Podcasts about Medtech

Why do so many MedTech products look brilliant on paper — yet still fail to get adopted in hospitals?A strong product alone is rarely enough to win hospital adoption. Even when the clinical idea is sound, devices often stall because they are hard to use in real workflows, lack an internal champion, or fail to show enough value to justify the cost. In this episode, Hakeem speaks with Dr. Torrie O'Daniel to unpack the three most common reasons promising MedTech products don't gain traction — and what founders can do differently to make real-world adoption far more likely.By listening, you'll:Learn the three most common reasons hospital teams do not adopt MedTech products that initially look promisingUnderstand how workflow fit, team-wide usability, and internal champions influence whether a device gets used consistentlyDiscover what founders need to prove clinically and economically to build momentum and justify adoptionPress play now to learn how to turn a promising MedTech product into one hospitals will actually use.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

When your MedTech launch has several weak points, how do you know which one to fix first before you waste 90 days improving the wrong thing?MedTech founders rarely fail because the device is poor. More often, they stall because they improve the wrong part of their launch first. When product, proof, pathway, and people all have room for improvement, deciding where to focus becomes critical. In this episode, Hakeem breaks down a practical decision rule that helps you identify the one move most likely to unlock real contracts and meaningful revenue.By listening, you'll:Learn why the lowest-scoring weakness is not always the first problem you should solveUnderstand how commercial conversations reveal whether proof, pathway, or people is the real revenue constraintUse a simple 90-day decision filter to prioritize the move most likely to accelerate traction this quarterPress play now to identify the one change that can move your MedTech launch closer to real contracts and meaningful revenueBook a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

In this episode, Merom Klein—business psychologist, innovation leadership expert, and co-founder of Courage Growth Partners—joins Duane Mancini to unpack why courage is a decisive differentiator for medtech innovators trying to earn funding, win pilot customers, and drive adoption of a new standard of care. Merom shares how his entrepreneurial family background, early work in organizational psychology, and experience building startups shaped his focus on making courage contagious. The conversation reframes fear as inevitable—and even necessary—and explores how leaders can “flip the switch” in high-stakes moments to avoid risk-averse traps, respond productively when partners or teams fall short, and turn criticism into forward motion. They dive into resilience, the value of pressure as a privilege, and why your #1 job in tough rooms is changing the energy and aligning people to shared purpose.Merom Klein LinkedInCourage Growth Partners Website“Courage to Champion” BookDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Etienne Nichols sits down with Staci Miller, a Human Factors and UX Strategist at GenUX, to demystify the role of human factors (HF) in the medical device regulatory pathway. Staci explains that many companies mistakenly treat HF as a "box-checking" exercise late in development, leading to costly submission delays or rejections when the FDA finds the documentation fails to tell a cohesive safety story.The conversation dives deep into the technical distinctions between a Use-Related Risk Analysis (URRA) and a User Failure Mode and Effects Analysis (uFMEA). Staci provides a framework for deciding which approach fits your product, emphasizing that while large conglomerates with post-market data may lean toward uFMEAs, startups and those with novel devices should prioritize the URRA to effectively map out user interactions without the crutch of existing market data.Finally, Staci addresses one of the most persistent myths in the industry: the idea that clinical trial data can replace human factors validation. She clarifies that while the two can overlap in specific, premeditated circumstances (such as complex implants like aortic valves), they serve entirely different masters—one focused on clinical efficacy and the other on the safety of the user interface across diverse environments.Key Timestamps04:12 – The common disconnect: Integrating Human Factors into ISO 14971 risk management.06:45 – URRA vs. uFMEA: How to choose based on your post-market data and predicate device status.10:30 – The "Definition of Done": Tracking the lifecycle of HF documentation from phase zero to market release.13:15 – System errors vs. Use errors: How to identify root causes during summative studies.18:50 – The "Clinical Trial Myth": Why efficacy data is not the same as usability validation.22:10 – Design Inputs vs. Design Outputs: The "Blueprint and the House" analogy for FDA submissions.25:40 – The impact of the "Use Environment": Testing for movement in ambulances and lighting in radiology suites.Quotes"The FDA doesn't put things out there just to have a good time... If they've made human factors a requirement and you're treating it as a 'suggestion,' you're giving yourself enough rope to hang yourself." - Staci Miller"People are obsessed with the product themselves—the design outputs. But the FDA wants to see the design inputs. They want to see the blueprints of how you built that house, not just the wallpaper." - Staci MillerTakeawaysPremeditation is Key: If you intend to use clinical trial data for HF validation, it must be planned in the protocol from the start; you cannot retroactively claim clinical data satisfies usability requirements.Map User Groups Early: Distinguish clearly between primary and secondary users. Bloating user sets without explaining how or why they engage with the device complicates your risk profile.Environment Matters: Documentation must account for the physical "10,000-foot view," including noise, lighting, and motion (e.g., an ambulance), as these are often where critical use errors occur.HF is Risk Management: Human factors should not live in a silo. It must align with the scales of harm (negligible to catastrophic) defined in ISO 14971 and work in tandem with Quality and Regulatory teams.ReferencesISO 14971: The global standard for the application of risk management to medical devices.FDA Human Factors Guidance: The primary document outlining expectations for usability testing and documentation.Etienne Nichols: LinkedIn ProfileMedTech 101: URRA vs. uFMEAThink of a uFMEA (User Failure Mode and Effects Analysis) like a car manufacturer looking at an old model to see why the brakes failed in the past—it relies on known data to fix specific parts.A URRA (Use-Related Risk Analysis) is like teaching someone to drive a brand-new type of vehicle (like a spaceship) for the first time. Since you don't have "crash data" yet, you have to carefully map out every single step the pilot takes and imagine every possible way they could push the wrong button in the heat of the moment.SponsorsGreenlight Guru: This episode is brought to you by Greenlight Guru, the only quality management platform designed specifically for the medical device industry. Whether you need to manage your QMS to stay compliant with ISO 14971 or streamline your clinical data through their EDC solutions, Greenlight Guru helps you move faster with less risk.Feedback Call-to-ActionWe want to hear from you! Do you have questions about your specific regulatory pathway or a topic you'd like us to cover? We provide personalized responses to every listener who reaches out. Send your thoughts, reviews, or suggestions to podcast@greenlight.guru.

Logan McKnight is the founder of GoodKnight Consulting and a strategic advisor to MedTech executives navigating growth, leadership challenges, and operational complexity. Logan shares her nearly 20-year journey from pre-med to neuromonitoring technologist to CEO, and explains why she now focuses on helping leaders build teams that scale without sacrificing culture or burning out. She discusses lessons learned managing remote surgical service teams, why “simple scales,” and how mission, vision, and values enable better decisions and hiring beyond gut instinct.  Guest links: https://www.goodknightconsulting.net/ Charity supported: ASPCA 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 075 - Logan McKnight [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am delighted to welcome Logan McKnight. Logan is the founder of GoodKnight Consulting and a strategic advisor to MedTech executives navigating growth, leadership challenges and operational complexity. With nearly 20 years in neuromonitoring and surgical services, including experience as a CEO, VP of Operations and business development leader, Logan brings an experienced perspective to executive leadership. She works with directors, VPs, and C-suite leaders to build teams that can scale without sacrificing culture or burning out. Well, welcome to the show, Logan. I'm so glad to speak with you today, and thank you so much for being here. [00:01:34] Logan McKnight: Yeah, it's great to be here. I appreciate you inviting me. [00:01:36] 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. [00:01:45] Logan McKnight: Of course. Yeah. So my name is Logan McKnight and I have been in medtech for almost the last 20 years. And I think my journey, I, a lot of people have a very similar like origin story of haphazardly finding their way into medtech. I was pre-med in college. I wanted to go into veterinary school and I think I panicked honestly last minute, not really wanting to go. I interned under vet who basically dissuaded me from doing all the work of vet school and said go to med school. And feeling a little lost, I found my way to medtech, particularly neural monitoring, which was a field, pretty niche, but basically I got trained by a company to go in and run equipment and monitor patient's nervous systems during surgery. And to me, just having my bachelor's degree and having that level of impact and being able to jump right into patient care without having to go to more, you know, years and years of schooling was right up my alley and it's been such a wild ride. You know, I was a technologist and then I became a manager and then VP of development of business development, and head of contracting. And then I went over to a small company where I was the vice president of the whole company, and then eventually CEO, and now I'm consulting for medtech companies. So it's been a really fun journey that I didn't plan at all. [00:03:06] Lindsey Dinneen: Yeah. Okay. Well, excellent. And that brings up so many questions, but to start, so you were thinking originally you might wanna be a vet. Do you have you know, like, did you grow up with animals? Did you just have an amazing love for them? Where did that come from? [00:03:23] Logan McKnight: You know, honestly, I think I would've had way more animals, but my parents were a lot more reasonable than I was. So we just had the regular pets, but I grew up like horseback riding and in the Midwest, in Ohio. So I was around a lot of farm animals and things like that and I was part of like FFA and horticulture. So future Farmers of America. And I actually was really interested in large animals because I didn't wanna deal with people, I didn't wanna deal with people or their pets. So, and you know, and so that was what panicked me about med school was like the whole plan was veterinary school was to avoid the people part. And then I found through medtech you know, neuromonitoring and surgery where my patients are asleep. And so I still got to do all the things that I love, like providing impact, but then, you know, not having to worry about, I guess all for me I just had my head like all the challenges and complications that deal dealing with patients that I thought would make my job and life really difficult. So it's been really fun to kind of focus on just like the care and how to move things forward and explore this big, wide open space of how to impact people's lives in surgery. [00:04:31] Lindsey Dinneen: Yeah. And you know what's interesting about that too is, though, I think it sounds like throughout your, though, as you've, you know, gone from technologist and then you've had all of these amazing career changes and growth basically. It sounds like, you know, you have developed though your own kind of leadership style, so even though maybe originally you weren't sure about dealing with people, so to speak, you've actually excelled at it. So I'm curious how that has evolved for you in creating and managing teams. [00:05:03] Logan McKnight: Yeah. You know, it's interesting. I think like initially I was trying to control all these variables before I got into leadership in people, and then realized like you can't do that once you get to actually working with people. And once you almost like acknowledge and recognize, you can't control that but there's some beauty in that of you just allow for what you allow and then you know, you have to give people the ability to function like at their level. And you create the parameters. But other than that, like some magic happens when you don't try to control every single thing. And I see so many, especially new managers, you know, being like, "I need to control everything." And they're wondering why they're exhausted or their team's not respecting them. And it's like, gotta let go, gotta let go of the wheel a little bit. So, you know, I think those are some lessons and sometimes they just come with time and experience. [00:05:55] Lindsey Dinneen: Yeah, absolutely. Yeah. So, when you started, well, let's go back to the beg, maybe it's kind of at the beginning of your career. What are some things that you learned as a technologist and as you were growing within the hospital systems themselves, that contributed to basically where you would become now to become an entrepreneur and all of that. [00:06:21] Logan McKnight: Yeah, I mean, I will be very honest, and this is not meant to be a dig at anybody who I'd worked with or any boss. But I just, I went to work for a private company and we went and we were almost like hired mercenaries. So we would go to like, you know, every day I was in a different hospital. I didn't know my schedule till the night before. I rarely saw my manager and, you know, rarely saw other members of my team and it really felt like I was very isolated and alone. And it added to my burnout and also feeling like I didn't have anyone watch, like looking out for me and my back as a younger employee. And I realized there was so much room for improvement there in how you manage a team remotely. And so I think I, I just like mentally I was a psychology major before I switched to pre-med, and so I think like the, like human brain, because I was, you know, neuroscience, but like psychology, I think is so fascinating to me and the way people tick and what makes them tick. And I, I'm a big believer if you can figure out the way people tick, you can unlock so many things in the world and like you can, you know, you can be the most brilliant person, but if you can't communicate effectively, if you can't manage a team, you're really not gonna take things to the next level because you're not gonna activate those people around you to perform and get something done. So I feel like it was a case study for me to kind of watch like these managers and struggle and I'm like, "Ah, that's what I'm not going to do." [00:07:47] Lindsey Dinneen: Yes. Yeah. Sometimes learning from examples that maybe you wish you didn't have to learn from though can be the best teachers and actually serve your, you know, your own leadership style and your people that you end up getting to influence. It actually does help in the long term, but so. [00:08:06] Logan McKnight: Totally. [00:08:07] Lindsey Dinneen: So when you started GoodKnight Consulting, what was the impetus for that? I mean, you'd had this you've had this amazing career so far. You're ready kind of just for the next step or what sparked that? [00:08:19] Logan McKnight: You know, it's interesting, I stepped down from my CEO position 'cause I was feeling, I was running a neuromonitoring service company in the Pacific Northwest. We also had a professional services arm with neurologists. And then I had a medical billing company that I was running and we did mostly out of network billing. And then we also started a company in India right before COVID. So by 2023, I was fried, I was very burnt out in the way that I felt like I was busy all the time, but not really having the same impact I used to have. I think a lot of that was like I, I got more involved on the litigious side of running a company and then also the medical billing side really takes it out of you. So the thing I enjoyed was the coaching and the mentoring, and once I took a little bit of a step back and thought about what would I do every day for free? You know, like, what would I just love to do? And the reality was coaching other leaders, especially one like scratched my itch for helping people and provide and like, impact, which I realize is my biggest driver is like, how do I impact the most people and walk away with, you know, my life feeling like I've touched people in a positive way, and I think that's, you know, my, my driving force. So that's kind of why I started. And I started honestly just trying to go to leaders individually and offer some webinars and some one-on-one coaching. And then I really realized working with companies actually is the best way to go about this because you get ownership and leadership that's totally aligned and they want that support for their leaders. And then, it's so much easier to see the impact spread throughout an organization, so that's been really cool, is to be this outside force driving an owner or an executive's vision of what they want their company or the team to be. [00:10:07] Lindsey Dinneen: Yeah, and I noticed when I was reading a little bit more about the company, one of the things that I thought was really interesting is you talk about there, this is not just let's say leadership or mindset coaching or something like that, although that is very important as well. It is also about the business strategy. And you talk a lot about, you know, you've been in the position to understand how much, of course, revenue matters. You ha you have to, you know, make sure that's a strong, you know, foundation for the business. So, so how do you balance the two when you work with clients? [00:10:45] Logan McKnight: Yeah, no, that's a great question. I think every client is unique. I have found that just stripping away-- actually with something I, a blog post I was working on today and something I posted on LinkedIn, and it's something I find myself saying to founders and owner operators all the time-- simple scales. And I think, you know, what ends up happening is a lot of times you get this great idea for a product, a service, a company, and you just go. And you don't sometimes sit down and create like the true mission or the vision and like the values of the company. And it's really hard for owner operators and people who are in startup land and you know, small businesses to pause and do that, especially if they've been going for a few years 'cause you know, it's like, "Well, I've been operating without this stuff. It's totally fine." The reality is it's so much easier to grow and scale and also to gut check yourself when you're making decisions and being like "This is the right call because this aligns with our mission and our vision for the company or our growth initiatives for this year. And then it aligns with my values. I feel good about this decision and I can communicate it to people I hire. So I trust those people." And like that's what scales is, the trust and people having like the unified mission and vision and values and like, I know it sounds a little touchy feely, but the reality is like that's actually what I feel like I end up centering owners and operators on. It's less about the minutia and the details and more about like, does this make sense with where you wanna go and the way you, and the way you wanna get there. [00:12:21] Lindsey Dinneen: Yeah. Yeah, exactly. Okay. Yeah, I really like that. And with the emphasis on the unified team in terms of, you know, we don't all have to view life exactly the same, but we need to be aligned, at least with our mission and values and things like that. What do you find are some of the best practices when it comes to building out a team? And on the flip side, what are some things that maybe are common or that feel like they would be good practices, but in reality might not be. Like, what are some lessons learned, I suppose, on both sides? [00:12:56] Logan McKnight: Yeah. I mean, I think, I'll be honest, I think a lot of owners and maybe leaders who've been in their position for a while, like, like there-- I was talking to somebody else about this, about your gut feeling and like, go with your gut and trust me. I was a big go with my gut leader especially as a CEO, but like that doesn't scale because you have to be able to verbalize like, what are the things you're looking for? Why did you pick this person? And so at the end of the day you know, I had a policy when I was probably right, became, when I became a CEO that I needed to like approve after a couple not so great hires, I needed to approve every hire. And like the reality is that's not realistic, that's not gonna scale as you grow. And so I just needed to create the, this is what we're looking for like, you know, we're hiring for attitude. We can train the aptitude, we can train the technical depending on what the job is. But, you know, here's what we're really looking for, is a good fit for the company and the culture. And then, because once I had people who I knew really got that and saw the vision, I knew they were gonna make the right choices. And so I didn't feel like I had to. Be the one making that decision, I could scale it and help, you know, allow my team to hire for the people in the places that they needed and saw. [00:14:09] Lindsey Dinneen: Yeah. Okay. Yeah, I really like that. So, one thing that I thought was interesting, especially so on your LinkedIn profiles, I was, you know, enjoying reading more about you and some of the things you've done. But you had mentioned that sometimes there's a trade off between hitting targets and then you're burning out your team for the opposite. You're protecting your team, but then you're not hitting your targets. Could you speak a little bit more about that and how you help companies sort of overcome that challenge. [00:14:40] Logan McKnight: No, and I mean, I think it's like, I equate like, I think when I first became a leader, you know, talking about how my viewed my other leaders maybe know what not to do, I definitely swung the pendulum too far the other direction when I first started. And I was way too, I don't know, I was way too, all the things I didn't get. And so two, like checking in with my team, "How are you doing?" Not wanting to delegate work to them and doing these things because you know, and so I realized there's you, I think that's like an initial thing a lot of leaders go through is that shift. It's when you get stuck in the one extreme or the other and you don't really find your good at equilibrium, that it's really hard to sustain. And I think it's really important to find your equilibrium of, like, "This drives us to hit quota. This drives us to get our metrics and to for success. And then it does it in a sustainable way that our team's gonna stay." Because to me, like, sustainable. I kind of was thinking about my values even this morning and I'm like, I think fun is really one of my values like, I want to really enjoy like not just my personal life, but my professional life, and I think your job, your company, all of those things is a lot more fun when it's sustainable, right, when you're like exhausted. So finding a way for it to be sustainable for your team, for, you know, and everyone likes to win. Like it's fun to hit quota. It's fun to like crush your metrics and celebrate. So it, how do you know, make that sustainable and fun? And I think that's like a long-term success or recipe for success with a company. [00:16:15] Lindsey Dinneen: Yeah. Yeah. Well, and you know, it's so interesting 'cause actually this has come up a couple of times recently on the podcast is the sort of core value of fun and how much that does actually transform people's experience with the company. And you know, because inevitably you're gonna have those days that are just really tough and hard. And so being able to though have a culture of fun and joy is, it does make a difference. Yeah. [00:16:42] Logan McKnight: No, for sure. I remember when I first started working in surgery and someone asked me, they're like, "Oh, is it like Grey's Anatomy?" And, you know, and I'm like, "It's not nearly as like sexy. Like there's no, you know, doctors in closets and whatever." The, I, it's actually more like the show Scrubs and the reality is, and people are like, "Oh, that seems like goofy and comedy." I'm like, "I know." But the, I think the reality is we view in like healthcare and medtech of like this, you know, taking care of patients, a serious job. We're talking to surgeons. But for anybody who's really good at their job, like, you know, you see, especially in surgery in these high stakes environments, like it's actually the best rooms to be in are a lot of fun because you rely on your team, you know everyone's gonna do well, or you know their job well. If shit hits the fan, the tone changes and you can trust that. But I think because you trust your team. It's fun, you know, in more moments than not because there's just so much trust that when things get serious, people will speak up and it's safe. I think you like when you're psychologically safe, it's enjoyable, it's fun, and you also feel like you can speak up when you say something wrong. And I feel like those are the healthiest like work dynamics, both in healthcare then, especially in medtech when you're putting a product out there, like you want somebody to say something if they see a problem with your product before it goes to market, right? [00:18:05] Lindsey Dinneen: Well, and I love that. I love that perspective too of, you're absolutely right, healthcare, medical devices, it is it is serious by nature and it should be like, we should take our jobs seriously. But at the same times, if we could not maybe take ourselves as seriously and, you know, and infuse the fun and it does help also I think dissipate some of that-- well, some of the really hard, you know, again, those days that are tough it helps to be able to say, you know, take a step back and go, you know what, "It's yes, and." [00:18:37] Logan McKnight: Right. A hundred percent. Yeah. It adds a little like, like brevity to those se really serious moments to be able to feel. You know, and I think that at the end of the day, like you being in whatever place whatever your place is in healthcare, in medtech, like whatever role you're playing, like you are helping advance the field, you're helping patient care. And I think always keeping that in mind, even on like the tough days, like you're advancing something in a good way keeps you centered on like your why and drives you forward in a really good way versus like, you know, and I'll be honest, like I, it got hard for me in my CEO role, like, I think I lost my why a little bit and my driver, because it's very hard to see, "Okay, well how am I impacting patient care positively. How am I impacting the world positively?" when you're chasing down insurance reimbursements and whatnot. And, you know, dealing with hospital shutdowns during COVID. So I think at the end of the day, I realize like I need to find a way for this to be enjoyable and fun because I also realize like I'm my best self and I'm more creative and I'm more in like a problem solving zone when I'm in that, that good mindset. And so I, I look at it as a huge positive to, to figure out what, what drives you and make you happy. [00:19:51] Lindsey Dinneen: Yeah. What drives you makes you happy. And I agree with you, if you can also take a step back sometimes and have that broader perspective and mix it with just a little bit of humor, even if just all you're doing is taking a quick break and watching, I don't know, a funny cat video or something. Yeah. [00:20:10] Logan McKnight: Sure. [00:20:11] Lindsey Dinneen: Reset moments make a difference. So difference, you're a board member of several organizations and I wondered if you could speak a little bit to those organizations and what led you to get involved with them. [00:20:24] Logan McKnight: Yeah. So the two I'm on the board of is one Nepal's Spine Foundation which I went to Nepal with a few surgeons I worked with. And then when I was in figuring out my why when I stepped away the surgeons who are started the foundation invited me to join the board. And actually I will be going to Nepal with them in April and we'll be doing another mission and then hiking to Everspace camp together. I'm looking forward to that, and it's been amazing 'cause I think that's also, I've gotten to go on a lot of mission trips in my career. I've gotten to go to Ghana and Barbados, Dominican Republic, Nepal, India. And so, like I also realized like impact being my driver, like I have so much impact to teach people about neuromonitoring, which isn't a well-known, you know, aspect of surgery always. And so the fact that I could leave a hospital, a community better for going there really was a driver. So the fact that I continued to do that work is really important. And then the second is STRIPES, which is how I met you, women in medtech. And you know, the nice thing is I was looking, I was a, I went back before I fully launched GoodKnight Consulting and became like a device rep just to kind of figure out, you know, do I wanna go back into sales? What do I really wanna do? And I was a little lost and I found my way, you know, I wanted community. And when I found this group, it was just transformative for me. Like I, my mentor was Lisa Jacobs, who is phenomenal and has been inspiring for a very long time. And she actually really pushed me to do my dream and start and really put all into my coaching and consulting. So I'm really grateful for that. And then she invited me to be on the board. So like to continue to give back to an organization that I feel like personally gave me, like it, it's why I am where I am today. It gave me that push I needed in that support. And there's tons of women in the organization like Claire Davis, Kat Hurd, like Courtney Turich. I just, they're all out there, they're all public on LinkedIn. And that was something that honestly, initially scared me. And so just, I was inspired by them, supported, and I think that's a really, you know, great thing when you are becoming an entrepreneur is finding your community and that support. [00:22:42] Lindsey Dinneen: Yeah. Yeah. Well, okay. So I just, I love the fact that you're doing both of those things. The mission work is really cool. It's amazing to hear how you've gotten to use-- well, because you're so driven by impact how you've gotten to do that and then make a big difference in, in the lives of people that, yeah, may otherwise never have had that opportunity or, you know, at least not for a while or whatever. So. [00:23:09] Logan McKnight: Right. [00:23:10] Lindsey Dinneen: Yeah, that, that's really incredible. So, you know, through that or throughout your career, are there any moments that really stand out to you as kind of affirming, "Wow, I am in the right industry at the right time." [00:23:23] Logan McKnight: You know, I think medtech, like always, even if it's not me and something I'm doing, like seeing people who I know in the industry and accomplishments they've made, and organizations that I've either been a part of or supported in some way in my career, like just seeing like the new tech coming out and the advancements they're making, just reaffirms like I'm part of a bigger picture in an ecosystem that's really great. And even, you know, like I, I came from the spine space when I was doing medical device and it spine is, you know, tough. Like ortho's tough, spines tough. That's a lot of competition. But you know, I think. Competition drives quality, and so it's really cool even if you see your competitor doing something, you know, you're like, "Oh man, I wish we would've," but it's getting done. It's, you know, it's pushing the envelope, it's making it better. And I think that's huge. And, you know, really exciting too when I found you and Project Medtech to see how you guys are helping support like startups and investors and people who are looking to get into this space. Because I think that's the other thing is getting fresh perspective and new innovative companies helps everybody like drive, drives the mission forward, drives the impact forward on patient care. [00:24:38] Lindsey Dinneen: Yeah. Yeah. I love that. Yeah. And okay, so another very random thing that I found on your LinkedIn, but I just really liked it 'cause I resonate with this aspect. So you started to paint, you learned how to paint. Tell us about that and does that play a role in your creativity overall, do you think? [00:25:01] Logan McKnight: You know, I think so. So I hosted like a happy hour for girlfriends and we did this thing where we painted like a thrift shop thrift store paintings and like Halloween things in them. And so, and I live in the Pacific Northwest, which is beautiful. We have a hundred year old cabin on three acres, and it's, it was October. It was just like, stunning. And I was looking out in our, my backyard and I was like, "I wanna paint this." And I just sat down. I mean, I'm not artistic. I've never and it looked like a 8-year-old painted it and my partner Joe was like, "Maybe watch a video." It's great. I love it. But, you know, and so I found, you know, like Bob, apparently all, every episode of Bob Ross was on Netflix at least last year. And so I just started watching some videos and some videos on YouTube, and I started getting better and better pretty quickly. Like I, you know, I started, you know, little tutorials here and there. And then I realized, like I was also reading books to help me kind of get in this entrepreneurial mindset like growth mindset or "Mindset" by Carol Dweck, which talks about growth mindset. And I realized like, you can teach yourself to do anything. Like I had told myself for the longest time, I mean, I started my I'm 40 and so I told myself for 40 years, like, "I'm not artistic." That was my box I painted around myself. And then all of a sudden I was like, "Well, let's give it a shot." And so, you know, there's, I realize like you set these boundaries in your parameters in your head and you blow them up a little bit. Like, you know what? Like, let's just see, let's try you know, and I see this with our teenagers too, it's sometimes like when they struggle in school, they'll be like, "I'm not smart, or I'm not this." And I'm like, "You just have to try." Like anything worth doing takes effort. And if everybody quit because they weren't good. The first time or even like the 10th time, like imagine how little progress we would make as a society. So I think if something you wanna do something recognizing, like you can learn to do it. And I think that also helped ignite, like me knowing I could be, do my consulting company and really launch it. And so I just started reaching out to people who had done it and I hired coaches and I started to learn more about what would make it work and what I would need to do. And you know what a novel idea, right? You find the person who's doing what you wanna do and you learn from them. You know, and it's just like that entire journey over the last year was really helpful to, I think, get me to the head place like I needed to be, to like leave the safety of a W2 job and launch a company. Just to like lie, you know, to myself every, and be like, "You can do it." Because, you know, if you start every day with the, "I don't know if this is gonna work," like I, there's no way I would've done this. I really had to tell myself I could do it, it was gonna work, and I realized now that I've gotten past that, it's very harder like to put a boundary around me now. Like now it's a challenge, right? Like if you tell me I can't do something, I'm like, "Oh, let's see." I bet you, you know, even if I'll fail, like the first few times, I want to try to see if I can do it because I now have this delusion that I can teach myself to do just about anything, so. [00:28:18] Lindsey Dinneen: That's awesome. [00:28:20] Logan McKnight: Or not. [00:28:20] Lindsey Dinneen: Yeah, no, that is incredible. And you're absolutely right. I think we can all relate to, at least in some element of our lives, painting boxes around ourselves and going, "I'm not this," or "I'm not that," or "I'll never get to be able to do this. I'll never be proficient." And those things aren't true. It's just what we tell ourselves. So I love the fact that painting opened up those doors for you. [00:28:43] Logan McKnight: Yeah. No it's so true. And I think it's like a. You know, a metaphor for life. And I think I hear that a lot of times from people will be like, "I wish I could do what you," and I'm like, " You can literally do anything." That's how crazy. And, you know, we're in peak New Year's resolution time, right? And I think a lot of people are like, "Oh, I wanna do this and do that." And that's like, you can, you just like, if you wanna be a person that exercises more. Just go start exercising. That's how wild the world, like our brains can make us do whatever we want. So anyway, I'm also a big psychology buff 'cause I, I'm a big believer in like the power of the human brain and what it can do over your decision making and your life and the impact it can have, you know, everything really. [00:29:27] Lindsey Dinneen: Yeah. No, absolutely. Yeah, I couldn't agree more. I love that perspective and yeah, growth mindset is a wonderful gift because, you know, you can explore, you can try, and as long as you're sticking with it and doing those things, then you're not failing. You're just, you're just exploring and then you can just keep exploring and find things that are right for you. And you know, not everything will stick, and that's okay too, so. [00:29:55] Logan McKnight: Yeah, a hundred percent. Yeah. I always tell people "I'm still figuring what I, or figuring out what I wanna do when I grow up." You know, and I think that's an ongoing thing, and I hope when I'm 80, I still am figuring out like what's next. [00:30:06] Lindsey Dinneen: Yeah. [00:30:07] Logan McKnight: It's exciting. So. [00:30:08] Lindsey Dinneen: Yeah. All right, well pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be within your industry, but it doesn't have to be. What would you choose to teach? [00:30:24] Logan McKnight: You know, I think this, it ends up being the thing I talk about most. And it's the thing I think I wanted to do initially, but it was really a struggle to just target and talk to managers, especially like frontline managers. But I think that transition from being an independent contributor to becoming a first time leader-- like if I could teach a masterclass in that, I think that would be really fun. I see so many very empathetic and like capable independent contributors, whether they be like rockstar sales rep or even a great like technologist or engineer. And then they were like, "Okay, well I need to move up the ladder. I'm gonna be a people manager," and then their next step is people management. And they're like, "This sucks. Like I, nobody told me about like all the things I have to deal with and the people." And you're still in the mindset of like box checking, of like, in order to be successful, "I have to do all these things. I have to do X, Y, and Z." And I think that the second I stopped checking all the boxes and trying to do all the things was when I went from being like a manager to an actual leader of people and activating them. And if I could just get a few people who I believe, like I've even seen so many really great people leave the industry because they feel like they want to advance, but they don't see because they weren't a good manager, like, "Well, how would I ever be a good director or a good VP," or so on and so forth. The reality is like probably the hardest transition is going from independent contributor to a manager, and yet it's like the least supported space. So that's I think that's something I feel deeply passionate about and would love to like able to offer as a resource more for people. [00:32:10] Lindsey Dinneen: And that would be an incredible masterclass. Okay, and then how do you wish to be remembered after you leave this world? [00:32:18] Logan McKnight: I love that one. I mean, I think at the end of the day, that's the impact thing. You know, and I don't even think it has to be this, like, big, you know, like, "Oh, I, you know, solved healthcare in Ghana." Like, you know, it's not that. It's almost like I, I hope that like my company and my interaction with people leaves everyone feeling a little lighter, a little happier, like a little more capable to do like something, and they feel like talking with me, working with me has unlocked like the next level of something that they've been struggling with and makes them feel like, "Okay, I can do this now." 'Cause I almost feel like that's what, what coaching and consulting comes down to is I'm not doing the thing for anybody. I am only helping to remove the roadblock around them, that they stop limiting themselves and they really see what's possible just by making a few changes in the way they think, in the way they operate their business or run their team. And, you know, amazing things happen. So my hope is that I just continue to get to do that and have people that really feel positive impact from that. [00:33:26] Lindsey Dinneen: Yeah. Well that is a beautiful legacy, so, yeah. All right. And then final question. What is one thing that makes you smile every time you see or think about it? [00:33:38] Logan McKnight: Oh, gosh. Well, we just talked about this before our call, but my dog, I have, I'm an animal lover, and so I have the fortune that every day, most every day I'm in my home office and I get to go on a hike or walk with my dogs, either around our property or out somewhere in beautiful Washington. And I think just like seeing the mountains and being out with my dog, like that just makes me smile. And I think it's also what inspired me to paint and all the things. So I, I think just all the beauty like in the world just makes me smile and makes my heart very happy. [00:34:12] Lindsey Dinneen: I love that. Oh my goodness. That's beautiful. All right, well this has been an amazing conversation, Logan. I so appreciate you and your time today. And we're so honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thank you for choosing that organization to support and we just wish you continued success as you work to change lives for a better world. [00:34:43] Logan McKnight: Yeah, thanks for having me. We'll talk soon. [00:34:45] Lindsey Dinneen: Sounds good. Thank you and take care. [00:34:49] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Many clinicians build Medical Devices that solve real clinical problems.They secure regulatory approval.They get positive feedback from early users.They even generate interest from hospitals or distributors.And yet… adoption stalls.Not because the product is poor — but because something critical in the launch is structurally weak.In this episode, we break down the four Ps that determine whether a MedTech product gets adopted or simply admired.This is not textbook marketing theory.It's the real-world framework that reveals exactly where your go-to-market strategy is breaking down.You'll discover:Why regulatory approval and engineering perfection don't guarantee adoptionThe difference between clinical enthusiasm and commercial proofWhy hospitals buy through processes — not passionThe hidden influence of decision-making units inside healthcare systemsWhy distributors and internal teams must align around the same commercial structureIf you're a clinician trying to turn a working prototype into a scalable Medical Device business, this framework will help you quickly identify the structural weakness slowing your launch.Because technically strong MedTech products rarely fail due to innovation.They fail when one of the four Ps breaks down.In the episode, we also walk through a quick self-audit so you can score your own launch and identify the single area that could unlock momentum in the next 90 days.Listen now and see where your go-to-market strategy might be exposed.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

You've done the hard part.You've secured regulatory approval. You've got two pilot sites running. You've even got distributor interest.But sales still aren't landing the way you expected.Now you've got 90 days. Limited runway. Board pressure building.And you can only prioritise one move.So what do you focus on?Do you activate the distributor and push for reach?Do you hire commercial support to build structure?Do you refine your messaging and economic case?Or do you double down somewhere else entirely?In this episode, we break down how clinician founders should prioritise when everything feels urgent — and why most MedTech businesses stall not because the product isn't strong, but because the commercial leverage isn't.You'll discover:Why regulatory approval is permission — not tractionThe difference between interest and evidence (and why only one protects your runway)The hidden risk of activating distributors too earlyWhy activity and progress are not the same thingThe decision framework that turns early traction into scalable momentumIf you're a clinician building a Medical Device and trying to simplify your go-to-market strategy, this episode will challenge how you think about traction, revenue and exporting.Because the difference between a working prototype and an international MedTech business isn't technical strength.It's commercial proof.Hit play and decide what you would prioritise — before you hear what we would do.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

How can take-back programs move beyond compliance to become a primary sales driver and scaling mechanism? In this episode, Daniel Unger, Environmental Sustainability Manager at Johnson & Johnson MedTech Germany, and Michael Leitl, Executive Director at Indeed Innovation, discuss how J&J's collection system solves a core operational problem for its customers: the waste management costs for hospitals. The conversation explores how their take-back program functions as a crucial sales and commercial lever. What you'll hear in this episode: • The function of the take-back program as a Unique Selling Proposition that secures sales and influences procurement. • The major regulatory barriers that block cross-border logistics and the strategic decisions that facilitate rapid market scaling and partner adoption. • The long-term business case and vision for industry-wide collaboration  This episode covers the practical trade-offs and operational shifts required to build a financially and environmentally viable take-back business model, despite regulatory and cost constraints. This is the second episode in the series Irresistible Circular Business, sponsored by Indeed Innovation, the global design and innovation firm pioneering the Circular Economy. The series showcases business practices that deliver irresistible commercial and circular results, with examples from different industries across different R-strategies.

In this episode, Duane Mancini sits down with Sarah to unpack her path from healthcare operator to investor and what founders should know when raising capital today. Sarah shares how her experience as the 10th employee at a digital health startup shaped her empathy for founders and the practical lens she brings to diligence, from ICP and pricing to building durable foundations early. The conversation pulls back the curtain on venture mechanics—how syndication and relationships really work, why fundraising is difficult when LPs demand DPI, and how fund structure, lifecycle, and co-investments can shape outcomes for startups. Sarah also explains Angelini Ventures' global strategy and thesis-driven focus in areas like cardiology and neurology, and why “exitability” requires forward-looking insight into strategic buyers, technology shifts, and long-term fit.Sarah Fox LinkedInAngelini Ventures WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Etienne Nichols sits down with regulatory expert Mike Drues, President of Vascular Sciences, to discuss the "culture shock" international medical device companies face when entering the U.S. market. They challenge the traditional assumption that a device should always launch outside the U.S. first, noting that shifting regulatory landscapes—especially in Europe—have made the U.S. a more attractive primary entry point for many.The conversation pivots to the technical and strategic nuances of "same device, different claims." Mike explains that if a device maintains the same design but utilizes different labeling or indications for use across borders, it is technically a different device in the eyes of regulators. This creates significant complexity for Quality Management Systems and post-market surveillance, particularly concerning reporting requirements for Class III (PMA) devices.Finally, the duo explores the "trap of equivalency," where companies mistakenly assume that a CE Mark or other international approval guarantees a smooth path through the FDA. From differing consensus standards to the strategic use of OUS (Outside US) clinical data, the episode provides a roadmap for global players to synchronize their regulatory and reimbursement strategies early in the development lifecycle.Key Timestamps01:45 - Challenging the assumption: Should you always launch outside the US first?04:12 - Defining the "International Company": Why every developer should think globally from day one.05:30 - The Labeling Trap: Why the same hardware with different claims is a different device.07:50 - Post-market surveillance nuances: Reporting OUS issues in a US PMA submission.11:15 - The "Sniff Test": Does a CE Mark actually help you with the FDA?12:40 - Leveraging Real-World Evidence (RWE) from international markets for US submissions.14:30 - The "Species Expansion" concept: Applying regulatory logic across different use cases.16:15 - Consensus Standards: Why the FDA might not recognize the "most current" version of a standard.20:00 - International Regulatory Strategy: Calculating the "lowest common denominator" for multi-country launches.25:20 - Using 100% OUS clinical data for FDA submissions: The three essential caveats.Quotes"If you're marketing the same device—same design, same materials—but the labeling and claims are different in the EU versus the US, then technically, it is not the same device." - Mike Drues"The regulatory logic is agnostic of the scenario. Whether it's a label expansion or a 'species expansion' from a dog to a human, the underlying logic remains the same." - Mike DruesTakeawaysSync Your Standards: Do not assume the FDA recognizes the same version of a standard (e.g., ISO 10993-1) as international bodies. Always verify via the CDRH Recognized Consensus Standards database.Design for the "Lowest Common Denominator": Identify your top 3–5 target markets early and pool their requirements to avoid redundant benchtop or clinical testing.Rethink Clinical Trials: While the FDA prefers domestic data, OUS data can be used if you can prove the patient population and user profiles (physicians/nurses) are representative of the US demographic.Anticipate "Off-Label" Pressure: If you market a device in Canada with claims not yet approved in the US, be prepared for US clinicians to find that information online and ask for "anticipated off-label use."ReferencesFDA Recognized Consensus Standards Database: Essential tool for verifying which versions of international standards the FDA currently accepts.Greenlight Guru QMS & EDC: Solutions for managing complex, multi-region quality systems and clinical data.Etienne Nichols' LinkedIn: Connect with the host for more MedTech insights.MedTech 101: Label ExpansionThink of Label Expansion like a smartphone software update. The hardware (the phone) stays the same, but the update allows the phone to do something it couldn't do before—like a new photography mode. In MedTech, if you have a stent approved for use in the leg (the "old label") and you want to use that same stent in the heart, you apply for a "label expansion." You aren't changing the device; you're just proving it's safe and effective for a new job.Sponsors: Greenlight GuruThis episode is brought to you by Greenlight Guru. Navigating international waters requires a robust foundation. Greenlight Guru's Quality Management Software (QMS) helps you maintain a "single source of truth" for your design history files and labeling, while their Electronic Data Capture (EDC) solution streamlines the collection of the clinical data you'll need to satisfy both the FDA and international regulators. Whether you are managing post-market surveillance for a PMA or running a multi-center global trial, Greenlight Guru has you covered.Feedback Call-to-ActionWe want to hear from you! Did this episode change your mind about your international launch strategy? Do you have a "culture shock" story from bringing a device to the US? Send your thoughts, reviews, or topic suggestions to podcast@greenlight.guru. We read every email and love providing personalized responses to our listeners.

Dr. Andreas Purde vom TÜV SÜD berichtet über den Einsatz der KI bei (s)einer Benannten Stelle. Im Gespräch mit Professor Johner schildert und bewertet er die Einsatzgebiete, gibt klare Handlungsempfehlungen für Hersteller und antizipiert übergeordnete Folgen dieser epochalen Disruption. Hersteller, die systematisch die KI für sich nutzen wollen, z.B. um das TD-Review zu automatisieren, wenden sich an info@johner-institut.de.

US equities were mostly higher in Monday trading, ending a bit off best levels. Big tech was mostly higher with NVDA the upside standout. Other outperformers included energy (crude), defense (Iran), software, banks (particularly regionals), PE, insurers, steel, rails, small-caps, and E&Cs. Laggards included airlines (fuel-price concerns), homebuilders (yields), semis, HDDs, managed care (ELV), pharma/biotech, MedTech, building products, travel/tourism, casual diners, apparel, housing-related retail, HPCs, beverages, and China tech. Treasuries came under meaningful pressure with yields up 9-10 bp at the short end of the curve. Dollar index was up 1.0%. Gold finished up 1.2%, though off best levels. Silver was down 4.8%. Bitcoin futures were up 5.8%. WTI crude settled up 6.3% and closed at its highest level since last June (though came off even higher overnight levels).SPI down 20 - Gold up slightly - Oil up on Strait closure news.—Marcus Today – Daily Market InsightsMarcus Today provides clear, practical commentary for self-directed investors – covering markets, portfolios, education, and decision-making without the noise.If you'd like to go further:Start a free 14-day trial of Marcus Today http://bit.ly/mt-trial-podcastJoin Marcus Today Use code MTPODCAST for 10% off http://bit.ly/mt-join-podcast-offerMT20 – Managed ETF Portfolio A professionally managed portfolio run by Marcus Padley and the team, using ASX-listed ETFs with active market timing. http://bit.ly/mt20-podcastPrinciples – How We Think About Investing A short video series on timing, behaviour, and decision-making. No stock tips. http://bit.ly/mt-principles-podcast—Disclaimer This podcast is general information only and does not consider your personal circumstances. It is not personal financial advice.

Clinicians saying they love your product doesn't mean hospitals will adopt it — and that gap is where clinician-led MedTech companies burn cash and lose momentum.In this episode, Hakeem is joined by Mark Tudor (20+ years in commercial leadership and advisory roles in medical devices) to break down why technically strong products stall after launch, how hospitals really decide what to buy, and how to build the commercial foundations that drive adoption, sales, and export readiness.Learn why commercial planning must run in parallel with product and regulatory workUnderstand what hospitals actually buy (risk management, simplicity, and economic clarity — not “better performance”)Get a practical lens for stakeholder mapping, validation beyond friendly opinions, and avoiding “inventor syndrome”Helping clinicians simplify their go-to-market strategy so they can stop guessing and turn their working prototypes into international MedTech businesses.Decision point scenario: You're advising a clinician founder with regulatory approval, two pilot sites, one keen-but-unproven distributor, limited runway, and 90 days before board pressure. You can only prioritise one focus — what do you choose and why? (Mark answers in the next episode.)If you tell me whether you want this episode to lean harder into adoption, hospital buying decisions, or export/distributor readiness, I'll pick the best 3 titles from above and tighten them even more.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

What if the next medical breakthrough could be undone—not by biology—but by a hacker? In this episode of Med Tech Gurus, we sit down with Christian Espinosa, CEO and Founder of Blue Goat Cyber, a leading medical device cybersecurity consultancy helping innovators protect patients by securing the technology behind modern healthcare. With over 30 years of experience spanning the U.S. Air Force, Department of Defense, and MedTech industry, Christian brings a rare perspective on precision, resilience, and empathy in cybersecurity After a personal health scare revealed vulnerabilities in his own implanted device, Christian turned mission into movement—founding Blue Goat Cyber to transform cybersecurity from a regulatory afterthought into a strategic advantage Christian shares how patient safety—not data protection—must be the heart of every cybersecurity strategy, why "bolting on" security late in development can derail innovation, and how emotional intelligence drives his leadership in high-stakes medtech environments. Whether you're a startup founder, RA/QA leader, or healthcare executive, this episode delivers powerful lessons on building trust, protecting patients, and creating a culture where security saves lives.

If you only had 14 months of runway left, no international sales team, and one shot at entering a new export market… would you choose the one that looks impressive or the one that actually gives you the highest probability of revenue?Most MedTech founders believe they're making rational expansion decisions but under pressure, choices get driven by ego, investor optics, or the allure of a “big” market. With limited runway, one wrong move can quietly burn capital and delay global traction.In the previous episode, you built your export business plan. Today, we pressure-test it. We walk through the exact scenario I posed and reveal which market actually wins when you apply disciplined strategy instead of ambition.In this episode, you'll see exactly how to eliminate two markets and confidently choose the one most likely to generate traction within 12 months.By listening, you'll:See how to apply your export business plan to eliminate the wrong markets with confidenceLearn how to balance ambition with execution probability inside a 14-month runwayUse a 180-day reality filter to validate traction before committing capital and credibilityPress play now to learn how to choose the export market that compounds your growth not the one that drains your runway.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

In this episode of Medsider Radio, we sat down with Rick Bente, co-founder and CEO of Indomo.Indomo's flagship device, ClearPen, is an investigational at-home corticosteroid injection designed to treat inflammatory acne.Rick has over 20 years of experience as an engineer and operator across medtech and pharma, with leadership roles at Medtronic, Insulet, and YourBio, focused on drug delivery and combination products. He is an inventor on more than 50 patents and has generated over $150 million in investments.In this conversation, Rick discusses how Indomo translated an in-office dermatology procedure into at-home care, why usability had to be engineered rather than trained, how the company decided when to exit stealth mode, and how proof-based milestones shaped its fundraising.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Rick Bente.

Subhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using practical tools and better problem statements.Timestamps00:00 Welcome and Guest Intro00:53 The Hairiest CAPA Case03:02 Human Error Root Cause04:58 Common CAPA Misconceptions06:11 Why Root Cause Fails12:16 When to Open CAPA17:26 CAPA Inputs and Triggers19:28 One Process or Two22:28 How to Investigate Properly25:09 Tools for Root Cause26:20 Problem Statement Basics27:48 Wrap Up and Where to FindGeorg Digel is the founder of Elevate CAPA and works with medical device quality leaders to make nonconformance and CAPA systems faster, stronger, and more audit-ready. He brings hands-on experience from early work on the production line through roles across consulting, startups, and larger organizations, with a focus on root cause and investigation quality. He also shares practical NC and CAPA breakdowns and training content with the MedTech community. LinkedIn: https://www.linkedin.com/in/georgdigel/Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Join us for a special 250th episode of The Project Medtech Podcast as host Duane Mancini and Director of Marketing and Engagement, Lindsey Dinneen, flip the script. Duane shares the journey from the podcast's inception during the height of COVID-19 to becoming a consulting, networking, and education resource for medtech startups. They delve into the core philosophy of creating value, the realities of team-building, and the exhilarating moments of client success. This episode is a candid reflection on the impact of the Project Medtech mission, the importance of a value-driven approach, and exciting future prospects. Lindsey Dinneen LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

This episode features Ivanny Franklin, Managing Partner at MedSight Capital, who brings a wealth of experience from her background in molecular biology and her decade-long tenure at NAMSA. The conversation centers on the shifting paradigms of medical device investment, specifically how the industry is moving away from service-based models toward a focus on clinical outcomes.Etienne and Ivanny explore the critical intersection of global regulatory bodies—such as the NMPA in China and the FDA in the US—and the necessity of a cohesive clinical evidence strategy. Ivanny emphasizes that for startups, understanding market-specific data requirements is not just a regulatory hurdle but a fundamental component of commercialization and investor conviction.The discussion also dives into the "patient empowerment" movement, fueled by the convergence of wearables, AI, and at-home monitoring. Ivanny shares her bullish outlook on technologies that give patients control over their data, while acknowledging the tension this creates for physicians and the ongoing need for rigorous regulatory oversight to ensure safety and effectiveness.Key Timestamps[03:15] Global Regulatory Strategy: Insights into the NMPA (formerly CFDA) and why China requires in-country clinical evidence.[07:42] Leveraging Data: How to run a single clinical trial to satisfy multiple global regulatory bodies.[10:18] The At-Home Monitoring Shift: The rise of wearables and OTC testing in the wake of COVID-19.[13:45] The "Data Gap": Addressing the friction between patient-gathered data and physician adoption.[18:22] Investment Non-Negotiables: Why revenue-generating companies and clear regulatory classifications are key for MedSight Capital.[23:10] Diligence and Deception: The importance of honesty regarding reimbursement codes and 510(k) vs. PMA paths.[27:45] SPV vs. Hedge Fund Models: A breakdown of how Special Purpose Vehicles allow family offices to be nimble in MedTech.Quotes"FDA and NMPA, for example, are quite strict in clinical evidence coming from in-country... as a startup, you really need to understand can we run a single trial with multiple global sites to achieve clearance cohesively." - Ivanny Franklin"I'm an advocate for [at-home monitoring]. I do think that's the future. However, there is concern around what types of information should patients be receiving and how are they going to act on that information?" - Ivanny FranklinTakeawaysRegulatory is the Roadmap: An investment is often "de-risked" based on the clarity of the regulatory path. If a founder cannot distinguish between a 510(k) and a PMA, it is a major red flag for investors.Harmonize Your Trials: To achieve "economies of scale" in clinical evidence, work with consultants to design trials that meet the stringent requirements of both the FDA and international bodies like the NMPA early on.

Dr. Amel Havkic, founder of EvoMed Consulting and a lung and critical care specialist, hospital clinical lead. Amel works at the intersection of bedside medicine and MedTech strategy, helping innovators build clinician-approved solutions that scale safely across real healthcare systems.In this episode, we unpack why “clinicians love it” is rarely enough to win adoption, and what hospital purchasing actually looks like when procurement, IT, finance, compliance and workflows all have a seat at the table. Amel breaks down why switching away from legacy tools is painful, how integrations can break care pathways, and why solutions that feel like a natural part of the hospital ecosystem win faster. He also shares a practical lens for building frictionless implementation by aligning with standards like HL7, FHIR and DICOM, while proving measurable value for patients and payers.We also go deep on decentralising healthcare. Amel explains how the Dutch model centralises high-end expertise while decentralising access through remote monitoring and home-based onboarding, and why this becomes a winning approach as staffing pressures rise. On AI, he makes the case for reframing it as augmented intelligence, not autonomy, and shows where decision support can raise the baseline of care by supporting clinicians in time-critical situations, as well as offloading admin burden that drains capacity.Finally, Amel shares the thinking behind the EMC StarMap framework, a navigation tool built from real-world patterns of what makes MedTech succeed or fail. His core message is simple: regulatory approval is a milestone, but clinical adoption is the real finish line.Timestamps[00:00:05] Clinician + Consultant Lens: Seeing Adoption and Safety Risks[00:01:22] Why “Physicians Love It” Does Not Mean Hospitals Will Buy[00:03:27] What Hospitals Consider Beyond Cost: Workflow, Integration and Training[00:05:09] Frictionless Implementation: Standards, EHR Fit and “Team Player” Products[00:06:24] Real Clinical Workflow: ICU Reality and Why UI Clicks Matter[00:07:31] Decentralising Care: Centralised Expertise With Home-Based Delivery[00:10:37] AI in Healthcare: Reframing as Augmented Intelligence[00:12:55] Staffing Shortages: Where AI Can Remove Waste and Scale Expertise[00:14:38] If You Could Change One Thing: Put the Patient Back at the Center[00:16:59] StarMap: Measuring What Drives Clinical AdoptionConnect with Rick - ⁠⁠⁠⁠https://www.linkedin.com/in/a-havkic/Learn more about Evomed Consulting - https://evomed-consulting.eu/Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠Subscribe to the Podcast

Dr. Stuart Grant, founder of Archetype Medtech, shares his journey designing and delivering breakthrough orthopedic and surgical innovations across the UK, US, and China. Stuart recounts how an early internship led him into medtech, what kept him there, and how building the ASPAC Innovation Center in China helped accelerate a total knee instrument system that dramatically reduced time to market. He explains the leap from corporate leader to entrepreneur: planning for years, earning a PhD in Medtech Product Innovation, and building a consultancy that helps startups and scale-ups turn early clinical unmet needs into market-ready, regulator-approved devices through a network of experts and an “expertise for equity” model.    Guest links: https://archetype-medtech.com/  Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 074 - Stuart Grant [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 Dr. Stuart Grant. Dr. Grant is a chartered engineer and the founder of Archetype Medtech, a consultancy and innovation studio helping medical device startups and scale ups transform early clinical, unmet needs into market ready products. With nearly 25 years of experience, Stuart has led global teams across the UK, US, China, and emerging markets delivering breakthrough innovations in hip, knee, shoulder, and trauma surgery. A highlight of his career was establishing the ASPAC Innovation Center in China, where he built R&D capability from the ground up and launched a pioneering total knee instrument system that dramatically reduced time to market. Passionate about advancing medical technology and mentoring future engineers, he bridges creativity, engineering, and regulation to accelerate safer, smarter medtech innovation worldwide. All right. Welcome to the show. It's so great to have you here today. Thanks for joining me. [00:01:57] Stuart Grant: It's lovely to be here, Lindsey. [00:01:58] Lindsey Dinneen: Yeah. Excellent. Well, I was wondering if you could start by sharing a little bit about yourself, your background, and what led you to medtech. [00:02:08] Stuart Grant: Yeah. So, I was actually, I'm obviously, as you can tell from my accent, I'm British, but I was born in Germany because my, my dad was in the military in the 1970s when I was born. So I was born actually in Berlin, which is quite interesting to be a place to be, grew up in. So I traveled around a lot here in the UK, in Germany with my dad getting posted everywhere. My mom's a nurse. So I was in medtech, not really knowing I was in medtech as a kid, but I, my family was, so yeah. And then obviously went to school, all the places I was at university. I went to university to do product design, and my goal was to be a product designer, a cool product designer, designing fancy products like Johnny Ive. And when I was looking for a job as a co-op, or an intern as you call them in the US, I was just really unsuccessful finding a job. I was doing a lot of interviews, getting turned down, sending my CV out a lot, and j happened just to advertise on the Board of University, and it said Johnson Orthopedics and no one really knew what that was in. And none of my fellow students at applied because they thought it would be designing baby bottles for putting talcum powder in and shampoo in and stuff like that. So they're like, "I'm not doing that job." So I desperately applied for it and luckily found out about all this medtech, and I've been here doing medtech for 25 years. So they gave me a job. I had to work hard to keep the job and get reemployed over and over again. But yeah, joining originally Johnson Orthopedics a long time ago is how I found out about medtech. I never knew when I was 18 that really it was a thing that existed. [00:03:47] Lindsey Dinneen: Yeah. So, okay. So you thought product design, and then when you got into medtech, what were some of the things that attracted you and that actually compelled you to stay and make a career out of it? [00:04:00] Stuart Grant: Ha. So I was a young guy with the student debts. What compelled me, I was getting paid to stay, but not to be too flippant about it, but, you know, when I was doing this engineering and design work in my early days in the CAD system, it was just so interesting. I was designing these products that were going into people or the instrumentation to make help the surgeon and going to these ORs and watching the surgeon do their job and trying to figure out how how I can make it better from their input was really interesting. I could apply it straight away, basically. In the early two thousands, there wasn't all these regulations and standards that slowed you down. So you could go and design an instrument, get it machined in the machine shop, get it clean, take it to the surgeon, he can use it, you know, probably be frowned upon 25 years later. But that's what we used to do and really adapt. And probably more interesting than going into product design and fast moving consumer goods where you're designing a, a kettle or a toaster or something, a plastic casing. It was actually much more interesting to do that. And I stayed because I spent four years here in Leeds, in the UK, was getting a bit bored and wanted to find something else to do, and then an opportunity came up in the US. So I moved over to Warsaw, Indiana, the orthopedics capital of the world, as you might know it. Worked there for, stayed there for seven years. Really enjoyed it.. People sort of bemoan Warsaw for being in the sticks in just a bunch of cornfields around it. But I enjoyed it. It's got, we had a good bunch of young friends there. I was in late twenties, early thirties at the time. There was Noah and Spikes. You'd go for a drink and some nice food. It was all right. I enjoyed my time and after that I was, after seven years, I was like, "Okay, what do I do next?" And I was looking around for jobs in medtech. Then another opportunity came up in and we were looking for people to go over and help set it up, train the staff on what MedTech product development was. And so I jumped to the chance and spent five years living in China, in Shanghai. After five years is your limit, so I had to come home. I couldn't stay. I wanted to stay, but they wouldn't allow me to. So, so I came back to the UK. And then started MDR for five years as leading the Joints MDR program, which was lots of fun, as you could probably tell, wasn't really R&D, was a lot of leadership and project management and dealing with a lot of people and a lot of problems on a day-to-day basis. And so, yeah, after that I I left J&J about three years ago and started my own product development agency. And we can talk about a little bit about that later. So that's where I am and where I got to. [00:06:50] Lindsey Dinneen: Excellent. Yeah, I definitely wanna talk about that as well. But going back a little bit-- and perhaps this is actually something that's occurred since you started your own company as well-- but are there any moments that really stand out to you along your journey of affirming that, "Hey, yeah, I actually am in the right place, in the right industry?" [00:07:12] Stuart Grant: That's a really hard one is sort of the, is the grass always greener somewhere else, type of question. Right? I guess compare, you shouldn't compare, but comparing to my friends at my university, my product design and what they've done and what I've done they've moved into the car industry a lot. Went to the car development and car industries always had its ups and downs and its problems. And you know, they've had some really cracking jobs working for McLaren and Ferrari and you know, but I think just the interesting things that medtech do that nobody really knows about is really what keeps me moving along and having conversations with people when they, you tell them like, "I used to design hips and knees and shoulders and things like that," and they're like, "Oh, my mother's got a hip and knee" and blah, blah, and you really talk about it. Actually, my mother does have a hip now and she's going in a couple months time to get the other hip done. I do know what brand she's got, so. [00:08:10] Lindsey Dinneen: See, that's really cool. Yeah. Okay. So, so, on your LinkedIn I noticed that you describe yourself as a fixer, a challenger, and a change maker, which I love. But I'd love to hear from you exactly what you mean by all those things as you have developed in your career, and now as you're doing, of course, your own consulting. [00:08:34] Stuart Grant: Yeah, so in Johnson and my colleagues are probably, I agree with this, I had a bit of a reputation of getting the more difficult projects. The, that's probably why I got MDR in the end 'cause I would always get the projects that had problems and I enjoyed that. I liked digging deep and solving the problem and wrangling everyone together and pushing everybody along to help. And that was actually one of the reasons why I moved to the US 'cause the original project I moved to was the project leader left and it was in a bit of a shambles. So I went over to sort of, sort of try and get it together and just ended up staying and working on multiple projects. So I like that. Really challenging, not just the engineering side. The engineering side is obviously really interesting, but the challenging project management and people management and process management in a big corporation, all of those things, people, product, process, all come together just to cause a big headache sometimes, you know, herding cats as say and going, trying to solve those problems as an engineer, always trying to solve these problems, right? So it's you're always trying to figure out how you can move forward. [00:09:52] Lindsey Dinneen: Yeah. Yeah, absolutely. So, okay, so that kind of brings us to the company. So what was it like going from employee to entrepreneur? Were you, did you feel ready and prepared for that leap? Or what has that transition and pathway been for you? [00:10:10] Stuart Grant: So I've, I was a long-term planner. I was planning for this for five years whilst I was working for Johnson. So I went and got, when I came back to the UK I started my PhD and I knew getting a PhD was a real way of building credibility immediately, right? Before you step in a room and have a conversation with you, if you've got a PhD in the subject you're about to talk about, people pay attention, hopefully. Right? So I did my, so I did my PhD in Medtech Product Innovation, what the process is. So I spent seven years part-time working for Johnson, getting my PhD, knowing that eventually in my mid forties, there'll be an inflection point, which usually isn't people in big corporations, right, that either stay to the end for until you're six, mid sixties. If you hit 50, usually stay for the next decade, right? Or you leave and do something else. And I was like, "Okay, 45, I'm gonna pull the bandaid, go in, get my PhD, set up my own company plan, get the plan to do it, get the savings," and so I was working on MDR and a new MDR was coming to an end, and then they'd have to find me a new project, which probably didn't exist. So I also knew that J&J would be like, "Ah, Stuart, you've been here for 23 years. There's not really anything of your level here." I'd be like, "Great, let's go." So this was all a, you always it's a big step, right? I have a family. I can't just sort of walk in, not come in the office anymore. So it was a big plan that my wife and I had for quite a number of years to execute. So it's still a struggle. I've been doing it for three years. It's still hard work, still building the company, finding clients, understanding what their pain points are and improving your picture and all those other things, still is still a challenge, but it's a new challenge. [00:12:06] Lindsey Dinneen: Yeah. [00:12:07] Stuart Grant: And as I say, as I said, when people worry about the risk, it's like I can easily just go and get a corporate job again as a move back and have all this new relevant experience. So it's a risk, but you have to balance that by the benefits. [00:12:21] Lindsey Dinneen: Yeah, calculated risk that you've planned for, so good for you. So, okay, so tell us a little bit about your company now and who you help and kind of where in the development or even ideation process that you can come in and really make a difference. [00:12:40] Stuart Grant: So, yeah, so Archetype MedTech is a product development, product innovation agency. And what we do, we usually work with startups or scale ups. Startup side, they'll have a proof of concept. They've already defined the unmet clinical need. They've sort of wrangled the technology and validated the actual technology does what it they're trying to make it do, but they just dunno how to make this a medical device product, right? They've they've got the technology, but they dunno how the product make a product that's sellable is releasable and it gets approved by FDA or here in the, i'll say here in the EU, I know I said in the UK, but MDR and I help them work out that product innovation strategy. So take them all through either they need to do the frontend innovation and understand their needs and the insights and the business case, and then the engineering requirements and specifications. The design and engineering part I help them with, and this is not just me. I have a network of experts, a sort of consortium of experts that come together and bring all these different specialties and then we help them with the testing, what testing they need to do, their risk management, usability, all that fun stuff. And then contact and help them work with the manufacturers. So contract manufacturers, then their regulatory approval. So really what we try to do is, 'cause we're bringing all this expertise as a group of people together, the entrepreneur, usually a salesman or surgeon at this point, who may be a university spin out, can spend a lot of time and money trying to find these experts, trying to find these resources, trying to understand the product development, the MedTech product development process, which is all written down in various books, but when you get down to the details, it gets really complicated. So what we do is help them go through that as fast and as efficiently as a possible, so they're not wasting capital fishing around for those experts. We already have that network of experts that we can bring in and take them through the process as quickly as possible. So that's what Archetype Medtech do for our clients. And has been successful. We have quite a number of clients, mostly in orthopedics and surgical 'cause that's my specialty in medtech. And what we also do, we just don't want to be a management consultancy firm. Well, we do if it's right, we share what we call expertise for equity. So we'll take some equity from the company, but we'll cut our day rates or maybe do it for free, do and help them go through the process as quickly as possible. That means we've got skin in the game, right? We're not just taking their money and going, "Great. This is great. Good luck on the commercialization. Not our problem." [00:15:29] Lindsey Dinneen: Right. [00:15:30] Stuart Grant: It is our problem. 'cause we want a return on our risk and our investment as well. So, yeah, that's what we try to do. And along with that we do a load of pro bono work with surgeons in the NHS who have had ideas. We help them just get their idea a bit further along so they can start looking for funding and investment, and I can share that with you later 'cause it's a really important program that the NHS run it. If there's any mentors out there that want to get involved I can point them in the right direction. [00:16:00] Lindsey Dinneen: Actually that's fantastic and I would love to hear a little bit more about the organization and yeah, how people can get involved and help and what do they all do. [00:16:10] Stuart Grant: Yeah. So the NHS have set up this called NHS Clinical Entrepreneurs Program. This is not my company. This is a completely separate organization. And what it is, clinicians, anybody who works in the NHS-- you know NHS is a 1.6 million people who are employed in the NHS. It's a massive company organization. They come up with clinical needs 'cause they're in the problem and they start working out how they solve it, even through medical device or health tech or an app or anything, right? And they can go into this, it is basically the equivalent of an accelerator program over about nine months. And we have mentors like myself who work with those clinicians to help them develop their idea. So I've got a couple of clinicians that I work with. One is developing a neurosurgical device for helping him cut out tumors in the brain. At the moment, they use two tools. They use a scalpel and a cordy, a bipolar cordy, and they're very basic tools. And what he has to do, he's under a microscope, and he has to swap these one by one, does this scalpel to cut the vascularization of the tumor. Then he has to seal it. And he has to pass the nurse has to pass in these tools and he can't see a, see the nurse passing him. So he is like, "Can I develop a tool that's in one a scalpel and a bipolar" so he doesn't have to keep changing the tool in his hand? And you can know by the cognitive load and changing that tool in the field that these surgeries take eight to 12 hours to cut out a tumor from the brain. So he's saying every, he swaps his tool about 200 times and it takes three seconds. So you can start doing the maths. [00:17:59] Lindsey Dinneen: Yeah. [00:18:01] Stuart Grant: Yeah. And then the other, so the other is a doctor, actually, the doc is a neonatal doctor and he's trying to develop a langoscope for neonatal babies. The langoscopes at the moment haven't really improved in the last 60 years. The Muller blades, they're called, and they're the stainless steel things that basically adult ones have been shrunk down to baby size and changed a little bit. They're not very good. And when you've got a newborn baby who's struggling to breathe, the mother's there obviously upset, so the father's probably there and you're trying to get langoscope down their throat, it's not a great, it is a very stressful situation, so he's kind of developed a, trying to develop a better one, right? Even the simple things. These things are made of stainless steel and you put a piece of metal on a baby's tongue. A newborn baby's obviously never experienced cold before, so they obviously start freaking out and squirming and you're trying to get this thing down her throat. It's crazy. So I'm helping him to see if he can come up with a better solution. He's got a, got an idea at the moment. He's developed some prototypes and we're gonna help him get it, see if we can get it a bit further along, and hopefully get to the market and solve this real small unmet clinical need, but really important one. [00:19:16] Lindsey Dinneen: Yeah. That's incredible to hear about both of those stories. That is really exciting. I love I-- this is partly why I love this industry so much is the innovation coming out of it is always amazing. People care so deeply about making a difference and improving patient outcomes, and then to hear about those kinds of innovations, ugh, that's awesome. [00:19:38] Stuart Grant: Yeah. Yeah. So if there's any experts out there listening who wanna get involved in the N-H-S-C-E-P program, I know Australia does one too. So yeah, get involved and share your knowledge freely to some clinicians who wanna, who have found an unmet clinical need and wanna solve it, but don't know how to. [00:19:56] Lindsey Dinneen: Yeah. Love it. That's fantastic. So it, it seems like, you know, from your career trajectory and your continuing education all this time that you are not someone who sits still very well. And I think you mentioned this a little bit in your LinkedIn profile, you like to keep moving. So one of the things that I noticed that you do, and I'd love if you share about it, is you do lectures on the history of innovation. Could you share a little bit about that? [00:20:24] Stuart Grant: Yeah. So. I I really, so I sort of got into reading about innovate. I love reading innovation books, right, nonfiction, innovation books, which I got in about 10 years ago. I read probably one of the first one was "The Idea Factory," which is about Bell Labs. And that was how Bell Labs has invented the telephone system and invented the transistor, won a load of Nobel Prizes. Shockley and Bardine were there. They just had this crazy Medici effect going on in Bell Labs. The Medici effect when you collect everybody together in a small area and they just start bouncing ideas and coming up with some hugely creative solutions. And that comes from Florence when DaVinci and Michelangelo and Raphael were all kicking about Florence and they were all paid for by the Medici family, so this why it's called the Medici. There's a book about it actually called "The Medici Effect." So I started reading all this and started just going backwards in history and getting to the industrial revolution and how the industrial revolution happened. And going further back to these group of men called the Lunar Men who were in Birmingham here in the UK who basically, it was James Watt, who invented the steam engine, Wedgewood, who was the pottery guy. It is Rasmus Darwin, who was Charles Darwin's great-grandfather. Yeah. All these people, they were called the Lunar Man 'cause they met every month in the full moon and discussed ideas and I think probably got drunk. [00:22:00] Lindsey Dinneen: I mean... [00:22:03] Stuart Grant: So yeah, I just love reading it and you know, I love, I'm now a little bit of a brag. As of last month, I'm a fellow of the Institute of Mechanical Engineers, and that is quite prestigious that was created by George Stevenson, and George Stevenson was the guy who created the steam train. [00:22:23] Lindsey Dinneen: Okay. [00:22:23] Stuart Grant: So we took Watts' idea of the steam engine, put it on wheels, figured out how to work. And I love, I just love steam trains and that's very dorky of me, I know. But I love, as a mechanical engineer, just seeing all the bits move and actually seeing them chug around all the noise and the steam. And here where I live in Yorkshire, in the UK, up the road in York is the National Railway Museum, which all the steam trains are at. Darlington is west. George Stevenson had his the original railway, the Darton Stock Railway. So George Stevenson created the Institute of Mechanical Engineers 'cause he was a mechanical engineer and his son created the rocket the first really fast once, Robert Stevenson. So learning all this and then figuring out how, then I went back-- I'm, so this is a long answer to your question-- then I went back went back and like understood why the industrial revolution happened and it was all about the banking system here, how people could get capital. And then the legal system grew up to protect that capital. And then agriculture improved in the UK so people weren't just stuck on farms, subsistence farming. There was enough food being produced to support the population so the population could go and work in factories and obviously James Watt creating the steam power created more power. So people in horses and everybody didn't have to work so hard. And then there was politics involved with the Hugonos, which were the Protestant, the French Protestants came over and they had all, they had the ability to make all these machine parts, 'cause that's our skill. Some of them came to the UK and the others went to Switzerland. And that's where the watch industry in Switzerland created. And then, you know, and then the scientific approach and the enlightenment came in the UK and it all just sort of bubbled up into the industrial revolution and then cascaded through the 19th century and the 20th century in. Here we are in the 21st century. So I just love knowing that whole pathway of somebody said "We need more legal," and then somebody said, "We need more banking" and as startups, right, investment is the king. So it all started 300 years ago with the UK banking system. [00:24:35] Lindsey Dinneen: Fascinating. Oh my goodness. That is so interesting. Yeah. Okay. One other interesting thing I caught from your LinkedIn profile is that you are a painter, but you are an exhibited painter, yes? [00:24:51] Stuart Grant: Yeah, I, well, I try. [00:24:54] Lindsey Dinneen: Okay. [00:24:54] Stuart Grant: So yeah. Obviously I did product design right? And I did product design because at school, I was good at art and I was good at maths and physics. So I was looking around going, "What discipline do those three things fit together?" And it looked like it was product design. I was like, "Okay, I'm half an engineer, half an artist, not good at either." So about 10 years ago I decided to pick up art again. It was, started to go to classes and doing landscapes and actually sadly the industrial decline of Britain's, so the old buildings of the industrial revolution and stuff like that. So I paint that stuff. [00:25:36] Lindsey Dinneen: Oh, that's so cool. [00:25:37] Stuart Grant: Put it into exhibitions and sometimes get rejected, sometimes get accepted, and try and sell a couple so I can at least call myself an artist. [00:25:45] Lindsey Dinneen: There you go. I love it. Yeah. Well, and that creativity and that artistry does, you know, impact your work in general, because I think sometimes having that outlet actually spurs some just creative solutions outside of the box that, you know, might have not come to you immediately if you were just like, you know, head down, really working hard on this project. And then if you could take a step back do you feel that it helps you in that way at all? [00:26:15] Stuart Grant: Yeah. Yeah, it definitely does. Not thinking about work is and just having it percolate in the background and not actually, 'cause it's a very slow deliberate process painting, right? So it does, you just lose hours and hours painting something, which is really nice. Obviously I've got a, I've got a 5-year-old at the moment running around, so I don't do that much painting. I usually just reserve it for when I go to my art class on Wednesday nights 'cause trying to focus is not a thing for a 5-year-old. [00:26:46] Lindsey Dinneen: Yeah, That's fair. Okay. Well, all right, so pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. It could be within your industry. It also could be your history of innovation, but what would you choose to teach? [00:27:08] Stuart Grant: So I thought about this when you gave that question because I was like, "Well, I've already talked about the history of innovation and that can pretty boring." So my other boring side, when you do a PhD, you always wish you did another subject. That's the thing is like, I wish I studied that instead. So my, as you go through the PhD, you learn other things and you're like, "Oh, that's really interesting." And you go down rabbit holes and you're like, "Oh, well stop. That's not my job. That's not what I'm trying to do here." One of the ones was how technology and society are interlinked. So technology drives society, and we've got lots of examples of that. Steam engines, trains, telephones, electricity, light bulb, broadband, and now AI. And so technology affects society. Then society drives technology. They're a virtuous circle. Some people say it not virtuous at all, but they, that's what happens. And understanding how those two things, society and culture and technology all interact is really interesting to me. And obviously not all technologies are adopted. Some are abandoned. Sometimes the better technology is abandoned for an inferior technology for lots and lots of reasons. There's examples. In the eighties, it was VHS and beta max, Blu-ray and HD DVDs. And what else? The keyboard, QWERTY keyboard is meant to be terrible. And that was designed 'cause of typewriters at the time. So the keys didn't smash together, but obviously that's not needed anymore. So those things interest me and I like to study that more, but I like to study it. Thinking about medtech and how our technology in medtech has affected society and using that lens 'cause we also always talk about clinical needs, right? What's your unmet clinical need? What are you trying to solve here? But there's also a social and cultural need that you are maybe not addressing directly, but you are addressing it. And how that drives medtech, and you know, it's we talk about like medtech equality and democratizing medtech and making it more accessible, but there's always the flip size of medtech inequalities. The big one probably at the moment is robotic surgery. Hugely expensive. Only available to very few. So how will that filter through society? How does that affect society? Will it just be for the rich developed countries to use robotic surgery? How will that affect it going forward the next 10, 20 years? Because it uses a capital equipment, right? They can't be diffused through society very easily. So that, that's one thing I would like to study and sort of talk about a little bit more, 'cause I think it's really interesting, especially now AI is being talked about and how digitizing healthcare is gonna happen over the next decade. Interesting if we're overclaiming that at the moment and a lot of startups are overclaiming, what they can really do and is it gonna, is there gonna be a backlash? Who knows? Let's see. In our, maybe in a decade, I'll present a course on it. [00:30:23] Lindsey Dinneen: There you go. Okay. And time will tell. Alright. I like it. Very cool. Okay. And how do you wish to be remembered after you leave this world? [00:30:34] Stuart Grant: Yeah. My PhD was like, I would probably like, I'd like to remember my PhD findings, but I'm like, no, who cares? [00:30:44] Lindsey Dinneen: Oh. [00:30:45] Stuart Grant: I, I've got, of course, my family, making an impact on my, what I've done here with my family, but, and I was really thinking about this question earlier. I was like, "Well, I hope this isn't the end. I hope I haven't peaked." [00:31:02] Lindsey Dinneen: Yes, that's fair, okay. [00:31:06] Stuart Grant: So maybe the next 20, 30 years, hopefully I'll be remembered for something, I hope. [00:31:12] Lindsey Dinneen: Okay. To be determined. I like that. I like that a lot all right. [00:31:18] Stuart Grant: It's a positive. [00:31:20] Lindsey Dinneen: Yeah. It's, and it's a forward way of thinking that, you know, you don't have to limit yourself to what you've already done or accomplished or seen. Who knows? The world is exciting. Yeah. I like it. Okay. [00:31:33] Stuart Grant: Well, yes, I'm yeah, definitely. [00:31:35] Lindsey Dinneen: Yeah, all. [00:31:36] Stuart Grant: One of the things we're doing-- I was looking at the Australian MedTech market and really just trying to figure out what's going on to see if there's anything I can do there. And talking to my wife, we decided, 'cause my daughter's not at school yet, we decided, "Let's go to Australia for an extended holiday." And it was gonna be like a month and we'll start working it all out, like we're just gonna go for three months, March, April and May this year, to sort of experience Australia, experience the MedTech market, go meet a lot of people, understand and just sort of grow and try to understand another way of people. I know Australia, they've got a similar culture to the UK and the US. But they do, they are far away. So they have a different take on things. And I wanna see what a difference is and see if I can get involved. So we're off to Australia on the MedTech market, so if anybody's listening, reach out to me on LinkedIn. It'll be we'll hopefully when I'm over there, we are in Brisbane. We can meet up. [00:32:32] Lindsey Dinneen: Excellent. Yeah, no, that's really exciting. And I actually have a few people I can connect you with as well, so, yeah. Okay. And then final question. What is one thing that makes you smile every time you see or think about it? [00:32:48] Stuart Grant: Oh. I think it's, it is back to my old answers, it's back to the steam trains. I just love watching the mechanism going around. My, me and my daughter who's exhibiting engineering characteristics, shall we say. Love, we love going to the railway museum and running around 'cause you can go and touch the trains, you can get on them, you can get your hands greasy if you want to, if you touch the wrong bit of it. She loves seeing them. And they're just, so when these engineers designed all these big bits of metal, they didn't have FEA or CAD or anything. They just sort of took a guess at the curves and how it should look. And some of these parts they designed are so beautiful when you start looking at them, it just makes me smile, like there was a person, a man, we'll have to say a man, right, 'cause it was 200 years ago... [00:33:44] Lindsey Dinneen: Right. [00:33:44] Stuart Grant: A engineer who decided he was gonna make it like that out of wood. And they were cast into iron and they just they were just sitting in their shop and just did what they thought was right. And most of the time it didn't break. [00:34:00] Lindsey Dinneen: Most of the time. There you go. Yeah. That's great. I love that. Well this has really been a fantastic conversation. I'm so grateful for you joining me today and sharing just some of your history and you know, what you're looking forward to next. I think it's, I think it's really incredible when you get to combine all the different things, like you said. You've got sort of that design and problem solving and you've got the engineering and you've got all these cool things that just make you an incredible help to the MedTech industry. And we're excited to be making a donation on your behalf, as a thank you for your time today, to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that charity to support. Thanks for joining and thanks for everything you're doing to change lives for a better world. [00:34:52] Stuart Grant: Yeah, thanks, Lindsey. It's been a real pleasure talking to you. [00:34:55] Lindsey Dinneen: Yeah, absolutely. Thank you again. [00:35:00] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Do you actually have an export strategy or just international ambition?In this episode, Hakeem breaks down the five-step commercial system that turns export from a hopeful expansion into a revenue-driven growth plan. Because export rarely fails due to market difficulty, it fails due to lack of structure.If you're a clinician-founder building a Medical Device business, this episode will show you how to stop drifting between markets and start executing with clarity.Learn the 5-step framework to build a structured, revenue-led export systemDiscover how to prioritise markets using probability and potential (not attention and hype)Understand how to engineer distributor behaviour and adoption triggersHelping clinicians simplify their go-to-market strategy so they can stop guessing and turn their working prototypes into international MedTech businesses.Hit play now to build an export plan that survives commercial pressure.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

In this episode of Disruption/Interruption, KJ sits down with Gennadi Seko, founder and CEO of Oxilight, who is revolutionizing wound care diagnostics by transforming smartphones into powerful medical imaging devices. Gennadi shares his personal journey from Bay Street finance to medical physics, driven by his grandmother's diabetic foot amputation. He discusses how his company is disrupting the medical device industry by making diagnostic technology portable, affordable, and accessible—moving critical wound care assessments from expensive hospital labs to patients' homes. This conversation explores the intersection of deep tech innovation, healthcare accessibility, and the power of multimodal diagnostics in saving lives and limbs. Four Key Takeaways [26:19] Multimodality is the Game Changer - Instead of multiple expensive single-purpose devices sitting on shelves, combining three technologies (multispectral imaging, fluorescence imaging, and thermal imaging) into one $200 smartphone attachment provides a 360-degree view of wound health and dramatically improves diagnostic specificity. [9:29] The Diabetes Crisis is Escalating - 27% of seniors (65+) in the United States have diabetes, and the disease is now affecting people as young as 25. Diabetic foot complications account for 80% of all non-traumatic amputations, making early detection critical. [21:44] Mobility Saves Lives and Money - Moving diagnostic technology to patients' homes solves the compliance problem and enables early intervention. Preventing one amputation saves healthcare systems 10x in costs while dramatically improving patient quality of life. [14:50] Physiological Imaging Beats Anatomical Measurement - Traditional wound measurement with rulers only tracks size over time, requiring multiple visits. Physiological imaging provides immediate prognostic information from a single snapshot, identifying whether a wound will heal normally or requires intervention. Quote of the Show (23:27): “I don't want to improve hospital healthcare. I want to improve healthcare in general." - Gennadi Seko Join our Anti-PR newsletter where we’re keeping a watchful and clever eye on PR trends, PR fails, and interesting news in tech so you don't have to. You're welcome. Want PR that actually matters? Get 30 minutes of expert advice in a fast-paced, zero-nonsense session from Karla Jo Helms, a veteran Crisis PR and Anti-PR Strategist who knows how to tell your story in the best possible light and get the exposure you need to disrupt your industry. Click here to book your call: https://info.jotopr.com/free-anti-pr-eval Ways to connect with Gennadi Seko: LinkedIn: https://www.linkedin.com/in/gennadisaiko/Company Website: https://oxilight.ca How to get more Disruption/Interruption: Amazon Music - https://music.amazon.com/podcasts/eccda84d-4d5b-4c52-ba54-7fd8af3cbe87/disruption-interruption Apple Podcast - https://podcasts.apple.com/us/podcast/disruption-interruption/id1581985755 Spotify - https://open.spotify.com/show/6yGSwcSp8J354awJkCmJlDSee omnystudio.com/listener for privacy information.

Industrial Talk is onsite at MD&M West and talking to Frederic Borne, VP at Resonetics about "Medtech manufacturing and microfabrication solutions". Fred Borne, a physics engineer and leader at Resonetics, discussed the company's expertise in medtech manufacturing, particularly in interventional cardiology, advanced diagnostics, minimally invasive surgeries, and bioelectronics. Resonetics specializes in microfabrication, including laser micromachining, and has expanded its capabilities through acquisitions, such as MemorySays for nitinol production. Borne highlighted the company's role in developing fiber optic sensors and implantable batteries, emphasizing their applications in neuromodulation and cardiac devices. He also touched on the potential of brain-computer interfaces and the future of neuromodulation technology. Outline MD&M West Event Introduction Industrial Talk, sponsored by MD&M West and the News and Brews team.Highlights the importance of MD&M West in delivering medtech automation, packaging, plastics, and design under one roof.Emphasizes the innovation, energy, and conversation at the event.Thanks the listeners for tuning in and celebrating the people driving industrial innovation. Welcome to Industrial Talk Podcast Scott reiterates the podcast's dedication to celebrating industry professionals worldwide.Encourages listeners to put MD&M West on their calendar for next year.Mentions the importance of meeting people like Fred Borne at the event. Introduction of Fred Borne Fred shares his background as a physics engineer specializing in fiber optics.Mentions his education at Laval University in Quebec City, one of the top photonics optics schools in North America.Discusses his career in fiber optics and the acquisition of memory says by Resonetics. Resonetics and Market Solutions Fred explains that Resonetics is a top 10 contract design manufacturing company for the medtech industry.Specializes in interventional cardiology, advanced diagnostics, minimally invasive surgeries, and bioelectronics.Highlights the company's expertise in microfabrication and the acquisition of memory says for the production of nitinol.Discusses the company's ability to provide micro components of nitinol, stainless steel, and other materials. Microfabrication and Medical Applications Scott and Fred discuss the concept of microfabrication and its applications in medical devices.Fred explains the use of laser micro machining for creating extremely small components.Mentions the company's ability to handle various materials and the importance of precision in their work.Discusses the challenges and innovations in the medical device manufacturing process. Fiber Optic Sensors and Medical Implantable Batteries Fred explains his role at Resonetics, managing the fiber optic sensors and medical implantable batteries divisions.Discusses the use of fiber optic sensors in blood pressure monitoring and other medical devices.Highlights the applications of fiber optic sensors in diagnostics and heart pumps.Explains the use of medical implantable batteries in cardiac applications and neuromodulation devices. Neuromodulation and Future Technologies Fred discusses the growing field of neuromodulation and its applications in medical devices.Explains the use of neuromodulation devices to treat conditions like urinary incontinence and asthma.Mentions the use of neuromodulation devices for sleep apnea...

You've come back from a medtech conference with five potential distributors. They all sounded good. Some were enthusiastic. One was keen. One asked hard questions.So who actually deserves your time in the next 30 days?In this episode, Hakeem walks through the real-world distributor scenario from the previous episode and breaks down why enthusiasm, speed, and confidence are often misleading signals. Instead, you'll learn how to identify execution capability before you commit time, energy, and commercial momentum.Learn how to distinguish between interest and true intent in distributor conversationsDiscover the early warning signs of misalignment that cost founders 6–12 monthsGet a practical 30-day framework to test real execution before signing anythingHelping clinicians simplify their go-to-market strategy so they can stop guessing and turn their working prototypes into international MedTech businesses.Hit play now to stop chasing noise — and start selecting distributors based on execution.Message me via DM on LinkedinTake the Export Readiness QuizThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

In this episode of Medsider Radio, we sat down with Shaun Bagai, CEO of RenovoRx. The company is developing targeted oncology therapies and is currently commercializing RenovoCath, which is focused on pancreatic cancer. Before joining RenovoRx in 2014, Shaun spent over a decade in the cardiovascular space, including leading global market development at HeartFlow and helping establish the European renal denervation market at Ardian, which Medtronic acquired for approximately $1 billion. He began his career in clinical research and device sales at TransVascular and Medtronic. In this interview, Shaun discusses how testing markets with minimal infrastructure reveals what leads to commercial success, why clinical trial enrollment benefits from sales discipline, and what founders should understand about going public when traditional capital isn't available.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Shaun Bagai.

In this episode, Duane Mancini sits down with Louise Yochee Klein to explore the fundamentals of fostering courage and innovation in the MedTech industry. Louise shares her journey from Canada to Philly, co-founding Courage Growth Partners, and emphasizes the importance of understanding and overcoming fear in business. The conversation highlights the critical need for aligning team objectives, adhering to detailed plans, and maintaining positive energy for personal and business success.Louise Yochee Klein LinkedInCourage Growth Partners Website“Courage to Champion” BookDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Etienne Nichols sits down with Edwin Lindsay, a seasoned MedTech operator and QARA leader, to discuss the systemic challenges facing the pediatric medical device market. Following a personal experience in a neonatal ward, Edwin highlights the stark reality that many pediatric treatments rely on adult devices adapted off-label, often leading to safety risks and clinical inefficiencies.The conversation delves into the "mismatch" of the pediatric market: these devices require the same rigorous regulatory and quality standards as adult products but offer significantly lower financial upside due to smaller patient populations. This creates a barrier for investors and manufacturers, leaving clinicians and nurses to "work miracles" with tools that aren't always fit for purpose.Despite these hurdles, Edwin shares an optimistic vision for the future. He discusses his initiative to build a collaborative network of experts—including regulatory consultants, testing houses, and grant writers—willing to provide pro-bono or at-cost support for pediatric startups. The goal is to create a streamlined regulatory roadmap that prioritizes patient safety without the prohibitive costs that currently stall innovation.Key Timestamps00:45 – The "Pediatric Gap": Why pediatric devices have adult-level requirements but lower ROI.03:12 – Personal Insight: Edwin's experience in the hospital and the "Guinness philosophy" of giving back.05:30 – The danger of adhesives and adapting adult materials for newborn skin.08:15 – Building a pediatric volunteer network: Testing houses and consultancies stepping up.11:40 – Regulatory Roadmaps: Navigating the age variability from premature infants to adolescents.14:50 – Off-label usage risks and the "mindset shift" required for manufacturers.18:25 – Micro-timestamp: The FDA's Humanitarian Device Exemption (HDE) and P-Sub programs.21:10 – Real-world clinical friction: Alarm fatigue and sensor sensitivity in NICU settings.25:40 – The hidden costs: Manufacturing complexity, multiple SKUs, and low-volume production.Quotes"We need to give clinicians the correct tools to work their miracles. They don't want to use products off-label; they want devices actually designed for the children they are saving." - Edwin Lindsay"If you have a pediatric project, there is a community behind you. We are breaking down the barriers of risk and cost because these babies deserve a chance." - Edwin LindsayTakeawaysRegulatory Flexibility: Utilize specific FDA pathways like the Humanitarian Device Exemption (HDE) and the Pediatric Submissions (P-Sub) program to gain early feedback and specialized guidance.Collaborative Cost-Sharing: Seek out "altruistic" partners; many testing houses and manufacturers are willing to work at-cost or under different financial models for pediatric-specific innovations.Design for Sensitivity: Pediatric innovation isn't just about miniaturizing adult tech—it requires solving unique issues like alarm fatigue and skin sensitivity (e.g., non-damaging adhesives).Workflow Integration: Engage the "head nurse" early in R&D to ensure the device fits into the high-stress environment of a pediatric ward without adding to clinical fatigue.ReferencesFDA HDE Program: A regulatory pathway for devices intended for diseases or conditions that affect small populations.Greenlight Guru: The industry-leading platform for QMS & EDC solutions, helping MedTech companies maintain...

In this episode of Investor Connect, Hall Martin speaks with Nader Fathi, CEO of Enlil Technology, about the innovative strides his company is making in the MedTech industry. Based in Campbell, California, Enlil Technology emerged from the Shifa Fame Innovation Hub. Their AI-powered platform brings compliance, product lifecycle, and regulatory traceability into one unified system for medical device and digital health companies. Designed to reduce complexity and enhance operational efficiency, Enlil's platform streamlines processes from concept to commercialization, empowering MedTech companies to navigate FDA and other regulatory pathways efficiently. Nader delves into the genesis of Enlil, explaining how it spun out from the internal needs of Shifa MedTech's portfolio companies. Initially developed to aid in internal compliance and process management, Enlil was commercialized in early 2022 and has rapidly gained traction, adding over 34 companies to its user base. The platform leverages a proprietary AI called Lilly, which aids in search functionalities, report generation, and even automates critical tasks such as FDA submissions, significantly accelerating product development timelines and reducing costs. The conversation also highlights Enlil's go-to-market strategy, including their expansion efforts on the global stage. Despite focusing primarily on the U.S. market in 2022, Enlil has garnered international interest from countries like India, Singapore, and Japan. Nader emphasizes the necessity for startups to implement robust systems early to avoid scalability issues and successfully navigate the complex regulatory environment. Reach out to at nader@enlil.com ________________________________________________________________________ For more episodes from Investor Connect, please visit the site at: http://investorconnect.org Check out our other podcasts here: https://investorconnect.org/ For Investors check out: https://tencapital.group/investor-landing/ For Startups check out: https://tencapital.group/company-landing/ For eGuides check out: https:/_/tencapital.group/education/ For upcoming Events, check out https://tencapital.group/events/ For Feedback please contact info@tencapital.group Please follow, share, and leave a review. Music courtesy of Bensound.

You've booked the flights, paid for the stand, and printed the brochures but do you actually have a distributor strategy?In this episode, Hakeem breaks down why conferences so often fail to deliver real export outcomes for clinician-led MedTech companies. He reveals the old way of approaching distributor meetings (scattergun, vague, hopeful) versus the new way (focused, qualified, strategic), and gives you the exact questions you must answer before attending your next event.Learn how to define your distributor strategy before you show up at a conferenceDiscover how serious MedTech teams use conferences to execute, not exploreGet a practical framework for turning random interactions into real pipeline progressHelping clinicians simplify their go-to-market strategy, so they can stop guessing, and turn their working prototypes into international MedTech businesses.Hit play now to stop hoping conferences will save you and start using them to close distributor gaps strategically.Message me via DM on LinkedinTake the Export Readiness QuizThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

SPONSORMedboard: https://www.medboard.com/EUROPE New Harmonization Standards -  Implementing Decision 2026/193: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600193Neurosurgical implantsEN ISO 14155:2020 on clinical investigationsEN ISO 18562 series on Biocompatibility for Breathing gas pathways Germany: Transition from DMIDS to EUDAMED - March 19, 2026:https://www.bfarm.de/DE/Aktuelles/Veranstaltungen/Termine/2026-03-19-registrierung-mp.html?nn=986770EUDAMED mandatory by May 28th, 2026  High-Level Conference on Medical Devices - March 16th, 2026 - Brussels:https://health.ec.europa.eu/events/high-level-conference-medical-devices-innovation-and-patient-safety-16-march-2026-brussels-belgium-2026-03-16_enThe conference will feature three breakout sessions focusing on:Enhanced predictability for conformity assessments: combining certainty with flexibilityClinical evidence at EU level to support the regulatory framework: the key role of Expert PanelsBreakthrough technologies for better care: turning guidance into realityTeam-NB: Letter on Cybersecurity - MDR and IVDR proposal draft version:https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdfSwitzerlandSwissmedic inspection on Importers -30 importers, 232 product samples, RESULT?:https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/smc-ueberprueft-ch-importeure-2025.pdf.download.pdf/md-schwerpunktaktion-importeure-2025_en.pdf Swissdamed Webinar - May 28th, 2026:https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/swissdamed-webinar.htmlUKUK to exempt Health Institution - Not a priority for nowhttps://www.gov.uk/government/publications/health-institution-exemption-for-general-medical-devicesTrainingTeam-NB: Training on MDR technical Documentation - For manufacturers on April 19th, 2026:https://www.team-nb.org/new-session-mdr-technical-documentation-training-for-manufacturers/EasyIFUCreate eIFU and Labels easily - Compliance to EU MDR/IVDR:Https://easyifu.comRoWNorth AmericaFDA: General Wellness devices - Guidance by the FDA:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devicesFDA: Cybersecurity in Medical Devices - QMS and Pre-market submission:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarketAPACMalaysia: Electronic Certificates issued by MDA - For FSC, Manufacturing Certificates and Export Certificateshttps://portal.mda.gov.my/index.php/announcement/1746-implementation-of-electronic-certificates-for-certificate-of-free-sale-manufacturing-certificate-and-export-certificate-issued-by-medical-device-authority-mda-malaysiaIndia: Import of IVD - Online Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4NDE%3DAfricaEgypt: Database for Product Registration -Online Electronic Service: https://eservicesdata.edaegypt.gov.eg/MedicalDevicesMiddle EastSaudi Arabia: SFDA inspection of QMS requirements - Process that would be followed:https://www.sfda.gov.sa/sites/default/files/2026-01/MDS-REQ10E.pdfPodcastEpisode 372 - How to remediate a Design History File (DHF): https://podcast.easymedicaldevice.com/372-2/Episode 373 - QMSR is coming: Why FDA inspections with change completely in 2026: https://podcast.easymedicaldevice.com/373-2/Episode 374 - Validation & Supplier Management in MedTech: https://podcast.easymedicaldevice.com/374-2/ServicesConsulting support: info@easymedicaldevice.comAuthorized Representative: EO@easymedicaldevice.comSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

In this episode, we explore why hyperconnected, orchestrated supply chains are critical, covering visibility, disruption management, talent, AI, collaboration, and how SAP and Deloitte help leaders modernize. Download the ⁠⁠⁠⁠⁠⁠episode transcript⁠⁠⁠⁠⁠ ===== This week we, together with Deloitte's Jagjeet Singh discuss the shift toward hyperconnected, orchestrated supply chains. They discuss today's top challenges - limited visibility, constant disruptions, and talent gaps - and how to break silos, align planning with execution, and use AI, control towers, and collaboration platforms to improve decisions. ===== Guest 1: Jagjeet Singh, US SAP Supply Chain Market Offering Leader, DeloitteJagjeet is a principal (equity partner) in the Deloitte US firm providing Consulting Services to clients in several industries including MedTech, Pharma, Consumer and Manufacturing. In his experience of more than 25 years, he has led global and complex enterprise transformation programs creating value for organizations through simplification, standardization, AI-enabled innovation and automation with SAP. He leads the US SAP Supply Chain market offering for the firm driving external relationships, internal talent enablement, and asset development for the supply chain domain. His end-to-end transformation expertise includes advising companies on implementing best business strategies to maximize revenue, minimize cost and improve margins. ⁠ Host 1: Richard Howells, SAP ⁠⁠Richard Howells⁠⁠ has been working in the Supply Chain Management and Manufacturing space for over 30 years. He is responsible for driving the thought leadership and awareness of SAP's ERP, Finance, and Supply Chain solutions and is an active writer, podcaster, and thought leader on the topics of supply chain, Industry 4.0, digitization, and sustainability. ===== Show Links: Deloitte: https://www.deloitte.comSupply Chain Management: ⁠⁠⁠⁠SAP Supply Chain Management⁠⁠⁠⁠ ⁠⁠⁠⁠SAP Insights: Supply Chain⁠⁠⁠⁠   Follow Us on Social Media  Richard Howells: LinkedIn, SAP Digital Supply Chain: LinkedIn   Please give us a like, share, and subscribe to stay up-to-date on future episodes!   =====  Chapters:   00:00:00: Intro00:01:25: Guest introduction00:02:19: Key 2026 challenges: visibility, disruptions, talent00:04:19:   What makes it difficult to react quickly and efficiently to disruptions? 00:09:06: Real impact of  internal silos and disconnected systems00:10:33: What leaders need: orchestration, risk mindset, and decision frameworks00:12:56: Using data and AI to automate and orchestrate end-to-end
00:16:36: Collaborating beyond the four walls and multi-tier visibility00:18:52:  Best practices & Quick wins: more agile and orchestrated supply chain00:22:00: How SAP and Deloitte partner on orchestration 00:24:32 What's the future of the supply chain?00:25:38: Outro

If you're a clinician building a MedTech business, the real question isn't just “Does my product work?” , it's “Can my business operate without me doing everything?”In this episode, Hakeem breaks down five key takeaways that will help you stop surviving loudly and start scaling smart. You'll learn how to fix the true bottlenecks in your business, free yourself from low-value admin work, and use virtual assistants not just to save money but to build an operating model that actually supports adoption, sales, and export.Learn how to break your business into 4 stages to identify where progress actually slows downDiscover the simple task audit that shows exactly what you should never be doing yourselfGet practical steps to set up lean workflows and delegate with confidence using VAsHelping clinicians simplify their go-to-market strategy, so they can stop guessing, and turn their working prototypes into international MedTech businesses.Hit play now to stop defaulting to hiring and start designing a business that scales without burning out.Message me for Virtual Assistant Recommendations via DM on LinkedinTake the Export Readiness QuizThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

In this episode of Medsider Radio, we sat down with Justin Zenanko, co-founder & CEO of SynerFuse.SynerFuse is developing the e-TLIF procedure, which combines spinal fusion with neuromodulation by placing leads directly at exposed nerves during surgery.A certified public accountant and serial entrepreneur, Justin previously served as CFO and senior vice president of corporate development at Recombinetics, where he led fundraising efforts totaling $68 million.In this interview, Justin discusses approaching FDA interactions as negotiations, validating procedures with off-the-shelf components before investing in custom devices, and structuring private raises through investment banks to preserve control while delaying institutional venture capital.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Justin Zenanko.

In this episode, Duane Mancini welcomes Aileen Helsel, Director of Innovation at Carilion Clinic, to discuss the exciting advancements in healthcare innovation in Roanoke, Virginia. Aileen shares her journey from academia to technology transfer and ultimately to her current role, emphasizing the transition from research to real-world application. They explore Carilion Clinic's unique position serving a diverse population, including rural communities, and how this drives impactful healthcare solutions. Aileen Helsel LinkedInCarilion Clinic InnovationDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Etienne Nichols sits down with Dr. Kristy Katzenmeyer-Pleuss, President and Founder of KP Medical Device Consulting, to unpack the complexities of the medical device life cycle. The conversation centers on how manufacturers often overlook critical phases of a product's journey, such as transportation, shelf life, and the decommissioning phase, focusing instead solely on the point of patient use.Dr. Katzenmeyer-Pleuss highlights the significance of the upcoming ISO 10993-1:2025 standard and its renewed emphasis on life cycle-based risk assessments. She explains how the transition between global markets—particularly between the EU and the US—can lead to unexpected FDA deficiencies when manufacturers rely on justifications that worked for notified bodies but do not meet more stringent FDA testing expectations for reusable or in situ curing devices.The discussion concludes with actionable advice on early design decisions, such as narrowing down material suppliers and reprocessing options to reduce testing burdens. They also explore the critical need for cross-functional communication and quality system integration to ensure that learnings from one project or regulatory interaction are captured and applied across a company's entire portfolio.Key Timestamps01:45 – Introduction of Dr. Kristy Katzenmeyer-Pleuss and the mission of KP Medical Device Consulting.04:12 – Defining the Medical Device Life Cycle: Concept to decommissioning and the "hidden" phases in between.05:30 – ISO 10993-1:2025: The impact of the new biological evaluation standard on risk-based approaches.09:15 – Global Regulatory Discrepancies: Why a device approved in Europe might face hurdles at the FDA regarding "worst-case" testing.13:40 – Reusable Devices & Reprocessing: Managing the "permutation explosion" of cleaning agents and sterilization cycles.17:22 – Early Design Decisions: How limiting options in the IFU can significantly decrease your regulatory testing burden.21:05 – In Situ Curing Devices: The unique testing challenges of materials that change states during use.25:10 – Quality System Integration: Strategies for linking regulatory deficiencies and materials across multiple projects.Quotes"The life cycle is really the concept of the medical device from when it's a concept all the way through to the end where you are disposing or decommissioning... shelf life and transport are steps that usually don't get a lot of focus, but they are very important." - Dr. Katzenmeyer-Pleuss"You might have one device where literally they don't ask these questions at all, and then other times they're very, very picky... the longer you go in that process, the harder it is to pivot without spending a lot of time and money." - Dr. Katzenmeyer-PleussTakeawaysFront-load Risk Assessments: Don't wait for FDA deficiencies to consider how shelf life or reprocessing affects device safety; integrate these into the biological evaluation plan from day one.

Rachel Knutton, founder and CEO of Alluvia Studio, shares how a 30-year healthcare journey—from hospital marketing and public relations (PR) at HCA Healthcare to medical device commercialization, product launches, and sales—shaped her belief that everything in MedTech ultimately comes down to storytelling. Rachel explains how her “been there” experience in hospitals, cases, and value analysis environments helps her create messaging that's compelling, compliant, and built to endure. She also opens up about becoming an “accidental entrepreneur,” discovering unexpected fulfillment in leading people, and building an agency culture grounded in authenticity, humor, and joy.    Guest links: www.alluviastudio.com | www.linkedin.com/rachelknutton | www.linkedin.com/alluviastudio  Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 073 - Rachel Knutton [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 Rachel Knutton. Rachel is founder and CEO of Alluvia Studio, a strategic medtech marketing agency based in Tennessee that supports some of the largest medtech brands in the world. Her experience in healthcare spans 30 years, including hospital marketing and PR for HCA Healthcare, as well as various roles in medical device commercialization, sales and marketing. Right. Well, welcome to the show, Rachel. It's so nice to you for having me. Of course. I would love if you would start off by just, uh, telling us a little bit about yourself, your background and what led you to medtech. [00:01:36] Rachel Knutton: Yeah, so I actually have a pretty interesting background and I bet I'll cover a little bit more of it as we go through the discussion, but currently I have an MedTech marketing agency. We have 16 employees. been in business technically since 2011, so 14 years. And just really focused on this industry. My path to getting into MedTech actually came through HCA Healthcare. I started working in hospital world back in 1996. And actually it was accidental. I, you know, I was pretty new outta school, a couple years outta school and I'd answered an ad and I dove right into a really exciting world. It's, you know, of course headquartered here in Nashville. Learned all about hospitals. I supported I think eight different hospitals at that time that were in region, the Nashville region, doing marketing and public relations, walked into my first open heart surgery case, helped feed employees at midnight, handled all kinds of interesting PR events because we're hearing Nashville, a lot of country music stars might get hospitalized. And I did that for about 10 years. And then I ended up moving into devices a recruiter, and it's when Kimberly Clark Healthcare had gone into the medical devices arena through the purchase of Ballard. so honestly I really didn't know much about it. But I had, you know, I did have my MBA, I had been working in healthcare, which sort of met the qualifications at that time. And I got a early start in marcom. Learned so much, got back into the hospital through that role from the other side of the coin and I had the chance to do product management, launch a product, and then I moved into sales and sold the product a whole bag and then got back into the hospital, you know, working through the whole value EIS ecosystem and working with physicians and being in cases. So it's been a very interesting path for sure. [00:03:37] Lindsey Dinneen: Yeah. Yeah. Thank you for sharing that. And so I'm curious about a lot of things, but I'll start with this. So what do you find are some of the differences and similarities between marketing and PR for the hospital side of things versus the device side of things? [00:03:55] Rachel Knutton: I mean, certainly I think PR piece is a much bigger aspect, the community aspect. Um. Every hospital is such an important part of the community. So there's a heavy weight there on that. And then of course, the regional aspect of it. So whereas in the device world, you know, all targeting like very large geographies, maybe either the US or outside of the US. And so in the hospital world, that tends to be more regionalized. I would say. That's like one of the big differences for sure. And then honestly, hospital world, it's more business to consumer. is a lot of physician related marketing as you're trying to drive preference to, you know, using your hospital for surgeries or trying to recruit physicians, but it's a lot more B2C in the, medtech world. world. [00:04:44] Lindsey Dinneen: Yeah. Yeah. So, okay, so you mentioned know, you responded to an an ad and that led you to was sort of like, well, a say, um, synergy, whatever you wanna say. that was was marketing and communications something that you always had a passion for or what led you to kind of pursue that? [00:05:05] Rachel Knutton: Yeah. Well actually I was a little bit more of a writer. would say telling stories is origin story. So I wanted to work in magazines. This is back when we still did print and newspapers and things like that. And always wanted to work in the magazine um, industry and I, and it started out writing for a business magazine. Started working for an agency for Ford, doing writing for a sales focused magazine. And so it just sort of morphed into that. I would say in the marketing and PR world, we were telling stories about patient stories, pitching those to newspapers. We were telling stories about physicians doing new types of procedures employees, you know, trying to promote them within the hospital world. That's also important to that ecosystem. And so I think that's kind of where that transition happened. And I would say that's still what I do today. So it's taken a lot of different forms and product management and working in Excel files and figuring out demand forecast isn't really about telling stories what it is, right? Everything is about telling a story in the end. [00:06:06] Lindsey Dinneen: Yeah. Yeah. So it sounds like you have the strategist side, the analytical side, and the creative side, which doesn't always, you know, align. And so tell us a little bit about your approach maybe to, say, there's a client of yours that is interested in bringing a product to market, and story tell to help them achieve their goals, and within compliance, because obviously that's a component. [00:06:35] Rachel Knutton: yeah, I mean, that's certainly in our industry, you know, figuring out are the guardrails. course in marketing, I always think, you know, we, know the rules. But we're also going to make sure that we're not self-limiting within those rules. So I let the regulatory people and the legal people push back. But I know what not to risk, right? So I think one of the things that's very helpful is having sold devices, having launched devices myself, having worked in the hospital system, I spent a lot of time on the floors watching how devices are used. I spent time in ICU collecting data. I think really having been part of that environment helps feed the story building process. It's almost like a natural part of what goes into building that story. So because of that experience, because I've walked those halls, I've been in those shoes, I kind of know what some of those limitations are and that just automatically configures into the storytelling process. I know what the product managers are up against when they're trying to launch a product. And theoretically, I should know the right questions to ask and how they got to the product that they have today and how they've, you know, customer feedback has fed into that. And then how do we take that and make sure that the messaging meets the same requirements? Like you have a, you know, you have design requirements, well, your messaging should have the same requirements and achieve a goal. So I think that's the analytical side is making sure, does the message achieve the goal? Are we being very committed to what's the business objective? How is the marketing objective supporting that? And then is the, how is the messaging fitting into that? I think that's a very important part of the discipline. We also are very familiar with, you know, claims matrices and the importance of having, you know, data and research to support claims. And so kind of knowing that framework, I think is helpful when you're building messaging because helps you think through like, okay, here's how the client is going to need to organize the messaging. Here's how they're gonna have to reuse the messaging. You know, how can we be very consistent in how we roll that out so they're not having to go back through and through their approval process every time. It's really important part of the discipline in the medtech world that we have to deal with that industries as well, of course, but it's certainly very important in ours. [00:09:01] Lindsey Dinneen: Yeah. Yeah. I, I really appreciate that insight and I think, you know, it's so interesting to see-- you're totally speaking my language about the consistency of, it's something I've, I've preached so much is you have to be consistent with your messaging and your branding. And it's not like everyone has to have the same cookie cutter language, but when you're aligned, that really translates. [00:09:25] Rachel Knutton: And it works. this is, you know, I, think this is a little bit of a, it's not a pet peeve, it's a passion project rather of mine is to get people to be consistent because I think what happens is internally, people get tired very quickly of their messaging or their creative. And I do think you need creative variability. We know with AI you need some of that, like that's gonna be important. But probably your customer, your target audience isn't tired of it and they might not have even seen it yet. And it's that very old, like nine times someone has to hear a message. And so my favorite clients are the ones that work very hard to get the messaging right in the first place. They go through the discipline process of doing it, knowing why we're doing it, getting full buy-in from an extended team, and then just keep with it, with some obviously refinement and tweaking when you get customer feedback. But you know, sadly, I'm sure we've all had this instance where it's like, "Oh, Dr. like this ad. We need a new ad campaign." And it's like, "Well, that's okay. I'm really glad he noticed it." You know? That's all right. That, might be okay. So, it, I think that the best companies are consistent and, you know, one of our clients is um, intuitive Surgical, and one of the things that we see is like, of course there's fresh creative. Of course there's brand evolution, but the overall message is very consistent and that's, it's fun to see how fruitful that consistency has been for them. [00:11:06] Lindsey Dinneen: Yeah, absolutely. Love that. So you worked for other companies and then you took a leap and became an entrepreneur and a leader of your business. What was that like? Were you prepared, so to speak? I'm not sure anyone's actually prepared to be an entrepreneur, but you know, how did that go for you? [00:11:24] Rachel Knutton: Yeah. was certainly an accidental entrepreneur. Some lifestyle choices, particularly marrying someone in the military at the time when we didn't do Zoom calls forced me to look at my career path and go, you know what? I'm not gonna climb the corporate career ladder moving. At that time, it wasn't a thing. And I thought, you know, I'm gonna need to do consulting in order to, you know, support family and then keep my business going. So I had lifestyle reasons that I became an entrepreneur and wasn't really sure how it was gonna work out, to be perfectly honest with you. And, you know, felt like a lot of people say, "Well, I'm consulting," which just means they don't have a job right now. And I, I know, you know, nothing bad about saying that, that can be very true, but for me, I was like, this is actually something I'm gonna need to do. And I did it as a as a solo consultant for several years, and then when I, we finally settled down and stopped moving said, "Well, it's time for me to get some help." The thing that was really interesting to me is I never really wanted to manage people even when I was in the corporate world, I just wanted to do great work. I wanted to, you know, I, felt like people slowed me down. You know, I just, I'm like, "Just let me go. I'm a star player." And it was really nothing that I was interested in at all. And now I have, you know, all these employees and I spend a very large portion of my time managing people. And the thing that has been so surprising is how gratifying that is, how fulfilling it is. One, to, you know, go beyond your comfort zone and find, I've learned so much. I've made a lot of mistakes. I've thought about other leaders that I've been lucky to work with in the past and follow what they do. And maybe some people who had some tendencies that I try not to do or I'll check myself and go, "Oh, am I, you know, am I doing that?" But I think managing team, developing people is the most exciting piece of it. always loved helping clients, so as I started out in this venture, I had a couple of offers to go work full time for those clients, but at that point I had been helping a few people and I was like, "Well, I can't say no to to the guy at this company, I can't say no to her because she needs my help. And if I have a full-time job, I'm not gonna be able to do that." So I really just wanted to help as many people as possible and I felt like owning my own business will allow me to do that. Now that I have a team, we are able to help so many more people and that is really gratifying. The other thing is. Where I am, my community is outside of Nashville and we're a micropolitan, which means we're kind of just far away for our commute to Nashville to be impractical. We have a local university here, and so one of the things I wanna do early on was work with the local university talent for people who wanna stay in this upper Cumberland area and have a great profession. And it's somewhat limited still. It is growing, but there's not a lot of big corporate jobs. So what I love to do is I bring that corporate experience into my small business in terms of professional development, evaluations, how we coach people. And then I try to get rid of all this stuff that I didn't really care about working in the corporate land, you know, and increased flexibility. Let's not have politics and things like that, and so that people can just grow and flourish. And so it is, I'm very passionate about it. I love helping clients and I love helping my team, and so it's really like the best of both worlds for me. [00:14:58] Lindsey Dinneen: Yeah. Excellent. So you have an interesting name for your company and I would love if you would share a little bit what led to that? [00:15:07] Rachel Knutton: Yeah. Thank you for asking about that, actually. So when I was the first name for my company was called Good Day Marketing, and when I realized I was really going to stay in medtech, at that time when I launched it, I was like, well, maybe I won't do medtech. Maybe I'll just do other marketing. I was like, "Well, medtech is where people want me. This is what I know. I have expertise. This is where I need to be." It made a lot of sense. I was like, okay, I need to rebrand, and I had gone through a period of testing. And so I'm a Christian and I'm familiar with scripture. You know, where you're like, you get refined in the fire, you're refined like silver and like gold. And I was like, "Okay, I need to have something about gold." And I discovered there's a type of gold called alluvial gold. And it's the kind of gold that you find in riverbeds. And soil in uh, riverbed is very, very rich because you have so much, you know, marine life and you know, plant life flowing over it, but then there's gold deposited there, and I was like, "That's we do, right?" Like when we're working with medtech companies, there's so much rich content, there's so much intelligence and innovation baked into what they're doing. Our job though, is to find the pieces of gold that will really help them tell that story and distill that, right? And like purify it. And it goes through a refining process to make sure the message is really clear. leave the extra behind. And then once we get it into a good spot, we shine it and we just like make the best part of that messaging, pull that forward. So it just made a lot of sense for the agency to be called Alluvia Studio. [00:16:42] Lindsey Dinneen: That's, that's perfect. That's such a great story too. I love the intentionality behind it and the thought process of it. Um. So yeah, so you have some core values with the company, and I'm assuming this also derives from yourself, and three me were the values of authenticity, joy, and humor. Can you speak to those and how you came up with that? [00:17:06] Rachel Knutton: Sure. Well, authenticity is, I, I just can't not be authentic. So one of the things you and I had talked about before is, I have a hard time talking about myself. just am naturally a little bit humble and I have to ask other people to tell me what I'm good at, right? And they're like, "Well, such a thought leader. You know what this industry so well, you're so great at telling this story." And I think just being able to say, "Hey, I don't know how to frame myself is something that's just innate to me." [00:17:40] Lindsey Dinneen: Hmm. [00:17:42] Rachel Knutton: I think I wanna work that way with people. It means that if you need to have a tough conversation with a client, you can have it. something doesn't feel right, I wanna pick up the phone and say, "Hey, this didn't feel right to me. I don't like how this conversation went. I don't like how this project's going 'cause I don't, I sense that you're dissatisfied, I wanna talk about it, I wanna understand it." from the client side, that's how authenticity works. And then with my team as well. So, for me, their personal lives are very important. I know we all bring our personal life into our work. If we say that we don't, we're lying. And so I ask that, you know, if someone's having a rough day or going through something as much as they're comfortable, at least just let us know so that other people aren't impacted by maybe, you know, a down day or, or take it personally because you know how we all do that, right? We read into it, go, "Oh, did I do something to upset them?" "No, I'm just, I'm not here today." And so I just think it's really important one, and I want people to feel comfortable with them, to feel themselves. And I think it helps with like diverse perspectives well. And then fun. So like humor, fun to me are lumped together and I just think when you have fun at work, you do your best work. And reminded of a couple of stories with our clients. So a lot of times we think in medtech, like everything's so serious. Everything, you know, and it is, it's a serious business. We're doing important things. There's nothing flip about what we do. However, we're all human beings. And we all need to have fun while we're working together. So we like our clients to have fun working with us, and I like sharing things that are fun about me. I had someone just this week who is from a very high level financial position in a big company comment that he loved that I had a roller skater in my LinkedIn profile. Now, I never would've thought that, right? I never thought that person would have really appreciated that, but that just goes to show that we all need to have fun. And even if we're working hard, we just like work hard, play hard, like let's just, and when we're stressed, let's just laugh it off and keep going. [00:19:58] Lindsey Dinneen: Yeah, and the joy aspect, just curious because that is, uh, the huge core value of mine, and so I would just love to hear your take on it. [00:20:06] Rachel Knutton: It is my purpose life. I have identified that. I got go through a leadership development class about 20 years ago with Kimberly Clark, and we identified our purpose, and bringing joy into other people's lives was mine and what that means for me-- it is funny, early on in my career I, didn't think I was gonna work in medtech. I thought it was more in like hospitality, tourism, something, you know, that's fun, you know, obvious fun. But what I really realized is that joy, um, joy comes from completing a project, feeling very good about what you do. We are often a very important part when people are presenting about themselves. So they do a lot of presentations. They're presenting to their boss or to a board. We wanna make them look good. We wanna make them feel very confident and relieving that stress is a joyful experience for them. So for me it's very personal. know, as much as we can, we want to help them feel that and experience that, and that comes down to how we communicate with them. You know, let's laugh a little bit. Our job is to look good. We, this business is not about Alluvia. This business is about you, and we are here to be a partner with you in that process. [00:21:29] Lindsey Dinneen: Yeah. Oh my goodness. Yes. That resonates very much. Um, yeah, so, you know, you've you've had an amazing career and you've worked, like you said, on the hospital side, you have had the device side and now your own business. Are there any moments along your journey that really stand out as affirming to you that "Yes, I'm in the right place at the right time?" [00:21:52] Rachel Knutton: Definitely. When I started my consulting business, I wasn't sure that I was going to be in medtech. So I had been in the hospital world for about 10 years and I had been in medtech for about 10 years, and I thought, "Well, am I supposed to be doing something different?" You know, that's that's a nice time to like, and my relationships and my reputation drew me back in. So it was almost one of those like. I'm meant to be here because I do have the experience that people value and I do have a way of thinking that's very helpful for people and it's a unique perspective that help. And so through my consulting business, I ended up launching two more products through very large publicly traded companies. And I thought, "Well, okay, obviously I'm supposed to be doing this." [00:22:48] Lindsey Dinneen: Yeah. Yeah. Excellent. Yes, and I think makes sense too because it's, it's also rather niche, you know? So, so having the skill sets really play a good part into-- it's, it's-- basically what I'm trying to get at is it's not an necessarily an easy path. So it's helpful to have had that background to, you know, you've got the communications and the marketing, but also the nitty gritty of, you know, I remember when I first joined, you know, somebody would say a sentence and it was like, half of it was acronyms and it was, it's just such a steep learning curve, [00:23:21] Rachel Knutton: Yeah. Mm-hmm. [00:23:21] Lindsey Dinneen: Yeah. [00:23:22] Rachel Knutton: It's, it really, and it still is. I mean, there's no way to know about every specialty in the world or all of the, you know, technical or clinical issues that our clients customers need to deal with. But being able to figure out which parts you need to understand and which you don't, I think is good. Like, what do you need to filter? do you really need to go in order to help them communicate their message is. Is helpful. And I think having that experience does provide that filter. And you know, it's funny because I was thinking about your podcast and I love what you're doing with it. Like I love that you're trying to shine a light on our community and it is about so many people trying to help people and save lives. And yes, I mean, I work so heavily with the investor community and startup community that sometimes it starts to feel a lot like it's about money. think money follows great ideas, right? Because there's an economic value to an innovation that's gonna save our healthcare system money, save lives and outcomes and, things like that. So I think it's all important. One of the things that I've thought about though is. Our unique position is we help people that help people save lives. So, you know, we are not on the frontline innovating new devices. We are not really on the frontline working with the patients. But if they don't tell their story, if there's not awareness of their solution, if it's not implemented correctly-- we think, I think a lot about that at the at the sales level, having been in, in those shoes-- if those things aren't done correctly, then the patient's not gonna be helped and making sure that we make that as easy as possible. people don't really wanna think about marketing, right? Like they wanna think about the clinical aspect. They wanna think about the innovation and the know, technical issues that they need to solve. And new product development, but the marketing piece is really important. All [00:25:28] Lindsey Dinneen: Yeah. Yeah, and it's just a fun, well, it's really a special role to play, I think. And I've always felt really grateful for that because, right, if somebody doesn't know that it exists, then they can't buy it. And so even though my role is small in comparison to maybe the scientists and the engineers and everything like that, I still get to play a part, and I think that's just delightful. Yeah. [00:25:55] Rachel Knutton: Yeah. Yeah, it really is. And it's really helpful too. So, you know, running an agency, I have a lot of creative people. Well, in our industry, we don't get to be quite as creative as other industries, right? Because as you mentioned, you know, we have regulatory reasons and it's a slightly more conservative industry for sure and should be. We're always looking to figure out how do we inject that joy? How do we inject that fun and authenticity into something that still feels as professional, as innovative, and as buttoned up the product is, as the quality process has been, as the clinical study has been, but still, how do we have a unique voice within that? And so that's really helpful with my creative team too, to say, right, like our guy boundaries are a little bit different, but what we're doing is so much more important than selling a consumer product. Maybe like a luxury item or jewelry or marketing a, I don't know, something sexier, you know, like a vacation. I don't know. To me that'd be like the ultimate, send me around the world and have me market a travel. That'd be very good. [00:27:05] Lindsey Dinneen: You go. [00:27:06] Rachel Knutton: But at the end of the day, like it, it's making a really big impact and I think that's really helpful to help people in that. We're always looking for ways to try to get that experience. Like I'm always looking for ways to get experience from my team to be able to do that. I think that's probably my next big goal is like, how do I get them into the hospital? How do I expose them to what the day-to-day life is of a sales rep? You know? think that's really important in our industry to have some sort of exposure to feed on the streets in the hospital setting, how it works, what the sales rep has to go through to get the product implemented, how long it takes for it to actually succeed, right? Because it's not just one sale, it is a long process, a long journey, and an ongoing journey to make sure that that it sticks and that people understand how to use it. And I think having that like empathy or at least point of view can be really helpful to anyone marketing in our industry. [00:28:10] Lindsey Dinneen: Yeah. Yeah. I I really like that. That's, that would be a really helpful thing for anyone, especially if they're newer to the industry, to have that sort of boots on the ground, this is what it's actually like, kind of experience. [00:28:24] Rachel Knutton: Yeah. [00:28:25] Lindsey Dinneen: So, okay, so pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be within your industry, doesn't have to be, what would you choose to teach? [00:28:39] Rachel Knutton: I think it would really be about this, like how to find joy. Like how to find joy in everything. You know, how do you cultivate a joyful outlook on life so that even when you're sitting in traffic or doing something you don't really love to do, how can you integrate that? You know, I think that one thing that's really important to me is my faith. So my values, I'm, Christian, and I really believe the only true joy that we have is when we have a relationship with Jesus Christ. And so that's not part of my business, that's part of my life mantra, but like if I could help people get to the real joy, that would be like the ultimate goal, right? If I can't get them there, if I can get them to, you know, experience joy in the day to day or experience joy in their trials, think that would be something worth, I'd do it for free. I don't even need a million dollars. a million dollars would be great. [00:29:34] Lindsey Dinneen: Yeah. Right. Excellent. Excellent. Yes. Okay. And then how do you wish to be remembered after you leave this world? [00:29:43] Rachel Knutton: I think it's that point I just made there, right, is that, maybe, I mean, it's so cliche, but I left things better than I found them. I left people better than I found them. And, you know, and ultimately, you know, if I lead them to Jesus, that is like the ultimate goal for me as a Christian. So for me, that would be a metric that if it was, you know, one person, if it was 1 million people, it doesn't matter. That's the goal. [00:30:13] Lindsey Dinneen: Yeah. Yeah. And then final question, what is one thing that makes you smile every time you see or think about it? [00:30:22] Rachel Knutton: It is my business. It really is. I mean, okay, obviously my family and my pets and things like that, but I really love coming to the office. This, we have our own building. Every time I come here, my spirits are lifted. I love seeing my team members and I love working with the clients and just hearing from them and building those relationships. Everything about this is so deeply personal to me that the money piece of it is like the very last thing that I think about. It's the last way that I run my business. It's the last way that I measure success. It's the last way I hire. It is really just follows that, that positive feeling of making an impact and having fun. I, it's just, I know it sounds crazy. We keep saying that, but I think it's really fun to do what I do. I'm [00:31:18] Lindsey Dinneen: Yeah. I love that answer. That's that's wonderful. And it, I think that's one of those affirmations that yeah, you are in the right place at the right time because you're having fun and you're joyful. I love that. [00:31:30] Rachel Knutton: Sometimes it's temping to work from home, and then I work from home, and then I come to the office. I'm like, "Why did I wanna work from home? It's so much lighter here. We have a disco ball here and I don't have a disco ball at home." [00:31:40] Lindsey Dinneen: Oh. Brilliant. I love it. Oh my goodness. Well, this has been such a fantastic conversation, Rachel. I so appreciate you and your time today, and I love the way that you bring joy and fun into medtech and into the lives of the people that you touch. And we're excited to be making a donation on your behalf, as a thank you for your time today, to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that charity to support. Again, thank you so much for everything you're doing to change lives for a better world. [00:32:18] Rachel Knutton: Thank you. This is a great interview, so I appreciate it. You made it easy. [00:32:23] Lindsey Dinneen: So glad to hear that. Alright, well thank you so much again, and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time. [00:32:40] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

If you think scaling means hiring fast and locally, this episode will make you think again.Hakeem is joined by Bob Lachance, founder of REVA Global Med, to explore how virtual assistants and lean operational systems can help clinician-founders grow sustainably — without burning out or bloating the business. This episode isn't about outsourcing for the sake of cost-cutting. It's about fixing bottlenecks, building reliable processes, and designing a business that scales without you doing everything.Learn how to separate clinical work from clerical work — and why it's essential to scalingDiscover the 4-phase framework for identifying operational bottlenecks in your businessGet real-world strategies for building a virtual team that increases margin and capacityHelping clinicians simplify their go-to-market strategy, so they can stop guessing, and turn their working prototypes into international MedTech businesses.Hit play now to stop surviving loudly — and start scaling intentionally.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon Foeger, Founder of SIFO MEDICAL, shares real-world experience and practical guidance on validation, risk management, and supplier development.Key topics discussed include:Test Method Validation: definition, regulatory expectations, and when it is requiredFDA warning letters and the risks of non-compliant validation approachesCommon pitfalls and best practices for Test Method ValidationProcess Validation and Packaging ValidationThe role of statistics in MedTech, including sample size justificationRisk management linked to validation activitiesSupplier management, from sourcing components to audits and long-term supplier developmentSimon also explains how SIFO MEDICAL supports medical device manufacturers through consulting and online training focused on:Process validation and equipment qualificationTest Method Validation trainingISO 13485 and 21 CFR 820.30 complianceSupply chain development, including injection molding and cleanroom manufacturing environmentsThis episode is essential for quality managers, regulatory professionals, validation engineers, and MedTech manufacturers looking to strengthen compliance, avoid warning letters, and build robust validation strategies.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkSimon Foeger Linkedin: https://www.linkedin.com/in/simonfoeger/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

You've got solid clinical evidence. People say they love your product. But adoption still isn't happening. Why?In this episode, Hakeem breaks down key insights from his conversation with Julian Moore on why so many clinically sound MedTech products struggle to gain traction in real-world settings. If you're a clinician-founder trying to cross the gap between “good product” and “actual uptake,” this episode is your blueprint.Discover why adoption is a system wide behaviour change, not just an individual “yes”Learn how to identify hidden blockers - including overlooked people in the workflowGet tactical: match your strategy to the real barrier, not the one you assumedHelping clinicians simplify their go-to-market strategy, so they can stop guessing, and turn their working prototypes into international MedTech businesses.Hit play now to find out how to move from barriers to behaviour change and finally see your evidence turn into adoption.Message me via DM on LinkedinTake the simple adoption risk quizThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

In this episode, Duane Mancini sits down with Stan Glezer, Managing Director at Outcome Capital, to dive deep into the roles of strategic advisory and investment banking in driving innovation within the life sciences sector. Stan elaborates on his multifaceted career, from his beginnings as a physician to leading roles in biopharma and MedTech companies. He discusses the importance of aligning a company's value proposition with market dynamics, the art and science behind M&A deals, and why realistic, transparent goals can unlock transactional success. Stan Glezer LinkedInOutcome Capital WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Etienne Nichols sits down with Thor Rollins, a leader at Nelson Labs and the convener of the committee revising ISO 10993-1. The conversation centers on the newest 2025 version of the standard, which represents a massive philosophical shift from a "checkbox" testing mentality to a rigorous, risk-based approach aligned with ISO 14971.Rollins explains that modern medical devices are far more complex than the metal and hard plastics of the past. With the rise of degradable materials, coatings, and nanomaterials, traditional animal testing often fails to provide the best science. The new standard introduces critical concepts such as biological risk estimation, foreseeable misuse, and a comprehensive lifecycle evaluation that looks beyond "time zero" safety.The duo also discusses the practical implications for manufacturers, including the controversial requirement to evaluate biocompatibility at the end of a product's lifecycle—a particular challenge for reprocessed devices. Rollins provides insider knowledge on the US's stance on the revision, the timeline for FDA recognition, and how companies can leverage biological equivalence to potentially reduce their testing burden.Key Timestamps01:45 – The shift from "checkboxing" to a risk-based approach.03:10 – The rapid timeline of the 2025 revision and the influence of ISO 14971.04:22 – Lifecycle Evaluation: Assessing safety beyond the "brand new" state.06:50 – Chronic toxicity vs. acute reactions: Why front-end evaluation matters.08:15 – Foreseeable Misuse: When doctors use scopes outside their intended anatomy.12:10 – The concept of Bioequivalence: Using existing data to justify reduced testing.13:45 – Breakthrough: The removal of material-mediated pyrogenicity testing for known materials.15:30 – Why the US voted "No" on the current draft: A call for better guidance.18:50 – Notified Bodies and MDR: The 2025 version as "State of the Art."21:15 – Practical chemistry tests for aging polymers (DSC, GPC, FTIR).25:40 – Advice for small vs. large companies on building material databases.Quotes"The testing that we developed back in the 50s and 60s actually doesn't really work the best with some of these complex devices... we've been moving the standard away from what we call checkboxing." - Thor Rollins"I only say that expensive tests always impact innovation. We don't want to over-test, but we want to do the right tests." - Thor RollinsTakeawaysLifecycle is the New Frontier: You must now evaluate biocompatibility throughout the product's life, especially for reprocessed devices that

In this episode, we sit down with Becca Meehan, a certified coach and advocate for gender equality in the MedTech industry. Becca shares her journey from corporate marketing and sales to founding her coaching practice focused on empowering women in medtech. Together, they explore authentic leadership, self-care, navigating career transitions, and why investing in yourself isn't selfish- it's essential. EPISODE CHAPTERS 00:00 – Welcome & Introduction 03:17 – "Go-Get-Hers" Origin Story 06:38 – The Importance of Sales Experience in Marketing 08:31 – Defining Moments in Leadership 09:55 – Early Career Lessons in Communication and Mindset 15:53 – Building Resilience Through Challenges 18:26 – The Ripple Effect of Caring Leadership 21:21 – Self-Care: The Key to Caring for Others 22:24 – Navigating Redundancy: It's Not Personal 28:39 – Embracing Change: The Path to Coaching 32:45 – The Transition to Coaching: A New Chapter 36:03 – Empowering Women in MedTech 39:55 – Women in MedTech Navigating Noise in the Modern Workplace 41:46 – Past Mentor's Advice: The Importance of Running to the Fire 44:10 – Uncovering Personal Narratives and Mindset - Face vs Fiction 47:58 – The Power of Reflection and Self-Discovery 50:16 – Investing in Personal Growth and Community 53:56 – Morning Rituals and Getting Your Ducks in a Row 55:31 – Mentoring with Care and Presence 59:45 – CTA - Becca's Offer SPECIAL OFFER FOR MEDTECH MENTOR LISTENERS This February, Becca is offering: 30-minute complimentary connect call for all Medtech Mentor listeners 25% off all coaching packages for the month of February '26 CONNECT WITH BECCA Website LinkedIn: Becca Meehan

This episode explores the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and the foundational elements required for medical device compliance. Host Etienne Nichols and guest Mike Drues discuss the philosophy of building a usable system rather than a "museum of SOPs," emphasizing that the standard list of QMS sections should be viewed as a starting point rather than an exhaustive checklist.The conversation examines the critical differences between 510(k), De Novo, and PMA pathways regarding manufacturing requirements. While a 510(k) submission may not strictly require detailed manufacturing information at the time of filing, Mike explains why companies must remain audit-ready from the moment they register their establishment with the FDA. The discussion clarifies the timing of registration and the "radar" companies enter once they become commercially active.Finally, the dialogue focuses on a "triage" approach for resource-constrained startups. By prioritizing Design Controls and Risk Management during early development, teams can remain compliant and ethical without over-investing in post-market systems, such as complaint handling, before they have a product on the market. Mike warns against the dangers of "copy-and-paste" quality systems, urging manufacturers to use professional judgment to tailor their processes to their specific technology.Key Timestamps00:00 - Introduction to QMS requirements and guest Mike Drues.03:45 - The core sections of a QMS according to the Quality System Regulation.05:12 - Why the QSR list is a starting point, not a stopping point.08:20 - Regulatory vs. Ethical vs. Economical: The three legs of the medical device stool.10:30 - Do you need a full QMS for 510(k) vs. PMA submissions?13:15 - Understanding the timing and strategy for FDA Establishment Registration.15:40 - The Triage Approach: Which QMS sections matter most during early development?19:00 - The dangers of boilerplate SOPs and non-specific quality manuals.Quotes"This is a starting point. This is not a stopping point... Use your own good judgment." — Mike Drues"The goal is not really to build a museum of SOPs; the goal is a quality management system that teams will actually use." — Etienne NicholsTakeawaysPrioritize the Big Four: During the development phase, focus your limited resources on Design Controls, Risk Management, Document Control, and Supplier Quality Management.Understand Pathway Nuances: While 510(k) submissions don't require manufacturing details, you must be fully compliant and ready for inspection once your establishment is registered and the product is launched.Avoid Boilerplate SOPs: Quality systems must be specific to your organization. Including irrelevant device types or procedures in...

(02:20) Pills that communicate from the stomach could improve medication adherence(07:13) Innovative Solutions for Tracking Medication(10:46) The Technology Behind the Smart Pill(13:42) Conclusion and Future Implications This episode was brought to you by Mouser, our go-to source for electronics parts for any hobby or prototype. Click HERE to learn more about making healthcare smarter with electronics. Become a founding reader of our newsletter: http://read.thenextbyte.com/ As always, you can find these and other interesting & impactful engineering articles on Wevolver.com.

In this episode of Medsider Radio, we sat down with Marina Pavlovic Rivas, co-founder & CEO of Eli Health.The company is focused on making hormone data accessible in real time through its saliva-based testing system that delivers results through a mobile app. A data scientist by training, Marina previously founded Gradiant AI, a machine learning company that was acquired in 2019. In this interview, Marina discusses how to evaluate form factor options without locking into a design too early, what beta testing reveals that years of lab work can't, and how existing consumer spending patterns influence positioning and pricing strategies. She also shares how regulatory considerations shaped product decisions from the outset and why building in-house proved more efficient than outsourcing when external partners said the company's goals were impossible.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Marina Pavlovic Rivas.

In this episode, Duane Mancini sits down with Katie Brinkman to discuss the nuances of biocompatibility, the critical role of biological evaluation plans, and the evolving regulatory landscape, including the importance of risk assessment. Katie also shares her experience with biocompatibility evaluation during significant regulatory changes such as EU MDR remediation and the 10993 standard updates.Katie Brinkman LinkedInHohenstein WebsiteHohenstein Group LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, host Etienne Nichols sits down with Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD). The conversation previews their upcoming session at MD&M West, focusing on the critical intersection of generative AI (GenAI) and quality assurance. While many AI applications exist in MedTech, GenAI presents unique challenges because it creates new data—text, code, or images—rather than simply classifying existing information.Ashkon breaks down the specific failure modes unique to generative models, most notably "hallucinations." He explains how these outputs can appear legitimate while being factually incorrect, and explores the cascading levels of risk this poses. The discussion moves from simple credibility issues to severe safety concerns when AI-generated data is used in critical clinical decision-making without proper guardrails.The episode concludes with a forward-looking perspective on how validation is shifting. Ashkon argues that because GenAI behavior is statistical rather than deterministic, traditional pre-market validation is no longer sufficient. Instead, a robust quality framework must include continuous post-market surveillance and real-time independent monitoring to ensure device safety and effectiveness over time.Key Timestamps01:45 - Introduction to MD&M West and the "AI Guy for SaMD," Ashkon Rasooli.04:12 - Defining Generative AI: How it differs from traditional machine learning and image recognition.06:30 - Hallucinations: Exploring failure modes where AI creates plausible but false data.08:50 - The Autonomy Scale: Applying standard 34971 to determine the level of human supervision required.12:15 - Regulatory Gaps: Why no generative AI medical devices have been cleared by the FDA yet.15:40 - Safety by Design: Using "independent verification agents" to monitor AI outputs in real-time.19:00 - The Shift to Post-Market Validation: Why 90% validation at launch requires 10% continuous monitoring.22:15 - Comparing AI to Laboratory Developed Tests (LDTs) and the role of the expert user.Quotes"Hallucinations are just a very familiar form of failure modes... where the product creates sample data that doesn't actually align with reality." - Ashkon Rasooli"Your validation plan isn't just going to be a number of activities you do that gate release to market; it is actually going to be those plus a number of activities you do after market release." - Ashkon RasooliTakeawaysRight-Size Autonomy: Match the AI's level of independence to the risk of the application. High-risk diagnostic tools should have lower autonomy (Level 1-2), while administrative tools can operate more freely.Implement Redundancy: Use a "two is one" approach by employing an independent AI verification agent to check the primary model's output against safety guidelines before it reaches the user.

Are you wondering why your clinically sound medical device still isn't being adopted—even after pilots, approvals, and glowing data?If you're a clinician founder ready to take your MedTech prototype to market, this episode breaks down the overlooked reason most devices fail to gain traction. It's not the product—it's your go-to-market execution. Learn how behavior change, system fit, and implementation science play a bigger role than your evidence ever will.Discover the #1 mistake clinical founders make after running pilotsLearn how to identify all the “whos” involved in adoption—and why missing one can ruin your rolloutUnderstand how to turn barriers into behavior-changing strategies that scale across bordersPress play to learn the proven system for moving your MedTech device from “great pilot” to international success—without wasting cash or time.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

Is your medical device vision actually helping you grow - or silently holding you back?If you're a clinician founder with a working prototype but struggling to scale or export your medical device, the problem likely isn't your product — it's your vision. In this episode, Hakeem Adebiyi breaks down why most healthcare innovations stall commercially and how to fix it using a proven, clinician-friendly framework.Here's what you'll learn:Why your current vision might be too generic — and how that's stalling your commercial growthThe DAMP framework: a 4-step system to pressure test your vision for direction, alignment, motivation, and peopleA practical on-the-go exercise to sharpen your vision and guide real business decisions immediately