Podcasts about Medtech

In this episode, IQVIA MedTech experts Michelle Edwards and Michaela Miller discuss key trends shaping the MedTech industry in 2025. The conversation covers advancements in 3D printing, real-world evidence (RWE), and clinical AI, among others. Read Ten MedTech Trends to Watch in 2025 to learn more. https://www.iqvia.com/locations/united-states/library/insight-brief/ten-medtech-trends-to-watch-in-2025Host: Michaela Miller, Practice Lead, U.S. MedTech Technology & Analytics, IQVIAFeatured Speaker: Michelle Edwards, Practice Lead, U.S. MedTech Real World and Clinical Solutions, IQVIA

Ce vendredi 18 avril, Jérôme Tichit a reçu Nicolas Fournier, cofondateur et président de Dessintey, Vincent Gardès, directeur général de Germitec, et Philippe Pouletty, cofondateur et directeur général de Truffle Capital, dans l'émission La France a tout pour réussir sur BFM Business. Retrouvez l'émission le vendredi et le samedi et réécoutez la en podcast.

In our 400th episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Greenlight Guru's Sara Adams to unpack the findings of the 2025 Medical Device Industry Benchmark Report. From the rise of family office investments to QMS upgrades and the impact of regulatory uncertainty, this episode delivers a candid and comprehensive look at the current MedTech landscape. Sara brings her quality expertise and industry anecdotes to life, while Etienne adds sharp insights on strategic planning and product development.Whether you're facing supply chain complexity, preparing for QMSR, or trying to navigate market shifts, this episode is your roadmap for the year ahead.Key Timestamps00:03 – Introduction to the 2025 Medical Device Industry Report05:00 – Market growth outlook: $800B by 203009:40 – Family office investment trends in MedTech13:15 – Hiring freezes and headcount reductions: what's behind the numbers?20:22 – Supply chain challenges and supplier qualification issues28:35 – Why only 11% of companies rate their supply chain management as “excellent”33:30 – QMS upgrades and the strategic focus on quality systems39:00 – Fundraising and clinical trials: top priorities for pre-commercial companies44:55 – Regulatory complexity: QMSR, EU MDR, and FDA staffing pressures53:50 – FDA Form 483s: top causes and how to avoid them1:04:00 – Action plan for 2025: technology, collaboration, and performance1:12:00 – Making quality your competitive edgeMemorable Quotes“Money is the air companies breathe, but safety is the ground they walk on.” – Etienne Nichols“If you're not reaching out to your FDA review team, you're already behind.” – Sara Adams“Dig the well before you're thirsty — especially in MedTech.” – Etienne Nichols

Innovating in the field of Med Tech presents a host of unique challenges. Formulating new treatments is a long and capital-intensive process. The regulatory regime for medical devices is extremely stringent. And even if you get approval, you still need to convince doctors that your treatment is safe and effective. But success in Med Tech R & D doesn't just mean profits for the company and it's shareholders, it means new treatments that can dramatically improve or even save the lives of patients. Jim Clemmer became the CEO of AngioDynamics in April of 2016, the company trades on the NASDAQ under the symbol ANGO. Prior to joining the company, Jim served as President of the multi-billion dollar medical supply segment at Covidien PLC where he directed the strategic and day-to-day operations for global business divisions that collectively manufactured 23 different product categories. In addition, he managed global manufacturing, research and development, operations, business development, and all other functions associated with the medical supplies business. Jim joins us to discuss AngioDynamics' innovative products that are helping treat a range of conditions from pulmonary embolism to prostate cancer. He also explains how their continued commitment to innovation has set AngioDynamics up for future success.  Highlights:The AngioDynamics Mission (4:03)Managing the AngioDynamics Portfolio (5:04)What sets AngioDynamics apart in the field (6:20)Meeting real-world clinical needs (7:24)AngioDynamics products (8:53)AngioDynamics approach to R&D (12:45)The impact on patients (15:36)Navigating regulation in different markets (20:06)The role of AI (21:35)AngioDynamics' balance sheet (23:01) Links:AngioDynamics LinkedInAngioDynamics WebsiteICR LinkedInICR TwitterICR Website Feedback:If you have questions about the show, or have a topic in mind you'd like discussed in future episodes, email our producer, marion@lowerstreet.co.

Gurus, get ready for an insightful conversation with a leader who understands the critical intersection of science and strategy! Today, we welcome Colin Smith, Founding Partner of ExecNow, a firm dedicated to helping biotech and MedTech companies build the leadership teams they need to thrive. Colin has worked behind the scenes with some of the most innovative biotech firms, ensuring that groundbreaking discoveries don't stall due to leadership gaps. With experience spanning AI, green tech, and life sciences, he knows what it takes to bridge the gap between research breakthroughs and commercial success. In this episode, Colin shares what separates the companies that scale from those that struggle, the common leadership pitfalls that derail startups, and the key strategies for assembling high-performance teams in today's fast-moving MedTech and biotech landscape. If you're an entrepreneur, executive, or innovator looking to build a winning leadership team, this episode is packed with invaluable insights. You will love this episode that will help you unlock the formula for biotech success!

In this episode of Medsider Radio, we sat down with Randy Pritchard and Erica Rogers, leaders of Axena Health. Axena is transforming pelvic floor therapy with Leva, a device bringing clinically-proven, supervised pelvic floor muscle training into women's homes. Randy, CEO of Axena, brings nearly 25 years of healthcare experience to the company, most recently as CEO of Pillar Biosciences and previously holding leadership positions at Roche Diagnostics, where he spent 18 years developing commercial expertise. Erica, who sits on Axena's Board of Directors, spent a decade as President and CEO of Silk Road Medical, leading the company from early clinical trials through IPO and eventual acquisition by Boston Scientific. A returning guest to the podcast after nearly half a decade, Erica previously held roles at Medicine360, co-founded two other medical device companies, and spent over 12 years at Boston Scientific prior to her role at Silk Road.In this interview, they share essential medtech commercialization insights: identify your specific patient segment, build continuous clinical evidence, and communicate consistently with investors. Their experience offers invaluable lessons for medical device entrepreneurs navigating today's complex healthcare landscape.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Randy Pritchard and Erica Rogers.

Most healthcare pros don't realize it—but they're already sitting on a mountain of untapped value. In this episode, Joe Lemon sits down with Daniel Walters, a physical therapist who's worked across human and animal health, now leading educational initiatives at Summit Professional Education.They dive deep into why so many clinicians are sitting on gold but feel stuck climbing someone else's mountain.Expect raw talk about burnout, cash-pay models, career pivots, and emotional fatigue in both human and veterinary medicine. You'll also hear practical advice on transitioning out of the clinic, how to build a brand on LinkedIn, and why curiosity—not slick pitches—is your best sales skill.Whether you're feeling stuck, seeking more freedom, or just wondering what's next—this one's for you.

In this episode, Duane Mancini explores the critical aspects of medtech regulation and product development with Niki Caporali Spaniel and Chad Gibson of CMD Medtech. Niki shares her expertise in post-market clinical follow-up and navigating the complexities of the Medical Device Regulation (MDR). Chad emphasizes the importance of integrating cybersecurity throughout the product lifecycle, rather than treating it as an afterthought. They both discuss the significance of robust design controls, the pitfalls of inadequate planning, and the power of leveraging professional networks. The conversation highlights how regulatory considerations should inform decisions across all business functions, and the crucial role of thorough market research in achieving success. Tune in for valuable insights on building compliant, secure, and market-ready medical devices.Niki Caporali Spaniel LinkedIn Chad Gibson LinkedInCMD Website⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Midwest Showcase Registration⁠

This week, Rachel and Liz discuss Liz's conversation with Nada Hanafi on the FDA approval pathway and how training can be used to mitigate risk. They share what they learned from Nada about the process and their insights for developing curriculum that has high standards to ensure patient safety. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Nada's interview Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Let's be honest—work-life “balance” often feels like a myth we're all chasing. But what if the goal isn't perfect balance… it's intentional alignment? In this week's episode of the It's Your Time podcast, we're flipping the script on balance. You'll learn: ✨ Why multitasking is not a superpower

Gurus, get ready for an electrifying conversation with a true game-changer in MedTech sales and practice growth! Today, we welcome Zed Williamson, the Founder and CEO of TrackableMed, a company revolutionizing how specialty private practices and MedTech sales teams accelerate growth. With deep expertise in neuroscience-driven marketing, Zed has cracked the code on how physicians and sales reps can drive sustainable success. Through Physician Growth Accelerator and Medical Sales Accelerator, he helps practices streamline operations while equipping sales reps with the tools to become indispensable advisors rather than just product pushers. In this episode, Zed unveils powerful strategies for cutting through the clutter, earning physician attention, and transforming sales performance. Whether you're a MedTech rep struggling to secure time with physicians or a leader looking to scale your impact, this episode is packed with actionable insights. Tune in now and elevate your sales game!

This panel was recorded 20 March 2025.⁠⁠⁠ Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the⁠ Knowledge Center⁠ at RQMplus.com.Women's health is finally getting the attention it deserves, yet progress is still slowed by gaps in clinical trial diversity, complex regulatory pathways, and funding challenges.In this RQM+ Live! panel discussion, industry leaders and regulatory experts will share real-world strategies MedTech companies can use to navigate these barriers and bring life-changing innovations to market.Why listen:Unlock Market Opportunities – Women's health is one of the fastest-growing MedTech sectors, with rising investor interest and funding.Gain Regulatory Insights – Understand how evolving regulations impact clinical trials, approvals, and commercialization.Learn from Real-World Success – Hear how industry leaders are overcoming challenges and making an impact.Ask Your Toughest Questions – Engage directly with panelists during the live Q&A.Bring Innovations to Market – Get expert insights on bridging clinical research, regulatory approval, and commercialization.Discussion topics:The Business Case for Women's Health Innovation – Why investors, manufacturers, and regulators are prioritizing this space and what it means for MedTech companies.Clinical Trials and Data Gaps – The urgent need for inclusive research, historical data biases, and evolving regulatory expectations.Regulatory and Market Access Hurdles – Key challenges in securing approval and reimbursement—and how to overcome them.Scaling Women's Health Solutions – Lessons from industry leaders on funding, partnerships, and commercialization strategies.Who should listen:MedTech professionals driving innovation in women's healthRegulatory and quality leaders navigating complex approval pathwaysClinical trial specialists improving diversity and data accuracyInvestors and strategists seeking insights into funding and market growthR&D and product development teams designing women's health solutionsHealthcare policymakers and advocates shaping the future of women's health innovationPanelists and moderator:Marissa Fayer – CEO, Her Health Equity & DeepLook MedicalMegan Callanan – US & Global Regulatory Lead, Natural CyclesStephanie Kladakis – Executive Vice President, Chief Technology and Regulatory Officer, AgNovos BioscienceAlexia Haralambous – Senior Principal, RQM+Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+ (moderator)Chapters:00:00 Introduction to Women's Health in MedTech10:09 The Surge in Women's Health Innovation20:08 Regulatory Challenges in Women's Health29:52 The Business Case for Women's Health Innovation33:54 Bridging the Gender Gap in Clinical Trials37:02 Enhancing Diversity in Clinical Trial Recruitment40:08 Understanding Regulatory Misconceptions in Women's Health44:09 Strategic Partnerships for Market Access56:03 Future Directions for Women's Health Innovation--

In this episode of Medsider Radio, we sat down with Ryan Rhodes, CEO of EDAP TMS. EDAP is changing prostate cancer treatment through Focal One, a robotic high-intensity focused ultrasound (HIFU) system that doesn't require the use of surgery or radiation. Ryan has over 30 years of experience in market development, with two decades focused on medical robotics. Before EDAP, Ryan was CEO of Restoration Robotics, where he guided the company to a successful merger with Venus Concept. He spent 13+ years at Intuitive Surgical, establishing the global Urology franchise, which became the company's entry point for broader adoption of the da Vinci system. He also spent 11 years at Ethicon (J&J) in sales, marketing, and market development.In this interview, Ryan challenges founders to ask: Are you creating a scalable medtech solution or a product with limited growth potential? He unpacks why standardization and scalability are critical for adoption, how clinical data fuels credibility and reimbursement, and why early adopters take the biggest risks — but also reap the biggest rewards.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Ryan Rhodes.

In the final episode of our Breast Cancer Panel, discover how groundbreaking medical technologies and innovative advancements are transforming breast cancer care. Hear firsthand from employees who share their experiences, hopes, and how MedTech is shaping the future of breast cancer treatment and patient outcomes.--

Why Are Physical Therapists Are Leaving the Clinic?Today's guest is Daniel Walters—a licensed physical therapist who made the leap from clinical care to the business side of healthcare.We unpack the growing frustration in the rehab world, the untapped sales potential of therapists, and why so many clinicians are quietly looking for the exit sign.If you're a physical therapist, a PTA, or someone who's just burnt out and curious about your next chapter... And you've wondered if there's a way into MedTech—without a sales background— I want you to visit MedTechSalesPro.com.We're helping healthcare pros break into this industry every week—starting as appointment setters, building real sales careers, and changing their income stories for good.Let's get into it.

Mike Knox is a standup comedian and the author of "Vivien's Rain." In this unique episode that reveals the perspective of a device end-user, Mike shares his personal journey into the MedTech field through the lens of his daughter's epilepsy and the life-saving (and life-giving!) impact of a vagus nerve stimulator. He discusses the challenges faced before discovering the device, the transformation in his daughter's life post-surgery, and his advocacy work. Mike also touches on the stigma surrounding epilepsy, the importance of compassion, and his career shift from law enforcement to comedy, using humor to inform and inspire others.    Guest links: www.MikeKnox.com   Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 052 - Mike Knox [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Mike Knox. Mike is a standup comedian and author of the book, "Vivien's Rain," about his daughter's epilepsy and the medical device that saved her life. He is a retired parole agent, and I am so excited that he is joining us today because he has a very unique take on the medical device field from a personal encounter. All right. Well, welcome, Mike. Thank you so much for being here. I'm so excited to speak with you. [00:01:27] Mike Knox: Thank you for having me. [00:01:29] Lindsey Dinneen: Yeah, of course. Well, you come to the medtech field and to medical devices in a very kind of unique pathway, and I'm very excited to dive into that. But before we do, would you mind just sharing a little bit about yourself, your background, and what you're doing today, what led you to today? [00:01:48] Mike Knox: Sure. I'm retired law enforcement and now I'm full time stand up comedian and an actor, much better than law enforcement. And I have a daughter who has epilepsy. She's 17 now. She started having seizures at the age of two. And by the age of eight, she got a vagus nerve stimulator, which basically saved her life. So it's a small implant that's like a -- I'm not supposed to say this-- but it's basically like a pacemaker, but for your brain. So it's a small generator that attaches onto your vagus nerve and sends impulses to interrupt your seizure. So she's now been seizure free for eight years. And I go basically go and I'm an ambassador for the company that makes this product. And I go and talk about this product, which is basically, I mean, it has saved my daughter's life. And not only that, but beyond that, it's allowed her to be get her life back basically because she was pretty much just a little zombie cause she was on so much medication at the time. So really for the past 15 years, it was just my wife and I living day to day as parents just trying, you know, in and out of the hospital with my daughter. So now she's in a great place and that affords me the time to go out and talk. [00:02:54] Lindsey Dinneen: Wow. That's incredible. Okay. So can we go back a little bit and talk about what life was like before this device, before you discovered this device, before all of the changes started happening for the better, but can you just paint a picture of what did daily life look like and how did that go? [00:03:13] Mike Knox: It was waiting for the seizure to happen. And most of them were at night, so it would usually be my wife and I taking turns watching my daughter all night long. And she'd be be on medication, but she'd have break breakthrough seizures. She would have partial seizures, but they would go into grand malls and we'd have to go always to the hospital because that's where the rescue medication was. And then it would be at the hospital, always confusion because they were the hospital that was local, wasn't really trained. And we kind of found out not a lot of hospitals, emergency rooms, were trained for seizures, which seizures have been around 2000 years. So there's a lot of misinformation, a lot of not really good education. And that's where I, as a parent thought, this stuff really needs to change. So that's what my wife and I did was, you know, started small talking to our hospital and just trying to get a policy in place where we could, you know, safely get my kid from here to the hospital. Then as time went by kind of technology caught up and we were able to have a rescue medication at home. But there were times where my daughter flatlined twice. So it was very scary. And it was just like living day to day because we we're in crisis mode and waiting for that next seizure to happen. It really did for us, was that seizure was stalking us, always waiting, we never knew when it was going to happen, kind of narrowed it down to that might be at night or coming out of her sleep when waking up, like on the way to school. But it really held you hostage. You weren't able to, we weren't able to go anywhere. You always had to think of where you were gonna go and plan things out. And your friends and family kind of abandoned you be just because they don't know what's going on. They don't understand what your family's going through. And I think a lot of parents see that also as, people just don't understand what it is you're going through when you have a medical problem. And so, when she did get this device that changed everything. And the number one thing that it did was it finally allowed our family to sleep, which we hadn't been doing for years. I mean, it was really same with my daughter. She wasn't able to sleep. So then she's not able to really concentrate at school. The school didn't understand, and they thought she was just being lazy rather than she has epilepsy. And so it's always there trying to advocate for your child. It's still doing that, still dealing with school things where I'm having to advocate for her. And that's just what you're doing as a parent is trying to do the best for your child. [00:05:24] Lindsey Dinneen: Yeah, absolutely. Oof. Yeah. Thank you for sharing more about that and painting a picture for us. And then, so in your research, in thinking, there's got to be something out there. I would imagine as a parent going, "There's got to be a solution. There's got to be something out there." Did that research eventually lead you to the company that you now help speak about and whatnot? [00:05:45] Mike Knox: Yes. And that was, and I always tell people this too, is don't rely 100 percent on the medical system, meet them halfway and do your research. Cause a lot of it is, it's what I realized is, just a lot of it is failure. It's constantly failing and failing. And we went to different doctors in different hospitals and the insurance would say that it doesn't cover this, but we kind of bypassed the insurance to get to where the doctor that we wanted to. It took us about five years to get a diagnosis, to find out what was happening, to find the right doctor cause there were a lot of horrible doctors. And then you have to understand that, because I never really was in and out of hospitals, and I never really understood what, what the policy, every hospital is different. Every doctor is different and different doctors don't know. We were going to doctors thinking that they knew what epilepsy was, and they didn't. They weren't going to say anything, but they were a primary doctor or they were a specialty doctor. They didn't know what epilepsy was. And so researching and finding out, and then we had read about VNS, Vegas Nerve Simulator. And our doctor at the time had said, "No, it won't work." Well, that wasn't true because it's worked. And a lot of it is the drive is pharmaceuticals and you're kind of experimenting. That one doctor, she was doing fine on one medication and he wanted to change it and that caused her to have all these crazy other seizures. And you got to let go of this kind of grudge that you have, and the kind of anger, which we did for a lot of medical, you kind of got to look positively at the ones who are helping you. I really found out that a lot of the nurses were a lot more helpful, where I always thought the doctor's the one that's going to have the knowledge. And a lot of it was the nurses that had the knowledge, not that the doctors don't, but there were more nurses that were more helpful. And I always, my number one thing was compassion. You as a parent coming in there wanting compassion for your kid. At least that's what I was looking for. [00:07:25] Lindsey Dinneen: Yeah. Yeah, and so okay, so you found this device or you found this technology and you go, "Okay I think maybe this could help my child. The doctor is a little skeptical, but we don't really know the reasons behind that. Maybe they just don't have the experience to understand how it could help. And there's new technology coming out all the time." But so, so that happened. And then what got you to a yes, where you could actually try this and see the impact that it could have for your daughter? [00:07:52] Mike Knox: A lot of it was desperation. We had left one doctor after just years there and kind of figuring out, he has no idea what he's doing, and we can never call him on that. Went to another doctor and what you're doing with epilepsy is you're trying to find out where the seizure is coming from. So they do an EEG, and so they're attaching all these leads to your head and we were in the hospital for eight days the first time. No seizure, you know, you're off the meds. They're trying to induce a seizure, nothing happened. So the new doctor said, "We've got to do the same thing again." It's just exhausting because you're like, "I don't want to put my kid through that." But you have to, so we went through another EEG, caught a seizure, saw that they were coming from three different ways. Cause we were first looking at brain surgery and then her seizure was coming through three different areas of the brain. So now you can't do that. And then that doctor showed us the Vegas Nerve Stimulator, which at the time we had just come to my daughter having this horrible seizure in the hospital. Her recovery was really bad at the time. So I was just overwhelmed with this doctor showing me this small device that looked like a silver dollar and it just was too unbelievable for me at the time, but I knew that we had to do something for my daughter because it was the last resort. We didn't really have we'd run out of all options. It had been years of hospitals and doctors and back and forth. And so really, to me, it was our only option. And It just seemed so unbelievable because it was such a small device and, I think a lot of it was, nobody else had ever talked about it before. And so I had to go back and like look and go, oh, at the time, it'd been around 20 years. And then I also looked at-- I mean, I was a horrible student-- but I looked mathematically at, "Wow, this percentage of-- it's not a cure, but she could have a life that's 80 percent better. Well, I got through college with all C's. I'll take those numbers." And so it was pretty much at the time it was a no brainer just because everything was just so horrible that it was just, it was-- another chance was given to us. We had run out of options. We didn't have any. [00:09:46] Lindsey Dinneen: Yeah, of course. So you take this risk and you go, "Well, you know, if it has the percentage potential of maybe it'll improve her life this drastically," it was worth the risk, I would imagine, from both your perspective and your daughter's perspective. And then, so you do this surgery, you've got this implant. Now what is life like these days? Can she travel? Can she do much more than she was able to do before? [00:10:11] Mike Knox: Life is great. I just want to talk about the surgery itself, was that was another fear. I didn't want to put my daughter through the surgery, how horrible it was. It was so easy. It was, we went in and out. It's an outpatient surgery. It took maybe about an hour. It was so simple and a lot of it was just me as a parent being afraid. I was so afraid of everything watching my kid go through so much that that's what I tell everybody now. It was so simple because she's on her second battery because it needs to be replaced. So the first one lasted almost about eight years. So she's on her second one. And the second time around was even simpler because now they've got, at the time we got ours, I think she was only the eighth, in Los Angeles that got it, so the protocol wasn't in place. Now the protocol is in place. So they'll kind of get you in and out real quick and they all kind of know what it is, where at the time when my daughter first had it they didn't know what it was, so a lot of strides have taken place and now the hospitals know exactly what to do. So it's very simple. Whereas, and I run into a lot of parents that are afraid to give that the surgery and kind of all the things that go along with the surgery. And it's so simple and you never, you don't really. Nobody really knows. Now her life is absolutely wonderful. I mean, she went from not being able to keep up in school to now. Shockingly is cause I was such a horrible student. Gets straight A's and she, I mean, to me, that's the amazing part of, I really saw this device propel her and she was learning, which she couldn't do before because she was having seizures and her You know, she couldn't think, she had brain fog, she had all these kind of things that we all kind of, kind of take for granted that we don't really know, but that's what I mean by she, when she was a zombie at the age of eight was that she just couldn't think because she was having so much brain activity from her seizures, and a lot of times she's having seizures you couldn't even see them just as a parent you would instinctively know, oh, this isn't good, I've got to get her out of these, you know, I've got to take her home or I've got to give her medication. You know, that was another fear of mine too, was that, you know, when she's at school or she's with, you know, I'd come to school a couple of times where she would, I'd had them at school, but the school wasn't aware I found her on the play yard. I found her in the classroom and the school just, none of the schools are equipped because they're by law, they don't have to be. And so what I love about the Vegas nerve simulator is it's her bodyguard. It's with her 24 hours a day. It's somebody watching over her and it allows her just to do the things that we all take for granted. And. You know, like she's able to go to school and I feel comfortable now that she's a teenager, which was another thing was growing up. I want her to have her independence. You know, and now I can feel comfortable where she doesn't text me through the day because she's just a teenager forgets that she has it. And that's the best part to me about it. [00:12:47] Lindsey Dinneen: Yeah, that's incredible. Wow. That's an amazing story. Thank you so much for sharing that. And I'm curious now. So you got to a point where you saw the incredible difference it made in your daughter's life and then of course your family's life. And you're obviously very passionate about this device itself and the company. So now you are helping to spread the word. Can you share more about your advocacy and your work for that? [00:13:11] Mike Knox: I just felt nobody was there to talk to me about it, and so if there's ever any parents or kids that are looking at it, and it's, again, it's just fear of the unknown. So I go and advocate and talk about this great device. I probably get four or five calls. Most people don't want to talk about it, but I probably get four or five calls a year from parents, then they just have all sorts of curious questions. Number one, "Is it going to hurt? Am I going to be able to," one kid asked me the other day, "Am I still going to be able to ski?" And I said, "You're probably going to be able to ski a lot better because you're going to be able to focus on that." And I just tell him basically my story, which going back to, because it's not a cure, you have to wait. And so in the beginning when she first got it, it was about six months of no seizures, which was great. But then she had about five, but the vagus nerve stimulator comes with a magnet. And you can swipe that over your chest and that'll stop the seizures most of the time. And so I saw that progressing. And so I was always kind of writing down stuff and seeing that progress. And it was really at the six month mark where we all slept through the night. And I said, "Oh wow, she's sleeping." She never slept through the night before. She was always a lot of insomnia and stomach pain and I'm just getting up through the night. So she slept like a good 12 hours. And I was like, "Oh wow, that's huge." That, beyond the seizures, is huge. And then there was a morning where she got up, dressed herself, which she could never do; made her lunch, which she never did; made her breakfast, ate breakfast. So while my wife and I were sleeping, she did all this stuff on her own, which she could never do. You always had to tell her, like you literally had to tell her, "Okay, it's time to get up out of the bed," and you'd have to tell her several times. It's not just being a kid. She just wasn't processing. Just like she couldn't process sarcasm or humor, which was very hard for me as a father 'cause I wanted to joke around with my kid. And then she put together this Lego set, read the directions, which she could never do before. So you can really see like, wow, the Vagus Nerve Simulator has got her basically mind on track and she's being able to focus, which she could never do before, always distracted about everything. And then on the way to school, driving her, she was joking with me, and you could see like that spark in her eye that I had seen when she was younger, but hadn't seen in a long, probably six years. And, so beyond the seizures I was like, "Oh wow, this is working." So it really doesn't matter if it's working 100 or not. Something is happening here, and it's for the betterment of my child. And that's what I run into also is, people want that quick fix. They want 100 percent. They just want a cure. That's not what this is, but it's a heck of a lot better than where she was eight years ago, almost 10 years now. That's another thing. It really flies by because she got her first one at the age of eight and then she got her next one at 16. And, that is another positive about it, because life kind of stands still when you're in this crisis from anything medical, and now she's just able to live her life and be a kid. And that's the amazing part about it. [00:15:54] Lindsey Dinneen: Yeah, absolutely. Thank you for sharing. You mentioned early on something that stood out to me is, it's often difficult, I think, when there's a medical diagnosis or some pressing medical issue. It makes it hard for people outside of the family to understand what's going on, and therefore they might feel uncomfortable, and they're not quite sure how to offer to help or to just be there for you. And I'm curious, since you experienced some of that loneliness and distance, going through this difficult time, as a parent and now as an advocate, is there just some general advice you might share with people who might be in a situation where they have a family member or friend struggling with something, but they're not quite sure how to be there for that person? [00:16:40] Mike Knox: Yeah. I think the easiest thing is send them a card and just let them know. 'Cause I think a lot of people are thinking, "Oh, just text, but I don't know what to text them. And I don't want to say like, 'If there's anything I could do,' cause there isn't anything I could do." And that's a lot when you have like with epilepsy, there isn't anything anybody could do. And then people, they're giving you bad advice because they see it on TV. Like I would always get advice about, "Have you tried smoking weed with your kid?" And I'm like, "She's two. Yeah, I'm not going to smoke weed with my kid." So that's why I say a card, because then you can think about what you're going to say, and what I think is nice is, send some food or something or send a gift card, because for my wife and I, we were at home all the time because we couldn't leave. And I think a lot of people didn't realize that. I could not go to the store because if I leave the house, she's going to then have a seizure and I'm not going to be there for the seizure. So it was debilitating because I'm having to watch her 24 hours a day and nobody else understood that. I just say a card so that people at least know you're thinking about them or something like that. And most people just don't do that. I mean, I think people are thinking that people are going to, I think you see on TV shows, people rally behind you or whatever. They don't. I mean, most people are living their life. And for you as the person that's sick or with the family that's sick, just know that the people still love you and they care about you. They're just doing their own thing, but so you have to then understand that and not be upset with them. I'm not upset with my family that just, my family and friends that just abandoned me, you know? And I think that's life also. It's like, you have to repeat yourself over and over again when you're sick or have a sick kid too, and you'll hear the same stuff like, "Oh, I didn't know your kid was sick," even though you told him a thousand times. You know, "I never knew she had epilepsy." And I just think that's human beings. I think you have to have the compassion for other people also. And that's just, I think you go through all those phases in the beginning. You're going through all that grief and regret and all that stuff. And you just have to kind of let it go. Because people don't know how to deal with it, nor did I as a parent. I had no idea. So I had that crash course in dealing with it. But I think we as a family came out the other side of it. So I am very thankful at the outcome. And all I have is gratitude for where we are now, very thankful that she's in a great place. [00:18:40] Lindsey Dinneen: Yeah. And now I'm a little curious. So coming back to you and your story and your career trajectory, which sounds like it's had some fun twists and turns in it over the years, but so how has this experience affected both your professional life when you were in law enforcement, and then now as a comedian, are you able to use some of that platform to help even sort of process and then maybe inspire or educate other people through that? [00:19:09] Mike Knox: Yeah, and I look at it like it's all like with my comedy. I use the epilepsy. It's not making fun of epilepsy. It's informing. And I have people that come up to me and talk to me. "Hey, I have epilepsy. I'm so glad you talked about this because there's such a stigma." And I meet so many people and I'm gonna do it again next week where they didn't want to come because they're afraid, they're getting bullied. They don't know how to talk about it. They don't know how to approach it. A lot of families look down on it. There is a huge stigma for some reason. They're embarrassed that their family member has it or their child or whatever it is. And I really think that starts with state laws. So there was a law that was just passed in California where the schools have to identify seizures and everybody needs to be trained and that passed. And that took about five years and I worked on that. And that's where it starts with trying to educate people and starting with that one on one, you going and talking about it. But I do believe that only laws are going to change things and change people's mind. There's a lot of fake seizure videos that are on YouTube, a lot on TikTok, under the guise of comedy. And I don't agree with that. I don't think it's comedy at all. It's not something that I do. And that's something that I try to educate people on also is, it's not funny. There's people that are dying from epilepsy. And so just getting out there and talking to people. When I get that information, I just write that down and categorize it and see where the problems are. And it all goes back to just misinformation and people not talking about it. And that goes back to the funding and how the world works. Can people make money out of this? That's the only way that they look at it. If I had tons of money, I think you could solve it a lot quicker. I just take it day by day, and who I can talk to, and who I can show compassion to, again, because I think that's what people are looking for. And people just want a voice. They want somebody to talk to and you, and listen to other people. You know, I, that's kind of how I approach it also is listening to other people's stories because they feel unheard. And I think that's important. And through my older jobs and this job. And I think all you can kind of do is laugh at it 'cause it gets so overwhelming and so crazy. And you can't force people to see the way that you see things. So you kind of just got to laugh at it. And I think that's, I think that's healing in a way, a lot of people also, and especially with comedy. I mean, people come there, they know why they're coming there. They're coming there to laugh. A lot of it is they're coming from their horrible life, coming there for an hour or two to get away from it all. So I think it is beneficial to a lot of people. [00:21:27] Lindsey Dinneen: Yeah, absolutely. So what is your hope for the future or your excitement for the future as things continue to progress and more awareness is in place, more legislation to help with responses to this kind of situation? What are you looking forward to or potentially excited about? [00:21:46] Mike Knox: So I just look forward to a day where I don't have to do this anymore. Not going to happen, but I do see a lot of great technology and I see a lot of great strides within the last five to 10 years in the medical field with medical devices. And that's what I hope for. I hope for something, like with the vagus nerve stimulator, they're looking at having a rechargeable battery or not having to replace the battery. And that's what I hope for. And I hope for, that I never have to hear anything about seizures or epilepsy. I know that's not gonna happen, but for my daughter and everybody else I would love to find a cure for it. And anybody that has to deal with any kind of medical device, hopefully, you know, we can put more funding into it and have more cures. And I think we are at a great time for so much success in, I mean, we're living longer, we're living better. These next couple of generations are, I mean, my mom's 88. People are living a lot longer and a lot healthier, and so I guess if I have to be positive, that's what I'm positive about. [00:22:41] Lindsey Dinneen: Yeah. Well, that's good. That's taking the challenge with the opportunity and saying, "Okay, let's see what happens from it." So, you know, it's a step in the right direction for sure. All right. 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 something that you've been working on from your career so far, so a skill set you've developed over time, but it could be completely unrelated. What would you choose to teach and why? [00:23:13] Mike Knox: It would have to be comedy because I've done so much comedy for free. I think that I can understand to teach that to other people and to tell them kind of all the traps of comedy. And it is just, comedy is consistency. It's getting your, you know, five minutes is really four minutes 'cause you're going to have about a minute of laughter if you're funny or not, but getting consistent and embracing the failure of it. And to me, those are the components of comedy because you've got to stand up there. A lot of it is you got to stand up there and embrace the darkness of being up on stage, which a lot of people don't want to do. And then you've got your material and you've got to be able to care. You've got to get new material and carry that material. So if you can, what I've seen, if you can get past that first five minutes and get 10 minutes and 15 minutes and so on, you're going to be okay. And so if I were to get a million dollars, I think that's the masterclass that I could teach. [00:24:00] Lindsey Dinneen: I love it. I love it. Okay. Awesome. And how do you wish to be remembered after you leave this world? [00:24:07] Mike Knox: To me, it's just that I did good. I think that to me, that's important. Do good and be good. ' Cause we see so much negativity all the time and we see so many people that it's like, you know, "Oh, I scammed this person out of that, but they deserved it." And there's kind of like no moral compass. So, when I was a, when I worked in law enforcement before, you know, people that you didn't even think that you touched their lives at all would say, "Hey, thank you. You made me recognize something different." And I think that's what life is all about. You've changed somebody's life or done some sort of kindness. It doesn't even matter. I think that's what a lot of it is these little things in life where you didn't even know that you did something to somebody. And it's that spider web of life where you your life intertwined with somebody. You weren't even aware of what you did but that impacted that person's life so much. And I think that's what we're here for is you're always trying to help other people. I mean, that's the whole point. [00:24:59] Lindsey Dinneen: Yeah, I agree. Yeah. Okay. And then final question. What is one thing that makes you smile every time you see or think about it? [00:25:08] Mike Knox: Definitely seeing the vagus nerve simulator working; anything with my daughter. I think being in crisis for so long, and just like yesterday, my daughter made cinnamon rolls. She likes to bake. So watching her make something from scratch and then having her happy and excited that she made something-- that, that to me is happy. Well, that always makes me smile. So it is those little things that always make me smile. [00:25:35] Lindsey Dinneen: I love that. Excellent. Well, this has been an incredible conversation. Mike, thank you so much for being here. I really appreciate your time and I really appreciate your commitment to sharing the word and being a positive helper in this situation. So if folks would want to get in contact with you, maybe because they have some questions or whatnot, or they want to follow your work, how could they do that? [00:25:59] Mike Knox: Sure. On all platforms, I'm Mike Knox, at Mike Knox comedy, or I have a website at mikeknox. com. [00:26:05] Lindsey Dinneen: Perfect. Excellent. Well, thank you so much again for your time today. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. [00:26:35] Mike Knox: Thank you so much for having me. [00:26:38] Lindsey Dinneen: Of course, absolutely. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I would love if you would share this episode with a colleague or two, and we will catch you next time. [00:26:53] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development. And we just wish you the most continued success as you work to change lives for a better world.

In this episode of The MedTech Talent Lab, host Mitch Robbins sits down with Carolyn Twomey, Global VP of Medical Affairs and Research at Iramax Corporation. Carolyn's career path is nothing short of remarkable—from starting as an OR nurse and cardiac cath lab director to leading global clinical services and now shaping medical affairs strategy in the medical device industry.She shares her personal and professional transformation, including:How an early passion for music unexpectedly led her to nursing.The pivotal career shifts that took her from clinical practice to corporate leadership.The emotional impact of battling cancer while simultaneously losing her sister to the disease—and how it shaped her leadership and perspective.The critical role medical affairs plays in bridging science, clinical practice, and commercial success in MedTech.Lessons on resilience, adaptability, and building a meaningful career in the industry.Why You Should Listen:

Gurus, get ready for an eye-opening discussion on the future of surgical education and collaboration! In this episode, we welcome Dr. Mark Soliman and Dr. Jeremy Heffner, two accomplished surgeons and innovators who are changing the way medical professionals connect and learn. Mark and Jeremy are the co-founders of SurgeON, a groundbreaking platform that has been called the "LinkedIn, Facebook, and YouTube of surgery"—a digital hub where surgeons worldwide can share expertise, collaborate on cases, and advance their skills like never before. With over 17,000 users in the U.S. and a rapid global expansion, Surgeon is proving that real-time, peer-driven education is the future of surgical excellence. From the challenges of launching a MedTech startup to the power of AI in healthcare, this conversation is packed with insights for entrepreneurs and industry leaders alike. Tune in now to learn how Surgeon is democratizing surgical education and transforming patient care across the globe!

In this episode of Medsider Radio, we sat down with Kirk Huntsman, CEO of Vivos, a company commercializing a non-invasive, FDA-cleared oral appliance designed to treat obstructive sleep apnea (OSA). Kirk is a seasoned healthcare entrepreneur with a track record for scaling and exiting successful businesses. He founded Dental One, growing it into one of the largest dental service organizations (DSO) in the U.S., with over 165 practices across 15 states. After selling the company to MSD Capital, he led ReachOut Healthcare America, a Morgan Stanley Private Equity portfolio company. He later built and exited Xenith Practices, another DSO, and founded Ortho Ventures, focusing on pediatric oral appliances. Now as CEO of Vivos, Kirk and his team are developing and commercializing proprietary treatments for sleep-related breathing disorders, offering patients an FDA-cleared alternative to CPAP therapy.In this interview, Kirk talks about his go-to-market strategy, the importance of credibility markers, the complexity of industry partnerships, and the challenges he faced pursuing an IPO.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Kirk Huntsman.

Hear from Dr. Soum Rakshit, Co-Founder and CEO of MV.Health, as he shares his journey of merging medicine and engineering to develop groundbreaking medical devices that adapt to the human body.As a thought leader in MedTech, Dr. Soum has led MV.Health to recognition in the Times Tech 100 list as one of ‘Britain's Fastest Growing Tech Companies.' Under his leadership, the company has scaled globally to become a leader in Women's & Men's Health devices, successfully navigating complex regulatory landscapes and attracting investment in a challenging sector.Discussions in the episode:Fundraising, regulatory hurdles, and global expansionBuilding a culture of innovation & independenceCommon mistakes leaders make when scalingThe power of constantly searching for knowledgeClick here to reach out to Peter Rabey direct Like this show? Please leave us a review. Every review helps. 

In this episode, Matt Sokany joins Duane Mancini at Project Medtech to share his extensive experience in the medtech industry, from his time at Ethicon Endosurgery (Johnson & Johnson) to his impactful journey in the startup world. Matt details his strategic approach to building successful companies, including his remarkable exit with New Wave Surgical, which raised less than $3M and sold for $115M. Matt also discusses his leadership at Standard Bariatrics, emphasizing the importance of setting quarterly and two-year goals, fractionalizing key departments like CFO and regulatory/quality, and securing strong legal and board support. He highlights the crucial role of company culture, clear communication, and the necessity of over-funding to navigate the unpredictable startup landscape. Tune in for invaluable insights on building a thriving medtech startup from a seasoned industry leader. ⁠Matt Sokany LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Midwest Showcase Registration⁠

Liz is joined by Nada Hanafi to talk all things clinical trials. They start by defining the clinical trial pathways and all the acronyms used. Then, they discuss how training can be used as a mitigation measure for avoiding risk, exploring the benefits and drawbacks for this approach and how the strategy can be modified along the process. Learn more about the process and how the answer is often "it depends."In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Related Resources:Nada Hanafi is a thought leader within the Life Sciences and MedTech industry with over 22 years of experience across the public and private sectors. She is a Founder of MedTech Strategy Advisors, LLC where she advises life science companies on regulatory strategy, product development, and clinical research to accomplish regulatory, compliance, and business goals.Nada spent over 12.5 years working for the FDA, serving in increasing roles of responsibility and ultimately as a Senior Science Health Advisor in the Center for Devices and Radiological Health (CDRH), where she led cross - Center and Agency programs for the advancement of FDA's mission to promote and protect public health, including as Co-Founder of the Health of Women (HoW) program, the Network of Experts program and the Patient Preference Initiative. She served as CDRH Liaison and Subject Matter Expert to FDs's Office of Women's Health (OWH) and the Office of Minority Health and Health Equity (OMHHE). She collaborated with the Center for Tobacco (CTP) and the National Institutes of Health (NIH) where she served as Senior Management Advisor to the Director at the Office of Research on Women's Health (ORWH), to improve regulatory efficiency and to strengthen data collection. Nada's drive and passion to address health inequities with a focus on women and minorities led her to Co-Found MedTech Color, a non-profit focused on advancing the representation of people of color within MedTech. Nada also serves on the Steering Committee and as Co-Lead on the Regulatory and Science Policy subcommittee for the Innovation Equity Forum (IEF) led by the NIH's ORWH and the Bill and Melinda Gates Foundation.Nada holds an MSc in Biomaterials and a BEng in Biomedical Materials Science & Engineering from Queen Mary College, University of London. She earned her MPH from Johns Hopkins Bloomberg School of Public Health. Nada is a Certified Quality Improvement Associate (CQIA) and a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠Nada Hanafi⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Navigating the maze of compliance in medical device sales often feels like an uphill battle, with stringent regulations frequently seen as barriers to innovation and market growth. However, when compliance is strategically aligned with sales and marketing efforts, it can transform from a hurdle to a powerful enabler of success. In this week's episode, sponsored by Physician Growth Accelerator, we're joined by Aryn Peled, Managing Director at Trackable Med. Aryn discusses her experiences and strategies for turning compliance into a competitive advantage. She also sheds light on effective ways to collaborate with compliance teams, ensuring that both safety and business objectives are met. What we discuss in the episode: Understanding compliance as a protective measure that can be aligned with business growth Strategies for MedTech professionals to collaborate effectively with compliance departments The importance of breaking down silos within organizations to enhance communication and cooperation Practical tips for transforming compliance challenges into opportunities for innovation Real-world examples of successful compliance integration that supports both patient safety and business objectives Resources from this episode:  Get the free MedTech Talk Tracks for Action Physician Growth Accelerator Social Media:  Connect with Aryn on LinkedIn Connect with Zed on LinkedIn

In this episode with Doreen Bedrossian Samaha, Global Clinical Application Manager at Erbe Elektromedizin GmbH, we explore the dynamic and evolving landscape of medical technology through the lens of a woman who is making significant contributions in the field.  Listen to this inspiring conversation with a female leader and innovator in the field, highlighting her unique journey, challenges, and achievements while juggling her children and family life.  #Medtech #FemTech #womeninmedtech #womeninSTEM #WomenLeaders #InspiringWomen #HealthcareTechnology #Breakingbarriers  

Since the first days of the new Trump administration, the White House has handed down orders to ban work focused on diversity, equity and inclusion (DEI) across the federal government. Some in the private sector—both inside and outside of healthcare—have followed the same path, eliminating DEI officer positions and ending initiatives that in some cases have been tied to millions of dollars in research funding. What does the field—and, ultimately, the patient—stand to lose from this effort? In this week’s episode of The Top Line, we hear from Nada Hanafi, co-founder of MedTech Color, a professional network aimed at building and supporting diverse leadership in the industry. Hanafi joins Fierce Medtech’s Conor Hale to discuss how studying diversity in a healthcare context has become integral to developing new medical breakthroughs and realizing the promise of precision medicine. To learn more about the topics in this episode: FDA issues draft guidance on ensuring pulse oximeter accuracy across skin tones How Trump's DEI executive orders could impact healthcare After White House transition, FDA’s diversity guidance for clinical trials no longer available As Trump targets DEI practices, 4 pharmas reaffirm commitment to diversifying clinical trials Amid Trump's push to abolish DEI, Roche and Novartis adjust hiring initiatives: reports See omnystudio.com/listener for privacy information.

Agentic AI is AI that does your work, right? ⚙️And Physical AI is just robots and stuff, right?

Gurus, get ready for an incredible conversation that blends artistry, innovation, and medical breakthroughs! In this episode, Nancy Hairston, CEO of MedCAD, a pioneer in patient-specific medical implants is our Guru. Nancy's journey is anything but conventional—starting in digital sculpting and special effects, she leveraged her expertise to revolutionize surgical solutions. Since founding MedCAD in 2007, her company has created over 8,000 custom implants, helping patients around the world, including Ukrainian soldiers recovering from battlefield injuries. Nancy shares how MedCAD combines cutting-edge 3D printing, precision engineering, and surgical collaboration to restore patients' identities with unmatched accuracy. From navigating FDA regulations to fostering a culture of innovation, her insights are invaluable for MedTech entrepreneurs. If you're fascinated by the intersection of technology and medicine, this is an episode you won't want to miss! Tune in now and be inspired by the future of personalized healthcare

In today's 40 Minute Mentor episode, our final episode of our VC feature series, we're joined by Pooja Sikka, General Partner at KHP Ventures.  KHP Ventures is a collaboration between King's College London, King's College Hospital NHS Foundation Trust, and Guy's and St Thomas' Hospital NHS Foundation Trust. The fund offers equity investments with Healthcare expertise for groundbreaking MedTech and digital startups.  In today's episode, you'll find out more about Pooja's squiggly career into Venture, and KHP's brand new mental health immersion programme. 

In this episode of Inside INdiana Business with Gerry Dick, we spotlight the Indiana-based startup MakeMyMove, which is luring remote workers from across the U.S. to cities like Noblesville, South Bend, and Evansville. Offering cash incentives, perks, and community engagement opportunities, the program has already helped more than 2,000 remote workers relocate, fueling economic growth and helping Indiana address its talent shortage. Plus, northeast Indiana is aiming to become a global gateway for med tech companies. Fort Wayne's Parkview Mirro Center for Research and Innovation is launching an initiative to attract international med tech firms by easing their entry into the U.S. market and leveraging the region's $19 billion medical device ecosystem. Also in this episode: Cadillac brings Formula 1 to Fishers: Construction is underway on a $200 million racing headquarters expected to create 300 new jobs. Hypersonic tech in southern Indiana: Kratos Defense is investing $50 million in a hypersonic testing facility near NSWC Crane, creating up to 100 jobs and strengthening Indiana's defense sector. Indiana's hunger fight: Leaders from agriculture and food industries unite at the first Indiana Hunger Summit to combat food insecurity, which affects 1 in 8 Hoosiers. University of Evansville's farm-to-classroom innovation: A unique container farm initiative is helping educate students and feed the Evansville community year-round. Recycling revolution in Indy: Republic Services and Blue Polymers invest $180 million in a state-of-the-art plastics recycling complex, a first in North America, creating 125 jobs and setting a national precedent. Join us for an in-depth look at how Indiana is growing its workforce, driving innovation, and addressing critical community needs, one bold initiative at a time.

In this episode of Inside INdiana Business with Gerry Dick, we spotlight the Indiana-based startup MakeMyMove, which is luring remote workers from across the U.S. to cities like Noblesville, South Bend, and Evansville. Offering cash incentives, perks, and community engagement opportunities, the program has already helped more than 2,000 remote workers relocate, fueling economic growth and helping Indiana address its talent shortage. Plus, northeast Indiana is aiming to become a global gateway for med tech companies. Fort Wayne's Parkview Mirro Center for Research and Innovation is launching an initiative to attract international med tech firms by easing their entry into the U.S. market and leveraging the region's $19 billion medical device ecosystem. Also in this episode: Cadillac brings Formula 1 to Fishers: Construction is underway on a $200 million racing headquarters expected to create 300 new jobs. Hypersonic tech in southern Indiana: Kratos Defense is investing $50 million in a hypersonic testing facility near NSWC Crane, creating up to 100 jobs and strengthening Indiana's defense sector. Indiana's hunger fight: Leaders from agriculture and food industries unite at the first Indiana Hunger Summit to combat food insecurity, which affects 1 in 8 Hoosiers. University of Evansville's farm-to-classroom innovation: A unique container farm initiative is helping educate students and feed the Evansville community year-round. Recycling revolution in Indy: Republic Services and Blue Polymers invest $180 million in a state-of-the-art plastics recycling complex, a first in North America, creating 125 jobs and setting a national precedent. Join us for an in-depth look at how Indiana is growing its workforce, driving innovation, and addressing critical community needs, one bold initiative at a time.

Kelley Satoski is the co-founder and CEO of Pelva Health, a pelvic health startup dedicated to making intimacy pain-free for women suffering from chronic vaginal and vulvar pain. Kelley shares her personal journey with vaginismus, which led her and her husband to seek innovative solutions where none existed. They discuss the staggering statistics of women affected by this pain, Pelva Health's progress, and the significance of addressing women's health issues head-on. Listen as Kelley talks about the challenges and triumphs of starting a medtech company, the importance of curiosity and bravery in leadership, and the profound impact Pelva Health aims to make.   Guest links: https://www.pelvahealth.com | https://www.linkedin.com/in/kelleysatoski/; | https://www.linkedin.com/in/douglassatoski/ Charity supported: https://www.savethechildren.org/ Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 051 - Kelley Satoski [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey. And I am so excited to introduce you to my guest today, Kelley Satoski. Kelley is the co founder and CEO of Pelva Health, a pelvic health startup on a mission to make intimacy pain free for women with chronic vaginal and vulvar pain.  All right. Well, welcome, Kelley, to the show. I'm so excited that you are here today. [00:01:18] Kelley Satoski: Yeah, this is amazing. I'm excited to chat. [00:01:21] Lindsey Dinneen: Yeah. Wonderful. Well, would you mind just starting by telling us a little bit about yourself and your background and what led you to MedTech? [00:01:29] Kelley Satoski: Yeah. So, we were talking before the show about you being in dance and all your different ventures. I also have a similar background in the arts, so I didn't really anticipate starting a medtech company. That was probably the furthest thing from my mind. But I did grow up in a very entrepreneurial family. So I went to school for art and design, wanted to do my own thing, wanted to start my own startup. So I feel like that was always something in the back of my mind. But we started this pelvic health company because me and my husband, Doug, had a condition called vaginismus, which basically is a problem that keeps people from being able to have sex due to chronic vaginal and vulvar pain. And so we struggled with that for about 10 years and then after seeking treatment for five years, not seeing any relief, we decided, "Okay. There has to be a better solution." And so that was really the catalyst for starting Pelva Health and for getting into medtech. And we're the perfect duo for it. My husband's a biomedical engineer, has worked in many companies, has worked at biomaterials before, and then me with my background in art design, entrepreneurial spirit, and really fits us really well. So we're excited to be a part of the community. [00:02:57] Lindsey Dinneen: Oh, that is exciting. Wonderful. Thank you for sharing a little bit about the background. So that just sparks so many questions and I love the fact that you two have both sort of, you've got the creative side, you've got the business sense, you've kind of married them together. So tell me a little bit about what was this journey like for you of going through this really painful, difficult, experience and frustrating. I can only imagine probably spending a lot of money on trying to find solutions, not finding the answers that you're seeking. So how did you go from, "Gosh, this can't just be us. Other people have to be dealing with this too," to "Let's figure out the solution," because that's, that's a huge leap. [00:03:37] Kelley Satoski: Yeah, definitely. People are always surprised that 75 percent of women have pain with sex. 75 percent. And nearly 30 percent will struggle chronically over six months. In fact, most will suffer two to seven and a half years without relief. These are massive numbers. This is huge groups of people, and this is not just affecting women. This is affecting couples. This is affecting, like you mentioned, finances. I spent over ten thousand dollars in out of pocket treatment for these conditions. I saw over five providers. And then the impact really for me, the worst impact, is the one that it can have on your mental health, on the mental health of your partner, and your guys' intimacy in your relationship. It gets you fired up because it's such a complex issue that doesn't have a lot of research around it, does not have a lot of innovation around it. So something that really catapults us into trying to innovate in this space was personally a lot of dissatisfaction with the options I had. So, you know, for women with vaginismus specifically, one of the most common prescribed therapies is called dilator therapy. So it's basically a bunch of dilators that are of different sizes, and you basically do exposure therapy to stretch the vaginal canal, improve elasticity, and also to try to get over the psychological fear around the pain that you experience with sex. But it's got incredibly low compliance rates. We're talking like 75 percent of women won't comply because of the emotional turmoil, the amount of commitment that's required, the slow results that they see, and often a lack of translation to sexual intimacy. [00:05:38] Lindsey Dinneen: Mm hmm. [00:05:40] Kelley Satoski: And so part of me was frustrated with, you know, there's a lot of companies and it's good that we improve dilators, but to me, if women can't comply to something, or if a user can't comply, or if it's emotionally exhausting, and it's causing these problems, then we need to think of a different solution, like surely something better exists. And so it was important to that us that we didn't just create a better dilator. [00:06:12] Lindsey Dinneen: Mm hmm. [00:06:12] Kelley Satoski: We wanted to figure out, "Okay, how can we prevent pain immediately? What could we create to give people relief so that tomorrow they can go out and enjoy intimacy in the way that they want without pain. Tomorrow, not in six months after therapy, like tomorrow." So that's what we have set out to do. And just from that personal experience is really what catapults us into doing this startup. [00:06:39] Lindsey Dinneen: Wow. Wow. Amazing. Oh my goodness. Thank you for sharing the statistics too. I mean, that is, yeah, I think what's, what's crazy is there are so many of these kinds of stories that are emerging more and more, especially for women, of oh, wow-- so many of us are affected by these things and there just hasn't been the research or the money or time, who knows, devoted to it. So, you know, kudos to you and your husband for starting this company and trying to solve something, but also to your point of Not just, you know, six months, one year, whatever down the line. But hey, let's, let's actually solve this tomorrow. So as you've started in on this amazing adventure, which I'm sure has your, you know, shares of entrepreneurial ups and downs... [00:07:24] Kelley Satoski: Oh, sure. [00:07:25] Lindsey Dinneen: ...What are some of the exciting milestones that you've achieved so far and what are you looking forward to? [00:07:30] Kelley Satoski: Oh, yes, so many good things. We're an early startup, right? So we've done some proof of concept studies with some really incredible results. We are heading into a pilot study at the Center for Vulvovaginal Disorders with 10 women with provoked vestibulodynia, which is another term for basically having some pain around the entrance of the vagina with any sort of penetration. So getting some of that real data and feedback and seeing that we are actually creating something that is helping is really exciting. So I'd say that's the biggest milestone that I'm most excited about. [00:08:09] Lindsey Dinneen: Of course. Well, and proof of concept is such a great thing to, to really go, "Okay, yes, here we are. We can go ahead and get this going." So yeah. So, okay. So then you're going to do this pilot study with these 10 women. And then after you get the results of that, what happens next in this journey? [00:08:27] Kelley Satoski: Yes. So hopefully that pilot data helps inform, "Do we need to make any more design changes? Is there anything else we need to be considering before we fully lock the design? You know, don't make any more changes. This is what's going to market" type of thing. And then start preparing for FDA approval 'cause we are going through the FDA. There's so many wellness... you can't see my, I'm doing quotation marks, "wellness," "vaginal wellness" products that exist on the market, that you would be shocked by the amount of products that are on the market but did not go through the FDA. But we really do want to give women a product that's done the work, that's done the safety testing, that's done the clinical data, that's really has efficacy behind it so that we give women the best. That matters to me a lot. So we're going to go through FDA approval and then it'll be market launch. Once the FDA says "Yes," which hopefully they will. [00:09:28] Lindsey Dinneen: Of course. Yes. Rooting for , . Absolutely. So, okay, that is so exciting. So, so backing up a little bit when you first started this, I know you've, you've had this entrepreneurial sort of background and mindset to begin with, but the actual reality of starting a business is definitely still a learning curve, no matter how prepared you feel like you might be. [00:09:50] Kelley Satoski: Yep. [00:09:51] Lindsey Dinneen: So I'd love to hear about your experience as an entrepreneur and leading a company. And in, you know, going from here's this, here's this idea and now let's make it happen. So how, how was that transition for you personally as a leader? [00:10:06] Kelley Satoski: Oh, man. Yes, definitely starting one, an FDA regulated device company, and two, a startup that typically raises venture capital funds. So there's certain things that come with, that are a little bit different maybe than some other types of startups that exist, is definitely a learning curve. And so when we first started Pelva, we were so fortunate to be connected to the Purdue University. That's where my husband went to school. And so they have a whole program for alumni to basically join their incubator and learn all the basics of startup. And they don't take equity. They don't do anything with your IP. It's like purely to help support alumni startups in the Purdue ecosystem. So that was the most transformative experience for me, because it just thrusts you into the basics of doing a startup, of doing a medtech startup, of doing customer discovery, and all that's required of that, and then surrounding myself with so many incredible advisors, mentors. I'm a firm believer you can't do it by yourself. And so, you know, I'd rather be one of those people that just jumps in and then knows that I have people to support me rather than waiting till I have it all just perfect before I go. And I couldn't do it without that support system and those people that helped us in the beginning, so helpful. [00:11:34] Lindsey Dinneen: Yeah, that's great. And getting to learn from people who've been there, done that, and have that perspective and just even the experience of, "Oh, here's a couple things to watch out for" or whatnot can, yeah, make such a difference. And then, you know, you have had such an interesting career, also. You know, you haven't just been-- not that it's 'just' at all, you are quite the entrepreneurial leader now as well-- but in the past you've also had a really interesting trajectory, so I'm just curious, can you tell us a little bit about even your, your career before this and maybe how it's helped influence what you're doing now? [00:12:11] Kelley Satoski: Yeah. That's-- oh man, I've done quite a few things. So I went to art school and I worked with different nonprofits and businesses, did some freelance work for a while, and that was helpful. I'm really used to a blank canvas and making something out of nothing. And that's like quite literally what we do is like, "Okay, there's nothing here. What are we going to do? We just got to start." And so I'm used to that, that overwhelming feeling where it just feels like so much, but you just have to jump in. And I think that's something that I've carried with me from that time is just making something out of nothing, thinking about things outside the box. I think so often we get, you know, so in our little boxes and ways that things have to be done, and I feel like that's very limiting most of the time. Sometimes it's good, but most of the time I think we could all do a little dose of new perspective and seeing things from maybe a different view. So that, that's a very applicable part of what I learned there. Then after I sought treatment for about three years, I started to feel the itch and this was, we were thinking about starting Pelva, but I, you know, we weren't fully in or anything like that, but I was like, I need to interface with more people that are struggling with this. I'm starting to get interested in women's health because of this problem. So I actually quit the work I was doing and I became a postpartum doula and I started taking patient intakes at a pelvic pain clinic in Atlanta, Georgia for about a year. And so this is right before Pelva actually, I went to Pelva full time. So I probably interfaced and took intakes of over 400 women with chronic pelvic pain and different vulva vaginal disorders for about a year prior to pelvis, which I say too was like a super. Incredible way to get a foundation of customer discovery before, before you start a company is to go talk to 400 patients day in and day out. So I also say that was super impactful to really immerse myself around people that are struggling and need a better solution. [00:14:28] Lindsey Dinneen: Yeah, absolutely. And I love how different things from our past can really translate eventually, and I'm curious for other people, actually, you have such a unique and great perspective. So, so maybe for other people who have the spark of an idea for something like a medical device, but just, you know, maybe they're not from the industry or they would feel like that's just such a huge next step. What are some pieces of advice you might have for somebody? [00:14:57] Kelley Satoski: That's a great question. It takes a certain personality. I feel like I'm not super risk averse, I guess you should say it, in a good way, I think. I think the biggest thing I see people hold up on is "I don't have all the exact perfect experience. I need to go and be a manager of people for five more years before I'm comfortable being a CEO of a startup." And to me, that feels more limiting than expansive. And I think a better perspective is to, sometimes you just have to jump and just, what you can do is make sure you have people around you to carry you through and to help support in areas that you will need help. You will need help. And so I feel like that's what we did is just the very beginning, "Okay, where can we get mentorship, what other femtech, what other medtech leaders exist in the place that we live, we should connect with them, we should tell them our idea and get their feedback. And then you create this support system that actually makes it easier to step into a space that is new for you because you have support. I'd say that's like the way to go. [00:16:13] Lindsey Dinneen: I really like that. That's great advice. And I think there's actually kind of a correlation because I was curious, I was looking through your LinkedIn profile just for fun. I always like to kind of see what the guests are up to. And one thing that piqued my curiosity was actually your article that you wrote at one point that was replacing fear with curiosity. And there was a beautiful short little article about some ideas for how to do that. And I'm actually curious if you could speak a little to that because I think this is the exact right scenario to apply it to, is maybe somebody who's nervous and feeling overwhelmed by the idea, maybe we replace that with curiosity and see where that leads us. So, but I'd, I'd love your take on it since this is your thing. Yeah. [00:16:55] Kelley Satoski: I was so wise back then. I think I wrote that article like back in 2020 or something. But no, it is, I wrote that at a time where I had just graduated from college and I was in the arts, right? We talked about this, "Oh, getting a career in the arts. It's tough. It's full of unknowns. It's really competitive and competitive for very little pay. And so there's all of these strings attached." And I was just, yeah, feeling pretty insecure about like, I want to have impact. I want to feel like I have purpose. And I want to do all these things, but it's all very unclear and very scary. And having to say yes to different opportunities that like we said, sometimes feel like they are outside of our realm of expertise or comfort. And I feel like when we can approach things more from a place of curiosity and less out of this quick, reactive state, we can better move through that fear a little bit more, you know? Instead of being like, "Oh, I don't have enough experience," or "I don't do that," or "That was never on my game plan," or " "That's too risky, that's gonna fail," or "Nobody has created a better solution for vaginismus, there's no other solution, so what you guys have put out there, that's not going to work." Or, "No one has made a hydrogel like that. So that's not going to work." And so I'd be a little more curious about where do these limiting beliefs come from? And are they as set in stone as everyone makes them out to be? Or can we be curious about this? And actually, maybe they aren't so hard and fast as we thought at first. [00:18:44] Lindsey Dinneen: I love that. Yeah. Thank you for sharing about that. What I love about the idea behind curiosity, too, is that it helps because if you're in a place where you're really concerned about trying something new and failing, 'cause that's such a common, shared experience for so many people-- so if, if you're in that boat, but you treat it as " I'm going to explore this next thing as an exploration," then failure is not even part of an exploration, right? You're just exploring. You're just curious. So you're going to learn. And hey, if you find out that this isn't for me, you go on, next thing. [00:19:19] Kelley Satoski: I love that. Exactly. Yeah. And I always say to, you know, entrepreneurship and doing a startup and MedTech is not for everyone, absolutely not. But for those that I guess have the itch-- and I feel like you can usually tell who those people are-- I always, this is a quote actually from my husband, not me, but we always talk about "what's the greater risk?"  The greater risk for us is never going after a greater dream, never doing the things that we want to do, never pushing and going after. The greater risk is comfort, the staying in what we feel is the comfort zone, but never going after. That's the greatest risk. And so if you can reframe what's risky for you-- is going after your dreams really the greatest risk? Or is the risk that you never go after your dreams? That's, that seems pretty scary to me. [00:20:12] Lindsey Dinneen: Yes. Yes. Wow. That is really powerful. I love that. That's such a great question to ask yourself too, because to your point, sometimes it just feels like the risk is this one thing. Like, you know, it's just this one idea you have or the dream you have. It's not a comparison. I love the comparison. "What's the greater risk?" Oh my goodness. That's fantastic. I'm going to hold on to that one.  Wonderful. So, you know, okay, well, as you've been going along this journey and you've been talking with these women and other folks that have a shared experience or similar experience to yours, and you're creating this innovative solution, are there any moments that stand out that just really confirmed to you, "Hey, I am, I am in the right industry at the right time, doing the right thing." [00:20:58] Kelley Satoski: All the time. It's always a thing, you know, as a startup, like talk to your customers, talk to your customers, never stop talking to your customers. But for me, I love talking to customers because it continually, day in day out, reminds me why we're doing this. I had one person literally say to me, "This is the first time I felt hope in 10 years." I've had women that have gotten, been divorced over vaginismus, over an inability to experience intercourse, couples on the rocks, tears, you know, like the whole thing. The just feeling hopeless, I think is a really common theme from the women I talk to. And in fact, we had feedback groups for our product. And, I was like, "Okay, guys we'll keep you in the loop. We might be doing some clinical trials, studies in the future." And it's not even been a month and I already have people messaging me, "When's the clinic? I want to be a part of it. So just making sure that you're still doing it." So it's so confirmed, the prevalence. And I mentioned the statistics, but the other thing that always confirms to me that this is a real issue is almost every space that I pitch Pelva or talk about Pelva, I always have at least two people, men and women, that talk to me afterwards and talk about what they're experiencing with it, which really lines up with the, you know, the statistics on how many people are struggling. So, it's, yeah, it's a really big problem. [00:22:34] Lindsey Dinneen: But knowing that you're making an impact and a difference and inspiring hope in folks who don't have that right now, that's amazing. Yeah. What a gift. [00:22:43] Kelley Satoski: It is. Yep. And women's health is all the rage right now. So it is like you said, is this a good time? This is a fantastic time. This is, there is no better time, I think, to innovate in women's health right now. [00:22:56] Lindsey Dinneen: Yeah, exactly. Absolutely. Yeah. So, okay, so pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industries, which you have several, or it could be something completely different. What would you choose to teach? [00:23:16] Kelley Satoski: Oh, I feel like, if we were gonna keep this related to Pelva, I would hand that million dollars to my medical team and we'd put out this massive broadcast educating everyone about women's gynecologic health and educate on our anatomy and all of that stuff. I'd put a broadcast out there for everybody. That's very cheeky, but, and related Pelva, but, you know what? Hey, it's a million bucks. You gotta do something. [00:23:53] Lindsey Dinneen: Very good. Yeah. And it would be helpful because gosh, like we've talked about earlier, I mean, I had no idea the staggering statistics and I'm sure many of us really don't. So just, just having that awareness and that education and, what do we do next, and how can we help? And that's awesome. Well, also, how do you wish to be remembered after you leave this world? [00:24:18] Kelley Satoski: My goodness, going deep. But no, I love it. It's an interesting question. I, I want to be remembered for being someone that really went after things and was somebody that also really encouraged people to do what they want to and made that possible. I love big dreamers. So big dreams, always went after it, and was honest, a really honest person, really real, and kind. Those things, you know, good qualities. But yeah, I think a go getter was, is the first thing that popped into my head. So maybe that's the one I should go with. [00:25:05] Lindsey Dinneen: Yeah. I love that. And you know, the way you answered that actually brought to mind, I, I had a question I meant to ask earlier, was it difficult for, for you and, and, or maybe your husband as you're forming this company and you're talking about a very personal, your own story, what was that experience like? Was that really hard to get comfortable and used to talking? I just... [00:25:30] Kelley Satoski: Oh yeah! I lead every pitch that I do telling my story. I say it really quick, "I spent over 10 years unable to have intercourse with my husband due to a chronic vulvovaginal pain disorder. And as crazy as that sounds, here's the statistics." I've got it down to, I've got it down line by line. 'Cause it is tricky, it's tricky to talk about in such a way that others are comfortable. How do I share it in a way that doesn't objectify myself and lose people when I'm trying to really pitch a real company? So it definitely felt like a bit of an art on sharing. [00:26:07] Lindsey Dinneen: Yeah. [00:26:08] Kelley Satoski: I'm learning how to share my story, but I do remember at the very beginning, I hadn't told really anyone that I was struggling with this, not my family not, yeah, like no one. And I remember telling Doug when we decided to start Pelva, "Am I going to have to start telling people about this? If we're going to start this company, I'm going to have to tell my parents, I'm going to have to like, we're putting this out there." And he's like, "Yeah!" And I bet I just had to make the choice that it was worth it. But the more I talk about it, the more other people talk about their experience. And it ends up actually feeling really good. You end up starting to get more experience as you feel more, more supported and less alone. In fact, sometimes I wish people would not tell me so much, but they do! Talking to you, to my mother in law, too much info. [00:27:01] Lindsey Dinneen: Mm mm. Oh, man. [00:27:03] Kelley Satoski: Yeah, you get to create these really safe spaces for people to also share what they're going through. We need to talk about it. [00:27:11] Lindsey Dinneen: It's so true. I definitely commend you for that. Because yeah, that that would certainly be uncomfortable for a while, maybe, maybe forever. I don't know. But, you know, being able and willing to share and be vulnerable to your point, I think, is what creates that safe space for other people to say, "Oh my gosh, me too." And, "How, how can we change this? How can we band together or at least support each other?" So I love that. Thank you for creating those safe spaces. [00:27:36] Kelley Satoski: Yeah, and I feel like, and the other thing that I would say is that, I always got a lot of like, "Ooh, be careful, you're going to run into a ton of pushback and people are going to be weird." And something I feel like I've decided really early on is to give people the benefit of the doubt. I think, yeah, sex is hard to talk about, like, it is, you know, and I'm not gonna blame anybody for feeling a little uncomfortable talking about it, and talking about me and hearing those really personal stories. So I think the more I've approached it from just a very accepting and less reactive and looking for people to be weird about it, or not accepting or not supportive, whatever that energy you project, you almost start to receive. So I've tried to be a little bit more open about it all. [00:28:29] Lindsey Dinneen: I love that. Yeah, that's fantastic. Thank you. So, final question. What is one thing that makes you smile every time you see or think about it? [00:28:40] Kelley Satoski: Oh. Oh, man, that is an interesting question, but I like it. I would say I was a part of this Herb Society in Minnesota here, the Minnesota Herb Society, and it's full of the most lovely old ladies, and I am the youngest person there, for sure, but they are the most wonderful ladies and the most joyful people to ever be around, so I think whenever I think about them, they make me smile. There's a bunch of old ladies digging in the dirt and planting herbs, what can't you smile about? [00:29:16] Lindsey Dinneen: Yeah, what's not to love? That's phenomenal. I love it. So cool. Well, oh my goodness, this has been an amazing conversation. And Kelley, just thank you so much for for sharing and for being willing to take the risks, right? And and to, to compare risks and say, "The greater risk is doing nothing or or not chasing after this. And we don't know where it's going to leave, but we're going to try." So... [00:29:40] Kelley Satoski: Yes. [00:29:41] Lindsey Dinneen: ...Thank you for doing that work. I know it's not hard. There are probably days where you're just like, "What did I do?" But you're doing it. So thank you for bringing this to the world and being open and vulnerable and, and letting other people be too. I appreciate that. [00:29:54] Kelley Satoski: Of course, I appreciate the opportunity. [00:29:56] Lindsey Dinneen: Yeah! And we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support. We just wish you the most continued success as you work to change lives for a better world. And thanks again for being here today and sharing your expertise with us. And thank you to all of our listeners for tuning in. And if you're feeling as inspired as I am, I would love it if you would share this episode with a colleague or two, and we'll catch you next time. [00:30:41] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

In this episode, Darrin Carlson will explain to us what are the main issues that are discovered during FDA inspections and how to correct them. We will also explain the different between an FDA inspection and a Notified Body audit. So stay tuned.  Who is Darrin Carlson?  Darrin Carlson has over ten years of experience in Quality and Regulatory in the medical device, pharmaceutical, and combination product fields. In addition to his current role as a Regulatory Affairs Specialist, he also helps small MedTech companies stay compliant with AI-powered, human-driven internal audits and publishes the QA/RA Playbook, a free weekly newsletter helping subscribers simplify compliance, empower innovation, and advance their careers.   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.  Link Darrin Carlson LinkedIn:  https://www.linkedin.com/in/darrinlcarlson/  Fix the Top 6 QMS Issues: https://qarasolutions.com/fixthetopsix  FDA page on Warning Letters: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters  FDA page on 483 data: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode of Medsider Radio, we sat down with Caitlin Morse, CEO and co-founder of BrainSpace, who has a decade of experience spanning medtech consulting, product development, and strategic advising. BrainSpace is developing an innovative precision drainage system with continuous ICP monitoring designed to automate cerebrospinal fluid management for patients recovering from strokes, traumatic brain injuries, and neurosurgery. In this interview, Caitlin shares her advice on assessing the viability of a medtech idea, tells the story of how her prototype won over stakeholders, and discusses navigating the development phase while balancing clinical and regulatory demands.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Caitlin Morse.

In this episode of NUCLECAST, host Adam Lowther engages with Dr. Robert Kittinger to discuss various aspects of nuclear policy, including the importance of tritium production, the role of small modular reactors in military applications, and the interconnectedness of nuclear energy and weapons. They explore the implications of denuclearization and the need for a dedicated supply chain for nuclear components, while also addressing the historical context of nuclear deterrence and its significance in maintaining global peace.Dr. Kittinger, is a Senior Fellow at the National Institute for Deterrence Studies (NIDS). He spent 10 years at Sandia National Laboratories, culminating in the Nuclear Threat Science department and working in Nuclear Emergency Support and Counterterrorism & Counter-Proliferation (CTCP). During his time at Sandia, he was also a 2017 graduate of the prestigious Weapon Intern Program (WIP).Before joining Sandia, Dr. Kittinger spent over five years as a civilian in the U.S. Navy and was part of a five-person tech startup, BookLamp, which was acquired by Apple in 2013. Following his tenure at Sandia, he served as a senior researcher at Amazon and currently holds the role of Chief Research Officer at a MedTech company.Chapters00:00 Introduction to NUCLECAST and Guest Introduction01:14 Presidential Address and Nuclear Policy Discussion03:40 Tritium Production and Its Importance12:10 Challenges in Nuclear Supply Chain and Future Needs13:01 Small Modular Reactors and Their Military Applications18:04 Nuclear Energy and Weapons Interconnection20:31 Denuclearization and Global Peace Perspectives28:50 Wishes for the Future of Nuclear Energy and DeterrenceSocials:Follow on Twitter at @NucleCastFollow on LinkedIn: https://linkedin.com/company/nuclecastpodcastSubscribe RSS Feed: https://rss.com/podcasts/nuclecast-podcast/Rate: https://podcasts.apple.com/us/podcast/nuclecast/id1644921278Email comments and topic/guest suggestions to NucleCast@anwadeter.org

Liz and Rachel dive into Liz's interview this week as they discuss competency exams for clinical support reps. As they do so, they share their insights into how creating assessments first can drive curriculum development and contribute toward a successful trial.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Listen to the interview with Varun here. Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

In this episode, Antony Watson, COO of Xenocor, joins Duane Mancini to share his journey from Medtronic sales rep to startup founder. Antony discusses his experience in the operating room, observing surgical cases firsthand, and how this unique perspective shaped his leadership approach and ultimately prepared him to launch and lead Xenocor. Discover how valuable lessons learned in the field can translate to success in the startup world. Tune in for insights on transitioning from a corporate environment to the challenges and rewards of entrepreneurship in the medtech industry.Antony Watson LinkedInXenocor LinkedInXenocor Website⁠⁠⁠⁠⁠⁠⁠⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Midwest Showcase Registration⁠

Every time a healthcare business talks to me about expansion, they say the same thing:“We want to go to America.” But here's the thing… just because it's the biggest healthcare market in the world, doesn't mean it should be your first stop.The US is complex, highly regulated, and fiercely competitive—so getting your strategy right before you enter is crucial.That's why, in this Five in Five, I'm sharing five key lessons from my conversation with Angela Spang, an award-winning MedTech entrepreneur who's successfully scaled her business across the UK, Sweden, and the USA.If you're considering an international expansion, this episode is packed with insights to help you make smarter moves and avoid costly mistakes.

While tariffs continue to dominate headlines, our Global Head of Fixed Income Research and Public Policy Strategy Michael Zezas suggests investors should also focus on the sectoral impacts of additional U.S. policy choices.----- Transcript -----Welcome to Thoughts on the Market. I'm Michael Zezas, Morgan Stanley's Global Head of Fixed Income Research and Public Policy Strategy. Today, we'll be talking about U.S. policy impacts on the market that aren't about tariffs.It's Wednesday, March 12th, at 10:30am in New York.If tariffs are dominating your attention, we sympathize. Again this week we heard the U.S. commit to raising tariffs and work out a resolution, this time all within the span of a workday. These twists and turns in the tariff path are likely to continue, but in the meantime it might make sense for investors to take some time to look away – instead focusing on some key sectoral impacts of U.S. policy choices that our Research colleagues have called out. For example, Andrew Percoco, who leads our Clean Energy Equity Research team, calls out that clean Energy stocks may be pricing in too high a probability of an Inflation Reduction Act (IRA) repeal. He cites a letter signed by 18 Republicans urging the speaker of the house to protect some of the energy tax credits in the IRA. That's a good call out, in our view. Republicans' slim majority means only a handful need to oppose a legislative action in order to block its enactment. Another example is around Managed Care companies. Erin Wright, who leads our Healthcare Services Research Effort, analyzed the impact to companies of cuts to the Medicaid program and found the impact to their sector's bottom line to be manageable. So, keeping an in-line view for the sector. We think the sector won't ultimately face this risk, as, like with the IRA, we do not expect there to be sufficient Republican votes to enact the cuts. Finally, Patrick Wood, who leads the Medtech team, caught up with a former FDA director to talk about how staffing cuts might affect the industry. In short, expect delays in approvals of new medical technologies. In particular, it seems the risk is most acute in the most cutting edge technologies, where skilled FDA staff are hard to find. Neurology and brain/computer interfaces stand out as areas of development that might slow in this market sector. All that said, if you just can't turn away from tariffs, we reiterate our guidance here: Tariffs are likely going up, even if the precise path is uncertain. And whether or not you're constructive on the goals the administration is attempting to achieve, the path to achieving them carries costs and execution risk. Our U.S. economics team's recent downgrade of the U.S. growth outlook for this and next year exemplifies this. Thanks for listening. If you enjoy the show, please leave us a review wherever you listen and share Thoughts on the Market with a friend or colleague today.

Gurus, get ready for an incredible conversation! Today, we're sitting down with Dr. Andrew Napier, CEO and founder of Intublade. His journey is nothing short of amazing—from being a battlefield medic in Afghanistan to an emergency physician, and now a MedTech entrepreneur shaking up airway management. Dr. Napier saw firsthand the challenges of intubation in high-pressure situations, and instead of waiting for someone else to fix the problem, he built the solution himself. His innovation is transforming emergency care, making airway management faster, safer, and more reliable. Dr Napier and I get into; How to Innovate Under Pressure – Discover how Dr. Napier's battlefield experience shaped his approach to problem-solving in MedTech. Turning a Big Idea into Reality – Hear the real talk on overcoming FDA hurdles, securing funding, and getting a new medical device into hospitals and EMS units. Why Collaboration is Key – Learn how breaking down silos between engineers, clinicians, and sales teams leads to better products and faster adoption. You won't want to miss this one—Dr. Napier's energy, insights, and no-nonsense approach to innovation will leave you inspired. Let's dive in!

In this episode of Medsider Radio, we had an insightful discussion with Drs. Asha Parekh and Adam Power, co-founders of Front Line Medical Technologies. The company's COBRA-OS (Control of Bleeding, Resuscitation, Arterial Occlusion System) is a compact, minimally invasive device, designed for temporary aortic occlusion in trauma situations. Asha has a PhD in Biomedical Engineering from Western University, and combines technical expertise with entrepreneurial leadership. Adam is an academic and practicing vascular surgeon at Western University, with extensive training from institutions including Dalhousie, McMaster, and Mayo Clinic.In this interview, they discuss how their clinical-engineer partnership accelerated development, their approach to clinical studies for regulatory clearance across multiple geographies, and their strategic decision to avoid VC funding during early development—and how that decision paid off.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Asha Parekh and Adam Power.

Today, we have a guest post by Mag O'Keeffe, Vice President of Global Additive Technologies at Stryker, focused on the role technology, talent and innovation can play in enhancing Ireland's position as a global MedtTch leader. The global medical technology (MedTech) landscape continues to evolve, and Ireland has been at the forefront of this transformation. The country has emerged as a leader in the sector, attracting multinational companies and driving cutting-edge advancements which are advancing patient care. With approximately 450 MedTech companies operating across the country, the sector employs over 45,000 people, making Ireland the largest employer of MedTech professionals in Europe per capita. This success story is the result of a unique ecosystem which has made Ireland a destination of choice for MedTech companies. As we look ahead, IDA Ireland has identified health as one of the four strategic growth drivers for investment for the rest of this decade. From the development of smart medical technology to advanced manufacturing, the agency's latest five-year strategy seeks to capitalise on opportunities within the MedTech sector. In an era of rapid change, driven by emerging technologies and increased global competition, the question we must ask ourselves is: How we do we unlock the opportunities that lie ahead and enhance Ireland's position as a MedTech hub into the future? The answer lies in a laser focus on research, development and innovation. However, to ensure that innovation can flourish, we must focus on developing and embracing new technologies, reinforcing ties with academia and healthcare institutions, and investing in the upskilling and reskilling of our workforce. Harnessing the power of technology Ireland's success in MedTech stems from the presence of international and home-grown organisations that are deeply committed to research and development. Ultimately, the global MedTech industry is dedicated to saving lives and improving patient outcomes, particularly in the context of an aging global population. Achieving this requires an ongoing commitment to innovation. Companies must not only stay ahead of evolving patient needs but also integrate new technologies seamlessly. Stryker, which has been at the very heart of Ireland's MedTech landscape for over 25 years, has a track record of staying one step ahead of change, developing disruptive technologies and advancing innovation to drive meaningful change for patients and healthcare professionals. We are particularly proud of the progress we have made in Ireland in the field of 3D printing. Our AMagine Institute in Carrigtwohill is home to one of the world's largest additive manufacturing facilities. The institute is pioneering the transformation of the manufacturing process, enabling the creation of custom devices tailored to individual patients. As MedTech companies embrace new technologies and move towards alternative ways of manufacturing like 3D printing, the realms of possibility will continue to expand, and innovation will continue to flourish. The success of our 3D technology is just one example of how Ireland's MedTech sector can continue to lead by developing cutting-edge technologies. Advancements in AI, robotics and digital twin technology are some of the other technologies that the workforce within the MedTech sector will need to continue to embrace to maintain Ireland's competitiveness. Deepening collaboration between industry, academia and the healthcare sector The MedTech industry cannot thrive in isolation. It is essential to broaden the culture of collaboration that has emerged in recent years and deepen the ties between industry, our world class research community, supply chain partners and clinical colleagues. As highlighted in Ireland's Industry 4.0 Strategy, the government recognises the need to foster collaboration both inside and outside the MedTech sector. To maintain Ireland's position at the forefront of MedTech, a strong collabo...

Welcome to this week's episode of The Power Lounge, where transformative ideas meet impactful action. Today, we feature Ikram Guerd, CMO and General Manager for the US at Aspivix, a leader revolutionizing gynecological care with groundbreaking solutions for painless IUD insertion. With over two decades of experience in MedTech and FemTech across the USA and Europe, Ikram has driven growth and innovation in both large corporations and startups.Discover how Ikram navigates the complexities of marketing innovative health solutions and leverages artificial intelligence to advance femtech marketing. Her dedication extends beyond her professional achievements; as a board member of Inspiring Girls USA, she mentors young women and champions gender equality in healthcare.This episode offers valuable insights for health tech enthusiasts and marketing professionals alike, providing actionable strategies to enhance women's healthcare experiences through innovation and effective marketing. Join us for an enlightening discussion that highlights the power of marketing and technology in transforming lives.Chapters:00:00 - Introduction01:46 - "Empowering Women: Amy & Ikram's Talk"04:32 - Passion for Marketing Career Pivot08:31 - Empower Consumers in Healthcare Choices11:42 - Engaging Early Adopters for Feedback15:49 - AI Revolutionizing Healthcare17:49 - Hopeful Solutions in Women's Health Marketing22:51 - Patient Advocacy in Prescription Choices24:34 - Data Crucial for Stakeholder Buy-In27:35 - Designing GERD Study Campaign for Kids30:56 - AI-Driven Hormone Health Apps35:54 - Hot Flashes and Inspiring Girls38:31 - "Inspiring Girls: Mentorship for Young Women"42:45 - Empowering Through Volunteerism43:48 - Patient Experience Impact Score49:32 - Bridging Investor-Audience Communication Gap52:19 - "Subscribe to the Power Lounge"53:14 - OutroKey Takeaways:Pioneering FemTech RevolutionBlazing Trails in Women's HealthNavigating Change and InnovationIgniting Passion and PurposeThe Power of Networking and MentorshipPersonalization and Hyper-Targeting in MarketingThe Future of FemTech and InvestmentQuotes:"Marketing is driven by passion and purpose. Harness them to truly connect."- Amy Vaughan"Turn every obstacle into an opportunity. Let 'you can't' fuel your determination."- Ikram GuerdConnect with Ikram Guerd:LinkedIn: https://www.linkedin.com/in/ikramguerd/Website: https://www.aspivix.comConnect with the host Amy Vaughan:LinkedIn: http://linkedin.com/in/amypvaughanhttps://www.togetherindigital.com/podcast/Learn more about Together Digital and consider joining the movement by visiting https://togetherindigital.comSupport the show

Many healthcare businesses dream of expanding into the US—it's the world's biggest healthcare market, after all. But size doesn't always equal opportunity. The US is highly regulated, expensive, and incredibly competitive. Without the right strategy, even the best companies can struggle. In this episode, I sit down with Angela Spang, award-winning entrepreneur and founder of June Medical, who has successfully scaled businesses across the UK, US, and Sweden. She shares the five key lessons she learned while launching into the US healthcare market—so you don't have to learn them the hard way. Tune in to learn:

In this episode of Medsider Radio, we sat down with Kelly Huang, President and CEO of Elucid. Elucid has developed a platform that uses AI to analyze cardiac CT scans to provide a detailed, non-invasive assessment of a patient's arterial plaque. Kelly's journey spans nearly 30 years of leadership in healthcare, with expertise in driving innovation and growth across medical devices, diagnostics, health IT, and consumer health. Before Elucid, he served as COO at Cardea Bio, leading its successful acquisition by Paragraf, and as CEO of Obalon Therapeutics, where he introduced noninvasive medical devices to expand treatment options for physicians. Kelly's career also includes senior roles at L-Nutra, Nestlé/Galderma, Endo Pharmaceuticals, and Johnson & Johnson.In this interview, Kelly shares advice on how to successfully bring novel devices to market, secure reimbursement, and drive adoption by focusing on the essentials—collaboration, trust, robust data, and transparency.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Kelly Huang.

In this episode of Let's Combinate, host Subhi Saadeh is joined by quality systems expert Aaron Snyder to explore the critical quality system element known as CAPA (Corrective and Preventive Action). They dive into the differences between CAPA approaches in the pharmaceutical and MedTech industries, examining their historical and regulatory contexts. Aaron explains how U.S. regulations describe deviations on the pharma side and non-conforming products on the MedTech side, and how these are handled differently under respective quality systems. The conversation also touches on topics like root cause analysis, verification of effectiveness, and the importance of management support in making CAPA systems effective. Aaron highlights the value of continuous improvement and debunks common misconceptions about CAPA in both industries.00:00 Introduction and Guest Introduction00:33 Understanding CAPA in Pharma and MedTech01:08 Regulatory Differences and Their Implications03:12 Event Handling and Investigation Processes08:13 CAPA System Effectiveness13:57 Quality System Approaches in Pharma and MedTech26:22 Root Cause Analysis and Continuous Improvement30:43 Conclusion and Contact InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.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.

Eric Semler, chairman of Semler Scientific, shares his journey from being an investor in technology and media to adopting a Bitcoin treasury strategy for his company. He discusses the origins of Semler Scientific, the challenges faced in the healthcare sector, and how he became convinced of Bitcoin's potential as a store of value. Eric elaborates on the transition from personal conviction in Bitcoin to implementing a corporate strategy, navigating regulatory hurdles, and the evolution of Bitcoin treasury strategies. He also addresses the concept of zombie companies and their potential to benefit from adopting Bitcoin as part of their financial strategy. The strategic timing for deploying Bitcoin in business operations, the high hurdle rate associated with Bitcoin investments, and the evolving landscape of Bitcoin treasury companies are few of the other aspects discussed in depth. Takeaways

Liz is joined by Dr. Varun Malhotra on the podcast this month to discuss clinical competency exams for clinical support reps. As both a practicing physician and an industry leader, he shares invaluable perspective on both how a rep should act in the OR and how companies should prepare reps to do so. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Related Resources:Dr. Varun Malhotra is an ophthalmologist with specialized training in glaucoma who has successfully bridged the worlds of clinical practice and biotechnology innovation.Dr. Malhotra completed his undergraduate education at Dartmouth College before earning his medical degree from New York University School of Medicine. He continued at NYU for his ophthalmology residency, gaining comprehensive training in diagnosing and treating various eye conditions. His education was further enhanced with a specialized fellowship in glaucoma at the prestigious Illinois Eye and Ear Infirmary, where he developed expertise in managing this complex eye disease.With additional credentials including an MBA from the University of Chicago Booth School of Business, Dr. Malhotra cultivated a multifaceted career spanning both academic and private practice settings before making a strategic transition to the biotechnology sector with a role at Genentech, where he was the clinical lead for the Port Delivery System Diabetic Macular Edema program. He also served as the global surgical lead for the entire Port Delivery System, where he oversaw the expansion and surgical training for all internal and external stakeholders of ophthalmic clinical trials from the United States to encompass countries in Europe, South America, and Asia.Dr. Malhotra is currently the Vice President of Clinical Development for Ollin Bioscience, an ophthalmic biotech company. He still practices ophthalmology and trains resident physicians in clinical and surgical skills on a weekly basis. Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Varun MalhotraCumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality."

What if the biggest obstacle to your medical sales isn't the market or the competition, but internal inefficiencies within medical practices themselves? Discover how addressing these challenges can unlock unprecedented growth in medical device sales. In this week's episode, sponsored by Physician Growth Accelerator, Managing Director, Erik Trattler, dives into how medical device reps can extend their influence beyond traditional sales roles by facilitating improvements in practice management. We also explore invaluable insights gained from his extensive experience in both medical device sales and as a consultant focused on operational efficiency. Join us as we explore actionable strategies that help medical practices streamline their operations, thus creating a more conducive environment for adopting new medical technologies and enhancing patient care. What we discuss in the episode: Identifying and overcoming the unseen operational barriers that can stagnate medical device sales. The crucial role of medical device reps in consulting on practice efficiency. How optimizing practice operations can lead to increased adoption of new medical technologies and better patient outcomes. Resources from this episode:  Get the free MedTech Talk Tracks for Action Physician Growth Accelerator Landing New Cases: The Missing Link for Medical Device Social Media:  Connect with Erik on LinkedIn Connect with Zed on LinkedIn

Tim Tobin, CEO of Planatome,is our Guru in this episode. Planatome isgroundbreaking innovation isreshaping surgical outcomes. Discover how nanopolished surgical blades are reducinghypertrophicscarring and transforming patient recovery. Tim shares insights from Planatome's journey, fromchallenges in commercialization to exciting breakthroughs in healing technology. Join us as we explorethe future of surgical precision and the societal impact of these cutting-edge advancements. Stay tunedfor an inspiring conversation with a true MedTech visionary!

In this episode of Medsider Radio, we had an insightful chat with Nitin Salunke, President and CEO of Supira Medical, a Shifamed portfolio company. Supira is developing a catheter-based heart pump that provides hemodynamic support for patients undergoing high-risk heart procedures. Before Supira, Nitin was Vice President of R&D at Medtronic Neurovascular, overseeing global product development. He has also held leadership roles at Altura Medical, Cordis Corp (then a Johnson & Johnson company), and W.L. Gore & Associates. Nitin holds a PhD in Mechanical Engineering and is an inventor and co-author on many patents and publications.In this interview, Nitin shares the philosophy that guided his journey as CEO of Supira, his strategy to evaluate and address major risk factors in medtech, how to generate value for all stakeholders—patients, physicians, and investors, and his formula for creating a next-gen medical device.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Nitin Salunke.