The Leading Difference

Sarah Aswegan, a seasoned biopharma leader and strategic advisor for global rare disease solutions, shares her journey from sales in pharma to her consulting work today. She discusses her experience in transitioning biopharma companies from clinical to commercial success, the evolution of medtech in diagnosing and managing rare diseases, and the collaborative efforts required to bring innovative treatments to market. She also shares insights on current trends in gene therapy, the dynamics of funding, and the importance of data in advancing care for rare disease patients.
Guest links: www.saraaswegan.com 
Charity supported: 
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPTEpisode 065 - Sara Aswegan
[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.
Hello and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and today I'm delighted to welcome to the show, Sarah Aswegan. Sarah is a seasoned biopharma leader helping organizations transition and grow from clinical to commercial success. She prides herself on the success of leading multiple global cross-functional teams and contributing to the success of the franchise areas she oversaw and served. Until recently, she's applied these experiences while serving in a consultancy capacity for many small to midsize biotechs entering or expanding in rare disease. She has also successfully helped organizations to start and scale adjacent spaces to biopharma, and most recently has been serving as a Global Head of Commercial Assets, Brands, and Care Solutions, and has led transformational change at UCP, having been part of the design and scale of the business unit for rare disease. She maintains a strong network among clinicians, access, bioethicists, and patient advocacy globally.
Well, thank you so much for joining us today. I'm so excited to speak with you.
[00:01:52] Sara Aswegan: Thanks, Lindsey. It's nice to be here.
[00:01:54] Lindsey Dinneen: Wonderful. Well, I'd love, if you wouldn't mind, sharing a little bit about yourself and your background and what led you to medtech.
[00:02:02] Sara Aswegan: Yeah, thanks Lindsey. You know, I, I started my career ages ago in the pharma side of things, and as my career has grown, so has the exposure across pharmaceuticals, into biotech and including aspects of medtech. As we look at some of the areas I've spent the last 18 years in rare disease, the medtech component is coming in largely around if we think about the diagnosis component and then the management of the different conditions over the lifespan of a child or adult affected by a rare condition. You can see things really evolving.
I started my career on the sales side of things. My education is in business and communication, so anyone can learn the science if you have good mentors and people to help you along the way. And I was really, really fortunate to work amongst a team of amazing individuals, both in the US and then now having lived away for about 15 years outside of the US that have helped open my eyes to what can be possible and the differences by markets.
And as I mentioned, I spent the last 18 years in the rare disease space really helping companies of all sizes build out and scale their teams, bringing in new assets and bringing solutions to the field of rare disease. And it's something I'm very passionate about.
[00:03:06] Lindsey Dinneen: Yeah. Well, thank you for sharing a little bit about that. So I'm curious, that's a very specific niche and I would love to understand how you arrived at that and how you realized, "Oh, this is what I'm meant to be doing."
[00:03:19] Sara Aswegan: Yeah. So I made a move geographically and company-wise to a small firm at the time. We were just a very small team. We called it the bootstrapping team at Shire Human Genetic Therapies, and I moved from the Chicago area to Boston, and that was my first really exposure to rare diseases. And, it's a completely different field and it continues to evolve even to this day. But the closeness and proximity you have to patients and their families and those with unmet need. And I have, you know, a couple of close friends as well as a family member that's been affected by a rare disease. So as you're seeking care and support for them, it's not always about the medications. It's about that total person and thinking really holistically about the individual and their care teams that are impacted by those conditions.
So the external community we were serving really drove me and introduced me to something that I've stayed with, and it brings great passion to try to find ways to support individuals in our western society, but also looking at low middle income countries and helping facilitate diagnosis to treatment to, again, that whole supportive care and largely from the internal teams within the organizations I've worked with has just is been tremendously rewarding and also equally challenging.
It's beautiful to see progress. I mentioned diagnosis and. One of the areas I worked in initially was in the lysosomal storage disease area. And it's the age-old question on diagnosis. Do you facilitate newborn screening, for example, so when your child is born, you have a heel prick done and you can do a series of tests depending on the state you live in, and in some countries in Europe it's also provided. But if there's not a therapy, is it okay to do that type of diagnosis support. And so that challenge, you know, in seeing the policy evolve on a state by state basis.
When I began in the rare disease space and MPS Type Two Hunter Syndrome, it's a condition that affects mostly boys and a very small part of our population. We knew we could do newborn screening and there was a therapy available, but it wasn't only realized until a few years ago to introduce newborn screening to help those families at the point of birth to know if their child was affected, and therefore start a different trajectory on how they planned for care for them and plan for if there was a medication or other supportive tools and resources available for them.
So it's been extremely dynamic to see how things have evolved. And then now as you see medical and pharma medical technology advance as well into gene therapies. You're seeing news about gene therapy and it's a one time treatment and then the individual hopefully will not have be re redos in their lifetime. Along with that come challenges on that diagnosis piece to make sure they're eligible for the gene therapy. So again, through the device and technology sector, it plays a key role. In addition to the supportive care that goes on for some of these really severe conditions, people have some pretty dynamic needs and it's great to see how things are progressing, but it's still as equally as frustrating, whether you're on the manufacturer side or the family side, to see things be kind of slow sometimes.
[00:06:15] Lindsey Dinneen: Yeah, of course. And you're dealing with a specific situation where many times-- please correct me if I'm wrong-- but it seems like many times there's these kinds of studies and conditions are not funded very well in terms of finding solutions to the problem. So how is that something that you, well, first of all, of course we're in a very interesting season of life right now. So how are you seeing funding evolve over the years for these different diseases that are a little bit more rare, and what can we all do in terms of even just awareness and understanding?
[00:06:51] Sara Aswegan: Yeah, so that's a huge question. We could probably have about five conversations on this just to scratch the surface, Lindsey. I think if I reflect on the question on what we've seen around funding, I mean there are some wonderful, supportive grants available for the brilliant scientists we have around the world that have a curiosity. So making sure we can facilitate that ongoing academic environment to explore and test the hypothesis. And one of the things that you see coming along, and it's not really around-- I won't think about funding as just pure financial-- but it's the funding of the smarts that go around the table. You see a lot more collaboration amongst academia, industry governments coming together to help build and scale so that there's an awareness and understanding of a condition.
I mean, a pediatrician could go through their entire career and never see a boy with Hunter Syndrome. It's just that rare. At the same time, and on the converse of that, if you're working in an industry where you do have access to more funds, the introduction of AI and looking at how we look at drug targeting, drug target selection, genetics and precision medicine have come along quite leaps and bounds in the last several years, but we're still not quite there. But you're seeing advancements with the different cell and gene therapies, having that precision medicine as an option. It's coming forward.
The challenge is the size of studies are normally very small because the population is small. So thinking about patient recruitment, how can we help facilitate better identification of individuals that may be out there and not have received diagnosis because of the rarity of the condition? So looking at technology and advancement of integrated electronic health records up to and including, how do we look at the trial designs? And how do manufacturers, academics, industry, and agencies work together to think a little differently around even designing clinical endpoints for the studies that really are meaningful, that will make a difference. And how do you balance that, right? Correct risk benefit conversation, in the spirit of doing no harm. But if there's one chance and there's something available, how do you do that?
And coming all the way downstream. If you think about where the organizations have advanced their thinking, their approach, and put funds behind, it's also that ongoing care of the individuals. If you look at the upstream, the types of tests that are available. It could be cancer, it could be the area I am so passionate about in genetic disorders, but it can also be thinking about the workflows that come into play in helping facilitate consistency of care across state borders, across country borders. It's a key piece that are really advancing in real time, but we're still trying to overcome the hurdles that are real.
And that's things around data privacy. How do we navigate that in a really meaningful way with the right ethics and integrity. If we think about the regulators, this isn't a huge anti-infective or cardiac study that's ongoing, that there are gonna be tens of thousands of people. So how can we think a little bit differently on advancing the care. In the area I'm working in, Lindsey, especially with some of these individuals that are kids, if they don't get access to care by a certain age point, their window of treatment has closed.
And so what could we do to help facilitate earlier diagnosis and then that advanced care. And so I think we can see a lot of really good intentions, and I think the most beautiful thing is even the collective gathering of different patient organizations that have a shared interest of a disease coming together and also helping raise research funds to help support the scientists that have a hypothesis on something that may really make a difference and may matter.
[00:10:21] Lindsey Dinneen: Yeah. Yeah. Okay, so, there has been so much innovation in the last few years-- of course, even before that, but it seems to be extremely exciting in the last few years-- especially things like CRISPR and all sorts of new technologies emerging. What are some of the exciting trends that you're seeing in this space specifically that give you hope as you continue to look forward and look for solutions?
[00:10:45] Sara Aswegan: I think for me, I mentioned, I touched on it lightly. I think it's that collective, that collaboration and the openness now. The FDA has advanced the way that they think and engage with agencies as well as industry partners. And so what I mean by that, Lindsey, is they're not just engaging with the scientists or with the manufacturers, the drug developers. They're also bringing patients in. And so that collaborative environment, they're even beginning conversations when there's discussion on clinical trial design to understand what really matters. Is it a six minute walk test or is it something around real behavioral or other abilities that can be learned and retained over time that help benefit the quality of life? If you're not gonna be able to cure something, what's really important at that patient front to help facilitate something meaningful.
So I think that type of conversation also with the agencies looking at, there was an amazing session held in Europe recently in the mucopolysaccharidosis or the lysosomal storage disease area, looking at advancements of science and saying, can we look at biomarkers alone and create that relationship and understanding there is a clinically meaningful impact if we can address this biomarker. And so, companies like Ultragenyx have really pushed to have that conversation and dialogue and have a drug filed now that's under review based on biomarker endpoints alone, where five years ago, you would never have imagined that being possible.
[00:12:12] Lindsey Dinneen: Yeah. Yeah. You touched on something that I would really love to explore a little bit deeper, and that is, when there's a situation that right now we don't have a cure for this disease-- and, you know, obviously we're still working towards it-- but if we don't have a cure, but we are trying to improve the quality of life, how do you balance that in your specific field in terms of: obviously you want the patients to live the best quality of life that they can while balancing so many other, and I don't mean this in a callous way at all, just from a practical perspective, balancing all of these other considerations and things that are also desiring funding and all those competing priorities. So how do you balance that? How, how does that come into play?
[00:12:57] Sara Aswegan: So that's a big one. It's a tough one. And I'll oversimplify it and just say data. And what I mean by that, Lindsey is really looking at, with the technology at our fingertips, regardless of the geography you're living in, there's a lot of meaningful information that can be captured. And it's not, again, around one aspect of a disease, but it's the totality of health. So really looking at what could be possible in capturing, is it around energy levels, activity levels. And you'll see that oftentimes in play with the gene therapy, for example, when it's administered, you may have up to 15 years of follow up that you're capturing specific data points.
But even in advance of a drug approval, and an area I am also equally passionate about, is access to unlicensed medicines for individuals that can't travel to a clinical trial site and could benefit from an investigational therapy, how do we do that with the right balance in place? And part of that is data and having the willingness of a participant or family member to be so consented in and participating in the study for their child to share that data and share that real world data or real world evidence so that you can measure back and show what impact that drug or treatment or intervention has been having on the individual.
So I think it's around that and figuring out how we can overcome some of the complexities and challenges that are real. Not everyone has electronic health records. There's still lots of paper-based offices out there. But in the meantime, there's a lot of advancements in technology. So how do you appropriately use that, that it's also not overburdensome for the individual, for the family as well, that you're doing what really matters and measuring back and having the right conversations with the individuals affected, the investigators, the clinicians, but then the regulators, and going back and sharing why this can be something to help substantiate. It's not your standard phase 1, 2, 3 clinical trial design. That's, yes, there's rigor, but it's a different way of looking at using data to help us advance our understanding of a disease and what's needed by the individual affected.
[00:14:53] Lindsey Dinneen: Yeah. So, so when you're speaking with these families and or-- well, first of all, let me actually back up. Do you have direct communication with some of these families and patients that you're working with?
[00:15:04] Sara Aswegan: Yes.
[00:15:05] Lindsey Dinneen: Yeah. And so when that happens, how. How is it for you? I mean, this is such a challenging area that you have devoted your life to and to, and I'm so impressed with that. And, you're doing the work that's helping save lives and make a difference. But that must be really challenging from a personal level to have these difficult conversations. So how do you balance that as a practitioner and somebody who's desiring to help, but you also have this real life compassion and human being that you're trying to help?
[00:15:38] Sara Aswegan: It's tough and it's tremendously rewarding. At the same time, I have so many patient stories I can share with you of meeting them and meeting 'em where they are. I made a trip to Sao Paulo, Brazil once, Lindsey, and met a family that were living in the favelas there, and their aim was to help raise awareness for Hunter's Syndrome because their son had been undiagnosed. They knew something was wrong. He was nonverbal. He had some physical presentation that you could understand. There was something going on, but the technology wasn't there for them. The access to the care center wasn't there for them to get a diagnosis. They were taking buses for hours to different clinics to figure out what's wrong with our son.
And he finally received a diagnosis of Hunter Syndrome and they wanted to share the photos because kids with Hunter Syndrome do have some different dysmorphism. So there's something that's strange. They have a bossy forehead, or their bridge of their nose is a little different. Their bellies might be a little bit bigger. So if you start looking at all of these different clues and putting it together, you might suspect and go-- there's other things going on, for sure. So I'm oversimplifying this. However, getting a diagnosis for him by just raising awareness to other families of the physical presentation and what their experience was extremely meaningful for them.
And on balance, a family in Florida that I met and their son was diagnosed at age 18 months because their grandmother had seen a program on Mystery Diagnosis and said, "That sounds like my grandson." And so creating the conversation and meeting people where they are is really important because you may have some individuals that are very aware of how drugs are developed and all of the rigor that goes through that to then others that just they don't understand that some drugs are intended for a specific indication, specific population, and helping explain why their child may not be eligible for a particular study. It's tough, and that's not my responsibility, but the clinical teams and the clinicians that are having those conversations. So it's listening and really coming with a open heart and mind and having empathy to help figure out how can you educate.
It's even moving into gene therapy. What does gene therapy actually mean? What are the risks? I'm afraid this sounds like it's something so futuristic. What will this mean for my son or daughter in 10 years from now? And, we may not have all of the answers, but you know, science has advanced and it's that risk benefit that you have to exercise. But really it's that coming with compassion and a listening ear and understanding and being honest. And if I can't help, maybe there's someone else that can help or there's a, did you know, there's a clinic here or a center there and helping that network stay connected and thrive is really important.
And also being their voice, Lindsey, I mean, we can, we have an opportunity on our pharma, biomedtech side of the world that we can share what we've observed and try to apply that as we come to work every day and think about that family we met in Brazil or in Boston or in Florida or in, you know, Frankfurt, and whatever they may be experiencing. So it's being their advocate in other areas as well.
[00:18:34] Lindsey Dinneen: Yeah, exactly. So with what you deal with, I am wondering what kinds of misconceptions or myths do you often encounter that are interesting and yet you would prefer to correct so that those of us in the general population are more informed?
[00:18:52] Sara Aswegan: That's a good one. So I think having worked in the rare disease space, one of the biggest scrutinies there, there's on two sides of the coin. One is around diagnosis and why we can't do more around diagnosis. And sometimes the science is just not there yet. So again, to some of these experiences, like the story of the family in Brazil, it may not be about a blood test. It may be about a physical appearance and helping people piece things together.
I think on the other end is at the point of delivery of the diagnosis and then if there is a treatment or intervention that can be taken, and not everyone has the same principle in their heart. There are companies that are motivated for different reasons, but certainly the big topic is are around drug prices, whether it's a gene therapy or a chronic lifetime medication, of how do we navigate that and how do we navigate that in a better way? And I think we have to start looking as an industry, as a community of people, of how do we address that?
The cost of doing a clinical trial is tremendous. It's hugely expensive. Does it warrant though huge price tags on drugs forever in perpetuity? What's that right balance? And I think having a level of social responsibility and looking at alternatives. And so imagine if we could reduce the time for clinical studies for requirements because we're able to look at other data. Things like the biomarker approach and the follow on real world data that could be captured, could that help us in the total overall offering and the cost to the overall health system? Maybe.
I think that as an industry, every company operates with different principles and wanting to do best for the patient community. Some are more profit driven than others, and so that's a reality, and it's one that I get so often at dinners with friends or in personal conversations, professional conversations, and it's a tough one. At the same time, a study of 60 individuals could be double digit millions of dollars. Just the cost of facilitating the study, the production costs of some of these highly technical compounds of different therapies also becomes a factor. So you have to put all these pieces together and really explore what's driving that.
[00:20:57] Lindsey Dinneen: Yeah, of course. And yes, I'm sure that's a really difficult conversation to have too, when you're especially working directly with patients and trying to explain all of that and that's a lot. That's a challenge.
[00:21:10] Sara Aswegan: Yeah. Yeah.
[00:21:11] Lindsey Dinneen: But on the flip side, you know, of course the work that you do makes a huge impact, and I'm wondering if there are any stories that come to mind that just really reinforced to you, "You know what? I am in the right place at the right time, in the right industry."
[00:21:25] Sara Aswegan: Absolutely. And I think it goes to, I touched on it very briefly, and there are people that aren't living in near major cities, near major medical centers, and that should not make them obsolete from receiving the best care. And there are two things that have happened and partly because of the pandemic, but also partly because of the willingness to educate and have that connected community amongst clinicians, is around that access to unlicensed medicine and finding pathways that it's not just because a doctor says your son or daughter needs this medication. I'm going to reach out to the manufacturer to see if I can get access because they're not near a clinical trial site or they don't wanna participate, or they're unable to participate in a study. But finding means to do that.
And there have been some really creative ways that clinicians have been able to do that, of setting up qualified treatment centers where the individual can go to receive the treatment and then that continuity of care is provided then over the life of their disease. It's something that's become real and meaningful, and you would be shocked at the number of individuals around the world that are receiving access to medicines that normally might have only 10 years ago been available if you were living in the Western Europe or the United States because studies weren't conducted in their country and so there's no pathway for access that is all changing.
Those dynamics are changing. It takes a team of people, though. It takes regulators, it takes lawmakers, it takes industry. It takes our logistics teams to be sure if something's stored at cold chain, that that product is delivered in the right context at the right time, just in time for that patient to receive it. So it's a complex challenge, but it's one that we've seen serve individuals in a really meaningful way. And without that, they wouldn't have, they wouldn't have another option.
[00:23:11] Lindsey Dinneen: Yeah. So having that impact and just being able to reinforce in those moments of maybe when it's especially difficult or you're especially frustrated like, "Oh my gosh, I wish I could help X, Y, and Z," at least you can look back and go, "Yes, but look at all this that we are doing."
[00:23:26] Sara Aswegan: You know, Lindsey, also it's that education piece and being curious and asking questions. The scientific community and one of the lead leaders in the NPS community is in North Carolina, Joe Munzer. Dr. Joe Munzer, he's brilliant. And one of the initiatives that we started was something called a masterclass. And so with Dr. Munzer and seven or eight other clinicians from around the world, we literally went on an educational program around the world. And some of the individuals that had just come out of their postgraduate work, pediatric geneticists or neurologists meeting the number one or two people that know this space so well, being mentored by them.
And now those individuals are facilitating their class, the same type of class in their local language to their local communities and creating that level of education and awareness. I mean, it's just to see that real impact over time. I actually get goosebumps just thinking back on the impact that has had. And you've got a community of clinicians that they're, I mean, there's a lot of needs still to study medical genetics. And so hopefully we have individuals that are scientifically interested and will continue that that journey so that they can be the next teachers across borders. That makes the difference.
[00:24:37] Lindsey Dinneen: Yeah. Absolutely. Wow. Yeah. Thank you for sharing that. I was also getting goosebumps just listening to it because that's incredible ripple effect that you had and continue to have. That's amazing.
[00:24:47] Sara Aswegan: Yeah. Yeah.
[00:24:47] Lindsey Dinneen: Yeah. Oh man. Okay. Well, I could talk about this for a long time, but pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach masterclass on anything you want. It can be within your industry, but doesn't have to be. What would you choose to teach?
[00:25:05] Sara Aswegan: Wow. That is a great question, Lindsey. A masterclass-- a million dollars-- a masterclass on anything I would want. I would be drawn to some of the advancements we're seeing in gene therapies, but I think that would be, I wanna try to serve a broader population. Do you know? I think it's, I think if I could look, I would do something around looking back on some of these, if you will use cases and best practices, to share those learnings, just because we know the impact that it will have and has had and continues to have.
And not just on the scientific community, but it ripples down into the patient communities of asking that question of "what can be possible, how can we together." Instead of " no," it's actually, "yes and" or "no and" we hear something else, another construct. And really breaking it down to really enforce what I've talked about on several moments during our conversation today is it can't just be the manufacturer, the, or the developer. It can't just be academia. It can't just be health authorities or regulators.
It's a collective community and it has to include that patient within that conversation to help for that learning and advancement and understanding. And so I think it's something around that, the best practices, use cases, and really things that made a difference. Meeting people where they are of a good understanding of the science, not good understanding of the science, that crosses all levels. Drug development overall. The total continuity of care for my individual affected. It's not just about a drug, but it's about assistive devices or other tools that they can have a better life. And so being really thoughtful about that I think would be something that would be really amazing. That it's actually captured and taught back.
[00:26:47] Lindsey Dinneen: Yeah, absolutely. That would be a fantastic masterclass. All right, and then how do you wish to be remembered after you leave this world?
[00:26:56] Sara Aswegan: Well, at some point I know my husband will admit I have the best sense of humor.
[00:27:01] Lindsey Dinneen: Yes.
[00:27:02] Sara Aswegan: I think for me, Lindsey, I really would hope that people would say an open heart, a generous heart, and just a connector of people, personally, professionally. It takes two seconds to be kind and open and nobody has all the answers. So help people connect with others and be willing to say, "How can I help?"
[00:27:20] Lindsey Dinneen: Yeah, absolutely. Yeah. And then final question, is one thing that makes you smile every time you see or think about it?
[00:27:31] Sara Aswegan: I just came in from my garden and I have to say, seeing my advancement of fostering my garden and I've got things blooming now. There is hope.
[00:27:40] Lindsey Dinneen: I love that. I feel that way every time I somehow succeed in keeping a plant alive.
[00:27:45] Sara Aswegan: There is hope. It's really around the simple things, right? That's it.
[00:27:49] Lindsey Dinneen: Yeah, absolutely. Now, for any of our listeners who are excited to get to know about you and your work a little bit more, can you just share briefly what is it that you do right now to help companies succeed and how can people get in touch with you?
[00:28:02] Sara Aswegan: Thanks, Lindsey. So I am currently doing some advisory board work for a couple of consultancies as well as helping some small and mid-sized biotechs figure out their pathway and how they go to market. How do they facilitate access to unlicensed medicines? I'm passionate about the rare space, so I'm serving also on a couple of special projects on getting drugs and diagnostics into low middle income countries. And it's something I'm very passionate about and I've got a great network of people. So if I can't help, I'm always happy to say, "Not me, however, I know someone you should talk to."
And to get in touch, it's not easy to spell, but it's www.saraaswegan.com. And again, if I can't help, I might know someone who can. And I think it's just, it's really good to share our knowledge and experience and really make a difference however we can.
[00:28:47] Lindsey Dinneen: Yeah. Absolutely. Well, thank you, Sara. This has been absolutely incredible to learn from you, to hear about your story. So thank you for sharing and being open. I really appreciate that. And my goodness, I just wish you the most continued success as you work change lives for a better world.
[00:29:03] Sara Aswegan: Thanks Lindsey, and thanks for everything you're doing. Really, hats off. Thanks a million.
[00:29:07] Lindsey Dinneen: Of course, and have the best rest of your day. And thanks also to our listeners for tuning in. If you're feeling as inspired as I am right now, I'd love it if you shared this episode with a colleague or two and we'll catch you next time.
[00:29:22] 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. Adam Power, co-founder and Chief Medical Officer at Front Line Medical Technologies, shares his fascinating journey from a background in vascular surgery to developing COBRA-OS, a groundbreaking device for hemorrhage control. He discusses the challenges and milestones in bringing this life-saving technology to market, the impact of the device in trauma and emergency care, and innovative future applications, including its unexpected use in non-traumatic cardiac arrest. 
 
Guest links: https://frontlinemedtech.com/
Charity supported: Canadian Cancer Society
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPTEpisode 064 - Dr. Adam Power
[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.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Dr. Adam Power. Dr. Power is a leader in innovative medical devices for trauma and emergency care that is committed to lowering the barriers and bleeding control and resuscitation. Dr. Power was instrumental in the development of COBRA-OS, drawing on his unique clinical viewpoint and expertise to ensure utmost patient safety and assist with the company's global expansion. In addition to his current role as co-founder and Chief Medical Officer at Front Line Medical Technologies Incorporated, Dr. Adam Power is a vascular surgeon in the division of vascular surgery at Western University, which he joined in the fall of 2012, and he is involved in all aspects of academics and clinical care.
Also, Front Line was just named the 2025 Medical Device Technology Company of the Year, so I definitely wanted to highlight that too.
All right. Well, thank you so much for being here today, Adam. I'm so delighted to speak with you.
[00:01:55] Dr. Adam Power: Yes, it's a pleasure to be here. Thank you.
[00:01:57] Lindsey Dinneen: Of course. Well, I'd love if you would start by sharing a little bit about yourself, your background, and what led you to what you're doing today.
[00:02:05] Dr. Adam Power: Sure, I'd love to. So I'm a Canadian. I grew up on the east coast of Canada and was always interested in science and math and those types of things. I think, importantly, I grew up with an identical twin brother as well. So we really didn't know what we wanted to do with our lives, and ultimately we're good in science and math and ended up in medicine. And then both of us, when we got into medicine, we weren't sure exactly what we wanted to do in medicine, and ultimately both of us became surgeons. He became a urology surgeon, and I became a vascular surgeon, where we joke that we're both plumbers. I deal with the red stuff and he's the yellow stuff.
But I did my initial medical school out on the east coast of Canada and then I did my general surgery training, which also involved trauma training, and then did a Master's of Bioscience Enterprise, which was basically biotech business from the University of Cambridge in the UK. When I finished my general surgery training, I continued on and did vascular surgery training at Mayo Clinic down in the US, and since that time after graduating from there, I've been at Western University in London, Ontario, Canada, for the past 13 years practicing as a vascular surgeon and an academic vascular surgeon.
But when I was here at Western, I was always interested in innovation. I filed my first patent as a resident way back when, and have filed many over the years. But ultimately, if I was ever gonna see anything that came outta my head and was actually used in a patient or I could actually use in a patient, I figured I'd have to do it. I knew that I couldn't do it by myself. And so, I was very fortunate to meet my co-founder Dr. Asha Parekh. She's a PhD, biomedical engineer, extremely smart jack of all trades, and we teamed up now about eight years ago.
We met here at Western, teamed up and really took an idea right out of our heads and patented it and raised money for it, prototyped it, brought it all through the regulatory steps to approvals, built a quality system and ultimately got it out onto the market in Canada, US, Europe, now Australia, and more to come. So the commercialization piece is what we've been focusing on over the past three years. And it's been really fun, but very exhausting but very rewarding as well. I think I'll stop there because I've been blathering on, but...
[00:04:39] Lindsey Dinneen: No, it's fantastic. I really appreciate it. Plus, it's really fun to hear about your trajectory and so, okay, so you've teased us a little bit about this company of yours and this innovation of yours. Can you now share a little bit more about that and the development of it over time?
[00:04:55] Dr. Adam Power: Yes, of course. Well, I mean, thing that we recognized early on is, and I'll just explain how I normally explain it, is if you have bleeding, it's a hemorrhage control device. And so if you have bleeding in your extremities, then you can often either put pressure on it or you can put a tourniquet on it. The problem when you have internal bleeding in the torso is that you can't actually put direct pressure on it, and there's no tourniquet that necessarily works for intraabdominal, intrathoracic bleeding.
And when people bleed to death before coming to hospital, I mean, they're bleeding in these areas. You can empty almost your entire blood volume into your chest or into your abdomen. And this does account for a significant number of fatalities in all environments, basically in the trauma environment. That's military, that's pre-hospital, that's any time that that people are bleeding from internal organs.
And so, because this is such a problem, the old fashioned way to fix it is to open up someone's chest and put a clamp on the aorta. So what does that do? Is it basically above the clamp, keeps blood flowing. The remaining blood in the body keeps blood flowing to the brain and the heart, keep you alive. And then below the clamp, it stops sort of the hemorrhaging from the spleen or the liver or whatever. So there's two things going on. One above the clamp and two below the clamp.
But opening up somebody's chest in, you know, side of the road or in the emergency department really is impossible. You need highly skilled people like vascular surgeons like myself to be able to do this. And even if we were at the side of the road, we don't have the resources available to keep a patient alive.
So there is this idea that we could do this minimally invasively, sort of accomplish this through minimally invasive means. And this, the idea of doing REBOA, which is an acronym-- Resuscitative Endovascular Balloon Occlusion of the Aorta-- came into being. This was probably 15, 20 years ago now. It wasn't necessarily a new idea. It had been done since the Korean War. There was somebody actually put a balloon up into someone's aorta to stop bleeding, but it came back again and was starting to be used a little bit more because.
And so really the idea is to, through the femoral artery in your groin where you can feel a pulse, you introduce initially a sheath, which is your access point, and then you place the device up through the sheath, up into the aorta and inflate a balloon in the aorta. So instead of an external clamp, it's an internal balloon clamp that keeps blood flowing above the balloon and stops the blood flowing from below the balloon.
Initially these devices were as big as my baby finger, like they were massive. And so if you put them in and you took it out, there was a big hole in the artery, had to cut down on the artery and repair the artery. But as it got more and more advanced and technology advanced, they become smaller and smaller.
So that's really where we came in. The initial devices were 12 French, about the size of my baby finger. And then it advanced to Seven French and all of a sudden Seven French-- and these are diameter, French sizes are basically diameter-- and so when it went from 12 to seven French, now we could start doing it through the skin without actually cutting down on the artery. But that Seven French size was still very large and you're putting this in the hands of people that don't do this all the time. And so, we had the idea to bring it down even further now to Four French. And so this is essentially the size of an IV.
And so you put a tiny little IV in somebody's femoral artery. And lots of different people can do that. And then you advance the device up in, inflate the balloon and you can magically occlude the aorta. In our first study that we did, the first inhuman study, we averaged about just over a minute to occlude someone's aorta, which was really fast to be able to get that amount of control that quickly. So that, that was really been the advancement is to decrease the access size, make this whole procedure simpler so that so that we can essentially save more lives.
[00:09:08] Lindsey Dinneen: Okay, so thank you so much for sharing a little bit about that. Can you tell me about the beginnings of this innovation and how you brought it to market? Because it's really wonderful to hear all the success, and I'm so excited to hear that it's spreading, you have presence all over the place now. But you know, that's not an easy pathway. And I'm curious if you could walk us through a little bit about that decision to go, "You know what? We have a solution to a known problem, we can make this happen." And then how did you actually go about doing that?
[00:09:42] Dr. Adam Power: Yeah. I think, I mean, I make it sound fairly straightforward, like a nice story, but it certainly was not that. I mean, we were very lucky I would say, that we had a lot of great advisors and mentors that we figured that we try not to fail early, fail fast. We wanted to make this one as successful as possible. So before we made any decision, we often would consult our mentors. And I'm a surgeon. I like to shoot first, ask questions later. My partner is not. And so I think we, we strike an excellent balance between not just the engineering and clinical side of things, but also from driving a business forward, getting all the information, but helping to get decisions made and moving forward.
You know, starting out, we really had to choose the right sort of fit for what we wanted to pursue. We like to say it checked all the boxes. It checked all the boxes as far as even where we are. We're in Canada, we're not in a tech triangle where there's tons of funding opportunities. We knew we would be limited from a funding perspective, so we couldn't choose something that necessarily required a hundred million dollars to start up. So, you know, we had this device that we knew that we could fundraise for it. And then once it was fundraised, it was simple enough that we could get it manufactured.
We chose to go the OEM route for the original equipment manufacturer, so we didn't have to build a manufacturing facilities ourselves. And then really from there, and building a quality system in the regulatory, we did work with a lot of consultants, that was both positive and negative experience. We had great consultants. We had not so great consultants. But really what our our goal was, is to learn the process ourselves. And so there's always manuals for things, even from the FDA perspective. They give out great documentation about what is supposed to go into an FDA application. And we dug into that.
We really tried to understand. We did not trust anyone. That's one of my rules in surgery is, "don't trust anyone, not even myself." So we really didn't trust our consultants, and we tried to double check and triple check everything so that we didn't make mistakes. And of course, we did make mistakes and had to go back to the drawing board a few times. But as much as we wanted to get this out there, we really did wanna learn the process and know the process because ultimately we're the ones that are responsible to the patients in the end, and we needed to make sure that we had a handle on each and every step of the way. We, of course, because of that, were maybe not as quick as we could have been but in other places we became more efficient because, as we learned the process, getting feedback back and doing it right the first time, it really made a difference. So.
[00:12:39] Lindsey Dinneen: Yeah, absolutely. Of course. Yeah, and I appreciate you going into a little bit more of the nitty gritty details 'cause it is so fun to hear the success stories, but of course, as you go along, there's that pathway to success. And it's helpful to understand that yeah, it's gonna be potentially a long road, sometimes windy, sometimes weird, but at the same time that it is possible. So as you look to the future with your company, what are you thinking of in terms of the future? Are you going to continue down this pathway and continue with iterations of this device? Are you thinking of new devices to introduce as well? Or, what are your thoughts for the future?
[00:13:18] Dr. Adam Power: Yeah. And I have to be very careful what I say here, obviously. I can share generically what our thoughts are. We love this. Ultimately there was no better feeling than to use-- I mean, I've used my device to save a patient. And, you know, I would say that Asha, who's my co-founder, she cares. I'm a physician, but she cares about the patients just as much as I do, as does everyone in our company, which is really quite rewarding.
But the future, what does the future hold? We really want this to get to everywhere. Yes, we're in lots of different countries ,have commercialized really all around the globe, but we really wanna go deeper into a lot of these geographies and really help as many people as possible. We realize that we can't do it on our own and are gonna need help. And so that's, we're in a growth phase right now of our company and we're looking for strategic collaboration. We're looking for those opportunities to deepen our ties and in all the different geographies.
That being said, we are inventors and of course we have an idea every day about what we could improve on. But as far as the pipeline goes for our company, we are focusing on some very specific up and coming applications that we hope to have in the next couple of years. And I also wanna say that, I talked about trauma and bleeding, but the more exciting side of aortic occlusion has really been the applications. And you'd think, okay, it makes sense for trauma to be able to stop blood flow and stop bleeding.
But some of our recent successes have been through postpartum hemorrhage. And there is this really, terrible condition called placenta accreta, where the placenta grows into the uterus and when you deliver the baby either by C-section or by delivery, and then the placenta attempts to be delivered, it tears, and you can have torrential bleeding. And, and so our device is being used in these women who are pregnant when inflicted with this condition and helping to decrease blood transfusions, helping to save a mother's life. So that's been really amazing.
And then next on the horizon is strangely there's, it's not even a bleeding application. We've done some research and there's research going on globally about using aortic, minimally invasive aortic occlusion for non-traumatic cardiac arrest. And so if, which is really, again, it's like, "Oh my gosh, does this thing do everything? It might make your supper tonight if you're not careful." So it, so what happens there is that if somebody drops dead basically in front of you, and you start CPR, if you start pushing on their chest and pushing on their heart, you're pushing blood to the whole body. And the way you get someone back to life is if you can get the heart muscle oxygenated again.
So if you put an aortic occlusion balloon up close to the heart, every time you push, you're directing blood right into the coronary arteries and right into the brain as well. And so what we're seeing is that there's increased return of spontaneous circulation rates when you do this with CPR. And there are different trials around the world that if this shows that there's an increase in survival or in better neurological survival, this will be the first time that we've really changed the script on cardiac arrest since advanced cardiac life support came out many years ago.
So this, again, is very exciting for a simple device to be able to make that much impact in all these different areas. So, you know, we have a lot to focus on right now, even growing into the future because some of these, like cardiac arrest, are quite early on. So we don't wanna lose sight of this great original product, but we do think all the time about different pipeline ideas that could help other patients.
[00:17:18] Lindsey Dinneen: Yeah, but, and to your point, even the amazing other use cases for this incredible device, like you said-- maybe it's gonna make us dinner next-- but the idea being that, who knows? I mean, there's so much more to discover even now, which makes me excited just to think about how many more use cases you could have for it and how many more people you could save.
So, speaking of that, are there any stories that kind of stand out to you, moments that you've had where, you know, either through your day job, so to speak, being a vascular surgeon, but also being the co-founder of this company that really sort of affirmed to you that, "You know what? I am in the right place at the right time, in the right industry." Just those moments that really stick with you.
[00:18:05] Dr. Adam Power: Yeah, I mean, it obviously all stems back to the patient and what patients are impacted. And I remember, the first time that the device was used at our hospital, one of the radiologists called me in and said, " We need to use one of these balloon occlusion devices for a patient that's been in an accident." And so I went in and I said, "I actually have the device that my partner and I created. We can use this for the patient." And so we started using it for the lady that was involved in a very serious accident, had a pelvic fracture, and she was a Jane Doe at that particular time. She was anonymous. And anyway, we noticed that she had actually had some vascular surgery done based on her angiograms, and I leaned over and I-- so she was sedated, but she was awake-- I said, "Have you had vascular surgery? Who's your vascular surgeon?" And she said, "It's Dr. Power. He's such a nice man." And so I was actually helping one of my patients. That was pretty crazy.
[00:19:04] Lindsey Dinneen: Oh.
[00:19:05] Dr. Adam Power: Also from my hospital, when I heard one of my junior residents was able to save someone's life. So, you know, junior residents are often good, but they're not trained surgeons. And so to have a simplistic device that one of my residents could actually place and help someone, that's pretty amazing too. There's also been times where like even the postpartum hemorrhage, we hear the first cases in the States of saving mother and baby. That's pretty incredible. Or that we donated some devices to the Ukraine conflict as well, and we heard that it saved some soldiers' lives as well. And there's different military groups that, that use our device and save soldiers.
So it's all back to the patient. And hearing those success stories and hearing about somebody alive because of this particular device, because of all this effort that we've put in. I mean, it's really makes it worthwhile. It sounds kind of corny, but as a surgeon, I can help one person at a time, but as somebody involved in industry and medical device industry, I don't even have to be there. You know, this device can help long after I'm gone. The tricky part of it, being the Chief Medical Officer is, I usually only have to worry about my patients. Now I have to worry about everybody worldwide and the device being used. That was a little hard to wrap my head around initially, but yeah.
[00:20:28] Lindsey Dinneen: Yeah, of course. But the ripple, the ripples, the impact that you get to have because of this device and because of your diligence getting it to market, because it isn't an easy path, and that's incredible. So thank you for doing the work that you're doing. That's not easy and it's very appreciated. This is incredible. So, yeah. So, okay. When you were growing up, let's say 8-year-old, Adam-- you know, you're having a good time doing whatever you like to do-- could you possibly have pictured yourself where you are now?
[00:21:08] Dr. Adam Power: No, I don't think so. I mean, I, I. I came from a very small, like, small upbringing and, you know, in my family I had absolutely lovely family members, but they really, apart from my aunt, they weren't overly educated. And so I really didn't know what it took to be successful in life, really. I had work ethic from my parents, that's for sure. And so that's what they bred into me. And all I knew is that I was gonna work as hard as I could, and I figured that as long as I keep working-- and I was lucky to have some brains as well-- then I figured things would fall into place.
They honestly haven't fallen into place exactly how I pictured them as I grew older and what it would look like. But I'm certainly thankful for where I am right now, and what is the next five years or 10 years gonna look like? I have no idea. And I guess I just don't even picture it. I have goals, but I also know that those goals change depending on circumstances. And you need, as I'm growing into middle age-- I think I'm beyond middle age now-- I'm thinking about midlife crisis and things like that. I get into philosophy and there's like telic and atelic things and so, it's sounds, again, it's about the path and the journey.
It's not about the ultimate goal because, having reached a lot of these successes, that good feeling lasts for maybe a day or half a day. And you think you know, I spent all these years coming with the, with our device, getting our device to market and getting FDA approval and like, oh my gosh, like, you'd think, I'd feel so great about that. And it did. It felt great, but you wake up the next day and you gotta keep going. So you have to enjoy the journey and that's really what it's the wisdom that comes with age is trying to enjoy the journey as much as possible and not focus too much beyond that.
[00:23:09] Lindsey Dinneen: Yeah. Yeah, and I think that's really good advice too, in that it is because the daily life isn't usually all the celebration and successes. I mean, that does happen and those are good moments, but because the vast majority of our life is spent on the journey component of it, and going through those peaks and valleys, it is important to find something you love and feel that you can make an impact in. So I'm so thankful that this is what you've chosen to do.
So pivoting the conversation a little bit just for fun, imagine that you're to be offered a million dollars to teach a masterclass on anything you want. Could be within your industry, but it doesn't have to be. What would you choose to teach?
[00:23:55] Dr. Adam Power: And would that mean that I was an expert in it?
[00:23:58] Lindsey Dinneen: Well, certainly if you're getting paid a million dollars, somebody has decided you aren't an expert at it. How about that?
[00:24:05] Dr. Adam Power: Okay. Well. Can I pretend like I'm an expert in it? There's something that I really love, but I'm not I'm probably not an expert in it. It would be, I would teach a masterclass in DJing. Isn't that strange? I know it's so random.
[00:24:21] Lindsey Dinneen: Oh my goodness! Tell me more!
[00:24:23] Dr. Adam Power: Well, I mean, I love music. I've, I grew up playing lots of sports and never was involved in music. And, and I've always appreciated music and art, but I was never able to do it. And, you know, growing up I did love sort of all types of music and then even electronic music and it just somehow talked to me. So I started DJing electronic music basically when I was around med school and have always loved it now, and when I was over in England, I DJ'ed on the campus radio and also DJ'd in a club.
It was really fun and it sounds pretty silly to be talking about this when I have these other things that are on the go. But honestly, being able to share space with other human beings these days, and actually having a good time and having it not be stressful and having it be only, you know, everybody's wishing others to have a good time. There's not many people that go out sort of dancing into electronic music that are thinking bad things about other people. Really they're just out for a good time. And so being able to steer that whole music and scene is pretty awesome. And I do love it. And I don't DJ as much as I used to, but I still do different events, usually Christmas parties for the operating room. I'll do the typically wedding sort of DJ, but then they always, 'cause they know me, they let me do an hour long electronic set, which is like hardcore electronic. But then I go back to the regular stuff. But I would want to teach a masterclass in DJing.
[00:25:56] Lindsey Dinneen: That is awesome. How exciting. Oh my gosh, I love that. And I think you're right. Music brings us together and it's a wonderful way to, to share a little bit of joy.
[00:26:07] Dr. Adam Power: Yeah.
[00:26:08] Lindsey Dinneen: Yeah. Okay. And then how do you wish to be remembered after you leave this world?
[00:26:15] Dr. Adam Power: I, so number one is I don't, again, with my midlife crisis, I've actually been trying to eliminate my ego as much as possible. And so when people talk about legacy, it actually gives me the hives these days to be quite honest, because I don't like that because I think you're focused a lot on yourself. In my opinion, a lot of legacy is all about you. The way that I would wanna be remembered, though, is truly that I was kind and compassionate to everyone that I met, and that I stood for something, and that I left the world a better place.
[00:26:57] Lindsey Dinneen: Yeah, those are wonderful things to want to be remembered for, absolutely. And then final question, what is one thing that makes you smile every time you see or think about it?
[00:27:09] Dr. Adam Power: My kids. My son Kai and my daughter Saoirse. They are the light of my life. And I, you would think that with how busy I am ,you know, those things would deprioritize, but they truly are the one thing in my life that makes me smile when I get up in the morning.
[00:27:30] Lindsey Dinneen: Oh, that's wonderful. Well, that is absolutely incredible. I loved getting to meet you and speak with you a little bit today. Thank you so much for sharing about your journey. Thank you for sharing about your incredible device and your bits of wisdom along the way. The idea of we've gotta enjoy the experience, the path, the journey. And I just really appreciate you spending some time with us. So thank you for everything you're doing to change lives for a better world.
[00:27:59] Dr. Adam Power: Oh, well, thank you for giving me the opportunity to speak with you. It was absolutely lovely chatting with you today.
[00:28:05] Lindsey Dinneen: Wonderful. Well, thank you again so much. Thank you also to listeners who are tuning in, and if you're as inspired as I am, I would love it if you would share this episode with a colleague or two and we'll catch you next time.
[00:28:20] 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.

Morgan Evans is a biomechanical engineer, serial medtech entrepreneur, and angel investor. She shares her journey from aspirations of becoming a doctor, to working in mergers and acquisitions at Medtronic, to co-founding/founding six companies, including Agitated Solutions and Avio Medtech Consulting. Morgan discusses the importance of supporting startups in accelerating market entry, the challenges and opportunities with innovative medtech development, and the value of servant leadership.
 
Guest links: www.aviomedtech.com
Charity supported: Polaris Project
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 063 - Morgan Evans
[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.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Morgan Evans. Morgan is a serial medtech entrepreneur and investor, which means her passion is launching new businesses. She's a biomechanical engineer by training, went to business school and worked for Medtronic in corporate development before jumping fully into the world of startups. Over the past 10 years, she has founded or co-founded six companies: two medical device companies, two medtech accelerators, and two venture investing vehicles. She spends most of her time with Agitated Solutions, which is developing several innovations related to contrast and ultrasound, and Avio Medtech Consulting, which helps lower the barriers to entry for new ideas and new medtech companies.
All right. Well thank you so much for joining us today, Morgan. I'm so excited to speak with you.
[00:01:42] Morgan Evans: Thank you again for having me. Pleasure to be here.
[00:01:45] Lindsey Dinneen: Of course. Well, I'd love if you wouldn't mind starting off by sharing just a little bit about yourself, your background, and maybe what led you to medtech.
[00:01:53] Morgan Evans: Sure, of course. Originally from Houston, I went to school in the Bay Area and studied to be a biomechanical engineer. I originally thought that I was gonna be a doctor, and wanted to start in heart lung transplant of all things. Did an internship between my freshman and sophomore year and quickly learned two things. One is that I love people a bit too much to distance myself emotionally, so it would've really been a hard career for me, I think being on the front lines with that.
But the second important thing I learned as well was there was a lot of technologies that existed in the medtech side of the world, just trying to buy people time and give options. And so I fell in love with medtech as a career relatively early. Started working for my first startup in the neuromodulation space before I even graduated undergrad, and loved that. Wore a ton of hats ranging from engineering, clinical commercial. I did some vertical line integrations in there and I started before we were even at 10 employees, left at 55. Thought it was massive 'cause we had middle management.
Then toward the tail end of that, started studying to go to business school 'cause I realized I was getting further and further away from my engineering degree. And then I went to Kellogg at Northwestern and when I was there, co-founded my first startup with a clinician that had a great idea, didn't really know how to navigate the regulatory side of the world, and we co-founded that company together. And toward the tail end of that, was recruiting for formal kind of post-business school. Where am I gonna land? What am I gonna do?
And decided to go to Medtronic and do mergers and acquisitions within the corporate development team. Did that for about two years. Loved it, learned a lot. The team was great. But big company was a huge change, especially as I just mentioned, you know, I thought 55 was large with middle management. And then you go to 90,000 at the time and deal teams of that. And kind of felt like my calling was going back to startups, so left in 2016 and have been innovating and building companies ever since.
[00:03:53] Lindsey Dinneen: Wow. Okay. Well, thank you for sharing a little bit about your background and everything that's led you to where you are today. I really appreciate it, and so I am so intrigued. Okay, so you were on track in, in theory, initially to be a doctor and to go that route and then decided, "Okay, well, maybe this isn't for me," which is so great that you learned earlier rather than later, of course. But so as you were processing through making this transition into medtech and going, "Oh my goodness, there's actually a whole lot here." Were there any particular things that really stood out as being the most intriguing? Were you just kind of interested in the industry as a whole, or were there specific things where you thought, "Oh gosh, I really wanna learn about X, Y, and Z."
[00:04:37] Morgan Evans: Yeah. Two things happened in relatively short order that I think landed me in my love, right? The first is, when I was doing this internship, they actually had some preclinical research going on in the basement of the hospital. And I, it's a long story, but I randomly ended up wandering into this place and figuring out it existed, and saw some of the early preclinical research happening live where they actually had a pig that they were trying to induce a heart attack in to then do a treatment for. And this pig actually coded in the middle of the procedure and they literally come out with paddles. And I'm just like, "This is the coolest thing in the world, this is actually how innovation is done and people learn." So that kind of, "Oh, cardiovascular sounds really interesting," was where I originally started.
And then, at the time when I was at Stanford, I was playing on the basketball team as well, and I went to a event with some supporters of the program. And the person at my table was Chairman of the Board of a neuromodulation startup, autonomic technologies. And the one thing I at least love that I'm not afraid to ask questions. And so I just was like peppering him with like, "What is this? How does that work?" And that actually led to my first job. And it's kind of fortuitous that you're in the right place at the right time, but then just get exposure, and that was in pain and pain's a hard space. The type of treatment we were doing was treating condition that was known as a suicide headache. And so I think that was helpful to see the impact of the work we can do so early on. And then I, like I said, I've been hooked ever since.
[00:06:05] Lindsey Dinneen: Yeah. Yeah, that's great. And those are great stories. I love the synchronicity and how those moments sometimes just play out perfectly and lead you to your next right step. So now you are in a position where you are advising startups, but you have lots of things going on. I feel like when I was looking at your LinkedIn, there were multiple different organizations you're a part of and participating in. So could you share just a little bit about all the wonderful things you're up to these days?
[00:06:31] Morgan Evans: Yeah, for sure. So my day job, as I call it, but where I spend by far majority of my time is I am co-founder and CEO of a company called Agitated Solutions. And we say that we're unlocking the potential of diagnostic ultrasound. So we have multiple products that include a contrast agent that's revolutionary and that it has a temporary micro bubble, looking for holes or flaps known as a patent foramen ovale in the heart that's highly associated with cryptogenic stroke. So we have contrast side, and then we also have some software as a way to have better prediction of what our high risk shunts and what could cause stroke. That had a company spin out of it called Moonshot Medical that is more of a traditional incubator where we put all of the IP and ideas that weren't quite ready to be full-blown companies, but we knew there were some things there that I also technically lead. So those are the two that I'm CEO of.
I founded a company called Avio, that I'm very passionate about, that is really focused on trying to help get these medical technologies to market faster. The work we do is on the backend of medtech, so quality systems, regulatory, R&D project management. But just in the theory that there's so much paperwork that is behind any innovation, like how do we get better at that paperwork so that we can keep innovators doing what they do best. And then we're just really that helping hand alongside.
I joke, all of the things I'm involved in, this was my happy accident. I felt like I was building what I needed for my own startups. Literally no intent of anyone else ever seeing this or offering that as a service. And I just remember distinctly, I woke up one day shortly before my son was born and I was like, "Oh, I think there's actually a business here. Maybe I should run it like one." So that's another one.
And then passionate about angel investing in early stage as well. When I fundraised for the first time, I was 29. I'm now 37. I get asked that a lot, although you're not supposed to ask a woman her age. When I fundraised for the first time, especially in these early stage rounds, no one looked like me, both in gender or age. And so I'm one of those believers, "Put your own money where your mouth is," even if they were baby checks to start, they were something. And that's been another area that I also spend some time.
[00:08:48] Lindsey Dinneen: Yeah. Wow. Okay. So you've got a lot going on to, put it mildly, which is fantastic. You mentioned something that really stood out to me. You're trying to help these startups bring their medical technology to market faster. And I'm curious, are there maybe one or two things that you see a lot of startup companies perhaps either accidentally overlook, or delay too long, or something like that, where, at the beginning, if they had done X, Y, and Z, they could have gotten their technology to market faster.
[00:09:21] Morgan Evans: Yeah, a couple thoughts. One is I think people underestimate the amount of time that it takes to formally document all of the things that go into getting your device compliant and on the market. For example, I've had a client before that came to us that had a product that was working. He had tested it, he'd done all these things and it was a software, and ready to go, and submit to the FDA. And then you're like, "Well, we need user needs and product requirements, and your design schema," which, you know, there is a reason that these processes exist and I think they can make you have a better product at the end of it.
But I think, you know, people assume, "Let's build the right product first and then worry how to document it." And then you forget sometimes why certain decisions were made or you know, is this actual requirement or was that done because it was an off the shelf thing? And so there is a lot of learning that I think can be lost by waiting.
Now all that said, the other part of it would be that if people kind of shore up too fast, so you overbuild the team, you have a quality person, a regulatory person day one that feel like they need to be doing all of the things and justify their full-time job, then you end up documenting and revising. So there is some healthy balance and tension between the two. So it's not easy to get it perfect. But I would say those are the two areas that come to mind.
[00:10:37] Lindsey Dinneen: Yeah, that makes a lot of sense. And I can see where the polar opposites could be challenging. So staying happily in the middle, working with an expert such as yourself, is a really wonderful way to go about that. You mentioned angel investing and being passionate about helping. It sounded like based on your own experience, you're very passionate about helping the next generation of leaders and entrepreneurs in this space create the products and bring what they envision to market. As you've gone about this, and even as you learned for yourself how to fundraise, maybe feeling like, "Hey, nobody else looks like me, is my age," or whatever, what are some learning lessons that you've experienced that you would suggest for somebody who's maybe in a similar situation that you were in?
[00:11:28] Morgan Evans: Yeah. Some of it is just to be a little bit fearless, I would say. There's a lot of people that have told me over the years, "Pick one. I don't understand how you do all these things." My least favorite question I've ever gotten is, "Do you ever see your kids?" Yeah. But people ask you that, you know? And I think it's easy to let other people tell you what you should be or what your product should look like or your path should be. And I think I have been fortunate to find some wonderful mentors that empowered me to be my own version. I didn't have an example of someone that had built the things in the way that I had built them or that had a couple of them at one time.
But I also knew very confidently that I wasn't dropping a ball and I was doing the right thing by the companies I was building and supporting. And it was helpful to have the army behind me that just loved me for me and supported me in that, in developing it. And I think that next generation of entrepreneur, if you can find the same, that's willing to lean in just for you and there's no ulterior motive other than just to see you be successful, hold on with both hands and then pay it forward to the next one.
[00:12:38] Lindsey Dinneen: Yeah. Yes. That's great advice and insight. So when you're thinking about your own career and the companies you're leading, what are some things that you're looking forward to in the future as you yourself continue to evolve and develop your own skill sets and whatnot, and also for your companies that you're leading? What are you excited about?
[00:12:59] Morgan Evans: Yeah, I think for me, I'm excited about building that next generation of entrepreneur, which we've talked about a little bit. And how do I influence and build and develop those things without me being the one actively leading them? That's been a new learning that I'm continuing to kind of dabble in and grow personally, which is leading through the art of board work or questions or advising, which is different than leading a company by physically being the head of that company. And thinking about how to train and develop and give people enough of a leash to go and run and be them, but yet have that support system that you're still within their appropriate guardrails that-- I'm kind of mixing metaphors, but I think you get it. You know, it's an art, not a science, and one that I'm enjoying learning and growing and developing in this next phase too.
[00:13:53] Lindsey Dinneen: Yeah. Well, and speaking to that in general, so I'm sure you've had a mixture as most of us have had, of good experiences with leadership and poor experiences with leadership, and I'm curious how that has shaped your own leadership style now, especially as you're in this new phase of further developing your leadership skills to look a little different than perhaps they have in the past. But what do you draw from and what's your inspiration when you've developed your own leadership style?
[00:14:23] Morgan Evans: Yeah. As I mentioned earlier, I've had a wonderful network of mentors that I think have really leaned in and and done it in the right way for the right reason. And I hope to emulate that myself, of being there to grow people and the technologies and the businesses that you're doing and giving them those chances to shine. As a leader, I believe very much in servant leadership. I never want someone to work a weekend that I'm not working as well. But then you kind of realize that isn't always feasible and can feel uncomfortable sometimes. And how I've evolved to give other people those opportunities, but recognize I'm not gonna be in the weeds enough to help them in the same way, it's a journey. I'd love to say I'm at the destination. I'm one of those, I love iterative improvement. I don't think I'm ever at a destination. But just really trying to lead through the art of question, for example, as opposed to coming with thoughts and opinions, has been a big one for me in the last couple months in particular.
[00:15:20] Lindsey Dinneen: Yeah. So approaching with curiosity, it sounds like in an effort to understand and or provoke even perhaps that person taking additional ownership or responsibility in their own creative solutions to perhaps what they're coming up with. Are there particular questions you've found that are really helpful as you're shaping these conversations, helping people understand their next right step?
[00:15:46] Morgan Evans: Yeah, I, it's funny because one of my mentors that's been coaching me on this is, she's kind of had that progression of learning to shift from, in the absence of leadership, lead, to leading someone else through that. I actually text her periodically and ask her for guidance of, "Hey, they came to me with... This is what I would normally say. How do I frame this in a question such that I'm giving them enough direction, but not leading the horse to water." So it the art of the question is in, in fact, itself an art. In general, I would think about asking something in the framework of, "Have you thought about the ramifications of?" or, " What is the key thing that we should focus on this week?" It's almost trying to pick out what I would focus as being the main thematic issue or next step, and giving them enough of a carrot that they can get there, but not quite telling them exactly how it should be done.
[00:16:44] Lindsey Dinneen: Okay. Yeah. So in general those sort of probing questions that might suggest, "Hey, have you thought about X, Y, and Z? Or, what are your thoughts about X, Y, and Z related to this?" And letting them continue to take ownership and responsibility for that. That's really great. One thing I noticed, and I don't know if this is something you currently still do or not, but I was noticing on your LinkedIn that at least at one point you had a Medtech Startup CEO Bootcamp, which just sounds awesome and I would love, if you don't mind, sharing a little bit more about that and what that looks like.
[00:17:17] Morgan Evans: Well, the good news is we are doing it, we're doing another one, I think in June. I'm happy to say I don't know the exact date 'cause that means I'm not in it enough to know exactly the dates. So in the spirit of me trying to take myself up a level -- success. But no, it's interesting because I had worked in medtech for five years before business school, went and got a traditional, you know, learning in all things business, right? Graduated, went to Medtronic, did M&A, and then came and did my first startup.
And I remember day one it was like, "Do I form an LLC or C corp?" No one had taught me that. And it's funny because, now you can understand the nuance of the question, but I can't imagine how much money I spent on the first attorney. And yes, there's pass through income, but you know, is that appropriate for investors for me to take a disproportionate loss or there's 1202 tax code and all these other nuance. So I started realizing that a lot of just taking the first step where things that you have to learn on your own or find a really awesome board member, advisor, et cetera, to lean in and help you too. Other examples would be, you know, "How much stock options do you normally give your board?" Or, " Should I do a convertible note or a safe? What is a quality system," right? I knew entrepreneurs that had no idea what those things were.
So the thought was, "How do I give enough detail to these other entrepreneurs, so where they at least feel that they can ask the right question?" Because to think that I can teach someone the nuance of verification, of validation strategy in an hour or four, versus someone that has done nothing but R&D for 15 years, right? That's not gonna happen. But if you could teach them enough to then say, "Hey, my CTO or contract design partner, should we dry run this test first? Or what test should we dry run?" Right? If we can give those people just enough there to phone a friend, that was the goal of the program. So just giving people that lay of the land and enough of a roadmap. And a lot of this too, like we literally have an acronym sheet because medtech is full of acronyms, and it's funny that like our acronyms can mean something completely different in other people's spaces. And so just even learning the lingo day one, like what's an SOP or CMO or CDO?
[00:19:40] Lindsey Dinneen: That's incredible. I love that. That's so great that you have a cheat sheet because I remember that being such a learning curve when I first got into the industry of, " You just said an entire paragraph worth of acronyms and I would love to understand what you're talking about, but I don't yet." so learning how to decipher all of that was great. I'm thankful for it, but yeah, that's wonderful. A cheat sheet sounds fantastic. You know, it's interesting 'cause you mentioned, with this bootcamp, first of all, I'd love that you offer that. What a fantastic offering for anyone in that position who's just needing that support and that extra guidance, and having something that's so specific to the industry is great. Do we just go to your website for details if anyone's interested in that?
[00:20:24] Morgan Evans: Yeah, it would be on the aviomedtech.com website. And then I believe there's a tab that is regard to the bootcamp. And yeah, like I said, it's all the stuff that I wish I would have learned or I learned. It took me way too much time and money, that I just want people to know where the landmines are that I had to step on. And if we can just accelerate that learning and that s-curve for the next entrepreneur, we can get these products to market a lot faster.
[00:20:50] Lindsey Dinneen: Yes. I love that you offer that. You've gotten to have an amazing career where you've been diving into the industry itself and working for other people, and then of course being a leader in your own companies now as well. I'm wondering if there are any stories that stand out to you as really just affirming, "You know, I really am in the right place at the right time in the right industry"?
[00:21:12] Morgan Evans: Yeah, it's funny. I don't get to reflect on this very often, but I co-founded Agitated Solutions and I founded Avio within one week of each other. I didn't know, again, that I was building what I was building on Avio's side. But what's been so much fun is that as I build and grow this awesome company, that's being an entrepreneur myself, being able to take learnings where I see them and try to pull them thematically into Avio so that you kind of have that flywheel effect. So I'm learning that I enjoy both operating within these technology companies, but also trying to figure out what of the system, or the process, doesn't make sense. Like I know other people might do it this way, but why? And, being able to innovate on the system and the output at the same time has been super fulfilling for me.
And like I said, it's kind of a little bit of coincidence that it was within one week of each other, but that's part of where I've learned for myself that I don't think I'm fulfilled by just being in one company or one thing fully, and in fact, me being in something else is part of what makes me better at the other thing. So I feel really fortunate to have found that and to know where my passion lies.
[00:22:41] Lindsey Dinneen: Yes. That's very cool. And definitely a gift. And you know how things sort of translate into each other-- I was thinking about this earlier because-- I noticed, and you also mentioned that basketball was, and is as my understanding, a core part of your life. And so you've been both a player, you've been a coach. How has basketball played a role in either life lessons, life skills that you've drawn from it, and or how does it just incorporate into your life?
[00:23:11] Morgan Evans: You know, it's actually a really fitting question. So first of all, as an athlete, it taught me I cannot stand to be the weakest link on a team. And when you think about that servant leadership, or that hustle or that grit, I was tall, but I was not the most naturally gifted athlete. And so a lot of where I excelled in basketball was on fundamentals, just solid, putting in the time and doing it. And then I got to the point in my career where I could not outwork other people. I could put all the time in the world in there and I was not going-- like I played behind All American Centers when I was at Stanford, and everybody was an All American coming in to play basketball. And it was a good evolution for me to learn a little bit of "How else can I then play a role if I'm not the most gifted athlete?" and to recognize that a team can function well with all those pieces regardless, right? So I don't need to be the leading score to still have an impact on the team was kind of a good mental awareness of how talent gets pulled together to make effective teams.
The other thing on the coaching side, so I actually had career ending surgeries between my junior and senior year. And basketball was, and still is, a big love of my life. And to then have my playing days over unexpectedly was a big transition, and I got to see basketball from the sidelines my senior year. And my job then was to make the other players more effective, to study scouting report, to teach, to try to do what I could to get the team ready, knowing I would never step foot on the court. And if you think about some of the parallels we've already just talked about, which is leading through the art of question or being able to lead and guide, but not being able to be out there, running around with everybody else in and of, in itself is a very similar transition to what I'm going through and continue to go through.
I coach young women. I did except for this last year. It's been hard with two kiddos, in particular on my husband, especially, you know, we would do travel tournaments and things like that. But coaching young women too, and realizing it's the end result, but it's also wanting them to be good people and life lessons and skills through it. And how do you have them help respond in adversity? All of that, I think, makes me a better leader, and there's a lot of parallels to the working place, for sure.
[00:25:35] Lindsey Dinneen: Yeah. Yeah, that's wonderful. And having a gift like that, even when it looks different and morphs over time, I love that you've been able to draw from it such inspiration and application to other areas of life. I think that's really special. Such a cool aspect of being an athlete. So yeah, thank you for sharing about that.
[00:25:51] Morgan Evans: Of course.
[00:25:53] Lindsey Dinneen: So, pivoting the conversation a little bit just for fun. Imagine that you are to be offered a million dollars to teach a masterclass on anything you want-- could be within your industry, doesn't have to be-- what would you choose to teach?
[00:26:07] Morgan Evans: I would teach something on scrappiness. From my experience, I think there's a lot of people that would know the industry really well, but the how to get things done atypically for less money faster. And that's some of the thematic elements that I hope I'm-- not for a million dollars-- but, you know, starting to teach in our bootcamp. Some of the belief that I think sometimes you get these companies in medtech in particular that are kind of overbuilt, too much too soon. And now they have a really high burn rate and everybody has to leave, essentially a unicorn exit or bust. And how can you burn down and mitigate risk with little dollars and making sure you're spending your dollars in the right places early on? I continue to learn from others in that too, I should mention, but I think it's an area with a lot of impact.
[00:26:59] Lindsey Dinneen: Yeah, absolutely. And so relevant and helpful for startups that have no choice but to be scrappy and learn how to be creative on a dime. I think that's fantastic. Great. And then how do you wish to be remembered after you leave this world?
[00:27:16] Morgan Evans: Yeah. I hope it's something to do with innovating on technologies that improve and help patients, but also innovating with people and process, that hopefully on all of this, that we're leaving the world a little better than we found it.
[00:27:33] Lindsey Dinneen: Yeah. Yeah, absolutely. And then final question, what is one thing that makes you smile every time you see or think about it?
[00:27:42] Morgan Evans: Definitely my family. I have two kiddos, Marley and Mason. So my daughter's three months, my son is three. And then my husband Matt. It's hard to do all the things that I do without having an amazing support system. And, you know, you can have the hardest, most stressful day and you come home and my son's like, "Do you wanna play with me?" Or, "Let's play hide and seek" or something. And it's just funny how instantly all that stress kind of melts away. Very grateful for my family.
[00:28:10] Lindsey Dinneen: Yeah, family is such a gift. Wonderful. Well, this has been such a great conversation, Morgan. I really appreciate you spending some time with us today, and thank you for sharing about your life and your story and your advice. I am excited to see how you could just continue to grow and thrive. I love the fact that you are just a total boss with all the things that you're doing. So thank you for contributing your gifts to the world, and gosh, I just wish you the most continued success as you work to change lives for a better world.
[00:28:42] Morgan Evans: Thank you again for having me. I appreciate you.
[00:28:45] Lindsey Dinneen: Of course, and we are so 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. 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 with a colleague or two, and we'll catch you next time.
[00:29:16] 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.

Bethany Corbin, a nationally recognized healthcare innovation attorney and femtech entrepreneur, shares her inspiring journey into the medtech industry, driven by personal experiences and a passion for women's health. As the founder of Women's Health Innovation Consulting, Bethany discusses her new book, "The Femtech Revolution," which aims to educate and empower women in navigating the women’s healthcare space. She offers practical advice for self-advocacy in healthcare settings, emphasizes the importance of privacy and equity in digital health tools, and highlights her role in shaping the future of femtech through leadership, mentorship, and legal guidance for startups.
 
Guest links: http://linkedin.com/in/bethanycorbin/ | https://femtechlawyer.com | https://www.amazon.com/Femtech-Revolution-Harnessing-Technology-Supercharge/dp/139433091X
Charity supported: ASPCA
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editing: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPT
Episode 062 - Bethany Corbin
[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.
 Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am so excited to introduce you to my guest, Bethany Corbin. Bethany Corbin, JD is a nationally recognized healthcare innovation attorney, femtech entrepreneur, and influential thought leader at the intersection of women's health and law. She's the founder of Women's Health Innovation Consulting and Fem Innovation Organizations Design, organizations dedicated to advancing equitable cutting edge solutions in women's health. Her book, "The Femtech Revolution," empowers every woman to confidently navigate the femtech space, equipping them with essential tools to protect themselves and advocate for their health needs.
All right. Well, welcome to the show, Bethany. I'm so excited to be speaking with you today.
[00:01:35] Bethany Corbin: Thank you so much for having me, Lindsey. I'm honored to be here.
[00:01:39] Lindsey Dinneen: Awesome. Well, let me just start by asking you if you don't mind, to share a little bit about yourself, your background and what led you to MedTech.
[00:01:48] Bethany Corbin: Absolutely. So I'm an attorney by background, which is not the traditional path that one would think of when we think of medtech. I actually, when I went to college, I wanted to be a doctor and get kind of into the biology and the sciences, and I realized I was actually really terrible at them.
It was not where my skillset aligned at all and I had to do a bit of recalibrating ,realized that I loved kind of research, writing, learning about new things, and ended up going into law from there. When I first went into law, though, I was actually in financial services and litigation, so it was like the farthest thing ever from healthcare and medtech, and it was horrible. I actually hated it.
And, from there, I ended up getting a clerkship in DC and that gave me time to really consider what I wanted to do after that clerkship ended, and really where I wanted to focus my practice. I have been involved in healthcare since I was eight years old. My mom actually had an illness where doctors continually dismissed her. And so it took us seven to eight years to get a diagnosis. So, I had a lot of background with healthcare, then had a lot of background in healthcare with my grandparents getting sick. And so for me, healthcare was always something I was really interested in.
I started to look into health law. I actually, at the time that I was doing my clerkship and going into my next job was doing a healthcare LLM-- so essentially a master's degree for lawyers in healthcare law, and I ended up transitioning into healthcare law from there. I was doing big law in Washington, DC at the time, doing your traditional healthcare things right?
Like your managed care pharmacy, benefit management all of those kind of things--some healthcare privacy. And, it was great. I actually got the opportunity to teach law at my alma mater, and it was while I was there, it was in 2018 that I actually came across the term femtech for the first time, and I had never heard this term.
I got really interested in it, really excited about it, and I started focusing my research portfolio and scholarship on femtech. So I went and did my first conference on femtech, wrote my first paper on femtech in that time, and really started to see the impact that this could have on women's healthcare going forward.
So I actually left teaching went back into big law in order to focus on femtech and while I was there I realized that a lot of the companies that were creating these products were startups. And of course, big in big law, you're not really working with startups, you're working with those larger corporate institutions.
So I actually left big law, went to a smaller firm where I could start and focus on a femtech practice and work solely in digital healthcare. And I absolutely loved it. I got a lot of expertise and knowledge, and then from there branched out into having my own firm focused on femtech and working with early stage founders to help them bring their products to life, to revolutionize women's healthcare.
So I know that's a long roundabout way of getting there. I'm now running my own firm, and I have a book on femtech that's coming out this fall.
[00:04:41] Lindsey Dinneen: Oh my goodness. First of all, I love hearing the background and the winding path that led you to this incredible calling, and I would love, okay, so many things stand out, but let's start with your book. Can you share about that? Because I am personally very excited about this, and I would love to hear about your journey and writing it, and then what's it about and how can we even get a copy.
[00:05:02] Bethany Corbin: Yes, absolutely. It's so funny, right? 'because if you had talked to me three years ago and told me I would write a book, I would've said that you were crazy. And it's interesting. My book is called the Femtech Revolution, and it's really about harnessing digital health tools to improve and help to transform and revolutionize women's healthcare because for so long, women have been left out of the conversation about healthcare. Our bodies haven't been studied. There's a lot of disparities that we have and a gender data gap that we have when it comes to women's healthcare. And this has continued today.
When my mom, you know, when I was eight years old, she was continually dismissed by doctors and told it was in her head. Coming full circle, I had my own women's health issue very unexpectedly in 2021, and my pain was actually dismissed and mismanaged with my surgical team.
And so seeing that occur in today's environment and how little we've grown in women's healthcare and innovation over that time period was something that, for me, was really a driving factor, not only in my transition to femtech, but also in writing this book. Because there's been studies that have shown that about 89% of women have actually never heard the term femtech, and yet it's this entire multi-billion dollar industry that's being created for us, but we don't know about it, and we can't get access to it because of all of the censorship and stuff that happens online.
So we don't even know this exists. These tools are being built, and then we're not seeing a lot of investment or adoption into the tools because we don't even know they exist. So then, the companies can't get the consumers that they need. And of course we're also living in a time in which we're in this post Roe v. Wade environment where, I'm sure as people remember, there were a lot of calls to delete your period tracking app, and things like that when the Dobbs decision came out.
And so when I've been working with startups, I always do it from a very consumer-centric perspective, which is we want to maximize privacy for consumers, we want to give them accurate tools and devices that they can use. And we want to be promoting health equity so that these tools can be available for women regardless of their income and their status and their circumstances.
And as I was working with startups, it dawned on me that there's actually nothing out there for consumers and patients telling them, "Hey, this industry exists," but B: how do you navigate this industry with all of those considerations in mind, and avoid these products that are probably just going to be fake products, right? ...or inaccurate products, and they're actually going to do more harm than good.
There's nothing that tells consumers how to navigate that space. And so I thought, "I'm going to write the guide for how consumers can vet these products in under 15 minutes, and how they can navigate and understand this space.
So that's where The Femtech Revolution came from. It is a playbook for women to not only understand the background of women's health, how we got here, why we're being neglected, but also to then say, "I want to use these digital tools. Here's how they can help me in my health journey. But here's how I vet them."
I created a four step framework for vetting products. It's called My Safe Method. So it, that's based on security, accuracy, foundation and equity. And it's really focused on making sure that you as a person and a consumer are choosing products that align with your privacy goals and your security goals.
So your health data's not at risk, and you're choosing products that are accurate and how you actually tell that versus products that claim they're accurate but actually have no scientific backing. It focuses on foundation too, so looking at who is comprising the company, right?
What are their values, their goals, so that you can make sure you're supporting companies that are in women's health for the long term instead of just to profit off of us. And then of course, equity, right? Making sure that we're. Choosing and selecting solutions that are going to be usable by the majority of women regardless of racial, ethnic status, income status--any of that. We want to make sure that we are developing products that have the core of women's health in mind. So that's really what the femtech revolution is about, and it's just about empowering women and showing them how to navigate the space in a way that's never been done before.
[00:08:54] Lindsey Dinneen: Wow. Well, I am so excited for this book. I cannot wait to get my own copy. Are you doing pre-sells right now or how is this working?
[00:09:03] Bethany Corbin: Yes, the book is available at all major booksellers right now-- Amazon has it, Barnes & Noble, Books-A-Million. And then for companies or individuals who want to purchase bulk copies, there's actually a way to do that through Porchlight that gives you a discount. It comes out September 23rd. But if you pre-order, you'll get a signed book plate and you'll get all of these other resources that I'm creating kind of behind the scenes to actually compliment the book. You'll get all of those in digital form free because of the pre-order.
There's a link on my website. Site. If you go to femtech lawyer.com, there's a book section and there's a form there that you can complete after you'd make your pre-order and you'll be signed up to get all of those great things.
[00:09:42] Lindsey Dinneen: Excellent. Ooh, this is so exciting. Okay, awesome.
[00:09:44] Bethany Corbin: It is, you know, and I will say it was so far been a number one new release on Amazon for health law. And it was also listed in Publishers Weekly in its preview for fall books alongside books like Dr. Sanjay Gupta that's coming out. So, it is, it is getting some attention, which I'm very thankful for because we really need to drive awareness to this space.
[00:10:03] Lindsey Dinneen: That is amazing. Congratulations. I'm sure this is just the beginning of its success and I cannot wait to see, where it goes and how it changes lives and, improves so many women's experience with healthcare. So thank you for writing it and congratulations on its success already and just, it's just the beginning.
[00:10:20] Bethany Corbin: Thank you. I'm, I'm so hopeful. You know, the goal is really to get this in the hands of as many people as possible, just so that we as a collective group, have the power to change women's healthcare if we act together. And so this book is really kind of that rallying cry for saying, if we're not going to do it now, are we ever going to do it because we've, we have the resources, we have the momentum for women's health right now, but we have to band together to show our interest in this industry.
[00:10:44] Lindsey Dinneen: Yeah, absolutely. So on a very practical side, what are maybe just a few key things that women can do to advocate for themselves in a situation where they are being dismissed, their symptoms are being dismissed, people aren't taking them seriously, or they're like , " you don't know what you're talking about," kind of thing. So what are some of the just very practical things that women can do in order to advocate for themselves?
[00:11:09] Bethany Corbin: Oh, absolutely. You know, and we also have a chapter in the book that focuses on EmTech, specifically, how you can actually take your data and use it to advocate at the doctor's office. So I'll, I'll go into some of those tips as well. But, you know, kind of from a, from a high level perspective, the first thing that I always recommend is.
If you think that you're going to be dismissed at all, take a friend, a family member, or call the clinic and see if they have a patient advocate's counsel and take a patient advocate with you because you're much less likely to be dismissed if you have somebody there with you at the appointment whose job it is to advocate for your needs.
And I found, too, that women are a lot less likely to be timid and kind of shy and sit back in those scenarios when you have another person because you know, if you don't speak up, they're going to, and that adds, you know, just a little bit of empowerment to that office visit or the doctor's visit.
So that's kind of the first thing. If you ever feel like you're going to be in that situation, potentially, bring someone with you. It's another set of ears as well. If you are dismissed, you've got somebody there who's able to back you up and support you if you know you needed to make a claim out of it.
So that's kind of the first thing. The second thing I always say, too, is make sure that you're taking your own notes, whether it's at the visit or right after the visit. Be careful about using apps like notes or things like that from a privacy perspective, right? You want to have. Either an app write or a piece of paper that is going to be protective of your privacy and not upload all of your health data into some cloud system without encryption.
So just keep that in mind. But make a note if you felt like you were dismissed in the doctor's office about everything that happened, your concerns, how they were addressed, and make sure that you keep that paper or that application or note somewhere where you can access it if you need to, if you know you end up having an adverse health event down the line.
The next thing that I always say, too, is if you are dismissed in the doctor's office, don't just accept it. Ask why they're not proceeding with additional testing. And if you think that there's a particular test that you would like to have and your doctor continues to say no, or they can continue to refuse to do any type of follow-up, ask if they'll refer you to a specialist.
You can say something that's very simple like, " I understand that you're not willing to look into my condition any further, but I feel that further investigation is warranted. Can you please refer me to a specialist who may have more expertise in this area.
If they're unwilling to do that, the other thing that I also always say is make sure that they put a note about the dismissal in your medical record. And a lot of doctors are going to be very unwilling to do this, and it can cause them to reconsider. So I always tell patients, say, "Can you please note in my medical record that my concerns, desire for additional testing were declined by you." And, oftentimes that will be enough for doctors to take a step back and say, "Do I really want that to be in writing in a patient's medical record from a liability perspective?" And, it can cause them to give you that extra testing because they don't want that dismissal noted in the record. If they don't, then you've got that dismissal noted in the record, which can be very helpful for you going forward if you ever needed to pursue a claim. And then the last thing I will say is, as women, a lot of times we are very, you know, we want to be seen as getting along, right? We want to be friendly, right?
We want to believe that our doctors have more knowledge about healthcare and medicine than we do. But, only we know our bodies. Only we know how we are feeling. And so, if you're continually being dismissed and something in your body's telling you that, that's wrong, listen to it.
Push back and get a second opinion, go to another doctor. Don't be afraid of being seen as confrontational, or difficult, or things like that because in the end, it's your body, it's your health. And, if you have something that's seriously wrong and it's not caught, you're, unfortunately, the one who's going to pay the price.
So just remember that it's not about being difficult or confrontational, it's about saving your life.
[00:14:55] Lindsey Dinneen: Oof. That is powerful, and that is great advice. Thank you so much. Even just listening to just that snippet, I feel personally more empowered to have those kinds of conversations with my healthcare providers if and whenever needed, because I feel like I have better tools and even phrasing. So thank you for sharing that. I think that's really helpful. Yeah.
[00:15:16] Bethany Corbin: 'Course.
[00:15:18] Lindsey Dinneen: So to your legal side of things, can you share what do you do right now? How are you helping in the femtech space --these different companies that are really in need of support from a legal perspective. What is your role in that, and how do you support those folks?
[00:15:34] Bethany Corbin: Yeah, so it's interesting because, whenever I worked at large and smaller law firms before I branched out onto my own, one of the things I continued to see was early-stage companies really kind of... They had their idea, right? They're somewhere between ideation and their Series A fundraising round, and they would come to us for legal advice, but they wouldn't have a ton of money, and we would have to turn them away--we would say, "We get it. You're not ready for us yet. Come back when you have X amount of money and we'll help you." And, when they would inevitably come back at that higher price point, we would say, Great, here's 10 things you've done wrong in the interim and now it's going to cost you double the amount of money to fix that."
And that, to me, was heartbreaking. You know, because so many of those things could have been fixed early on and, nobody was really providing that support. So, I found a gap really, for these early stage companies who needed legal support, but really didn't have a lot of places to turn. So, whenever I branched out with my own law firm, what I did was I actually specifically chose to focus on those companies somewhere between ideation and Series A fundraising round, where I could guide them through those startup phases in a way that was not going to be cost prohibitive to them, and would allow them to get that early foundation set so that they could grow scale, build, get excess capital get investors, all of that type of thing.
So my role, it's interesting because it straddles two lines, right? It's of course legal advisor, but also there's a bit of, you know, kind of business planner in there as well with them and helping them conceive their ideas, right? Helping them kind of think about which features work or don't work from, not only practical perspectives, legal perspectives, but consumer perspectives as well. And so I get to wear a lot of those different hats.
So, on a typical day I might do anything from advising clients on corporate structures, you know, how they want to set up their business. Is it a corporation? Is it an LLC? Working through those equity issues--how you think about equity for co-founders, or for investors, or for your employees. I do a lot of that. I do a lot of setting up very specific corporate structure models. There's actually a lot of corporate practice of medicine laws out there that prohibit individuals who aren't doctors or medical professionals from owning companies that provide medical services.
And, it's very interesting because oftentimes the people who want to build these companies and make money are not the doctors who would be providing the services. Investors, for instance are not doctors. So there's a very interesting corporate structure that you can create that gets around that in most states.
I do a lot of that to help my company stay in compliance with the laws. I also do a lot of privacy work. So I have several privacy certifications, and privacy is one of the key areas that I'm very passionate about. But, I help companies with everything from their privacy policies, to disclaimers, to thinking through how their different features in the app could compromise privacy, and kind of everything in between there--security, cybersecurity, and really working with them to think about it from a consumer perspective.
I actually am selective about the clients that I do take on because there are so many companies out there that want to prioritize money over the patient experience. And so I'm very cautious to work with clients that want to make sure that they're doing things right and really wanting to make sure that they protect patient privacy.
I do a lot on the patient privacy front. I do a little bit on the fundraising side with my clients, as well. And then of course, everything from contract drafting and negotiations. I do a lot of that as well. And I've actually co-written a book on contract drafting before.
[00:19:02] Lindsey Dinneen: Oh my goodness. So, okay, first of all, that's awesome. I love all of this. And you know, I was thinking as you were talking, I was like, "Oh my goodness." I love how you're helping your clients and I love your your passion for especially helping clients succeed who they are about more than the money.
Everyone has to make a living, so that's important too. But, I love the fact that your heart is for those people who are so invested in actually changing lives, and that's their primary driver and motivation. I think that's really powerful. And then, listening to you talk about this, I'm like, "Okay, so you've got this amazing, probably more than full-time opportunity, you've written a book and then, you're also CEO of Fem Innovation and a mentor with Femtech Lab.
[00:19:48] Bethany Corbin: Yeah, I did a lot of mentorship through Femtech Lab. They were kind of an accelerator program for femtech companies, and I've worked with other accelerators over that time, as well. So it's the pro bono advice that you're able to give to some of the early stage startups across the world throughout their early stage journey through those programs, which has been really great and fascinating to work with.
And then through Fem Innovation, our focus is a little bit different there because we're focusing on both startups and medical professionals. We actually have a course that we've created that teaches clinicians and healthcare professionals about femtech, how to get involved in femtech, and how they could be using those tools to actually support patient care and help empower their own patients because there's such a lack of knowledge even among clinicians today femtech exists, and how you incorporate it, especially if we're thinking that there's so many tools out there, and the risks associated with them--how do you know which ones are appropriate as a clinician, that type of thing. We've also seen a lot of clinicians wanting to get involved with femtech companies as advisors, or even as part of their boards or, coming on as medical professionals in those companies.
And so some of the courses that we've done before have been focused on that as well, on helping them interact and get those roles with femtech companies. So we kind of see ourself at fem innovation as an ecosystem builder. We've obviously I have the legal side but now we're bringing in the clinicians, getting them integrated into this, getting them connected with the startups because it's their industry. This is what they're working on. But, there's oftentimes such a disconnect with the tech companies building the products and the healthcare professionals. And then we do offer some other additional non-legal resources to founders as well.
[00:21:27] Lindsey Dinneen: Wow, that is incredible. I-- good gravy. I love your heart for all of this. And I also am like, I don't know how you-- I think you must have a superpower of like squeezing more time into your day-- somehow you just add hours miraculously.
[00:21:42] Bethany Corbin: You know, it's so funny whenever I worked at, whenever I worked at a firm, a couple of my colleagues would come to me. They'd be like, "How do you get everything done? Like, there's gotta be 10 of you because how are you doing it?" And honestly, I honestly, it's just because at this point I don't have kids, and so I'm kind of able to really devote all of my time to working.
But no, it's, but I get such fulfillment out of it too because I really feel like we're pushing an industry forward in a way that hasn't happened before. And, getting to see all the new companies come into the space, the new organizations that are supporting the companies, it's been really heartwarming to see all of that. And, you know, on the horizon, we're also hoping to loop in the consumer side a bit more as well. Obviously, you know, the book that I've written is very consumer focused. It can also be used, you know, by clinicians or by startups who want to make sure that they're doing the right things. But, to date, as well, there also really isn't a single location for consumers to go to, to find all these companies.
And we have so much censorship that happens that unless you know exactly what you're looking for, you're probably not going to find the companies that are out there to serve you. And so we we have a partnership that's in the works right now to actually build a database of all those femtech companies and products and have them vetted to a certain extent, or information on there to a certain extent, about clinical accuracy, and privacy, and those things that I talk about in my book. So that's kind of the third component that we'll be weaving in later this fall.
[00:22:58] Lindsey Dinneen: Oh my goodness. How exciting. Oh, I am, I'm so thrilled about all the work that you're doing to push this industry forward and to really make a difference in women's health and, you know, you're such a thought leader in this space-- what was it like stepping into more and more leadership roles to the point of leading your own firm. What was that journey like for you?
[00:23:20] Bethany Corbin: Scary, I will say. You know, it's, interesting because I've always thought of myself, you know, kind of as somebody who could be the backbone of a firm, meaning that I do a lot of like the behind the scenes work, right? A lot of the legal research and writing, and that's kind of what I had made myself in at big law, and you know, also in the smaller firms that I worked with. Whenever I decided, I, was actually initially going to take a break before, you know, starting my firm, I was going to take two years off. I lasted five months. Oh no, I'm sorry--I lasted five weeks. Excuse me. And by that point in time, I had clients knocking down my door saying, "Where did you go? We need this kind of help. Nobody's out there providing it." And so that was kind of the impetus to say, "Okay, I'm going to start the firm earlier, you know, right now. And, I'm going to also look at kind of this ecosystem building, because of all the pain points that we were seeing."
And, so I will say. I, went into it probably unprepared. I, never, if you had told me three years ago that I would have my own firm, I would've said you were absolutely crazy--more crazy than me writing a book. And I'm, very glad I did it because there's something to be said about kind of plotting and planning your own trajectory and, you know, being able to pivot with your clients instead of having layers of bureaucracy that you have to go through.
So, I have loved it from that perspective. I'll also say it's definitely been the most challenging thing that I have done because as a leader, you're responsible for all the decisions. You're responsible for the trajectory, you're responsible if you're not making money. And you know, there's of course that fine line, right, between philanthropy and making money, and walking that whenever you are really, really wanting, you know, to help every single femtech company that's out there can be difficult.
So I would say, that can be a little difficult sometimes, and making sure that you have the right support system to actually allow you you know, to bounce ideas off of them or, get feedback, and being able to pivot when those initial ideas don't work. That's been something that's been really critical for me is pivoting. This really isn't like the first time, you know, this isn't like the first idea I had, for fem innovation and things like that. So, so being a leader is definitely challenging, and making sure that you kind of develop your own leadership style and leadership, you know, capabilities as well while you're through this journey has been something that I've been working on, too.
[00:25:27] Lindsey Dinneen: Mm. Yeah. Yeah, and, you know, it's a fun, thing because if you're, if you're passionate about helping people, which is clearly at the heart of who you are, and you desire to see improvement in the industry, but in individual people's lives, then as a leader, you're able to take that passion and allow it to help you in developing those leadership skills, and building onto them as time goes by, because you are already starting from a place of deep care and respect for others. And that's a great start.
[00:26:01] Bethany Corbin: No, that's exactly right. And, you know, I love what kind of comes with it too, is a certain level of creativity that we often don't think about whenever we hear the term leadership. But, for me, it comes with that level of creativity where I'm actually able to build something, almost from the ground up, and that is really exciting. I can kind of plan it, take it in different directions, I can pivot with it. And, that to me is just--it's really exciting because as a leader, right, you often think, you've got management, right? You've got delegation, right? You have all of those things that sound bureaucratic and boring, but there's this underlying current of creativity that I think gets missed a lot.
[00:26:37] Lindsey Dinneen: Yeah. I love that. I love that you highlighted creativity because I think that makes everyone's lives easier, right? If you have that flexibility to... this is such an overused word, but to pivot, I mean, it's, it's just, it's true. And so being willing to come at a problem or a situation with curiosity and go, "Hmm. I'm not sure that that's working the way I intended, or hoped it would. And then go, "Okay, what are some creative solutions to this?" And, maybe that means looking outside of your industry, too, for ideas. I think sometimes we can get kind of stuck like, "Oh, this is how the industry is, and that this is what they do," and then we forget that.... But that, you know, that's not necessarily bad or wrong, but we sometimes forget that we can learn from all sorts of different sources and, then bring it together, and creatively handle a situation that we might not have otherwise been capable of doing.
[00:27:27] Bethany Corbin: Oh, exactly. And, the other thing too that it's really done as well is make me a bit of a better lawyer, right? Because as a lawyer, it's interesting, there's always this tendency when you know something is going to either violate a law, or not be the best in practice, to say "No" to your client.
And, so for me, right, clients never want to hear the word "No." And, being a leader has, has allowed me to come up with some other creative solutions for my clients where I can say, "Okay, we can't do it the way you've proposed, but here's a different creative solution that I think could get around these key roadblocks.
And, so for me, with my clients, it's about trying to say, "Not that way, but this way." Right? Kind of like a "Yes, but" rather than a "No." And I kind of take that same approach in leadership, too, because I want to make sure that, you know, with the people who are working for you and things like that, that you're making sure that you're meeting their needs, as well. And so it's really caused me to adapt to kind of a "Yes, but" framework rather than like a flat out, "No, we're done."
[00:28:24] Lindsey Dinneen: I love that. That's really cool. And, that's a great example of how you can approach, again, a problem with that mindset of, "Okay, hmm. That will not work the way that you hope it will work. However, I've got an idea."
[00:28:40] Bethany Corbin: Exactly. It's so easy to say "no," but coming up with this creative solution--that's the fun part. That's really the rewarding part.
[00:28:47] Lindsey Dinneen: Yeah. Well, speaking of rewarding parts, I wonder if there are any moments that stand out to you along your journey so far of really affirming to you, "Wow, I am in the right industry at the right time, in the right role."
[00:29:01] Bethany Corbin: Yeah. You know, it's, it's interesting. I think kind of the first instance of that, that I had-- so I had a very unexpected women's health issue. I ended up with fibroids that were so large, I was the equivalent of six months pregnant. And, they were crushing some of my internal organs. And I'm that person, right, who... I go to my doctor every year, right?
I get my annual--I get all my checkups, and things like that. And somehow all of this was missed. And, so whenever I had to navigate that journey as a patient who-- and I have all of this, obviously, advocacy experience, right--legal experience. I'm navigating this at the height of COVID. I'm getting referrals and consultations with Mayo Clinic, right?
I'm getting the best care that I can. And then seeing how even when you can do everything right, you can still be dismissed... For me, that was a moment in which I said, "I'm not in the right industry at the right time," because at that point in time, I was still in big law, and I wasn't doing anything really related to femtech.
I had kind of resigned myself to not doing that--j ust given some of the internal politics of the firm where I was at at that time, and their desire to not expand into the health-tech industry. I had that experience, and all I could think of was, "This is not what I'm meant to be doing. I had this experience for a reason, and if I'm not going to make something out of that, what have I learned? Why did I go through this?"
That, for me, was the turning point to say, "I'm leaving big law, and I'm going to a smaller firm, and I'm going to work on femtech. And, I'm going to see where this pans out." It was so scary, right? Because you're leaving that high six-figure job, and something you're good at, the work you know, the people you're comfortable with, and you're going into something where you're making half as much money, learning a new industry. And I would be lying if I said I didn't cry my first week on the job, because even as a healthcare lawyer, digital health law and health-tech, medtech--all of that is so different than traditional healthcare, and there's so much to learn.
And honestly, I felt like I was back at school in a course that I didn't understand for a week. So, there's a lot of challenges with that. But, fast forward a few years, we had the, you know, unfortunately the Dobbs decision come out, and that for me was really an affirming moment where I said, "I'm definitely in the right industry, at the right time because I'm helping these companies build privacy practices and policies that are going to be protective of consumer data in this world. I'm helping to build an industry where women can get access to care in less traditional methods that won't compromise their privacy and their data."
And one of the moments that stands out to me --one of the highlights--is I actually got to testify before one of the congressional committees on reproductive health data privacy. And, you know, it was funny, I was actually on vacation at the time. I was in Greece, and we were supposed to be on a ferry going from one island to another. And like the night before I get this request to come and testify on reproductive health data privacy. And I was like, "Yes, I'd love to."
And, of course, the timing was exactly when we were going to be on the ferry with no internet. So, we actually had to charter a helicopter so that we could get over to the other island, get there, get me set up with the internet in order to testify. So that was kind of like my, my full circle moment where I really felt like I was having an impact, and being able to even influence some of the policies in the future of reproductive health privacy.
And then every day since then, I have just loved getting to work with these companies. And, as we continue to see the trajectory of women's health in America, it's just really reaffirmed that we need people doing this type of work for me.
[00:32:37] Lindsey Dinneen: Wow. Oh my goodness. Well, first of all. Wow, what powerful stories you were sharing. Oh my goodness, that is incredible. Thank you. Oh, I, wow. I just like, I was like so interesting how life works sometimes and the unexpected adventures that unfold, and I bet your, your creativity-oriented mindset helped you even in that circumstance, be like, "Okay, so we can't do the ferry. I have to do this. I know I need to do this. How do I make it happen? I don't know. Let's charter a helicopter." Cool.
[00:33:12] Bethany Corbin: It was definitely a moment. I tell you, it's one that has just remained in my head since then. It was just very funny when it happened.
[00:33:19] Lindsey Dinneen: That's amazing. "I'm going to do this." I love it. Oh my word. Okay. Awesome. Well, gosh, this conversation is so good. I know I could probably talk to you for hours and learn so much, but I do want to pivot the conversation a little bit just for fun.
[00:33:36] Bethany Corbin: Absolutely.
[00:33:36] Lindsey Dinneen: So, so, okay. If you were to be offered a million dollars to teach a masterclass on anything you want; it can be within your industry, but it doesn't have to be, what would you choose to teach?
[00:33:49] Bethany Corbin: Ooh. I love that. I love that question. Ooh, a million dollars to teach any class that I wanted, you know, I would probably create a class that would be... I would say it would probably be at maybe like the high school level I'm thinking. You know, because whenever high school students go through those health classes, I would want to start early, there, for women to teach them all about the ways in which they can advocate for themselves and stand up for themselves at doctor's offices, right?
Things, for instance, period pain that they're probably having there, and thinking that's normal, right? Telling them about, you know, how that's not normal, how that you don't have to normalize your symptoms and your pain. Here's how you can protect and advocate for yourself at a doctor's office. Here's how you can use the tech that's out there to protect yourself, because even though, you know, a lot of tech is for 18 up, we know a lot of teenagers are using, I mean, the period tracking apps are like the number or three most used app for adolescents, so pretending it doesn't exist is not helping anyone.
But, we have to get to women sooner and empower them at an earlier age, so that those lessons and that knowledge carries with them as they navigate the healthcare system for the rest of their lives. So, for me, I think it would be a course that was really focused on the early high school student, teaching them all about how you navigate not only femtech, but health-tech in general, the healthcare system, how you advocate for yourself, how you have those conversations with your doctor without feeling embarrassed, and why that's so important.
[00:35:22] Lindsey Dinneen: Wow. Yeah, that would be a really powerful class and so needed, and I love the idea of starting that way, that that would be a part of just education in general, so that, you know, everyone benefits from that, it's a win-win when we, when we advocate for women, help them understand how to advocate for themselves, and how to protect their longevity, their health. You know, that's really cool. I love that.
[00:35:47] Bethany Corbin: I would love, I would love to do it. That would be a dream, really kind of creating a curriculum to incorporate into health classes for high school students.
[00:35:54] Lindsey Dinneen: Ooh, maybe your next writing project.
[00:35:56] Bethany Corbin: There we go.
[00:35:57] Lindsey Dinneen: More to do... when you find yourself bored at some point.
[00:36:01] Bethany Corbin: That's right. That's right. Next week.
[00:36:03] Lindsey Dinneen: Right, right. Amazing. Amazing. Okay. And how do you wish to be remembered after you leave this world?
[00:36:13] Bethany Corbin: Oh, interesting. You know, after I leave this world I would love to be remembered as somebody who participated in the women's health movement. We think back, you know, of course like to the suffragists, right? And you know, all of those amazing women who helped get us the right to vote...
I want to be considered part of the women who helped get women's healthcare on the map with men's healthcare, right? That helped really spur this movement forward for women. So I don't even need to be remembered by name, right, but just as somebody who was involved in that movement, and was very active in promoting women's healthcare and getting us to the place where women aren't being dismissed and we're being taken seriously.
[00:36:51] Lindsey Dinneen: I love it. Beautiful, beautiful legacy to aspire to. And you're already, you're already there. So that's, that's an encouraging thing. You're working on that right now.
[00:37:00] Bethany Corbin: Oh, thank you.
[00:37:01] Lindsey Dinneen: I love that. And then, final question, what is one thing that makes you smile every time you see or think about it?
[00:37:10] Bethany Corbin: Ooh, I love that. Ooh. Okay. So one thing that makes me smile, I have so many things. I'm usually not ever, like, not smiling. Okay. So I have, I have a couple obviously I'm a huge pet lover, so my dogs... we're getting to the point where they're a little old now. One of them's 15, one's 13.
But, any kind of animal, pet --especially little puppies, I love... so that's, that's something that makes me smile all the time. I will say, I also have a slight obsession with books that have sprayed edges. Which, you know, is, is becoming a major thing now. So it's, it's really cool. But there's actually artists who will paint the edges of books, and I'm a huge book lover, so I actually have a library of sprayed-edge books that I just love looking at, and they make me smile all the time to see the different, you know, artists and artwork on the bookshelves.
[00:37:58] Lindsey Dinneen: That's awesome. Oh my goodness. Yes. Well, I can relate to all of that and I. I, yeah. That's so fun. I love that too. Animals always make me smile. I mean, it's like a running joke around people that know me. It's like, okay, if you bring an animal around, I'm going to be like, "Can I hold it? Can I touch it?" Like, instantly.
[00:38:16] Bethany Corbin: You know, I've, already warned my family. I'm like, "If anybody... if you guys die, I'm sorry, but I'm going to have 10 pets. Like, it's just going to happen.
[00:38:22] Lindsey Dinneen: Yeah.
[00:38:22] Bethany Corbin: I'm not going to be able to control myself.
[00:38:25] Lindsey Dinneen: Right. It just... Yeah, that's what happens. I get it. Oh my word. Well, this has been such an amazing conversation. I'm so thankful for you and for your time today, and gosh, just sharing so much practical advice, and insight, and your journey. So first of all, thank you so much for doing the work that you're doing, for being in this industry, for pushing it forward for being somebody who is a pioneer and your own version of suffragette. And, I really love what you're building, and I'm so thankful you're doing this work. So, gosh... I just wish you the most continued success as you continue to work to change lives for a better world.
[00:39:00] Bethany Corbin: Oh, thank you so much, Lindsey. This has been so great talking with you, and sharing the knowledge, and I'm so hopeful that we can push this industry forward together because we do have the power to change it. We just have to act on it. So, thank you so much for helping to spread the word.
[00:39:15] Lindsey Dinneen: Absolutely. Amen to that. And, thank you so much to our listeners for tuning in, 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.
[00:39:29] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Dhruv Agrawal is CEO and president of Aether Biomedical. Discover Dhruv's unique journey from studying medicine in New Delhi to creating life-changing bionic limbs. Under his leadership, Aether Biomedical has achieved significant milestones, including CE certification and FDA registration for its Zeus V1 bionic limb. Dhruv shares his personal story of transitioning from medical school to MedTech innovation, the obstacles faced and lessons learned as a young entrepreneur, and the hope and inspiration of seeing Aether's prosthetics transform lives, especially in war-torn regions.
 
Guest links: https://www.aetherbiomedical.com | https://www.linkedin.com/company/aether-biomedical | https://www.instagram.com/aether_biomedical/ 
Charity supported: ASPCA
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPT
Episode 061 - Dhruv Agrawal
Dhruv Agrawal
[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.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Dhruv Agrawal. Dhruv is the CEO and president of the management board of Aither Biomedical. He studied medicine in New Delhi before dropping out to pursue a bachelor's in business management. He also has a postgraduate diploma in Medical Device Development Regulatory Affairs from University of California Irvine, and a Master's in Data Science from the University of London. Under his leadership, Aither Biomedical has achieved CE certification and FDA registration for the Zeus V1 bionic limb, and established distribution across nine European countries, the US, and India. Additionally, Aither has raised over 12.5 million US dollars in private capital from leading VCs and has been a part of multiple European grants and research programs for an additional 6.5 million US dollars in non-dilutive capital.
All right. Well, thank you so much for being here. Welcome to the show. I'm so excited to speak with you today.
[00:01:49] Dhruv Agrawal: it's a pleasure to be here, Lindsey. Thank you so much for inviting me.
[00:01:52] Lindsey Dinneen: Of course, of course. Well, I would love, if you wouldn't mind just starting by sharing a little bit about yourself and your background and what led you to Med Tech.
[00:02:02] Dhruv Agrawal: Yeah, absolutely. So I'm Dhruv Agrawal. I'm the CEO of Aither Biomedical. We are a company based out of Poznan in Poland, so on the western part of Poland. It's a little bit chilly here. As a company, we are a team of about 55 people right now, currently present in the US, Europe, Middle East, as well as India. And we focus on making bionic hands for upper limb amputees.
[00:02:25] Lindsey Dinneen: Amazing. Yes. So I wanna get into everything amazing that your company does, but going back for just a little bit, in your own personal history, can you share a little bit about maybe growing up and what experiences led you to think, "Hey, in the future, maybe I wanna do X, Y, and Z."
[00:02:43] Dhruv Agrawal: Mm-hmm. So first of all, entrepreneurship was never a plan for me. I didn't even knew that there was a thing called an entrepreneur until I was easily into high school. Both my parents are doctors. My dad's a pediatrician, mom's a gynecologist, and as it happens in India, if your parents are doctors, you kind of know that you have to become a doctor as well.
So I went to the coaching classes to pre, to prepare for medical entrance examinations. I actually met my co-founder there about 10 years ago. We both got into medical school. I was generally comfortable with medicine, you know, growing up in a hospital with doctor parents around. So I was generally comfortable in a clinical setting, but I realized that I was much more interested in the technological aspect of medicine rather than the clinical aspect of it. And that was when I was getting into the second year of my university.
And luckily my dad, for my 18th birthday, bought me a 3D printer, like a very simple 3D printer from China as my 18th birthday gift. 'cause I was really wanting to get into that world. And that's where the story begins. So even till today, my dad jokingly says that that's the worst gift he has ever bought for me, because that made me drop out of medical school.
[00:03:57] Lindsey Dinneen: Oh no. Okay, so you were given this gift and you started, I imagine, tinkering with it, learning how to use it. So tell me about that.
[00:04:06] Dhruv Agrawal: Yeah, the thing with my co-founder as well, even though we went to the same medical university, we were not really friends in the first year. We were just colleagues. But when I got this 3D printer, it was like one of those things that you assemble, you get a kit and you assemble. And I was asking around people in my university and they were like, "Come on, what are you doing? Like, I don't wanna come to your apartment to assemble a 3D printer." And my co-founder was the first one who said yes to coming down and assembling that printer with me.
So that's how our friendship essentially started in the university, even though we had known each other for three years by that point. And then we started, of course, by very basic things like printing mobile phone covers and key chains and we were just in awe with the fact that I have something in my room, in a studio apartment, where I can just build physical things, right? And this was back in 2018, so 3D printer was not such a consumer product where, you know, if it was of course used in industry, but it was not something that you would imagine having at your home, at least not in India.
And then we actually found out that there's a society called Enable, which is an NGO that makes very simple basic prosthetic designs for kids. So we started by printing those and started going to some amputee clinics around and trialing that out with patients, just purely out of technical curiosity. We didn't really had a draw towards amputation, so to speak. We were more driven by the technical curiosity of, you know, it sounds interesting to make a prostatic hand. So that was the beginning.
And then slowly, slowly things happened very organically that we went from wanting to 3D print basic things to starting a biomedical innovation club in our university, to incorporating a company in India, then to coming all the way over to Poland and now having 55 people.
[00:05:49] Lindsey Dinneen: Holy cow. That's an amazing story. Thank you for sharing about that. So, okay, so, so you started off with this curiosity, like, "Hey, let's see what we could do with this printer and, and how we can make it work for people." And I love that your initial pull with it was to actually provide something that does help people. So that's obviously a core value, something that you hold very dear. So can you speak a little bit more, did you have sort of any personal experience or within your family or what led you to say, "You know what, hey, I've got this really cool tool at my disposal. Let me start using it by actually doing something that helps others."
[00:06:27] Dhruv Agrawal: I mean, the honest answer, I would love to say I had some personal experience, but the honest answer is no, not, not really. I don't have one of those stories where I can tell you that, like I met an amputee 15 years ago, 20 years ago, and have had that motivation for that time. It was just pure technical curiosity to begin with. But of course, as we started building basic devices and giving it out to people and seeing the response of what a very simple, you know, $50 thing can do for a person who's missing a limb in an impoverished family in a village in India, that's a very powerful thing.
So at that point, we realized that we started getting more and more close to upper limb amputation as a field, as a clinical specialty within itself. Of course, both me and my co-founder coming from medical school growing up in family of medicals, we've always had it in our heart to work in the clinical side of things. We've always liked working around, helping people get healthier and better. But amputation specifically was an area that we were very lucky that we found as an area of interest that developed within the both of us.
[00:07:31] Lindsey Dinneen: Yeah, of course. Okay, so, so you started printing these limbs, and then you realized, "Oh my goodness, there's such a need for this. There's so much opportunity here to really help people." So, so tell me a little bit about the evolution over time of how you have made it better and better, more technologically advanced, more ergonomic, all the things that go into that. Can you speak a little bit to that learning curve and process?
[00:07:56] Dhruv Agrawal: Mm-hmm. Yeah, it was a very long learning curve because not only did, me and my co-founder had zero background in business. We were 18-year-old, 19-year-old kids, right? We were just teenagers and we really had no idea what we wanted to do. And not only that, we also were not engineers, so we didn't have any engineering experience or expertise either. So everything that we did in the very beginning, at least, was self-taught. I just knew I had an inclination towards electronics and programming. My co-founder was much more towards mechanical CAD design and things like that. So we started learning these courses for free on edX and Coursera and all these, you know, MOOC platforms. And that's how we built up the very first prototype of the product by getting some small grants here and there in India.
Of course, the situation is very different right now. We have R&D team of 30 people, very experienced, a few PhDs here and there. So I don't really design anymore in my day-to-day life, but that's how we started. And same was the side of the journey of coming from India to Poland. Again, that was not something that was planned at all. We had no experience in business. We had no experience in raising funding or raising money and things like that. We just learned on the go, applied to over a hundred different programs 'cause most of the investors said no to us back then in 2018 to funding 'cause why would they say yes?
And we looked at like, "Okay, can we get some grants and things like that?" Applied to over a hundred programs. Luckily got selected in this program in Poland, which was like a $50,000 program back in 2018 and decided, "Yeah, let's try that place out." And came to Poland. I literally came with a backpack with stuff for two months 'cause there was a plan, come for the grant, stay for two months, go back to my family in India, and it's been seven years since then.
[00:09:44] Lindsey Dinneen: Oh, there you go. Oh my goodness. That's great. So Poland, and you get along it sounds like just fine. Excellent. Excellent. Okay, so, I really appreciate you sharing about, especially, you were both so young and but so eager. It sounds like just, "Yes, let's learn, let's develop the skills that we need to along the way."
I would imagine though, coming into it, perhaps that young and not having as much business experience, or, or any really in, in the past, I-- something that I really admired when I was kind of looking through your LinkedIn profile was when you post, a lot of times you share stories about areas that, that may be considered I, I guess mistakes or stumbling blocks or things that, that you've overcome on your path.
And I would love if you would share maybe just a couple of things that come to mind, as an early founder, because your story is amazing and unique, but there are lots of other founders too who find themselves in similar situations where they're like, "Whoof, I've got this great idea. I know what I want, but here's maybe what I should look out for to avoid." could you share a little bit about that?
[00:10:49] Dhruv Agrawal: Yeah, absolutely. I mean, the first thing is mistakes are unavoidable, right? it doesn't matter whether you're coming from a background of a medical school dropout, or if you have 10, 15, 20 years of corporate experience and things like that. 'Cause I do find myself thinking a lot about, you know, wouldn't it have been better if I would've graduated and then did a MBA and then started a company? Yes, it might have been better, but the things that I deal with in my day-to-day life in the startup, I don't think this is taught anywhere. So the first and foremost thing, which is of importance, is that mistakes are unavoidable. It's okay to make mistakes.
The biggest learning that I have is mistakes are unavoidable, but it's up to you to be decisive enough to pivot as quickly as possible. So don't look back at the mistakes that we have made, because one of the worst things that we have done in this company, or where we have failed the most, or where we have seen that like, "Ah, this is where we could have done things better," are not about making a wrong decision. They were just about being indecisive and being in a dilemma for a long, long time. It would've been far better if we would've made certain decisions quickly, gotten feedback and quickly pivoted, instead of just being in a dilemma and trying to balance two sides for a long time period.
An example of that would be when we launched the first version of our product into the market, we realized that we had made some errors from the point of view of what should be the feature set in this product. And so, for example, the product was available only in a medium size hand in terms of the dimensions, but majority of the market is for a small size hand. So at that point we couldn't really just miniaturize things because there's a physical limitation.
So at that point we had to make a decision of do we scrap this thing completely and build a new hand from scratch that starts with a small hand and then has a medium sized option as a grow up? Or do we continue to work on the medium sized hand, and then launch a small sized hand separately? Finally, we decided to do the second option. But looking back again, I, I don't think it would've been better or worse either way. I think both of these options are fair. It's just the fact that we spent over nine months going back and forth between, "Okay, let's continue putting our efforts in energy into the medium sized that we have right now" versus, "Okay, this month we are now suddenly feeling, ah, that's not gonna work out. Let's start building the second version."
So that dilemma of indecision is probably the worst thing that you can do. Just make a decision, own up to it, move on. If it works out, great, if it not, if it doesn't work out, you're gonna have learnings and you'll be stronger at the end of the day. So that's, I would be an I would say would be an example of one of the key errors that we made.
[00:13:23] Lindsey Dinneen: Yeah. Well, thank you for being willing to share that, and that's such valuable advice and feedback. And so, as you recognize this and go, "Okay, so that didn't work as planned, or in the way that I would prefer," what did you end up deciding? How do you go now, moving forward, when you are in a position of "I have a major decision to make. I feel like both options have value and merit." How do you end up deciding, "Okay, I I'm not gonna leave this just in this hazy middle ground, I'm gonna make a decision." How do you go about that now differently?
[00:13:54] Dhruv Agrawal: I think the first and foremost thing that entrepreneurs, or anybody who wants to build a new product, or anybody who just wants to build something new, is be very, very, very honest with yourself about, "Am I solving a real problem?" As founders, as creators, as developers, it is so easy to go into that mindset of you find a problem that you can relate to or you somehow think that this is a real problem. It doesn't matter what feedback you're going to get. You're going to convert that feedback, or create a narrative or story from that feedback, that is going to align with the impression that you have built in your own head about what the real problem is.
So one thing that we really do right now is just focus on problem market fit at the very early stages of launching a new software, building a new product, building the next version of the hand, or whatever else we do is really try to question, "Are we solving a real problem?" And in a completely unbiased manner, "Do people agree with me that I am solving a real problem?"
So that's what I would say would be a primary thing that we do differently right now. Of course at this point, we start getting users involved much earlier into our development process. That is something that we did not do in the past, and hence the surprise that we got at that point. So we start involving users, different stakeholders, and things like that much earlier, but at the same time, I would say that it's not to say that I would penalize myself for the historical decisions that I took. We did the best that we could potentially with the resources that were available at that point. Now we have much more resources so we can do all these things. So don't feel pressured to do everything on day one. You know, start with something, move forward and build that maturity as you grow.
[00:15:38] Lindsey Dinneen: Oh, I love that. That's excellent advice. Thank you for sharing. Yeah, so you know that's a great segue and I love the fact that you were talking about the end user and the importance. And it's so funny because of course, ultimately your goal is to help these end users and improve their quality of life and whatnot. But to your point, it does get easy to get so bogged down in the details of what you're creating and innovating that perhaps you forget sort of the bigger picture at times. So, speaking of these end users, can you share any stories that might stand out to you as really reinforcing to you that, "Hey, gosh, I am in the right industry, doing the right thing at the right time."
[00:16:17] Dhruv Agrawal: Yeah, no, absolutely. So we have had many phenomenal end users that have reiterated our belief in the product that we are building, the problems that we are solving, the company, and the organization that we are building as a whole. I mean, generally speaking, patients change their devices every three to five years, and that's really our entry point of getting a device into the hands of the patients. But even with those, a patient is using another prosthetic device, they start using ours, they will see a step change in the functionality, and that's always empowering.
But the most interesting stories are where we have really seen patients who, for example, congenital amputees tried a prosthetic device 10 years ago, 15 years ago, and then made a decision to live their life without any prosthetic device. So got used to a life for 15, 20, 25 years of living a life without a prosthetic device, just with an amputated limb or a limb difference. And then, we come in with our product, they see it, they use it, and they are ready to adopt that again. And that's a much powerful validation for us because somebody who has used a device, looked at all the advancements over the last two decades, decided actively decided to not use any of those advancements, and looks at our product and says, "Ah, this really solves the problems that I was waiting for someone to solve for the last two decades."
Like we had this situation with a very famous Polish guy, Marek Kamiński, who is the youngest Polish person to go to both poles, North Pole and the South Pole, and he's a bilateral amputee on legs and he has a unilateral amputation to one arm. He has not used a prosthetic device in, I think 15 or 20 years, something like that. So for a very long timeframe. He met with an ambassador of ours and was finally convinced after 15 long years to give another try. And we fitted him over three months ago and he's been performing phenomenally with the device and he's so happy with that. So those are the moments that really give us more confidence or give us a boost of confidence in the product that we are building and the company that we are building.
[00:18:19] Lindsey Dinneen: That's incredible. Wow. What a story. Yeah, and I love hearing those kinds of stories and that just to reinforce, " Hey, you really are making a difference." And I'm sure that helps on the days that are a little bit harder, a little trickier, you know, it helps to have that to hold onto, so you know your impact goes so far beyond even the places that you've mentioned before. I was reading about how you've worked with the Open Dialogue Foundation and there's been some work in Ukraine, and I'm wondering if you could share a little bit about perhaps that collaboration, and or some of the other exciting collaborations you have going on with these amazing organizations all over the world.
[00:18:54] Dhruv Agrawal: Absolutely. I mean, the work that we do in Ukraine is something which is very close to our heart and what you just mentioned a moment ago, it's exactly that type of work that keeps us going on the hardest of days. I have so many amazing stories from the patients who have been fitted with our device 'cause at this point in the last year or so, we have already fitted over a hundred patients with our bionic hands in Ukraine. We primarily work with Superhumans, which is NGO based out of Kyiv, a great place, really the mecca for prosthetics at this point, I would say. They're doing a phenomenal job of getting these patients in, rehabilitating them, fitting them with our device and then training them on how to use the device. In fact, even supporting them in the post rehabilitation, acquainting them to back to the real world as well.
And we send teams of doctors from the US, from Poland, to Ukraine to actually fit these devices to patients. And we have had a lot of success stories come out of it. We have people who have amputations, even at the level of shoulder who are amputated all the way up to the shoulder or four quarter amputation, and they are successfully able to live a independent life with our device. I think the best story that I've had, or the part that really made me tear up, was when one of the soldiers got fitted with our device and his really, really big wish was to be able to do the first, to dance with his wife, with both hands. And I got to see that and it was, it was the most amazing feeling ever.
[00:20:20] Lindsey Dinneen: Oh my goodness. Yes. I don't know how you couldn't just have the waterfall start with that kind of story. That's incredible. Thank you for sharing about that. So, as you look toward the company's future and your own, what are you excited about moving forward?
[00:20:34] Dhruv Agrawal: I mean, we are currently in the process of getting a new version of our hand in the market, which has all the learnings of the last four years or so. So we are definitely really excited about that. You have to keep in mind when we launched the first product, we didn't even have enough money to-- because prosthetics are expensive-- so we didn't really have had enough money to buy our competitor devices, or the devices from the past to look around to see, touch, feel, how they are built. Everything that we built was purely out of our imagination and based on what we could find on the internet. And, you know, go visit a doctor who fits these devices, have that 10, 15 minutes to look around that device, and so on and so on.
I mean, four years later, now we have the experience of fitting close to seven, 800 patients with our device. All that feedback that has gone into the next version product that we are gonna be building. So very excited about that. We continue to develop the software platform, so we are not just a company that is focused on providing a device to the patient, but we provide an entire software platform that's like a digital twin for the patient. So it supports the patients throughout their end-to-end journey.
Because it's not just about giving a device to the patient, but it's all about can we improve their quality of life? Can the patient pick up a glass of water? Can he tie his shoelaces? Can he water a plant? Can he do the activities that he really wants to do? And from that perspective, the software platform that we continue to build focuses on things like adherence, occupational therapy, physical therapy, monitoring of the usage of the device. Because the thing in prosthetics industry is, the day you give the device to the patient is not the day you have won the battle. That's the day the battle actually begins, 'cause now it's all about making sure that you deliver on the promise of helping him get better quality of life.
[00:22:20] Lindsey Dinneen: Yeah. Yeah. I'm sure that's an exciting challenge, but it's a continually evolving challenge too. And there's probably variations, I would imagine, on people embracing the technology a little bit differently and how you handle all that. Yeah. Excellent. Well that is a very exciting future and it's so much fun to hear about, and you know, you've had a great career so far. I'm sure it's wildly different than what you may have imagined as a kid. But what a cool gift that you're bringing to the world. You've been recognized quite a bit. You're 30 under 30 for Europe, and you've been involved in lots of different cool organizations. You've been a TEDx speaker. What are some of those moments like, have they been surreal? Is it just like, "Oh, thank you." Just confirmation that, hey, you are on the right tracker. What are those kinds of moments like for you?
[00:23:08] Dhruv Agrawal: I mean, definitely the first round of funding that we raised in Poland was was a huge check mark for us, because it's that moment at which you realize, "Ah, somebody wants to give me money and somebody wants to give me a quarter of a million dollars." I've never seen that much money together on a single bank account or in any way, shape or form, right? I come from a normal middle class family. We don't have that. So, that was definitely the first micro checkpoint, let's say. I mean, both the things that you mentioned, the TEDx thing, the Forbes 30 Under 30 thing, coming from a background in India where these things are really important, although they're not so important for me as a person, but they're much more important for some reason to my parents and to society. It is a different place. We put a lot of emphasis on these types of things.
So from six, seven years ago, looking at these lists coming out or looking at, "Oh, this cool guy spoke on a TEDx talk, sending him an email about, 'Do you want to be an advisor in my company? I'll give you 5% shares,'" and so on and so on, to actually doing those things by yourself, that's definitely pretty well as well. But again, at the end of the day, there is nothing better than seeing a new patient get fitted with the hand, seeing the reaction of their family members. They have a daughter, they have a son who they hold their hand for the first time. They hug their wife. I mean, just, just being around amputees and patients who use your device, something that you built and that helps them get better at their daily life, that's, I would say, the most rewarding thing ever.
[00:24:39] Lindsey Dinneen: Yeah, of course. That's, that's wonderful. Yeah. So, oh my goodness, this is so great and very inspirational, but pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars-- speaking of those wonderful sums of money-- to teach a masterclass on anything you want. It can be something within your industry, but doesn't have to be, what would you choose to teach?
[00:25:03] Dhruv Agrawal: I have two topics in mind. One is I would probably teach a masterclass on pitching, especially for first time founders. I think that is something which I'm good at, and we have obviously raised a pretty decent amount of capital up 'till now. So that would be the one thing that I would say. So kind of a combination of pitching and starting a startup for the first time, especially in the field of hardware, medical devices, things like that.
And the second thing that I would really like to talk about is just probably trying to put my thoughts together and making a masterclass on how to never give up, because I think that that's a very underrated quality. But that's a very important quality. There have been complex times in the history of our company where we have felt that like, "Ah, this might be it." But it's all about what you do in those moments and how you go beyond those. I think it's all about that.
[00:25:47] Lindsey Dinneen: Yeah, absolutely. And how do you wish to be remembered after you leave this world?
[00:25:53] Dhruv Agrawal: Just as a positive change maker. I really would like all these patients that we are helping and giving these devices to. I, I just want to be a small part of their lives. Just as I was part of the life of the veteran who got married, I, I just wanna ha have those small moments club together amongst these different individuals that we are privileged to work with.
[00:26:13] Lindsey Dinneen: Hmm. Yes, of course. Wonderful. And then final question, what is one thing that makes you smile every time you see or think about it?
[00:26:22] Dhruv Agrawal: Oh, that's very simple. Patients getting fitted with our device. Today we see a patient getting fitted with our device, and that smile on their face and things like that. And, you know, that's even much bigger, much more interesting in Ukraine because many times when you go to these hospitals, and when I go to these hospitals in Ukraine, you have to understand that these people have gone through a lot. These soldiers who are putting their body on the line for their country.
There, of course, there's a certain sort of low morale that they have when they're amputated and when they're in these hospitals and things like that where they don't really think that there is ever a possibility for them to regain something back. And you go in there and you show them a bionic hand, and they're not sure if this thing works, and you put the electrodes on them and they open the hand or close it for the first time, and then you suddenly see those expressions change from like, "Ah, what has happened to me?" to, "Oh, what can I achieve?" That is also an amazing feeling.
[00:27:16] Lindsey Dinneen: Yeah. Oh, I love that. What an amazing gift to be able to help somebody bridge that gap and witness it. How cool is that? Oh, well, I think this is incredible. I am so grateful for you and your co-founder for starting this company and just being able to give so many people hope and new life, really, just a new way of experiencing life. So thank you for all of the incredible work you're doing. I'm so excited to continue to follow your work, support your work, as I'm sure all of our listeners are as well. So, gosh, I just really appreciate you sharing all of your advice and stories and wisdom with us. So thanks again so much for being here.
[00:27:55] Dhruv Agrawal: Of course, Lindsey, thank so much for having me.
[00:27:56] Lindsey Dinneen: Of course, of course. And we are 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. We really appreciate you choosing that organization to support and thank you just again, so very much for your time here today. I just wish you continued success as you work to change lives for a better world. And thank you also so much to our listeners, 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'll catch you next time.
[00:28:43] 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.

Nidhi Oberoi is a dedicated medtech executive with over 17 years of experience and currently serves as Business Leader, Imaging Franchise at Terumo Medical Corporation. She discusses her journey from India to the heart of the medtech industry, her impactful work on innovative heart valve treatments while at Medtronic, and her advocacy for women's health. Nidhi shares her leadership philosophy centered on empowerment, the importance of mindfulness in business, and her vision for a future in cardiology and women's health.
 
Guest links: https://www.linkedin.com/in/nidhi-oberoi-278a111/
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPT
Episode 060 - Nidhi Oberoi
[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.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Nidhi Oberoi. Nidhi is a seasoned MedTech executive dedicated to the mission of serving clinicians and patients. With over 17 years of experience working on commercialization of innovative technologies, She has led various strategic and operational initiatives that have transformed standard of care. Her bold, collaborative, and empathetic leadership style allows her to push boundaries and inspire teams to create durable value. She currently leads business initiatives for the structural heart business in Medtronic, which serves patients with heart valve disease. She's also an advocate for evidence based care for women's health. Nidhi has an undergraduate degree in economics from India and an MBA in marketing and entrepreneurship from Syracuse University.
Thank you so much for being here, Nidhi, I'm so excited to speak with you.
[00:01:44] Nidhi Oberoi: Yeah, thanks for having me.
[00:01:46] Lindsey Dinneen: Of course. Well, I would love, if you don't mind just starting off by sharing a little bit about yourself and your background and what led you to MedTech.
[00:01:56] Nidhi Oberoi: Yeah, absolutely. I was born and raised in India, and just like any typical Asian Indian household in those days, if you were a bright student, you were generally expected to pursue a track in sciences, medicine or engineering, or maybe a second option in accounting and finance. Predictably, after I completed my high school, I was on my path to pursue a career in sciences. But then I changed courses and ended up pursuing an undergraduate degree in economics, and eventually an MBA in marketing and entrepreneurship from upstate New York.
Now, as I reflect back and realize that what attracted me to business eventually, it was this realization that it's both in art and a science. The science aspect helps to ensure that the business can financially run smoothly with a strong P&L, while the art side of the business is the ability to set the vision, the direction, inspiring people, innovating, connecting with people.
So what I really was interested was in a career in marketing and general management. You asked me what led me to medtech, I'd say my entry into the healthcare industry was by chance. I got recruited into this industry through a summer internship when I was doing my MBA with a company called Conva Tech, which was part of Bristol Myers Squibb then. And by the time I had completed my internship, I already knew I wanted to be in the healthcare industry given the impact you have on the patient's lives. I did have opportunities to interview with other companies like Philip Morris and others, and I just decided that this is what I wanted to do.
And after I graduated, I started working for a company called Covidian, which was then a spinoff from TCO International. And Covidian was eventually acquired by Medtronic. It's been 16, 17 years since I've been working for this company and it has a really strong mission of elevating pain, restoring health, and extending life of patients around the world. So that's that's my story there.
[00:04:07] Lindsey Dinneen: Excellent. Thank you so much for sharing that. I'm curious. Of course your career trajectory has been really interesting and you've had a lot of different experiences along the way. So what are some of the key things that say maybe your schooling or your early career really set you up for success for what you're doing now?
[00:04:29] Nidhi Oberoi: Yeah, so there's just so many different experiences that either have shaped my interest, where I wanna go, or has shaped my leadership style. Now, as I mentioned, I decided to move away from sciences to a more kind of social sciences field, economics and then business, and that was due to the fact that I was not the person who could just crunch numbers sitting on the table. I liked connecting with people. So I think some of those personality traits helped me decide what I wanted to do.
And I would say one of my core value is impact, purpose. And so healthcare, it was just natural for me to gravitate towards healthcare because you are truly impacting people with different technologies. And I'd also say, as I grew further along in my career, early on when I joined Covidian, I had some great leaders who gave me a lot of ownership, and that shaped my leadership style as well. And that's how I operate. I empower my teams. I coach them along, but give them a lot of accountability. So there's so many different experiences, but these are some of the experiences that come to mind as. As as I reflect back now what that has shaped my career and also my leadership style.
[00:05:55] Lindsey Dinneen: Yeah, absolutely. And speaking maybe more into your leadership style, I'm really curious if you could tell us a little bit more about that philosophy of yours. I love that ownership mentality. It sounds very counter to what a lot of folks don't appreciate, and that's micromanagement. And so I'm curious, how do you bridge the gap yourself as a leader between making sure that, your team stays on track and the goals and really key, important performance indicators are met, while also giving them that ownership and that empowerment to make decisions and do things in a way that best aligns.
[00:06:35] Nidhi Oberoi: Yeah. So I think there's so many different facets of leadership, and let me highlight some of the others that feeds into the third aspect, which is the empowering team. So I think as a leader, first thing first, you need to provide clarity, direction, focus. I've been part of so many different teams where if people can relate to what they're doing, why they're doing, they can get lost, right? So I think that's the first thing. You need to have the ability to cut through the noise, provide direction to the team, organization you're leading.
And then the second part is inspiring and bringing people together to execute on that vision. So this is the culture piece. You are listening to others, you're hearing others' perspectives and being inclusive. And the last thing, which I mentioned early on, is empowering your teams and making them accountable. So to your question of how you bridge the gap, I think you have to give clear direction. And when you empower teams doesn't mean that you don't coach them, right? You are just telling them that you trust them to do the job and you are here to help them.
And one of the technique that I use is I ask questions, so I don't give answers. When you ask someone in your team to lead the project, they come to you. Then you ask questions. And I've seen, based on my experiences, that gives them a sense of ownership that this is something they're thought through. And oftentimes I've heard from people that they feel like they become a better version of themselves because I ask a lot of questions. I make them think. So that's my approach on how I kind of bridge the gap, but also make sure along the way that you're supporting them in the right direction.
[00:08:24] Lindsey Dinneen: Absolutely. Yeah, and you mentioned as you were speaking a little bit towards how your past experiences shape who you are and how you kind of relate to the world now, you mentioned core values, and I would love, if you don't mind, if you would share a little bit more about your core values. I noticed that on your LinkedIn profile, that was something that was very highlighted as being extremely important to you, which I love. I'd love if you would share a little bit about maybe how you developed your core values and how those play out for you.
[00:08:57] Nidhi Oberoi: Yeah, absolutely. I think core values is something that you always have, but you just sometimes need a little bit of handholding to unfold those, right? And so in my case, a few years back, I had an opportunity to work with a coach, and she really helped me understanding what I'm good at. These are things that you already have, but you may not realize or you may not know how to articulate.
So for me, the number one thing that came out was purpose. And I'm like, "No wonder I'm in the healthcare industry. I'm big on impact. I like building things." And so that's where it's coming from. The other core value of mine is excellence. I like to do things with excellence. I put my heart and soul into things. I'm a very passionate person. But also you gotta have an eye on quality versus decision making, right?
Over time, I've learned excellence is my core value, but it's a journey, it's a process. It's not a destination. So you don't have to dwell on things. Sometimes things go wrong and you just have to keep moving on and have a growth mindset. So there's a good aspect of the value, but there could be a blind spot, like in this case for excellence and I've learned to manage that as well.
And yeah, so I think these are some of the core values, which is, I think, also part of being a leader. You have to have self-reflection. You need to dig deeper and understand what you stand for. And, this has just guided me along the way. And yeah, so those are some of the things that I'd say has really helped me all along in my career.
[00:10:41] Lindsey Dinneen: Yeah, of course. So, tell me a little bit more about your current position and what are you looking forward to as you move forward in your own career as well?
[00:10:53] Nidhi Oberoi: Yeah, currently I'm in the structural heart space, and these are really old and sick patients. And it's just amazing to see these patients getting impacted by our technology, getting back to their day-to-day life. And as part of structural heart, also, most recently I've been able to work on therapies. I've been focusing on the congenital portfolio, which is, these are devices that are used to treat patients that have congenital disease, and it's very impact driven because you're dealing with children here who tend to get multiple surgeries throughout their lifetime. So my role right now is to focus on business initiatives. Some of it is expansion across geographies. Some of it is increasing supply for these products. I mean, there's not a big business case for these kind of products, but the impact is huge.
So that's my current focus. And, moving forward, in my career, I'm looking to grow into a general management track, and that's what attracted me to marketing because I consider marketing as running a business within the organization. So for me, running a business would be something that I would be looking forward to. And that's why I have spent time in so many different kind of roles, whether it's marketing, it's commercial transformation, whether it's global roles. So that's how I've been building my skillset so that I can one day lead a business.
[00:12:25] Lindsey Dinneen: Yeah, that's very exciting. Okay, so you're building all of these skill sets. You're working towards this incredible goal. Do you have an idea of what kind of business you would want to get into? Or is this, " We'll see," and I'll interview you again when that happens?
[00:12:38] Nidhi Oberoi: Yeah, I think cardiology, there's so much opportunity in cardiology. There are so many people getting impacted by cardiovascular disease around the world, and there's so much innovation too happening, not just on the treatment side, but also on the diagnostic side. So I would say either something in the cardiology space would be very attractive because it's innovative. There's such a huge population that gets impacted by it.
Or the other area of interest for me is women's health, and I think it just makes me smile how there's progress being made. I know there's so much work that needs to be done. We know there's not enough evidence, it's underfunded, but I think the work is starting there, and better evidence generation will lead to better decision making, which will lead to better outcomes. So I would say either in the cardiology space or the women's health space, these are the two areas of interest to me.
[00:13:38] Lindsey Dinneen: Yeah. And I noticed again, with LinkedIn, you are very passionate about women's health and I love that. And I am wondering if you could speak a little bit towards some of themes that I kind of picked up on, things like stigma with women's health, medical gaslighting and self-diagnosis. And I know there's a lot to that and it's probably too much for one conversation today, but can you highlight a couple of the areas that you particularly find concerning, that are things that we can all do better?
[00:14:11] Nidhi Oberoi: Yeah. Yeah. I think first of all there's such lack of education and awareness. As women transition through different stages of life, I feel like a lot of it is taken for granted. We don't question it. And as someone who's been following this for a little bit of a time, I almost feel like it's my duty and being in the healthcare industry, to raise awareness about this or encourage them to be more educated patients. When they go to a doctor, if they don't get answers, they should ask more questions. So I think, so that's that lack of education and awareness piece. There's a lot of work happening. There's so many advocacy groups. Women are coming together, supporting each other, so I think that's happening as well.
The other thing that really bothers me is on the diagnostic side. I wrote an article around women get mammograms. Just because there's not enough evidence out there, sometimes you just have to go through a number of tests to have a diagnosis, either a positive or a negative. So I also feel like maybe the advent of technologies like AI in the diagnostic field can help improve that, because it starts with the diagnostic side, and we just don't have enough right now. And like I said, it can either be a good thing or bad thing. I've also heard of women going through a number of tests to find out that they don't have anything, which is fine, but it's just a lot of money along the way getting to the diagnosis.
And then, the third thing I'd say is as we get more intelligent with evidence, it will lead to better awareness among the physician community too. And that's what gaslighting comes because there's not a lot of evidence, there's not a lot of awareness. Even physicians sometimes can't guide you in the right direction. But if you have more studies coming out, it will make them more aware and guide their patients in the right direction. So there's just so many different things, but I feel like you could start being a self-aware patient and not just assume as you go through different stages of your life that this is what it comes being with a woman. Be more proactive, ask questions, research, talk to other people and get help.
[00:16:32] Lindsey Dinneen: Yeah. Yeah, that's really great advice, and I appreciate your perspective in sharing with us a little bit about maybe even some of the things that we all can do as we're trying to hopefully push the quality of women's healthcare forward and make it more widely available and whatnot. So thank you for sharing. As you have been going throughout your career-- and you obviously care so much about purpose and you have a lot of passion for helping people and for the healthcare industry in general-- are there any moments that really stand out to you as affirming, "Hey, I am in the right industry at the right time?"
[00:17:11] Nidhi Oberoi: Yeah, there's been so many moments and I would say most of these moments are when I've interacted with patients. When I started with Covidian, I was leading an initiative which would help a lot of women who were having open hysterectomies-- this is like 10, 15 years back-- to have a minimally invasive hysterectomy through a new procedure technique. So it was called single incision surgery. And I happened to talk to some patients, and it was just amazing to hear those stories where they were telling me how they could get back on their feet, travel, within just a week after the procedure. So that's the defining moment.
And then, when I was working on one of the businesses where patients have very varicose veins, I met a patient who was a mom of four. So she had four kids within a span of six, seven years, and she had very visible varicose veins on her legs. And that impacted her quality of life. And when she got the procedure done with our technology, she was just so happy. It was not just cosmetic, but also less painful, and being more present with her kids because of that.
And then I'd say most recently in the cardiology space, these are really sick patients, older patients with multiple conditions, and just hearing their stories of getting a new heart valve, it's amazing to see how, again it's getting back to life. So it's always, when you meet these patients, those are the defining moments, and it just reaffirms why you're in healthcare and why you need to continue to work in the healthcare space.
[00:18:58] Lindsey Dinneen: Yes. I love that so much. Yeah, so pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry. It could be related to anything your background, your experience, but it doesn't have to be. What would you choose to teach?
[00:19:19] Nidhi Oberoi: Yeah, that's a great question. I don't think I have an expertise right now, but maybe something on mindfulness and yoga. One of my goals is to do a yoga teacher training, but the importance of mindfulness in business. There's so many things you can do: power walks, taking a break, journaling. These are so underrated, but I think these things are necessary. It's more important than ever now, given the fast change. There's so much, so many changes happening at such a fast pace. So I would say that would be my topic, but I don't think I'm ready yet to have that masterclass.
[00:20:03] Lindsey Dinneen: Fair enough. Fair enough. So I'm curious, how long have you been incorporating these kinds of really important mindfulness practices into your own life and your own routine. Is this something that you've had for years and years or is it a more recent development?
[00:20:19] Nidhi Oberoi: Yeah, I think it's more recent. I would say three to four years, although I wonder why I did not do that. I think within the organization, as you are managing multiple things, it just forced me at that point of time when I was juggling a lot of things in my life and I wanted some pause and clarity. And I actually, years back, I had take a yoga class and then I started doing core barre yoga as well. So I realized that it really has a big impact on me.
And then I just try to be more disciplined and try to take out time, if not every day, maybe every two days, but I would say it's more of a recent phenomena. It does require a lot of discipline. Earlier you start, the better it is because you're not going to get it right away. It takes a lot of discipline and commitment to incorporate these. And you won't be able to do it all the time, but at least starting that and trying to incorporate day to day life is a good start.
[00:21:26] Lindsey Dinneen: Yeah, absolutely. I found personally that starting my day with a much more intentional routine that includes things like meditation and those kinds of mindfulness practices makes a huge difference in how I feel throughout the whole day and the week in general. So, and that's a more recent development for me too. So it's one of those interesting things about how that evolves over time. So I love that. Thank you for sharing about your own journey. All right, and then how do you wish to be remembered after you leave this world?
[00:21:59] Nidhi Oberoi: As I said purpose is my core value, big on impact. So I just want to leave the world a little bit better and do my bit. And whether it's working on things, like working on technologies and providing access to health care to patients, probably globally. So it's just continuing to make an impact in the healthcare space and leaving the world a little bit better than I inherited it.
[00:22:27] Lindsey Dinneen: Yes. Excellent. And final question, what is one thing that makes you smile every time you see or think about it?
[00:22:37] Nidhi Oberoi: Yeah. There are so many different things. As you start meditating or focusing on mindfulness, it's the small things in life that you start enjoying. Being in Minnesota, the good weather is difficult to come by. So sunshine really makes me happy. But yeah, I think being present makes you more joyful. You just start enjoying everything in life. The other thing I would say is just simple acts of kindness. People helping other people is also something that just moves me and touches me.
[00:23:11] Lindsey Dinneen: Yeah, of course. I'm really curious. Okay, so I said final question, but then I have a follow up. So when you said being present helps bring you joy, could you share a little bit more about what you mean by that?
[00:23:24] Nidhi Oberoi: Yeah. So I think being present means that you are not thinking about your past and you're not thinking about your future. And so what that means is all you're focusing is what's in the now, and I'm going to start speaking the language of someone who teaches yoga or meditation, but being present really is you're not in the past. You're not in the future. You're just enjoying your day, the moment, as it comes by, it's as simple as that. You're centered. You're aligned with yourself and you just focus on what's in your control. You don't dwell on things either of the past or in the future. So I think that's a very, that's a beautiful moment to be in.
[00:24:11] Lindsey Dinneen: Yes, I couldn't agree more. Well, thank you for sharing a little bit more about that. I really appreciate it. And thank you so much for your time today. This has been such a great conversation. I've loved learning about you, and I'm so excited about your career future, especially with your goal of starting your own company at some point. So I will be cheering you on for that whole process. I know that's no small undertaking. But in the meantime, I just want to say thanks again for your time, and thank you so much for working hard to change lives for a better world.
[00:24:45] Nidhi Oberoi: Well, thank you so much. Thank you for the opportunity. It's been so fun chatting with you. You're joyful.
[00:24:52] Lindsey Dinneen: Thank you. Well, excellent. 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 choosing that charity to support. 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.
[00:25:30] 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 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.

Jessica Richter is a medtech executive and a board member with MedtechWOMEN. Jessica shares her inspiring journey from B2B sales to becoming a leader in the medtech industry, including overseeing a wide range of vital functions such as clinical trial strategy, regulatory affairs, and market access. Jessica provides insightful advice on overcoming common industry challenges, and underscores the value of quality systems, expert team-building, and fostering a supportive network for women through MedtechWOMEN.
 
Guest links: https://www.linkedin.com/in/jessica-richter-5aa43517/ | https://medtechwomen.org/
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPT
Episode 059 - Jessica Richter 
[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.
Hello and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Jessica Richter. Jessica is the Executive Vice President and General Manager at Veranex, a global provider of end-to-end solutions that accelerate MedTech innovation through deep expertise and integrated resources. As the leader of Veranex's contract research organization and consulting services business unit, she oversees clinical trial strategy and execution, clinical data services, regulatory affairs, quality and compliance, market access and reimbursement. She also manages operations, client engagement, business development and performance tracking.
A seasoned leader in medical devices and diagnostics, Jessica has extensive experience in software as a medical device, surgical innovation, oncology, aesthetics, cardiology and gastroenterology. Her tenure at Medtronic and Becton Dickinson shaped her expertise in commercialization, sales strategy, physician education, patient advocacy, and change management.
Beyond her current role, Jessica serves on the boards of medtech, women and UCLA's technology development group. She actively advises startups, accelerators, and universities, including medtech innovator UC Berkeley's Master of Translational Medicine Program, the Mayo Clinic's Executive Steering Committee for the Surgical Innovation Summit, and UCLA BioDesign. 
 Thank you so much for being here, Jessica. I'm so excited to speak with you.
[00:02:15] Jessica Richter: Likewise, Lindsey, thank you so much for having me.
[00:02:18] Lindsey Dinneen: Of course. Well, I'd love if you wouldn't mind sharing a little bit about yourself and your background and what led you to medtech.
[00:02:26] Jessica Richter: Awesome. Yeah, happy to. So, I was born and raised in California. I am the youngest of three girls and my entire family is really in the healthcare delivery field. So both my grandfathers were surgeons. My mother is a nurse. Both my sisters are clinical psychologists. And so when I went to school, I had aspirations at one point to get into medicine, and then through a really challenging organic chemistry class, kind of started to realize that maybe the practice of medicine wasn't where I belonged.
And so I initially graduated from Berkeley, had my sights set on potentially doing something in communications, and started off in business to business sales in the telecom industry. So as far from medtech as maybe one could think. Had some experience with software, this is when Blackberries were a thing, if you remember those.
And then a friend of mine was a recruiter and reached out and said, "Hey, I, I know that you're into medical and into medicine, and that was something you were interested in. Have you ever considered a career in medical device sales?" And frankly I didn't even know that that existed. I mean, this was 20 years ago, so this was before, you know, internet and all of those things existed, obviously, but it wasn't as pervasive as it is now. And so I wasn't even aware that these jobs existed. The fact that you could be working on the delivery of care but not be a healthcare provider was an eyeopening moment.
And so I got in and started actually working at a surgical company called Deval. It's part of CR Bard, which is now part of Becton Dickinson, and I cut my teeth in medical device sales. And then I went on to work in a commercial role within other companies Given Imaging, Covidian, Medtronic. I ascended to sales leadership, working with key opinion leaders, working on the patient advocacy side.
And then about eight years ago, I had the opportunity through an organization that we'll talk a little bit more about, called MedtechWOMEN, that I was involved in to learn about a consultancy that was looking for a head of business development marketing. It was a small group called Experian Group. I joined them and then within nine months was promoted to Chief Operating Officer, which was a position that I absolutely loved because we were working on the pre-commercial side of things and regulatory quality systems, clinical trials. And I had always had experience in the post commercial side. So eyes open to what happens, everything leading up to commercial. And I got a masterclass from my colleagues there, learning so much about what happens again, pre-commercial.
But then one of the other things that came out very quickly is I've always been someone who loves operational efficiency. And I know that's not sexy or cool, but I just like seeing something that isn't working optimally and get it working optimally is something that brings joy. So I had the opportunity to do that within Experian Group, and then really help the organization, which was already very successful, go from a very successful kind of local consultancy to a much larger, broader group with a broader footprint, more global client base. And then we were acquired by the firm that I currently work with called Veranex, and that really exploded capabilities of what was a 50% consultancy to now over a thousand people with a much broader global reach in the US, in Europe, and in India.
[00:05:36] Lindsey Dinneen: Wow. That is incredible. Well, first of all, thank you for sharing your story and your background and all the amazing things that led you to where you are right now. That's incredible. So many questions, in a good way. But let's dive in a little bit about, yeah, so, so tell us a little bit more about your role right now, and what are you excited about as this consultancy continues to grow and new opportunities arise. What's on the future for you?
[00:06:02] Jessica Richter: So now I lead one of three business units here at Veranex. So I lead our CRO and Consulting Services Business Unit, and that encompasses regulatory, quality, and clinical, as well as commercial strategy, market access reimbursement, things like coding, coverage, payment. So we help mid-size, early stage, and some of the largest strategic medtech companies, as well as some biopharma as well with companion diagnostics, navigate sometimes the tumultuous waters needed to bring a device from inception all the way through to commercialization.
Veranex also has two other business units in preclinical as well as extensive design, development and engineering. So there's leaders in each of those capacities. And what we do on CRO and consulting services is really consultative. So we work with clients to develop strategies in all of these areas, and then we roll up our sleeves and work alongside them to make sure that those strategies are actually executable, so to help them along the way. And some of our clients have teams, so it's strategic and we're advisors. Other clients, if they're early, early, may not have extensive expertise or the ability to build out teams in that way. So we go in, or our team goes in, and really provides them that support along the entire continuum.
It's interesting, just today, we have a client we've been working with for two years. They're in Switzerland, but they've been working with our US and global team. They just got news from FDA that they obtained FDA clearance. And I'll tell you, I think our team is as excited as theirs because, when you're in a company, it's all that you're living, breathing, doing. When you're consulting, you're a little bit at an arm's length. So when our clients achieve their results, and it's their work, but in concert with ours, the feeling of accomplishment really is just, it's one of those that's explosive. So we've celebrated that. We ring a bell. We'll share a lot, we'll do some marketing around it with this client. But it's really fun. That's the part that really drives not just me, but members of our team as to "How can we help more companies get more products to patients?"
[00:07:58] Lindsey Dinneen: I love that. First of all, congratulations, that's exciting, and I'm thrilled for your clients and for you guys because it matters so much and what a great milestone. So that's wonderful. But yeah, so I'm curious, you've seen a lot of different sides to medtech and to the business side of things, and I'm curious what are some potential stumbling blocks that you have seen that companies, especially when they're perhaps a little bit younger or earlier on in the process, what are maybe one or two stumbling blocks that you see that you think, "You know what, hey, if we put a little bit of thought into this, we can overcome this very easily, but we need to be thinking about this from the start."
[00:08:36] Jessica Richter: Okay. There's two things. One of them is gonna be a shameless plug, but I swear it's true, and that's quality. I think companies don't focus enough on quality systems 'cause it's just not the fun or sexy thing, but it's literally where we see companies struggle because they think about it too late. They do just in time. They think an EQMS is the answer, and it's not the only answer, it's a component. So quality would be the short answer.
The longer answer is people. So what we see is oftentimes, people, especially in a cost constrained environment, which we are today, where fundraising is tough, people do need to be financially astute as far as what they're spending and how they're spending it. But sometimes you get more by spending a little bit more to get the right advice. So for example, if somebody is expert in engineering or expert in regulatory, excellent. Know where your expertise is not, and then supplement. So either hire a consultant or bring on an employee or have a member of your board that can advise them that way.
More often than not, we see people trying to just kind of figure it out as they go, which isn't a bad strategy, but there are critical decisions and inflection points along the way. For example, if you're developing a clinical trial, thinking only about your regulatory strategy and not about your commercial goals or the claims you're going to make, you are gonna have to ultimately spend twice as much when you have to do secondary studies that you could have avoided by including that in endpoints.
So there's little things like that along the way where if you don't know what you don't know, it's really difficult to see those hurdles. It's helpful to bring in people, even in an advisory capacity, to help you say, "Okay, these are the hurdles that you're gonna face." You're gonna have new hurdles that maybe that you won't know or people won't know, but it's really making sure that you surround yourself with experts in those key areas.
[00:10:25] Lindsey Dinneen: Mm. That's great advice. Experts in those key areas. Well, speaking to the advisory point, I'd actually love to talk about your involvement with MedtechWOMEN, and tell us a little bit about that organization and how it serves women in this industry.
[00:10:39] Jessica Richter: Absolutely. Thank you for asking. It's something that I could literally talk about for this entire podcast. So, I alluded to it earlier, but MedtechWOMEN, I got, and I say "roped in" lovingly, but I was introduced to this organization, gosh, maybe a decade ago now when I was at Covidian and then Medtronic, and a mentor of mine, Amy Belt Raimundo, was one of the founders of MedtechWOMEN.
And she had mentioned to me, because there weren't a lot of female leaders within that section of my business at the time, so I was paired with her and it feels like kismet because she was this spark of like, this is what badass female leadership looks like. She knew her stuff, she was really focused on the issues. She made time and said yes anytime I had a question or wanted to meet. Our conversations were really meaningful and actionable. Sometimes we just talked as friends. It wasn't always so agenda based, but she introduced me to MedtechWOMEN and shared with me that there's this organization.
It's all volunteers. It's kind of membership based and it's literally women getting together talking about the issues in our industry. And it wasn't as focused on things like work-life balance, which quite frankly is a challenge, no matter what your gender is. There are great forums for talking about work-life balance and how you prioritize your health and your mental wellbeing, and that is really, really important.
But some of the events that I had gone to as far as women in leadership or women in medtech were really focused on those things and that wasn't what I wanted to talk about. I wanted to see incredible pioneers or trailblazers in our industry talking about the things that mattered in industry and sharing their perspectives. And that's exactly really the thesis of MedtechWOMEN. And so it was an organization founded over a decade ago. It started really as just an annual event, this MedtechVISION event, where we brought women together on a podium talking about the issues impacting healthcare today.
It evolved. So after a couple of years and a couple of different topics, what we started to see is that there was a real thirst in the community that we had beyond just that individual or that one time a year we got together for the event. And so we developed a kind of MedtechWOMEN 2.0. We brought on an Executive Director. And we essentially launched a much, much grander vision of what MedtechWOMEN was. So it included membership. It included mentorship, so formal pairings. We created a board of directory, kind of a pathway to get to more women on boards. We also have local events, networking events, virtual events in partnership with our sister organizations like MedTech Color and Diversity by Doing. And then of course we still have our annual event.
And then just this past month we actually brought on a new executive director. Her name is Yvonne Bokelman. She is a longtime industry veteran, tremendous leader in medtech, and someone who's really passionate about the organization, the mission, the vision. So we're excited to see what she will do in her role here.
[00:13:38] Lindsey Dinneen: Yeah. That's incredible. Thank you so much for sharing a little bit about the organization and its history and who it is serving, and it really resonated because I agree with you that there's wonderful platforms for being able to talk about some of the. Some of the topics that tend to come up quite a bit for women, especially women leaders, and I love the fact that you are fully acknowledging that those things are great as well, but that your focus is a little bit different. And so I'm curious, what are some interesting stories or things that have happened maybe unexpectedly from this network of incredible women supporting each other, learning from each other. Can you share a little bit that?
[00:14:17] Jessica Richter: Oh yeah, absolutely. And I'll tell you, many of us that have been members for a long period of time will attest to the fact that job opportunities come via this network, learning opportunities, sales and business opportunities. I mean, we network in the same way that we would in any other conference or any other meeting, but deals certainly have gotten done within and at MedtechWOMEN and MedtechVISION events. But most importantly, and one of the things that I always tout, is that MedtechWOMEN is a sisterhood that will take that call.
And what I mean by that is if you have a question, if you need to phone a friend-- going back to what we were talking about earlier of that network of you don't know what you don't know, but somebody probably does-- within MedtechWOMEN, someone definitely does. And so what we encourage our members and our mentors and anyone that's a part of the organization to do is reach forward and reach back. And so when I say take that call, if someone calls-- and I just had literally three conversations in the last three weeks-- with more junior people looking for career advice or wanting to have a question about regulatory or their thinking about a decision point in their job, and what should they do?
I always take that call and, you know, we're all busy. We all have things to do, but that 30 minute conversation can have a really big difference. And I know for me, likewise, when I have a question, when I'm coming up against something where it's helpful to have a thought partner, sometimes you want that outside of your own company, or outside of your boss, or outside of your team. And so the MedtechWOMEN Network is incredibly powerful and very supportive. And in my experience, and I've tried it both ways, we will always take that call.
[00:15:53] Lindsey Dinneen: Oh wow. That's incredible. So, okay, so mentorship and leadership is obviously a key component of your life, something that you're passionate about. From your own experience as a woman in this industry, are there any things that come to mind that you would say, just pieces of advice-- let's say for other women who might be younger in their career and they're looking to grow, they're looking to become leaders, they're looking to become maybe thought leaders, or own their own company, things like that-- what are some things that you might suggest to them from your own experience would be helpful?
[00:16:27] Jessica Richter: Oh yeah. It's, it's a great question, Lindsey, because there's a lot of things. I wish we could just mind share. First and foremost, I would tell women to go for it. I think sometimes we self-sabotage or hold ourselves back if we don't have all of the information or feel like we're a hundred percent qualified. And there's been tons of studies that demonstrate that. So first and foremost, go for it.
I had this conversation with one of my mentees who was taking on a new role and I said, "It's okay that you're feeling this way or that way. Do it and do it scared." Like it's okay to not feel like you have all of the confidence, right? And it doesn't mean fake it till you make it, although there's a little bit of that too. But I would say don't let fear hold you back. So that would be the first piece of it.
The other piece of it is make sure that you have, really, your own board, meaning advocates, mentors, coaches, thought partners, people that you can reach out to and rely upon. And that has to work both ways. I will tell you, I have learned as much from mentees as I have learned from mentors. And so recognizing that knowledge is shared both ways, no matter what your seniority is. For people that are junior, they have their on the pulse of things that I'm not as privy to, and sometimes I feel, feel that even more strongly. Likewise for people that have been in this industry 40, 50 years, they have institutional knowledge that I only wish that I had. And so, being at this midpoint in my career, I'm sandwiched between both and really appreciate, so I would implore people that are hoping and wanting to pursue leadership, go for it.
[00:18:00] Lindsey Dinneen: Yeah. Thank you for that. I, I love that advice. I really appreciate it. So, you have had such an interesting career and going from communication and sales, and then to this new role and Chief Operating Officer, all these cool things. For your own leadership style, what would you say are maybe one or two key things that you have found to be really helpful for you as a leader in the industry in the way that you approach the people that you lead?
[00:18:30] Jessica Richter: Another great question, Lindsey. So I would say, well --first maybe I'll share some lessons learned 'cause I've made a ton of mistakes. So I think one of the things that I didn't appreciate early on as a leader that I definitely appreciate now, is that we all have our own lens, our view with which we take on and see the world, and that's the view in which, you know. And so as a leader, initially, my thought was, "Well, everyone kind of sees and feels it this way with their own flavor." That is not true. Everyone has their own view and that's really shaped by their family, their background, their culture, lots of different aspects.
And so I think for me, some advice as a leader would be, be humble, take the time to really seek to understand, and then, even if you are heightening your communication, multiply that times three or four and then you're probably scratching the surface, 'cause people need to hear things different ways, multiple times. And it doesn't mean you need to micromanage or drill things down, but when you're leading an organization and bringing people along on a change, especially, it is important that people understand the why, the who, the what, the how come, and that they hear that re repeatedly so that they can understand it, they can buy into it, and that you're creating an environment to make sure that their questions are addressed. So, lesson learned kind of recommendation on the leadership piece.
I think the other just piece of advice is that sometimes people aspire to leadership because they think it's glamorous or there's gonna be a lot of money there, or it looks like the leader doesn't have to do that much work, they're just delegating. What I would say is leadership is not glamorous. It's often thankless. It's super hard. I work tons of hours and I love the team that I work with, and so for me the why is that. But if you are not loving that, don't do that. There's plenty of opportunities that you can contribute meaningfully as an individual contributor or a principal or a subject matter expert, and that's great too. So know that if you want to lead people and be involved on that side of leadership, I welcome it. I think it's fantastic. I think there's a lot of people that get into it with a misconception of what it will look like. And I'll tell you it's worthwhile, but it's hard.
[00:20:43] Lindsey Dinneen: Yeah, absolutely. Yeah, when you were talking about that it, the glamor side of things, I just remember so vividly and I, I joke about it because I think it's funny-- but very quickly, I used to own my own dance studio and I built that from the ground up. And people would say things to me like, "Oh my goodness. What you're doing, you're living your dream. That's amazing! Oh my gosh, how cool is that?" And inside, I'm like, "Ha, yeah, I mean, I spent the first two hours as the janitor this morning, and then the next two hours as the CEO. And then, you know..." And it's funny, but it's true, you wear a lot of hats as a leader and sometimes your job is literally getting down into the nitty gritty and cleaning up, and that's fine too. So I love that.
[00:21:24] Jessica Richter: My quip is always from the janitor to the GM, like, "What needs to get done? There's no task too big or too small." And ultimately, I think that what you described in yourself, and I love that, is servant leadership, right? Like for me, I've always responded well, when a leader isn't above any task and doesn't ask for something that they themselves would not be willing or aren't willing to do along with their team member. And so again, that's, that's not the definition of leadership, but in my eyes, that's a definition of leadership that really resonates with me.
[00:21:55] Lindsey Dinneen: Mm-hmm. I agree. Yeah. Well, speaking of stories and those kinds of fun things too, are there any that stand out to you, perhaps along your career or with MedtechWOMEN, or anything really, that just affirm to you that, "Hey, I am in the right industry at the right time, doing what I should be doing?"
[00:22:14] Jessica Richter: Oh yes. So there's a couple of different specific examples. So firstly, one of the things that has happened as of late, and I feel like-- not to get too woo or California on you-- but these synchronicities where you'll be thinking about something or remembering something, and suddenly a project and people come together around it-- and again, I think that's part of the power of the network. But there was a friend of mine that I had run into at a conference, we were talking about a specific aspect of their business that was really needing some, some development, and it turned out that after that conversation, literally not a week later, I got a call from a prospective client that was interested in working in this specific space. We were able to connect them with this person that was in need of that exact thing. And it was with software and with AI and so a partnership was forged and now they are literally about to embark in this really explosive and announcement will be forthcoming about it.
But there's so many examples of little nuances and synchronicities like that, that again, happen because of staying open, staying curious, that powerful network right place, right time. But I also think it's the magic of our industry. It's really small. People sometimes fail to appreciate because you have these large organizations that are hundreds of thousands of people, but the leaders within the organization are fairly connected and tight. It's really an interconnected ecosystem. So that's just kind of one broad example.
There's also other really small examples of the power, I think, of MedtechWOMEN in just how it ignites and how it brings people together, especially across senior and junior roles. So when we do our networking events, we try to do them regionally, just to try to bring different people together. And you can have like the CEO of sometimes a large organization, like Lisa Earnhardt from Abbott is a member and an active participant. She often will come to events talking to someone who's their very first year in medtech.
And when you see these examples of sponsors of ours really showing up and demonstrating a commitment to giving back, and you see these people that are junior that may not even know the seniority of the leader that they're speaking to, recognizing that we're all people at the end of the day, trying to really ideally propel healthcare and help patients in their journeys to health and wellness. And so when you see examples of those sparks and those little ignites, it reinforces why we're here, what it is we're doing, and really the power of the organization.
[00:24:41] Lindsey Dinneen: Yeah! Well, I think that the more times that you get to see those connection points, and those synergies or whatever we wanna call them, I think that that does impact us in a way that goes, "Yeah, the work that I do matters and it's impacting people's lives and maybe in very different ways." So some of it is, yeah, that end user and that patient, and oh my goodness, what this device can do for them and their quality of life. And sometimes it's the person behind the invention and what does that journey look like for them personally and the impact on their own family and their life. So I love hearing about those connection points.
[00:25:16] Jessica Richter: Well, and that's the joy of working also with, I mean, large strategics for sure, but the startup companies, oftentimes it's a physician and engineer. The physician is seeing the unmet need because of the patients coming into their clinic. They're feeling hopeless 'cause they can't address it, but also empowered because they know what to do. So those are the really fun, kind of feel good projects, especially because there is no one better equipped than a clinician, right, to say, "Okay, here's the gap." Engineers can help to design and develop, but oftentimes that's where the teams are sort of left in the lurch to say, "Okay, what do we do from here?"
And so it is incredibly powerful to enable these innovators, no matter what their backgrounds are along that journey. And it's not a quick one as you know, being on the manufacturing side. It's not something that's quick or easy. It's not something that is a high success rate. And when it works, there is no better feeling. When you commercialize a device or when you get it through the FDA, that's just the start. When it's actually used in patients and you start to hear those patient advocates and those stories, and you expand indications and are able to help more patients, that's the thing that makes it worthwhile. And when the going gets tough, 'cause it does that, those are the stories, right, that really inspire us to continue.
[00:26:33] Lindsey Dinneen: Yes, absolutely. Amen to that. So, okay, so I have so many thoughts swirling around, but I do want to pivot the conversation a little bit just for fun. So imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach?
[00:26:53] Jessica Richter: Oh, I love this question. I'll try to make it not about our industry 'cause it's something I've been working on a lot lately, and it's a testament to patience, which is something that I think we could all use more of, but I could definitely use more of. So we rescued a dog in Covid. She's a Doberman pit mix. Her name is Poppy and she's delightful. And she was severely neglected.
So when we got her, we knew she was really shut down and that we would have to do work to bring her out of her shell. My husband and I don't have kids. We have a quiet home. I knew that we could take that on. And so while I won't say I am the expert, what I have done in the four years we've now had her, is extensively worked with her on the, what I would call the "Art of the Dog Walk." So we have learned how to really master exercise, training, and discipline as a way to show affection, 'cause for a dog that shut down like that, that's really what she needed to thrive. It was humbling and very educational for me.
I've always been a huge animal lover. I used to volunteer when I had a lot more time with an animal rescue. And so I was able to parlay that and work with a trainer really on honing those skills so that Poppy could not just be social in the world, but be less shut down. So it would be so fun to share a masterclass on that 'cause I had so many reflections and learnings on patience. The art of going slow, the art of taking in the world, of just slowing that down, not being on my phone, right, being really present with her.
And I sort of joke with my husband, I feel like now when I walk her-- I dunno if you've seen the movie "Avatar"-- but like we connect our avatars and we like go on into this world, and it's meditative. It's our morning practice and it's something that for me has been incredibly rewarding, and challenging, and a huge learning experience that, that I would love to share.
[00:28:50] Lindsey Dinneen: Oh, that's wonderful. Oh my goodness. Yes. I am a huge dog lover, so anytime someone's telling me about their dog, it's just instant happiness.
[00:28:59] Jessica Richter: Likewise. And for my, my favorite thing that it will always bring a smile to my face is the unlikely animal friends, like if you see like a squirrel a dog or a kookaburra or something, you're like, "Ahh!"
[00:29:10] Lindsey Dinneen: It's so cute. It's precious. Yes. I love it. And to me it reinforces, "Hey, we can actually all get along if we try." I mean, I know it's a little different in the animal kingdom, but still, I still love that. Oh my goodness. Great. Well then, how do you wish to be remembered after you leave this world?
[00:29:32] Jessica Richter: You know, legacy is something, that I think is important. It's funny, I've been working with my niece on her college essays and college admittance, and reflecting back to my views when I was 18 versus my views today in the world now. And even speaking to my mom about legacy, 'cause it's something, you know, she's approaching her eighties that she thinks more and more about. So it's conversations that we have a lot.
I really would love to be remembered as an enabler, as someone who really enables those around me to be successful, to achieve more, to obtain what they want right to, to drive forward. I love being around creative people and innovators and people with really expansive imaginations, and I think my superpower is kind of capturing and enabling those things. So it would be great to be able to enable more people around me.
And that's true with patients and healthcare and the clients that we support as well. You know, one of the things that has always been pointed out to me-- and again, my grandfather was a huge proponent of this-- is when things aren't going well in the world, you can focus on what's going wrong or you can look for the helpers. And so, as a surgeon, he was one of those helpers. And so I think he ingrained that in me very early on. And so I'd love to be remembered as someone who is a helpful enabler.
[00:30:51] Lindsey Dinneen: Hmm. Yes. That's a beautiful legacy. I love that.
[00:30:54] Jessica Richter: I am curious, Lindsey, I know this is like, you're the, you're the interviewer, but how would you like to be remembered?
[00:31:02] Lindsey Dinneen: Oh, thank you for asking. First time! You know, there are so many things, so many things that I love doing for other people. But I really actually resonated with your idea of enabling. And I would say mine is very similar. And that is that I love helping people achieve their dreams. And that can look like lots of different things to lots of different people. So it's when I'm working with a company, it always started with one person's idea, right? All these big companies started off as this tiny little one person's idea that became something.
And I think just helping that, those sparks, especially when maybe they're eager, but they're not quite ready. They're scared, they're nervous, they're whatever, and helping them see a clear path to achieving those dreams and goals is one of my favorite things. And whether that's just a personal, I wanna run a marathon, I don't even how to know how to get started, or whether it's, I have this great idea for a book, but I am concerned about, like, "Nobody will read it, no one will care." Well, that's not the point. Let's start somewhere. And so I think for me, it's about empowering people to live the life that they want to live and hope that they can live. That's what I would love to be remembered for.
[00:32:16] Jessica Richter: Well, that's beautiful. I hope that via this and the other things that you're doing, it seems like you're already on that track.
[00:32:22] Lindsey Dinneen: Well, thank you. I appreciate that. I really appreciate you asking me too. Thank you. Well, and then final question, and you've sort of perhaps alluded to this-- I'll see if it's different than your first time-- what is one thing that makes you smile every time you see or think about it?
[00:32:37] Jessica Richter: Oh, well, definitely the unlikely animal pairings for sure.
[00:32:41] Lindsey Dinneen: Yes.
[00:32:42] Jessica Richter: Anytime with family. Family is super important to me. So anytime I can spend time with our family, that is for me, a smile doesn't go off of my face. And also kind of what you said, celebrating other people's wins. And I celebrate my own as well-- I think it's important that we do that-- but there is nothing like, it's a grin, like when someone on our team has an accomplishment, the grin is twice as big, right? Because you just, to see that reflected, that success, that attainment, that win reflected for the people that you work alongside, that brings a smile to my face every time.
[00:33:20] Lindsey Dinneen: Yeah, nothing quite like it, and it's so powerful. Yeah, huh. Oh my goodness. Well, this has been an amazing conversation. I don't really want it to end, but I know we have other things we have to get to today, so I just wanna take some time to say thank you so very much for being here with me, Jessica. Thank you for sharing all about your incredible career so far and all the exciting things that are to come, and speaking to MedtechWOMEN and that incredible organization. So I'm really excited for our listeners who might not have been familiar with it to go check it out, lots of opportunity there. And gosh, I just wish you the most continued success as you work to change lives for a better world.
[00:34:01] Jessica Richter: Thank you, Lindsey, for hosting and I would encourage anybody who's unfamiliar with MedtechWOMEN, if you're new to industry or if you've been here a while, there is a place for you within MedtechWOMEN. Membership is super low cost. It's $150 for standard membership a year, $75 for junior members. You can follow us on LinkedIn, but highly, highly encourage everyone to join the network. And thank you for the opportunity to share a little bit more about MedtechWOMEN today.
[00:34:26] Lindsey Dinneen: Of course. 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 choosing that charity to support. 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'll catch you next time.
[00:34:57] Jessica Richter: Thanks, Lindsey.
[00:34:59] 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.

Ryan Phelan is a partner and patent attorney at Marshall Gerstein. He discusses his journey from a background in computer science and fintech to becoming a prominent IP attorney serving clients in the MedTech industry and beyond. He shares insights on the importance of protecting intellectual property, especially for startups, and the burgeoning role of AI in medical technology. This succinct yet fascinating conversation highlights the critical intersection of law, technology, and medical innovation.
Guest links: https://www.marshallip.com | https://www.patentnext.com/ 
Charity supported: Sleep in Heavenly Peace
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPT
Episode 058 - Ryan Phelan
[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.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I am so looking forward to my conversation today with Ryan Phelan. Ryan is a partner and patent attorney at the Chicago based intellectual property law firm, Marshall Gerstein, where he counsels medtech companies on protecting their valuable IP. Ryan ultimately believes that AI is an important technology to embrace, but cautions medical device and related companies to approach it pragmatically, developing a policy to govern and protect intangible assets and innovation.
All right. Well, thank you so much for being here, Ryan. I'm so excited to speak with you today.
[00:01:29] Ryan Phelan: Yeah. Thank you for having me. Thank you, Lindsey.
[00:01:31] Lindsey Dinneen: Of course. Well, I'd love if you'd start off by sharing a little bit about your background and what led you to medtech.
[00:01:39] Ryan Phelan: Sure, absolutely. So I'm an attorney by trade. And I started off in probably a different place than most people in MedTech, but I have a computer science degree and I worked in industry first for Accenture, doing a lot of programming and consulting in the FinTech world. So, high frequency trading and programming some pretty complicated data algorithms in order to trade stocks and bonds and securities, and things like this. That let me see aspects of intellectual property that people were doing with respect to the code I was writing.
So I got curious with IP and law, and that led me to law school, Northwestern Law, in pursuing a joint JD, MBA program, which I finished in 2010. And I went into IP law with a passion for technology, pretty much in the computing space. And then in the last decade or so, IP practitioners, not unlike doctors, like to practice in specific areas and one of the ones that I focused on is software medical devices. And so that, that kind of led me into the realm of medtech.
[00:02:48] Lindsey Dinneen: Very nice. Okay. So you have had such an interesting career trajectory and I'm wondering, back in the day, say you're a six year old Ryan, could six year old Ryan have predicted that you would be a lawyer and particularly intellectual property?
[00:03:04] Ryan Phelan: Absolutely not. I mean, first of all nobody in my family, at least immediate family, was a lawyer. And so going to law school was not on the radar. I grew up in Louisiana in a small town, basically farm life, so certainly technology and stuff like that wasn't available in the city. But I did have a passion for things that were tech. I was certainly a kid that loved to take things apart and put them back together and build all kinds of Legos and stuff like that. So that basic kind of STEM acumen or desire was always there from the beginning.
And so, as I, I grew up and got exposed to more things, certainly in college, it became kind of a passion. And so, I ended up doing that. We did have some medical issues in my family, including cardiac and cancer and stuff like that. So, those types of things always hit home with me and you're getting to a chance to kind of lean into medtech, at least on the software side, with medtech devices that include or incorporate medical technology became very interesting to me personally.
[00:04:07] Lindsey Dinneen: Yeah, of course. And so going back just a smidgen when you decided to go into law and you know, you've come from this background that was the software engineering and you've got this fintech background and you have all of these amazing skill sets already, what led you specifically to say, "Okay, I want to focus on intellectual property, and so this is going to be my, my sweet spot."
[00:04:33] Ryan Phelan: Yeah. So when you go to law school, you get exposed to a lot of different classes. In fact, in your first year law school, you're required to take a bunch of baseline courses like criminal law and all these things. And so you quickly figure out what you like and what you don't like.
And so for me, a computer science degree is always kind of the beating heart of what I loved. And so I wanted to, I tended to like, classes that were up that alley, so to speak. And the IP course that I took was definitely there because it was all about technology, inventions, people making things, and how those inventions played out in court.
So I found my greatest joy in law school to be in those classes. So I spoke up the most in class and did the best. There's common saying that "you should do things that you love because you never have to work a day in your life" kind of thing. So I always try to think about that, and certainly fun today because I practice in IP and picked that direction.
[00:05:27] Lindsey Dinneen: Yeah, absolutely. So, in addition to all of the other credentials you have, you are also a published author and you are a speaker. And I would love if you would share maybe a little bit more about how you got into being a thought leader as well in your industry and how that path has taken you.
[00:05:51] Ryan Phelan: Yeah, for sure. It's the same kind of thing. I've always liked to write as well. And I feel that when I write about something, I really get to understand it. And so in my field, there's a lot of stuff happening all the time. Like a court will come out with a new case, an IP and medtech or AI or something like this, and I really like to dig into it to figure out how can I use this court decision as a tool for clients, or how does this change things up? What will clients ask me questions going forward, or how can this be an interesting topic to either write about or to speak about? And so, I try to learn when I'm reading, and then I write it, and that teaches me, and I think and hope that others get a benefit from that too when I publish, so.
[00:06:34] Lindsey Dinneen: Yes, of course. Of course. And you are also, if I'm not mistaken, an adjunct professor. So, first of all, do you sleep? And second of all, tell me more about this as well, please.
[00:06:47] Ryan Phelan: Yeah, so I'm an adjunct professor at Northwestern Law. I teach a course on patenting software inventions. I do sleep because it's only once a year for a power week. You know, I think it's like three days out of the year. There's the long classes, they're like a few hours each, but we pack in several 30 minute core sessions into a day. So one day, maybe we'll go for three hours or two hours. And, you know, we will get the benefit of several weeks of coursework by doing all of that at once in those three days.
And so, I teach on that. We teach fundamentals of patenting softwares and inventions, which includes medtech software devices. For example, the FDA classifies software, medical inventions in, in, in certain ways, like their software as a medical device where you have the software only such as, you have database with medical data and you're either formatting it or storing it or processing in some unique way, or you have software in a medical device where you actually have a physical device. It's a cardiac device where the software is running or at least partially running that device. And so we talk about ways to, to patent those inventions primarily with US law. So.
[00:07:59] Lindsey Dinneen: Very nice. So specifically thinking about your medtech clients, because I know you probably have clients in many industries, but specifically in medtech, what are some of the common mistakes you see medtech companies making? Especially say, you know, an earlier startup or something like that, when maybe they haven't thought through an aspect that really should be thought through a little bit earlier in the process. What are some common things that you see that people should be aware of?
[00:08:27] Ryan Phelan: Yeah, I mean, easily one of them is not filing a patent application early. And if they are a startup company and they have their biggest selling product, or what they think will be their biggest selling product, and they don't file a patent application on it, that could be bad because you have one year to get to the patent office with that, at least in the U. S. to file something once it's been publicly disclosed. And if you miss that deadline, then effectively you're allowing your competitors to copy it. And if you're a startup company, the last thing you want is for your product to become extremely successful and then a big Fortune 500 company gets wind of it, figures out you don't have a patent, and then just starts making it themselves and it takes away your market share. So that would be, you know, I think that's every inventor of startups like worst nightmare, right? So, getting that patent on file before the deadline is pretty important.
[00:09:22] Lindsey Dinneen: Yeah, of course. Now, I noticed you had recently written an article on LinkedIn about when to file this patent. And I know part of maybe some concerns that might arise are, "Well, we don't necessarily want this to be in public awareness yet." So how do you walk that line between "This is our IP, we're really trying to keep it very tight," versus, "But I also need this protection, this legal protection." So how do you navigate things like that?
[00:09:54] Ryan Phelan: Yeah, so the point at which you need to make your invention publicly available or to disclose it because you need to, you know, maybe you're going to pitch competition and you need to show your invention on like a PowerPoint deck in front of hundreds of people. Then that's probably a good point to start thinking about filing a patent application if you're still developing it, and it's like in your basement, so to speak, and nobody's seen it. It's still secret then. You don't need to necessarily file a patent application at that point.
Although, there's a funny thing in patent law where, if you have an idea, sometimes there's somebody else thinking about it too, and the first one to get the patent office, wins, and so, you certainly don't want to wait around too long and find out years later that you filed your patent application the day after somebody else.
This actually happened with Thomas Edison and the light bulb and he had lots of fights about the other person that was claiming the same thing that lost, and we don't remember his name today because of that. So anyway, so that's one thing to keep in mind when you're starting out.
[00:10:54] Lindsey Dinneen: Yeah. Well, and speaking of those kinds of stories, are there any that particularly stand out to you as you've worked with all of these incredible clients who have seriously life changing products they're creating. Are there any that really stand out to you in your memory as affirming, "Oh my goodness, this is why I'm here. This is why I'm doing what I'm doing."
[00:11:17] Ryan Phelan: Yeah, for sure. One that stands out is one in the opioid or the narcotics market. In my family, we have an individual who is unfortunately affected by this. And so, I had a client that reached out to me to create a VR program that helps to eliminate or to reduce cravings in this field. And that one was really impactful because using technology and non pharmaceutical way in order to reduce cravings for people that are struggling with addiction of some type, I felt to be very important. So I thoroughly enjoyed working with that inventor and helping to, to create that patent application for that invention.
[00:11:59] Lindsey Dinneen: Yeah, of course. Yeah. Thank you for sharing about that. I think sometimes those really personal connection kinds of stories are the ones that really stick in your mind because it, it helps to have this moment of realization, like you know that what you do matters, of course, but then having that extra layer of confirmation that "Yes, this is helping somebody who could literally be a family member or a close friend or relative" is really impactful.
[00:12:25] Ryan Phelan: Exactly.
[00:12:26] Lindsey Dinneen: Yeah. So considering all of the industries that you currently serve, and of course, you have this incredibly varied background, which can only be wonderful to draw on from this rich history and experience of yours. What are some interesting crossovers you see between industries that can be useful in terms of, maybe one industry approaches something in a way that you've seen could actually really benefit folks in medtech or vice versa. Are you seeing trends like that?
[00:12:59] Ryan Phelan: Yeah, absolutely. I mean, one of the biggest ones that I can think of now is artificial intelligence coming into play with medtech. I mean, certainly, medtech kind of runs the gamut of, you know, like, like we mentioned before software only to physical devices that incorporate software. And so AI is interesting because you can load it and AI model onto one of these physical devices, or you can have an AI model that's medtech based sitting on a server somewhere that can help doctors look or find particular cause or whatnot like that, based on symptoms that a patient may walk into, or maybe there's a device, like a needle, that allows that has an AI model on it that helps with injection or something like this.
And so, these AI tools are becoming smarter. And I think that they help in the field of medtech and they require a different level of expertise with these inventions to not only create them because they're complex, but also to bring them to market because they require specific FDA regulations. Even the FDA right now is trying to figure out AI. They have approved several AI devices, but it usually comes down to, you know, is your AI device going to change in the near future because you're going to update the model? And if so, does that change it enough to require like a new submission? So the fact that AI moves so rapidly doesn't really mix well with the FDA's process of approving the device and having it set in stone at that approval state.
[00:14:30] Lindsey Dinneen: Yeah. So where do you anticipate that this will take medical devices? Do you think it'll become so naturally ingrained in many of them that it's just sort of part of our reality, or do you think we'll still have those --what do we want to call them-- not AI functionality devices?
[00:14:48] Ryan Phelan: Yeah, I think both will exist. You know, certainly a spectrum of these devices, right? Certainly there's surgical tools that exist now that have hundreds of years, or a hundred years, just in different, maybe better forms. So, those will stay, stick around. The AI assisted ones, I'm sure will find their niche, and live alongside the the existing tools.
[00:15:10] Lindsey Dinneen: Yeah, absolutely. If you could narrow it down, what would be maybe your top piece of advice for a MedTech startup founder from your perspective, in your role?
[00:15:23] Ryan Phelan: Yeah, I guess the number one would be again to, you know, make sure you're not giving away your crown jewels. Have your patent filed before you step out. If you're trying to raise money, just be careful that you're not sharing information publicly. You have to share with a potential investor, consider an NDA or if they won't sign an NDA, you can file a provisional patent application with the patent office. That shows that you have something on file before you talk to others. And as long as you describe the invention sufficiently in the four corners of your provisional application, then that's often the best way to protect yourself going out. So I think, as an IP attorney, that, that would be the number one advice that I would give a startup company in the medtech space.
[00:16:10] Lindsey Dinneen: That's incredible. Thank you for that. That's really appreciated advice. So, it's so interesting because when I was looking at your LinkedIn profile, of course you have all of this incredible experience, and one thing actually really stood out to me, and that was that at least at some point you have been a and --I'm sure you've done this throughout your career multiple times-- but a pro bono lawyer for Lawyers for the Creative Arts. And I was curious about that and how you got involved, and can you share a little bit about that journey?
[00:16:40] Ryan Phelan: Yeah. So LCA or Lawyers for the Creative Arts is an organization here in Chicago that deals with artists of limited means. You know, usually they have some type of basic issue that they want handled and it mainly deals with IP. Typically, I work on a different capacity for these because I see them as like kind of fun learning opportunities. I usually work in the copyright space and the clients that I work with need help either filing a copyright for maybe a piece of art that they've created, or maybe have a question about how their IP is being used or sold in some way, and they need to figure out if their IP has been infringed. And so, we'll work with them in a pro bono capacity to help write a letter to a company or to file a copyright registration and things like that.
[00:17:28] Lindsey Dinneen: Well, as a, as my side thing as also an artist, I just want to say thank you because it is so great that you're doing things like that for the artist community. It is not always easy. So, oh, that's great, appreciate it. Yeah. So as you look towards your own future, what are you excited about say in the next year or two?
[00:17:50] Ryan Phelan: Very excited to see how, I guess, AI is playing out with medtech. You're seeing regulations and guidelines coming out that The United States Patent and Trademark Office and also the Copyright Office about how these laws will impact artists. I've sat on a panel with the Copyright Office and the United States Patent and Trademark Office as they're thinking through these decisions and putting out these guidelines.
There is questions about, is the new administration going to change things up with respect to guidance and guidelines that have come out. So, you know, artists are looking at AI is like a tool, like a paintbrush. And the law is kind of looking at it, obviously from the legal perspective and it doesn't seem like those two things are aligned yet. There's common in, in history that the law typically lags the technology by, you know, a decade or two or more. And so that's certainly the case with AI.
For example, there is a famous -- I wouldn't call it a case-- but a denial of a copyright registration at the copyright office for a gentleman that had created an AI piece of artwork, won the Colorado state fair, I think in 2022, and tried to file a copyright registration, but was denied. And he told the copyright office, basically he had entered in 500 plus prompts in order to generate, or at least partially generate, this work of art, but was still denied . Not because of his effort, just because of the way the law is written under current copyright statutes.
And so, things like that seem to be, at least from a policy perspective, incorrect. And so it'd be great to see exciting how this plays out. Will Congress care enough to change it or how will artists be impacted under these types of laws and policy considerations going forward?
[00:19:35] Lindsey Dinneen: Yeah, absolutely. So pivoting the conversation a little bit just for fun, imagine that you were to be offered a million dollars masterclass on anything you want. It can be within your industry or part of your amazing background, or it could be about something entirely different. What would you choose to teach?
[00:19:55] Ryan Phelan: Yeah. Wow. You know, I guess I would teach what I'm currently teaching. Cause I, I do enjoy the class I teach now. I'm at Northwestern, my alma mater, which I love. It's down the street from the office, get to go in same place where I went to school and teach the law and things that I do every day, which is patenting software inventions, including the medtech space. If I could get a million dollars to teach what I do now, that would be wonderful, in this hypothetical, so.
[00:20:22] Lindsey Dinneen: Right. I love it. Excellent. And how do you wish to be remembered after you leave this world?
[00:20:30] Ryan Phelan: Wow. I hope people remember me as someone who was fun loving and enjoyed tech and hopefully brought some information to the world that helped them in some way.
[00:20:42] Lindsey Dinneen: Yeah, of course. And final question, what is one thing that makes you smile every time you see or think about it?
[00:20:51] Ryan Phelan: Oh, wow. I guess there's a lot of stuff. I also like to do some type of sports. Currently, the ski season is ending, so I certainly enjoy skiing, so when I see or think about that's one of those things, and now coming is the golf season, so I transitioned into that. We're looking forward to some good weather here, finally, in Chicago. It was 80 degrees last week, and it snowed yesterday, so things are changing from golf to ski season, but one of those is always fun, so.
[00:21:17] Lindsey Dinneen: That's awesome. That's fantastic. Yeah. If folks who are listening are in a position, would there be a way for them to get in contact with you and then how early should they do that actually?
[00:21:31] Ryan Phelan: Yeah. There's multiple stages. They can get in touch with me anytime they want. You can always find me at our firm's website, Marshall Gerstein. Or if you want to, you can go to patentnext.com, just patent and the word next. com. That's my blog that I write on typically, and it has my contact information there, including my email address.
[00:21:51] Lindsey Dinneen: Perfect. Well, thank you so much. Well, Ryan, it has been a joy to speak with you today. I really appreciate you sharing a little bit about your career and your insights, your advice, especially appreciate that for MedTech founders who might, you know, not quite know where to start with this whole legal element that they really need to consider. So I really appreciate you sharing kind of when and how to do that.
And we're excited to be making a donation on your behalf, as a thank you for your time today, to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that charity to support. And thank you again so much for being here. This has been a wonderful conversation, and I just wish you the most continued success as you work to change lives for a better world.
[00:22:41] Ryan Phelan: Thank you, Lindsey. My pleasure. Happy to be here too. Thank you for having me.
[00:22:44] Lindsey Dinneen: Of course. And for our listeners, thank you so much for tuning in. If you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time.
[00:22:56] 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.

Maria Artunduaga is the founder & CEO of Samay, the winner of the 2024 MedTech Innovator accelerator, as well as a groundbreaking physician, scientist, and inventor. Maria discusses her inspiring journey from a small town in Columbia to leading a top MedTech company in the US. After pivoting away from plastic surgery training, she channeled her efforts into creating Sylvee, an AI wearable sensor for COPD patients. Maria shares her relentless determination, innovative problem-solving strategies, and the creation of a company culture that emphasizes learning and diversity. 
 
Guest links: https://www.samayhealth.com/home | https://www.linkedin.com/in/drartunduaga/ 
Charity supported: ASPCA
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPT
Episode 057 - Maria Artunduaga
[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.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I am delighted to welcome as my guest today, Maria Artunduaga. Maria is a physician, scientist, and inventor with 60 plus prizes, including becoming the first woman to lead a US LATAM company to win MedTech Innovator, the world's most competitive accelerator for medical technology surpassing over 1300 global companies. A top 1% student in Columbia, her country of birth, she relocated to the US to pursue plastic surgery training, but abandoned it to dedicate herself to solve the problem that killed her grandmother-- a lack of home technologies that can detect COPD exasperations early. Maria has raised 5.2 million, almost 60% in non-dilutive capital from NSF and NIH to build Sylvee, an AI wearable sensor that can provide COPD patients with continuous data on pulmonary functions similar to what continuous glucose monitoring sensors do for diabetic patients.
Her invention has been featured by a hundred plus media outlets, including Forbes, TechCrunch, Bloomberg, Fierce Healthcare, and more. Before Samay, Maria completed postdoctoral studies in human genetics at Harvard Medical School, started a plastic surgery residency at the University of Chicago, and completed two master's degrees, one in global public health at the University of Washington, and another in translational medicine at the University of California at Berkeley and San Francisco. She lives in Mountain View, California with her husband, 2-year-old daughter, and four pets. In her free time, she enjoys flamenco dancing, bolero singing, traveling the world, and fostering diversity in and outside the workplace by mentoring underrepresented scientists and entrepreneurs.
All right. Well, thank you so much for being here, Maria. I'm so excited to finally get a chance to speak with you. I'd love if you would share a little bit about your background and your career trajectory. What led you to MedTech?
[00:02:40] Maria Artunduaga: Sure. So it's gonna be a little long and I'm gonna tell you everything about my life because the personal history is very important to me and for my company too. So, as you have noticed, I have an accent. So, I grew up in Columbia in a very small town in the southern part of the country. My parents were both doctors and I'm the oldest of four kids and two of us followed their lead. So my life in my city was pretty chill. Everyone knew everyone. I spent most of my days at a Catholic school studying very hard on weekends where I usually spent tagging along my parents to doctor events.
One of the things that I really like to tell, it's how my parents work as entrepreneurs really shaped my life. They were real pioneers. They built in my hometown the first big clinic back in the eighties and the nineties. And my mom was the only woman in that group, and she actually was the CEO for a while, which was a big deal. She was the only woman in a partnership of 10 people. And watching them build that clinic, that hospital really taught me a lot about dealing with uncertainty and finding solutions. Every day we'll have supper or lunch and I'll just hear all of these challenges and stories, their struggles and how they solve things. Something that was, that is definitely super helpful in what I do now, right?
So, and then I was 16 and after high school I moved to Bogota, the capital, which is up in the mountains, it's very cold. I got a scholarship 'cause I was always a very good student. You know, career I spent my last year, I spent nine months in the US. Honestly, coming to the US blew my mind. The technology that I got to see, the speed, effects on science, it was nothing like I've ever seen before, and that was true inspiration for me. So I knew that I had to come to the US. I needed to come back to learn from the best, of course.
And it's interesting because my parents didn't want me to relocate to the US. I was the oldest. I was supposed to follow into their footsteps and obviously, like inherited that clinic, right? That hospital, we call it clinic, it's actually a hospital. And I was a very contrarian. I didn't listen to them. I told them, you know, I really wanna be where the best people are. And what I did was that I, it took me three years to save the money to come to the US, to get Harvard to actually sponsor me my visa because they wouldn't pay me for the first year. So I remember I had to save $30,000, which in pesos is significant.
So back in 2007, so many years ago, I made it to Boston, and the original idea was that I wanted to become a pediatric plastic surgeon and bring that level of care back to Columbia. I spent four years of researching a genetic ear condition that's called microtia. And with that work, I was able to land a plastic surgery residency spot or position at the University of Chicago. And I shared this with a lot of people. I actually had a really negative experience. Things didn't go as planned. I actually faced discrimination. I eventually, you know, had to leave and I made the top choice to never ever go back into clinical practice.
And I changed paths. I was 32 years old and yeah I decided to switch gears. I retrained into public health and tech. And then in 2016, I moved to the Bay Area where I am right now. And I got another scholarship to finish master's in translational medicine at UC Berkeley and UCSF. And during the courses that I took, some of them with business class etc., etc., I decided to found Samay in 2018. I really wanted to build something that would really make a difference in respiratory medicine.
And this is where my grandmother comes. So my, the grandmother, my abuela, her name was Sylvia and she had Chronic Obstruct Pulmonary Disease or COPD and she's the reason behind my company. So, she often couldn't tell when her symptoms were getting worse. That's a huge problem. Catching the respiratory attacks, exacerbations is definitely key to keeping people outside of the hospitals, and obviously feeling their best to have a better quality of life. So, that's what we are trying to solve with a company, right?
If we are able to catch those exacerbations even with a day or two notice in advance, right, that we can all make a difference. And so by missing these exacerbations, we are having really high expenses in hospitalizations and ER visits and the problem we trying to solve is that today technologies that are adequate enough to be used outside of the hospital because the ones that are considered to be the gold standard, they are very expensive. They are confined to their hospitals and they are very difficult to complete for the patient, especially when they're exacerbating. They need to blow out forcefully for about 10 seconds, 21 times.
So what we are doing is, we are developing a sensor that makes it super simple for people to use it at home to track their lung function without doing those forceful maneuvers and ideally in the future to warm them, right? Like to let them know when things are starting to go south or obviously, you know, not going very well, and that's what it's all about. I mean, that's what we do with Sylvee right here. And it's wearable sensor and we have done significantly well over the past couple of years. We actually just won MedTech Innovator.
[00:08:04] Lindsey Dinneen: Yeah. Significantly well over the last few years. Yes. So congratulations on that, and I want to dive into all of those exciting milestones in just a second. But I am, first of all, so inspired by your story. Thank you for just sharing that your resilience and your grit and your determination are really admirable. So thank you for sticking with something that was not easy, not an easy path.
[00:08:29] Maria Artunduaga: I know. I know.
[00:08:31] Lindsey Dinneen: It continues not to be, ironically, as we've kind of touched on before, but just going backward a little bit in your story. So I, it sounds to me like getting the opportunity to watch your parents have this incredible impact on their community and the healthcare and the opportunity is just so valuable for you. And even just learning about how your mom was the CEO and those kinds of things, did that help shape the idea for you that not only is entrepreneurship possible, is innovation and healthcare possible, but you can also be this in incredible leader as a woman in whatever capacity? I would just love to dive into that.
[00:09:13] Maria Artunduaga: Yeah, it's super interesting, right? My mom really taught me a lot about leadership. She's a surgeon, so you can imagine how good of a leader she is in the operating room at home, everywhere, right? I mean, she's definitely the general, that's how I call her. And I honestly, I try to replicate, so my leadership and styles pretty much shaped by her. So I always call her my best role model whenever somebody asks me about the question, right? So I'm just like her. I lead from the front. I like setting the pace by working the hardest.
So I really like to lead by example and I also, just like she did, and obviously because of her surgical training, I hold myself to a really high standard, and I expect everyone on my team to do the same. So people in my company know that I'm very strict, I'm very disciplined, and they know that from the beginning. It's so funny because when I interview all of them, at the final interviews with me, and I actually do the anti sale to join Samay. It's like, this is, these are all the reasons why you shouldn't join. I start describing myself as a very intense, obsessed CEO with insomnia, which I still have, because I really wanna make this work, right?
So, yeah, I, ask them, and most of them say yes. I really like, I attract people that like challenges, especially intellectual challenges. So, yeah, to this point, most of them say yes. Some of them have obviously, you know, because probably too much. But at the same time, I tell them, "Look, this is going to be very hard in terms of the deliverables, the things that we're expecting from you." But at the same time, my goal is to not only help people with respiratory problems, I try to sell the company as a company where everyone that gets hired can be themselves and thrive.
So, so for example, I tell them," Look, I'm trying to be the boss that I never had." And this goes obviously very tied to the very negative experience that I had during my surgical residency and even before, right? So, I never had a boss that really supported me, who recognize my true self and those characteristics as good things, right? So they always try to tone me down. I'm very energetic, as you can notice, and I'm also super ambitious. I'm really ambitious. I wanna do all of these great things. And they always thought that I was aiming for too much, especially for a woman.
It's like, " You need to lean in, Maria. You need to behave." So I remember my residency, they were criticizing like, "Why are you behaving like this, Maria? Why are you asking so many questions? You're asking too many questions. You look more as an internal medicine doctor. Why are you always smiling, Maria? Why are you so happy?" So now, with everyone that I hire, what I try to do is that I focus on understanding their dreams and I try to figure out how this job is gonna help them get there.
So if they wanna become a top engineer, maybe they wanna learn managerial skills, or they wanna run operations, or they eventually wanna become a founder themselves. So I try to create a partnership with them where they obviously help me succeed with the company, build Samay, but at the same time they get to do this personal growth. So it's extremely important that they get to place where they wanna be.
[00:12:32] Lindsey Dinneen: Yeah, that's wonderful. And such a gift to your employees. And I also honestly, that sort of anti interview or whatever technique is brilliant because you do want it to be a fit for everyone, and it's so much better to have aligned expectations from the start. So, oh my goodness, that's so interesting. So, okay, so then. Speaking into that, how do you develop a company culture for yourself? You've learned from some pretty negative experiences, so obviously that's what not to do, but you know, as you're crafting your own company culture now, what kinds of things are sort of your core values, other than of course, your hard work and your excellence and holding yourself and others to high standards, but what kinds of things do have you developed that make it special to be where you are?
[00:13:19] Maria Artunduaga: Yeah, I mean, that's a really good question. I'm very true to myself, and one of the things that I wanna do with Samay, it's I wanna create legacy. If you go to my WhatsApp, that's exactly the little logo or the slogan that's below my name: I'm creating or building my life's legacy. That's how I pitch myself. So I really wanna be remembered as someone that made healthcare more accessible, especially for the people that get left behind.
So growing up in Columbia, I saw firsthand how unfair things will be and I wanted to change that. So that's how the values of Samay go, people first. I think legacy, it's extremely important, right? It's about getting those life changing tools and opportunities into the hands of people who really need them. And again, it's not necessarily, the group that we're building. It's the own experience of building a company with me, learning from the company, from the people that are working with. I really wanna make it accessible for people.
And I wanna also be obviously a source of inspiration. You don't necessarily need to be this perfect person to be a CEO. You know, life is a struggle and that's totally fine. Just be very passionate about building legacy, right, your work and how you're impacting other people. And especially for me, I do a lot of work with women and minorities. I really wanna empower them to chase their dreams in science and technology. I really care about people. I don't know, I'm selfless about me. It's all about the others and creating legacy and being remembered. So, yeah, that's how I, that's how I roll.
[00:14:59] Lindsey Dinneen: I love that. I love that. So speaking of you embracing the CEO role, when you first started your company, did you feel ready to step into this kind of position? Or was it something where you just were like, "You know what? I see the need. I know I can make a difference in this field. I'm gonna do it and I'll learn along the way."
[00:15:19] Maria Artunduaga: No, not at all. And let, so there's a very good anecdote that I'm sharing. Again, back to all of these life changing experiences. I got into medtech because of, I don't know, somehow the planets got aligned, right? So I was doing a master's in public health because I thought that was going to be my real call, working for Gates in Seattle, because that's where I actually lived for about two years. Then I came to realize that it was very bureaucratic. It's very, was very slow. I have a type A personality. I really like to fix things very quick. I like to implement stuff.
So I decided to do a second master's degree, and as I mentioned, here in Berkeley, I decided to join one of Atma METs minority programs for students, right? It's called SMDP. And I remember that was back in 2016, and they sent me to Minneapolis for the big conference. And that's where I got my first real taste of MedTech. And I remember watching the MedTech Innovator finals with Paul Grand. He was introducing the program, the finalist.
I remember clearly seeing all of his pitches and how Green Sun Medical CEO won, and it was a game changer to me because when I saw them pitch, it was very exciting. You know, all these technologies, the many millions of people they could definitely impact, I saw that, and it clicked. I could turn the scientific ideas into something that helps millions in a way, the way how I would practice medicine, but in a more impactful way.
So interesting story though. So the other thing that was very inspiring or at least that motivated me, I was the only person in the room who looked like me and spoke with an accent from South America, from Latin America. So it was like two reasons behind it. For me, it was I wanna be a medtech entrepreneur, but at the same time I wanna be able to break the glass ceiling, right? The first Latina physician CEO building a company that has hardware, software, and AI, this is what we actually do.
And yeah, so it, it's mainly that. I really like challenges and I'm very motivated to show people that I can do things that might seem impossible or too difficult. So I really like showing people that anything is possible with a lot of hard work and determination. So yeah, that's mainly it.
[00:17:47] Lindsey Dinneen: I love that. Embracing those challenges, running full steam at them and having that, I don't know, that gumption is fantastic too. And the desire, like...
[00:17:57] Maria Artunduaga: Thank you.
[00:17:57] Lindsey Dinneen: ...you said, to break through those ceilings and to represent and say, "No, it is possible." It is, and I love that. So, excellent. Okay, so can you share a little bit about the journey that the company has gone under recently and some of the really exciting milestones? I know there have been bumps and whatnot, but maybe some of the exciting things that have been developing and what you're looking forward to as you continue down the road.
[00:18:24] Maria Artunduaga: Sure. I mean, whew. There are so many things that have been happening for the last couple of months. So it's been a long journey. It's been six years so far. Initially, you know, I wanted to build a company with an idea that was inspired, obviously, by the fact that I lost my grandmother to exacerbation and also because, at the time, I didn't know what I wanted to build.
When I was doing an interview with a pulmonologist, what I realized was that I could actually build a technology that could be inspired by consumer devices, so hearing aids for example. And funny story is that my husband who is also Columbian, and went to MIT, he's been working at Google for over a decade and he's an auto engineer. He does a lot of things. He's very smart and he's one of the main architects.
What I decided to do back then was, let's repurpose hearing aid technology by sending signals through the chest, and let's use the physical principle of acoustic resonance to understand what's going on inside of the lungs. And that's exactly what we are doing. We have 10 granted patents so far. We have 20 more pending on pulmonary so far. So we've done a lot of things. So we've tested that device on 450 people almost. All of our numbers of accuracy are over 90. Sensitivities and specificities are also between 82 to 98. Right now we are starting to see changes a few days before an exacerbation is actually diagnosed by a physician, which is extremely exciting.
We have data from two people. Obviously it's a small sample size. We are following eight of them, and we're aiming to finish at 60 to hundred people in the next year or so. So that's our main goal. We've raised 5.2 million, 60% of that money is coming from grants, federal grants, and we just submitted a breakthrough designation to the FDA about a week ago, so fingers crossed, though, we get it right?
There are a lot of things in the pipeline, things that are very exciting. Right now I'm super excited 'cause those six years were very hard. I was running a science project with my nails, getting money from grants, help from people who have known me forever. It was very hard for me to recruit a full-time CTO. So my husband has been helping me with some hours here and there. And we have right now 12 people in Columbia. So for developers, designers, clinical researchers, we are running most of our operations in Latin America because it's extremely, well, obviously cost efficient, and more importantly, we have access to people that are patients especially that are, that exacerbate more often. So we are to leverage all the different angles that we can get.
[00:21:04] Lindsey Dinneen: Yeah. Wow. So lots of exciting things in the works and in the future, and oh my goodness, I'm so excited, can't wait to continue to celebrate all those wonderful accomplishments. So I'm curious, as you've taken this journey and even before with your other health experiences and finding this path, are there any moments all along the journey that really stand out to you as affirming, "Yes, I am in the right place at the right time, in the right industry."
[00:21:31] Maria Artunduaga: Yeah, beyond the MedTech Innovator, the experience eight years ago, I mean, every day I find that this is the perfect fit for me. I always tell people, "Look, entrepreneurship is not for everyone. It really needs to be a fit of personality." So when I talked to my parents, because at the beginning they weren't very agreeable with the idea of me becoming an entrepreneur 'cause physicians don't do this, right? I was sort of like a black sheep of a family, 'cause my sister, she's successful and she's a pediatric radiologist as she's working for an academic center in, in Dallas.
So, my personality, I'm Type A. I'm very anxious. I really like doing things super fast. I really like to get things done, right? So, I dunno if I picked the wrong career, probably could have done a better job as an engineer, as a scientist myself. So at heart, I'm a true scientist. That's what I really enjoy. I like practicing medicine, sort of miss it a little bit, but I'm more in the quest of solving questions and discovering, right?
That's what really excites me. And then, every day is a new day when you're building a company. And the challenges that I have every day, all of the problems I have to solve, I really enjoy the process of solving them. And this is a little crazy. Who gets excited with problems, right? So, I don't know, that's probably me. So I guess every day, the moment I go home or that I go to sleep, I say, "This is perfect. I don't think I'll be as happy as I am right now if I had stayed medicine. I don't think so."
[00:23:10] Lindsey Dinneen: Wow. And that says a lot. And that just affirms to you on a daily basis, "Yeah. I am doing what I'm supposed to be doing. That's wonderful.
[00:23:17] Maria Artunduaga: Exactly. Right. It's like, yeah, I'm good at this thing. You know? I like solving problems. I got, I really enjoy the fires. I really like them. I's like, I don't know. I'm, yeah. I'm addicted to them.
[00:23:30] Lindsey Dinneen: I love that. Well, and that is unusual, and I'm curious, do you? But it's a great thing. No, it's a wonderful thing. Yeah, no, absolutely. I love that. So, so when you're at finding yourself up against a problem, do you start with any particular kind of established framework? Do you like to just brainstorm solutions? How do you approach problem solving?
[00:23:53] Maria Artunduaga: Gosh, this is a really good question. It's like, you know, if I had to teach something, right? So I'm very good at solving problems, at connecting different disciplines, right, to solve those issues. So for example, the way how I go about them, first of all, I don't get frustrated or too anxious about it. I always try to think first, right? And then, yeah, I start brainstorming. I'm very quick at thinking, my mind goes super quick.
I have a whiteboard right behind me. I do a lot brainstorming on my own. I ask a lot of questions too. So I rely on a lot of people, and I get a lot of feedback on the way, how I think a problem needs to be solved. And obviously with time and experience, the older that you get, the better you become, right? So yeah, honestly, every problem is different. I just like seeing it from different angles, right? I'm very good with social stuff. I'm very good with arts too. I really like doing science, learning a about engineering. I really like different ways of solving problems.
For example, I remember that I we had this NIH grant and we were working collaboration with a big, famous academic center right here. And things weren't working very well. That was through during a pandemic and I was getting charged things that we actually didn't approve. So things were getting a little awkward. I decided to finalize that agreement. But then I got through this situation that I had no access to patients here in the States, and at the time, I didn't have my clinical site in Columbia opened up.
So what I did was the craziest thing, which is what I did, was that I bought an $80,000 machine and I came into an agreement with a friend from medical school who has a pulmonary practice in South Florida, one of the largest pulmonary practices. He's a partner with nine other guys, and they see probably a hundred patients every day. Can you imagine that? So respiratory patients, and I told him, "Look, I don't have any money to pay your rent, but I'm gonna give you equity for that rent, and you're gonna use this machine from Monday through Thursday, and I'm going to test your patients from Friday to Saturday. And I'm going to bring people, I'm going to become my own CRO, right? So I'm gonna bring people, doctors, from Columbia on a J1 visa as a research scholar visa. I'm gonna train them and I'm gonna get them to do the recruitment, review everything, test the patients. We are going to become our own CROs, and we are going to do as many people as we can every single week."
So we were able to do 430 people in a span of a probably a year and a half. Something that usually would cost us thousands of dollars. I dunno how much money I spend, probably just 300,000 to do everything. Can you imagine? I mean, that's significantly cheap compared to any other quote that I've been getting from an academic center. So, I sometimes go for the crazy idea, right? Like, what's the craziest thing that I could think of? I literally, I write it down, right? And then I just try to double check with my lawyer. "Am I doing something illegal here?"
And I, yeah, I cross reference with other founders. " I'm thinking of doing this, how that's that sound?" And they're like, "This is pretty non-traditional, Maria, but I mean, if you can get it done..." I'm like, "Yeah, of course I can get it done." And I just get it done. I just don't take a no for an answer. I'm very good at also finding, convincing people to jump on board with the vision, the mission. This excitement, this energy, people really get very engaged with Samay and with me as a founder, and they love it. Most of these people either have invested in the company, they are helping me many more hours, pro bono, literally free, and we are building together.
[00:27:43] Lindsey Dinneen: Wow, that is so cool. And what a fantastic story. Thank you for sharing that one as well. Oh my word.
[00:27:50] Maria Artunduaga: I have way too many stories to share. This is the one I really like to, to tell people.
[00:27:55] Lindsey Dinneen: I love that, and I love the willingness to come up with those crazy ideas. And it might be just so crazy that it works. So, hey, you never know until you try, and that's fantastic. Oh my gosh, I love that approach. Alright, so pivoting the conversation a little bit just for fun. Imagine you are to be offered a million dollars to teach a masterclass... I know! ...to teach a masterclass on anything you want. What would you choose to teach?
[00:28:22] Maria Artunduaga: Yeah. So, good question. So, gosh, I, I tackle problem. So my, my brain again is very good at figuring stuff out. That plus the fact that I'm very stubborn. So if I'm into something, I don't give up easily. And now I'm gonna tell the story about our winning MedTech Innovator. We beat 65 companies globally, right? And I still like, sort of, I cannot process that we won. So the story goes like this, but a year ago, I tried to raise five millions, my very first institutional round, and I totally flopped.
[00:28:55] Lindsey Dinneen: Oh.
[00:28:56] Maria Artunduaga: I only got $200,000 because multiple funds that I was talking to, they wanted me to feel half of the round before weighing any money or signing anything. So you can imagine. So do I got, you know, chicken or the egg problem? I failed. And instead of crying or mopping, I thought, "Okay, wait. I got into Medtech Innovator. You know what? I'm just gonna win that competition, still $350,000." And why not? So obviously people, my advisors, my best friend, "Like, you're crazy. It's the most competitive thing ever. You're not established in the field. People know who you are, but it's not like you have exited a company or anything, right? You're not even an engineer, Maria."
So what I did was, again I went back to my whiteboard. Again, I probably should have become an engineer before, I dunno. I'm really good at solving problems. So I was like, "You know, this is a problem. These are the different ways how I can tackle this." And more importantly, I'm very good at the studying stuff. I really like, again, knowing, wisdom, information. I just love that. I really love that.
So what I did was, I treat it like a big project, and I talked to the past winners, anyone who had done or won any sort of like prize with MedTech Innovator, and I figure out their secret sauce. So I either talk to them, I studied every single video, every single pitch. I spend many hours studying everyone who had one or had done significantly well throughout the accelerator. So what I discovered was the accelerator was kind of a school, like a school. So the harder you work, the better you do.
And one of the things that I realized was that mentors and reviewers were key players. So I focused on building those connections. I met with many of them. I probably spent about, I don't know, probably four to five hours meeting with mentors, anyone who I thought could help me somehow, obviously, for free, because a lot of the help that they give used for free. And I also spent a lot of time doing homework, the webinars, et cetera, et cetera. I ask a lot of people for advice. I really got people excited about Samay. I recruited my mentors and they got on board from day one.
Because of that, I started building those relationships and it was authentic. I mean, don't get me wrong, this wasn't like, you know, I'm trying to play anybody. I really care about what they had to say, and I incorporate all that feedback into my company to this day. So the other thing is, I make sure to go to everywhere, every webinar, every event, everything. My camera was always on, because most people, when they do their webinars, they don't even turn on their cameras, right? So I was very engaged. I was asking questions, I was getting involved with everything.
Same thing with the Slack channel that we have for MedTech Innovator. I was helping people, I was sharing stuff. I was even offering to make introductions. I really made sure that people knew who I was. And I obviously also asked the MedTech Innovator people, the staff, for help, feedback, right? Am I doing this right? What do you think I should do? Anything that you can share with me that you think. I was very clear with them. I wanna go to the, I wanna get to the finals.
I told them, and I remember they telling me, "Oh, Maria, about getting to the finals, it's so hard. It depends on the strategics and the sponsors." And I was like, " I'm gonna get there. What do you think I should do?" So I literally ask a lot of people how I needed to get there. And with the finals, the way how they pick the finalist, it's actually the mentors who go in front of the strategics, and they sort of champion your company. And they really went to bat for us. They told them how committed I was, the many people that from my team were actually going for participating to the winner because I brought people from my team...
[00:32:45] Lindsey Dinneen: Yeah.
[00:32:46] Maria Artunduaga: You know, very few founders did that. I brought people from Colombia, obviously online, people who barely could understand English. But, I made them prepare questions. "You need to do this and that we need to be super engaged. We need to help other people." And they saw it was hard work. And at the end, we got into the finals and what I realized was, okay, so after the finals, I understood that the game was, obviously it changed. The way how the winner is chosen is that the audience votes, right, during The MedTech Conference.
So what I did was, I went all in on social media. We made an awesome video for the best video competition. I remember that that was the first thing that I did back in June. I scheduled two weeks. I flew to Columbia. I hired right people. I made sure that I was perfect, so I was part of the creative team. I designed everything. Again, I really like arts, right? That's why, one of the reasons why I didn't, I was in pleasantry and that's why I really like dancing too, right? So I'm obsessive with everything that we do. I really am into the details and I supervise everything. And we also got into the finals for the best video competition.
So I was going to this problem from every single angle. I didn't let anything up to chance. I, yeah, I'm a freak. I'm a control freak. That's what I did. I remember that even for the pitch, the four and a half minute pitch, I practiced, I don't know how many hours, but every single thing that I say that was obviously memorized, needed to be perfect. The way how I, let's go back to dancing since you're a dancer yourself, the way how I moved my hands, right? The way, how I walked on that stage, everything was rehearsed. So, yeah, I mean, I just I worked my ass off. I mean, everything was the way it needed to be and that's how we won.
[00:34:39] Lindsey Dinneen: Yeah. Wow. That's great. What a fantastic story. Yeah. Amazing. Yes. I love how it's so choreographed. Yeah, that's
[00:34:48] Maria Artunduaga: great.
It was choreographed,
[00:34:50] Lindsey Dinneen: I love that. Excellent. Well, I know you have touched on the importance of legacy and how much that means to you, but how do you wish to be remembered after you leave this world?
[00:35:03] Maria Artunduaga: Oh gosh. Yeah. I mean, so I have a little daughter, I want to some somehow replicate the same experience that I had with my mom. Maybe she doesn't even realize how much of the inspiration and the impact that she had on me. And again, leading by example, I don't spend a lot of hours with my daughter, right? I have a nanny for 12 hours. So my salary goes to her payment, right?
Yeah, I wanna be remembered as somebody who tried very hard, who literally, instead of saying things, I walked the talk. The things that I said I was going to say. For example, I'm very opinionated with anything diversity and inclusion because, as I've said, I've experienced discrimination myself. So I walk the talk, I build a product, I build the change. I worked really hard. I impacted a lot of people.
And more importantly, the world has changed somehow because I existed. So that's that. It's as simple as that. I wanna help other people get to fulfillment of their lives and their dreams. And yeah, and I obviously wanna be happy while I do all of these things. And more importantly, I wanna feel that I learned a lot. I really like learning. The process of learning every single day, learning a new thing makes me super happy. So if I don't learn something new, I consider day as, you know, as like a flop or something. So yeah, it's very simple. I'm actually a very simple person, I'm not that complicated.
[00:36:30] Lindsey Dinneen: Yeah. Okay. And then final question. What is one thing that makes you smile every time you see or think about it?
[00:36:39] Maria Artunduaga: Oh, cute. I mean, obviously my daughter. So I'm a mom. I'm 44, well, almost 45, and I had her at 42. So just thinking about her makes me smile every single time. She's a miracle baby. She's, you know, after four years of IVF, eight retrievals, it finally happened. I finally had her, and having her in my life has turned my world upside down in the best way. She's determined, and she's only three. She's diving into doing all sorts of things. She's doing gymnastics, she's building Legos, she's doing engineering stuff. I really like that "I can do anything attitude" and obviously I'm sort of like reinforcing her to do anything she wants to try.
So seeing her try all these new things, all this confidence that I, that she has. It's like, I don't know. I mean, that inspires me. That motivates me to be a better mom, a better CEO, and to do exactly the same thing with the people that I work with. So everyone in my company, I I tell them I'm a mom, right? So, remember that, and I try to do the same with them. It's like I tell them, what do you wanna do? What do you wanna learn this month? What do you need? Right? My work as a CEO is getting the resources and put out the fires. Just tell me, and this is your playground, so I'm trying to do exactly the same with my daughter too. But yeah, I'm very happy with her.
[00:38:07] Lindsey Dinneen: Aw, that's wonderful. I'm so glad. Well, oh my goodness, this conversation has been amazing. I kind of wish it didn't have to end, but I also wanna respect your time 'cause obviously you have so much going on. But thank you so much for sharing about your story, your advice. You're so inspiring, and I know this is gonna inspire so many people to go for it, and not to have the fear, to have that problem solving mentality, and growth mindset and learning and, hey, look where curiosity got you.
[00:38:37] Maria Artunduaga: Yeah, exactly. That's a perfect slogan. It's all about that curiosity and it gets you places. Look at me.
[00:38:43] Lindsey Dinneen: Yeah, exactly. Yeah. And this is just the start.
[00:38:47] Maria Artunduaga: Yes, of course.
[00:38:48] Lindsey Dinneen: Indeed. So I just wanna say thank you again for your time today, and we just wish you the most continued success as you work to change lives for a better world.
[00:38:58] Maria Artunduaga: Thank you so much and thank you again for invitation. I really enjoyed it.
[00:39:02] Lindsey Dinneen: Yeah, absolutely. Me too. And we are 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. We really appreciate you choosing that organization to support and thank you just again, so very much for your time here today. Yeah, and holy cannoli, 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'll catch you next time.
[00:39:44] 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. Shalabh Gupta, founder and CEO of Unicycive Therapeutics, shares his inspiring journey from practicing medicine to leading groundbreaking innovations in kidney disease treatment. Dr. Gupta discusses his comprehensive framework for identifying and developing medical solutions, his vision for Unicycive's future, and the importance of focus and execution in medical startups. He reveals the challenges and triumphs of bringing life-changing products to market and offers profound advice for new entrepreneurs in the industry.
 
Guest links: https://unicycive.com/ 
Charity supported: Feeding America
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost & Editor: Lindsey DinneenProducer: Velentium Medical
 
EPISODE TRANSCRIPT
Episode 056 - Dr. Shalabh Gupta
[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.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am so excited to introduce you to my guest, Dr. Shalabh Gupta. Dr. Gupta is the founder and CEO of Unicycive Therapeutics. He is a visionary in healthcare, leading groundbreaking efforts to design innovative therapies and reimagine how we approach unmet medical needs. His work goes beyond the lab as he's driving a healthcare revolution by developing innovative therapies addressing critical gaps in treatment. His perspective combines decades of experience and expertise in drug design with a deep commitment to equity in health care.
Well, welcome to the show, Shalabh. I'm so excited that you're here with me today.
[00:01:35] Dr. Shalabh Gupta: Thank you. Thank you for hosting me.
[00:01:36] Lindsey Dinneen: Of course. I'd love if you wouldn't mind just telling us a little bit about yourself, your background, and what led you to MedTech.
[00:01:45] Dr. Shalabh Gupta: By way of background, I'm a physician, trained, practiced, did my medical training in internal medicine, residency in physical medicine and rehab, research fellowship in cardiac and pulmonary rehabilitation, board certified physician, practice in New York at NYU hospital, NYU Medical Center. This is where I did my medical training for roughly decade after finishing medical school.
I also have a graduate degree in finance management from NYU. While I was doing my residency training, I realized that I wanted to find a way to have a broader impact on society as well as what we were working on in learning medicine. So, I started my career working initially with a biotechnology company at the time to help them get their drug with FDA through a regulatory approval process. The beginning of the process is called IND following a investigation new drug application, IND application. I actually visited FDA on their behalf, met with FDA back in the time when everything used to be in person.
Built from there onward, joined Wall Street from working as a stock analyst. So I covered biotech companies as a stock analyst, and the weekend and holidays that were available, I worked to continue to practice the medicine at NYU as an attending physician, and then joined another bank and covered pharmaceutical stocks and worked covering six of the largest pharma companies that include Pfizer, Merck, Viacom, Selling Power, Eli Lilly, Bristol Myers Squibb.
From there, I moved to California. I worked for Genentech in corporate strategy. Genentech, at the time, and continues to be, one of the largest biotechnology companies. And from working at Genentech, I got my inspiration to start my own companies. So I founded two companies prior to finding starting Unicycive.
All my companies are focused on aesthetic therapeutic area. Unicycive is focused on nephrology, treatment of kidney diseases, and we have two drugs in development. We have a lead drug that is pending approval from the US FDA in June of 2025 this year. And the second, I guess, finish phase 1 clinical trial in the UK. And we are in discussion with the agency to proceed with the next stage of clinical trial in the US. So that's a quick background.
[00:04:14] Lindsey Dinneen: Wow. That's incredible. Thank you for sharing your story. Yeah. So let's talk about your company now. You've become CEO of this company. You're developing these products that are going to change lives. What first made you realize that there was a gap that needed to be filled in the market for this? And then, what prompted you to go, "You know what? Hey, I think I can have the solution for this or I can have the answer to this."
[00:04:38] Dr. Shalabh Gupta: The first question that you ask, understanding the unmet need in medicine, there are a lot of problems that you can address. So, to give you a framework, if I am thinking about a problem, I want to understand if a couple of things, and in order of priorities, these are: can I find a solution that with my resources-- resources is time, energy, and money-- can I create a product that will truly make it to the market?
Number two is that I also feel that one can get very blindsided that "I have a solution," but not understand what other solutions exist in the market. So understanding the competitive landscape. If I create this drug, this device, this product, and it is going to take three to four years in the market to come to the market-- which, by the way, in medical word is a still very fast track because it takes much longer-- what will the competitive landscape look like for 5 years down the road? So that's the second part.
And third is that what is the solution that I'm developing? Is it unique in terms of having a novel, either as a drug device or drug device combination, or as a patented drug, patented device, because in our industry, it's not really possible to scale up something until unless you have an IP or intellectual property protection.
And then from there onward, the last thing is also, who's going to fund me, how I think about funding, not for next six months a year, but also a continuum of the product development. If I think about all these 4-5 problems, then you start to narrow it down.
There are some problems that are very much worthy of exploration. For example, treatment of Alzheimer's, we all know it's a big unmet need, we all know there's a big market opportunity. But I realized that was something we couldn't do it with the products or the development candidates that I had seen.
So, being able to define where is the end point and goal. Being able to understand, can I make an impact? And when I say I, I speak for myself, but each one of us, I always remind entrepreneurs, we each one of us have our own deck of cards. We have to play with our cards, we can't compare ourselves with somebody else, or we can compare some other cases study.
So understanding more about what is so unique that I can bring to table that can I make a difference and then making a business around this where the thesis lies. Once you identify that, then there's a question about continuing to execute and keep changing your plan as you go along.
[00:07:11] Lindsey Dinneen: Yeah, absolutely. Well, I love your framework for thinking through all of those things. And so of course you use that when you thought, "Hey, here's this issue. I could potentially have a solution," and you went through this process. And then can you tell us about your innovation now and how that is helping and how you expect it to help change all these wonderful lives?
[00:07:33] Dr. Shalabh Gupta: So, so for treatment of kidney diseases, first of all, it has been one area of development that has not had that much of innovation. And, and I think that is where the initial part of the thesis was that focusing on nephrology of kidney diseases is not same as developing a drug for cancer treatment.
Cancer treatment changes every six months a year. The standard of care continues to evolve. Is there an unmet need in cancer treatment? A hundred percent, but the part is that the pace of innovation is very rapid. Is it same in nephrology? It's getting there, but it's still the development of a new products in nephrology still is not at the same pace.
So I thought there was something we could make a difference by a small company. The drug that I acquired from another company was a drug that had finished a clinical trial. So it had shown that the drug is safe. It had also shown some signal of it working in healthy volunteers. That's a phase one trial.
And the innovation came from a car battery company that had figured out how to make a big, large size pill to make it smaller. And sometimes greatest innovation, greatest insight come from the fact that when I talk to the kidney doctors, the physicians who take care of these patients there with the treatment of kidney diseases, they said the problem for these patients are the patients have to take 12 to 15 pills per day.
And this innovation allowed us to be able to make that number of pills go down from 13 to 12 or 15 to three pills per day, one pill with each meal. And then the regulatory pathway became a bit more clear that if I can show that our drug is similar to the drug that was in the market, maybe there was an opportunity to go through expedited pathway, which is what we did.
And I acquired the drug in 2018, went to FDA right after acquiring the drug to expedite the pathway again, thinking about de risking the development pathway. And as I mentioned in 2025, we are expecting the approval. So that is the process about it. And that's the story behind the lead drug.
[00:09:51] Lindsey Dinneen: Great. Excellent. So that is really exciting. And as you continue to go forward with this company and the innovations that you're creating, what is your ultimate goal or dream that you're really striving for?
[00:10:06] Dr. Shalabh Gupta: So, the focus for Unicycive is building new novel treatment for kidney diseases. Our lead drug is expecting approval in June 2025. But we have a second drug in development, and we continue to think about what will be something that we as a small company can bring to market. There are other areas of unmet need in kidney treatment.
But instead of doing too many things at the same time, we continue to think, "How do we grow our company? What will be the vision for the company three years down the road, five years down the road?" And what we want to continue doing is to develop the drug candidates, advance them. Right now, after the first drug we get through approval, it will be the second drug.
There is a thought process behind it. One of the biggest challenges that I've seen for smaller companies and startups is that they end up in doing too many things at the same time, which is difficult to do, even for big companies. You know, big companies, they have a one product that is a marquee product, they launch that and then they develop other things. So, being able to stay focused is also key because you can have a lot of energy, you can have a lot of ideas, but you have to focus on which one you can do first.
[00:11:22] Lindsey Dinneen: Yeah, that is so true. It's such great advice, a good reminder. Yes, focus is so important. You know, honestly, that's probably one of the tricky things that startups in this particular field might struggle with is that focus. So I'm wondering what kind of advice do you have for say a brand new entrepreneur in the industry who has these great ideas, but you know, maybe has so many that they're a little too scattered.
[00:11:52] Dr. Shalabh Gupta: Right. So, I think you may start with 10 ideas but the framework I gave you that: can this idea in this given timeframe with my resources and the funds that I can raise, can it make a difference? So you start to narrow it down. You start with a big funnel, narrow it down. And then maybe you have two or three ideas. Instead of thinking to yourself that "No, I'm not going to tell my idea to anyone because somebody else can take it away," find people who will be willing to pressure test those ideas. Then you will have identified something, maybe one Idea that is worth the pursuit. So then you focus on that.
So that's one part of how to triage it because we all have ideas, but those ideas may not be worth developing once you go and talk to the marketplace. And marketplace is your investors, the physicians, and the patients. I keep saying about these three stakeholders, because if physicians cannot prescribe what you are developing, then it's of no use. If patients don't necessarily benefit, then it's of no use. And if you cannot get insurance companies a reimbursement for that means the product will never get here.
So it's a process, but nobody can come up with an idea. And there is no great idea. There are ideas that you have to, and then once you find that one idea that resonates with all the stakeholders, physicians are excited about it. If you talk to patients, and you want to do that early on, you don't want to develop an idea and then go, you know, that is the greatest idea but nobody really perceives it that way that except you and a couple of your friends and people who work with you.
I don't mean in a bad way. I mean, that you want to be able to test this idea very quickly. So once you get that idea, once you identify what is that the company should be focused on, then the question about is actually building an execution plan. And the only advice I can give is that at any given day for a company, startup, especially whether you're a founder or you're a founding team member, the list of priorities is 50, 5, 0, or maybe 100. It takes time to figure out of those 50, which are the top three that are most important and then being able to focus on those three.
You know, the reason I say that no one can work on 50 priorities at the same time. But we all can take two or three priorities and say, "These are the three things that I'm going to work on today. That is this week. Those are the things I'm going to do this month." And therefore you start to develop identifying priorities. The right ones takes time. Sometimes it is a fundraising. Sometimes it's a building a team. Sometimes it's a product development. Sometimes it's all three of them, but being able to allocate your time and energy and focus is a key.
People say it's the question of money. I don't think it's a question of money. Money is one of the resources, but the biggest resource we all have is a time and energy and focus. In a company of our size, we are a publicly listed company, and we now have grown from where we used to be, and it's still small. Even today, there are a lot of things we choose not to do. We choose not to go to conferences. We choose not to publish papers.
If something is a priority to us, we say, "This is the only thing we're going to focus on. This is the next three months, this is our main goal." And every team meeting I have, I always remind people, three priorities. More than three, way too many. One may not be enough. But because if you can't remind people, what is the priority for the company, then you will not succeed. It is a very challenging environment to think about a startup company or companies in general. And when you have too many priorities, you tend to lose focus on.
By building priorities, having priorities, executing them. You create momentum, you create confidence. They create success and you keep climbing the ladder. But truly the biggest challenge for us in the beginning of the career is that identifying which are those three priorities that matter. And once you have had some experience, then the challenge is to keep those priorities and change them as you go along, right?
As you go along, you have to continue to grow. For example, in the beginning, it may be the five people you have and that may be enough. But as where we are in the company, it's a question about growth of the organization, right size, not too many people, not too little, hiring enough people so we can continue to execute on our vision and the promises that we made to ourself and to our investors.
[00:16:27] Lindsey Dinneen: Thank you for that advice. That was fantastic. And such a great way to narrow it down and help people understand how to narrow down so that they can actually focus and succeed before moving on. I love that. Thank you. So, you know, looking back over your life, and of course, you've had such an incredible career that has really taken you in a lot of different directions. Could 10 year old you have ever anticipated where you'd be today?
[00:16:54] Dr. Shalabh Gupta: I don't think so. I think I think we all have a what I call a true north compass. What I did think at the 10 years of age, if I can go back, maybe 10 is too early but maybe 15 or 16 or 17, that hasn't changed. Let me tell you 2 things that I always felt most inspired and excited about.
Number one was that I wanted to be in healthcare because, intellectually, I like biological sciences. I felt, "My gosh, what could I do with that if I could make a difference?" And number two was that I, from very early on, I wanted to be something which could help people directly. As you know, there are many ways you can help people, but being in medicine or healthcare, I felt there was a direct impact.
Now, looking back after several decades, I feel that part of the influence was my dad. My dad is a physician, continues to see patients and do pro bono work. So that had a very lasting influence on me. That helped me to think about, okay, this is what I want to do. Then being trained as a physician, then going to work on Wall Street, then there was a question about understanding how the impact can be broadened, if you will.
The way to think about what I do today versus what I did, say, as a physician, physicians see, say, 10 patients, maybe 12 patients if you're seeing an outpatient basis per day. And if you're in an ICU or ICU doctor, an ER doctor, you could see more number of patients, but then smaller time. And you multiply that impact that many patients, let's just say 10 patients per day, and you work at 300, 350 days, 360 days, 365 days, don't take any break, but that is that many patients a year.
What we do today has a potential to impact hundreds and thousands and millions of patients and not just in the U S, globally. So from one vantage point is just magnifying the impact. And the other vantage point is doing what I would have done before. I still love sciences every day. My job is to not just talk about business, but also think about, "How do we fundamentally solve the problem?" And having had those experiences you know, it helps you to keep yourself grounded.
One part, I know this wasn't your question, but one advice I can give people who are thinking about developing their careers as an entrepreneur, if you are a founder and CEO, especially think about your career or skill set as I spoke, a wheel, a circle. Every skill that you have, some of us start with more technical background, like me and MD. Then you have to develop their finance and business skills and the business development skills.
So sometimes people say, "Well, you know, ABC went to grad school and they dropped out of grad school and they started a company." That's wonderful, but think about much longer beyond a two-year, three-year, five-year time horizon. And that's what helped me to think about my career.
So I worked on the Wall Street, but that gave me a finance and understanding about how public companies are valued, not just by the company, but how stock analysts value the company, how investors value the company, what moves the stock, what did Genentech to understood. That gave me the chance to understand how a big biopharma company thinks about their product development. And at Genentech, in some interactions we have had, we were looking at the products from other smaller companies, either to collaborate with them or to acquire those products. So that's a different skill set.
I went very early on, as I said, in my career, I went to FDA. So even though I'm not regulatory expert, but I understand how agencies think about the product approval so that helps you to make a more of a holistic viewpoint because the business has become more complex, and you cannot just have a only business degree and you say, "Well, I'm going to succeed." Some people have rounded that up by years and years of experiences.
And then there is also innate desire to learn. I learned from not just doing the work I do every day, but my, my, you know, talked a lot about it. I read anytime I get I read books that are not related to medicine, that are not necessarily related to health care, because you have to understand how to grow a revolution. You have to understand leadership skills that are not necessarily taught in schools. So, you have to find a way to continue to refine yourself, because the only way you can create a great company is to become a better version of yourself.
[00:21:31] Lindsey Dinneen: Thank you so much for talking about that and for sharing your advice. And I love that image of the wheel. It's a good reminder that sometimes life takes you on very interesting tangents, but sometimes they all do merge at some point. You've got this little sliver of this knowledge that you're working on, and then this experience, and then they start building and I really love that, that, that way of thinking about it and also remembering that It's very useful.
So, so like even earlier, I was struck, you talked about how there was inspiration from car batteries, right? And so how interesting is that to go from, what you might expect within your industry, here's how to solve a problem. But then you guys went outside and said, how do other people solve problems? Like maybe we can borrow from that. And I think that's really cool.
[00:22:21] Dr. Shalabh Gupta: And I also think that if you stop focusing on only in your industry, learn from anywhere. Some of the best learnings that I have personally, that felt inspirational to me, did not come from biotech companies. They come from tech companies, truly. When you think about the worst, most successful tech companies like Amazon, Apple. I can go on and on, but there are things that you can learn from them. There are things you can learn from the founder of Amazon, Jeff Bezos. He talks about building Amazon and he talks about doing many experiments at a smaller scale that fail at Amazon in order for them to succeed at a few that really work.
And this is where I was saying that culling the ideas, you may start with 10 ideas, but no one can develop 10 ideas, no one. And it's not because of money. People say, "Well, that if I had money." There have been numerous examples where companies have been funded with lots of money and the companies fail. Part of the problem is that when you get too much money, I think you may not realize that you still have to deliver. Because focus and execution takes really knowing what the target is, and then hitting the target and not one time and time again. Targets may change, but the companies cannot focus in 20 different things. In the beginning, you have to start with a very key thesis.
[00:23:39] Lindsey Dinneen: Yeah. Absolutely. Absolutely. And yeah, so learning from other industries, and that actually kind of also brings up a thought. So as you've gone along in your career and you've had many different iterations of who you are and what you bring to the world, now, are there any moments that really stand out to you as affirming, "Yes, I am in the right place at the right time?"
[00:24:04] Dr. Shalabh Gupta: Yeah, that's a very good question. And I have had a chance to think about it every now and then. So there are there, there are certain observations I'll make. You know, people always say, " What will be your dream job?" And I think the dream job for someone is the job that which you will do any given day, and you will feel a joy that you're doing it and you're not doing for remuneration. You're not doing because you're going to get paid.
And we all have those different moments in time. People talk about "flow" where the time stops because you're doing something so deeply engaging that you lost track of time. You forgot where you are. You're not feeling tired. For me building of this company and the team that we have assembled at Unicycive is that flow. Any day that I'm not traveling, I am in my office. I don't work from home. I am every single day in my office.
And sure we have a small team, but when we work with the team, these are motivated, driven people with decades of experiences. We feel that we are in a common mission, like we are solving the world's greatest problem. And I know that may be exaggeration, but that's how it feels. And being with them in a room and thinking about a complex problem-- and not just thinking of a problem like how big companies think about it-- but thinking of the problem in a scientific way, but delivering it a solution that only a small company can do that to me is a joy.
Number two part is that as I've gone further on my career, I, I am a mentor to a number of startups from Stanford and UCSF, and many Stanford companies, many of them come with a very different problem than purely a biotech company. Since the pro bono work, I do this because I find by telling other people from their problem, I get to reflect on my own problem, and I do that on every quarter.
There's one or two companies and I've been really privileged. I feel one of the greatest joys to meet with these great CEOs and Stanford has been a great collaborator. They have a program called Start X in which they have these companies that are participating in a accelerator program. And Stanford's accelerator is different and unique that they don't take any equity. They provide you the opportunity for mentorship. I was part of that program many years ago.
So I meet with the CEOs and many of these CEOs will come very different problem. As an example, there is a company that's focused on artificial intelligence using interaction between a physician or healthcare provider and patient, and being able to use AI to streamline that interaction. That is a point that I saw of 10 years of clinical practice, how that communication is broken, literally is broken.
Patients go to doctors, not because doctors are the world's greatest knowledge source, but patients at the end of day, they need someone to help them feel better, help them understand the problem that the physician can solve it. What ended up in being in today's healthcare system in the U. S. is that doctors have become mechanical and not because doctors are bad, because we are given these many things to document these many things to chart.
If you talk to a physician, a primary care physician, many times the physician is sitting behind the computer screen. Those bedside manners are gone, like literally they are not there until you go into concierge medicine because the physician has to fill up this chart. I practice medicine.
So understanding how this company and this CEO, this entrepreneur is trying to solve that problem, I lean back to the years of clinical practice. Then I lean back to the building the company. They're prioritizing it, having three priorities, having five priorities, and then being able to understand. And every company has some things which are similar, growth of your product development, continuing to advance the company, continuing to tell the story, attracting the right team members.
It just gets magnified at a broader level. But the problems start similar, very similar. You know, think about when we talk about tech companies, Apple, the first thing they had to do, develop a product, then build a team, then sell the product, tell the, sell the vision, you know, and then continue to raise money.
And that part is seems sometime very lonely. It also seems that I am uniquely burdened with these problems. And I always remind people, "You know, as much as you would like to think that you are unique. I assure you, it is not a problem that we are gifted with. We all have to face the same set of problems, sometimes more, sometimes less."
So then you start to take them less personally. You start to say, "Okay, I'm not the first one to face this problem. These problems have happened to people like me before and they will overcome. How can I do it?" Then you'd become safe, a solution based thinking versus a place where you get overwhelmed with the problem because problems exist.
And if anyone is listening to this podcast and if they've developed a started a company, I can assure you the problems come with a flood. They are not going to end ever. So it is disappointing. Sometime it feels that, "Oh my gosh, it is me versus the world," but it is not so. If you have good set of mentors, people who are not directly involved in day to day in your business, there are people who can help you think through it.
And that is something that I find a great joy in talking to these CEOs, being able to help them understand the problem. And I say, you know, a couple of hours a month, but then when I go back to my own work, one that I realized this was the same problem I faced a few years ago. Two, it's a similar version of the problem I face at a slightly larger scale today. And three, being able to step out of from your own narrow zone, it gives you perspective. Then what I said to you about that problems are not, these are not personal problems. These are the problems we all face developing a product. It doesn't matter whether you healthcare.
People tell me health care or product development is really hard. You talk to my colleagues, our CEOs who are running tech companies. Products in development and tech companies may seem easier, but to create a great product that truly solves customers problem, it's not easy.
[00:30:30] Lindsey Dinneen: Yeah, and well, I love that mentorship and sort of teaching and guiding, giving advice to the next generation is something is of a core value of yours and something you really care about. And it actually is a great segue into my next question, which is just pivoting the conversation for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, what you're doing right now, but it doesn't have to be. What would you choose to teach?
[00:31:02] Dr. Shalabh Gupta: I think as much as we all feel that entrepreneurship is an external game, I think it's a lot of internal mindset, being able to understand yourself better. Being able to understand who you are, what are your true core values, what really drives you. It takes time and it requires a continuous interrogation, asking yourself, "Is this really what I enjoy?"
Some of us feel it's a glamour that we feel like we want to be CEO. Some of us would be better off as a CTO, Chief Technology Officer. Some of us would not want to do startups. It's not for everybody. And it's okay because you can work in a bigger company and can be, you know, people talk about entrepreneurial pursued within a large organization. Maybe that's what for you.
But being able to understand yourself, it's a very important part. And I think unfortunately, formal education does not help us no matter what degrees and which schools. And it really doesn't matter whether you a science degree, MD, PhD, or your business school degree like MBA, we're all very uniquely different, and we have different values. What one person sees inspired by, for somebody else, it may be a nightmare, you know.
It's a thing that people think that startups are so much fun. I read a joke. It says, "People leave 9 to 5 job to work from 5 to 9, which is 5 a. m. to 9 p. m." So I think that's because this is some truth to it. And I've said to people again and again that if making money is your objective, please don't go as to run a startup. It is probably the worst way to think about pursuing the financial part.
You do something because you have a faith and belief in something. And it doesn't have to be the faith about changing humanity. It's about something that you have a unique skill set or unique product idea that you believe you can bring to the marketplace. The biggest focus we all can have is making an impact. If I can serve a large number of patients, I can serve a large physician, I will have a product that will make money, therefore, that will make money for enterprise that will make money for investors. And therefore, as a company, we will make money.
It's a very simple truth, but we like to make it complicated. I really mean it. The more I got to understand this part of the process better, which goes back to the basic thing that I said to you, if you said that you have a master class, the one thing I will say to you, it's spend time to understand yourself. And it's okay to realize that what I thought I like, I don't like it. The part that I talked to you about flow, it takes efforts.
I've had many careers, but when I work in my company, the time can stop for four or five hours, literally we can be working on something. And I have a team and it's not just me alone. I have a team that when we think about a problem, these are people who have spent three decades in working in different companies, large, small, many size companies, we could work cohesively, collectively, think about a problem.
And that to me, it's a joy. For me, that is a creation, right? You know, we're thinking about the problem, which may be a design of a clinical trial, because we have to think we have to use brains. And I always say, "God gave us a gift, which is a neuron. So use it, let's use them." And challenge yourself, right? And the challenge in a good way, not be a condescending ending jerk and say "No, how could you do it?"
I try to say to people, "Look, I understand this is how it is done, but I want to do two things. Number one, please believe me that we can do better, faster, cheaper. And number two, I promise you that whatever I'm telling you, I'm not going to tell you and walk out of the conference room. I will work hand to hand." We call it a hand to hand combat is essentially that I'm not just telling you I'm going to work with you. I want to find the solution, but we can't do that thing that are you used to.
Every trial, people tell me it's going to take 18 months, 12 months, it's going to cost as much. We shrink that thing timeline cost by not 10, 20%. We talking 50%. And these are people have done this before. So, so I need the courage to be honest and say, "No, we can't do it. We have to do it faster, better, cheaper, but how?" And then asking them. So, I say, "It's okay that we walk away and we don't have a clue. It's okay. Today's Thursday. Let's come back. Take three days to think about it."
But the reason is that because when you ask yourself from a place that I can't do it, the mind is start to find solution versus when you say, no, I can't do it. Because in that case, it's a subconscious mind that keeps on giving you 15 reasons why you can't do it. People talk about growth mindset. I've always said to people, "We may not be able to do this thing today, but the understanding that with a little bit of help, a little bit of patience, a little bit of it, making ourself better, we can become that company, we can become that organization."
And that really requires challenging ourself. And that's where I went back to. I want to go back to this question you asked earlier. People talk a lot about entrepreneurship as if it is some very specific skill set. I think because if you know yourself, you know what is your true zone is, then you want to surround yourself places that you are either not good at, or you don't enjoy doing it, right?
In the beginning, it is just you and a vast amount of problems to face. Then you start to build your team. Then you start to see yourself, "You know, maybe Bob can do this work. I really, I'm not that good at it. I don't like doing it." Then you start to rely and surround yourself with not same skill set, but the people who are complementary skill set. And that's how you build a team. That's the foundation of team. Then you build trust and you say to Bob, "Whatever you do, it's not your fault. I'm here to protect you." You don't point fingers at each other.
We always remind the example of Navy SEAL. You know, I've never worked in the US Army. I was not an Army veteran, but the ethos that Navy SEAL uses where the team wins, I always tell people we are a winning team. We are not looking for MVPs, you know, because the teams win. Teams create products, teams create value. Individual glories is not useful and this is something you have to keep reminding us that we keep drilling it down and say " No, it's not Bob. It's not John. It's not James. It's us. It's as a team."
Again, as you grow through the company stages, your skill set has to continue to evolve and people always say, "Well, how do you lead a team?" The first thing that I always said, "Every single person in my team, you are a leader. Why? You wake up in the morning, brush your teeth. You're leading yourself." Really! Like, what do you do with your day? If you happen to be a parent or partner, a spouse or somebody, you have people you influence around yourself, right? So instead of worrying about, "Oh, you know, I want to lead a company."
First, you have to lead yourself and you have to lead with courage. It's starting a company, building a company, right? Yeah. No matter what the media tells you, it is hard. It's hard to develop a product. It's hard because the challenges are not one or two. There are many. Being able to drill down, saying "These are the three things I'll focus on. These are the only things that matter." And then if something new comes up, you have to face that challenge and put the third in your list. It comes in a different page.
You know, I use this basic exercise. I have a notebook, a physical notebook and not electronic one, and a piece of paper. What are the top three priorities? And then the other part is that I've asked people to do this exercise when startup companies, CEOs come and tell me all their problems, all the things they want to do. I said, "Humor me if you will. This is the end of the year. And let's say today is we are in 2025. What would you like to tell yourself a year from now? If everything happened the best you could imagine, how many customers, how many products, what will be the stage of product, who would have funded you? Who are the people behind you?"
And I asked him to write in a whiteboard. And I say, imagine, no, this is the five thing. If they write 25 things, I say, "No, this is down to five things. What are those five things you would like?" And again, everything has just gone and you can't believe you're sitting there. What will it take? Is it this? And then you start to have a goalpost, right? It's a target. Then you work backward.
[00:39:37] Lindsey Dinneen: Yeah. Yeah. Well, that's great. That is such great advice. So thank you, first of all, for sharing, but I think in general, your masterclass would be so much-- you'd have to have a full day or more. That's great though. I love that. How would you wish to be remembered after you leave this world?
[00:39:57] Dr. Shalabh Gupta: That's a very good question. That's one that I ask myself every day. The most important thing for me is to be who I am to make a difference for people who are around me. For me, my family is very important. I have kids and I always think about it. What will my children remember?
Then it comes down to people who work with me. We want to give an experience to people. I've had people who have worked for I keep saying it two or three decades. My true wish is that I always say for whatever time they work at Unicycive, I want them to be remembering this is the best time they work for a company and that is the best hope we can do it. Because as a entrepreneur, if I can make our company the best experience, best environment, then that creates the best products.
And a company like us, we realize that we are going to face challenges and it's not a question of this, the question is how many challenges. The question is not going to be, "Will the challenge defeat us?" The question is, "How do we overcome the challenges?" So it's about growth mindset, having a very distinct, clear vision and empowering people.
And last thing is that what we do in healthcare affects millions of people people. Our drug is not going to be just in the U. S. We have partnerships outside U. S. We think about patients in China, South Korea, Southeast Asia. We are talking to companies in Europe. It's an opportunity to make a difference globally. And that is what keeps us going. That's what, you know, when that's when I talk with flow, that is what makes you want to work, whether it's a weekend or whether it's a late evening.
And I think that is something which we all need to do to find something that is meaningful. And meaning means different things to different people in different phases of life. So it doesn't have to be, you know, I tell even my own team member, " Unicycive does not have to be the purpose of your life, but let me help you to manifest your best version so you can work well, because you are working here, you are spending your time, might as well make it meaningful for you and for the company."
So finding that balance is key and it's a constant challenge. I never take anything for granted. It's a constant to my own team members. How can we make it better? You know, people always say the company grows and we started with the company. We went to IPO with one person. That was just me as an employee, which is not a common thing. I frankly don't know any other company that I've ever seen that went to a straight IPO with one employee.
But that wasn't about me. It was about building the company, building the team. Today, we have 25 or so more, but it's still a small team. And people always ask me, "How do we go from 25 to 50 and it still remain the same." I said "Exactly how we became 5 to 10 to 15, 15 to 20." Because if you keep the culture same, focus same, and you remind people that it's not about who we are individually, but it's what we could be collectively.
And you have it going and you know, something you're passionate about, you will give all that you got and then some more or else there is not worth fighting for because life is hard and building a product developing a technology or running a company is hard. So, either you are a full believer or else you can't do it. I mean, if you can do it, it's going to be miserable on both front. You want to do a good job and you will find it very difficult. So.
[00:43:24] Lindsey Dinneen: Yeah. Indeed. Yeah. Excellent. Well, and then final question. What is one thing that makes you smile every time you see or think about it?
[00:43:36] Dr. Shalabh Gupta: I think when you look back on the challenges that you once thought were unsurmountable, and then you say to yourself, "Huh, that was just a curve in the road, not a roadblock." Then you start to smile because of not because how smart you are, but how much together a team can accomplish. And you start to find, if you're working in a company setting, you start to feel that people start to feel empowered. My team says that you did it. I said, "No, we did it. I just showed you a judicious path, but you did it. I didn't do it. All I said to you is to change your framework."
Because it's a framework. It's a mindset. And I keep saying about mindset because if you come with the idea that " No, I only, I need this much money, this much time, these many resources," you'll find you the subconscious mind keeps on validating those challenges. But if you say, "No, people like us have done it before I can do it, we can do it." And give them the time and space and say, "Look, you don't have to have an answer right now, but please go back and just think about it."
Then they come back with the answer and they themselves surprised. But it truly requires a authenticity, a vulnerability, and being absolutely willing to fall on your face and get up and just fight again. And that's part people don't realize. People think about that every company is a smooth road up, but the companies go through the cycle. It's not when you're going up, it's what happens when you fall down. Can you pick yourself up?
And it's not just with your team, but with your investors too. You know, we thought that we're going to file an NDA in 2020. You know, 2024, we had planned for everything and the whole thing was there, but we ended up in having to run an additional trial and then you have to communicate with integrity through transparency. This is what happened. This is what is there, but we can accomplish that.
So then that all of all that helps you to look back a smile, laugh and say, "Okay, I accomplished that. We can do the next one." And that keeps the growth happening. And at the end of the day, we are not happy because we accomplished small things by doing small effort. Most of us as human beings want to be challenged in the right way and we feel joy in doing hard things that take a lot of efforts and once seemed just impossible to do it.
And the question is, can you do it with your entire team, not just personally? And that's what inspires people. We want to be that company that people want to work for not because they need a job, not because we can take care of their 401k. I mean, those are a wonderful thing and I'm blessed that we can do all of that, because once upon a time, we didn't have any of that. So I don't take it for granted, it is something. But the fact is that what was the mission hasn't changed ever.
And you know, that that is something which is worth pursuing it. And I think if people start to see that they can accomplish that, these challenges are not personal, that they are bound to come. And then they have a support group, you know, we all need somebody other than ourselves and people whom we are surrounded with somebody to hold our hand and say no, you fell down, but it's okay.
You can get up. I think it's that support system, right? The more you can have it, the more different types of people you can relate to and call them friends, mentors, that helps. And I have tons and tons of them because my gosh, I mean, there are days seems like, how would I ever get out of this? As much as you may think that I have all the source of inspiration, but then if somebody else holds your hand, they say, no, you can do it. That is what gets you going to the next step.
[00:47:25] Lindsey Dinneen: Absolutely. Well, goodness, this has been an amazing conversation, just packed full of incredible, helpful advice, and just very practical down to earth sharing. So thank you so much for your time today. I really appreciate everything you're doing to, to make an impact. So thanks again for your time.
[00:47:44] Dr. Shalabh Gupta: Thank you very much. Thank you for hosting me and thank you for your time and interest. Really appreciate it.
[00:47:49] Lindsey Dinneen: Of course. We are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger. And also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support, and we just wish you the most continued success as you work to change lives for a better world. 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.
[00:48:31] 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.