The Leading Difference

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MedTech Leaders Changing Lives for a Better World

  1. 3 小時前

    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

  2. 7月24日

    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, '

  3. 7月10日

    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

  4. 6月26日

    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

  5. 6月12日

    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

  6. 5月29日

    Staci Miller | Founder, Gen UX Consulting | The Intersection of Human Factors, MedTech Innovation, & Building a Resilient Career

    Staci Miller, founder of Gen UX Consulting, shares her winding path from fashion design and psychology to human factors engineering in MedTech. Staci explains what human factors is—through stories from World War II aviation and modern healthcare—and why the FDA now mandates usability work to reduce catastrophic use errors. She breaks down formative versus summative/validation studies, the role of risk documentation (URRA/UFMEA), and why founders should think about usability as early as they think about risk. Staci also opens up about the challenge of starting a second business after losing her first in 2008, how she built Gen UX from $0, and the leadership lessons behind year-over-year growth.   Guest links: https://www.genuxconsulting.com/ | https://www.linkedin.com/company/gen-ux-consulting/  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 081 - Staci Miller [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, Staci Miller. Staci is the founder at Gen UX Consulting. Her expertise is in applying user-focused research to develop innovative solutions, and it's essential to the growth of any technology organization. As a detail-oriented and tenacious executive in human factors engineering and UX design, she has a proven record of elevating the end user experience and achieving targeted client outcomes. She has created innovative medtech and big tech solutions through a comprehensive user-centered development process, leveraging artificial intelligence and industry agnostic design tools to optimize products and services. In her current role with Gen UX, she's a key leader facilitating strategic company growth plans and service offerings while managing the capacity and workflow of the UX HF design team. Well, Staci, welcome to the show. I'm so excited to talk with you today. [00:01:49] Staci Miller: Me too. I've been looking forward to it all week, so I'm very excited to be here. And I don't know what the day has in store. I, I know that there was like a, a, a kit that you sent out and I didn't read it on purpose, so everything's gonna be organic. [00:02:03] Lindsey Dinneen: Perfect. Those are my favorite conversations anyway, so I'll take it and run. Some people I know really love to have the questions ahead of time, and others are just like, "Yeah, I don't want to know. I'm just gonna go off the cuff. Here we go." So, brilliant. All right, well, let's start, if you don't mind, by sharing a little bit about yourself, your background, and what led you to medtech. [00:02:24] Staci Miller: That is, those are my favorite questions. So, I have a background in fashion design, psychology. I spent most of my classes in cognitive psych, but it wasn't like a difference of degree, it was just psychology. And then I have a master's degree in human factors and ergonomics. So I went the psychology route and the design route. That's kind of my background. So when I graduated my master's degree, through my master's program, I was able to intern for both years and one was in tech, big tech. I interviewed and landed a, great one year long internship at Samsung, which was actually supposed to be just three months, and I stayed there for a full year. So they kept me through my whole, my whole semester, which is something they don't normally do, which was really fun. I mostly just said, "Hey, can I stay here for the year?" And they're like, "Great, no problem. Sure. We'll figure it out like that seems like a good option. We like you, you like us. Cool. We'll do that." And my second internship was in medical device at a company called Interface and Analysis. My, that was actually my internship. My second one was at Samsung, so I got to really look in like I, I guess you got the curtain. If you think about Wonderland and Oz and the curtain and being able to pull back the curtain between both industries, what did I like better? I ended up liking medical better, mostly because the research was more structured and not necessarily conversations about, "Yeah, so how do you feel about that? Did you like it?" Like to me, that's not really. What I would consider the best opportunity to gain data. Data to me, like there has to be like a clear objective as to what you're doing, the whys behind it, and what do you wanna learn. And I found that in, when I worked with engineers in medtech, they definitely had things that they wanted to learn, whereas in tech, they just had so much money. They were like, "Yeah, let's just see what people think about this." And I'm. Okay. And then when I would be really structured and I was working with people who didn't have backgrounds in research, had very strong, very good backgrounds in design, like legitimately awesome, they were leading the research and they were missing the boat. So the narratives started to be focused on the N of one. This one person said this really interesting thing, so let's base our whole design off of what they said. And I'm like, "Dude, wait a second. Wait a second. All of them said this thing about the design though, and like we have four or five data points about when you ask this question." They're like, "Yeah, but that's not interesting." And I was like, "Okay, keep my mouth shut. I got it. Move on." Like from that moment forward, I, it wasn't like "Staci, don't talk, it was more like this is how we design based on the narratives that we've learned how to, how to research on." And so it wasn't as I would say-- it wasn't considering the actual 360 view of the user. It was considering the really cool thing that happened this one time that was like totally an outlier. And it happened consistently when I was working in big tech. So I was like, uh, medtech, probably more my speed. And then my first job was at Abbott. [00:05:39] Lindsey Dinneen: Nice. [00:05:40] Staci Miller: And I ended up there. Yeah, [00:05:41] Lindsey Dinneen: Okay, great. Well. [00:05:42] Staci Miller: Cool. [00:05:43] Lindsey Dinneen: Lots of questions based on this incredible background. I want to go back a little bit. So fashion design, was this something that you grew up thinking, "Oh, this is what I wanna do and be okay?" Right. All right, so... [00:05:57] Staci Miller: it's all I ever wanted and I did that. So... [00:06:00] Lindsey Dinneen: Yeah. [00:06:02] Staci Miller: That's a, that's a great question. I think that my interest in fashion peaked around when I was 12 years old and during the time, Cindy Crawford and Naomi Campbell, and I was so fascinated by how beautiful these women were. And, and fashion was a thing in the nineties. There was like a lot of Dolce and Gabana around, and I loved it. And I couldn't wait to get my new print of Vogue every, every season. I loved Harper's Bizarre, and I would just pull pictures out of these models and what they were wearing. And then I would start you know, freehanding stuff and things like that. And I think a lot of people do that when they're really interested in clothing and things like that. And if you really think about it, fashion is art that people wear. So I was very attracted to that part of it. And it's all I wanted to do. So after high school, I went to FIDM and studied fashion design. And right outta FIDM, I started my first company in fashion design, and I was a clothing manufacturer, and we had 500 open doors in the United States and in Canada, and I was hoping to expand, but unfortunately 2008 hit and they hit it hard and fast and I lost most of my managing capital in the year that I think was my tipping point. So it was the, the year that I finally got a lot of traction and had a lot of repeat business and a lot of new business as well. And a lot of those new businesses just refused orders. Just from the east coast to the west, and it was just tons of money out that wasn't gonna come in. So there was really no way to, make that work after that, like I lost literally all the money I had in my business in like the span of, I would say three, four weeks. It was just mortifyingly scary. But I was young and people who are young are resilient and they move on and they find a new dream. And it took me a minute, like I didn't really know what the french toast I was gonna do. And I was like, well, I was still planning on staying in fashion and long, short, I was offered a job to do and run production for a one, a different company. So make sure that their goods were produced on time. Deal with the, the timing of all the orders, making sure the product line. So it was basically operations for manufacturing. And I was super excited about the job and I moved back to my parents' house at the time because things were just that tight financially for me. My parents were like, "Yeah, just, you know, come back, we'll figure it out." And I remember saying to my

  7. 5月15日

    Spencer Jones | Founder, XO Medtech & MedtechVendors.com | MedTech Innovation, AI Integration, & Building Community

    Spencer Jones, Founder of XO Medtech and MedtechVendors.com, shares how frontline nursing experiences led him to patent vascular access innovations and ultimately take devices from idea to FDA clearance and product launch. Spencer walks through learning business fundamentals through accelerators, raising early funding, and building sales and distribution networks, then explains why launching a digital-first, AI-native ecosystem has enabled faster, leaner execution than traditional medtech pathways. Spencer also discusses leadership, clear communication, and why AI adoption is essential to accelerate and de-risk early-stage medtech.  Guest links: https://www.linkedin.com/in/medtech-innovation/ | www.xomedtech.com | https://medtechvendors.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 CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 080 - Spencer Jones [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 Spencer Jones. Spencer is the founder at XO Medtech and MedTechvendors.com. He is an RN, MedTech entrepreneur with 12 years of med device leadership. He's a two time med device CEO with 10 plus patents under his belt and has taken devices from idea to FDA clearance and product launch. Spencer has built sales and distribution networks, led product development teams, and raised over 10 million in VC and Angel Capital. Spencer founded XO MedTech in 2024 to create a digital first medtech ecosystem, deploy AI native tools for medtech operators through medtechvendors.com and cultivate the next generation of medtech innovators. All right, Spencer, welcome to the podcast. Thanks for being here. [00:01:43] Spencer Jones: Thank you for having me, Lindsey. I'm very, very excited to be here. Like it's, it's always more fun to be a guest than it is to host the pod, so absolutely thrilled to be a guest on the pod. Thank you for having me. [00:01:54] Lindsey Dinneen: Of course. Absolutely. Well, yeah, let's just, if you won't, don't mind just sharing a little bit about yourself, your background and what led you to medtech. [00:02:04] Spencer Jones: Yeah. Born and raised in Arkansas. I've lived, I traveled a ton and lived in Memphis and whatnot, but grew up in a healthcare household. Dad did anesthesia for, what was it, 36 years or something at the same place. So I thought I was gonna be a CRNA, like actually started pre-med. Took chemistry my freshman year while I was, you know, it was just, I got a C and I was like, maybe, maybe med school's not for me. But but anyways, did the nursing school thing, got out, started working, pretty quickly, knew if you've ever spent any amount of time in frontline healthcare, you just kind of get, it's like a barrage of things that suck. It's just, especially nursing, the devices you're using are commoditized. Like just the workflows are bad. You know, people, it's, healthcare is very broken. Every, it's no secret. Everybody says that. Everybody knows that. So anyways, I noticed pretty quickly that hey, like why isn't this better? Why can't this be like this? And, you know, kind of had that mindset. And before I could even go through like critical care enough to apply to a CRNA school, ended up patenting some devices in the vascular access space. Really leveraged accelerator programs and the entrepreneurial support organizations that were in my area, in my region to, I call it that get that dirt money, which is like the before the seed, you know, your pre kind of, your pre-seed /seed you know, before the pre-seed money. And, and also like the business training, right? Like I wasn't formally trained on business stuff like that. So did that. Did the venture capital hamster wheel a little bit, took a, you know, device through class two de novo clearance. Was doing ride-alongs training, sales reps, doing marketing stuff, you know, managing our ip, managing clinical you know, 300 patient RCT that we had to do in the middle of COVID, launched the product and then past couple years, I left, left that company in 2022. Products still on the market and they got, you know, clearance in, in Europe now and et cetera, et cetera. But just been working more in laparoscopic spine or laparoscopic surgery orthopedic spine and then doing some like consulting projects and, and things like that. And then yeah, XO Medtech and Medtech Vendors that's been. You know, for the past two years, like a big focus. And I know we're gonna talk more about that, but yeah. So it's just been, it's been a great journey. Medtech is one of my --I love it and hate it at the same time, but I wouldn't wanna be doing anything else, frankly. So. [00:04:17] Lindsey Dinneen: Awesome. That's a great intro. Okay. You were, I really, I enjoyed how you sort of went straight from okay, so, so "I, you know, started the career, started in the industry, and then I, I, you know, got a bunch of patents." What were the ideas for the patents? Where did those come from? If we could just go back, how did that, what was that inspiration like? [00:04:39] Spencer Jones: Yeah. So I was night shift, med-surg, big, pretty big hospital in Little Rock. It was like one of the, one of the bigger ones in Little Rock, St. Vincent's, which is like CHI, St. Vincent, et cetera. And like one of my patients --well the, the very first one was a dual lumen peripheral IV. A patient has a peripheral IV in, I need to get a blood draw. They're like, "Go stick his other arm." I'm like, "Why can't we get it out of his, you know, IV that's in his, that's in his forearm?" And, and they were like, "Well, you, you know, you don't want to contaminate, you know, the thing." And I was like, "Oh, okay. That kind of makes sense." And I was like, well, PICC lines have two lumens. So you know, I was like, why couldn't, you know, why couldn't we just have a second lumen on, you know? And I was like, do those exist? And they didn't really exist. There was kind of one that existed, but it was more of like a longer extended dwell peripheral and you know, you kind of needed ultrasound to place it. You didn't really place, you know, normal nurses on the floor weren't gonna place it. And so I kind of, that one was just sheer-- I experienced something that I was like, "Dude, you're kidding me. There's gotta be a better way to do this." You know what I mean? And you know, kind of similar approach in that one. We, you know, that was the very first one so I was like doing these drawings on note cards and then like meeting with a patent attorney and I was like, did that provisional filing and wrote the patent myself and the claims and all this stuff. And the guy thought I was like, just " Okay, yeah, I'll, I'll file the provisional for you, bro, whatever." Filed the provisional, you know, ended up like going to a different attorney 'cause that guy was kind of just not taking me seriously. And so, ended up going to a different person, filed a non-pro provisional, started raising all this money, and that original attorney reached out later, was like, "Oh, so glad, glad to see blah, blah, blah." I was like, "Yeah, yeah, whatever." But then the second one, I, which was Safe Break Vascular, had the, it's kind of similar. Patient was like, had patients pulling out their IVs, pulling out lines, you know, and it's a million things. It's, it's walkie talkie, so like Alzheimer's, dementia, memory care type stuff. You, it's TBIs, it's agitation, sundowners. It's, you're coming off medication, you're drowsy, you forget, you're hooked up. You need to go to the bathroom. You trip on it. The nurse trips on the tubing. There's like a million reasons how, you know. Where mechanical force can get applied to an IV line. And same thing, I was just like, man, like this, it, it feels holding on for dear life is like the wrong approach because skin is only so strong. You get skin tears. Adhesives, you only want them to be so, you know, so, so strong. And it just, you know, it, wrapping it up, then you can't assess the site, you can get infiltration. So it didn't feel like any of the options we had were great. That one, I started to do patent research literally on the floor at the hospital. Like that night. I was like, I, 'cause I knew enough then found someone that had patented it. Like same exact concept. It was a nurse. And design was bad. Like the design, it had springs in it and it was just like not manufacturable and not a good design, but there were like conceptually it was like spot on. And then there were some elements of it that I was like, this would be very useful to have if I was gonna like actually do this. So me and somebody I'd met, and in accelerator program, we bought the patent from 'em for 20 grand which was a steal of a deal. It was like 10K up front, 10K after 18 months. And yeah. And then we turned around and raised a, you know, million dollar see

  8. 5月1日

    Kat Hurd | Founder & CEO, Med Tech Collective | Shaping Industry Leaders & Enhancing Patient Outcomes through Sales Excellence

    Kat Hurd, executive coach and founder/CEO of Med Tech Collective, shares how nearly two decades in medical device sales and leadership, including at Boston Scientific and Saluda Medical, shaped her mission to help reps and leaders build influence, ownership, and long-term career momentum in complex, high-stakes environments. Kat explains why strong clinical partnership can elevate sales conversations into trusted-advisor relationships that impact outcomes, and outlines how she coaches individuals, trains teams, and supports go-to-market strategy. She also dives into the distinct challenges women face when navigating rooms where they’re “the only,” the career accelerant of mentorship versus sponsorship, and practical ways to break into medtech by identifying gaps and learning the industry’s language.    Guest links: https://kathurd.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 079 - Kat Hurd [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 today Kat Hurd. Kat is an executive coach and the founder of MedTech Collective, where she helps medical device sales reps and leaders build influence, ownership, and long-term career momentum in complex, high stakes environments. With nearly two decades of real world experience in medical device sales and leadership, including senior roles at Boston Scientific and Saluda Medical, Kat brings a rare blend of commercial rigor, strategic insight, and credibility earned in the field based in Arizona. Kat is a speaker, advisor and coach who believes that when sales reps and leaders learn to own their voice, their business and their influence, the ripple effects extend far beyond individual success, shaping teams, cultures, and the future of the industry itself. Kat, welcome. Thank you so much for being here today. I'm super excited to speak with you. [00:01:45] Kat Hurd: Thank you so much for having me, Lindsey. It is an honor. I always love these conversations. [00:01:49] Lindsey Dinneen: Excellent. Well, if you don't mind just starting off by sharing a little bit about who you are, your background, and what led you to medtech. [00:01:58] Kat Hurd: Yeah, absolutely. Well, medtech, I like to say it's always, I was kind of born into it. So my mom is a nurse and she ran a medical clinic when I was in middle school and high school. So truly I would go to the clinic after school and, if, if actually we didn't have school, I remember one of the days sitting in a pharmaceutical rep lunch presentation, so I really got exposed before I even knew what it was. Even in that moment, I wish I'd understood more of what that rep was doing and really dug deep. You know, I thought I was gonna go to school and be a doctor, and then I quickly realized I didn't like freshman bio. And I wanted something where I could have an impact but still have some flexibility. So I actually, my to, to take you back to like how this all started, my background, sports medicine and so my undergrad and graduate degrees are in exercise science. I used to be taping ankles and rehabbing knee injuries and doing all of those things. And then I got exposure through that of being in the operating room when our athletes would have, you know, the injuries that were being surgically repaired, and that was really where I got that secondary introduction into medical device and started having conversations with other people who'd made the transition from athletic training where you have a ton of, you know, in insight into the human body and understanding of the medical world. And moving that into the sales arena. And so I met with someone in Iowa City. I'm a University of Iowa grad, and he was running the western half of the US for Boston Scientific at the time. And one thing led to another, led to me flying to Arizona and interviewing and then moving their site unseen really. I was there for, you know, max of 24 hours total in my interview process. And I just packed two suitcases and said "I wanna break into medical device." And that was in 2010. And I just fell in love with the industry and the therapy. So I was in neuromodulation working directly with spinal cord stimulator patients and started as a clinical specialist, and then I really quickly realized the way to have very clear impact on patients and providers was really actually to be in that sales role and be the one directing the support, directing the resources. And in neuromodulation, because you're in the OR and actually programming the stimulator, you're also kind of supporting the patient's care, which for me was right in my wheelhouse. And then I moved into leadership. And you know what you really wanna know is probably how did I land where I am now? And so I spent 10 years or 11 actually at Boston Scientific. And then moved to Saluda Medical, so to commercialize a small Australian based startup here in the US, which was such a fun and unique opportunity. And I always knew that was gonna be more of a three to five year play, and I just had it on my heart that I wanted to build a business to help reps be better reps, because I believe that the quality of care and the quality of outcomes is also directly tied to the partnerships and the caliber of the industry that supports the therapies. [00:05:00] Lindsey Dinneen: Okay. I love that. And I have so many questions as a result, but okay, let's start a little bit with what you're doing now and then maybe, we'll, we'll get to some of the other stuff as well, but, so you're supporting reps, and I think you said something really impactful about a lot of the patient outcomes kind of goes back to how, how the reps can be the best they can be. So I'm curious what all goes into that for you and what kind of training or coaching do you provide? [00:05:31] Kat Hurd: Absolutely. You know, I really, I saw that squarely and believed it when I was a sales rep myself. So I spent the first six years of my career on the sales side of things, and then moved into being a sales leader. And as a sales leader and then an area Vice President Saluda, it was the thing that I saw of like our teams and our people that excelled the most, weren't just the best salespeople, but they were the people that understood how to, for lack of a better word, leverage that clinical and patient experience into the entirety of the sales process and sales cycle. So good clinical care and driving good sales conversations, levels up the partnership and really creating this layer of, not just being a partner, but being a trusted advisor with the providers that you work with. So how that translates into my business now, 'cause oftentimes, you know, I get the question of like, why did you leave a burgeoning career? I had one physician who was like, "You were gonna be a CEO. Like, why'd you leave medtech?" I'm like, "I didn't leave. I'm just doing it differently," because I saw so strongly and so clearly that having the right resources as a sales rep and at the right time as a sales rep changes your career. I was lucky to have great mentors, but there's things that if I had had the right support and resources at the right time, I could have been even, you know, faster or more impactful in my results. And so that's what I do now. What my business looks like now is really, you know, threefold. So I work directly with sales reps who, not through their companies, but they'll come to me directly and we do sales and leadership coaching. So working on the strategies in their business, how they're, you know, clinically supporting. But, you know, I, I leave the clinical nuts and bolts to the organization because I'm not an expert, and that, unless it's spinal cord stimulation, then we can talk that for days. But you know, really how they're leveraging their clinical prowess into their sales process and building systems for success. And then I work directly with companies helping train and elevate their talent, both on the sales and leadership level. Then I also have an arm of my business where I do, and that's kind of more of the consulting arm of my business. I also help with sales strategy and go to market strategy. And then I also do more of like corporate speaking. So keynotes and workshops and seminars really focused on both how do you build and grow your career in medtech, particularly as a woman, because we know there's just not a lot of us. And you know, part of what I'm so passionate about is helping everyone and raising the caliber of talent everywhere, but also making sure that women have the structure, the resources, and the idea of the systems that they need to create so they can go as far as they want to. Doesn't mean they have to go all the way to the C-suite level if that's not what they want, but to ensure that they have the representation and the pathway in f

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簡介

MedTech Leaders Changing Lives for a Better World

資訊

  • 創作者
    Velentium Medical
  • 活躍年代
    2023年 - 2026年
  • 集數
    86
  • 年齡分級
    兒少適宜
  • 版權
    © Copyright 2026 All rights reserved.
  • 節目網站
    The Leading Difference