The Leading Difference

Velentium Medical

MedTech Leaders Changing Lives for a Better World

  1. قبل يومين

    Stephanie Rupp, Patent Attorney at Hoffmann Eitle & Ryan Phelan, Partner at Marshall Gerstein | Navigating Medtech IP Protection: U.S. & European Perspectives

    Stephanie Rupp (Hoffmann Eitle) and Ryan Phelan (Marshall Gerstein) explore how AI is reshaping medtech innovation and the IP strategies founders need to know. They break down key trends, from traditional model training to today’s generative AI workflows, plus common pitfalls like novelty-destroying disclosures in pitch decks, websites, and investor conversations. Ryan explains why “file early” matters in the U.S. (and how provisional applications can backfire if they’re too thin), while Stephanie shares how Europe’s strict novelty rules and EPO “technical effect” requirements change how AI patents must be drafted. The conversation also covers cross-border collaboration, the Unified Patent Court, and why strong IP can become a startup’s moat for investors and future growth. Guest links: https://www.marshallip.com | https://www.hoffmanneitle.com/ | rphelan@marshallip.com | srupp@hoffmanneitle.com  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 CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 089 - Stephanie Rupp & 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 today I'm delighted to welcome as my guests Stephanie Rupp and Ryan Phelan. Stephanie's technical expertise stems from working in various fields of electrical engineering and information technology. She is particularly interested and experienced in communication technology, telecommunications engineering, and artificial intelligence due to her time at the university and various projects in the industry. For example, Stephanie gained industry experience with a leading technology company of measurement and high-frequency technology in the field of measurement technology for LTE. Working with a variety of clients from all over the world, Stephanie specializes in prosecution and oppositions at the European Patent Office and German Patent Office, freedom to operate, and patent drafting, in particular in the fields of computer-implemented inventions. Stephanie studied electrical engineering at the Technical University of Munich. She wrote her master thesis at the Chair of Communication Networks in the field of artificial intelligence with a focus on reinforcement learning. Ryan is a registered patent attorney who counsels and works with clients in all areas of intellectual property with a focus on patents. Clients enjoy Ryan's business-focused approach to IP. With an MBA from Northwestern's Kellogg School of Management, Ryan works with clients to achieve their business objectives, including developing and protecting their innovations and businesses with IP. Ryan has been published in several well-known IP publications, including World Intellectual Property Review, Bloomberg Law, and IP Litigator, and has spoken as a panelist at various IP conferences, including for the International Intellectual Property Law Association and for the University of Illinois Chicago Annual IP Conference. Since 2024, Ryan has been selected for inclusion in The Best Lawyers in America list in the practice of patent law. All right, Ryan and Stephanie, welcome to the show. I'm so glad that you are here. Ryan, this is your second time. Delighted to have you return, and Stephanie, I can't wait to learn more about you and all the ways that you both contribute to the industry. So thank you both so much for being here. [00:02:54] Ryan Phelan: Yeah, thank you. Yeah. Glad to be back. [00:02:56] Lindsey Dinneen: Awesome. [00:02:56] Stephanie Rupp: And thank you v- very much for having me. [00:02:58] Lindsey Dinneen: Yes, of course. Well, I would love, if you don't mind, starting off by sharing just a little bit about yourself, your background, and what led you to medtech. [00:03:09] Ryan Phelan: Yeah. So I'll kick it off. My name's Ryan Phelan. I'm a partner at Marshall Gerstein, which is an IP boutique here in Chicago. I have a computer science background, so I see the world through, you know, everything computers and, of course, nowadays that means AI. On the, the medtech side you know, I, I have, experience in robotics and so, a lot of medtech devices are in the robotics field, so it's very natural for me to apply my skill set, to that, area of expertise, one of which is, prosthetics. So you have a robotic, prosthetic medical device, and that lends itself to, you know, some type of computational control. And there's certain, legal issues that usually come up in, the US practice. So I enjoy, applying that skill set, to the, to medtech space. also, you know, family members als- have, you know, ailments and things that, I have, grown up with, you know, as a, you know, young boy and, now I'm very happy to you know, give back in my own way. I'm not a doctor. I'm just a-- I'm a, I'm a humble patent attorney, but, helping the, IP world, and, doctors and physicians, with not only, you know, in the robotic space, but also, software medical inventions as well, and I, enjoy working in this space. [00:04:22] Lindsey Dinneen: Love it. Thank you so much. Stephanie? [00:04:26] Stephanie Rupp: Yes. So as you hear from my accent, I'm from Germany, specifically from Munich, so that's a city in the southern part of Germany, close to the Alps. people might probably know Munich from the Oktoberfest that we have each year. And, so I'm a German and European patent attorney at Hoffmann Etile. I also throw it in as well, I'm also UPC representative, so we have, for three years now, we have the Unified Patent Court, so a really new court in Europe for centralized litigation for infringement and revocation actions. So I can also represent clients there. yeah, Hoffmann Etile is a, also a p- a IP boutique firm. not only in Germany, we also have offices, in other places in, Europe. And, yeah, my technical background is electrical engineering and information technology. And, during my studies, I just didn't work a lot in the medtech space. I was, ... my work concentrated more on the telecommunications side, working in a, bigger f- company that, concentrated on measurement and high-frequency technology. But, my master thesis was already about AI, so it was at the Chair of Communication Networks, and it was about, like, reinforcement learning, virtual network embedding. I won't say too much about that. I think it will bore the listeners. But so I didn't know at that time, but it opened my way to the medtech space afterwards. because when I joined Hoffmann Etile nine years ago with my training, the partners were really happy to hear that I have experience in the AI field and the technical background on that. And, around nine years ago, we saw a lot of patent applications being filed in the AI space, like using AI technology in different technical fields, and especially also in the medtech, field. And, so I had the opportunity to jump in there, like, right away when I started and was really happy to do that and also, like, still very glad to have that opportunity to work with the medtech, companies and to get the best patents for them in that, especially in that field. [00:06:26] Lindsey Dinneen: Awesome. Thank you so much. Yeah, thank you both. So, all right. I have so many questions, but I will start here. I'll just, 'cause I'm curious. So how, how did you two meet? Do the firms come together and, and, collaborate? [00:06:38] Ryan Phelan: Yeah, absolutely. so Marshall, Gerstein and Hoffmann, Eitel had a relationship prior with, attorneys, that go back a generation or two, before Stephanie and I met. And so, their-- one firm would send attorneys to the other and vice versa. And then, after a while, given that Stephanie and I have similar backgrounds, it was very, simple just to connect us. And then we've worked together on matters, before and have similar backgrounds like Stephanie mentioned. She has electrical background, but has done a lot of stuff with AI. And so whenever you're doing, matters across the pond, as they say, you need expertise, in the EPO and the US and the laws are different, so you have to collaborate. And it's great to have, have people that you can collaborate and work with. [00:07:21] Stephanie Rupp: Yeah, and a lot of clients, they're not only interested in getting an EP patent, but they also want to get a US patent. And, I'm not a US patent attorney, so, usually tell them, "Oh, yeah, I know a really good patent attorney in the US." And, thank you ... so I will, like, hand over the work to him and then the other way around if they have, like, clients that they want to get a EP patent, and that's how we work together and, also dis-discuss these cases together. And, so yeah, I'm currently in Chicago for a week, also to meet Ryan in person again. I do that, usually once a year. And, yeah, just have time to discuss some cases more regularly. [00:07:55] Lindsey Dinneen: I love that. That's cool. [00:07:56] Ryan Phelan: Yeah, I was in, And I was in beautiful Mu

  2. ٤ سبتمبر

    Dr. Andrew Holman | CEO of Inmedix | Innovative Diagnostics in Rheumatology & The Power of Stress Management

    Dr. Andrew Holman is a rheumatologist and the CEO of Seattle-based Inmedix, which recently received FDA clearance for the first cloud-based heart rate variability (HRV) diagnostic platform. Dr. Holman shares how a “detective” mindset led him from early interests in orthopedics and cardiology into rheumatology, fibromyalgia research, and ultimately entrepreneurship. He explains how chronic stress, the autonomic nervous system, and conditions like sleep apnea and restless leg syndrome can influence cardiovascular risk and autoimmune disease outcomes, and why measuring stress biology with medical-grade precision matters. Dr. Holman also offers hard-earned advice for physician-innovators, reflects on pivotal study results, and shares what he hopes to be remembered for: never dismissing patients in distress.  Guest links: https://www.inmedix.com | https://www.linkedin.com/company/inmedix-inc 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 CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 088 - Andrew Holman [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 be welcoming as my guest Dr. Andrew Holman. Dr. Holman is a rheumatologist and the CEO of Inmedix, a Seattle-based medical diagnostics company that recently received FDA clearance for the first cloud-based heart rate variability diagnostic platform. He has 25 years of clinical experience with 16 peer-reviewed papers and clinical trials demonstrating that measuring stress biology with medical grade precision can improve success rates in autoimmune diseases. All right. Andrew, welcome to the show. I'm so glad you're here today. [00:01:30] Andrew Holman: Yes, happy to be here. Thank you for inviting me. [00:01:33] Lindsey Dinneen: Course, of course. Well, I would love, if you wouldn't mind starting out telling us a little bit about who you are, what your background is, and what led you to medtech. [00:01:44] Andrew Holman: Sure. Well, I'm a, a guy from Seattle, Washington. Grew up here, but trained everywhere else, became a rheumatologist. We study autoimmune diseases, lupus, rheumatoid arthritis. I also was very interested in fibromyalgia and pain. We're the immunologists of medicine. So, I started my practice, golly, a while ago. 1992, I finished my prac- my training, and I was the main rheumatologist at a large suburban hospital at the southern end of Seattle. So hometown, circle back to the hometown. I went into rheumatology because you have many choices when you do internal medicine. You can go be a specialist in many things. But I like the puzzles. The immunology has grown and it's a, it's a particularly sort of detective-oriented specialty. So, I didn't set out to be an entrepreneur. That came 25 years later. I was an in-the-trenches doc trying to help the person in front of me with these devastating diseases that are crippling diseases, usually of young women mostly. [00:02:45] Lindsey Dinneen: Yeah. Okay, and I'm sure there's, there's much more we're gonna dive into, but one thing that really stood out really fast was you, you kind of called yourself a detective, which I really love that term. And so I'm curious, is that something that you always thought you wanted to specialize in, in medicine, or was this, you know, detectiving to come later? Was this something that, you know, you ended up learning more about while in med school and thought, "Oh, this sounds really cool. I could put really two interesting passions together"? [00:03:19] Andrew Holman: Yeah, it was-- you know, things just sort of come into play sometime. For those who are not in medicine, they may not realize it takes about ten years to go to college, med school, re- internship, residency, fellowship, you know, and then you, then you finally get to go be a doctor, and you have to go learn how to be a doctor s- a little more. The patients teach you a lot more than people realize. So I was gonna be an orthopedist. I liked orthopedics. I liked architecture, bones, joints. I thought it was a lot of fun. I just had very little aptitude for what they do. I, I don't-- I, I'm not very g- a good carpenter. I just, you know, I didn't-- just wasn't gonna be a great orthopedist. So then I thought, "I really love cardiology." Rhythm disturbances, all kinds of things. In the 1980s, when I was in medical school , all the new stents and procedures and non- less invasive things than bypass surgery were all coming up. Joint valve replacement. You know, it's really exciting. But I never... and I never took a, a f- a course in rheumatology until I was actually an intern in internal medicine program in Denver, all set to be a cardiologist. And there were 12 of us in the, in the program per year, and s- five of us became rheumatologists because of this one doctor who took us out, a guy named Daryl McCarter. Prob- maybe people who know him, he's retired recently. He would bring us in the office, and we'd see every other patient with him because in between the patients, he would give us an X-ray, say, "I want you to look at this. There's a clue here. See if you can find it." Or, "I want you to look at this pathology slide," or something. "There's a secret, you know, to figure this one out." And I go, "Wow, this is really fun stuff." And once you figured it out, we weren't as good at treating it yet, but we were getting better. We were getting better. So it was the cutting edge and very fertile ground for discovery. So, rheumatologists are called the consult of last resort for a reason. There aren't very many of us. You've usually seen everybody else first, and by the time they-- you see us, we're pretty good at figuring out the rare diseases that are not in other people's board exam. But we're also pretty good at figuring out the common disease that presents in a very strange way, you know? And, and that's what our strength is. So we may... Everybody who sees us who gets diagnosed may not have a rheumatology answer, but we try to get them an answer. And now we're really in the golden age of rheumatology in the last 20 years of really making a difference for so many people. The downside, we don't make a difference for enough people, you know? We, we... That's the problem. So we've got these very motivated doctors out there, eager, and we just need, you know, more. And that's why I became an entrepreneur, because I learned more neurology than I was supposed to know and more sleep physiology than I was supposed to know. You just follow the breadcrumbs, you know? [00:06:17] Lindsey Dinneen: Yeah. Okay, so I know you didn't start out wanting to, or maybe even being interested in being an entrepreneur, but that is the path that you chose, and I would love to hear about that, the company, and what you're all doing. And then also would love to hear about your journey into deciding that this is the next right step for me. [00:06:38] Andrew Holman: Yeah. Well, thanks for asking it. It is a little unusual. So I was actually studying and trying to help patients with fibromyalgia about 30 years ago. And fibromyalgia patients terribly dismissed till they're all making this up. There's not 10 million people that can make anything up and be consistent. I mean, they all say the same thing. So I thought that was nonsense, and I was really thrown into the crowd of, you know, "You're, you're crazy too." And I go, "Well, I'm board certified in crazy." So I w- I was interested in it, and I was irritated that these people were dismissed. And I was around other doctors in Seattle who were similarly that way, which was very, very unusual. It's unusual to find people in the '90s who had an avid interest in that disorder. And so I started doing what rheumatologists are good at, incrementally advancing ideas and therapeutics very carefully, very cautiously. We do a lot of things off-label. When I was-- finished my fellowship in 1992, half the diseases on our board exam had no FDA-approved treatment. We had to do something, right? You couldn't just say, "Well, come back when there's a couple of articles in the New England Journal of Medicine." You, you can't do that, right? People are depending on you. So rheumatologists are particularly good at that, and that's not something most doctors want to do. Most doctors find that very uncomfortable. They're very, very careful people. And, and rheumatologists are careful too, but we take this mission seriously that we need to do something for you. So basically, I was looking at off-label ideas and work on fibromyalgia, and I'll share this with your audience. I was actually pulled up-- pulled in by some senior doctors who said, "We wanna talk with you." And I'd been there about three years as a new doctor. Oh, you know, seem to be doing a good job. Maybe they wanna pat me on the back or something. No, not that. It was actually an intervention, which I had never... I

  3. ٢١ أغسطس

    Ofer Shalev | Co-Founder & CEO, New Phase | Pioneering Cancer Treatment through Breakthrough Nanotechnology

    Ofer Shalev, co-founder and CEO of New Phase, shares his journey from leadership roles across high-tech, biotech, banking, and even serving as a fighter pilot, to pioneering a nanotechnology-based hyperthermia treatment aimed at transforming stage four cancer care. Ofer explains how the company’s mission focuses on prolonging life while preserving quality of life through a systemic approach designed for metastatic disease. He discusses New Phase’s progress, including treating 33 stage four patients (including at Mayo Clinic), achieving stable disease in over 60% of cases after one month follow-up, securing FDA medical device designation and IDE approval, and building a science-driven team supported by patents and peer-reviewed publications. Guest links: https://newphase.co.il/ Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 087 - Ofer Shalev [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 as my guest, Ofer Shalev. Ofer is the co-founder and CEO of New Phase. With more than twenty-five years of management experience in the high-tech and biotech industries, Ofer leads New Phase operations and is pioneering a breakthrough nanotechnology-based treatment to transform the management of stage four cancer. Ofer combines deep technological insight with strategic business acumen. He previously served as CEO of several technology companies, including ReDent Nova, which led innovation in dental medical devices alongside his co-founder, Dr. Rafael Hof. Earlier in his career, he held senior leadership roles in the banking sector, including serving as VP of Operations, which strengthened his foundation in large-scale operational excellence. He holds an MBA from the University of Edinburgh and is recognized for guiding multidisciplinary teams, driving complex R&D initiatives, and scaling companies from concept to global market presence. At the core of his work is a clear mission: to redefine the future of cancer care by offering patients a safer, more targeted, and more effective treatment, one that not only attacks tumors but also preserves the quality of life. All right. Well, welcome to the show. I am so thankful you're here today. [00:02:09] Ofer Shalev: Thank you, Lindsey. Good evening. Very nice to meet you. [00:02:11] Lindsey Dinneen: Very nice to meet you too. So I would love, if you wouldn't mind starting off by just sharing a little bit about yourself, your background, and what led you to medtech? [00:02:25] Ofer Shalev: Well, I would say that during the year, I had extensive managerial experience across many multiple sector, including industry, high-tech, banking, and obvious-obviously life science. I have also to mention that about fifty years ago, in my experience I was a fighter pilot, pilot in the Israeli Air Force. It was, again, about fifty years ago. I would say that it probably significantly shape who am I today. I mean, it's developed my ability to to take a calculated risk, for example, or to act quickly and precisely to plan ahead, to build contingency plans. So all that kind of thing that probably was very relevant to the time I, I w- I used to serve in the Israeli Air Force, but also very relevant to the, to the industry. Okay? And furthermore, I would like to say that probably I am highly motivated by challenge. It, it's make my day. In addition, I am a father to four children and a grandfather of seven grandchildren. And I do hope that at the end, I will have about twelve grandchildren. So, the kids have still to work about it. Yeah. And I would say that you asked about myself, so probably I have a very, very strong belief in the path, in the way that I'm choosing. It's I would say, enabl-enabling to, to overcome about the difficulties, mainly when you're looking for challenge, especially in, in a new and unfamiliar field, like in our case of New Phase And furthermore, I, I, I, I truly believe in the word "never give up." You will find solution to everything. Never give up. I like very much as I mentioned before, to, to meet a challenge and to overcome our challenge many times by breaking some problem into pieces and then to assemble it again. Furthermore, I would say we, we met many, many problems in our life. I, I think that we have to focus about the solution, not about the problems. You cannot change problems. It's happened. But let's try to find and, and to think about how to find the right solution to it. And I would say that I, I f- I feel very, very, very good to to operate or to, to function in a turbulent area. I mean, I like it very much. I, I know that not, not, not anyone like it, but I feel very good in, in this area. [00:04:59] Lindsey Dinneen: Wonderful. Well, thank you for sharing a bit about your background. I have so many questions, but I would love to actually learn about what you're doing right now with New Phase, because I know you're passionate about it. There's, there's a lot that goes into cancer research and treatment, and I know that that's been such a challenge for so many years, and I love the fact that your company is really diving into that challenge and tackling it. And I was just wondering if you could explain where the concept of New Phase came from, and what exactly makes your company so unique in this space? [00:05:39] Ofer Shalev: So the, the idea came that it was 14, 14, 15 years ago, while me and my partner, Dr. Rafael Hof, we were involved with some other company, and after that at that time his mother, her name was Sarah, she wa- she had lung cancer. She passed away. And during that time, we have a very, I mean, many time conversation about the disease. No, no, no, none one, none one of us is, was oncologist, okay, by training. But we have many, many discussion about the treatment what are the relevant treatment that are available, et cetera, et cetera. And after she passed away we, I mean, Rafi, who is a great technology guy, came with this idea of nanoparticles and hyperthermia, and we start to work about it. Again, we have to learn, both of us, we have to learn a new area of technology, of biology, of chemistry, of physics, engineering, regulation, everything. And it was not only that we have read and learn about it, but we decide al-also to, let's say, to, to jump into the pool, into the water. We put each one of them, each one of us put some money. We hire some chemist. We also hire from one of the university in Israel some space. Like you, I mean, usually, I, I believe it's the right way to develop a company. I mean, to start and building it, the company, in the garage, okay? Right. And, and, and sure, you have, you have to-- you cannot just think about it, you have to, to, to do something. And the outcome was actually the proof of concept. We show in the in vitro, under microscope, how some very, very primitive nanoparticles were being irradiate, caused damage to the cancer cells. And that was the time that we founded New Phase. I truly believe that it's the right approach that first you have by yourself to, to deliver, to show the proof of concept, then go to investor and try to convince them to, to invest in your in your company. So that was what we have done. It was a very, very long way. I mean, the company was founded just 13 years ago. The vision didn't change. I mean, from the beginning, the idea was to prolong life of cancer patient, and in order-- and in addition to maintain the quality of life. At that time we used the word of chronic treatment or managing the disease, and many of the people that we met, skeptical one said, "But you, you don't cure the disease." So we explained that as we see in the next twenty years, nobody will cure the disease, but for the meantime, people have to live. [00:08:35] Lindsey Dinneen: Hmm. [00:08:36] Ofer Shalev: Now, the vision is still today. It was implemented into a technology. But yes, the technology was changed several time along the year, but the vision is still here, and that is, that is the, the outcome as of today. We already treated thirty-three patient with stage four, six of them in a Mayo Clinic, very distinguished hospital. I mean, I would say ranked number one worldwide. A great cooperation with them. I would say that till the summertime, we will treat another six patient, and after we move to the feasibility study, where we will have to choose few indication, and we will add another to a US hospital to join to the feasibility study. It become a product. As I mentioned, we treated already thirty-three patient. We have about fourteen patents that already granted. We have about, since we are-- we truly believe that we are in a deep science company, so we truly believe in the, in the scientifics based evidence, and we already publish nine peer review scientific articles. We have done a lot of work and

  4. ٧ أغسطس

    Dave Rosa | CEO, NeuroOne | Advancing Electrode Technology for Neurological Disorders & Passion for Helping Others

    Dave Rosa shares how a lifelong drive to help others and his own health challenges led him into 32 years across orthopedics, cardiovascular, and neuro. Dave walks through his path from early marketing roles to becoming a CEO, and explains the innovation behind NeuroOne’s electrode platform designed to combine diagnosis and treatment in a single procedure—starting with epilepsy, expanding to trigeminal neuralgia, and now targeting lower back pain. He also discusses early work using the same technology for precise drug delivery to the brain, including a program focused on glioblastoma. Dave closes with leadership lessons on vision, culture, learning from mistakes, and giving back.    Guest links: https://nmtc1.com/ | https://www.linkedin.com/company/n1mtc/ Charity supported: Opportunity International Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 086 - Dave Rosa [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 as my guest, Dave Rosa. Dave is an entrepreneur with three decades of experience in the medical device industry, spanning a variety of technologies and products. In addition to CEO roles with early-stage medical device companies, Mr. Rosa's background also includes senior roles with C.R. Bard Inc., Boston Scientific Inc., and St. Jude Medical, where his responsibilities included marketing, product development, and business development. He has been named as an inventor on multiple medical device patents, serves on seven corporate boards, and has raised 200 million in the capital markets. Well, Dave, thank you so much for being here today. I am absolutely delighted to have you on the show. [00:01:33] Dave Rosa: Well, thanks for having me. [00:01:34] Lindsey Dinneen: Yeah, of course. I would love, if you wouldn't mind, by starting out and just telling us a little bit about yourself, your background, and what led you to medtech? [00:01:45] Dave Rosa: Yeah. So, born and raised in a small town called Richport, Pennsylvania, outside of Philadelphia. And really was in love with the medtech industry from the time I was much younger. So I, I have been in medtech now, it's going on 32 years and that's everything from large medical device companies to, to startup companies. I've been in so many different areas of medtech. I've been in orthopedics, cardiovascular, and I mean everything involving the heart, I've been in it in some way, shape, or form, a-a-as well as neuro, which is what I'm in now. And, and I think, you know, why did I get into medtech? I think this all goes back to when I was a little kid. You know, I, I was the little kid that was walking street people to my house and bringing them into my home for my mom to make a meal. I don't know that she always appreciated that me doing that, but, but there, there were more than enough times where she sat me down and I was maybe only four or five years old, and she's like, "Honey I, I, I know you wanna help people, but you can't bring everyone home." And I was like, "Oh, oh, you know, okay, Mom." Of course, until the next time. But, you know, I think it started at an early age and, and really has carried through you know, the rest of my career [00:03:07] Lindsey Dinneen: Yeah. Yeah, okay. So you've always been interested in helping people, and you've had a really nice variety of experiences within medtech. But tell us about your path from that early just interest and care in, in people and their wellbeing, to perhaps your educational journey and maybe, like, the first little bit of your career that led you to where you are now. [00:03:32] Dave Rosa: Yeah. So, in high school I was involved in sports and, and even prior to high school, and I had so many physical issues. So I had initially a shoulder problem that was I'll, I'll say pretty complicated, at least back in those times. And what I found is by the time I got to college, and, you know, I'm still trying to figure out what I wanna do with with my life and what career I wanna take. I, I was actually in chemical engineering, but came, came to the conclusion that I hated chemistry, which, which didn't help things out. And, and I really knew, you know, my, my passion was on the medical side, and a lot of it, you know, was driven because of my own issues, my own shoulder issues, because it really put a damper on, you know, any, any potential I had at especially playing baseball. So, so, i- in college, I went to Drexel University, there really wasn't a course for biomedical, undergraduate biomedical engineering that was, like, a graduate program. And, you know, I, I decided that I would take courses in electrical engineering and a program called commerce and engineering, which kinda merges both the business and engineering side of the equation. So, I, I actually started out not in medical. I was in electrical engineering, and I was probably one of the worst electrical engineers working at Westinghouse at the time. And I remember one of the managers saying to me, he's like, "You know, all, all the other engineers and marketing people really like working with you. Why is that?" And I said, "I, I really don't know other than, you know, I've always been a passionate person about whatever I'm doing." So, you know, so at that point, I started thinking that engineering was not the path for me, that you know, that I was really more, much more passionate about medical because it was impacting my life with my shoulder. And then by that time, you know, my knees and everything else started to go as well. But I graduated with a degree in commerce and engineering, and then after working a few years in electrical engineering for Westinghouse Electric I just started knocking on doors because I, I really-- my passion was, you know, helping others, and I wanted to be involved in an area that might help me being orthopedics. So that, that's kinda how I got my first job, knocking on doors, and Stryker Instruments decided they would take a chance on me, and that, that was kind of the beginning. [00:06:12] Lindsey Dinneen: Very nice. And so when you found medical device, was it this really exciting moment of realizing that it could marry your interests in engineering and your desire to help people? Was that like just this cool moment of going, "Oh, wow, like I, I can do both"? [00:06:31] Dave Rosa: Yeah. I, I, you know, I remember actually praying about this, like, "What am I supposed to do?" Like, you know, and, and "How do I go about this?" And I don't know, you know, it, it, it brought back some memories you know, of when my father was you know, was at the end of his life, and he was this stern Italian man. Never, you know, never-- there, there was no discussion about feelings or anything like that. It was like, "You do what I tell you to do. You, you talk when I tell you to talk. Otherwise, you know, you say nothing." So my, my dad's literally on his deathbed, and he says to me, "You know, I, I really wanna thank you, son, for taking care of your mother and I all these years with, you know, medical decisions." And he said, "You know, you, you always were helping people from the time you were a little boy." And it actually stunned me that my dad, who never appeared to be paying attention to anything regarding me, was like, "Hey, you know, you, you know, you really cared about helping people, not just us, but, you know, this, this goes back to the beginning for you." So it, it was also more of a reinforcement of like, "Yeah, I've, I've really gotta be in medtech, and I'm gonna start with, you know, how I can help my own issues and/or, you know, family's members' issues that they may have." [00:07:52] Lindsey Dinneen: Mm-hmm. Yeah. Yeah. I think sometimes we don't realize the impact that we're making at the time and being able to just do what we feel is right and, and what we know helps others can actually make an impact, and then hopefully we get those opportunities like you got with, with your father to s- realize eventually, "Oh, okay, yeah, I, I am, I am on the right path doing, doing the right thing at this time." So yeah, it's great to have those moments of reinforcement, but. [00:08:26] Dave Rosa: And if you fast-forward, you know, to something again, just more reinforcement, although it's much later in my career and I've had other moments like this, but this was just last month. I was at, at a memorial service for one of the physicians that used our product to treat a, a young lady, she was 17 years old at the time for epilepsy. And so the doctor that performed a procedure on her had a tragic accident, passed away, and we were all at this memorial service for him. And the father along with the mother and, and this young lady who's now in college, they came up to me you know, we were, you know, just chatting about how unfortunate the situation is. And when I got ready

  5. ٢٤ يوليو

    Anastasia Mironova | Founder & CEO, UpLevelMedTech | Leadership Evolution, Medtech Innovation, & Artistic Influence

    Anastasia Mironova is the founder of UpLevelMedTech, a leadership development and executive coaching practice focused on shaping the next generation of medtech executives. Anastasia shares her path from joining Medtronic as an MBA intern to building a career across marketing, strategy, sales, and M&A, and the pivotal moment that cemented her purpose. She breaks down the core themes she sees in leaders at every level—team effectiveness, operating with GM-level ownership, and influence without authority—and explains how “leadership by subtraction” and time inventory create the capacity for strategic impact. She also explores how music shaped her leadership through listening, pausing, and performing under pressure.    Guest links: www.uplevelmedtech.com 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 CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 085 - Anastasia Mironova [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 as my guest, Anastasia Mironova. Anastasia is the founder of UpLevelMedTech, a leadership development and strategic advisory firm dedicated to shaping the next generation of executives in medtech. Through a blend of executive coaching, strategic advisory, and custom leadership programs, she helps senior leaders and teams elevate their influence, decision-making, and organizational impact. She is a passionate advocate for advancing women in leadership and brings two decades of lived experience navigating corporate growth, career transitions, and motherhood with authenticity and humor. Known for her relatable approach and her ability to make leadership growth feel both practical and empowering, Anastasia helps leaders show up with clarity and confidence in complex environments. When she's not coaching or facilitating programs, she loves spending time with her husband and daughter, often recharging at a beach somewhere and supporting mentoring initiatives that help women lead boldly and thrive in their careers and lives. All right. Well, welcome to the show. Thank you so much for being here today. I'm, I'm really excited to speak with you. [00:01:55] Anastasia Mironova: Thank you for having me. I'm excited also. [00:01:58] Lindsey Dinneen: Awesome. Well, if you wouldn't mind starting off by just sharing a little bit about you, who you are, your background, and what led you to medtech? [00:02:08] Anastasia Mironova: Oh my gosh. My name is Anastasia Mironova, and I'm the CEO and founder of UpLevelMedTech. We are the leadership development and executive coaching practice focused specifically on medtech, but I have not grown up around medtech at all. You probably hear that from other guests, I'm assuming, quite a bit. But I was born and raised in Kazakhstan in Central Asia, and I kind of grew up more around music and entrepreneurship and totally did not know anything about medtech. I came to US in early 2000s to do my MBA program, and one of my classmates was, at the time, working for Medtronic. And when I was finishing my MBA program, she said, "You know, we're hiring for a variety of marketing roles, including an intern, and I was thinking maybe you should apply because you have some of those skills." And I said, "Sure, I, I'm interested." And so the rest is history. I joined as an intern working for Medtronic and eventually worked my way up into product management roles and then global marketing, marketing and strategy, marketing strategy and sales, and then added M&A components to it. So loved it, and I very shortly thereafter, there was a situation that made me completely fall in love with the industry. And I would say that what I really appreciate about it the most is just how much purpose there is behind it, and that's what really connected me to it, and also just how much innovation is being brought forward because I come from a place that didn't necessarily have a lot of innovation readily available, you know, at the speed that we're producing it here. And so I, I really appreciated that, and that's how I-- that, that was my journey in medtech up until I then became a, an entrepreneur and opened up my own business. [00:03:51] Lindsey Dinneen: Awesome. Okay, well thank you for sharing. There's so much I wanna dive into, but you said you did grow up around maybe not medtech, but entrepreneurship and leadership and things like that. Do you mind sharing a little bit about that and what maybe intrigued you? Because obviously you've become not only an incredible leader yourself, but you are coaching other leaders too. [00:04:11] Anastasia Mironova: Yeah, sure. It's, it's a really good question. I grew up around my parents' little, I call it mom-and-pop loving business. That business didn't start until after the wall fell and, and, and all of that, but because the business was so tiny, everybody was involved, and I was very much spending a lot of my time around that. And my mother was my early impact on how I was shaped as a leader later on. Unbeknownst to me, I would say she was what you and I would describe a servant leader today, probably long before that term was coined somewhere in a book or in a business school. But what it really taught me was one thing, which is you're not bound to any specific functional area. You are in the business of something, whatever your business is. And so it taught me to think more broadly and to think like a business person, and I would say, again, I was very unconscious to that at the time. I was just doing a lot of things, helping out, having fun, sometimes thinking about how I absolutely don't know what I'm doing, you know? But then later on, I became more and more self-aware about the fact that how much that business thinking actually helped me to succeed later on as a leader and, and help other leaders grow. [00:05:29] Lindsey Dinneen: Yeah, and I'm curious about that aspect. So you, you said it was lovingly a mom-and-pop place, which is wonderful, and, you know, you said sort of everybody was involved, and I feel, feel like that is a very common theme. And so one of the things that I'd be curious to have your take on is something that I discovered owning my own dance studio is there were, there were a lot of moments that were really fun, right? And you, you got to kinda show up in the community, and you, you had a business, and that's, that's a fun thing to do. But, you know, on any given day, I was everything from the CEO to the janitor, and everything in between. And I think that's a wonderful thing to experience as a leader, but I'm curious as to how that experience probably shaped your own style of leadership beyond being able to observe really good leadership up close and personally. But I'm just kinda curious how that, how, how sort of having a take in all the different aspects of the business may have really helped shape you. [00:06:27] Anastasia Mironova: Yeah. It, it, it's really kind of fundamental when I think about it, 'cause my mom said exactly the same phrase that you just mentioned. She told me always, "You have to be able to get along with everyone equally and treat everyone equally with respect, whether it's a janitor or your CEO, and your ability to get along with every level of the organization is what's going to shape the success." And, and she was very much modeling that behavior. But where I feel it shaped me was that when you work in, in medtech in particular, it's very cross-functional, right? So when you work in a particular area, say I was in marketing in early, in early days, I didn't think of myself as a marketeer. And, and what that meant for me is certainly I would focus on what I needed to do and my goals and our functional area imperatives and all of that, but I always was curious about how does the rest of the business work. And so I didn't think of myself as "I'm a marketing leader." I thought of myself as "I'm a business leader." And when you remain curious in how other aspects of the business work, how it all comes together, what are the macro trends? You know, what do the customers want? How are people compensated? How does the innovation pipeline get shaped? All of those things working together helps early on to make better decisions in your own swim lane. And it kind of like, it shaped me as a leader because I felt that it helped me to make better decisions in larger context in mind. But also it helped me to relate, to relate to a lot of people in a lot of different functional areas, and not assume what their life was like and what their day-to-day was like, but be curious about it. So I would say that definitely both of those things shape how I saw business as well as people in it, if you will. [00:08:18] Lindsey Dinneen: Yeah, I love that. I love the idea of curiosity and being willing to have conversations, meet other people, learn different aspects of the business, '

  6. ١٠ يوليو

    Brent Lavin | Principal, Ironwood Medtech Partners | Insights on Medtech Leadership, Commercial Strategy, & Industry Impact

    Brent Lavin, principal at Ironwood Medtech Partners, shares how he helps early-stage medtech companies build commercial strategies from concept through commercialization and exit. Brent reflects on his path from electrical engineer to launch expert, including lessons learned after seeing how overbuilt product features can complicate V&V and FDA review, and why founders must make early decisions with the end in mind. He discusses common startup pitfalls, the importance of pairing technical innovation with a strong commercial plan, and practical leadership insights on hiring “the right seat,” delegation, and setting clear standards while allowing teams flexibility in execution.    Guest links: https://www.linkedin.com/in/brent-lavin/ 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 CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 084 - Brent Lavin [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 as my guest Brent Lavin. Brent is currently principal at Ironwood Medtech Partners, where they help build the commercial logic into medtech startup innovation from concept through commercialization and exit. As an engineer turned launch expert, Brent has helped commercialize 20+ 510K PMA products and led the buy side of four M&A transactions, so he knows what buyers value beyond the science. With a diverse background from GE Healthcare to C.R. Bard to BD to now leading Ironwood Medtech Partners, he thrives on helping early-stage companies navigate the complex healthcare landscape and build successful companies. All right. Brent, welcome to the show. So glad to have you here today. [00:01:39] Brent Lavin: Yeah, great to be here. Thanks so much for the invite. I appreciate it. [00:01:42] Lindsey Dinneen: Absolutely. Well, I'd love if you would start by just sharing a little bit about yourself, your background, and what led you to medtech? [00:01:50] Brent Lavin: Yeah. So, I'm Brent Lavin. I live here in Phoenix, Arizona. I've recently founded Ironwood Medtech Partners, which is my company helping early-stage medtech. But I spent nearly 20 years in strategic medtech, and so I originally came to the industry through the engineering function. I was an electrical engineer in product development and innovation. And after three or four years of that, decided I wanna move over into what was, what is traditionally product management. And so, through my MBA program and then starting with GE Healthcare, I've spent the last 20 years at this intersection of R&D innovation, strategy, business development, and marketing. And so, really great run. Have been on the buy side of several M&A transactions, and I try to bring all of that experience to the early stage so that, you know, companies as they start out, can be building for the future. And so, it's been a great journey in medtech, and I've loved it so far. [00:02:46] Lindsey Dinneen: Yeah. Okay, so, so many things to ask about, but I'll, I'll start here. So, all right, so you're sa- you know, as you, you mentioned building towards the future and especially with these young startups that might not have a lot of experience in that particular kind of environment, or they're leading their company for the first time. What are some of the things that you see that maybe are pitfalls to avoid? Just, just like maybe some of the things that you've seen startups struggle with a little bit, and how can we help them mitigate those risks? [00:03:17] Brent Lavin: Yeah, there is a lot there, but let me just start by saying there is no linear path, and it is a very circular, ongoing process as you work through those early stages. And we call it the fuzzy front end for a very good reason. And sometimes you need to go down paths to realize that's not the right path, and you need to be comfortable with that. But at the end of the day, one of my goals is to help early-stage companies build with the end in mind because whether you acknowledge it or not, you're making decisions today that are ultimately gonna affect how you commercialize in the future. And so at least being able to make those decisions with your eyes wide open and understanding the trade-offs that are going on. And so for somebody that's been at the very end of that process, I, I can help inform, you know, those early stages so that you make priority decisions and trade-offs, you know, with full-scale information. [00:04:17] Lindsey Dinneen: Okay. Yeah. Well, I, I love the fact that you highlighted it's not a linear path, and there are a lot of things that go into, of course, the success of a startup. I'm wondering, in, in your role now, what are some of the areas which you see successful startups really thrive in as they're working with, with somebody like you to help make them successful from the start? [00:04:42] Brent Lavin: Yeah. Thanks for that question. I love working with early-stage founders that are passionate about their technology but especially those that realize where they may need to supplement their technical background with more of a commercial mindset. And so the, the people that work, that I work best with, are open to inputs and consideration of other options as they go through that process because you know, the, the famous saying, "What got you here is not what's going to get you there." And so while technical innovation is, is key that may not lead to an acquisition if you can't tie it to a strong commercial plan. [00:05:22] Lindsey Dinneen: Mm, mm-hmm. Yeah, so actually this is an area that I'm very curious about even in your own journey is, so you started off with that technical background as an electrical engineer, and I'd love to hear a little bit more about that as well. But maybe if you don't mind sharing a little bit about the transition or the learning process of going from that as a really good base to also being able to understand the full life cycle and how to make something succeed. [00:05:47] Brent Lavin: Yeah. Well, let me kind of go back to those engineering days and talk a little bit about how I made that pivot from engineering into product management. And to be honest, I didn't know exactly what I was doing at the time, but a-as an engineer, I was working with a product development team where we were creating a project. I was at a s- a contract design manufacturing company, and we were working with an outside company that owned a patent for a laboratory blood culturing instrument. And so we were their engineering partner, and what I saw firsthand was unfortunately, this customer at the time did not have full insight into the workflow and how the device was used in practice. And so as an engineering team, we frankly overbuilt many options into the product in order to try to s-satisfy everybody. And that seemed attractive at the time, but ultimately when we got to V&V, verification validation, and the FDA review process, it was a real struggle to get this on market. Now we ultimately did, but the epiphany for me was, I am really good at understanding engineering trade-offs and working with engineering teams to go through the process of evaluating different options. But I also really like working with customers and understanding what moves the needle and what's the difference between a nice to have and a need to have. And so, it was that kind of experience firsthand that led me to say, "I wanna operate at this intersection and really operate in both sides of that equation." And so ultimately I decided I needed to get an MBA in order to do that. So I left a, a good paying engineering job right after I got married and we moved to Madison and I got my MBA and then, you know, that ultimately led to GE Healthcare and, and then, you know, continued career in medtech. So thanks for asking that question. [00:07:43] Lindsey Dinneen: Yeah. Well, okay, so your leadership journey, of course, has, has evolved over time as, as often happens, and, and you've gone from leadership positions within other organizations to, of course, now leading your own. And I'd love if you'd just share a little bit about that journey of, of growth and discovery, maybe some, you know, lessons learned along the way. [00:08:06] Brent Lavin: Yeah. So, let's talk a little bit about kind of my formal leadership in the, you know, corporate structure and organization. I would say, we were chatting beforehand that, you know, I really moved through slowly at the beginning of my leadership from one person to three people to five people. And as an ambitious person, I always felt like that was too slow. And so, but I think it was those foundational aspects of working very closely one-on-one with people, hiring, deciding who to hire, selection, onboarding having crucial conversations about performance management and how to put people in the right seat to be successful, all occurred when my leadership span

  7. ٢٦ يونيو

    Allison Komiyama | Founder, Bluestocking Health | Medtech Hype Woman, Former FDA Reviewer, & Community Advocate

    Allison Komiyama, a consultant and senior regulatory strategist at DuVal & Associates and founder of Bluestocking Health, shares her journey from neuroscience and an FDA reviewer role into regulatory affairs and consulting. Allison explains why companies should educate FDA about their device by telling a compelling, respectful story, and discusses why “getting through FDA” is often the starting line. She highlights the post-clearance work of launch, adoption, and promotion while staying within FDA marketing rules. Allison also reflects on leadership, relying on community and advisory boards, her volunteer work, and the moments that affirm her impact when devices reach patients.  Guest links: https://www.bluestocking.health/  Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 083 - Allison Komiyama [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 as my guest, Allison Komiyama. Allison is a consultant focused on getting medical devices to market and helping them stay there. She frequently presents at conferences, is an advisor at numerous technology incubators, and teaches students around the world about the regulatory submissions as a faculty member at SDSU Global Campus. She received her doctorate in neuroscience in 2009, was an FDA reviewer from 2010 to 2011, received her Regulatory Affairs Certification US in 2014, and became a RAPS Fellow in 2024. Throughout her career, she's been actively involved in hundreds of pre-submissions and pre-market submissions for a wide variety of medical device companies. She recently started a medical device hype company called Bluestocking Health, where she continues to elevate and amplify the message of exciting technologies entering the market. She's also a senior regulatory strategist at DuVal & Associates, where she helps companies navigate the FDA pre-market process. Alright, well, welcome to the show. I'm so glad you're here today. [00:01:59] Allison Komiyama: Thank you so much. I'm so glad to be here. [00:02:02] Lindsey Dinneen: Well, I've been looking forward to this conversation very much. I got to meet you, I think it was maybe last fall, and it was after watching a video where I believe you were chopping wood while explaining a medtech concept, I and was like, "I have to meet this person." [00:02:21] Allison Komiyama: I like that that is how we, we, yeah, that you were introduced to me is through a wood chopping video. But yes, that was me. I love... I am a lumberjill, so yeah. [00:02:31] Lindsey Dinneen: See? And we will get into this, let's start with just a little intro into who you are, your background, and what led you to medtech. [00:02:39] Allison Komiyama: Sure. So background's actually biology, neuroscience. Left academia after graduate school and went and worked at FDA. I was just there for a brief period of time, but it was very instrumental in having me understand what I wanted to do with my life. I knew I loved regulatory affairs. I knew that I loved med devices and the intersection of medtech and innovation and regulatory and, and, and, and, and, right? Like, so all the things I was just super excited to be part of this space. But after leaving FDA, sort of tried to figure out what... You know, did I wanna work at a company? Did I actually wanna be at a specific industry job? Tried that on. Tried that hat on for a little over a year at an IVD company and just sort of missed all the stuff I got to work on at FDA. So I kind of saw it as the second-best thing after FDA is to go into consulting. So really worked with a lot of startups and companies that were bringing their technologies to market, and yeah, never looked back. I did sort of change positions over the years from going from a small consulting company to my own consulting company to a large consulting company, and now I'm sort of back at a, a smaller regulatory law firm. It's not that small, but, you know, 15-some people at DuVal & Associates working with companies that need help with strategy and regulatory support as well. And also started my passion project, which is Bluestocking Health. It is a medtech hype company, is what I call us. And we really work on helping companies after they've made it through FDA onto what... you know, what does, what does their launch look like? How do they get people to adopt their technologies and not sort of flounder and, and fail, right? So I, I love seeing really cool, nerdy, geeky tech get to market, and I think we all have a sort of inner geek that loves stuff like that, and it's my happy place where I can just kind of talk about those things and share it with patients and caregivers alike. [00:04:47] Lindsey Dinneen: Amazing. I love that. Yeah, and so much to dive into. But one of the things also I remember, so so I, I watch this video and you're chopping wood, and you're, you're clearly super passionate about medtech. And then I think the next one, were you possibly like baking or doing some sort of maybe chopping? [00:05:08] Allison Komiyama: Yes. I do flower arranging, so it might've been that one. I, I-- That's a great idea, though. I love to bake. I love protocol, so I think you're onto something. I need to come up with a video maybe where I'm talking about, like, the de novo process and, like, baking a cake or something. So. [00:05:27] Lindsey Dinneen: Amazing. And you're right, it was flower arranging, and I was thinking at the time, "Is there anything you don't do?" [00:05:35] Allison Komiyama: Yes. I-- There's a lot of things I don't do or don't even dare to do. Mostly dangerous sports. I, I'm a rower, so I love to row where no one's touching you. You know, like no one... There's no physical contact. You're just in a boat pulling an oar, and it's quiet and peaceful and, you know, also you're working hard. So, but otherwise, yeah, don't want any contact sports in my life. And but there's a lot of things I don't do, of course. I just have a lot of hobbies and things that I enjoy doing. [00:06:10] Lindsey Dinneen: Okay. So did the idea for Bluestocking Health come from? I mean, I know you explained a little bit about what the company does and who it helps, but first of all, I'm really curious about the name, and second of all, I'm just curious about, yeah, what made you go, "Gosh, this is the right time for this"? [00:06:27] Allison Komiyama: Yeah, great question. I-- So Bluestockings were... I'll, I'll go first into the origin story 'cause I think it kind of helps explain why I picked up that name. The Bluestockings were a group of mostly women in the 1700s in England who were, you know, kind of tired of sitting around playing card games and, you know, learning new dance routines-- not that there's anything wrong with that-- I love doing all of those things. But they decided they wanted to pursue some more intellectual and intellectually stimulating conversations with people. So they would invite women and men into their salons to have these conversations, and they would talk about botany and, yeah, science, art, literature, theater, all of the things that sort of sparked their interest. And they would say, you know, "Don't worry about wearing your black stockings," which were, like, the highly fashionable, expensive stockings of the day. They said, "Just come in your blue stockings. It's fine." You know, which were wool and, you know, cheaper. And I was like, oh, I love that idea of just people getting together, talking about stuff that they find interesting, and having it be like, "Come as you are. Wear your sweats," you know? "Don't worry about getting fancy." And that resonated with me. And so I thought, you know, what I want to build is something similar to what the Bluestockings had, but have it be more medtech or health-focused, and so hence Bluestocking Health was born. I, yeah, I really... A-as I said earlier, I saw a lot of companies feel like getting through FDA was the finish line, and I s- you know, I would tell them, like, "No, that's kind of the starting line with a lot of what you're going to now need to build." You know? It's-- I, I think historically FDA was seen as, like, the hardest thing to get through, which isn't always the case, right? The, the 510K program is historically very successful with getting devices cleared. You know, FDA does wanna work with you, and that was my narrative and my mantra always was like, you know, "How do you work with FDA to get through FDA?" And then once you're through FDA, what's next? And I wanted to have those honest conversations, you know, as these companies were considering the product development, their quality system, their regulatory, and, you know, even reimbursement is also part of that post-market conversation. And I wanted them to also think about, "How are you gonna get patients to know

  8. ١٢ يونيو

    Dr. Amel Havkic | Founder, EvoMed Consulting | Enhancing Patient Care, Clinical Adoption in Medtech, & a Practicing Physician's Perspective

    Dr. Amel Havkic, founder and Managing Director of EvoMed Consulting and a practicing physician, unpacks why so many amazing medtech solutions never reach the patient bedside, along with advice on how to change that. Driven by frustration from frontline care, Amel built EvoMed to guide companies from development through real-world clinical adoption, and shares how his MBA research became the StarMap framework: seven success factors spanning workflow alignment, implementation friction, ecosystem fit, quality of care, and economic viability. He explains why staying in clinical practice matters as medical knowledge rapidly evolves, offers a real example of digitalization increasing clinician burden, and discusses AI as “augmented intelligence” that supports—not replaces—human decision-making.  Guest links: https://evomed-consulting.eu/ | https://www.linkedin.com/in/a-havkic/ | https://www.instagram.com/evomed_consulting?igsh=aTlyaGVmeXYybGt3 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 CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 082 - Amel Havkic [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 my guest, Amel Havkic. Amel is founder and MD of EvoMed Consulting, Department Head for Weaning and Home Ventilation. Dr. Amel is also a consulting medical director for many companies, apart from being an educator, mentor, author, and currently working physician. All right. Well thank you so much for being here. Welcome to the show. I'm delighted to talk with you today. [00:01:23] Amel Havkic: Thank you so much. It's a pleasure being here, and thank you for having me. [00:01:27] Lindsey Dinneen: Of course. I'd love if you wouldn't mind starting off by sharing just a little bit about yourself, your background, and what led you to medtech. [00:01:37] Amel Havkic: Okay, so my name is Amel Havkic. I am still a practicing physician. But on top of that, I'm a advisor in medtech. I am in medtech since something like six, seven years, and it actually came from the frustration that I had in everyday work on the patient bedside. I was already consulting some medtech companies on specific topics. And I've seen this huge gap between amazing medtech solutions which, however, for whatever reason, never made it to the bedside. So I ended up, I ended up fund founding EvoMed Consulting consultancy, which helps medtech companies with clinical adoption, pretty much helps them guide from the development all the way to the patient bedside. The solutions really getting adopted, really having an impact. We've had quite some success with this. We've been named best Market Access Consultancy in '25 in medtech. I personally also celebrated recently award for Best Rising Star of the industry. And yeah, all of this came from the idea that I wanted to see a world where no patient is left behind and independent of geography or economy or economic status. Every patient gets the best care imaginable. And yeah, what better way to deliver that than medtech, right? [00:03:05] Lindsey Dinneen: Yes, that was the perfect plug for medtech right there. That was excellent. So first of all, congratulations on all of your success and these recent achievements. That is really exciting and incredible and I, I know that your motivation goes obviously so much deeper than that, but I love the fact that you're getting recognized and it's, it's nice to have those moments of affirmation, so. [00:03:31] Amel Havkic: Yes, it is. I said it on the interview, which I got after the, after the award. It's not even about the award itself. It is actually about what I stand for and that is the human side of medtech. I mean, it is technology, but we're still doing it for humans. And as a doctor getting recognized and not as a founder, it is something it, it is a signal. So that's the, I think that's the positive, the good part about it, and that's what makes me proud. [00:04:03] Lindsey Dinneen: Yeah. Yeah, absolutely. So did you always have an interest in medicine? Did you always think you were gonna go this route? [00:04:11] Amel Havkic: In medicine, yes. I think as far as I can remember, thinking I wanted to be, I wanted to be a doctor. I was trying to cater to wounded animals as a, as a kid with, I don't know, four or five, six years old. Then I went to med-- no, before I went to med school, I was doing basically nursing school. I grew up in Bosnia, in Sigovina There it's after eighth, eighth grade, you decide what you actually want to do. So I decided I wanted to go into medicine and at that time, Dr. House came out and or house MD in, in the English, English terminology. And I was a huge fan. So that was pretty much my, my route was set from that. I was al also always tech savvy, so if I wouldn't have done medicine, I would've probably done IT. And at one point it kind of merged. [00:05:09] Lindsey Dinneen: Wow. Okay. All right. So Dr. House, I can totally understand why that became an, an inspiration. Do you have any examples that you could share that are like, is, is the medical world ever as wild as some of those stories on Dr. House? [00:05:27] Amel Havkic: Oh yes. Oh yes. It is specifically. So besides working in the hospital, I work in a private practice, and funny enough that private practice is focused on difficult to diagnose and rare diseases of, obviously for, for that reason. I was also working in a hospital department, which was working with with or in discovering rare diseases specifically when it comes to, to respiratory diseases. So, yeah, it is like that. I can share a story of one patient, which came to me because she had thoracic pain every now and then. And it was reoccurring, came again and again. I did an ultrasound, and so she was at a cardiologist, she couldn't find anything. The, the whole thing. And it, I did an ultrasound of the chest and I found a, a little a little mass, which is not supposed to be there. So I sent her to a CT. Funny enough, the CT came back negative because it was so small that you couldn't see it on a ct. However, when you know exactly where to look, you could still like see outlines of it. And then in the, in the discussion came out that she had an endometriosis at one point. So, we said, "Okay, this might be somehow connected." We took a tissue sample, so in the end it was indeed an endometriosis, which got discovered after 20 plus years of or, or 10 years of, chest pain every now and then. So, it's just one of the examples of the, of the, so yeah, it's Dr. House specifically is quite realistic. [00:06:57] Lindsey Dinneen: Oh my goodness. That is wild. I, wow. Okay. That is, that is really cool. So, so do you also have these these moments, I could just imagine you just feel like you've solved a mystery and you can help this patient and you know exactly how, is that just like the best feeling? [00:07:13] Amel Havkic: For, for me it is, for me, it is, I always have to describe or, or tell to my assistants in a or, or not assistants, my residents. Please don't misunderstand me. I get excited by this, not because I want the patient to be sick, but because first of all, we find a way to help after so many people could not. And yeah, just for the pure love of the game, so to say. [00:07:37] Lindsey Dinneen: That's amazing. Okay, so, well, I feel like we can go off on many tangents, but I'll, I'll try to, I'll try to stay focused because I, but I love that. I love that. So you're a practicing physician and you're, you're seeing these instances of medical technology that I imagined isn't getting adopted in the way that you know it should, that would have clients or patient impact. So you're, you're seeing this for a while. So did that lead to direct opportunities to consult for some of these companies that needed a physician's perspective or how did, how did that go from, "Hey, I, I, gosh, I'm seeing this gap" to, "Okay, I know where to go from here." [00:08:19] Amel Havkic: So, it exactly like that. So I was brought into a medtech company to consult them as a clinical medical expert on, at that point, risks associated to their solution. Of course it makes sense to have someone who is still in the trenches, so to say, because the logic behind certain workflows in hospitals or in healthcare environment is not the same logic that it guy would have when talking workflows similar. So that's how it started. And then a pattern started emerging. When I did my MBA thesis, I basically took, took these two, these two, that, that gap that I saw and made it a topic of my MBA thesis. I was looking specifically on success factors in healthcare and what makes a solution gets adopted or delivery system healthcare path, what makes it get adopted in the real world and what does not. And what emerged was basically knowledge graph constellation, so to say, of seven success factors. And that constel

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MedTech Leaders Changing Lives for a Better World