one person hears this one post, one mention can sometimes change a life. And so if you're a woman out there, and if you've had abnormal uterine bleeding. That is your warning sign. And so go get checked. Don't wait. Do not pass go. Do not collect $200. Go to your physician and do not accept a subpar answer. [00:34:17] Lindsey Dinneen: Yeah. [00:34:18] Allison London Brown: So I think if I can get, just as important as it is to get physicians doing the right thing is for us to be asking for the right thing and being our own advocate. And write me a check. while y'oure at it, write me a check, I'm not sure I'm actually allowed to say that. There's probably some like SEC violation I just did. But [00:34:40] Lindsey Dinneen: Write the company a check. It's important. [00:34:42] Allison London Brown: Yes. Write the company a check if an accredited investor, please. Yes, no, I'm happy to talk to anybody who would like to know more. [00:34:51] Lindsey Dinneen: I love that. Well, thank you again. I just wish you the most continued success as you work to change lives for a better world and thank you also to everyone who has listened to this episode, and if you're feeling as inspired as I am, I would love if you would share this -episode with a colleague or two, and we will catch you next time. [00:35:11] The Leading Difference podcast is brought to you by Velentium. [00:35:17] Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. [00:35:32] Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. [00:35:49] Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. [00:35:56] Visit velentium.com to explore your next step in medical device development.

Joe Landolina is the co-founder and CEO of Cresilon, a biotech company that developed a plant-based gel technology to stop bleeding within seconds. Joe shares his unique journey from inventing this groundbreaking technology at the age of 17 to building a manufacturing facility in the heart of New York City. The gel, known as Vetigel, has saved numerous animal lives and recently received FDA clearance for human use. Joe discusses the challenges of building the company, the importance of community support, and his passion for helping the next generation of entrepreneurs. Guest links: https://cresilon.com/ | https://www.linkedin.com/company/cresilon/ Charity supported: ASPCA Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   EPISODE TRANSCRIPT Episode 019 - Joe Landolina Joe Landolina Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I am excited to introduce you to my guest today, Joe Landolina. Joe is the co founder and CEO of Cresilon, a Brooklyn based biotech company developing and manufacturing a plant based gel technology that stops bleeding in seconds. The revolutionary technology, which was created by Joe, recently received its first FDA clearance in human use. Well, welcome, Joe. Thank you so much for being here. I'm so excited to talk with you. Joe Landolina: Definitely, Lindsey. Thank you so much for having me on. Lindsey Dinneen: Of course. I would love if you don't mind by just starting by telling us a little bit about yourself and your background and how you ended up in medtech. Joe Landolina: Sure. So I have a bit of a unique story coming into medtech because I got a really early start. But to start from the basics, I'm a chemical engineer by training. I did both my undergrad and my graduate work at NYU in New York. I'm a New Yorker, born and raised. And my grandfather was a Hoffman LaRoche executive, that in retirement, started a vineyard. And he also learned lab safety in the sixties. And so that meant the day I learned how to walk, I was taken into a chemistry lab with my grandfather and told, "Mix some things together, don't kill yourself, kid." And so, from a very early age, I got an intro into lab research. And so that led to me inventing the technology that Cresilon was based on at the age of 17 when I was a freshman at NYU. And over the last 13 years, I've taken that passion and that invention and turned it into what Cresilon is today, which is a biotech company that has sold our products in 30 countries outside of the US. And we do all of our manufacturing and are headquartered here in Brooklyn, New York. Lindsey Dinneen: Wow. Oh my goodness. Well, first of all, the fact that you started off in a lab and we're just kind of told, "Go have fun." Okay. So what are some of your first memories of experimentation? Joe Landolina: So, I'm not sure if I can tell all of the first memories on a podcast as upstanding as this one. But what I can say is that my, my first several experiments created such fear and anger in my parents that they cut me a deal, and the deal was I had to go learn how to do lab research the right way, anywhere, please, quickly. And so, the end result of that was at the age of 13 or 14 years old, I did a summer research program at Columbia University in tissue engineering. And that program really opened my eyes up to the field of medtech, because at that time, I had a simple worldview where career paths were either doctor, lawyer, accountant, and so on. And so realizing that there were so many other shades of possibility within this industry was something that, that I realized thankfully at that age, and it started this path of really falling in love with this type of research and I dove headfirst into it. Lindsey Dinneen: Yeah, absolutely. It sounds like in general that you've had a passion for basically what you're doing now from a very young age. So how did Columbia help you narrow down this passion into a more specific area of focus? Joe Landolina: Definitely. And so let me talk a bit specifically about what I was working on at Columbia, because there was a lab there that was using plant based scaffolding. Meaning polymers that come from plant based materials to grow stem cells that come out of a human patient and have them differentiated into a target tissue. And this lab was working specifically on chondrocytes or cartilage. And so it was just amazing for me to see this material taken completely from nature that was able to be repurposed to take a patient's own stem cells and turn them back into cartilage that could potentially be put back into that same patient. And so it set me down this path where at the time I only had access to-- the internet was good for a lot of things, but not really finding information yet at that point. And so if you wanted to learn, you had to go to a library, you had to, whether it was a public library or a university library. And so I surrounded myself with Eastern medicine books, and books that looked at how pharmaceuticals derived from nature around us, because the one thing that I had, I grew up on a vineyard. And so I was able to grow anything or collect anything that I wanted to. And so I had a real interest in finding solutions to the experiments that I was trying to run in nature. And I got fairly good at identifying these sources of material, because again, no one would sell a winery lab or a 13, 14, 15, 16, 17 year old, agents to do these types of experiments. So, I had to get creative. And so that was really my entry point into that and Columbia opened my eyes that that was being done at the highest levels. Lindsey Dinneen: Wow. Okay. So nature based solutions. And as you have continued to go down this path and then of course develop your company and your products, can you tell me a little bit about the origin story of the company? Because, gosh, doing this at 17 years old, that must've been a remarkable breakthrough. I'd love to hear more about that. Joe Landolina: Sure. So, to start with, I was running this experiment in the winery lab where I was trying to make a plant based scaffold to effectively replicate some of the stuff that I had seen at Columbia. And that experiment went terribly because instead of having a multimillion dollar university funded lab, I had a winery lab, which you can interpret that as effectively a glorified kitchen counter with a bunch of equipment that was "borrowed" from Roche in the late 70s when my grandfather retired. And so it wasn't very fancy by any means. And so I didn't get the result that I wanted. But what I did get was this material that was this mess that came out of algae that would form a gel that would simply stick to skin and wouldn't let go until you wanted it to. And I had this idea, which was, what if you could take a material like that, inject it into a bullet wound, and at least plug up that bullet wound from bleeding so you can get a patient and move them from point A to point B without them bleeding out. And at around the same time, as a freshman, this was my first week of school, there was a poster in the engineering quad at NYU that said "best business plan idea $75,000 top prize." And what really drew my eye was that they would give free MBA classes to anyone who got into the quarterfinals. And I thought, you know what? There's no way I win, but I wanted to be a doctor and I was an engineer's engineer and I was really looking for things that were around me on my resume. And I thought that this stuff isn't going to work and it's not going to become a company, but I may as well join this competition. And worst case scenario, maybe I can talk my way into getting some free business classes and get me an internship over the summer. And so I met my co founder, Isaac, who was a student at the business school at NYU at the time, and we entered the competition and we ended up taking first place at the engineering school, and second place at the business school where he was at, and and the rest was history. Lindsey Dinneen: Wow. Oh my word. Well, congratulations. That's a fantastic origin story. And I love the fact that you just went into it with this mindset of, even if we don't necessarily win, we're still going to see the benefits from this other education. And I think that's so important to have a lot of cross experiences that eventually help lead into the success, and sometimes you don't see how they all interrelate, but eventually they do. I love that that's how you approached it. What a great mindset. Joe Landolina: Thank you. Lindsey Dinneen: Yeah. Well, so, okay. how many years have you been in business? Joe Landolina: 13 years later. Lindsey Dinneen: 13 years later. Okay. So 13 years later and you have now gone through several rounds of funding. And so I'm curious how that process has gone for you, 'cause that's a whole other kind of learning curve as well. How has that been for you? Joe Landolina: So we've been very unorthodox in a number of ways here at Cresilon. And the way that we raised funding was was no exception to that rule. And so we've done over a hundred million dollars in funding to date across several rounds of funding. Our first round was in 2013. So our seed run was raised from angel investors, high net worth individuals that read about us in social media. We were lucky in those early years, we had a lot of press coverage, both because of my age and really just because this technology is unlike anything else that I've seen in that you can, in a 20 second video, understand exactly what it does and what the value is. And we had this video of a steak that I cut and we pump blood through it and it's this massive bleed. You put the product on it, it stops instantly. And that video had over 140 million views on it, all in all, so we get a lot of attention in the beginning there. But then, those investors that we brought in to raise a couple million dollars in our seed round, ended up reinvesting time and time again, just all the way through the company's history, and so those same investors-- along with some other investors that we collected along the way-- ended up being the bulk of the funding that we brought in. And that's incredibly rare in this industry, especially in biotech, where there are usually different VC funds that come in at each stage, it's not like we don't have venture investing or investment here at Cresilon, but primarily our largest investors and the average investor is a private individual. And that's very rare for this type of funding, but it's allowed us to build a cohort of investors that primarily are end users. We have a number of surgeons and doctors and veterinarians who have used the product and who were very vocal in helping us design the product in the very beginning, and it allowed for this healthy conversation where if there's an investor who has money behind something, that they're not going to pull their punches when they tell us what they like. And then more importantly, what they don't like about the product. And it allowed us to get really raw, involved feedback from day one effectively. Lindsey Dinneen: Yeah. Which is so important and what an interesting funding experience you've had, like you said, it's definitely unique. Now looking back over the last 13 years: what has been one of the biggest challenges in either starting or building the company. What has been either unexpected or the largest obstacle to overcome so far? Joe Landolina: So I think that the biggest obstacle by far has been the middle phase of the business. And so when I say the middle phase, from the end of 2015 until the end of 2020. And so if we look at the business in sort of five year packets of time, from, 2010, which is when we founded the company and had the idea, to 2015, we were building a product that worked. And so at the end of 2015, we had Vetigel. We knew Vetigel would work and we were able to manufacture it. But we realized that the market demand far exceeded our ability to manufacture. And in fact, we were too reliant on third parties. And so, in 2015, the goal was to effectively outsource everything that we could. And unfortunately, when you make a highly novel product like this, we were finding that we were unable to find partners that could outsource. So in fact, there was not a single manufacturer that could manufacture Vetigel gel. We had to do everything ourselves, but there weren't even labs that could do the testing that we needed. And so we were getting false positives and false negatives. And so in 2015, we were ready to launch and I made one of the hardest decisions that I ever had to make. I pulled the plug on the whole thing. I went back to our investors and told them, "Look, if we can't do this the right way, if we can't ensure the safety of our product, we're not launching." And we raised 10 times the amount of money that we'd raised up to that point, just to build brick and mortar manufacturing. We brought in individuals who had built quality labs and done this at scale for large vaccine manufacturers. And Cresilon at that point became the very first or the very only sterile manufacturer in the five boroughs of New York, something that we're proud of. But it took us five years, and that was a very hard, onerous time where, frankly, we didn't know if it was perfectly possible or completely possible to do what we needed to do. And so the entire time we were working on perfecting, on validating, on standing up this factory where we had to design all of the equipment from scratch. Our product is like the consistency of hummus. So it's not incredibly viscous and there are lots of machines and manufacturers that make vaccines and lots of machines that manufactures and make hummus, but no one dumb enough to do it together. And so, we were lucky enough to be the first and we had to figure out a way to get it done. And so we had to design clean rooms. We were one of the first production clean rooms that had to be made in New York City under New York building code. So we had to even custom design things like sprinkler heads to comply with FDNY regulations, but also maintain the sterility of our clean rooms. And so it was literally nuts to bolts. Like every test that's run on a syringe today was designed by a Cresilon employee and something we're proud of, but it was hard. We were going effectively month to month where we couldn't sell. We couldn't make revenue until we got these pieces put together. I mean, obviously when you're doe eyed and naive, you think it's an 18 month process to stand up a factory, but it took all of five years and it culminated with launching in the very best time to launch a new product to a direct customer in an operating room, which is at the height of the COVID pandemic in October of 2020. Lindsey Dinneen: Oh, my goodness. Yeah. All those years of just waiting and planning and executing, but not, not quite being there. Oh, my word. Your patience and your stress. Good for you to have gotten through that. I would love to hear about what you consider your biggest win, but I recently read something that I wonder if we'll be on the same page here with that, but tell me what your biggest win is so far to date. Joe Landolina: So frankly, Cresilon's mission is saving life lives and the biggest win still to this date, right, it's saving our first animal life, right. I'm, my guess is that you're going to mention that the recent FDA approval for humans, but what I tell my team is it's not about the paperwork. It's not about the regulations and that's an amazing accomplishment that I don't want to minimize by any means. It's about what we do for our patients and what we do for our clinicians. And so, you know, for me, I'm an engineer by training, and so that means I'm a natural pessimist. And so I always look for flaws in products because I like to fix flaws. And the thing that you can't argue with is when you take a patient that would have not survived a procedure and translate that into a successful outcome. And we've now done that over 45,000 times on the Vetigel product line. And what I'll say is that excitement doesn't diminish. And we're now ever closer to being able to do it for the first time in a human patient. And that's something we're looking forward to. But we still have some some ways to go before we can achieve that. Lindsey Dinneen: Yeah. First of all, that's incredible how many lives you've already impacted through what you're doing. And I love your mission statement. I think you're so right to get back to the heart of it. But also I do want to say congratulations for the FDA approval, because I know that was no easy feat. That's really exciting that you're there now too. So on both ends, lots of lives being saved. Thank you for what you're doing. Joe Landolina: Yeah, thank you so much. It was a journey and a half to get to that point. It takes a lot, especially for the first time on a new technology to get it through. But I can take no credit for it, it was all my team. And they were the ones who put in the countless hours and overnights to get it done. But for now, that means we can start growing. Lindsey Dinneen: Yeah, absolutely. Is there any specific instance or memory that stands out to you as reinforcing the idea that you were in the right place at the right time? Like, this is your field, what you're doing, your specific path. Did you have a moment that was just like this affirmation of, "Yes, I'm in the right place." Joe Landolina: I'd say that's a really good question. What I'll say is that we've been very lucky throughout the entire journey. I think that the silver bullet that allowed us to stand up our factory was something that was only invented itself in the same year that we implemented it, meaning that if we had gotten there, even a year earlier after developing the technology, the thing that allowed us to solve our problems wouldn't have been there. And to get it back to, to what I was mentioning earlier, I think that there are definitely cases where surgeons that we've just trained have a case come in that day, where on a Monday, we teach them about the product and on Tuesday morning, they have a dog that's been hit by a car that would have been unsavable a couple days before without our product. And, and there are countless cases like that that we hear about and it just shows that the world keeps turning whether or not our products are out there, but the fact that we can be there and make a difference and truly save lives is something that, that just is validation enough. Lindsey Dinneen: Yeah, Oh, absolutely. Speaking about being able to use this product with animals, I noticed on LinkedIn that you seem very passionate about animals and especially shared some really heartwarming rescue stories and whatnot. So I have to ask, have you always loved animals? Is this always been a passion of yours? Joe Landolina: So I grew up on a vineyard with a bunch of property and I always joked that my parents had a menagerie at home and so we always had everything from dogs and cats to llamas and alpacas and ducks and they're interesting animals going around and and so I've always been a lover of animals. It's hard living in Brooklyn now. My wife and I recently took a plunge last year. We adopted a German shepherd puppy who very quickly grew to 85 pounds. She keeps me fit. We do 10 miles a day together. So she's adapted well to the Brooklyn lifestyle. But it's it's definitely nice to be able to do that in the city because I went for years without having a pet of my own. Lindsey Dinneen: Oh, yeah, and dogs are just such great companions. It's hard to not fall in love with them. So what's next for you and for your company and what are you excited about coming up? Joe Landolina: So on the back of this FDA clearance of of our technology, what's next is translating that into our first human life saved. And there's a lot of work that still needs to be done. We still have to scale everything up and get ready for that launch to do it the right way. But it's coming; it's scheduled for next year. And it's something that, that we're looking forward to is it just allows us to extend and expand our mission beyond what we've already been doing. And then on the Vetigel front, we've been seeing really amazing results in indications that frankly, when I came into this market, I never thought that we would be doing surgery. And so Vetigel is being used today in brain surgery, is being used in spine surgery to help dogs that were paralyzed that now can walk again because their surgery time is short enough that they're no longer at risk of of going under that procedure. And so really amazing things that are coming out of that market that we've been working with commercial partners to make sure that we're able to get that in the hands of any vet that is able to use Vetigel, or willing to use Vetigel. And so a lot of growth is ahead of us and it's just trying to put our heads down and come back to mission which is making sure that we can save lives. Lindsey Dinneen: Yeah, I love that. So is the plan to continue for both animals, and now because you'll have the opportunity to test with humans as well. So is the goal to always have both things going simultaneously? Joe Landolina: Definitely. And because we're in the human market, it doesn't mean that animal becomes an afterthought in any way. And so our team in animal health-- we have a direct sales force here in the US, the partners that we have abroad are still staying. And so we're still growing those teams pretty substantially. It just means that, for better or for worse, we have a lot of hiring to do. We have like 45 open positions right now as we start to beef up the human commercial side of our business. Lindsey Dinneen: Wow. Well, that's exciting. So anyone listening could potentially go to your website and learn more about working with y'all. Joe Landolina: Exactly. We have a careers page on Cresilon.com and if anyone interested checks that out, we have a number of roles open for for people who are interested and willing to join our team. Lindsey Dinneen: Awesome. So one thing that I noticed also on LinkedIn was I saw a couple of different posts about various speaking or resources that you seem very passionate about helping the next generation of professionals in the field to level up their skills, feel comfortable, gain the experience and the knowledge. Would you want to speak anything to that and in terms of your interest in helping the next generation? I really appreciated seeing that. Joe Landolina: Definitely. I think that I'm not the only one by far that's doing this, but it's just, founder resources are tricky because there's a level of healthy competition that happens in startups. And so something that's been very near and dear to my heart is just talking openly about sharing of resources, talking openly about mental health challenges that the founders go through, and being there for the communities that I'm a part of, and that may mean the New York community, that may mean the NYU community, or that may just be the larger entrepreneurship community as a whole, but in my opinion, this only works if the community comes together and supports one another. And I think that I've gone through this journey and there were resources that I had that were amazing, and there were resources that I didn't have, and what I'm trying to do is if there are entrepreneurs out there that don't have the same resources that I did have or that are looking for something that I also couldn't find, if I can be a little part in helping alleviate something, then I'm all for it. Lindsey Dinneen: Yeah. Yeah. Well, I love that. Thank you for paying it forward. I think that's really important and it's very encouraging to continue to see people speak out about various struggles and obstacles. And when you're real and honest and transparent with those kinds of things, you can really help somebody else who might be going through similar challenges. So thank you. I appreciate what you're doing. Joe Landolina: Definitely. Yeah, it's been a lot of fun. And in fact, I have much younger siblings. So my parents, when I was in high school, wanted to try for a daughter and ended up getting triplets, two boys and a girl. And one of the triplets who turned 18 last week has just founded his first company. And so it's it's nice to see it run in the family. Lindsey Dinneen: Oh my goodness. Yes. Congratulations. That's pretty cool. All right. Well, pivoting and just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your field or industry, but it doesn't have to be. What would you choose to teach and why? Joe Landolina: I think, negotiation would be what I talk about . Because it leans into entrepreneurship, right? And what I find is both in young entrepreneurs and in candidates that come to work for us, or members of my team, or even myself, people don't realize that the way to affect change, whether it's in, in their personal lives, in, in their work or as they're starting a company, it all comes down to how you position it and what you ask for. And so I think that it's something that people realize maybe too late on average that if you want something, all you have to do is ask for it. And one of the best learnings I had early on was that the beauty of New York is that there's so many resources just around us and at our fingertips. And if you want something, most people, their tendency is to say, "I'm going to keep that hidden. And I'm not going to, I'm not going to tell anyone else that I want this thing, but the worst you can get is 'no'." And if you ask enough people, odds are, you'll find someone who will say "yes" at the end of the day, right. And that's how we got our first lab space. That's how we got our first checks. That's how we started putting the pieces together to build the business. And so understanding how to do that is just such a great launch pad. And maybe I'm not the best professor or teacher of that in myself, but it's been a skill set that I find has helped me greatly and that people, on average, don't seem to realize that, that it's a possibility in pretty much in any circumstance. Lindsey Dinneen: Yes. Great. Great answer. And I would definitely attend that masterclass. I'm really passionate about this topic too. I think there's so much hidden power in just asking. And like you said, the worst someone can say "no". And a lot of times that "no" is "not yet". So if you've got a great idea, if you have something you need or want and you do put it out there, there are so many people that are willing to help. So yeah. I love that. What's one thing that you wish to be remembered for after you leave this world? Joe Landolina: I think that I feel bad giving the same answer, but it's true. So I so I'm going to say it again, but it's just-- if there is one patient that had their life or had a family member affected because of technology that we put out, that's enough. And so the way that I view what we do, right, I want to have made a difference in someone's life. I want to have made a product that swings the needle in, in, in the direction of good, rather than worse. Lindsey Dinneen: Yeah. And just think of all of those animals already. That alone to me is very cool as well. And this is just the beginning. So yeah, that's exciting. And final question: what is one thing that makes you smile every time you see or think about it? Joe Landolina: I'm going to say my German shepherd. Yeah. She's been a a massive positive influence in my life. So I think doing what I do, it's hard to stay grounded and stay present. And having a dog forces you to be grounded and present at least for a good part of your day. And there's something here that relies on you. And so she, she makes my day every day. Lindsey Dinneen: I love that. Well, thank you so much for joining us today, Joe. This was so much fun. I'm so excited about the work that you and your company are doing. Obviously you're making a huge difference in people's lives, you're living out your mission, and I just commend you for that. Thank you for contributing so positively to the world. We're honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thanks for picking that organization to support and we just wish you continued success as you work to change lives for a better world. Joe Landolina: Definitely. Well, thank you so much, Lindsey, for having me on. This was an absolute pleasure. Lindsey Dinneen: Wonderful. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Rebecca Whitney is the Spine Global President for ZimVie. The episode explores Rebecca's journey into MedTech, her leadership philosophy centered around trust and mutual respect, and the profound impact of innovative spinal solutions, such as the Tether device for pediatric scoliosis. Rebecca also shares personal insights, including her love for travel and the daily ritual of morning lattes with her husband, emphasizing the importance of finding joy in everyday moments. Guest links: https://www.zimvie.com/en  Charity supported: Opportunity International  Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   EPISODE TRANSCRIPT Episode 018 - Rebecca Whitney Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to the Leading Difference podcast. I'm your host Lindsey, and I am excited to introduce you to my guest today, Rebecca Whitney. Rebecca is a tenacious and passionate business leader with over 20 years of experience leading both large and small organizations in the MedTech space. As ZimVie Spine Global President, Rebecca leads a team that designs, develops, and commercializes spinal implants to treat patients with spine related disabilities. ZimVie is the market leader in motion preserving solutions for the spine, and Rebecca and her team are passionate about expanding patient access to these innovative technologies. Hello. Welcome to the show, Rebecca. I'm so glad to have you here. Rebecca Whitney: Thank you, Lindsey. I'm really looking forward to this. Lindsey Dinneen: Absolutely. I would love, if you don't mind starting off by telling us just a little bit about yourself and your background and how you got into MedTech. Rebecca Whitney: Sure. So I grew up in a suburb of Salt Lake City, Utah. I'm the oldest of three children and have always been kind of inherently pretty driven. And so what happened is, just because of my age and a bunch of AP credits, I was done with college at the University of Utah at age 20 and realized that was too young for me to jump into the workforce. And so I went straight into grad school to get an MBA. And while I was there, I took a summer internship with BD Medical that turned into a full year opportunity and it was really great. I learned a ton about product management, the medical device industry, and when I was in the final spring of my MBA, they actually offered me a full-time position. And so, I jumped right into it and didn't realize at the time just how fortunate I was to launch this career into medtech. But I've always felt very fortunate to have found a career in an industry that I enjoy so much. It's been love at first sight, and I've never left the medtech space since. So, professionally it's been just a great run. And then personally, I live in Boulder, Colorado with my husband James, and we definitely embrace a work hard, play hard approach. We love the outdoors, we love adventure travel, and are always looking to find ways to optimize our life to the fullest. So, we actually met a guy on a backpacking, hiking trip about three or four years ago in Escalante National Park. And this has always stuck with me because he said to us "Every day, do something that makes you feel more alive." And that resonated with me because we've always tried to live our life that way. And so, it's been really great. So my job is a huge part of who I am. But also I like to have as much fun as possible, as many adventures as possible when I'm not working. Lindsey Dinneen: Yeah. Oh, I love that. Yeah. Feel more alive. That's such a great way of capturing it. I've heard variations on that. One of my favorites is " do something every day that inspires your soul." I love that too, of the feel alive, because there are some days too where you might not be feeling super inspired by whatever your circumstances happened to be at the time, but the "feeling more alive" seems very attainable because you could just go out into nature if that's something you very much enjoy, or maybe you put on some of your favorite music and you just let that absorb. Okay, I'm getting carried away. But I love that. Rebecca Whitney: No, I agree. And to your point, it can be five minutes, it can be, you know, a huge adventure. But I think just that mentality, and it stuck with me, I think about it every day. So anyway, it's just a nice reminder that life is short and take advantage while we can. Lindsey Dinneen: Yeah. So looking back at growing up-- and obviously I love the fact that you dove kind of straight into the medtech world and that sounds like a happy coincidence, so to speak. But looking back, would you have ever anticipated that's a field you might end up in, or was it kind of a surprise? Rebecca Whitney: No, it was totally a surprise, a very happy, lucky one. I have always said my life and my career has followed a series of happy accidents, if you will. And so this was one of those where I was getting my MBA, I actually thought I was going to go into finance and I had interned at Merrill Lynch and so had full intentions of going down the finance path. And when I took this internship in marketing, I realized that, okay, there are a couple things about this that are really clicking for me. One, marketing brought that data and analytical elements together with the commercial and strategic elements that I love. And so I kind of found a sweet spot in product marketing at a very early age. And in the medtech space, I remember the boss that hired me, he said medical devices are recession proof. And while that's not always the case-- especially when it comes to elective surgeries in times of COVID-- for the most part, that's been true. And so, I kind of fell into the industry, but feel so very fortunate that I hopefully am helping to impact patient lives at the other end of all this. So, I never looked back and never, ever even thought about making a switch. Lindsey Dinneen: Yeah. Yeah. So what exactly does your role entail these days? How are you combining some of those interests and your passion for this particular industry? Rebecca Whitney: So what I'm doing now is I lead our global spine organization and we make and manufacture, produce spinal implants. And so we help people with back pain or related pain to any type of back or spinal cord injury. And I love the global responsibility. I can get into that a little later. But international travel has always been a passion of mine, and so being able to work internationally is just fantastic because I think it brings just a whole different perspective to healthcare and patient needs and some of those variable aspects as you work throughout the globe. And I also love leading teams, and so having this cross-functional responsibility to, to set the strategy and then mobilize the various functions and team members to get behind the strategy and execute is just really great. I've been in all different parts of medtech throughout my career. I will say that working in the spine space has been one of the most rewarding, just because you are able to see firsthand that the impact that these products are having on patients' lives and whether it's alleviating pain or getting their lifestyle back. It's just very rewarding when we hear from patients who benefits from the products and the solutions that we've been able to bring to market. Lindsey Dinneen: Yeah, I can only imagine. Are there any particular moments that stand out to you as clearly confirming that this was the right choice of industry for you? I know you're so passionate about the space and the spinal aspect in general. So I'm curious what kind of moments have you had where you thought, oh my word, I know why I'm here. Rebecca Whitney: Yeah, it's a great question and I will tell you that in this particular job, in this industry, there is a product that, that we have brought to market that is unique and it treats pediatric scoliosis. So these kids that are coming in and are needing basically to be addressed because they've got a curve in their back, the traditional standard of care is to put a bunch of rods and screws up and down their back and then fuse their spine into alignment. And while that clinically solves the problem in most instances, we have developed, an innovative way to, to basically provide the same procedure for these patients that are properly indicated. But we do it without fusing their back. And so we have this product called The Tether that we brought to market in 2019. And leading up to 2019, we partnered with thought leading surgeons, the FDA, parent advocates, and a whole slew of others to advocate to bring this technology to market. And when we hear from these kids who have had the surgery and they're back to gymnastics and cheerleading and horseback riding, skiing, snowboarding, when we hear from these kids and their parents, it is such a wonderful endorsement. And, I can't take the credit for the innovation. Those are our very talented engineers and researchers. But to know I've had a small hand and our company has had a hand in helping change the trajectory of these kids' lives, it is truly inspiring. And we bring in patients all the time to speak to our internal team members. And it just really kind of puts the context behind all the hard work, whether it's the engineers or the shipping and operations teams who are making sure the product gets to the right spot, the salespeople who are out selling it. It's just really impactful. So I would say that's probably the clearest example of every time I hear from a patient, it is just another reinforcement that I made the right choice and that there's something really special about this medical device industry when you can see how it helps patients. Lindsey Dinneen: Oh my goodness. Yes. As an adult, I'm sure that kind of an operation or procedure would be just as impactful. But I got a little choked up thinking about a child who has this condition that maybe is inhibiting their dreams of becoming a gymnast or even just as a hobby, but something that they love. And then to have that hope restored again, that's that's, immeasurable. That impact is immeasurable. Rebecca Whitney: You know, it, it really is, and I say this all the time, this is a true passion project for so many of us. And internally we have a team saying, and kind of a mantra, if you will. It's "having the courage to do things that haven't been done before." And we all kind of got behind this starting several years ago to say this is the right thing to do and we're gonna keep advocating to, to get this technology to market because no one's done it before. We were the very first. And to be able to actually see this materialize in the lives of these kids-- yeah, to your point, it's just, it's very inspiring for all of us that have worked on it and we're not gonna stop. We really are very passionate about continuing to develop this space. Lindsey Dinneen: That is wonderful. Well, I know that you are also really passionate about leadership and leading teams. I know that's an aspect of your job that is enjoyable to you. And I wonder if you wouldn't mind sharing a little bit about how you got into that leadership role and a little bit about your philosophy towards leading and managing teams. Rebecca Whitney: Yeah, so I'll start with my philosophy. I think everyone has a slightly different take on what does leadership mean to them, and to me, first of all, I've always felt very humbled and honored to be in a leadership role and I take that responsibility very seriously. As I've worked throughout my career and observed leaders, I have found that the most effective and the most admirable leaders are those that take a true interest in the individual. Because at the end of the day, we're all people, and I personally believe that the basic principles of healthy and strong relationships are the same, whether it's a sibling, a spouse, a friend, a colleague, a boss, or an employee. And so I think that you've got to start with two basic principles. For me, trust and mutual respect. And it's very important to me that I build and establish and maintain trust with the teams I lead, as well as my colleagues and my leaders. And so that's kind of number one. Those are table stakes for me. I think too, I have learned over the years that leadership does not necessarily mean being liked all the time. And early on when I was starting out, that was difficult for me to learn. And it was hard. And I remember it was about six months into my career and at Becton Dickinson, BD Medical, we'd just gone through a pretty major layoff and I was eating lunch in the cafeteria and the division president came and joined my colleague and me, which was intimidating 'cause I was fresh into the role. And he was just making conversation with us and asked how we were feeling about these layoffs that had just happened. And I said to him, "Yeah, I dunno how you do it. I can't imagine having to lay off all these people." And I'll never forget this. He looked at me and he said, "You know, you really can't call yourself a leader until you've hired and fired. You have to be able to make the tough decisions." and as a young 22 year old product manager, I remember sitting there thinking, "Wow. I can't imagine what that must feel like." But he wasn't wrong. And I think what I've learned over the years is, if you can operate with those principles of mutual trust and mutual respect, it builds up that bank account with these individual relationships that you have as a leader. And so when you have to make the tough calls and you have to make the unpopular decisions, hopefully, if you can at least help people understand the "why" behind some of these decisions. I've seen people do this really well and I've seen people do it very poorly. And I am by no means perfect at it, but I'm constantly striving to be as transparent as possible. So that people at least understand the "why." And then finally I would say, leadership is so much about creating the right environment for healthy teamwork. And so for me, I always love it when I start to see my various leaders on a team click and start to build those connection points without me in the middle of it. Because to me, that is an indicator that this team is starting to really work together in a high performing, high trust fashion. And that is the secret sauce behind every team I've ever led is creating that environment, getting the right chemistry between the various team members in the group, and then watching those connection points really take hold. To me that's where the magic happens, and I think that's what makes it all worth it. Lindsey Dinneen: Yeah. Yeah. So you've obviously had a really lovely career so far, and I'm sure will just continue. But you know, one interesting element is it sounds like you had opportunities to lead fairly young into your career, and I'm wondering how you approached perhaps teams that had a diversity in terms of ages. And was that ever intimidating to you if maybe you were coming in as a younger leader than some of your followers? Was that ever a challenge or how did you handle that? Rebecca Whitney: You know, it was, and that absolutely happened. I was probably 26 years old when I started managing people that were older than I was. And the whole team was, it wasn't just one or two. And initially I was extremely intimidated because I felt I had that imposter syndrome, you know, what right do I have? And it did take me a little bit to, to feel comfortable. I think for me, I just told myself, "Look, somebody had confidence in me and somebody put me in this role for a reason. I have to trust myself and I'm going to prove to my team through my actions and earn their trust and show that they're in good hands with me." And luckily I had a team that was very receptive, and I think when they saw how I approached it and what I brought to the table, they were very supportive. But yeah, initially I had to get over my own internal talk track that said, "You know, this doesn't make any sense. Why in the role would somebody take direction from me when I'm 10, 20, 30 years younger than they are?" But it was a great learning opportunity and frankly, it continued for, not so much now 'cause I'm a little further on in my career, but that was the case for at least the first decade of my leadership opportunities and so it was important for me to learn that early on. Lindsey Dinneen: Yeah, absolutely. As a woman leader in a field that isn't predominantly women led usually, what are some of the pros and cons you've seen? What are some of the exciting elements about that? And then what are some of the opportunities for growth as the industry continues to evolve and change over time? Rebecca Whitney: That is a great question, especially in the orthopedic spine world. It's extremely male dominated, at least historically it has been. And just like managing team members that were older than I was, I had to learn very early on that, especially when I started out, I was likely going to be one of, if not the only females in the room. And I had a boss fairly early on that, that gave me some great advice because, by default, I remember-- first of all, I have horrible handwriting. I'm probably the worst scribe you could ever pick out of a group. I've just never, ever had good penmanship and I was constantly being asked to take notes on flip charts. And I was doing it, and my male boss pulled me aside and he said, "You know, we teach people how to treat us." And he said, "I know that you're just being collaborative and helpful, but you've been taking notes for the last six times we've been in a group." He said, "The next time you're asked to take notes, say no." And that seems like a little thing, but I did, and not because I was refusing to take notes, but I just was making sure I was a little more balanced of an approach. That's a silly example. But I think that for me, I had to learn early on that there was nothing wrong with me being one of, or the only woman in a room, just like there was nothing wrong with me being on the younger side of people in the room. And again, there's that imposter syndrome. But I think having confidence in my abilities and recognizing that the more I could be comfortable in my own skin, that was what would enable me to bring probably a different and unique perspective. I was told in my twenties that I should dress in subtle tones and black and gray and navy blue suits. This was from kinda a leadership coach, and I remember thinking about that, and I thought, "I don't want to wear black and gray and navy blue suits." And so I've always tried to keep my own brand and my own authenticity while at the same time recognizing that it is difficult to kind of be the one outlier of a group. I will say that as time has gone on, I'm very pleased that the workforce is starting to better reflect our society. And I think that, that gender diversity certainly is expanding, which is nice. But my advice for anybody out there, regardless of gender or ethnicity or even just diversity of thought, is recognize that we are put into these roles because of what people see in us, our abilities and our potential. And if we stifle that in any way, shape, or form, the company and our teams and our customers are not getting what we have to offer. And I think the more comfortable I got with that, the more effective I've been able to be. Lindsey Dinneen: Oh my goodness. That is excellent advice. Really, thank you for sharing that, that really hit home. I appreciate that perspective that you've had. You've had such an opportunity to really grow in your role and I just love seeing that progression. So yeah, thank you for that advice. That was really good. I'm curious, how do you, these days, continue prioritizing your own learning and growth as a leader? Are there still things that you keep doing in order to sharpen those skills? What does it look like now for you? Rebecca Whitney: Yeah, so I'll start with something that probably is an obvious answer that most people give you. But podcasts are amazing and I'm probably a little late to the party on this because I didn't start listening to podcasts until Covid. But I have found that is a fantastic way-- I mentioned-- I live in Colorado. I will spend Saturdays and Sundays out on very long walks, either around Boulder where I live, or even up in the mountains. And I will just binge listen to podcasts on all different types of topics: leadership, business, life skills, you name it. And they're not all work oriented, but I have found that to be a really good way to just get a sampling of advice, opinion, and learnings from a wide variety of people. So that's one. And I think for me, being able to do that on the weekend, disconnect a little bit and really dig into these podcasts that I compile and save up. It, it's just it's a major reset for me in a very good way. I'm sure I drive my team crazy 'cause I'm constantly sending them these podcasts over the weekend as I listen to them as well as my family. But that's been really great for me. I would say the second major thing is, I love to travel. My husband and I look to enhance our lives any way we can, and I have found that one way that helps me learn is looking for those connection points between my personal life and my professional life. And what I mean by that is I try to be very authentic and consistent. So whether I'm in the workplace or at home with my family or on my own, the more consistent I can be is a healthier place for me, because you're not having to put on one persona versus the next. And so the more I can find those connection points, meaning if I learn something in my personal life, I can apply it into my professional life. And to me, that's where I get a lot of my continuous growth and development. So if it's tackling a big aggressive hike I haven't done before, I find myself, while I'm training for that and doing the hike, I find myself thinking about ways I can push the team at work or push myself. So strangely, as I've continued to grow in these roles and in my personal life, that balance between work and life has blurred, but I think that's been to my benefit, both personally and professionally. So I'm always looking for opportunities to enrich my personal life, because I do think that transfers back into the workforce as well. Lindsey Dinneen: Yeah. So what are you looking forward to next in terms of maybe both personally, professionally, and as your company continues to innovate and develop new things, what are you excited about these days? Rebecca Whitney: So our company, ZimVie, is relatively new. We were spun out from Zimmer Biomed, our former parent company, not even 18 months ago, and it's been really fun to help shape this new identity and this new culture. And talking about this tethering device I mentioned earlier, we have another device that allows us to treat cervical neck issues with a disc replacement which, long story short, means we're able to preserve motion for these adults who are looking to have their pain addressed. And so, what we're trying to do, and we do have a mission: we've got a number of patients that we're trying to treat in 2023 for both this cervical disc replacement device, which we call Mobi-C, as well as this tethering device for pediatric scoliosis patients. And so, what's next for us is continuing to develop these markets and make sure that we bring these amazing solutions to every patient who is indicated to receive it. And so, that's gonna keep us busy for quite some time. I'm sure we have work to do beyond that, but we're just also passionate about it. That's definitely what's next for us, at least professionally, is continuing to carry that forward. And then personally, it's always about the next adventure to, to push ourselves. So, we're actually headed to the Grand Canyon in December, my husband and I are, with my sister and brother and their spouses, and we're going to do a multi-day hike backpacking trip. So really looking forward to that and just looking forward to being outdoors with my favorite people, doing something that challenges us physically and spending a lot of good quality time together as well. Lindsey Dinneen: Oh, that sounds so exciting. Both the company's trajectory and then your upcoming adventure, that all sounds really fun. So I'm sure that will be a lot to look forward to. Rebecca Whitney: It's busy, but that's the way we like it. Lindsey Dinneen: Absolutely. Oh, I would always rather be busy than bored. Well, pivoting just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It doesn't have to be in your industry, but it could be. What would you choose to teach and why? Rebecca Whitney: So, I will say that my dream job, if I weren't doing my current dream job has always been to be a travel writer. I would love to travel the world and then write about my experiences. And so if I could do that and then teach a masterclass on it, to me that would just be the most amazing opportunity. I am driven by two things. One is influence or language and ideas. I love to communicate and I love to inspire others by speaking and sharing, whether that's talking or writing. And so to me, to share that know-how and knowledge and passion about travel-- and not just the regular beaten path, but having these adventures that are off the beaten path and the food and the culture and the people and the adventures-- I would love to, to master that and then teach people how to go tackle that so that others can share in that passion and see what the world has to offer. So, that to me just sounds like a dream come true. I would love to do that. Lindsey Dinneen: Yes. Yes. That sounds like an amazing masterclass and yes another dream job for sure. I'm just curious because I completely agree with you that in traveling internationally is such such a gift and it is so important if you can do it in terms of broadening your horizons. But I'm curious, what do you think are the main one or two things that, that you find are the most important elements of traveling abroad? Rebecca Whitney: So I would say the first thing is don't be afraid to say yes. My oldest nephew just graduated from high school and in my letter that I wrote him, as part of his graduation gift, I said, " Bias yourself towards saying yes when you're out on these trips and these adventures." And I think that when you're on an international trip, it can be really easy to just stay in your comfort zone. I'll give you an example. My brother and I were traveling in Africa several years ago and we had a driver pick us up when we landed in, where were we? It was off the coast of Tanzania. And it just happened to be the last day of Ramadan and he invited us back to his home-- we never met this man before-- to break fast after 30 days of Ramadan. And I think if we had been less open to trying new experiences, we both would've said "no way." But we said yes, and we had the most incredible experience that enriched our whole time. It was Zanzibar, that's where we were, and it was just one of the most incredible travel days of our lives. And so I think the first thing is being open to the experiences and biasing yourself towards saying yes, whether it's a dish or a food that looks terrifying to, to try. Or seeking something out that enriches the experience. I think that's one. And then two is staying flexible because travel these days, especially international, it's going to be fraught with setbacks, whether it's a train strike or a ferry schedule. So just being very flexible to kind of roll with it. Because I've seen, myself included, too many instances where some of those glitches can unfortunately ruin the experience. And so, being open to the new experiences and saying yes-- and then staying flexible to just roll with it, and take the trip as it comes, and let it go down whatever path presents itself-- I think are two really important ingredients for maximizing a global travel experience. Lindsey Dinneen: Could not agree more. Yes. Okay. What is one thing you wish to be remembered for after you leave this world? Rebecca Whitney: So this is probably a very cliche answer, but it's really true. I, I've thought about this and I do want to be remembered for the way I make people feel. And I say that because speaking about the job first, I feel like people have a choice. And any job that we take has the day-to-day tasks and requirements. But when I look back on my career, by far the most rewarding and the most challenging elements have involved people. And so I think whether it's a tough situation or a very successful celebratory situation, I want to be remembered for how I made people feel, and hopefully that's a positive thing. And that translates outside of work too: my nephews, for example, and my nieces. I want to be remembered for enriching their lives and giving them new experiences, but I also want them to know that I was there for them and the people that matter most to me. I think it's just very important. It's that old cliche saying, "people won't remember what you said, but they will remember how you made them feel." So, to me, if I'm doing my job right, inside and outside of work, hopefully people's impression after I'm gone is net positive in terms of how I made them feel. Lindsey Dinneen: Yes. And that ties right into your discussion earlier about leadership and having that bank, right? And putting in those credits and and so when things do get a little difficult sometimes you have had a net positive in the end. Rebecca Whitney: Yes. Yeah, that's right. Yes, exactly. Lindsey Dinneen: Yeah. And then final question, what is one thing that makes you smile every time you see or think about it? Rebecca Whitney: So I am a big believer that yes, we all have these milestone events and these big trips and things that come up, but I really look for the little things that bring joy on a daily basis. And when I took this role about two and a half years ago, my husband and I said, "Okay, we, we've got to find a way to stay connected because my days get busy." Even evenings are not that predictable. And so we've started getting up very early, which isn't as awful as I thought it would be. So we're typically up by about 4:30 in the morning. And one of the reasons we do this is because we have this daily ritual now where my husband makes the lattes, he's much better than I am. And we just sit together for about 30 minutes every morning. And if I'm on the road, we do it through FaceTime and it's just this dedicated little moment of time before the day gets crazy and busy where we connect, we have our coffee, we watch the sunrise and we talk. And I look forward to it when I open my eyes in the morning and throughout a busy, stressful day or trip, knowing that we have that daily touchpoint to kind of anchor with both always puts a smile on my face and it just starts the day off on the perfect tone. And I look forward to it all the time and it definitely makes me smile. Lindsey Dinneen: Yeah. Oh my goodness. That sounds like such a lovely time set aside to prioritize your relationship and get that special connection time. And of course a good latte never hurts. Rebecca Whitney: That's right. Lindsey Dinneen: That's amazing. Well, Rebecca, thank you so very much for joining us today. I really appreciate your perspective and your advice, especially for those who might be younger in leadership roles, maybe women who are coming into the medtech world, so thank you for that. And we are honored to be making a donation on your behalf as a thank you for your time today to Opportunity International, which designs, delivers and scales innovative financial solutions that helps families living in extreme poverty, build sustainable livelihoods, and access quality education for their children. So thank you for choosing that as the organization, and we just wish you the most continued success as you work to change lives for a better world. Rebecca Whitney: Thank you so much, Lindsey. I so appreciate the opportunity. Lindsey Dinneen: Yes, my absolute pleasure, and thank you also to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a friend or two and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dr. Kyle Flanigan is the co-founder and CEO of US Specialty Formulations. In this episode, Dr. Flanigan discusses the importance of providing specialized formulations that aren't typically addressed by larger pharmaceutical companies, shares about the company's focus on developing a unique oral vaccine platform called Kinder, and expresses his passion for leadership and innovation.  Guest links: https://ussfgmp.com/  Charity supported: Equal Justice Initiative  Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   EPISODE TRANSCRIPT Episode 015 - Dr. Kyle Flanigan Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to the Leading Difference Podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Dr. Kyle Flanigan. With more than 25 years of experience, Dr. Kyle Flanigan, co-founder and CEO of US Specialty Formulations, LLC is an expert in pharmaceutical and medical performance materials development stages. He consults with companies providing robust, stable solutions and services for formulation, scale-up technology, contingency planning, supply chain issues, quality systems implementation, and new facility design. He brings this knowledge and guidance to his company's clients and their pharmaceutical and medical developments on the best path to market. Thank you so very much for being here, Kyle. I'm so excited to speak with you today. Kyle Flanigan: Yes, thanks for having me. It's a pleasure. Lindsey Dinneen: Yeah, absolutely. I would love, if you wouldn't mind starting out by telling us just a little bit about yourself and your background and how you got to where you are. Kyle Flanigan: Sure. I'm Kyle Flanigan, CEO of US Specialty Formulations. I'm a co-founder with my business partner, Gary Moorefield. The two of us founded US Specialty Formulations with the idea of being able to provide specialized formulations to the public at large. So formulations that aren't typically picked up by the larger pharmaceutical manufacturing companies. And being able to provide those to, to patients or to doctors who are treating patients with compounds and formulations that they otherwise wouldn't be able to get ahold of. And that's kinda what started US Specialty Formulations. In addition to that, both of us have deep foundational knowledge in specialty materials processing, pharmaceuticals processing, clean room operations, SOPs, setting up and building groups that work on a variety of different types of technologies like this. So we also looked at how do we further a vaccine project that my co-founder had going. And in doing that, we just, we decided to set up this company and make this service available to other people. In addition to providing just your standard formulations used to treat certain diseases out there, we also provide a service for producing investigational drugs that new inventors may come to us and ask us to make, to deliver a high quality, clean, sterile high quality product into their investigations so they can continue with their clinical trials. So that's kind of where we are. And then out of that, we developed a vaccine platform, Kinder, which is the oral vaccine platform which we just got into, we just finished up its clinical trial out of New Zealand. And we got some awesome results out of because we adapted the platform from its original intended purpose, which was strep, and into a COVID 19 targeted vaccine. And this oral vaccine actually shows improvement over the existing mRNA vaccines that are out there as far as protection capability. It operates on a slightly different regime. It's a mucosal vaccine, which is really interesting and part of a new wave of vaccines that are gonna start showing up in the next decade. And also, it's really easy to take. It's so great because this allows treatments without needing to stab someone with a needle. That's as simple as it gets. It's you don't need to have a needle to, to administer a therapeutic. Lindsey Dinneen: Wow. That is very exciting for somebody like me who hates needles. Kyle Flanigan: Yes. Both of us. I hate needles. Also, it's, that's part of the reason I got into this was to avoid-- when I was little, getting a battery of boosters and that was such an unpleasant experience. Part of the kinder thought process, and the reason we call it Kinder is because it's a "kinder" way to administer a vaccine. It's a much more pleasant patient experience. Lindsey Dinneen: Yeah, absolutely. Backing up just a little bit, you mentioned founding the company, but I would love to hear the inception story of, how did you get connected with your co-founder, and then how did you guys come up with " this is what we want to do with our careers"? Kyle Flanigan: Right. So Gary and I met through our daughters and we're in gymnastics and they're on the same gymnastics team. Anyone listening who is from a gymnastics family will know this very well. And what happens is, the person doing the gymnastics is maybe performing for a whole 30 minutes, maybe 50 minutes total time on the floor. But at a gymnastics event, typically with all the teams and everything out goes on for easily four to six hours. And so Gary had his other company that he was working with, I was employed by another company. But we were both very interested in technology . And so while we sat in the stands trying to be supportive of our daughters as they're doing these crazy death defying moves, to kind of pass the time we would just talk shop sometimes. And, over the course of a couple of seasons, we recognize that one, we got along, but two, we both had very strong and clear ideas of how to do a variety of things. So that's key. And our vision and our goals kind of align with, "Hey, if I had the ability to do this, this is what I would do and here's how I'd run it." And as we work through those casual conversations, we recognized that we were aligned in kind of our thinking of what we wanted to do with our careers. And an opportunity came up so that I was able to leave what I was doing and devote some time to some business planning, business modeling and things like that. We developed the model and then incept the business in 2013. And bring it up and just begin to build our clean rooms and things like that. We built everything by hand at first. Just the two of us again. With such intimate knowledge of the space, the operational side, as well as the development side, as well as the business side from our past lives, the two of us were able to do what typically you would expect a high powered team of, 10 to 12 people to do, just to start the company up and running. So we were able to do that, and that was, that's really what started, USSF off in this pharmaceutical space. It's really a cool story. I think our first clean room looked a little-- you could tell it was hand-built-- but it was very functional. It worked very well. Our next set of clean rooms is a lot better, and then our third set that we're still in the planning stages for our expansion, those look much more much more we'll say professionally built. Lindsey Dinneen: That's amazing. Kyle Flanigan: It was a good story because, again it's kinda like the two of us had the vision, put a business model together. And we've worked through it and surprisingly from our original business model, the environment and everything else hasn't changed all that much. So our model has held consistent through the test of time over these past what is it, 10 years? 10 years now. Lindsey Dinneen: Great. Wow. Yeah that's amazing. I love those kinds of stories where it's just a person or a couple of people with big dreams and big goals, and they just set out to do what they know that they were meant to do. And sure, sometimes it looks a little wonky at the beginning, but it works. Kyle Flanigan: Yes, we were very happy. The first formulation we had for sale was a very celebratory day. I think it was just, I think our first product was saline. We had saline for injection and it was a monumentous day when we got it packed and ready to ship to a customer. Lindsey Dinneen: Oh, yeah. I can only imagine. That's so exciting. I love those moments. So I'm curious, is there a particular moment that stands out to you because it clearly confirmed that this was the right career for you? Now, that's a broad question. So it could be related to your experience in the industry as a whole, or it could be specific to your company. But in general, is there a moment or a series of moments that just said, "yes, this is it." Kyle Flanigan: Yeah. I think, one of them actually happened fairly recently. We made an investigational drug for a customer. And they used it. And this particular one was made to enhance the survivability of organs during transplant. From that, you know, it's still in development and it's still being going through its processes. But we had to refine the formulation, develop the formulation really quickly to get it available for a-- I think they were going for a compassionate care use, I'm not entirely certain-- but you know, we were able to get the team trained and ready to go and we were able to get this formulation out the door to the customer. And we received a note later that was forwarded from their CEO to us, and it was, " Hey, you just wanna let the team know that because of your diligence and capability this, this was used and we applied it to an organ. And the surgeon let us know that the organ would not have been viable if not for the additive that you guys supplied to us and the transplant was successful because of what you provided." Otherwise, I think it was a girl of like 17 or something, she would not have made it if it, if they had not used this. I did not think it would have such a big impact in my thought process, and then after it, as it kind of sunk in what we were able to accomplish. This really is one of the satisfying things about what we do. We were able to successfully get this out. We were able to produce a high quality thing and it saved someone's life. That makes the entire team as you're going through it, it focuses you and allows you to say, "Hey, this is the goal, this is why we do this. This is why this is important." And the results are very tangible at the end. And that just affirmed that, so it was, it was awesome. But I would say that's the moment that was, you know, a couple years ago, but it let me know that, "okay, you're in the right field. This is what I like doing." You know, putting a team together that can do that. Having, the technology and the bits and parts that all come together to culminate in being able to provide that lifesaving action is really important. Lindsey Dinneen: Yeah. It is so important. And I can only imagine too, being a father yourself and realizing, you have a daughter too, and that like connection-- yeah-- of, of this is so impactful to somebody. And it could be somebody that you know personally in the future, who knows, but the point is you're making a difference. And that's-- ugh. Yeah. That's a good feeling. Kyle Flanigan: Right, it's one of the feelings-- when we thought about why does USSF exist? And that's one of the things is we handle a lot of the formulations that the big companies don't handle. For a variety of business reasons, they don't. But really, when it comes down to it, when you're a patient sick and your physician prescribed a certain medication, if that medication's not available, then it's effectively you don't have any healthcare, right? That's the problem. That's one of the reasons USSF is here, is to be able to provide, certain medications or vaccine technology, so that we are able to provide this healthcare when the larger companies have passed on providing for that. Lindsey Dinneen: Yeah. Yeah. That's great. So growing up, was medicine always of interest to you or chemical formulas or whatever, like was that always of an interest or is that something you kind of developed? Kyle Flanigan: It was always an interest. It was always, we'll say an ancillary interest. Truth be told, I'm a pilot and I love flying and anything aviation or space related. So I always wanted to go into space to do pharmaceutical research on the space station or zero G or microgravity type stuff. So , chemistry has always been a part of my training and my background. Both my parents are chemists. My dad was big pharma, my mom was analytical lab chemist, so, so it's always been there. My training is as a chemist. But I think, I always want to do from the beginning is, it's that explore and build kind of drive in me. Go into unchartered territory where I am the first, or only among the very few, that actually have blazed the way down a certain technology path or being able to introduce new things to the market. And I think that drive is one of the things that influenced my spin up into deciding to found effectively a startup, and then grow it into a much larger entity. And it's not for the faint of heart, right? As we discussed earlier, this is extraordinarily challenging. You need the technology, you need the chemistry chops, you need the science chops. But there's also more, you also need a energy and an underlying drive in order to really do this. It's that goal to explore, create, and bring people up behind me as I keep charting a path. And that's kinda the drive that's pointed me in this direction and laser focused me in this direction. Lindsey Dinneen: Absolutely. Yeah. And I love your idea that you brought up of exploring and creation and sort of being the first to go into some uncharted territory. I think that's a common theme I've noticed in this industry of people who are curious and they're interested in learning and they're interested in growing not only themselves and their own abilities, but also the industry as a whole, pushing it forward and whatnot. Kyle Flanigan: I was gonna say it's that, read everything. I think when I was growing up, the net was still-- it wasn't the net that we know now. But, reading The American Scientific or whatever business journals my dad brought home from the office. But just picking up those magazines and devouring them and reading, even though I didn't have the background in training for them, I would still read them and pick up little bits of knowledge here and there. And even today, I think one of the things that separates the kind of people on our team that do really well are those that if they don't know something or there's a meeting where there's some bit of information that they don't know offhand, the behavior that I see that really makes me proud is, they'll just go look it up. Yeah. No one goes, "Oh, I dunno," and then move on. No, you've got three or four people go look it up and like, "Oh, okay, here's what it is, now we understand it, let's proceed with this new knowledge." Those are the kinds of people that enable technology to grow rapidly because, to commercialize any technology, it's not a one man show. You might come up with certain things, but once you try to commercialize it or bring it into production or run it through a regulatory process, it becomes a major team effort, and the curious make that effort much easier than if you just have people who just do exactly what they're told all the time. That works for very large kinda sustaining type companies. But for these, the leading edge-- although as they say, the bleeding edge-- of technology, it's those kinds of people that is what's required for companies to be successful. Lindsey Dinneen: Yeah, absolutely. I'm curious how your own leadership abilities have evolved over time and how would you define leadership or what does it mean to you? Kyle Flanigan: You know, initially when we first found it, it was the two of us, then three of us, then five, and now we hover around between 13 and 16 at any given time. And I think it's gone from, initially when you first found, you're a doer, a planner, but you're focused on daily ops with a little bit of strategic stuff in there. And now it's shifted with more of a team. What has shifted is into being able to lay out a roadmap for people so that the team leaders understand where we're going. And, I'm not, and Gary's not focused on, explaining to people how to do a certain task. It's more of a "Here's where we're going, here's the task that you need to accomplish. You guys know how to do it. We've trained you how to do it, or you've got the training on how to do it now, just execute to your training, but here's where we're trying to go." So that's how it's shifted. It's shifted from the tactical to the strategic. I think for me, a leader is a person who can identify the strategic direction that the team should go. And usually that's getting input from a lot of people, not just in the company, but you know, knowing the lay of the land, right? Being out in the industry, taking in the voice of the customer, all that great stuff, and then saying, "Here's the direction this company should go. Here's what's required for us to go there, and here's what I need each of you to do to get us there." And being able to lay that out. That's kind of the strategic side. The other side as a leader is to be able to remove roadblocks from your team, meaning reading the team, how does this particular team member operate? What are their buttons? What is preventing them from accelerating and providing that feedback to them. And if it's something that you can address, addressing it. So, removing roadblocks. Again, as I say to my logistics person when he says, " We can't get this our, our supplier doesn't have this anymore." Then it's working with him and saying, "Okay, let's work through this and find some alternates and we'll work through our process for identifying alternates and picking new ones." That's a basic one, but you know, it could be as simple as, "Hey, my childcare person just quit." Right? "I have no one to babysit my child and so I can't do what we're doing." Okay, let's figure out how you can still do what I need you to do, but also your home stuff is taken care of so that you can focus, you're not worried about that while you're executing your other duties. And I think a leader has to be aware of the different challenges their team members are facing and be able to, one, create an environment to make it pleasurable to work. But two, help them overcome those different things. And so I call it just removing roadblocks, whether that's on the business side or the personal side. What are the roadblocks that I need to assist with? And sometimes you just can't do anything, right? And you have to say that. But if there's things within your power to, to help with, then I believe a leader should do that. So set the direction strategically. Empower the people to do what you're asking them to do, right? Don't tell someone to do something and then give them no power to do it or authority to do it, right? That's pretty poor leadership. And then remove any roadblocks that are coming, whether it's professional or personal, if you can help with that. Lindsey Dinneen: Yeah. That's great. Thank you so much for that advice. I think that's really important to have all those components, like you said, because people are multidimensional, so it can't just be one thing that you're trying to help manage, say. So it's not just the strategic side as a good leader, although that's extremely important. But like you said, the roadblock, I really like that analogy of helping someone to do their very best. And that could be through the work. It could be through the personal lives or whatever, but since people, it's all intertwined for us, it's so helpful to have a leader who understands that and can put it all together. So I really like your 360 approach to that for sure. Kyle Flanigan: Ah, thanks. And again, both Gary and I come from large corporate environments. So we know how not to manage people. Lindsey Dinneen: Yeah. I hear ya. Kyle Flanigan: We've both experienced that. Yeah. Lindsey Dinneen: Yep. That is sometimes not a lesson that you would prefer to learn that way, but it is a good teacher. Yeah, absolutely. Pivoting just a little bit. Just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? Kyle Flanigan: Oh, I think, yeah, for me it would be how to commercialize a product. And I say that because a lot of the world, when you hear notes about technology and the challenges associated with just being a human today, right? You'll have people say, "Oh, well someone invented X, Y, and Z." Okay. And then you have a large company, many years ago that will say, "All right, we produced 80 million of these widgets a year, and we're providing them to, to these people to make their lives better." Okay. That's two ends of a very long spectrum. Very few people are familiar with what has to happen between the person in the lab saying, "Yes, I now have a working model of what we're going to ultimately produce" to when you can go buy it on a shelf somewhere, right? And here's an example. I think, during Covid, a lot of people were saying, "Oh, we're gonna throw all this money at this problem. And we should be able to then have it go away." And it's that in between having something in the lab to having it on a shelf ready to use, that's a very long time period or a very complex period. Not necessarily long, but complex period. In some cases it is actually a fixed amount of time between certain steps in that, that have to occur, and no amount of money that you throw into it is going to speed that up. So I see this a lot in the investor discussions and other types of discussions with politicians and things where, okay, if you throw a million dollars at a given problem, it doesn't mean it's gonna be fixed tomorrow or in six months. And so teaching that class of what are the things that actually have to happen at the high level. For instance, I talked a lot about teams and building and things like that. If you were to throw up a new facility, you have to staff it. That takes time. You have to find these people. Even then, once you have the people, you have to train them on all the new equipment you put in the facility, right? So all that takes time. And that could be six months, it could be a year. The team has to get comfortable working well together, so they're probably gonna take another eight months before of actually doing it, before everyone knows what each person's supposed to do. So now you're in a, a 24 month time period from someone just throwing a lot of money at something. So, I would love to teach a, a masterclass on when we say we're gonna commercialize and start up as an entrepreneur or something like that, here's what that involves, right? Here are all the considerations that, that are gonna go into this, and these are the choices you're gonna have to make. Some, you can make early on to make your life easier on the backend. Some, you won't be able to make until the day or the month you actually have to make that decision. Some are instantaneous. But these are the kinds of things that you have to consider while going through. While I was at grad school, actually took an entrepreneur course. We used Guy Kawasaki's book. But it talks about that, that beginning cycle. How do you pick what you're gonna do? But the commercialization side, I think a lot of people who are in the field, looking at it as industry specific. But I think it could be taught a lot broader. That would be my, my thing. But how do you, commercialize looking at supply chains? We saw a perfect example of broken supply chains, right? So how do you design for those? And these concepts have been around for a long time. Certain industries are better at it than others, but it's not something that is ubiquitous in the industry. It's not a regular thought process for people. And I think in a masterclass set up, those are the things that, that if they're called out and actually focused on with a little bit more attention on stabilizing, or teaching people these considerations, it'll go a long way to mitigating those scale up risks in the future for all the other really cool inventions and technologies that are out there. But, everyone depends on a supply chain. So that's what I would teach, I would devote some serious time in examples into trying to teach people about that. Lindsey Dinneen: Yeah, that's a great subject and very important, so that would be a great class to take. What is one thing you wish to be remembered for after you leave this world? Kyle Flanigan: Yeah, again, we go back to having daughters and things like that, but as I look at them growing up and maturing, I think it's really having left the world, let's say, a better place. And by being in a better place, meaning the human condition is a lot more pleasant than it was when I entered the world. And I contributed to that. So again, vaccinations, you don't need to get stabbed every time you get vaccinated. I just hate needles. But, you know, that goes a long way at making the deliverance of healthcare process more pleasant, and making it more available to people who otherwise would not have access to it in using conventional methods. So I think that is improving the human condition considerably. And enabling a lot better care and opportunities for people throughout the world. Lindsey Dinneen: Yeah. I love that. Yeah. And I love that you're actually living what you are passionate about and so you're building your legacy as you go. So, final question. What is one thing that makes you smile every time you see or think about it? Kyle Flanigan: So many things. I'll give you two things I can't decide between them. Lindsey Dinneen: Sure. Kyle Flanigan: One is both my daughters are competitive in their sports. So one is a cyclist. And when I see her racing around the track on her bicycle, winning or placing and medaling, I am thoroughly thoroughly proud of that. And the other daughter is a gymnast, like I said. And when I see her out competing and again, medaling and things like that, I'm just immensely proud of their dedication and focus that allows them to do that. And I would say at least I married someone who was able to teach that to them probably. So I smile whenever I think of the two of them. And then drone drops, drone dropping of medications and essential supplies to the outback, places where there are no roads and things like that. I think that's just awesome. It's the combination of multiple technologies to again, improve people's lives and it's gonna be the start of something. Right now we're talking about little packages, right, for those things. But as the tech gets better and people get more and more comfortable with trusting the robots. Again, that has some science fiction implications, but I think as people get more familiar with the technology and work some of the bugs out of it, more and more things will begin to be employed that way. And it makes me smile because it is reducing the risk for people living out there and for the delivery people who have to deliver that stuff. You know, all around it's a risk reduction exercise. And it embodies everything I love about technology, aerospace, pharmaceuticals, and drones and logistics. So it's just awesome. So, I do smile when I think about drone dropping of stuff. Lindsey Dinneen: I love that. What a great answer. So relevant to what you do, but also just such a unique answer. That's fantastic. Kyle, this has been so much fun. I really appreciate you joining me today and sharing your story and your insights. So, thank you just for the time that you spent and we're honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongly convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. Thank you for choosing that. And again, just thank you for being here. We wish you continued success as you work to change lives for a better world. Kyle Flanigan: Okay, thank you. Thanks, Lindsey, for having me. And I appreciate it. I'm honored to always be asked to speak about various topics. Lindsey Dinneen: Absolutely. Yeah, of course. And thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dr. Ben Freedman and Dr. David Wu are the founder and advisor of Limax Biosciences, respectively. In this episode, they discuss their breakthrough innovation of novel biomaterials to transform healthcare, why collaboration and mentorship are so important, and how slugs inspired their work to the point of Ben being featured in a German TV show as the superhero Snail Man.  Guest links: https://www.limaxbiosciences.com/  Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW NOTES Episode 016 - Dr. Ben Freedman & Dr. David Wu Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to the Leading Difference Podcast. I'm your host Lindsey, and I am very excited to introduce you to my guests today. They are Dr. Ben Freedman. He is the founder of Limax Biosciences, and along with him I am honored to have Dr. David Wu, who is an advisor for Limax Biosciences. Gentlemen, thank you so very much for joining me. I am so delighted that you're here. Thank you for being here. Dr. Ben Freedman: Thanks so much for having us. It's great to speak with you today. Lindsey Dinneen: Absolutely. Dr. David Wu: Thank you for having us. Lindsey Dinneen: Yeah, absolutely. Well, I would love if you all wouldn't mind starting by sharing just a little bit about yourself, some of your background, how you got into the industry, and what you're excited about right now. Maybe we can start with Ben, and then David, I'll turn it over to you after that. Dr. Ben Freedman: That sounds great. Yeah, so for me, I was always interested in science and technology in high school and prior to that point in time, and when I was looking at opportunities for what to major in as an undergrad, I came across bio-medical engineering, which at the time was really an emerging field that kind of blended a lot of the interests that I had between medicine and engineering and technology. And I got involved with a number of different courses. Had a number of different research experiences as an undergraduate and a lot of really fantastic dedicated research mentors that really pushed me to start to explore so many different areas within the field and industry and get a sense for all the different neat and exciting activities that were going on. And I really enjoyed research at the time, in the bioengineering space that led me to do a PhD in Bioengineering at the University of Pennsylvania where I was asking a little bit more basic science questions but had really strong interest in translation, in developing new therapies. So, after that point in time, I continued to do a postdoc at Harvard and the Wyss Institute where we started kind of combining a lot of my interests from my PhD in soft tissue biomechanics with developing new therapies to try to improve the healing process. And one of those therapies that we came across very early is that we realized that for material to deliver something, whether that be a some cells or other type of drug therapy, two tissues. It really needed to be coupled to tissues locally. So we started exploring this area bioadhesive, quickly realized that this was a really exciting area, not for just areas within the orthopedic space, but really many different types of diseases throughout the body. And it basically led us to kind of explore not only the academic path, but also a lot of the translational paths as well. That's really what's brought us here today. Lindsey Dinneen: Amazing. Thank you. David? Dr. David Wu: Hi everyone. So, I am right now a clinician scientist at Harvard University and what got me interested in the space, so during high school and an earlier part of undergrad, I was really fascinated by this idea of biotechnology and the fusion between the biomedical engineering, biology, as well as healthcare. So I did my undergraduate training in anatomy and cell biology at McGill University in Montreal. And during that experience, being fascinated as a student to learn more about research, I was involved in several different aspects of research, including stem cell biology, tissue engineering and immunology. Wanted to explore a little bit more about how these things were intertwined together. At the same time, through working with the local community on certain humanitarian initiatives and community initiatives, I got exposed to the field of dental medicine actually because I was interested in having a very direct impact on each individual patient's lives, on a daily basis, as well as learning more about research and how to advance the field. As a scientist, I managed to combine both. So during my dental school at McGill University, as well, I was involved in a project in stem cell biology and regenerative medicine, looking at how we use bone marrow cell extract to help patients who have oral cancer and have undergone a radiation therapy. So as a result of these type of radiation therapy, patients would have their salivary gland destroyed, and that could lead to a lot of oral complications, including rampant caries, different types of infections, so making these patients lives very difficult. And exploring different regenerative therapies, and that introduced me to the field of tissue engineering. So, fast forward a couple of years in terms of graduation from dental school, I had the option of pursuing specialty training to become a specialist. And the specialty that I chose was the field of periodontology or periodontics. And for those of you who don't know what that entails, periodontology is basically a specialty treating gum diseases and building a good foundation of supporting structure, supporting your teeth. So your jawbone, your mandible, your gum. And right now what we do is a series of plastic surgery, a reconstructive surgery, to help patients with severe disease to build them back to a health condition to allow them to smile and chew. And part of that involves regenerative medicine and tissue engineering. So when I started at Harvard University, I had the privilege of meeting professor David Mooney, who was a world expert in tissue engineering and bio materials, and decided to start my doctoral thesis at the lab. And at the same time, that's how I met Benjamin Freedman, who was postdoc at the lab at the time, and we started collaborating on these projects, exploring the application of bio adhesives in different indications. And one of the indications we're exploring has to do with the cranial facial complex. So that kind of attracted me to the MedTech industry as well. Lindsey Dinneen: Wonderful. Yeah. And so I would love to hear then more about Limax? Dr. Ben Freedman: Yeah. A number of existing topical adhesives such as the super glues, the cyanoacrylate-based adhesives that are used commonly for superficial wound closure actually don't perform very well once you start using them in any sort of wet or actively bleeding environment that those types of glues become very rigid and don't bond well to the underlying tissue surface. A lot of existing tissue pieces are very weak. They're brittle upon any interaction with dynamically moving tissues or organs, compression, which is very common inside the body where a lot of these materials simply crumble upon any sort of mechanical stimulus that you place on them. That is coupled with a lot of the complications and challenges with the human body. There's a lot of wet tissues, a lot of tissues that are bleeding or exuding other fluids. And while these materials are really designed to try to prevent leaks and things like that, when they actually don't perform very well once they start to interact with wet surfaces. So for all these reasons they certainly demand for new materials. There's also, of course, a number of complications that have been reported for other types of bio adhesives, depending on their cross-linking mechanisms that include areas where they're toxic to underlying tissues. They can create all sorts of catastrophic embolization events and many other areas which are reported in the literature, which has really driven a big demand for developing new materials. But there's been a limitation in the field and kind of a breakthrough that we had made a number of years ago before I had started working in the lab with Dave Mooney at Harvard and the Wyss Institute. There was a discovery that was made for generating materials with really unique mechanical properties. And this was actually something that we didn't realize was gonna be as important for adhesives until recently. Because the reason why existing adhesives fail is that there's been a huge amount of efforts placed on generating strong adhesion to underlying tissue surfaces. But there has not been as big of an emphasis on generating materials that have strong cohesion such that the materials may be sticking strongly, but they have such weak matrix properties that they will fracture upon any sort of mechanical stimulus. And it turns out that you actually need really strong, cohesive properties first before you can generate really strong adhesive properties. So it turns out that a number of years ago, about 10 years ago at this point there was a discovery made at Harvard University where a new form of hydrogel was created. So hydrogel is a swollen polymer network. It's about 90% water, and It was discovered that if you created a dual interpenetrating network of two different types of polymers, one that dissipates energy and another that has high elasticity, that either one alone has relatively weak mechanical properties, but if you couple the two together, they interact synergistically to create a material with very high what we call material toughness. And these tough hydrogels have really enabled us to reimagine what we can do with a biomedical tissue. This same high toughness principle was later applied in around the year timeframe of 2016, 2017, when the bioadhesive were first developed in the Mooney group by a very talented postdoc, genuinely, who was now faculty at McGill. And this is around the time that I was starting in the lab and since then we've been working to, to create new versions within materials that have really interesting new properties, but it's really the synergistic interactions between this interpenetrating network with high toughness that's then added, coated with an adhesive layer that allows us to generate strong adhesion. And where all this came from is we were inspired by nature. We are coming from the Wyss Institute for Biologically Inspired Engineering at Harvard where we tried to turn to nature for new ideas to create new materials that have unique properties. So here we actually turned to the slug. And when slugs feel threatened, they secret a very sticky mucus that prevents 'em from being taken away by a predator. If you analyze the composition of this mucus, there's a whole series of slug slime researchers out there who have done a fantastic job quantifying some of the compositional and mechanical properties of this mucus, that it has actually very tough mechanical properties. You can stretch slug slime about 10 to 15 times its initial length without breaking, and if you analyze the composition of that same slime, it's about 90% water. It's a hydrogel, and it has a dual interpenetrating network of ions, proteins, and sugars that give it its unique mechanical properties. So, once we started realizing this, it, became clear that, hey, we have actually a material already in the lab that has really high material toughness, our tough hydrogel. Maybe we could actually couple that to tissues by applying some of the same principles of this interpenetrating network with a very amine rich bridging polymer, which we try to recapitulate in the lab. So we don't use any slug components. Full disclosure, no slug components. It's inspired by slugs and actually, Limax is Latin for "slug." So we have kept the slug theme all the way up to the creation of this entity. So it's something that we, hold very closely near and dear to our hearts. And something that we think has a really unique strategy to solve a very pressing, unmet clinical need. Lindsey Dinneen: Well that is amazing and I love the story behind it. And so I just have to ask, are you ever gonna have a snail mascot or is that a thing? Dr. Ben Freedman: That's a great question. That's a great question. But before we all laugh, we do integrate a little bit of the slug with our logo. So if you go back and look at the logo now, you'll probably notice there's a little component that does have some slug- like characteristics. And actually for fun back in 2017, a TV show based in Germany, which is essentially the Discovery Channel of Germany, came by to do a segment on our materials and they actually turned me into a snail superhero that they coined Snail Man. So, that is online someplace. But it's a fantastic snippet of what our materials can do and how they may have a, what we hope a great impact on healthcare. Lindsey Dinneen: That's amazing. I love that and I am definitely gonna have to Google that later because that's pretty fantastic. Well, I'm curious for both of you, are there any particular moments or a moment that really stands out to you as something that reinforced the idea to you that this is the right industry for you? Dr. David Wu: I think I can get started on this one. So my interest to get into the medtech industry is as a clinician, as a surgeon, you are doing a lot of surgery. You see a lot of different cases where you need a certain technology to make a treatment available to the patient in order to obtain the best results. But sometimes these treatment modalities or these technologies are not yet available. There's some maybe basic science research that demonstrated certain effects that are promising for clinical application, but in clinic, there's no such thing available. So my goal as a clinician, as a scientist, and entrepreneur is basically bridging the gap between benchtop research as well as clinic. And in order to translate this technology, I think the involvement of the medtech industry is so critical because it's a long, arduous journey to translate a basic science discovery all the way to benefit each individual patients. It involves a regulatory process. It involves manufacturing, design, marketing, so many different steps. So that was the main catalyst and my mission that drives me to not only doing these translational type of research, but also to building a strong line of, of products, of technologies to change how we treat patients and how patients benefit from these type of treatment in terms of quality of life, as well as successful outcome. Lindsey Dinneen: Yeah, that's great, Ben? Dr. Ben Freedman: And for me it was, I don't know, going back to when I was really young. When I was in fourth grade, I think I, I had a kind of this toy robot that I was trying to build and the instructions kind of had a relatively basic design of the wrist of the robot. So it was pretty much fully rigid. The hand could open and close, but it couldn't exhibit the other types of range of motion that our human wrist could have. So I added some other motors and gadgets and things like that to kind of re-engineer the wrist. I think maybe that was an early sign that I was I was going to be a bioengineer cuz I was kind of curious to innovate, curious to try to develop new solutions that could better represent the actual human condition. And through that in a number of different projects that had been going on for a number of years, well before PhD undergrad projects, early on I took a technical entrepreneurship course. Kind of got involved with what would go into a business plan relatively early, got the chance to enter some competitions very early, which were great learning experiences and kind of left me hungry for more. And I think all these experiences, have kind of added up where, I definitely wanna be an innovator. I want to inspire new scientists, train new students, and develop new solutions for really pressing unmet needs that exist. I think, talking to so many folks, clinicians in this space, having family members that have also experienced a number of these terrible diseases and disorders that there's certainly so much work that still needs to be done and not enough folks out there developing new solutions here as we're running out of time to, to do all these things. So, certainly feel kind of the time pressure to develop new and an important solutions. And really to try to think big. I think that's really the most exciting part is to have a problem and really develop a solution that can really address that, that specific problem in the best possible way. Lindsey Dinneen: Yeah. Yeah. Absolutely. So both of you have had really interesting career paths that have led you to where you are today, and it sounds like leadership has been a winding thread through various different avenues for you both. So, I'm curious, two things. One is what does leadership mean to you? And then the second thing would be what advice would you have for someone who might be interested in doing something similar to what you're doing or is looking for a leadership role within the medtech industry? So whoever would love to take that, I'd just be curious to know your thoughts. Dr. David Wu: Yeah, I can start. I think the most important part of leadership is finding a common mission and enabling people on your team to achieve that common mission together, whether it is teaching them the skills to do so or encouraging them. I think just bring everybody to achieve a same mission, the common mission, the common goal. For example, in the MedTech industry, it could be developing a new biomedical device to, to solve a particular technical or surgical issue in order to improve treatment outcome for a specific population. It could even be broader, right? Tackle aging or tackle specific type of cancer. So, having the ability to really gathering the team and to inspiring every individual team member, who are from different backgrounds, who have different priorities and different level of life experiences and skills. And how do you find the common denominator and how do you motivate them? I think that's the key to success to leadership. Dr. Ben Freedman: And I think just to add to that, there's certainly different types of leaders, different types of leadership positions, even within a single organization. I think just finding the right people that can help build that positive work environment, that can help motivate a group and inspire group to go after a common goal. And I think if you can get everybody on board with not only the mission, but but really have the drive to where it doesn't necessarily feel like work. It feels like everybody's going after something that's gonna be extremely impactful. You know, award credit when credit is due. All these things are really important characteristics of what I think goes into making somebody be a good leader. Certainly lots of things that you could learn in a class, but also a lot of it is practice and learning how to manage a lot of things going on at the same time, communicating really effectively, really recognizing accomplishments and achievements for those in the team. And being organized and focused to define goals that are within reach are all the different kind of important qualities that will go into being a successful leader. I think, we're relatively both early in our careers. So I think we're still trying to learn some of the key things here and in talking to some of our mentors about how they may handle situations and learning from others. There's always things to learn in this space to further advance our own careers. Lindsey Dinneen: Of course. And what about any advice you might have for somebody who's interested in, again, either doing something similar or obtaining a leadership role, just maybe somebody who's even earlier on in their career. What would you say to them? Dr. Ben Freedman: So, I mean, I think there's a number of things here. A number of different little key bits of advice. Certainly, people will say that you need a lot of grit, you need to work hard, you need to be determined. It's easy to say those things, but it's also, you have to practice going through those different things too, where not every day's going to be winning a competition, where there's gonna be a lot of failure. There's gonna be a lot of unanswered questions. There's gonna be a lot of things where it may not feel like you're making a huge amount of progress. You might be making a little bit of progress. You might be taking steps forward, you might be taking steps backward. But hopefully, you just have to keep your eye on the goal. And I think a lot of these skill sets with grit and determination and, not just working hard but working smart. Being really efficient with hours and time are some of the things that we've developed during this postgraduate, graduate training which, I think has been helpful probably for us as young, aspiring scientists and entrepreneurs to really have an eye on where things can go. Appreciate that it's not necessarily a straight line and things can go in all sorts of directions. But just to, try to keep a focus and we heard an analogy last night, we were at the Resolve Mass Challenge event and taking place in Boston. One of the keynotes was talking about thinking about approaching problems with kind of a bandpass filter. Filtering out the really good things and how that might affect you and the really bad. So just to keep kind of a more moderate response to a lot of the different things that are coming. And I think, part of that is true. Keep a steady pace and surround yourself with folks that, that share in your, mission and that can hear your stresses and successes and you know, just surround yourself with the people, great people and that can push you to do new things. And I think that's really an important part for folks in this industry and other industries. Where you're not doing this in a silo. I heard once that, the hardest job of somebody in these, top leadership positions, whether that be CEO or academic professors is not necessarily the company, or the lab or the whatever. It's managing your own mental health. And I think, that's certainly, an important part and something that we all have to work toward. And I think if you do that in addition to doing really good science and really good in innovative technology development, hopefully that will be something that leads to success, but it's not an easy path. It's a lot of factors that can be out of your control as well, depending on industry dynamics and people, et cetera. But until that point we're certainly in this interesting phase of great determination and surrounding ourselves with fantastic people that, that share in our vision. Lindsey Dinneen: Absolutely. David, anything to add to that? Dr. David Wu: Yes, I think one of the advice to, to any young folks either in the industry, in academia or in clinical practice is be open-minded. There's a lot of things we currently don't know. So having the foresight to network within your own industry, but also in adjacent industries. And really exploring what are the different innovations, the different discoveries going on, and how to cross pollinate and how to collaborate with each other because we have to acknowledge that we only have so much time and so much expertise in, in our domain. So having the opportunity to collaborate with people outside of our immediate field, that could be really beneficial. A second point I'd like to touch on is a mentorship. As young, aspiring leaders and inventors in the industry, entrepreneurs, it's important to seek mentorship and to learn from those veterans who have been there, done that. They have a lot of advice to share. How did they start their own journey? So by talking to these different mentors and really building your core group of mentors, or for example, there's one particular term in the literature I'd like to refer to as your "personal board advisors." So identify these people that play a certain role in your own growth, in your own development that could really expand your horizons in terms of knowledge as well as network. And the third point I'd like to touch about is dream big and also act on it. And recently, I heard somebody in my network talk about this concept. When opportunities come knocking on your door, you gotta be ready and you gotta be there to open that door. So, when you have a dream, you're not gonna be able to foresee what's gonna be coming towards you next year or the year after. But what you can do is to build a set of skill, to build a network within the industry and to understand what are some key areas of opportunity and aligning yourself up for that. And when you're presented with these opportunities, see those opportunities. Lindsey Dinneen: Absolutely. Yeah, that is great advice. Thank you very much both of you for that. I think you've touched on something that is really important and kind of a running theme of the interviews I've done so far is the concept that there are many avenues to a dream, and if you're open and you're willing to explore the opportunities that come your way, whether or not you initially thought that's how it would work out, I mean it leads people to some pretty amazing opportunities and experiences if you're willing to be open and you're willing to be humble enough to know that you're gonna be learning and growing your whole life. Well, on a different note, for both of you, just a fun question. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want, doesn't have to be in your industry, but it could. What would you choose to teach and why? Dr. David Wu: If I were offered an opportunity to teach a masterclass, and this might be coming from a totally different angle, but I would teach the art of Japanese sushi and sashimi making. And part of the reason why is first, it's full of art and history. And as the culinary arts is embedded in history. There's also a lot of knowledge you need to know and a lot of training. So just out of interest, for background knowledge, a Japanese chef for a Japanese sushi chef, when they undergo through training, it takes them about three years just preparing the rice for the sushi. And that is the amount of detail, technical knowledge, repetition, and perseverance. And once they're passed onto that stage, they move on to, to teach 'em how to make it a piece of omelet or egg. And that process also takes years. So to really become a master and to hone your skill to reach that level of master sushi chef it takes, 20, 30, even 40 years. And one of the most famous chef in Japan actually is well into his eighties and still perfecting his craft. And that is an analogy to my specialty, which is periodontal surgery. We do a lot of plastic surgery and a lot of the techniques in plastic surgery is very refined. You need to have fine control of the surgical blade. You need to master different levels and tiers of techniques. So that's kind of in parallel to, to the art of sushi making. So if I was offered a million dollars, I will definitely teach a class on these different aspects. Lindsey Dinneen: I love it. Ben? Dr. Ben Freedman: Yeah. So before I was-- I guess in parallel, actually, while I was doing science, I had a side job of teaching sailing. I grew up doing some water sports and got really passionate about teaching sailing and not just competitive sailboat racing, but I just loved the whole concept of working with somebody that's never been on the water, may have just learned how to swim and teaching them an entirely different skillset. It's not necessarily like walking or riding a bike, it's something where there's a lot of controls. You're on a boat that's floating and, and the ocean, there's lines to pull, there's ways you have to maintain your balance. All these things that, that go into place so that the boat goes forward, doesn't go in circles and you don't flip the thing over. And I've had such an enjoyable time working with younger students, adults. I volunteered for a number of years for the Sailing Special Olympics, working with athletes of all different backgrounds that, I would, in a heartbeat, love to build a, a whole career out of sailing. Probably not even pay me to do it. I would, certainly do it for free just because it's been such a strong passion of mine over the years. I think there's a lot of similarities to sailing a boat and doing a lot of things in life, whether that be entrepreneurship or learning a new skill or working harder in a class or doing a PhD, et cetera. A lot of times with sailing, it's not like driving a motor boat where you can go from point A to point B, you have to zigzag through the wind. You have waves, you have unintended obstacles that you'll hit, and you have to sometimes adapt on the fly. You can't predict what the weather is going to be or what might be out on the water. And I think that certainly resonates closely with me and the different activities that I'm doing in academia and the industry. And something which I think is true for a lot of us in life. So, without a doubt, I would teach a masterclass in sailing and I would do it for free. Lindsey Dinneen: Well, we could put the million dollars towards your business. How about that? Dr. Ben Freedman: Sounds good. Lindsey Dinneen: Or a cause that you care about? One of the two. Dr. Ben Freedman: Perfect. Lindsey Dinneen: Oh, amazing. That is awesome. Thank you both for that. What is one thing that you wish to be remembered for after you leave this world? Dr. Ben Freedman: I think certainly, we're in this area because we certainly wanna make a difference and we don't wanna necessarily have any regrets of not going after something that could be, a chance to improve healthcare, improve our environment, improve world peace, et cetera. So, I think that we wanna be remembered as or at least I want be remembered as something that goes after challenging problems that are facing the world, going after them in ways that are, of course ethical and, creating a great community and, and group along the way. I'm also really passionate about training folks and enabling them to be successful at whatever they do and solve other really important pressing problems that we're facing. Hoping to make a mark in many different areas I'm gonna hopefully be remembered for those things and hopefully they do result in some new novel device. But if they don't, the way that we're going about it, just wanting to do that in the best possible way that enables others to have a great impact on the world. Dr. David Wu: And as for me in terms of one thing I wanna be remembered for, as a clinician and a scientist, and I teach a lot students along the way, and I had a lot of mentors who have played this role in my life. I want to be remembered as somebody who really encouraged people to pursue their dreams and provided them with concrete advice, resources, and opportunities so they can find a fulfilling career-- whether it is in the medtech industry developing new devices to help patients, or whether it is to become a scientist to advance their research project or become becoming a clinicians to treat patients-- to help these trainees and students find the ideal career path and the ideal sense of fulfillment for themselves. So as a mentor and as a leader, that's one thing I wanna be remembered for. Lindsey Dinneen: Yeah. Those are great answers. Thank you. And then my final question is, what is one thing that makes you smile every time you see or think about it? Dr. Ben Freedman: Oh, right now the number one thing that makes me smile-- we just had a our first child a few months ago. And seeing our baby smiling or crying makes me smile every single time. Lindsey Dinneen: Aw, congratulations. That's wonderful. Dr. David Wu: And for me, also in terms of you were talking about personal milestones. So this past summer I just got married to my wife. We've been dating for almost 11 years now. So it's a long time coming. And just being able to spend time together, whether talking about our future or going on new adventures, exploring different parts of the world, that's something that makes me smile. Lindsey Dinneen: Those are great answers. Well and clearly, great reasons to smile, so I'm so glad to hear about those things. Dr. David Wu: I'm smiling right now. Lindsey Dinneen: I love it. Well, I just wanna thank you both so, so very much for your time today. We are very honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational and safe environment. I am truly inspired by what you all are doing and the different solutions that you are developing for a whole variety of different uses. And thank you for your passion and your drive to change lives for a better world. I just wish you both massive, continued success as you go along your paths, and thank you, thank you for being here. And thank you so much to our listeners for tuning in and if you're feeling as inspired as I am right now, I love it if you'd share this episode with a colleague or two and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Haven Tyler is a Senior Client Relations Executive in medical device development at Boston Engineering and an aspiring interior designer in her spare time. In this episode, she discusses her innate curiosity about the world, why she decided to focus primarily on the medtech industry, her passion for furthering women's health, the power of mentorship, and the time she starred in a horror film. Guest links: https://www.boston-engineering.com/industries/medical/ | https://www.linkedin.com/in/haventyler/ Charity supported: Polaris Project Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW NOTES Episode 015 - Haven Tyler Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm excited to introduce you to my guest today, Haven Tyler. Haven is a senior client relations executive at Boston Engineering, a consulting and technology development firm based in Boston. Haven brings over 30 years of a consulting experience to her clients and she has worked with such consulting firms as IDEO and Continuum. Haven appreciates the variety in her work, especially the broad range of technical business and regulatory challenges her clients face. In her varied career she made the personal professional shift eight years ago to focus on medical device development because of the impact her teams have on improving patients' lives. The path her current role has not been traditional. Haven has a BA from Sarah Lawrence College, studied history of art and fashion, and is an aspiring interior designer in her spare time. Along the way, she also had a short-lived acting career and starred in a horror film in her senior year in college. What knits it all together is an innate curiosity in the world around her and solving tough problems. Well, hello, Haven. Thank you so very much for joining us today. I am so excited to learn more about you. Thanks for being here. Haven Tyler: Oh, Lindsey, thank you for inviting me. I'm excited to go through this with you. Lindsey Dinneen: Yeah, absolutely. Well, I was wondering if you wouldn't mind starting by just telling us a little bit about yourself and your background and maybe how you got into the industry. Haven Tyler: Oh, sure, I'd be happy to. So I have to say, in perfect honesty and transparency, my path to where I am has not been a straight one. So it's quite varied. I started out by going to college in New York. I went to a small liberal arts school called Sarah Lawrence. And I studied art history actually. But I think that the thing that education, and also in my family, that was instilled was the sort of innate sense of curiosity. So I think that's a thread that runs throughout my career. I ended up in the Boston area and started actually working for an industrial design firm and learned about industrial design, which is something that was totally new for me. So I'm clearly more of a visual sort of design person, but I've appreciated the sort of messiness of the creative process and the complexity of problems and I've really always loved that kind of, there's a problem and everyone's brainstorming and coming up to a solution as a group. So that's always been something that I've really enjoyed and I learned a lot from an industrial design perspective. And I was really lucky I got to work at some pretty amazing places. I was able to work at IDEO as their Head of Business Development on the East coast in what I would consider the halcyon days, if you will, of design and design thinking and innovation. And, you know, a lot of those words are buzzwords now, but we were actually living them, you know, back in the day. And that was just such an exciting sort of heady time . And it really just opened up my eyes to how our work could make a difference in the world. And at that point I was professionally focusing on a range of products including consumer products as well as some medical. But then during the course of basically 30 years, at some point, maybe about eight or nine years ago, I had reached a sort of apex in my career and in my life and just really thinking about what my-- "legacy" is a big word and it's not exactly how I was thinking about it. I don't know what the correct word is, but I was thinking about what difference I could make in the world. And that's when I made the professional and personal decision to shift to focus just on developing medical devices. And at Boston Engineering, I've been able to do that, which has just been a great privilege to be on the team. And I've loved the complexities of the problems we face and our clients face on a daily basis. I have things that come across my desk that are fascinating and they're disease states that you didn't know about, and understanding about that and sort of diving into what those patients experience, what the doctor's experience, what the hospital's experience in terms of purchasing equipment, what our clients experience in terms of their business needs and their regulatory hurdles and reimbursement hurdles, and the challenges are really complex. And that's what I love is cuz then you have lots of different people with lots of different areas of expertise contributing. I hope that helps answer the question. That was a long-winded, long-winded answer, I apologize. Lindsey Dinneen: No, I love it. I love that your story is not linear and that you have so many different really interesting twists and turns in your path. I think that's really exciting. And then, I really appreciated the sort of theme of curiosity is being what kind of ties it all together and I'm sure keeps you interested and motivated every day. Haven Tyler: It does. And you know, it's interesting because in preparation for this, I've been thinking about how I ended up where I am. And I grew up in an academic family in New Haven, Connecticut, and my parents were-- their upbringing, they were born after World War II, so it was like forties and fifties. So their upbringing was very strict and restricted. And then when it came to their own children, it was the seventies and the eighties, so it was hands off parenting. It was very different than it is today. But it was also explore your bliss, like find your passion. There was never a sense of you're gonna have to pay the rent or have a career. There was no thing involved. Lindsey Dinneen: So, so that was a wonderful thing growing up and maybe a slightly rude awakening as an adult, or were you prepared? Haven Tyler: Well I think I was prepared in the sense that they instilled a sense of, "you can figure it out." You have the tools to figure anything out, no matter what it is. And it was a question of perseverance and grit and, all of those things. So, I think that it was definitely a little bit of a rude awakening, but you could figure your way out of it. Lindsey Dinneen: That's fair. I think no matter how prepared you think you are, you're not, anyway, you know, it's always a learning curve, but that's what keeps life interesting. Haven Tyler: Exactly. Yeah. It's interesting too because I love the fact that if you had asked me at 20 or 21, when I was graduating school, where do you think you'd be? This is not what I would've predicted at all. And I'm also grateful for that because I've ended up in a place that's really great and I, I couldn't have made that up. I couldn't have fantasized that. So, I think that the fact that I get to go to work every day and feel like possibly I'm being helpful to the planet or the world, and maybe we can make a difference in people's lives. And I work for a company that has a ton of integrity and they believe that, they really do. It's not just some kind of byline. It's something that the whole group lives and breathes and that's pretty incredible to be able to say that, right? So, I feel lucky to have landed in a place that feels authentic, you know? Lindsey Dinneen: Yes. I completely agree. That's one of my very favorite parts about being in the industry is knowing that even if your role is a little bit on the fringes, perhaps it's not the actual engineering of the product, but you're still helping to talk about the product and introduce it to the world, or however you fit into it, you're still making a difference. And I think that's a really powerful motivator and makes it fun to come to work every day because you just know inherently that you're doing good. So that's really special. Haven Tyler: It is special and I don't think everybody gets to say that, you know? And I have friends who do a variety of different things and I have friends I've known since I was a kid and they're scratching their head going, "you do what for who," you know? How did you get there? And I was like, "I know it doesn't really make a ton of sense, but it's really where I should be." And I don't know if everyone gets to say that. Lindsey Dinneen: Yeah. It's a special situation when you do, for sure. And especially if you've been through other seasons of your life when perhaps you didn't feel quite as connected to what you were doing. All work is valuable, but sometimes, your personal connection, if it's not there, makes it a little bit harder to be excited about getting up every day and going to work. Haven Tyler: Yeah. And there was a large part of my career where there was a a focus on really sexy products, if you will. But they were more based in the consumer realm. I loved being a part of that. And it was really cool. And it definitely had its attractions. But at the end of the day, I was like, I'll be walking down the aisle in Target or whatever with my kids going, "Yeah, I helped make that," and I just, I don't know, it wasn't moving the needle or helping the way I wanted to help. So I think that kind of spurred me on to look at medical a little bit more closely. Lindsey Dinneen: Yeah, absolutely. Is there a particular moment or series of moments that stand out to you because it clearly confirmed that this was the right next career choice for you? Haven Tyler: Yeah, I think you're right-- the word "series" is probably the best. It's a lifetime of experience, and I can say this now cause I'm getting towards the tail end of my career. I had some health concerns in my own family that we had to address and I think my gratitude for the help that we got living in the Boston area-- I mean-- how fortunate are we to live in that area? You know? So I have access to some of the best minds and medical community. And I grew up in a medically privileged environment. My stepfather is a medical doctor. And our pediatrician was Uncle Sid and Uncle Sid would just like come on over to the house, and it was just amazing that you had access like that. And anyway, my, my appreciation and my gratitude for the people who are helping me and helping my family through a couple of different medical things was really profound, and it gave me a new line of sight into how complex that world was and how complex it was to get to the point where you were able to receive that kinda help. So I think that was definitely an aspect of things. I think that also having certain people put into my life. So certainly working with my colleague, Paul O'Connor, who heads the medical business unit at Boston Engineering, that has been a really wonderful partnership, and I appreciate working with him. And he's, he has much more experience and depth in the medical arena than I do. But I think that we have a skillset that really complements each other and I rely heavily on him for aspects of building our business. And I hope that, I hope the inverse is true. So, I think, having a combination of those types of things. I think one thing I wish that I had, and this is something that I talk to my own children about, is finding a mentor. And I didn't have that. So everything I did was really either sort of self-guided and I was just following my curiosity. Or something got put in front of me, and maybe it was fate, maybe it was, who knows? Something was in front of me. I think that large part of that was the product of my upbringing, of the sort of "follow your passion" kind of thing versus the " I'm trying to find a different kind of balance for my own children" and thinking about it with them as they're embarking on their careers. And maybe there could be a little bit more planning involved than there was in my career. Yeah, so I think the value of having mentors in your life, professional mentors, is something that could really be a great tool. Lindsey Dinneen: Yeah. Oh, a hundred percent agree. And that brings me to-- I'd love to hear some of your advice for perhaps somebody who is interested in coming into the medtech field. Maybe as a, either a young career person who would be interested in growing into a leadership role or somebody who is switching careers. Is there any advice that you would relate to that person to help them as they begin that process? Haven Tyler: Yeah, I think, the notion of a mentor is really the strongest drum I would beat in that regard. I may not also be the best person to ask that question just because I've always been on the consulting side of things. I have not been a part of a larger corporation, like a big med device firm. So I don't really have that perspective necessarily. I do know what I hear at conferences. I do think, and I'm gonna really stress this, that we need more women. I think that the more women we can have in medtech leadership, the better. I've been going to a number of conferences and doing my own research and women's health has been sorely underrepresented for a long time. I think we're getting slightly better and I think we're talking about women's health in a different kind of way, which is fantastic. But the numbers of research and development dollars that are spent globally on women's health is very low. I mean, I think the percentage is about 2%, which somebody said at a conference is a rounding error. I would love to see that change with the next wave of leadership and I would love to see more women writing checks and making those decisions to expand those conversations and learn more about the different phases of women's health that we go through cuz there are topics that we talk about and there are topics we don't, and I think there's been a decent amount of conversation around women's health, particularly around childbearing years. But, the topic of, let's just say menopause, is one that's very complicated and I think it's a potentially huge market. So from a business perspective, I think big companies should perk up about that. But I think we need to know more because I think that we don't know enough about that. It's not necessarily a disease state, if you will, but there are lots of varied symptoms with that phase of life and it can be quite confusing. So, I'd love to see that improve. So I guess, mentorship. If you're a younger person, maybe be a little bit more strategic with the help of someone who can guide you through so that you can attain the goals that you, you want to achieve. Lindsey Dinneen: Yeah, absolutely. Mentorship is such a wonderful gift when you find a good match and are able to learn from that person and benefit basically from their own experiences and things that they would've done differently looking back or whatnot. You know, you talked a little bit about how-- because you didn't have a mentor-- you were self-taught and self-motivated or whatnot. And I'm curious: you have such a interesting eclectic background and you've had lots of different experiences. So how do you personally prioritize your own continued learning and growing, cuz obviously that's just been part of your life along with your curiosity, but I'm just curious how you prioritize it. Haven Tyler: Oh, it's such a funny question because it's, it's not even a question of prioritization. It just happens. I'm just a curious person. I mean, I'm constantly taking classes that may have nothing to do with my professional life. I think I mentioned I'm pursuing a certificate in interior design because I like it. It's just interesting to me. Color and how colors relate to each other, and color theory. I go down these little rabbit holes that I think are very interesting and I go from there. I love architecture, I love gardening. It's never a dull moment, unfortunately for my family. But yeah, I mean, it's always been that way. It's definitely fun. So I know a little bit about a lot of things which I think has actually served me well in my particular role, because my role at Boston Engineering is to identify where opportunities might be, develop the appropriate program, and I get engineers to help me with that. And that's creative in a way 'cause if you're looking for an opportunity, I'm looking for the negative space, right? I'm looking for where the hole is and, can I go in there and, is there a problem there we can help solve? And so, as I said, it's messy, but it, it ends up being not messy once you find the solution, if that makes any sense. So no, I don't really have any sort of prioritization. The one thing that I have gotten better at though is, and I think Covid taught us all a lot, but it's just personally that I've gotten better at is boundaries. So, I start my workday at a specific time. I end my workday at a specific time. And so that allows me to have the space to do the other things I get curious about. So, during Covid, I personally found it a little hard because I think like a lot of us, there was a lot of fear. We didn't know what was coming around the corner from a health perspective, from an economic perspective. It was just scary for everybody. And so I was just very driven. And I think that while it's great to be driven, it can also be unhealthy. So, yeah. Lindsey Dinneen: I'm just chuckling because I relate to that so much. Haven Tyler: Yeah, exactly. And you can burn out and burnout's not good. I have a 18 year old who is going to be a college freshman, and she's incredibly driven. And she's just a good student. I've never had to check her homework. I've never had to do anything. And she can burn out. And I, I see this cycle in her and I think she's getting much better at having a balance, but I think left to her own instincts, that's where she goes. And so while that's a great thing in a lot of ways, how do you temper that, so, yeah. Lindsey Dinneen: Yeah. And that is a really hard balance. But like you said, trying to put in some specific boundaries really does help. It sounds like you are boxing yourself in, but it's actually a freedom generating exercise. Haven Tyler: Absolutely. I do think that one of the things that I've learned over life is that because I have three children and I, I've been a single parent for most of my children's lives, and taking care of myself was something that I didn't do very well for a long time. And making that a priority is really important. And that can come in many different forms. That can come with, I need to get enough sleep, I need to drink enough water, I need to exercise, I need to make time to walk the dog or sit outside in the woods or whatever it is that I need to do, to be able to do everything else effectively. It's like that analogy where they give you the instructions on the airplane. And it never made sense to me that you would put the air mask on yourself first before the child. And I always thought that was just the complete opposite. I was like, "this is crazy." And then the reality is no, if you can't breathe, you can't take care of your child. So if you're a crazy person and you haven't slept and you're not eating well and you're not exercising, then you're not gonna be able to take care of anyone else. So, that's been something that has been a priority for a number of years for me. And like finding those balances and saying to people who need my time, like, "Yes, I really want to talk to you. That is very important. I have to get back to you in an hour." Or whatever that is. " But I can't have that conversation right now. I want to have that conversation, but let's do it in a little bit." And creating those guardrails has been helpful. Lindsey Dinneen: Yeah. Yeah, that makes a lot of sense. Yeah. And not to pivot too dramatically, but I really do have to ask you about your short-lived acting career. Okay. First of all, how did this even come about? And second of all, what was that experience like? Haven Tyler: Yeah. So it's, it was a little surreal, but yes. So I, as a part of my schooling, I took my senior year in Italy for art history. It was just an amazing experience. And that's one thing I encourage everyone to do. Try and study abroad if you can, or live abroad for a little bit. Anyway, while I was there, I was doing a lot of, and I had been doing while I was in school in New York, a bunch of kind of modeling and that was a great way to make money, but it was painfully boring. So I wanted to get out of that, but I still needed to figure out a way to support myself. So, an American woman, who I met in Rome through a friend, was a casting agent, and she said, "You know, let me send you on a few things." And she sent me on one audition and it was funny because my mother, who is a dean of a college at Yale, she's like a serious person. She had flown in, we were gonna spend two weeks together and she had flown in and I said, "Oh, before we go, I have to go on this audition." And she is looking at me with her blue eyes going, "What the heck is this?" And I said "No, no, no, it's fine." And we went into this place that kinda looked like a dentist office, but it had these big posters with monsters. And these guys come out and they don't speak any English and they say, "Come with me." And so I go back there and all I had to do was scream. So my poor mother was waiting in the lobby and all she hears is me scream. And so, I got the part. But I think that largely had to do with the fact that I had red hair and freckles and Sigourney Weaver was a thing at the time and the movie was a very specific genre. It was sort of a mashup, which was common then. It was a mashup between sort of "Aliens" and "Terminator." Anyway, it was just an absolute blast. I'm so grateful I had the experience. I am a horrible actress. But it was just really fun. And we spent two months filming in abandoned nuclear power plants. We spent a week in Venice filming overnight. I mean, it was just incredible. Lindsey Dinneen: Yeah. Oh my gosh. Thank you for sharing about that, because that is an amazing story and such a unique opportunity. I love that you did that. Haven Tyler: It was very fun. And I think two years ago, it was the 30th anniversary or something of the film release, and it has this unusual kind of, but very fun, cult following cuz it's this bad, bad horror movies. It was a part of a big drive-in movie theater movie festival up in upstate New York. So we all went, my family all went, we had our beach chairs and we got to watch it. And we had posters and signing autographs. It was just, it was very funny. Lindsey Dinneen: That is amazing. I love it. I love it. Well, okay. That is fantastic. Just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry or related to your education, but doesn't have to be. What would you choose to teach and why? Haven Tyler: That's a really fun question, and it's a big question. I think it would be a combination of teaching people to be their authentic self, and curiosity and creativity, all jumbled up together. And how to explore those and find them in yourself. Lindsey Dinneen: Yeah. So when you say finding your authentic self, is there a specific thing that you would highlight? Or how would you talk more about that? Because I think that's an important thing that, that isn't always talked about as much. Haven Tyler: Yeah, I think that I'm fortunate to have landed in a place professionally where I feel comfortable being myself. I think that when you're starting out your career, there's this feeling that you might misstep or you might make a mistake, and you clam up, you don't speak up, because you are concerned that you might say something wrong or you might embarrass yourself. Or you know, I mean, and I was guilty of this too. I'm not saying this with any judgment. I just think that it's, it's a natural thing. But to encourage people to feel, especially younger folks, to feel more confident in sharing because like 99.9% of the time us old folks in the room, we wanna hear what you have to say. But to let go of that fear to allow yourself to, to shine, whatever the topic is. Lindsey Dinneen: Yeah, absolutely. Yeah. And I think that's especially something-- in fact, I was just having a conversation about this yesterday of the tendency and I think-- maybe not all women, but a lot of times for women-- especially the tendency to shrink and not show up as your full, authentic self. Not because you don't want to, but because you're not sure if you're gonna be accepted or if your opinion's gonna matter or count or any of those things that, that kind of keep you a little bit more quiet when actually you have a voice. You have things to say. And your contribution matters. Haven Tyler: Yeah, it absolutely matters. And I've had the privilege of having younger folks on our teams and having these conversations with them and then once they start to feel encouraged and more supported, the solutions and the things that the ideas they have are just fantastic, really great stuff. And I see this with my own children as well. I love talking to my adult children. I'm like, "Wow, that's really interesting that you thought about it that way." Or they'll know something profoundly different than I do. And I think it's fascinating. So I would encourage people to find a place where you feel safe enough to be able to express yourself that way. Lindsey Dinneen: Yeah, and I absolutely agree with you. And conversely, I think that's a good reminder also for leaders to, to provide that space, to provide that encouragement for especially younger folks to speak up and that it's safe, it's accepted. So kind of on both sides, like yes, encourage the younger career folks to, to speak up more and also encourage those who do have the privilege of being in leadership to do their part to foster that environment too? Haven Tyler: Absolutely. And I think it's our responsibility to do that, actually. Lindsey Dinneen: Yeah. Well, you know, you mentioned legacy a little bit earlier and that ties in very well to one of my questions, and that is, what is the one thing you wish to be remembered for after you leave this world? Haven Tyler: So again, a very big question. I think I would really appreciate if people could think of it as like, "Oh, she was helpful." I don't need to be a rock star. I don't need to be a shining star. I just wanna be helpful. Lindsey Dinneen: Yeah. Love that. Yeah. And then final question, what is one thing that makes you smile every time you see or think about it? Haven Tyler: Oh, my dog. A hundred percent. Lindsey Dinneen: Okay. Tell us about your dog, because I love dogs. Haven Tyler: No, she's a total punk. I love her dearly but she hates people except for us. And she's just, yeah she's wonderful, little cuddle bug. But she's a Boston Terrier, but she's sort of the wrong colors. They're normally black and white and she's brown and white, and so she's a little offbeat, which makes me like her even more. Lindsey Dinneen: I love it. She is her own dog. Haven Tyler: Exactly. Lindsey Dinneen: That's fantastic. Well, I love hearing your stories and your insights and your advice. Thank you just so very much for taking the time today to speak with me and for sharing just a little bit about yourself and what's important to you. I just really value that. So, so thank you. Haven Tyler: Thank you, Lindsey. I appreciate this, and I appreciate before we jumped on the recording, you describing your motivation for starting this podcast. And I think that it's really important the work that you're doing, and I think that getting at the underlying motivations for people being in this industry is really interesting. I mean, yes, at the end of the day, it is a business and we do live in a capitalistic society. I mean, that's just like baseline. However, within that there's a lot of choice that people have to make, and how you go about achieving those goals can be very different. And I think that on our side of the fence, on the consulting side of the world, none of us are ever going to be the next Bill Gates. But it's such a motivator to think that, " Okay, this might make a difference in somebody's life." And it just gives me goosebumps to think about, like that we can say we helped make that. It's really pretty cool stuff, so I'm glad to talk about it. Lindsey Dinneen: Yeah, absolutely. Well, we are honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non-governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support and really appreciate that, and we just wish you continued success as you work to change lives for a better world. Haven Tyler: Thank you so much, Lindsey. Lindsey Dinneen: Absolutely. And thank you also to our listeners for tuning in ,and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Alex Condon is the COO and co-founder of Galen Data. In this episode, he discusses how his background working with small businesses prepared him to grow and scale Galen Data, why he occasionally looks outside of the medtech industry to gain inspiration and insight, and how showing up and being a good person will write your legacy for you. Guest links: http://www.galendata.com Charity supported: Opportunity International  Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 014 - Alex Condon Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm excited to introduce you to my guest today, Alex Condon. Alex is the COO and co-founder of Galen Data, a medical device cloud data platform. Prior to starting Galen, Alex was the Chief Strategy Officer at Tietronix Software, a longtime NASA contractor. Alex is originally from Scottsdale, Arizona, having attended Arizona State University, but now calls Houston home. Thank you so much for being here today, Alex. I am so excited that you're here and talking with me and welcome! Alex Condon: No, thank you for the opportunity, Lindsey. Sincerely appreciate it. Lindsey Dinneen: Absolutely. Well, if you don't mind starting off by just telling us a little bit about yourself and your background and maybe how you got into the medtech industry, I'd love to start there. Alex Condon: Sure. So I'm originally from Scottsdale, Arizona. That's where I grew up. I went to school at the WP Carey School of Business at Arizona State University for finance. So something way outside of MedTech. When I was 19, I got hired at a private investment management firm that was there in Phoenix and worked there until I was about 27. And then parted ways and took a job at NASA, Johnson Space Center, working for a NASA contractor, Tietronix software. They've been around for a long time. I usually focused on advanced technology across a wide spectrum of use cases. Things from system modeling and system engineering, all the way to augmented reality and blockchain applications and things like this. And one of the things that a lot of NASA related kind of space flight software companies do down in Houston where offices is, is they moonlight doing medical device software because the compliance rigor of NASA space flight software is very close to class three medical device. So, the NASA contractor was splitting maybe 50% NASA related work and 50% custom medical software. And from that we saw a pattern merge of companies that needed cloud connectivity as part of their medical device offering. And typically if you're going to engage in that kind of work, it tends to be very costly and take a lot of time to develop. But the requirements from project to project are very similar. Everyone needs a way of seeing their device data, showing it to stakeholders, whether that be patients or clinicians or maybe someone else in the value chain. They needed a way to run algorithms, create notifications against the data. And from there we saw the opportunity to create a product and that's where Galen Data got started. So, went from finance to working with a NASA contractor and now in MedTech. Lindsey Dinneen: Wow. Oh my goodness. Yeah. So you have had quite the exciting background. When you first started, could you have imagined that you would be now a COO of a company that you helped get off the ground from the very beginning? I mean, was that ever an idea of yours or was this just a complete surprise? Alex Condon: I've always worked for small companies. When I worked for the investment management firm, I was the first employee, it was a team of three. And then when I left, I wanna say we were somewhere north of about 30. I think that number sounds right. When I started working for the NASA contractor, they'd always been small by design, liking to take on projects that they could really dedicate a lot of time and focus to. And it was about, I wanna say 75 people. And when I entered, I was in a Director of Strategic Initiatives role, and then moved up into Director of Strategy role. So, always worked for small companies. When the opportunity to create Galen rolled around, it felt very comfortable. So, no real surprises. But the journey itself was the surprise. Lindsey Dinneen: Right. Getting from point A to point B was the surprise. Very nice. Is there a particular moment that stands out to you that this was the right career for you specifically? It could be Galen Data specific, but just in general working within the medtech industry, are there any moments or a series of moments that stand out to you as just, "Yes, I'm in the right place?" Alex Condon: I think that the product was launched out of a need that we saw out in the world. So I think that being able to analyze the gap and seeing that these medtech companies were having to take on a large burden when it came to their cloud software. So those companies would have to, like I said, put up a lot of money, a lot of time, but there's an operation side of kind of owning cloud infrastructure and medical device that a lot of them might not be able to wrap their heads around. So when you have the software, that can connect your device to the cloud, you're responsible for all the data that ingests, so you're responsible for all of the privacy concerns, the regulatory concerns. On the IT side, you're responsible for things like cybersecurity. You're responsible for things like disaster recovery. And in all of those landscapes, things change all the time. There's new regulations. There's new cybersecurity threats and all of those things can tend to morph a medtech company into an IT company. And that seemed like kind of a growing risk concentration, especially as more medical devices started leveraging the cloud for whatever they needed. So, seeing that gap and seeing that the team we put together the CEO, Chris DuPont, the CTO of Abbas Dhilawala, both of 'em have very deep industry experience and by the work we'd done together, working at the NASA contractor, we all came out of the same place. I believe the team had the ability to execute. So if you marry that idea of product that has a need could seriously help people get their device to market in a safe and de-risked way, and then also have the team to execute on it, that to me solidified this is something that I wanna do and I think that it benefits the greater good. Lindsey Dinneen: Yeah, absolutely. So could you tell me a little bit about the history of starting the company and where you are now and where you're looking to be? I'm always curious of the evolution of a small business and how you can go from that very first idea to reality and beyond. Alex Condon: So, Abbas Dhilawala, our CTO, had the idea of creating this platform. Chris DuPont, our CEO, he has always had an entrepreneurial bent, and so they both latched on this idea of this is something that they want to do. But there was no kind of execution arm to get it done. And that's when I entered in. So, far before we became an actual company. But this idea of, well, Alex has this background in helping companies grow and seeing how a company should come together at an early stage. So putting some kind of, some meat on the bones. From then, we registered the company. The name, Galen Data, it doesn't really mean anything and it was by design. We knew that it was going to be in medical device or healthcare. So we picked an ancient Greek physician, Galen, to tack onto the name and then data, because we knew we were gonna have big data in some respect. Took those ideas, made the name, and then when the product came around it seemed to fit fairly seamlessly: a medical device cloud product for kind of cloud data management. So Abbas had the idea and then a lot of it existed in his head. So from the time that we started the company in terms of kind of filing all the documents, we raised some funding and then Abbas just hunkered down and it went radio silent for a long time pouring his evenings into making an MVP for us. And from then it was okay, now we have this product, now it's time to try to scale it a bit. So we brought in a VP of IT Ops and started trying to attract some kind of initial clients. And when you have a company like ours that's housing a lot of this medical device data and the medical device companies who are our clients are reliant on our ability to execute, our ability to persist as a company, you have to knock on a lot of doors to find early adopters. As a small company that's being entrusted with a huge piece of operational infrastructure for a medical device that might have raised tens of millions of dollars and employ dozens of people, it requires a tremendous amount of trust. And one of the things that's not lost on me is the amount of trust that those early clients put in us. The idea was relatively new to the space. Connectivity as a platform idea was something relatively new. Prior to that, everything was like what we were doing, kind of built the spoke. So, I look back and I love all of our initial clients, do anything for them. But awed by the amount of risk they took on working with a startup. And actually, one of the greatest days of Galen's existence was when we finally looked at the books and realized that we could persist through time. And that you were making enough money to pay all the bills and it was a huge sigh of relief across the company. And that is a, a great day that I'll always remember. Lindsey Dinneen: That is a great day. Oh I love hearing those stories because I know how hard it is to get a company up and running and to be profitable and actually viable. So, so kudos to you because that is no small feat. So I am curious, you come from a finance background and found your way into the medtech space, which I think is fantastic. Do you have advice for others who might be in a similar situation, come from a background that is different, maybe not engineering, but that might be interested in being a part of the industry? Do you have any advice for those kinds of folks who might wanna make that leap? Alex Condon: I think that this is a small industry that is very welcoming. And they put a lot of emphasis on knowledge. And so I think that if you are looking at becoming a leader in the medtech space, understand where your niche is, right? Go deep in that area. Network. People will respect you for the depth of knowledge you have and whatever it is you choose to pursue. And I think that's an easy way of integrating into the greater ecosystem. I think that the medtech in general, it spans so many different facets, right? From the people who are going out there and creating the product or the scientists behind the reason for the products to exist all the way through things like quality, regulatory, in our case, software supply chain, all of these different things. And I think that as long as you can show that you know your stuff in where you fit in the greater big picture, that people will naturally gravitate towards you. And I think that if people naturally gravitate towards you, it's also a good sign of trust and I think that, you know, if you have trust and you have people who believe in you, that's what kind of takes you places in this industry. Lindsey Dinneen: Yeah. That is really a great perspective, and I think that you're completely right in terms of, when you know your own area of expertise, it doesn't have to be the same as anyone else's. In fact, it's helpful to have a bunch of complementary skillsets. And you're right, I think this is a very welcoming, it's very respectful industry and sort of allowing each person to have their own area and own it and people are really friendly here. Alex Condon: Agreed. And I think that it's one of those-- the kind of the beauty of the space is that, everybody is aligned towards inevitably the goal of helping people. Even if you work in some aspect of supply chain and you're far removed from maybe the doctor with an idea, everyone is moving in that same direction. And I think that when you have all of those people paddling the same direction, not only do you rely on each other, but you can also create a lot of momentum. And I think that momentum has a pervasive way of working into people and bringing people together. Lindsey Dinneen: Yeah, absolutely. And you mentioned at the very beginning of answering that question, that knowledge is such an important component, and I couldn't agree with you more. And I'm curious how you as a leader in this space, and as somebody who has had a couple different iterations of your career so far, how do you prioritize your own learning and growing as a leader, as a individual, as a contributor to this field? Alex Condon: So I think that again, kind of knowledge in the space being important. I always try to focus on, be the best that I can be in the space that I'm in, right? So we probably work right now with 20% of large companies, 80% kind of startup companies, and so understanding the value that we add in both places. Always trying to stay on top of new happenings that would affect either our company or kind of the state of the industry, both from the big company kind of perspective and also from the small company perspective. And always trying to take time to also study things on the periphery, right? How we can improve as a company. How I can be a better part of the greater team. And really keep the focus there. And I think that a lot of my job also is going out and talking to different folks in both places, the small companies, the big companies, and trying to be an active listener. And understand what their pain points are. Pain points can evolve over time. And they're usually unique to each individual conversation, right? And then try to take those things and formulate them in a way that I can then better my own learning by turning actionable, right? Where are my gaps by listening to the outside world and trying to chase after that information or that answer, or try to seek out that key opinion leader or something like that who might be able to add more to to the story that I can ingest and then put into practice. Lindsey Dinneen: Yeah. Great answer. I also think, sometimes it's helpful to look beyond your own industry's standards when it comes to any aspect of the business and to sometimes look at other industries and see how they're being successful in various ways and see if you can't grab some of those ideas and make them your own. And I'm curious if that's ever happened for you too, where you can get stuck in, "Oh, this is how everyone in the industry does it." But there's a lot of great resources outside too that can sometimes apply. Alex Condon: Sure. Absolutely. I think that we are a SaaS product, right? Software as a service. And there isn't a lot of that in the medtech space, right? You have some quality management system companies that are doing things, maybe you have some supply chain platforms and things like this. But medical device in general has been a laggard when it comes to adopting new technology on the operational level. So when we first entered, you had to look around and see other areas where connectivity was more widespread. So, when I was looking at how my piece of Galen would form itself, I looked at the Internet of Things space. So looking at how companies had been successful in connecting devices in energy or in consumer devices in the home and things like that. And seeing how we could turn those ideas and those success stories and try to make them a part of our narrative with a MedTech flavor. And it's been interesting. The perspective that you get today is based off a lot of success stories, right? So right now, when you look at how other people were successful, you have to remember that it's winners biased, right? You don't hear about the mistakes that companies made that no longer exist, right? And in our case, we were bringing a product that was new to the market. This idea of cloud data management for medical devices, a very compliance heavy industry, wasn't something that a lot of people had kinda pursued wholeheartedly. There might have been some fleeting attempts but not enough documentation to make something useful. So, looked in those areas and tried specifically to find why people failed. And why is it that some of these companies that were hot in the connected device industry didn't make a mark? And then also I think that goes back to your question about kind of understanding your industry. Why, if at all, is MedTech different, right? And it is. The product life cycle is so long. The funding cycles for the startup companies, the decision cycles for the large companies. In both instances, the slightest hiccup can throw you off for months. So being able to appreciate the buying cycle, work it into kind of a greater business plan. And then making sure that we had realistic expectations heading into it was something that I think was critical that we learned as a result of both knowing our space, but also looking out and seeing where other people had success in aligned areas like IoT. Lindsey Dinneen: Yeah. Yeah. That's great perspective and I really appreciate you sharing about that because, just in terms of what you were saying regarding winner's bias and things like that, where we have a tendency, even from an outside perspective, to only look at the wins or to only hear about the wins, right? And so I think it's really helpful to also be able to have those honest and transparent conversations, when appropriate, to say, "Yeah, we tried this and it flopped, and here's why. And that's okay cuz we learn from it." Alex Condon: Absolutely. And I think that to your point about transparency, that's probably one of the most core pieces about Galen Data everywhere that I've ever worked has been a very transparent and flat kind of organization. And that's very much the culture that we have with Galen Data. Try to value everybody's opinion, always make them feel like they're a part of the team. Always allow ourselves to be open to criticism, even if it's from the lowest person on the org chart all the way up. And always think about the feedback that we get. And like you said, approaching problems with kind of introspection and brutal honesty. Lindsey Dinneen: Yeah, that's just been a reoccurring theme that I, I keep hearing from folks that I've been talking to is that idea of curiosity being such an important component to not only your own personal learning and growth and whatnot, but also as an organization. And if you can stay curious, then you can stay teachable and you can stay humble too, actually, which is not a bad thing. Alex Condon: No, I think that I kind of find myself to be a naturally curious person. And I think that everything amazes me. I'm one of those people. I have a million interests. Everything amazes me. And I think that if you can bring that to a job or to a company, whatever, that it'll really take you places because you get out of your own kind of mental trench, right? It's important to pop up and look around every once in a while. And I think just being a naturally curious person creates that naturally. If that makes sense. Lindsey Dinneen: Absolutely. I will say, when you were talking about popping up and looking around for a minute, I had this instant vision of this meerkat, so we can have our meerkat moment, you know, where we pop up and look around... Alex Condon: That is a perfect example. I'm a huge outdoorsy person and one of my favorite things to do is just go out and look at Prairie Dog Towns. And so, sometimes you're digging and you're digging and digging in the dark, and every once in a while it's important to pop up and see what's going on around you. Lindsey Dinneen: I love it. Oh my gosh, that's amazing. Well, okay, pivoting just for fun. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be about something in your industry, but it doesn't have to be. What would you choose to teach and why? Alex Condon: So I grew up-- my family, me, mom, my dad, and my sister-- we did road trips a lot to the national parks. And I've always been, like I mentioned, a huge fan of the outdoors. And so I think that if I were to teach a masterclass on anything, it would probably be maybe national parks and kind of conservation in general. And this is not just something that's talking about here domestically in the US, but you know, national parks exist everywhere and every national park has a narrative around it. And I think that also, the outdoors kind of needs to fit inside of that work-life balance. And so for me, one of the things that I'm passionate about, and I try to do as often as I can, is go see the national parks, get some fresh air, take in the beauty that's around us and try to exist in that moment. Try to kind of take things in for the wonder that they are before you go back to work or family life and things like that. So, I love telling or reading about the narratives behind some of the big national parks here, hearing stories about the ones that are overseas, and I think that if I can share that passion with other people and get them more outdoors and enjoying that side of life, that's something that I would do if I had my druthers. Lindsey Dinneen: Yeah. Oh, I love that. And that would be a great masterclass because it seems like not a lot of people necessarily prioritize as much, but when you've had the privilege to grow up and visit those places and experience what it's like to be in nature, and like you said, just take a moment and slow down and just be present. That is so important. So yeah, I would attend that masterclass. Alex Condon: Sure. No, absolutely. Knowing a bit about your travels, I'm sure that you feel the same. It's, it's an important part of of our short time here. And so, make the most out of it. See all the things, do all the cool stuff. Try to soak in as much as you can and at the same time, if you're passionate about something like I am about Galen Data, you can have your cake and eat it too. Lindsey Dinneen: Yes. Amen to that. Well, what's one thing you wish to be remembered for after you leave this world? Alex Condon: So this is not something that I think about too often. I think that, it would be great to be remembered by friends and family as just a good person. Again, I have a lot of interests and when you extrapolate out, if I could take my experience in the business world, or maybe socially, and apply them to all these various interests that you have, there's probably a narrative that gets left as a residual if you're able to pursue those paths, right? And so I think that if you show up and treat people well, the legacy will write itself. And in our case, one thing that's not lost on me is our product, it's a great accelerant when it comes to medical devices coming to market. And when I think of medical devices-- we'll take a startup perspective-- there's a lot of education, a lot of late night working, investor money, time spent, creating these medical device products. And if we can help those companies get to where they need to go in a de-risked way, maybe they come to market far faster, that means that their impact can be by more people, right? More people sooner who need these kinds of products. So in that vein, we're a small piece of the puzzle. But our kind of legacy I guess would probably live on through the devices that we service, right? So that's one thing that's extremely gratifying about the role, right? We have many devices, devices on four continents, dozens and dozens and dozens of companies that are using us. Being a piece of that narrative, even if the champion is the inventor, happy to carry them on our shoulders as best we can. And at the end of the day, we'll never really have an idea of the number of people that we help. But it's satisfying to know that we've been a piece of the process for so many device companies. Lindsey Dinneen: Yes. Absolutely. Couldn't agree more. That's fantastic. And final question, what is one thing that makes you smile every time you see or think about it? Alex Condon: I laugh as I say it because a lot of it has been talking through it with you is, how we end up where we are, right? So, from working in Phoenix, Arizona, and essentially a basement with two founders of a investment management firm, and grinding my teeth there for years. And then, working with astronauts as part of this NASA contractor and getting to meet a whole lot of interesting people. And now being surrounded by some of the brightest people in the medtech space. I'm always happy to be the dumbest guy in the room. And looking at that play out in your own life is something that I smile about. And then, outside of that, for me again, hearing positive feedback from the companies that we help, where they tell me something that was tangible to them: "we were able to save this much time, money or whatever we were able to launch our product this much quicker," or something like that. Going back to the last answer, hearing the results of your work. Again, being able to pop up from being that prairie dog digging in the ground and looking around and hearing people have liked what you've put a lot of sweat equity into and hearing how it really helped 'em, that always brings a smile to face a hundred percent of the time. Lindsey Dinneen: Yes. Oh yeah. That's a great answer. Well, thank you so very much for joining us, Alex. We are honored to be making a donation on your behalf as a thank you for your time today to Opportunity International, which designs, delivers, and skills innovative financial solutions that help families living in extreme poverty build sustainable livelihoods and access quality education for their children. So, we appreciate you picking that organization to support and thank you again so very much for your time today and we just wish you continued success as you and Galen Data work to change lives for a better world. Alex Condon: Thank you so much for having me. Yeah, I sincerely appreciated it. Lindsey Dinneen: Oh, absolutely. Thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you share this episode with a colleague or two and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Kevin Saem is a brand leader at Zapyrus, a lifelong learner, and a passionate problem solver. In this episode, he shares stories from his early childhood in Cambodia and how that inspired his interest in medtech and healthcare, why he's so passionate about creating impact wherever he goes, and why he places a high value on curiosity.  Guest links: https://www.linkedin.com/in/kevin-saem/ | https://welcome.zapyrus.com/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 013 - Kevin Saem Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference Podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Kevin Saem. Kevin is a brand leader at Zapyrus, a lifelong learner, and a passionate problem solver. Having lived in Asia, North America and Europe, Kevin is a leader that values diversity and believes that the small differences are what give intrinsic value to an individual. Kevin, thank you so very much for being here. I'm just so excited to have you here and learn all about your background and what you're up to these days. Kevin Saem: No problem, Lindsey. It's a pleasure to be here. Thanks for having me. Lindsey Dinneen: Of course. I would love starting off by just sharing a little bit about your background. I know that, even from your bio, you have had such a cool life so far, all sorts of places that you've lived, and I'd just love to hear a little bit about that and maybe what brought you to where you are today. Kevin Saem: Yeah, absolutely. How far do you wanna go back? Lindsey Dinneen: Whatever would make sense in terms of inspiring you to do what you're doing now. Kevin Saem: Yeah, absolutely. When I look back right in my life, I always think of it as like the movie Inception. I don't know, have you, if you've seen Inception? Lindsey Dinneen: I love that movie, one of my favorites. Kevin Saem: So it's like a, yeah, so it's like a dream within a dream. When I look back at my life, cuz I grew up in a third world country. I grew up in Cambodia and it's almost like a different life there. So I almost see like a life within a life when I made the transition over to Canada. I was born in Cambodia, lived there for 10 years, lived through the nineties. And during the nineties, Cambodia experienced a couple things. So in the early days in the seventies, eighties, we experienced the Khmer Rouge, the genocide which my parents and my grandparents lived through. And then right outta that, when I was growing up in the nineties, we experienced the HIV/AIDS epidemic, which was a delayed onset from what North Americans experienced in the eighties. And so because of the whole genocide and internal warfare, the country was in already recovery while being compounded with a healthcare crisis, right? Super chaotic. Hospitals were not a thing at the time. There were like some, and I lived in the Capitol, and just seeing people that you knew, like neighbors or friends and family be affected by this disease. And nobody kind of knew what was going on until the UN stepped in and brought some aid and support through portable kind of diagnostic testing for this disease, which kind of helped brought the spread down and help control the spread of the disease. And seeing that impact of what healthcare technology, especially in the MedTech space, diagnostic specifically, could do to a small population in a third world country like that really stuck with me from the early days. So when I moved to Canada in 2000, started studying here, really gravitated to the STEM field. So science engineering, was able to put my thinking cap on in that space, so to speak. So I went to university and studied chemistry. I went in with a life science background and then specialized in chemistry and decided to go to grad school and do my PhD in chemistry and infectious diseases specifically for diagnostics and medical devices, for testing of infectious diseases because I had that in the back of my mind growing up in Cambodia and seeing the impact that those technologies could make. And I'm a firm believer in chasing impact and creating value at every stage of your life. Like within your inner circle, what value you could create before you move on, what long lasting impact that you could create. So from Cambodia to Canada to my graduate days I was fortunate enough to meet a bunch of intelligent people, be taken in by very talented researchers in the space. I did my studies in McMaster University, which has now become, I believe, the most research intensive university in Canada, if I'm not mistaken, a few years back. So I studied under professor Jose Moran-Mirabal and I had a bunch of other professors as mentors, and they were really great. I was able to touch a lot of different topics in research, which is unconventional from a graduate experience. Usually you're narrowed down into kind of one scope, but I was able to start with kind of material science, materials engineering, like making novel, conductive, stretchable, elastic materials. Moved from there to nanotechnology, biosensing, and then eventually closed off my graduate degree in doing some work on premature 3D printing and tissue engineering work to create synthetic scaffolds for testing or biomimicry, which that work has been able to mature over time. So that's like my graduate experience. So when I was, I would say in the last year of my graduate study, again going back to the impact theme. I wanted to understand, what was the next step after a research paper. Like how do you go beyond just benchtop work into actually creating a product that could affect people's lives on a day-to-day? And I wasn't able to get that just being in research. And so that got me thinking about the startup path going into industry, you know, the typical challenges you come across as you're nearing your graduation, right? What is the next step? Do I pursue a career in academia, become a lifelong researcher, and just stick in that space? Or do I take a step out and look at the rest of the world and see what other cool things people are doing? So putting on my curiosity cap again. Got a chance to network when I was doing a sabbatical research with my professor at the time, Dr. Jose Moran-Mirabal. He had a sabbatical in the south of France and he took me along. It was really great experience, right? We had a lot of great wine, traveled everywhere. So again, unconventional, I would say, graduate experience. So I was very lucky to have had all those sorts of experiences. And it was like a France/Canada collaborative research internship where we were starting kind of new project in tissue engineering and really novel biomaterials, right? And this was like at the very start of the early days of 3D printing for medical devices. And so, got a chance to meet a bunch of cool people. And then one professor that sponsored us there started this liquid biopsy startup company out of the institute that we were working in. And so nearing my graduation, I was presented with an opportunity to be a part of that early day kind of startup life or this novel liquid biopsy startup company that was in the south of France. And so, I spent a bit of my time there again, wearing multiple hats, helping raise capital, managing R&D strategy, managing relationships with industry. So I did that for a little bit of time and got to know the medical device system from an OEM's perspective at an early stage and then the pandemic hit and it threw a wrench in everybody's plan, not just my own. And so at that time, our Prime Minister gave out a signal to all foreign workers to come back home. So I had to come back home and it was another reset. And I was looking at kind of new opportunities in the space and I stumbled upon this local Toronto bootstrap SaaS company. At the time it was called Zymewire and I did a little bit of digging and found that it was bootstrapped by a couple of guys. The CEO, Pete Bastedo, he came from the pharmaceutical side of the business. And then the co-founder Ryan, the CTO, he had a technical background. So I was really fascinated by this kind of bootstrap company model. And I took a look at their site and fell in love with the culture that they represented. And it aligned really closely with the philosophy that I had as well. And so that got me even more interested and took me down a rabbit hole of like, all right, what are they about? And so, I made the connection between Pete, the CEO, and a good friend of mine that came out of the same graduate program. And I pinged my friend Faheem. I was like, "do you know anything about this guy, Pete? How is he?" And then he gave me nothing but great reviews on Pete. He's a really intelligent guy, really smart, and he's doing cool, exciting things with the company, right? And so, eventually ended up speaking with both Pete and Ryan and they were telling me about their plans for the company and kinda where they wanna go. And given kinda my background in MedTech, they wanted to expand the product offerings beyond Biopharma and into MedTech. And that's how I came about into Zymewire at the time. But now we recently rebranded to Lumerate. And now Zapyrus was born just last year around this time as a premium MedTech business intelligence tool specifically for the MedTech industry. And so now we have that. Now it's real. Lindsey Dinneen: Wow. Oh my gosh. That is amazing. First of all, your story is incredible. Thank you for sharing all of that, and it's so fascinating to me to learn about how someone's background and often childhood can really shape who they end up becoming. But it's interesting because for a lot of the guests that I've had so far, there's been something that says, " I wanna make a difference in this area." But then their career trajectory and their education has allowed them to sort of weave in and out of all sorts of avenues of pursuing their dreams in very interesting ways. So I just love hearing about that. So thank you so much for sharing and I would love to hear a little bit more about your company and how it helps MedTech companies now. Kevin Saem: Yeah, absolutely. The industry is made up mainly of these small players. I would say 80, 85% of MedTech companies are small, medium size businesses, and then they eventually get acquired by the big ones, right? Basically, our platform helps to connect MedTech service providers with MedTech OEMs at the right stage and at the right time so that they can be supported to bring their lifesaving technology to market. And as you know, a lot of medical device companies come from maybe a doctor had an idea, right, that there's this unmet need and they need this device to come to market, but they don't have any business background or they don't know how to get device to market. And so there's a lot of mess that goes into the early days that a lot of service providers can't help these companies and get this medical technology to market and actually affect people's lives in a positive way. And so for us, we wanted to humanize business development. We were seeing a trend where there's all these solutions that would give you lists of companies, lists of contacts, and then a way to just bulk email them or bulk spam them. And with a industry like MedTech and the community is so small, that doesn't really tend to work well, especially because you're talking to founders and CEOs that are passionate people that are looking to bring medical technology to help and enable patients and better their lives. So we wanted to create something that was a tool, yes, to help the salesperson and the marketing team in service provider companies to be able to identify the right companies to help at the right time. But we wanted a way for them to do it where it reflects the industry-wide belief of like, "hey, we're passionate people helping other people and that's our community." And so our tool was designed for that, right? That's what our philosophy is. That's how it was based around. We have this mission to bring humanity into MedTech business development. And we do so through suppliers. Lindsey Dinneen: Love it. That's awesome. That is a very needed service that y'all provide, so I'm so glad that you are out there doing that work. And thank you for sharing about it because it's great to learn about the various resources that are available. Kevin Saem: Yeah. Yeah, definitely. Lindsey Dinneen: Well, I'm curious, is there a particular moment that stands out to you because it clearly confirmed that this was the right career path for you? Kevin Saem: That's, that's a very tough question, Lindsey. For me to pick a time point in my life, honestly, I keep thinking back to a theme. I don't know if there's a particular moment, but I think there is a theme where, for me, I'm always looking for a way to create impact whether it's big or small, whether it reaches globally or it reaches my inner circle. That's always been my driving force of how can I do something that would benefit others around me in a positive way, and that would be long lasting? If I was gonna build something, it should be the best thing and it should do good. It's not enough to just do well. I think we should also focus on doing good. And so that's been my primary driver. And so a particular moment in my life that I remember, this was back in my Cambodia days, from a very young age, I was always interested in building new things. So if I was presented with some sort of toy I would be disengaged really quickly because the toy was already built. I'm just playing with something like a finished product. I gravitated more towards building new toys out of clay, that was more my style. And so that theme just recurred. Like through research I was building out new projects, new process, I was developing new things. In this role as well, bringing a brand to market, you have to build things. And so that I think is in my DNA, that theme of creating impact through building new things. Lindsey Dinneen: I love that. Well, And I know you've talked quite a bit about the creating impact theme throughout your life, and I just love that. I think that has clearly shown throughout your career and the various different things that you've done. It seems like having that running theme is really helpful because it guides you as you maybe look towards the next thing or how do I go about this project? If your goal is creating impact, then you always have that guiding light and I think that's really valuable. So I'm curious, how has that affected your leadership philosophy, or is that part of the way that you interact with others including in a leadership capacity? Kevin Saem: Yeah, that's a great question, Lindsey, and I think it, it does, it really does because in a leadership role I'm always looking to create positive, lasting impact as well for the people and for the business that I'm with. So it helps me to separate leadership from management in a way, if that makes sense. Lindsey Dinneen: Yeah. Kevin Saem: So for me, that helps me to put people at the heart of it all and then it manifests outside of that. So if you're leading a team of people you're constantly thinking and you got your worried hat on of like, "are these people being fulfilled? Is their work enriched? Are they doing well? Am I helping them unlock the next stages of their progression?" That type of stuff lives in my mind when I think about leadership. Essentially empowering people to do great things and helping them achieve their goals. I think that's what it's all about if you're serious about leadership. Lindsey Dinneen: Oh, I love that. Oh, that's a great definition of leadership. Amazing. How do you prioritize your own continued learning and growing as a leader? Kevin Saem: Yeah. That's also another great question. You're coming with the heavy hitters here. So, I just wanna take a step back. And I think two people that kind of help me understand what good leadership looks like. The first person was my PhD. supervisor professor, Jose Moran-Maribal. He had a way to approach leadership where it's like an extra layer of inclusion that he has in the back of his mind and his ability to help support his students was amazing. I learned passively just through watching. Another person that currently I report to actually, Pete, I respect as a leader and I emulate a lot of my thinking through these key figures and mentors. Throughout my career, I always have at every stage several mentors that I like to learn from, either passively or actively. And so I guess that's helped shape the meaning of what leadership looks like, and I use that to surround myself with those types of people. Lindsey Dinneen: Yeah. And so emulating has been a huge component in your own growth as a leader. Do you find that there are other resources that have helped you or continue to help you, or is looking towards those models of great leadership, is that primarily your source? Kevin Saem: My source is actually in the people that I surround myself with. It's silly to say, but I think throughout my graduate school days I've really finally learned how to learn or how to ask questions the right way. And I guess to summarize that, it's how to think versus what to think. Leading up all the way to graduate school, you're told you know what to think. This is right, this is wrong. And then throughout my graduate school experience, I really understood the mechanisms of how to think. And for me, my philosophy at continuous learning for leadership is trying to be the dumbest person in the room. It helps to protect me in a sneaky way where if you're the dumbest person in the room, you know there's only one direction, it's up, and you just learn so much. You just absorb everything, you soak everything in like a sponge. I learn things every day from the intelligent people that I have the opportunity to work with. And so yeah, I take that dumbest person in the room approach and ask tons of questions. That's the only way, I think, to really learn. And leadership is a funny thing where it's almost like trial by fire and you have to just go through it. You can read a lot of stuff-- obviously, I do read stuff-- but you kind of have to go through it and experience it and figure it out as you go and continuous process improvement along the way. Lindsey Dinneen: Yes, absolutely. Yep. Great advice. Okay, just for fun, imagine someone were to offer you a million dollars to teach ambassador class on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? Kevin Saem: Oh, there's so many bad answers to this and there's very few good answers to this question. I don't know if I am skilled enough to teach a quote unquote masterclass in anything, but if I were to pick one thing to teach, and this is probably another unconventional answer, it's probably the application of curiosity to fuel success in anything that you pursue. I think that's very underrated. As as a trait in people that are successful, I think they're intrinsically curious and they continue to be lifelong learners. Lindsey Dinneen: I love that answer. Yeah I absolutely agree with you. I had the good fortune when I was young, I was very curious and I was asking a lot of questions all the time. And I had an adult one time say to me, " You know, it's so good that you ask questions because then you'll always keep learning, so don't be embarrassed about it. Always keep asking those questions." And I'm so glad that someone thought to acknowledge that and point it out because it helped me retain that curiosity and not be afraid to be, like you said, the dumbest person in a room so that I could keep learning. So I love your advice. Curiosity is underrated and it's hugely important. Kevin Saem: Yeah, absolutely, and I think there was a drastic contrast when I was going to school in Cambodia and when the country was in recovery, it was very authoritative interaction between students and teachers. It was seen as like the teachers know all the answers and you should just be quiet, right? And just absorb knowledge from this beacon of wisdom, so to speak. And I would get in trouble in class all the time, I would be sent home with notes saying, " your son is just a troublemaker. He is asking too many questions in class. He, he is disruptive." And they don't like challenges to what they know in that kind of culture at the time. I'm sure it's changed a lot now, now that it's more modernized as a country. But when I came here, I was very surprised as to how much encouragement in Canada and in North America as a whole to like question ideas and question what's right and what's wrong. And always be very inquisitive and almost skeptical of what's presented in front of you. And I really appreciate that philosophy over in North America. Lindsey Dinneen: Yeah. Yeah, and that's really interesting perspective to have experienced both, so you can contrast and compare. What is the one thing you wish to be remembered for after you leave this world? I think I have a pretty good idea of your answer, but I'd still love to hear it from you. Kevin Saem: Oh my gosh. I'd love to hear you guess. Lindsey Dinneen: Okay. I'm gonna guess that it has a lot to do with impact in the various areas, whether it's personal or professional. But I will let you go into detail. Kevin Saem: You got it. I think you summarize it pretty well. You know, being remembered for having created something or opportunities or memories that has changed the lives of those around me in a positive way, I think that's enough for me. I don't need much more than that. Lindsey Dinneen: I love that. Absolutely love it. Okay, final question. What is one thing that makes you smile every time you see or think about it? Kevin Saem: Oh, that's a good question also, and it's a good one to end off on. There's one fond memory and like I said, it's like life-ception. It's like a life in a life. When I was living in Cambodia versus here, you had to really mature quickly when you're living in a developed country. As a young child, you'll understand kinda the risks when you take a step outside. There's dangers all around you. You learn to be quite self-aware at an early age. And I just remember there was a relative that came from France to visit the country and they brought a pair of roller skates back. And this was like a size 10 and we're like eight years old. And there's a group of just street kids playing around on the rooftops and stuff cuz we had concrete buildings with flat rooftops and that's where all the kids would hang out. And there's like about 10 of us and we remember just, we had a pair of roller skates and we were just taking turns using one each, actually, cause we didn't know how to ride roller skates. We're each just taking turns using one roller skate and just having the best time of our lives. And that reminds me of this, I guess, mantra that I have in my mind of " it's not about what you have, it's about who you share it with" and it's like that part of my life, we didn't have much, but we were so happy. We didn't know that there was anything outside of that. And so it's all about perspective, I think, and that's the memory that comes back to me that makes me smile every time. And I don't think anything else matters once you have things like that, that type of experience. Lindsey Dinneen: Yeah. Oh, I love that story that I'm just smiling thinking about it too. Thank you so much for joining us, Kevin. I just really appreciate your perspective and advice and bringing such a powerful background to the industry. I'm so thankful for the work that you do. We are honored to be making a donation on your behalf as a thank you for your time today to Save The Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational and safe environment. That was the organization that Kevin chose to support. So thank you so much for your time and thank you for all of your great quotable quotes. Kevin Saem: Quotable. Yeah. No, thank you, Lindsey, for putting all this together. I think what you're doing is incredible. I think you're highlighting the other side of MedTech, right, that is probably less technical, but is just as important. And I think you'd know, as better as I know, that storytelling is a big part of passing on knowledge and sharing with the community. And our community is so small that I think this is gonna really help bring us all together, especially coming outside of a pandemic years. This is a great, refreshing podcast. Lindsey Dinneen: Oh, thank you. I appreciate that feedback and yeah, that is the hope. It was so fun earlier when you were talking about bringing the humanity into MedTech, I just had to smile 'cause I was like, "there you go." We're very aligned. Kevin Saem: Yeah, that's right. That's right. Yeah. Lindsey Dinneen: Oh man. Again, thank you so very much. We just wish you continued success as you work to change lives for a better world. I know that impact is really important to you, and I know that you're gonna continue to make an impact on the world, so thank you. And thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.   rjwA2u2Sx2mukDo1jErj

Lindsey Jardine is a Senior Clinical Research Associate at FARAPULSE, Inc. In this episode, she discusses her love of designing and organizing clinical trials, her zest for life and continual learning, and the very human moment in her career when she realized she had to make a major change from academia to industry.  Guest links: https://www.linkedin.com/in/lindsey-jardine-5a0985103/ Charity supported: Opportunity International  Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 012 - Lindsey Jardine Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Lindsey Jardine. Lindsey is a clinical trial manager renowned for her exceptional leadership and groundbreaking achievements in the healthcare industry. With a passion for advancing medical technologies, Lindsey has successfully managed two breakthrough innovations: one at Farapulse Inc. which was acquired by Boston Scientific in 2022, and another at Shockwave Medical that went public in 2021. Her entrepreneurial spirit has also led her to contribute to the success of Cala Health, now commercially available. Lindsey has earned a reputation for excellence in leadership throughout her career in clinical research. Lindsey, thank you so very much for being here. I am so excited to have you as my guest and welcome. Lindsey Jardine: Yeah, super excited to be here. Thank you so much for having me. Lindsey Dinneen: Yes, absolutely. I would love if you don't mind starting out by telling us just a little bit about yourself and your background and how you got to where you are. Lindsey Jardine: Oh yeah. I work in medical device. I work in clinical research. So the story of me, it's a long and twisty one, but I'm currently the Clinical Trial Manager at Boston Scientific in the electrophysiology division. So in electrophysiology, you kinda split in between cardio and neuro. So I've worked in both cardio and neuro. But yeah, just closed out my study for a atherectomyectomy device. Lindsey Dinneen: Yeah, that's great. I'd love to hear how you either intentionally explored the medical device industry or whether you meandered in, either way I just love hearing the background of what got you to where you are. Lindsey Jardine: Yeah. So my background was originally in biochemistry. So I went to school to get a degree in biochemistry, and in biochem there's only basically two ways that you can go in any kind of industry. So you can go into academia and do a PhD, or you can go into medicine. So in a PhD you'd usually go into genetics, which is a fascinating topic. Genetics is super fun. So I did work in a genetics lab after I graduated college, but with the intention of going into medicine, so while I was working in the lab doing a lot of like really interesting genetics work at UCSD, I was also studying for my MCAT, which did well, got into med school. While I was filling out the financial paperwork, I looked around and I was like, "everyone in medicine is miserable." And then I had this moment where I was just like, "you know what? I don't know if this is what I want." Because in medicine you have this grind and it's like the glory is in the grind. And you sacrifice, and then eventually maybe you'll save some lives and your time on this earth will be worth it. But that seemed like a really bad idea because I love being outside. I love my family. I love my friends. I wanted to love life in a very profound way, so I decided that sacrificing everything for maybe some kind of hope that I'm going to further the human race was probably not best served in a hospital. So I got very lost for a long time. Continued working in the lab doing genetics. I was like, "okay, maybe I can help figure out some cures. Maybe I can figure out some other way to help humanity at not costing me my life." So started working in research, decided that I was not a lab person, not because I don't love the problem solving of the lab, it's just more of a very isolated not as personal. So, I was at lunch one day and somebody who works in clinical research at UCSD, she's "oh, why don't you come into our office and our clinic and figure out what clinical research is all about?" I was like, "Oh. That's a thing. Clinical research, I don't even know what that means." That's not really a degree that you can have in undergrad. It's not really something that you really hear about. At least when I was in college or immediately after post college, that's not really something that was, I'd never even heard of before. So, I started working at the Chelie Eye Institute, which was also like, not to get into too many too much detail, but a lot of genetic abnormalities present in the eye. So there was like a really strong genetic component. But also I got to work with patients in clinic, which was really fun. So on the hospital side, you get to implement a lot of other people's research and you get to interact with people and you get to see the benefits of research on a daily basis. So I fell in love with clinical research. Then eventually I was recruited to work on a project at Stanford. So then I moved from San Diego up to the Bay area, started working on the baseline project at Stanford, which was a collaboration with Google and Duke University. So, that was a lot of fun. That was a lot of logistics that project was logistically super complicated, which was fun. I love that. That one was trying to figure out how all the puzzle pieces fit together and then also getting a really good deep dive into like data science. So that was my first like foray into like data science which was really fun. And then also I got to see what industry is like. So from up until that point, my entire career was in academia. And I did like academia, but it was definitely still that grind that no matter what you do, it's never really gonna matter. You might serve somebody at some point in some time and then your life's gonna be worth it. It's like this noble sacrifice basically. But so then I got to see what industry is like and how innovative it can be, and like that really tickled my creative process and that was something that I really fell in love with was being able to move really fast, help a whole lot of people, and be creative in the process. And you get to put together all these like logistics puzzle pieces and understanding the science and really deep diving into something that gets noticed and that helps people in the immediate. So that's that juxtaposition with academia and industry is-- academia you grind forever and then maybe someday you'll get a card saying, "You saved my life 10 years ago and my grandkids are now amazing people and it never would've been possible without you." But in industry you get that immediate kind of reward, like you see it come to market and you see your project. All that sacrifice, all that immediate hard work that you put into something, you see it come to market. And it's really fun and it's really great and you get to see it from not that 10,000 foot view where we're all contributing in the greater scheme of things. It's-- you get to see it, like you run a study of 20 people and you see the immediate effect of those 20 people. So that's why I chose MedTech specifically. But yeah, so, after Stanford, I moved into the startup space. I started working at Cala Health which was neuro. So, that was my first transition into the electrophysiology, neuro cardio kind of space. For anybody listening who doesn't understand what electrophysiology is, it's basically understanding the way electricity governs your body, which is a really fascinating topic to me 'cause I'm a physics nerd. I love physics. So, being able to take all of my physics information, all my physics, like chemistry background, and then getting to split that time between the brain and the nervous system and, and the heart was really interesting. So that's when I fell in love with the heart and the brain. But yeah, so Cala Health is doing really great. They're commercialized. I was part of the team that put together some of their early feasibility trials and also their pivotal trial, which was a lot of fun to work with them. And then almost immediately after that they got commercialization and being able to understand and talk through or hear the leadership team strategize for something like that was really interesting. And that was a whole new thing that I had never even seen before. Like, how do you bring a product to market and what capacity, who are we gonna reach? Who is this best suited for? So listening to all that strategy was really fun. And then after that I worked for a company called Shockwave Medical, which is an atherectomyectomy device. So that's a cardio. So electrophysiology in the heart space. And that was a super fun, that was a breakthrough IDE/PMA trial. So it was huge. It was global. It was a lot of moving pieces that, all those logistics that I loved with the electrophysiology portion of it and I got to work with great leaders, and that's one thing that I find like really consistent about when I'm choosing my next job or my next project. I look at the leadership team and I get to see how they approach problems and that is how I make my decision of who I wanna work for, is if you approach problems in a methodical and innovative way, I love seeing that. I love being inspired by that. Those are the kind of leaders that I look up to is how well they approach problems in their thought process and their ability to innovate in a space that's either new or has been done a thousand times, either one. But yeah, so worked at Shockwave, we were able to go IPO, the company went public and then we closed our trial. We started moving into the post-market trials, and I just still have that adrenaline high from the breakthrough study. We can get into this a little bit later, but those breakthrough PMA/ IDE trials are huge and they are a lot of logistics. It's very intense. It's a lot. It's a lot. And it's a grind, but in a fun way. For me, I love this. I love. So yeah, the thing that attracted me to medicine also attracted me to the breakthrough kinda trials, those breakthrough pivotal trials. And so after that I was like, " I need another one." So I started looking. I got approached by a recruiter and this recruiter sent me a bunch of stuff and then I saw the Farapulse offer come across saying that they were looking for a clinical trial manager for their pivotal breakthrough trial. And I was like "That company looks like it's gonna change the game." Same thing with Shockwave, also changed the game. So I got on board with Farapulse which is another cardio EP, electrophysiology technology. And it was magic from the very beginning. And we just closed our trial-- which that trial had its own complications. It was a blinded trial and all the sites and like trying to figure out how to do all that through Covid, through all the things. So that's how I got to where I am now. Eventually, last year we were acquired by Boston Scientific. So, yeah, that's the very short background of how I got here, and now moving on to my next adventure, which is gonna be back in the neuro space. Lindsey Dinneen: Nice. Oh, that's so exciting. That is something that kept resonating with me as you were talking, was just your enthusiasm and passion for this particular industry and for your role within it. And it's just so much fun to hear how all of your different interests and passions are coming together in a way that, it sounds like just keeps you constantly engaged with the process, and you know that you're making a difference as you get to see it right in front of you. It sounds fabulous. Lindsey Jardine: Yeah, it is. It is. I really do enjoy my job, even like the daily logistics, and not every day is magic. Some days are just the grind, but then two days later or a week later, you're back inspired. So I do love what I do and I love the pace in which the trials that I do sign up for go and it's really fun. Lindsey Dinneen: Yeah. So, in your role as manager for someone who doesn't know what a typical clinical trial might look like. How does it work? Is there like a typical process or it, I'm sure it varies per trial, but I'd just love to hear a little bit more about how you go about even organizing it to start with. Lindsey Jardine: Yeah. Oh man. Oh, that's a good question. So there is, the FDA does have a reasonably prescribed way to put together a trial. So, when you're working in the startup space, what happens is you have somebody with a great idea. That person usually doesn't know how to build it. They usually don't know how to commercialize it. They usually don't know how to run a trial with it. So they have this great idea and then they go about trying to build this leadership team. So you'll try and find a CEO, you're gonna find funding, you're gonna start like prototyping some stuff. And then once you get to a point where you think that what you're building is viable, you bring on some engineers that work in the space, that are professional, they work in the startup space, kind of the same way I work in clinical trials. There's definitely people who work specifically in startups to engineer and build stuff like this. So you bring on an engineering team, they build it, they test it, and then once they've gotten it to a point where, It's a viable product in a lab they usually bring on somebody like me, clinical trial manager, preclinical trial expert to start testing it in larger animals before we go into humans. So then you start putting together your preclinical data. And a lot of the times that's where somebody like me would jump in as a clinical trial manager or a clinical trial expert in some way. So it's usually not necessarily a clinical trial manager, but a clinical trial expert. In the service space, it's a fluid term. You could call 'em clinical trial specialist, whatever you want, but again, it's just somebody who has the expertise of bringing something from an engineering perspective all the way through market. So, in that process, I get to build the protocols. I get to ask the questions. I get to set up the preclinical work so I can inform my clinical work, if that makes sense. So when we're putting together the preclinical work, you're putting together the studies, you're understanding the device, you're understanding the product, you're understanding the demographic that you're going after. So, the disease space basically. So that's one thing about clinical research, as somebody who specializes in clinical research, is the disease space changes with the technology. So I've worked in electrophysiology and neurology, so, atherectomy, ablation, therapy, neuromodulation. So the disease space changes, the technologies change, but how you think about your job and how you approach things should be consistent, so it's that innovation. I think that's really what the difference is when you go into academia is you focus on as a very specific disease space and you focus on one very specific and you get into the minutiae of one specific thing. So if you're going into medicine you specialize, you subspecialize, and then you really understand that one protein of that one gene. So, coming back to where I am now, I don't necessarily understand one specific disease, I have the opportunity and the privilege to work with a lot of different disease spaces. There's a lot of different products and I get to understand and innovate and build my knowledge as I move through my career. So I've worked in a lot of different types of medical devices and it's really fun being able to learn from the engineers and learn from the physicians, and learn from all of my colleagues as I go through my career. So I'm building my knowledge as I go along. So my specialty is building clinical trials. So to answer your question, there is a reasonably prescribed way to do it, but that prescribed way is driven a lot by your logic. The FDA is your partner in all of this. So they have regulations that you have to follow. So as you're going through and you're building this process, as you're building these clinical trials, you have to make sure that you're adhering to all of the regulations that the FDA has set forward. So that's everything from building your internal standard operating procedures at your company to making sure that all of your regulatory documentation is above board and your operations, all of that stuff. So the FDA's your partner through all of this and making sure you're putting together a clinical plan and/ or protocol that is safe, effective, gets at the correct end points, targets the right demographic of people, disease state, and making sure it's safe and effective as you go through all of these steps from preclinical all the way through clinical. Lindsey Dinneen: Yeah. And that actually brings up a question that I had, and that is, have there been any moments that have been scary in clinical trials because part of it from my understanding, please correct me if I'm wrong, is that you are trying to establish, not only does this product work as intended, but is it safe? And of course you hope you've done enough pre-work with that to have a solid idea. But are there moments where you've just been like, whew, that did not go as planned? Lindsey Jardine: We have a term for that. It's unexpected adverse events or unexpected device malfunctions, but that's a good question. So it's yes and no. To be clear: one, you want to make sure that you study your device in the preclinical setting as thoroughly as possible. So that's your engineers. And your engineers are also going to the FDA for pre-submission and the FDA's double checking everything. But with that being said, that's why we do so much diligent testing before we put it in humans in order to make sure that once we get into clinical trials, it is absolutely safe. So, protocols, they test out for years after a procedure. But to make sure that we have all of our ducks in a row, all of our T's crossed and I's dotted, we're not gonna hurt anybody. I've never been a part of a product that I was ever afraid was going to hurt somebody. That being said, there are definitely times in lab where just " Oh, that happened." So there's definitely times where you're just like, "Oh my God, how did that happen?" In a lab setting, but never in a clinical setting to be very clear, I've never been a part of that. So in a startup, you'll have like your engineering on one side of the building and your operations or something on the other side. But when you're going through user testing or trying to design user interface, the engineering department will bring somebody in you're like, "Hey. I'm gonna teach you how to use this. Let me know if this makes sense to somebody who doesn't build it." So, I've definitely been in a few situations where I was using something and something unexpected happened. I was like, "What was that?" They're like, "Oh, we found a bug!" So, stuff like that definitely happens, but I've never been clinically in fear of any of the devices that I've worked with. But I also work with really amazing engineers and really amazing physicians. So that's another really great part about what I get to do is I get to collaborate with physicians who do this for a living, who do that very specific, very granular work in one very specific disease state. So they also inform and help, and it's ultimately their responsibility to make sure that whatever they're using on their patients is safe and effective. So that's why we work really closely with all of our physician surgeon collaborators to make sure that we aren't doing anything that could hurt anybody, cuz that's obviously, that's the opposite of what we wanna do. So yeah, that's another thing that I love about my job is the collaboration. Lindsey Dinneen: Yes, it does seem the more that you've talked, the more I can sense how much you enjoy working with people and having that collaboration, that problem solving, we're in this together trying to make a difference. That's really cool. Another thing that you brought up that I really liked and something that I tend to ask my guests is about how you as a leader in the industry continue to prioritize your own learning and growing. And it sounds, because you get to work on so many different devices and with so many different indications, you really have this opportunity. It's almost built into your job. And then it just sounds like you as an individual are just a really curious person. So you're probably getting to learn and grow all the time. There's no stopping it. Lindsey Jardine: Yeah, that's true. It's true. There is no stopping it. Honestly, that's why I chose the space that I'm in is I love learning. It's one of my favorite things in life is just expanding my knowledge base, learning fun new things. And even in my personal life, I'm always going out exploring, doing new things like learning and absorbing the world that we live in. And that's one consistent theme of my life is I just want to love the life that we have right now. And so learning and exploring and doing and driving yourself to, to a point of excellence is something that I truly enjoy doing. But yes, that learning is my job. And if I ever stop learning, I think that I would stop being good at my job. And hopefully by that time I can retire and learn something new, learn something that I haven't learned or even attempted to learn before. So, to answer your question, learning is definitively what I get paid to do. Lindsey Dinneen: I love it. I love that. That is fantastic. Yeah. So is there a particular moment during your career that stands out to you as kind of a defining moment of "Yes, this is the right industry for me." Just confirmation that you really chose and that it was fulfilling some of those deep desires that you've had. Lindsey Jardine: Yeah. That's a really good question. I can't say that there was ever one like lightning moment that told me that I was on the right path, but I do recall one specific moment where I knew I was on the wrong one. I think that the consistent feedback that I get throughout my career now is a continuing affirmation that I've chosen the right path and the fact that my personal happiness gets more-- like I, I gain more and more happiness with every passing day of my job. Not to say that you have to be happy every single day. I think that there is definitely something to be said with the highs and the lows in a moderated way, not the extreme highs and lows. But I consistently reaffirmed that I made the right decision. But I remember probably the lowest point of my career that I had to take a step back and say, "This is not okay for me." I was working at that, the baseline project, and a lot of my mentors would call me probably more of a racehorse kind of personality, where I want to do stuff, I wanna improve, I wanna run it at full speed. And working on a project that was that logistically complicated with that many people and that many things, it was really fun. But, in the academic space, slow and the hierarchy, and it was definitely not my my favorite place because I remember there was this one instance where we had this intern and I was helping him and he and I were collaborating on a project and I was like, "Okay, this is how I'm gonna put all this stuff together." And I have, like I'm known for my spreadsheets. I have this 80 tab spreadsheet and we're putting all together and we're putting all these formulas together. And he was helping me and it got to a point where I was like, "Man, I am super proud of this." I was really excited that I got to learn something about putting all of this stuff together. And I got to teach it as I was learning it. And I did it and then I got to teach it and then I got to see him like do some stuff and he felt very rewarded by it. And I felt very rewarded by that too. So that particular project had lots of different principal investigators. So we had four different principal investigators that I can remember. And so we're in a room of 30 people. All of them are my superiors and obviously his superiors. But I'd found out that he had taken my work and he had presented it to my boss's boss as his own. And I had no idea that this was happening. And so I'm sitting in this meeting and he's presenting my work and you can't really stand up and be like, "Hey, get outta here, that's mine. I taught you that." And I was just fuming in this meeting. And there's just so much bureaucracy in that context that even if I were to say something, it would've fallen on deaf ears. And I did say something to my supervisor and they're like "Sorry, it's for the greater good." So, oh no, and I was just furious. And so I talked to him after and I was like, "Hey, you just put your name on my work." And he's, " I've changed the color scheme." And I was like, "Did you now? That's so cute." But there was like, there was no repercussion. There was no anything. So I probably did an immature thing and just stopped talking to him. And he didn't take that very, he was an intern. It's fine, but so I'm just like, I'm not working with you anymore. I can't trust you. So he brought me flowers and he put them on my desk and I threw them. And that was brought like, but I remember like taking these flowers and throwing 'em at a wall and I was like, "This is a bad spot. I should not be here. I'm setting myself up for failure." So, that's when I decided that I needed to leave. So I moved into the private industry, which was much more intimate. Everybody saw everybody else's work. Everybody knew, everyone was all striving towards the same thing, and it was never an ego trip for anybody, if that makes sense. And there's always that greater good feeling like we're all trying towards the greater good, but you personally are not sacrificing for somebody else's glory. And that's the thing that really got me about academia and that kind of " grind until you die" space. I was like, but. I did that. I feel good about that. Not that person gets to present my work and they get to feel good about it. So, to answer your not question. That was the moment where I knew I was in the wrong place. Lindsey Dinneen: Yeah. But those moments are just as important cuz they're teaching you what doesn't work and what does not align with who you want to be or, or how you wanna show up in the world. So I think actually, I really appreciate you sharing that story in that very just sort of human moment because I think it's so important to be honest about those kinds of moments that also are exactly what you said, " this is not the right path for me." And then it sounds because of that experience, you were able to go, okay. It's not like I have to get rid of the entire industry or anything like that. It was just, this isn't the right place for me and I'll find the right place for me. And I think that's really important too. So. Yeah. Lindsey Jardine: Yeah. And I do get reaffirmed by my job every day, and I love that. So it wasn't some shock, like lightning bolt moment, like this is the one. It was a slow burn that keeps burning brighter over time for me. Lindsey Dinneen: And I love that too, because how wonderful is that? It's not just this one flash of inspiration, which could be the catalyst to continue on the path and do something great and whatnot. But I love that you're in a position now where you can just be constantly, maybe in very tiny little ways, but just constantly reaffirming this is right. And that's special. That's really cool. Lindsey Jardine: Yeah. That is special. It is. And being invited on a podcast like this, I'm like, "When did this happen? When did I become the leader?" Like yesterday I was throwing flowers at people in a violent way. And all of a sudden I've been getting interviewed for a leadership podcast. Yeah, there's definitely been some significant changes that, all of a sudden, you turn around and you're like, I am the person that I wanna be. I did get here. This is amazing. Lindsey Dinneen: Yeah, absolutely. I worked hard for this and it is paying off. And yeah, I can change and grow. That's great. That's fantastic. Lindsey Jardine: Yeah, it is. Yeah, it is very special. Yeah. Lindsey Dinneen: Just for fun, I'm gonna take the interview in a slightly different direction, but imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? Lindsey Jardine: Oh man, that is another really good question. You're making me think. I like it. I would say if I could teach a masterclass in anything, it would be confidence. When I was sitting there watching my work that I've been, the project that I've been working on for months, being presented by somebody else, and then my reaction to it, that was a deep feeling of insecurity. And I think building confidence is a very important thing and building the appropriate confidence is another very important thing. I mean, for many years I was a "fake it till you make it" person. But having all of that insecurity being presented and then having somebody else take credit for my work, and then everybody else saying " So what, who are you?" If I had more confidence in myself, I would've reacted differently. And if I would've had more confidence in my ability to figure out problems, I would have not put myself in that position. I would have figured out how to get out earlier or figured out that "grind until you die" was not the right path. So if I could build a masterclass, if I could help people understand, knowing their own personalities and finding that confidence in themselves. And I think that is an invaluable skill in any industry is not that you don't have to be the person up on stage presenting the project. You can have your own confidence in building something and saying " that's mine" and owning it as opposed to having that insecurity and exploding all over everybody. So I would say that, yeah, I think that is definitely something that we are facing in a society that is troubling to me is the we're gonna go meta completely away from my specific story, but I see so many people with anxiety, I see so many people with imposter syndrome. So many people that even like Instagram, all these like social media feeds, it feels like a very deep-seated insecurity. And I dislike that. I dislike how we have to look a certain way or have to act a certain way or like all of these different movements to make people be seen and understood. And if we could collaborate and if we could speak with confidence, if we could speak with understanding that everyone here has some issues and if we could speak confidently about what we know, if we could be confident about who we are, then I think we could solve a lot of problems and not erupt into this, this really controversial space. So I know that having confidence also means having compassion and having that ability to reach out and say, "these are my flaws, but that doesn't mean I'm incompetent. I'm confident in myself. I'm confident that I know that this is the space that I don't know anything about and I need somebody to teach me, and that has so much confidence." And that's another thing that I've learned over my years of working in clinical research is there is no space, there's no time to fake information. You have to learn information and you have to have the confidence to say that, "I don't know this. I need to learn it." No matter how stupid that question is. "I need to learn that piece of information so I can do my job confidently and I can be confident in the product that I'm putting forward." So, if I was going to teach a masterclass, I choose confidence. Lindsey Dinneen: Yeah. I love that. That was really insightful too. I appreciate your perspective on confidence and, like you alluded to, appropriate confidence too with empathy, with compassion, with collaboration. Lindsey Jardine: You can't possibly know everything. But somebody else knows something. And if they don't know it, you have to have the confidence to be able to figure it out. Lindsey Dinneen: Right. And that curiosity is a strength. Because you don't know everything. Like you are highly specialized in, in many different ways, and you have this fantastic capacity to learn, but it doesn't mean that you're necessarily an expert in every single thing you come across and so having the confidence to be curious and to say "I, I didn't know this. Tell me more." That's fantastic. Lindsey Jardine: That's truly it. That really is the curiosity and the confidence . You said it really beautifully. Just tell me more. Teach me everything and then we can change the world together and we can be better people to each other. Lindsey Dinneen: Yes. I love it. What is one thing that you wish to be remembered for after you leave this world? Lindsey Jardine: Oh my goodness. That's a really good one. The one thing that I wanna be remembered for I would say, my confidence. Yeah, I would say my confidence. And that's my all-encompassing confidence, compassion, and curiosity, because I roll all of those things up into confidence, if that makes sense. So my confidence doesn't come from perceived understanding of myself, but it comes from the feedback that I get on a daily basis from my family, my friends. My confidence is something that I hope inspires and I hope that people remember me for the type of confidence that I have. How about that? The type of confidence. Lindsey Dinneen: Yes. I like it. Awesome. Okay, final question. What is one thing that makes you smile every time you see or think about it? Lindsey Jardine: Oh, man. Okay. The one thing that makes me smile. I would say, life. That's not too tacky. Yeah. Life makes me smile. I am continuously impressed by the world around me. And that comes with all of the changes that life brings, and it's not always pretty. It's not always great. I've definitely had some times where I didn't wanna do it anymore, and I want to encourage anybody who's listening, who does not have that passion for life to just wait cuz it does get better. Because I, I threw flowers at people, and not in a fun way, in a very violent way. There's definitely times where I was not happy or impressed with life and I didn't wanna do it anymore, and I just I didn't think the next thing was gonna be any better than the last. But I can honestly say right now, life makes me happy, not on a daily basis because I think it's a misconception that you have to be happy every single day because you don't really understand happiness and you don't really understand what life has a capacity for until you know what the bad looks like. So having bad times is just as important as having good times and understanding that the next piece of your life has the potential to be the best, has potential to be better than anything you've been through so far. But it makes me smile every day knowing that I get to keep doing this in this space and time that we're in right now. And in the world right now, there's turmoil everywhere, but I am very encouraged about life and it makes me happy because I get to see how hard everybody works. I get to see that we are going through something very profound and I'm very confident in the future. And life makes me smile. Lindsey Dinneen: Oh, I love that. That's the first time anyone has said that, so I love it. Beautiful answer. Lindsey Jardine: Thanks. It's kinda meta, but that's the one thing, yeah I don't know. Boyfriends, girlfriends, family, the sunshine. All of it's nice. All of it's good. Life makes me smile even when it's making me cry. It's the pain and the struggle and the future that, that just inspires me. And I love that and that makes me happy. Lindsey Dinneen: Absolutely. Lindsey, it has been an absolute pleasure to have you on the podcast. I just really appreciate you taking the time to join me today. We are really honored to be making a donation on your behalf as a thank you for your time to Opportunity International, which designs, delivers and scales innovative financial solutions that helps families living in extreme poverty build sustainable livelihoods and access quality education for their children. So thank you for choosing that organization to support, and seriously, thanks again for your time. I just wish you the most continued success as you work to change lives for a better world. I love the fact that you have such a passion for life and for your work, and I know what you're doing makes a difference, so thank you. Lindsey Jardine: Thank you. I really appreciate you having me on. This was a lot of fun. All your questions were so good. I loved it. Lindsey Dinneen: Good. Glad to hear that. Lindsey Jardine: Thank you for doing this, for doing you. It's very inspiring. Lindsey Dinneen: Appreciate that. I appreciate that. And thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development. B5IkdlvEu8YlwXbE9H3a

Miguel Adao is a passionate leader in the medical devices, internet of things and consumer wearable spaces, and serves as the Senior Vice President of Sales & Marketing for Voler Systems. In this episode, he discusses how living in nine countries and traveling to over 65 has impacted his life, the difference between managing and leading people, and the importance of having a "North Star" to guide your decisions and actions. Guest links: https://www.linkedin.com/in/migueladao/ | https://www.volersystems.com/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 011 - Miguel Adao Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference. I'm your host Lindsey, and I am excited to introduce you to my guest today, Miguel Adao. Miguel is a passionate leader in the medical devices, internet of things and consumer wearable spaces, and works for Voler Systems. Miguel, thank you so much for being here today. I'm so excited to chat with you. Miguel Adao: Yeah, Lindsey, thanks for having me. I'm really looking forward to our chat as well. Lindsey Dinneen: Absolutely. Well, I was wondering if you don't mind starting by just telling us a little bit about yourself and how you got into this industry. Miguel Adao: Sure. Yeah. Oh my, where do I start? It's been an interesting ride. I've lived in nine countries. I was born and raised in Portugal, in Lisbon. Went to high school in Rome, Italy, and then I lived in Paris, France, in London, England, in Munich, Germany. Spent many years in Rio and Sao Paulo in Brazil. Lived in Buenos Airs in Argentina. I went to college in Florida and grad school in Ohio and doctorate school in New York. And I've worked for some fantastic companies. I worked for Proctor and Gamble and Pepsi, and Hewlett Packard and Petco, the retailer, and Cigna Healthcare. That was my first kind of exposure to the healthcare side in a way. And now I live in San Diego. I'm married to Lindy. She's British and we have two teenagers. Olivia's 15 and Nico is 13. And I joined this company called Voler Systems almost a year ago in May of 2022 and we focus on medical devices. We help healthcare and medical and wearable and IOT companies develop and design their prototypes and their devices. And I just love where I am in my career at this point in my personal life with with my family and geographically. We love San Diego. So yeah it's been a very interesting journey, indeed. To your second question, the whole medical healthcare side obviously touches all of us personally, right? We have parents and relatives who get older and unfortunately sometimes sicker. So it touches us on the personal side. I lost my father years ago due to a health condition. So, on that personal side, I have obviously strong affinity to this industry and to this space cuz I want to make the world better. And it's almost a cliche, but I also wanna help people live longer and healthier lives. And then on the professional side, I'm trying to think. I've worked so closely with healthcare and medical devices and pharmaceutical companies through the years. When I was at Hewlett Packard for 12 years, I worked for a company called VMware as well. I was with Cigna Healthcare Insurance for three years, and now at Voler Systems, 80% of our business is around medical devices and medical wearable devices as well, not just the FDA classes one, two, and three. So not just on the scan, like a wearable watch or ring or a skin patch. But also other types of devices that actually go inside the body, like a stent or a catheter or perhaps devices that are used in robotical arms for surgery, et cetera. So I'm very close to the medical device world and the MedTech Industry as the Head of Sales and Marketing here at Voler. And yeah, from a personal side, I'm very passionate about this industry as well. Lindsey Dinneen: Yeah. Well first of all, your background is so cool, and I love that you've lived in so many diverse places. I, I have to ask, is there a favorite? Miguel Adao: I get that question all the time and my, my kind of cheesy answer-- my wife thinks this is so cheesy, Lindsey-- I love the most the place where I am currently. Lindsey Dinneen: Oh. Oh, that's great. Miguel Adao: I always say that. I always try to at least, I don't always succeed, but I try to live in the here and now, so I try to enjoy the most the place where I am currently. But certainly looking back, I'm very biased to Portugal. I love going back. I go back twice a year to visit my mom and my friends and family. In fact, I told you before the recording, I'm going to Portugal next week to visit my mom for a big 80th birthday. I'm so excited about that. So I always like going back to Portugal, but my favorite country in the world is by far Italy. Both because of course, historically and culturally, and in terms of beauty and architecture and food and fashion, it's astounding. But also just because I lived there from the ages of 14 to 18, went to an American high school in Rome, and those are formative years. That's when you start to become an adult and you start to really define who you're gonna be and, and who I am today is in large part because of that time in, in Italy. So I absolutely love my time there and I love living in California now. Lindsey Dinneen: Yeah, absolutely. Well, I love that perspective. I think that's a great way to go about life and just enjoy where you are in the moment and I guess also take the good from the various other places you've gotten to experience along the way as well. So I love that. But I agree with you that Europe definitely has some particular charms. Miguel Adao: For sure, as does the US, as does Asia. Lindsey Dinneen: Of course, as everywhere does. Miguel Adao: But it's interesting. Yeah, this whole thing, I've been talking a lot with my wife about this as well. She's a life coach and it's very interesting how, isn't it true? Isn't it just so absolutely true that we in our lives spend most of our time revisiting the past with regrets or anger or sadness or whatever. Or pre-living the future with anxiety and doubt and insecurities. We're never in the moment. Right? I've been talking about this with my teenage children as well. We're always worried about what's going to happen next and sad or regretful or upset about something happened in the past and I think that's just something I've been working on myself and it's been an interesting topic for my family as well. If you can live in the here and now, just enjoy this moment and just learn from this moment-- don't have to enjoy it, not everything is joy in life and thank God, because you need to have a balance. But it's an interesting challenge that I'm presenting to myself, and I'm using this podcast on industry with you, Lindsey, to remind myself, just enjoy this moment, enjoy this podcast and nothing else matters. Enjoy this podcast right now. Lindsey Dinneen: I love that. I love that perspective. Well, and that actually brings up an interesting thought. So, you know, as you were talking about that I absolutely agree with you, but what's interesting is in the medtech industry specifically, there's of course such an emphasis on innovation and it is partially to either solve past dilemmas or perhaps anticipate future ones. So, how do you think about that in terms of your role of sales and marketing for Voler? How are you able to stay present and grateful for the here and the now, but also think about it in terms of the industry, which sort of naturally has to be both problem solving and problem anticipating? Miguel Adao: That is such an interesting way to look at it. Yeah. Let me think about that for a second. I really like that. And I guess it could apply to most themes in our personal family or professional lives, right? You gotta learn from your past, obviously. You gotta just not repeat the same mistakes of the past. I think that's a definition of insanity, right? So you wanna learn from that. And obviously you are looking to the future. We all want in the medtech industry to cure cancer, right? And obviously you wanna have a future goal and you want to learn from the past experiences, failures and successes, and certainly I'm a marketer before being a business development guy. Really, my entire career was in marketing. And marketing is nothing more than storytelling. It's about basically bringing folks along with you on a journey so that they can find what you're presenting or delivering or selling impactful and beneficial and insightful. And so as a storyteller, whether we're storytelling from a brand perspective, from a digital podcast, a program or whether we're talking to a potential customer or existing customer, you wanna be able to tell that story and to be able to articulate that vision of how exactly your organization will help them accomplish that future goal. Learning from the past experiences, but we're doing it today, right? So, the present in a way is the bridge between the past and the future. Right? And so in my day-to-day, although I haven't really thought about this in this light, but your question kind of makes me think about it-- both from a business development and from a marketing standpoint, what we wanna do is help our organizations or partners or customers essentially help their end users, right, i.e. either consumers or their patients with better outcomes and so what does that better outcome mean? It means curing a disease or it means extending the life of someone or resolving a medical problem of sorts. And so from my company's perspective, If our engineering prowess can help a medtech company develop a device and launch and improve a device that will make people's lives better, healthier, and longer, then that's it. What else is there that more aspirational than to help people live a better life. I don't think there's any other industry that can come close to the medical and the MedTech industry in terms of making the planet and the inhabitants of the planet better. Lindsey Dinneen: Yeah, absolutely. That's a great answer to that question. And I think that like you said, it's just such a unique industry in that way. And so it, it definitely brings up different considerations perhaps than other jobs or careers. Okay. Well, is there a particular moment that stands out to you because it clearly confirmed that this was the right career path for you? Miguel Adao: Yeah, certainly as family members have become ill or even lost their life because of medical conditions that certainly raised my awareness as I was growing up and becoming more and more aware of my mortality and others, the people I love and their mortality and their lives. So certainly the fact that I've been touched as perhaps have all of your listeners and, and folks that we know been touched by illness and by medical conditions, if not ourselves, and by those we love. That always was in the back of my mind. And although I've worked in soft drinks and hair care, when I was with Procter and Gamble, I worked with Pantene and Head & Shoulders, and that's not saving lives necessarily. It's making you, I guess, feel better about yourself And that's also important for mental health, et cetera. But really throughout my career, as I got exposed, as I said with Hewlett Packard, a lot of engagement with hospitals and medical groups in England, I worked with HP in the UK and also in Germany, and that was my first exposure and it was, it's just so, what's the word I'm looking for? Empowering and rewarding. That's it. It's so rewarding to work with a company with a customer and providing a solution, a technical solution or whatever, when you know that solution is going to make people's lives healthier and longer and better. More, more than just, I don't know, build a better golf club which is important too, certainly if you're a golfer. But my exposure at HP to hospital groups, medical organizations was the first time where I really got this personal satisfaction of seeing that what we're doing with our HP computers and printers and devices was actually helping the hospitals and the surgeons and the nurses and the practitioners make things better for their patients. And so when I was approached by a head hunter last year to join this company that is focused on MedTech and medical device development, Voler Systems, I met the founder and the president, still my boss, Walt MacLay, and we just hit it off and I wake up in the morning, the alarm goes off at six, and I'm excited because I feel like, "okay, we're gonna work not on a chip or a sensor or we're not gonna work on a wireless connection or power management solution. We are working on something that will make somebody's mom, daughter, sister, friend, live longer and live better." And so, that makes me want to get up and makes me want to put in another good day of work. And approach it with a lot of passion. If I may say this, Lindsey, it's an analogy I always like to say also when I'm talking to new employees who join my team or others, there's this old story of the king visiting these folks, brick layers putting bricks down on this construction. And the king asks the brick layer, "what are you doing?" "Oh, I'm just laying my bricks." Day after day for the last 40 years, and I'll lay my bricks. And then the king asks the second brick layer, "oh, I'm building dreams. I'm helping to build cathedrals and visions that will last generations long after I'm gone." And it's like if you have that vision, that what you're doing is more than just a stupid little brick, then your contribution is so much bigger than that, and therefore your passion about it will be commensurate to your vision of what your contribution is. Lindsey Dinneen: Yeah. I love that. I also love that story. Thank you for sharing that. I think I'm in a similar situation in that I'm also in marketing and being able to be in this industry is one of the coolest things I've ever gotten to do because it is so impactful. And I agree with you. You know, you wake up in the morning and go " it's really not a cliche to say I am a part, maybe a small part, but I am playing a part in hopefully helping someone live a better, healthier, longer life. And my role is letting people know about what we do." And it's not engineering itself, but I do play a small role and that's really cool. Miguel Adao: Yeah, and it's not so small. I'm sure in the grand scheme of things, it's not so small a role. Lindsey Dinneen: There you go. Yeah. Well, I'm curious, I know your career has been really eclectic. Essentially, you've gotten to work in a lot of different industries and for different companies, and I would imagine that along the way you've picked up some good sort of leadership tips and tricks. Do you mind sharing your perspective on leadership? Miguel Adao: Yeah, sure. I think there's a big difference between being a leader and being a manager, right? That's a cliche of articles and other podcasts perhaps, but you don't want to be just a manager going through the motions and ticking off the boxes and the to-do list. But a leader actually brings folks along on a common vision. And by definition, folks will come to the party with a different point of view, a different perspective, a different vantage point that is influenced by their personality, by their upbringing, by their history, by their preferences and passions. And so you need to be respectful. And I must say I was not a good leader earlier in my career. I learned through the years, through good leaders of mine, by replicating and mirroring their behaviors and their attitudes that you need to be more empathetic and more understanding that not everybody, in fact, you don't want people to be exactly like you. I'm very outwardly enthusiastic. You can tell, right? I'm outwardly passionate and energetic. At first I used to think, "why aren't those folks equally rah, rah, rah?" They can be just as committed to the vision and even more so in their own way, and they're absolutely happy and passionate inside, and they don't have to demonstrate outwardly. So the extrovert versus introvert dynamic, et cetera. And so I've learned to appreciate that as a leader, what you want is people to rally behind and align with a vision and in their own way and in their own rhythm to follow along and to help build that. Not only follow along, but in many ways lead the leader, right? And help move the organization towards that common goal. I also like this notion that not everybody needs to agree, but everybody needs to align, right? So you don't always need to agree. How can you expect a larger team of dozens and hundreds and thousands of people to agree on everything? It's impossible and thankfully so, but as long as folks align, then they can go towards that common goal with give and take and compromise, et cetera. So I think the biggest role of a leader is to bring those folks along on that journey with a combination of resolve and focus but also empathy. The empathy part is what I learned later in my career cuz I was always, "come on, let's do it." If you're not doing this, get out of the boat and all those cliches, right? You're either with me or what is it? Or you're in front of me and if so, step out of the way or something like, and it's just so harsh and, and there can be cultural differences. There can be gender differences, that can be historical differences. And so, I've learned and I continue to learn more about empathetic and more kind of generous understanding of leadership. Because folks will contribute in, in different ways. I always find that there are fundamentally three major drivers in life, and I always go back to my personal life as a father, as a husband, as a son, as a brother. But also at work, there's three key senses or key drivers. One is a sense of purpose. You want to get up and you want to have a sense that what you're doing matters. We all want to feel that what we do matters, hence the cathedral analogy. Hence the, we're here to help people live longer lives that matters. So a sense of purpose. The other thing is a sense of achievement. A sense of accomplishment. So it's not just that kind of more ethereal sense of purpose and meaning to life and to what you do, but a sense of achievement. You're growing as a company. You're in percentages and in dollars and in market share and in number of customers and successful partnerships. So a sense of achievement that's the athletic kind of sports men like approach to not necessarily that you're competing and putting somebody else behind you, but that you're competing against yourself and you are getting better. And then I think the third big driver in life is sense of connection, of human connection. Right? And we are very collaborative and gregarious and tribal animals. And that's why the pandemic was so tough. It was tough on us. It was certainly tough when my kids and children in particular suffered with skipping a year and having to do it at home. I'm just saying being away from other human beings is tough. And so in this new day and age, especially post COVID, we're still very much doing Zooms and Teams and podcasting, which is great. But every chance I get in the car, like I told you I'm gonna do in about 15 minutes, and I drive an hour and a half to see somebody. I live in northern in Delmar, north of San Diego. I'm driving up to San Clemente in Orange County, just south of LA to meet somebody for 40 minute lunch, cuz I need that human connection. So yeah, sorry, another long elaborate answer to your question, but for me, leadership is about connecting. It's about giving folks a sense of purpose and meaning, and it's about allowing folks to also accomplish and celebrate accomplishments and achievements. Lindsey Dinneen: Yeah. Yeah. I love that. And so how do you continue to prioritize your own learning and growing as a leader? And perhaps, as a manager as well? Miguel Adao: Yeah, I'm very big on this. I love learning and I love teaching. I always try to remember when I lie down in bed at night, I'm trying to remember, "okay, what did I learn? What are two highlights from today? And, and what did I teach? What, is something that I share with somebody today that I think will also maybe improve their lives or their journeys?" And I do the same thing with my kids when I pick 'em up at school. Three highlights. "What did you learn today and how did you make your school day better for your teachers, for your classmates?" I've been doing this since they were kids, and I only speak Portugese with my kids. It's so funny. Because if I speak English with them, they'll just say, "Papa, that's weird. Don't do that." Even though they're 15 and 13. And one was born in England, the other was born here in San Diego. I only speak Portugese with them and so, I'm always prioritizing continued learning. I got a doctorate in business years ago in New York and in Paris, not because I need it for business. I only did it because I wanna publish and I want to teach one day. I'm very big on mentorship. I'm training four different people now in different companies, in different countries. I'm also mentoree, if that's the word. I like to mentor. I always seek out mentors, and right now I have two, one helping me on more strategic financial P&L, managing the financial health of a company, which is not something that I was ever that close to. And one is helping me more on those topics I mentioned earlier about empathy and about those emotional intelligence as well, which historically has been a little bit of a blind spot for me. So those are two areas. That one is more hard skills, financial skills, strategic, running a business. And the other is more about how to be a better, more empathetic human. And so that's something I do all the time. I also, whenever I can, I. I I do an executive program. I'm looking forward to doing a short program at Stanford University up in the Bay Area soon. And it's great to, to be able to do these programs, to be around like-minded individuals or maybe even unlike-minded individuals, but folks who also are looking to improve themselves and, and learn regardless of age. I'm 55, but I still want to learn as much as when I was 25. And just as I like to learn, I like to teach, so I love to present at different events and also mentor, as I said, I'm advising different entrepreneurs on their organizations as well when I have the time and the opportunity. So, yeah, continued learning both ways is a must, otherwise, you're a bike, and a bike if it stops moving, it falls over. Lindsey Dinneen: I love that. Yes. What a perfect illustration. Thank you for that. My next question ties into that actually pretty well, so I'm happy about this. So for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It doesn't have to be in your industry, but it could be. What would you choose to teach and why? Miguel Adao: For a million dollars I can do anything at all, I'll make it up as I go along. Lindsey Dinneen: Right, right, right. Miguel Adao: We'll use ChatGPT to really learn about it 15 minutes before the masterclass. Lindsey Dinneen: Oh my gosh. Miguel Adao: But I probably wouldn't be as knowledgeable and therefore not as passionate about it, and they wouldn't want to give me the full pay for the events. No, but on the professional side, the more corporate side, I'm passionate about marketing, about helping organizations, helping my organization move from awareness to consideration, to preference to purchase. And I feel that I'm very comfortable talking about this theme of growing brand awareness and generating leads and pipeline, and ultimately, like we were talking about, storytelling, helping folks come along on that journey with you so that you were saying the right thing to the right person at the right time and the right particular need, whether it's a B to C consumer need or a B to B kind of business need. And so I can talk about marketing in all its different aspects and tactics and vehicles till the cows come home, but nobody would pay even $10,000 for that cuz there's a lot of knowledgeable people who know a lot more about that than I do. One area that I find I'm equally passionate more on the personal side, but that it touches obviously businesses and corporations and organizations as well, it's a combination of international intercultural experiences. Having lived in nine countries, speaking five languages, and having been exposed-- I've visited about 65 countries. I actually took the time to count one day. I've understood that actually the world, as diverse as it is, at the end of the day, everybody wants the same thing, right? It's just in a different way, in a different language, in a different approach, but everybody just wants to live a meaningful life. I'm not even gonna say happy life because happiness is relative, but a meaningful life, and they want to give their children or their loved ones the opportunity to do so as well. And so I'm, I've always been very big on inclusion and diversity, not so much from the kind of catchphrases, which are so topical today and can generate all kinds of emotions, both positive and negative, but more from the point of view that from an early age I moved around the world. I had to learn different languages. I have to learn different habits and different attitudes. And so I find that I adapt myself easily to who you mentioned, different industries and different types of organizations from a Fortune 10 company to a small boutique engineering services firm. So that's something I would love to teach a masterclass about how to adapt to different scenarios and certainly in terms of moving abroad, my friends and colleagues always check in with me if they're either visiting a place or moving to a place, what are some tips and tricks? So that's something I'm very passionate about, international and intercultural experiences. Lindsey Dinneen: Oh, I love that. Well, and that is so cool too, because of your background , like you said, you have had such cool opportunities to, to travel to different places and experience different things. So I really think that adaptability is such a good skill to learn. I can say that from personal experiences as somebody whose natural inclination is towards the more sort of routine driven, you know, learning to adapt and be flexible is so important. Yeah, Okay. What is the one thing you wish to be remembered for after you leave this world? Miguel Adao: I'm never gonna leave this world. I'm immortal. Lindsey Dinneen: Alright. Miguel Adao: Yeah. It's, it's so stupid, isn't it? We come to this existence. We live 80, if we're lucky, 90 years, and then we're gone. It can't be, it can't be. When we were in our twenties and thirties, we think we're gonna live forever. And then certainly as friends and elderly parents or relatives leave this world too, you realize, "yeah, this not, this is, this gig is not gonna last forever." I do want to be remembered as more than anything, as a good father and a good husband, and a good son, and a good brother. I'm not always, as those relatives would happily testify. I'm not always living up to my promise and my aspiration, but that's certainly my aspiration to be remembered as a good parent and husband above all, but also is a good friend and a good son and brother. That's, that's kind of the journey in the here and now that I'm on at all times. And so I try to remind myself in moments of stress, anxiety, sleeplessness, whatever, try to remember, this is your ultimate goal. What is the right behavior and the right thought, the right action for the moment. Also, just more generically with Voler Systems, the company that I work for, that helps organizations build their medical devices and their wearable devices. And we talked about this at the beginning, how I'm so happy that I work for a company that's making organizations better so they can make their patients better. I want to leave Voler Systems better than when I arrived. Just as every other company that I worked for, I wanted to leave the company and the team as the organization, the department, better than when I arrived. And I think that's my summary is to just leave this place, quote unquote place, whatever the place is, a company, a city, a community, a planet, better than when I first got there. That's, that's my legacy. Now I am far from this, but certainly it doesn't hurt to have a wish and a desire and an aspiration, kind of a north star to help guide. I fall down time and time again in this goal, but, but it's still my goal. I'm not letting go of it. Lindsey Dinneen: Yeah. Oh, I love that though. I, I love the perspective. In fact, I don't think I've heard anybody else say it quite like you did in terms of, if you have a goal and it's your north star, and this is how you wanna be remembered-- when you're feeling not at your best, you still have something to look at and go, "you know what, here's my ultimate goal." So here are the behaviors or the things I should say or not say to help get you closer to that goal. I think that's a beautiful way to put it. So it's not this aspirational idea that feels somewhat insurmountable or even unquantifiable. But instead you're doing tiny steps, tiny decisions make a big difference. So I love that. Miguel Adao: Absolutely. Everyone should have a North Star. Everybody should have an ultimate goal, both in their personal, family, professional, financial, romantic, religious, spiritual, whatever. Everyone should have a goal and then you have many goals and many objectives to get there. And the line from here to that goal, to that north star is never a straight line. It's a zigzag. Sometimes it goes backwards. Sometimes it stalls for two years. But you should always be aspiring to get there. And so if you have a goal, aspirational and unreachable but still possibly reachable, then it's gonna keep you motivated and focused. And you will make mistakes and as you will invariably, cuz we're human, but you'll learn from it. And at least one thing, you can rest easy in knowing that at least that North Star does not change. Lindsey Dinneen: Yes. Great advice. Thank you. And then final question, what is one thing that makes you smile every time you see or think about it? Miguel Adao: Oh, that's so easy. My kids and my wife, they crack me up. They're the three most incredible people I've ever met. And yeah, and it's just so interesting-- for those listeners who have kids-- you had this little baby that you shaped and molded and pretty soon that baby becomes an actual human being with thoughts and opinions and perspectives and intelligence and humor and wit, and some of it does not match what you say. And you're like, "where's this coming from?" And it's like, oh, I'm in awe. So, yeah, Olivia and Nico, and Lindy that's who makes me smile the most every day. And I, I live a blessed life because of them. Lindsey Dinneen: Oh, I love that. What a great answer. Miguel Adao: They'll like it too when they hear the recording. Lindsey Dinneen: Yeah. Miguel Adao: Awkward. Lindsey Dinneen: Nice. Well, this has been an amazing conversation. I'm so thankful that you joined us today, and I just really appreciate learning more about your background and your experience and your passion. And so I really appreciate your time, and we're honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational and safe environment. That was your choice of charity to support and I am just so thankful that you chose that one. So, thank you again so much. This has been amazing. Miguel Adao: I loved it. Thank you so much. Thank you for that charitable contribution as well. And thanks for the engagement, Lindsey. I really enjoyed it. Let's do it again next week, shall we? Lindsey Dinneen: Yeah, there you go. Absolutely. Well, thank you again. We just wish you continued success as you work to change lives for a better world. And thanks also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Zoe Lalji is a junior at UT Austin studying neuroscience with a minor in entrepreneurship on a pre-med track, and she is working to make virtual reality accessible to ALS patients. In this episode, she discusses what it was like when her dad was diagnosed with ALS and how that changed the trajectory of her career, her work with advancing virtual reality technology to better support patients' lives, and how hardship has developed an essential self-awareness.   Guest links: https://www.linkedin.com/in/zoe-lalji/ Charity supported: ALS Heroes Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 010 - Zoe Lalji Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Zoe Lalji. Zoe is a junior at UT Austin studying neuroscience with a minor in entrepreneurship on a pre-med track. Her passion for neuroscience began when her father was diagnosed with a Amyotrophic Lateral Sclerosis (ALS) in 2017. And since then, she has been constantly searching for ways to improve his quality of life and expand his avenues of connection with the world around him. As part of this work, she is working to make virtual reality accessible to ALS patients and other highly disabled populations as a way to provide them with autonomy in the form of novel experiences and immersive activities that they're unable to engage in physically. Zoe, oh my gosh, thank you so very much for joining us. I am just so very delighted that you're here and I just can't wait to hear more about your story and your background. But first, thank you just so much for being here. Zoe Lalji: Aw. Thank you, Lindsey. Thank you so much for inviting me. It's awesome to be a part of this great podcast you have. Lindsey Dinneen: Awesome. Well, I was just wondering if you wouldn't mind starting by just telling us a little bit about yourself and your background and what led you to what you're doing now. Zoe Lalji: Sure. So, right now I'm a junior at UT Austin and I'm studying neuroscience on a pre-med track and minoring in entrepreneurship. And as far as what kind of got me to where I'm at and-- I've been passionate about medicine for as long as I can remember. Both of my parents are in medicine. My dad was a dentist and my mom studied as a gynecologist and transferred into functional medicine. And they both had their own practices, so I've had that business background as well. But that all shifted, I would say, when my dad was diagnosed with ALS in 2017. And from there it was a pause button if you could say on on my entire scheme of my life, my plans. You know, I think with pre-meds there's a track that is a starting point and you have a series of events that are lined out for you until you reach medical school and get that MD. And that kind of stopped me in my tracks and made me reassess what was truly important because I had to spend a lot of time caring for my dad, caring for my family, and it definitely shifts your priorities and makes you reassess your life. And although, everything was still of in line with my values growing up, which was, I've always wanted to help people and that's what drew me to medicine. That's what I had really admired about my parents is the impact they had made on others' lives that were struggling, that had health conditions and needed guidance in that area of their lives. And I think watching my dad undergo one of those health conditions and just doing everything in my power to make it better for him in any way that I can. It just truly strengthened that core value for me. And I think when you're in pre-med, there's kind of a tendency to get tunnel vision. And, kind of that check mark mentality where you go, "Do I have the grades? Do I have the volunteer hours, the extracurriculars," all that stuff. And I think, you lose sight of the why of medicine, until even after residency when you're actually in the field where you actually meet the patients and you actually you know, talk to the people that are struggling and realize how important it is. And until then, it's more about, memorizing facts and figuring out how the body works without really putting it into the context of the bigger picture. So I think studying medicine alongside actually understanding what it's like to be on the other side, on the patient perspective, was a real driver for me. I guess the turning point for me for where I really realized that making an impact for medical problems is where my heart really lies. Lindsey Dinneen: Yeah, that is such a powerful story, so thank you for sharing that. I was wondering if you would be willing to share a little bit more about ALS and how that affects people's lives. I know it's a very difficult disease, but just from your perspective, especially having experienced it and trying to help someone who is dealing with it-- I would just love to hear a little bit more about it. Zoe Lalji: Yeah, absolutely. So ALS is a neurodegenerative disease. It impacts the motor neurons in the body, which effectively causes people to lose their ability to walk, talk, move any part of their body and eventually breathe on their own. And it's a interesting disease in that there's not much known about the pathophysiology of it, in that like they don't know what causes it. They don't know how to even approach treatment. Only 10% of ALS cases have been found to be connected to a gene. And even then they haven't really found a way to reverse any of that. So it's a completely uncured disease, the treatment is very limited, in that there's maybe a few months of life expectancy increased by the treatment, but in contrast you get a lot of side effects from it, which effectively makes you pretty much zombified. You know, it's a lot of fatigue, a lot of nausea, and a lot of patients just opt not to do it because the quality of life is really reduced from just being on those treatments. And so it's just a hopeless disease. And when you're given that diagnosis and told that it's always fatal and there's nothing that really you can do, you just feel completely helpless. And then as you lose your agency over your body, your ability to do things on your own, that helplessness sort of grows and consumes you. It's a very difficult disease to be diagnosed with on the patient and the family. Lindsey Dinneen: Of course. Yeah. Well, and I know part of your work, something that you are doing right now is working to make virtual reality accessible to ALS patients. And I love this idea, and I would love if you would be willing to share more about this and what brought that idea about and where is it taking you. Zoe Lalji: Yeah, of course. I love talking about it. This idea came from just my desire and my constant searching for things to do with my dad or things to bring him happiness in his life, or greater quality of life. And it came about from actually an internship I had during my gap year, which I took before college. And I was at a startup accelerator and there was a XR lab in the accelerator where they had virtual reality headsets, and I had talked to the head of the lab and he let me use one of his headsets and I ended up using Google Earth on the headsets. And I don't know if you've ever used virtual reality, but for whoever has used it, it's very life like, like you actually feel like you're there. You feel like you're walking the streets of Rome or you're in, you're in Paris, or so many different places that you can just click a button and just be fully immersed there. And that's just Google Earth. There's so many other immersive scenarios that you can dive into in virtual reality. And with the immersion of the Metaverse and so many different concepts of the growing interest in virtual reality as a way to have a life outside of the physical life. And just from seeing that Google Earth scenario, immediately I thought, "Wow, this would be incredible for my dad." Because for patients that have all of these life support machines, when they lose their breathing, you have to get a surgery and you have to be basically connected to a machine that controls your breathing. And obviously with that, you can't travel, you can't get on a plane. And for many of these patients, like my dad, you have all these hopes of where you would like to travel one day, things you would like to do one day, and life just happens and you don't end up doing it. But you always think there's time. You always think, " Maybe when I retire, I'll go and travel the world." The common notion that people say. When something like this happens and puts your life in pause where you realize you're never gonna be able to travel again, or you're never gonna be able to skydive or bungee jump or do those bucket list things that you said that you would one day do. And like, even further than that, it's more the things that you used to do every day that sort of defined you, that sort of made you feel like-- for example, my dad would, for as long as I can remember, probably my earliest memory of him is him waking up every morning and going for a run. And he never missed a day. And it was so important to him, like being who he is and his day working out the way he wanted it to, that he had that run, he had to start his day off feeling like himself. And I feel like we all have those hobbies and habits that really all together define who we are. And when you get a disease, not only is it like you're losing all of those things all at once, you start to define yourself as your disease then, because there's nothing else really left. I think for me, virtual reality meant giving those back this semblance of who they once were that they've lost. I think we're all the sum of what we do every day and our dreams and hopes for the future. And when those are taken away, it's who are we really? And that's not even considering the communication that patients lose. So you can't even really express yourself either. So with that, it's like there's this huge disconnect with their identity and I, I just see VR as a way for these patients to enter the world where they don't have to be defined as their disability, where they can do everything that anyone else can in virtual reality. And the problem lies with the modes of interaction with the devices where VR right now has remote controls that you need to use to interact with the environment, and you have to walk around to see the full environment, which for all quadriplegics, there's no really way to do that. So I'm trying to make that aspect accessible for that population so that they can have access to those virtual life-like immersive experiences that can tie them to the things that they used to love or would love to do one day. Lindsey Dinneen: Yeah. So essentially taking some of the existing tech, but putting it into a new method of delivery, I suppose? So that folks who can't, like you said, walk or that can't necessarily interact through a series of controllers or something like that, would be able to still experience those wonderful, immersive things. Is that... Zoe Lalji: Yeah. Yeah, exactly. Lindsey Dinneen: Ok. Wow. Yeah. Oh my goodness. Okay. This is so exciting, just to hear all about this. I know that you are still pursuing medicine and then now you're also pursuing this sort of tech side of things. I understand the background of you coming into it and why, but how have you found these interactions? Have they played out easily? Has it been an odd transition, or how has that all worked out? Zoe Lalji: Yeah, as you can imagine, it's like I have two sort of big things that I love and I'm passionate about and they both take a lot of time and effort and energy. And to say the least, it has been difficult to prioritize one or the other and find the time in the day for both. What I love about medicine is that the hope that we can bring to the patient. I love the innovation of it. I love coming up with solutions that aren't out there, that for the patients like my dad that don't see hope in existing medicine. I wanna be the hope for those patients. And that's, that's how I feel right now. I, I know I will always love every aspect of medicine, but that's what really drives me is that notion of helping those people that are feeling the medicine has failed them, and providing them with unconventional solutions that maybe they didn't think to look for or didn't think that there was one, you know? I think that until there's a cure for some of these diseases, technology can bridge that gap of function and bring back what people have lost. And I've seen it, I've worked with Paradromics as a BCI company in Austin and that was my first exposure since developing my startup into the, the medical technology world. And they're just such a amazing team and they have such a noble cause that they're fighting for and they just wanna help people like my dad. And to be surrounded by people that want to do that and the technology and seeing how impactful it has the potential to be. It really inspired me, especially coming from such a hopeless diagnosis that we had, it really gave my family hope. It gave me hope, and that's the feeling I wanna give to other people. And so my plan right now is to finish out my pre-med prerequisites in college and take a gap year or two to really work on my startup, really work on things like put myself in different environments in the medical technology world, get more experience and really understand my passion and what I can offer to the field. And from there I'll really decide if an MD is the right path for me or if I want to go a different route to get a different degree, you know, and still work within medicine, but not maybe bedside and not maybe in a hospital and not maybe with direct patient care. So yeah, I think that's the route I'm thinking right now? Yeah that's the plan. Lindsey Dinneen: Yeah. That's a great plan. And I love, I love your willingness and your openness to explore and continue to evolve, perhaps, over time in terms of, when you go into a new path and you've had this set of expectations for yourself for a while, that this is where you were going to head. And then things change and I just think it's quite remarkable when someone like you who is obviously very talented, smart, multi-passionate, is able to pivot and say, " I love this aspect, but I also love this aspect and maybe I can do both in a really creative way." I think that's fantastic. Zoe Lalji: Yeah, I mean, it was such a difficult thing for me since I had wanted to do medicine my whole life. It was something that was so ingrained in who I thought I was. Everyone asks you when you meet them, like "What do you wanna do with your life? What are you majoring in? What's your path?" And always it's pre-med, ever since I was a kid, I'd say pre-med, and it's strange to change that. And I think what really helped me get there is my life has been so turbulent and I've had to really get used to things not being how I planned, you know? And like that with my dad's diagnosis, throwing us into a spiral. And then after that actually, the gap year itself was another event that I had not planned for. I had decided to take one because my dad really needed me, and I found in my value scope that really came first before anything else. And then it became a serendipitous decision because in December, after I had taken my gap year, my mom was diagnosed with breast cancer. And luckily she's cancer free now, but we had to go through chemo, radiation, surgery and I could not have dealt with that at college. I had to be home, I had to be with her. And somebody had to take care of my dad. Somebody had to help her keep everything together and keep herself together. And I think, that was probably one of my biggest teachers is that, things are gonna happen. You can't avoid change, and I think that was really difficult to realize that maybe my plan wasn't the right plan for me, and maybe I need to take a second and let myself sit in the ambiguous unknown, which is really uncomfortable, but sometimes it's necessary in order to figure out where you really belong. But yeah it's definitely not easy. I definitely have not figured everything out. It's definitely some days I'm like, I just want to go back to the known, it's so much easier. But yeah, I think it's just getting used to the unknown and getting used to change. Lindsey Dinneen: Yeah. Yeah. And kudos to you for that viewpoint. And I'm sure, I'm sure some days are easier than others. I certainly understand that. But seriously, kudos to you for being willing to adapt to changing circumstances that you didn't plan for and you wouldn't have wished for, but this is really amazing to me as to how you've taken something that is so incredibly difficult and challenging, but you've really embraced the challenge-- and maybe that was a long time in coming-- but you've embraced that challenge and then you're not just helping your own family, which is incredibly important, but you're doing work that's gonna help so many people. And I think that is just amazing. Thank you for doing what you're doing. Zoe Lalji: Absolutely. Like you said, it definitely was a long time of really a lot of self-awareness, a lot of self-work, to get to a place where I was ready to embrace it, like you said, like it's something that has been difficult, has been so trying on our family, so trying on my dad. And a lot of days I am like, why did this happen? And I feel a lot of grief and a lot of sadness and unwillingness to embrace it. But for the most part, I've reached a point where I've realized that this is something that we've come a long way from, and we try to make the best out of the situation and make every day as bright as we can, given everything. And that's all we really can do. And I think watching my dad overcome it himself has been just what has given me the strength I need to get out of that sort of pity, out of that grief of like, why me? Why has this happened? And anger because when you think about what ALS patients go through, it's like you just can't even imagine what it could be like to be in that position. And to watch my dad really take that in stride and be this ferocious warrior through it and keep fighting no matter what life throws at him. He's almost at six years since his diagnosis and he's still fighting and he's still finding a reason to smile every day. And when I think about that it reminds me that it's okay. If he can fight like he's been fighting, then we all have that strength in us and that's, I think, what inspires me to want to help people like him, to want to bring more light into others' lives that are going through what we've gone through. And I think it's our duty really. I think I've gotten a very unique experience to watch somebody rise from the ashes and learn from that and I think that hardship, it sucks, and I'm not gonna say it doesn't at all like it, it does suck. All of it sucks, but it's an opportunity to learn. It's an opportunity to grow and it's an opportunity to become the best version of yourself through it. And there's moments when you don't want to learn , you know, you just, "I'm done with the lessons," like "I've had enough!" I think at the end of the day, it's like everything that I am and everything that I've learned it's valuable, regardless of what I have to go through to get me here. It's who I am. And so I think the best thing I can do with that is use it as a way to empathize with others in a way to really understand what's needed and how to help people that go through similar things that I've seen with my dad. Lindsey Dinneen: Yeah. Yeah. That's absolutely beautiful. Well, I'm wondering is there a particular moment or perhaps series of moments that stands out to you because it clearly confirmed that this was the right career path for you, even though it's been a bit of a meandering one, a pivoting one. Is there any particular moment where you thought, "Okay, this is why I'm here." Zoe Lalji: Like you said, it's a lot of moments. I mean, I would say the first moment was definitely when my dad was diagnosed. But even then I didn't really make that shift of " I'm definitely gonna do this for the rest of my life." It was more of a shock where I realized this is something I really care about. But I think really working on my startup has been so empowering. And then also my internship at Paradromics. I think the main moment that recently has made me realize that kind of clarify what exactly about medicine really drives me is I was invited to speak at a brain computer interface conference at the Chamber of Commerce. And through that I met so many key players in the the ecosystem. And I spoke to a lot of them about what I was passionate about, what I was doing, my story. And it was remarkable to me that so many people really cared and it was so obvious that everyone genuinely cared about the patient and about helping that person. It wasn't about the product, it wasn't about the business. It was about how can we help people the best way that we can and how can we use the potential of this technology to really help people's lives. And I think that energy and being in that space of like people just wanting to help, that was just so new for me because I think when something happens like that, you feel so incredibly alone and nobody could ever really help you, and it's like there's no hope. And people can try to support you and they can try to take care of you, but there's no way that they can actually help. And then even from the medicine side, there really wasn't anything there. And to enter into a room where so many people were making things actively that could help, for me as a daughter of somebody that was going through it, it wasn't so impactful and it made me think what about for others that are like me or for others that are like my dad to be exposed to this world of increasing potential and technology. And I was like, this is where I wanna be. This is home. Lindsey Dinneen: Wow. Yeah. That is a very powerful story. Thank you for sharing that. I have been personally so inspired by people in the medtech industry and healthcare because, you know, you start talking to them and it's easy to see how much they care. It's like you said, it's not just about the product, it's not just about the business, it's not about making money, although everyone needs to to make a living but it's about truly helping people, and I think that's just one of the most inspiring things that I have personally gotten to witness by meeting truly remarkable people through this field. That makes sense to me that, that was a moment that stood out for you. Well, that's amazing. Well, I'm curious, so you're in a really interesting new phase. Yeah. And I, I'm curious as you continue to develop your startup and whatnot, how would you define leadership? Or what does leadership mean to you? Zoe Lalji: I think for me, and from my experience with it, leadership is really about empathy and understanding your team. And the analogy I would use is like a wolf pack. The leader of the wolf pack is always walking behind the pack and making sure nobody gets lost and making sure everybody has purpose and a destination. And I think that as a leader, it's your responsibility to make sure that the team is whole, in a way, where everybody on the team-- you understand them enough to know their strengths and to know their tendencies and set them up to succeed and set them up to benefit the full team and have everybody on the team feel like their strengths are building the team into the best version of itself. And I think having that ability to really understand people really qualifies someone as a great leader. And I, I would liken a leader to a mentor in a way, because it's not about you, if you're leading a team, your success is the team's success, right? And your goal is to inspire success in each of the individual people on the team so that the team can be greater than the sum of its parts. Because everyone's strengths play in a way that they add to each other and compliment each other. And I think from what I've found is that when people realize that you truly understand them and you see what really makes them unique, they're more willing to devote those strengths to whatever cause you're going for. And they're more attentive to the goals you place for the team, the end goal. And I think another thing that a leader really has to do is understand the why of the team and really show that or really demonstrate that to the team and align them under the same why. Because I think what makes a team really unique is their ability to align themselves under that goal and all fight for that goal together. I think those are two things that I find are really important in a leader. Lindsey Dinneen: Yeah, absolutely. Agreed. Yeah. So pivoting a little bit, just for some fun. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry or something you're working on now, but doesn't necessarily have to be, what would you choose to teach and why? Zoe Lalji: Wow. That is a fun question. Wow. Okay. I think I would probably want to teach a class on self-awareness through hardship. I think that is one of the biggest things that I have struggled with especially when I think in my gap year was the biggest moment where I realized, I am really defining myself as a caregiver. I'm defining myself as someone that cares for others because I did that every day. And it was so difficult to have my own identity, to have my own sense of self, and I think that really finding that balance of what do I need to be the best version of myself and to do the best for others because of that. I think that journey for me of really finding what's important to me, reprioritizing, because I think moments like these shift your priorities so much. They shift your view of the world. They shift who you are. And to catch up with that is there's so much change going on in your life to keep a pulse on you and who you are, what you stand for, is so incredibly difficult. And I think if you're not careful and you're not placing importance on that, you become misaligned and you don't live in your true values. You don't live within your true values because you don't have that alignment within yourself. And I think, once you've gone through a phase where you've completely lost sight of that and it's a phenomena with caregivers that we tend to forget about ourselves completely. And we place focus on others, on the people we're caring for. And I think in my gap year with both of my parents needing me to be there for them, it made me feel like this is more important, right? Because before the diagnosis with my dad, my highest priority was always family. And caring for others and giving back was such a huge thing that had been instilled in me, and it's still a huge priority for me. But I never had to take care of myself. I never had to place importance on that because there was never a point where I was gasping for air and gasping for care. And I think it also just felt like I didn't know who I was anymore, and that's such a terrible place to be in. And that's why I can say that for, for patients that undergo this, it's that to a totally different extent, and that goes back to my VR project. But I've done so much, coming into college and really getting the space to put myself in different scenarios and see who I am.  I think that sitting with myself and taking that time and doing that work has really allowed me to be there better for my parents, be there better for my family, because I'm just more aligned. I'm more me. And being around my dad when I'm not even me is not helping him. He wants to spend time with me. I think when you neglect yourself, it's hard to be you, you know, it's hard to explain, but I think just having that alignment through something so pivotal in your life, something so earth shattering that happens to you, that kind of shifts who you are. And keeping track of that shift and keeping yourself in your care and treating yourself as a child, because you are. You have to nurture your inner child and really take care of that child and not think that child is perfect because they're not. And the thing about this particular class would be that I haven't figured it out. But I have done a lot of work and I would want to help people that are trying to navigate that because I feel like there's been a lot of trial and error and if I can help people in any way with my experience with it and what's worked for me, and how I went about figuring out what works for me, I think finding that balance within such a all-consuming situation and hardship, that I would wanna help people through that. That's been monumental for me in realizing that myself was important, in defining myself and being aware of myself and who I was. And so yeah, I think realizing that was important through all of this hardship. I think that's one of the biggest learning moments for me, and I'd really wanna share that. Lindsey Dinneen: Yeah. Yeah, absolutely. And like you said, there are so many people who are going through similar things that could really benefit from that. So that would be an amazing masterclass. So I'll look forward to that whenever that comes up. What is one thing you wish to be remembered for after you leave this world? Zoe Lalji: Honestly, I feel like my impact will be in the lives that I've impacted, and if I can be remembered as a friend, as an advocate, and as a mentor for those people, I would be fulfilled. I feel like I would just want to at least help one life that needs that guidance, you know, that feels so alone and feels so hopeless, to bring that small amount of hope, even if nothing at all. And I think where my fulfillment comes is that I want to help people like my dad, people like me, people that have been struggling, that can't find what way is up, which way is the light, either guide them or provide them with some semblance of hope. Or just be a friend, or just be support. Because coming from someone that's been there, coming from someone that can empathize and make them feel like, "Hey, you're not alone. It might feel lonely and it might suck, but you're not alone." Lindsey Dinneen: Yeah. Yes. Absolutely. That is very powerful. Final question, what is one thing that makes you smile every time you see or think about it? Zoe Lalji: Well, I think that one is easy because it's my dad. He's my inspiration. He has so much light within him that only comes from overcoming something like this. And his energy is just so incredible, and he is the reason I keep doing what I do. And I think also, the memories I have of him, the memories of him as my father when I was a kid and things that he used to do with me and things that just really showed that he loved me so much. And those memories that are just so sacred to me and every time I think about it, it's bittersweet, but it always makes me happy to remember what he means to me. Lindsey Dinneen: Yeah, absolutely. Well, Zoe, oh my gosh, you are so very inspirational. I would not wish the path that you have taken on you in the way that it has happened, but I just admire you so much for taking a very hard path, but making so much good come from it and embracing the light and embracing choosing to help others see that light and see hope in a difficult time. Gosh, I cannot wait to continue following your work and seeing what you do because I know you're gonna be impacting a lot of lives. Oh my gosh. Zoe Lalji: Thank you. Yeah, and I really loved being on your podcast. I loved talking to you. This form is amazing and I can't wait to see what other amazing speakers you get on here. Lindsey Dinneen: Awesome. Well, thank you, and we are so honored to be making a donation on your behalf as a thank you for your time today to your family's organization, which is ALS Heroes. This organization honors the heroes amongst us who have stared devastation in the face, only to say, "you do not define me." The organization hopes to guide those heroes in navigating their resources and provide them with hope in the midst of a seemingly hopeless disease. And I'm so excited to continue to learn more about the organization and how we can get involved. So thank you for bringing our attention to it, and thank you again for being here. We wish you continued success as you work to change lives for a better world. Zoe Lalji: Thank you so much, Lindsey. It's been a pleasure. Lindsey Dinneen: Absolutely, and thank you also to our listeners for tuning in. If you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two, continue to pass along the word, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.