Podcasts about Medtech

This week Liz and Rachel dive into the interview with Liana Mari-Gordon on building best practices during the clinical trial. They share what stood out to them and how they've seen Liana's comments play out at other organizations.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:Liana's interviewSubscribe 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.

Christian Espinosa, founder of Blue Goat Cyber and leading voice in medical device cybersecurity, joins Etienne Nichols to unpack the urgent and often misunderstood topic of cybersecurity in MedTech. From FDA's 2023 regulatory overhaul to real-world hacking scenarios that could harm patients, Christian provides practical advice for innovators, RA/QA professionals, and software teams. He also shares why waiting until the last minute on cybersecurity could cost startups millions—or even kill a project entirely.Whether you're a quality professional trying to build compliant systems or an innovator racing toward FDA submission, this episode lays out exactly what you need to know to stay ahead of cyber threats and within regulatory guardrails.Key Timestamps:00:01 – Intro to guest Christian Espinosa and Blue Goat Cyber06:28 – Why medical device cybersecurity is different from traditional IT security11:49 – Real-world hacking example: acne laser device turned skin-burner13:57 – FDA expectations post-September 2023: what changed17:12 – Secure boot: a microcontroller mistake that derailed a launch20:35 – Common cybersecurity vendor mistake MedTech companies make23:40 – SBOM: Software Bill of Materials and why it's legally critical27:58 – Cyberattacks in hospitals: assuming a hostile network35:44 – AI in medical devices: data bias and cybersecurity challenges41:10 – Developers ≠ cybersecurity experts: the training gap nobody talks about45:20 – What RA/QA professionals need to know now49:30 – Why cybersecurity must be iterative, not a final-phase add-on55:20 – Espinosa's final advice for MedTech professionals57:52 – The story behind “Blue Goat Cyber”Standout Quotes:“Cybersecurity for medical devices isn't about data breaches—it's about patient harm. You could paralyze someone or misdiagnose sepsis. This isn't theoretical.”— Christian Espinosa, on the real risks of insecure devices“Most developers don't understand cybersecurity. We assume they do—but that's like expecting an architect to be a locksmith.”— Christian Espinosa, on why so many devices fail security assessmentsTop Takeaways:Cybersecurity isn't just about data—it's about patient safety. From burning skin to missed sepsis diagnoses, vulnerabilities in devices have real-world harm potential.FDA now requires more than just a basic security plan. Post-September 2023 rules mandate testing (SAST, DAST, fuzzing), SBOMs, and risk assessments tied to patient harm.Start cybersecurity planning during the requirements phase. Hardware like microcontrollers must support secure boot and other protections—retrofits can cripple product plans.Iterate cybersecurity like any core development activity. One-time testing near submission is too late; build security into your pipeline just like QA or usability.Traditional cybersecurity vendors aren't enough. Many fail to meet FDA's nuanced expectations for medical devices, causing costly submission rejections.References & Resources:Christian Espinosa on LinkedInBlue Goat CyberEtienne Nichols on LinkedInMedTech 101 – Understanding SBOM (Software Bill of...

Send us a textIn this episode, industry experts discuss the evolving landscape of technology and its impact on investment strategies. Key topics include the role of AI in driving innovation, the potential for consolidation in med tech and healthcare, and the increasing importance of operational due diligence in private equity. Panelists share their experiences and insights on how technology has streamlined due diligence processes, enhanced transparency, and shaped decision-making in their investments. They also offer valuable advice on how family offices and private investors can approach M&A, divesting strategies, and niche investing, while emphasizing the importance of focusing on a clear strategy and avoiding distractions from emerging trends.

✨ New Episode Alert! ✨ Ready to sell more and stress less? In today's podcast, I'm unveiling my brand-new Priority Playbook Sales Edition — packed with powerful, proven tools to help you protect your energy, amplify your strengths, and thrive in medical device sales.

In this episode of Medsider Radio, we sat down with Dr. Arun Menawat, Chairman and CEO of Profound Medical. Profound is commercializing the TULSA-PRO system, an alternative approach to prostate cancer treatment that uses MRI-guided thermal ultrasound to target and eliminate cancerous tissue without surgical incisions. Before joining Profound in 2016, Arun served as the Chairman and CEO of Novadaq Technologies for 13 years, guiding the company from a startup to one of the fastest-growing, NASDAQ-listed medical technology businesses with a market cap exceeding one billion USD. Earlier in his career, Arun served as President of Cedara Software, a company that developed the industry's first medical imaging software platform. Today, it's part of IBM's Watson Health.In this interview, Arun shares insights on building credibility with physicians, the strategic approach to clinical trials that led to their recent Medicare reimbursement coverage, and his vision for transforming the future of surgery beyond prostate cancer.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 Arun Menawat.

What trends are shaping the Medtech industry today? In this episode, ⁠Adam Torres⁠ and ⁠Julio Martinez-Clark⁠, CEO at bioaccess®, explore Julio's journey and insights into the state of the Medtech industry. Follow Adam on Instagram at ⁠https://www.instagram.com/askadamtorres/⁠ for up to date information on book releases and tour schedule. Apply to be a guest on our podcast: ⁠https://missionmatters.lpages.co/podcastguest/⁠ Visit our website: ⁠https://missionmatters.com/⁠ More FREE content from Mission Matters here: ⁠https://linktr.ee/missionmattersmedia⁠ Learn more about your ad choices. Visit podcastchoices.com/adchoices

What trends are shaping the Medtech industry today? In this episode, Adam Torres and Julio Martinez-Clark, CEO at bioaccess®, explore Julio's journey and insights into the state of the Medtech industry. Follow Adam on Instagram at https://www.instagram.com/askadamtorres/ for up to date information on book releases and tour schedule. Apply to be a guest on our podcast: https://missionmatters.lpages.co/podcastguest/ Visit our website: https://missionmatters.com/ More FREE content from Mission Matters here: https://linktr.ee/missionmattersmedia Learn more about your ad choices. Visit podcastchoices.com/adchoices

"In this 5-in-5 episode of The H-Files, we review the key takeaways from my podcast with MedTech entrepreneur Spencer Jones to break down 5 practical ways AI is transforming how we build and scale MedTech businesses. From FDA submissions to ROI calculators, these aren't hypotheticals, they're real-world strategies you can apply today.Hit play and discover how to save time, scale smarter, and stay competitive using AI."

Send us a textJoin host Aaron Moncur as he sits down with Dr. Stuart Grant, a seasoned med tech innovator with over 25 years of experience at industry giants like Johnson & Johnson and DePuy. Dr. Grant shares his journey from design engineering to founding his own consultancy, offering invaluable insights into medical device development, regulatory challenges, and the future of medical technology.Main Topics:Career progression in medical device engineeringChallenges of starting a medical tech consultancyRegulatory differences across global marketsInnovation strategies in medical technologyAdvice for young engineersFuture trends in surgical robotics and AIAbout the guest: Dr. Stuart Grant is a seasoned expert in the MedTech industry with over 20 years of experience at major companies like Johnson & Johnson and DePuy Synthes. In 2023, he founded Archetype MedTech, a consultancy that helps medical device companies achieve market approval through innovation strategy, technical evaluations, and team training. He holds advanced innovation and project management degrees and is a Chartered Engineer with several medical device patents. In addition to his technical work, Stuart lectures on innovation history and is a visual artist. His international experience and multidisciplinary expertise make him a key advisor for MedTech startups and scale-ups.Links:Dr. Stuart Grant - LinkedIn Archetype MedTech Website The Idea Factory: Bell Labs and the Great Age of American InnovationExactly How Precision Engineers Created the Modern World

In this episode of Medsider Radio, we sat down with Claire Dixon, CEO of Neuraura.Neuraura is developing LoOop, an over-the-counter wearable that targets PCOS through low-frequency electrical stimulation.Claire brings over 25 years of international leadership experience to her role as co-founder and CEO of Neuraura. With a master's degree in engineering from Cambridge and an MBA from Harvard, she spent 15 years as a strategic consultant to capital-intensive businesses before transitioning to entrepreneurship. She was recently named among the “Top 200 Trailblazing Leaders in Women's Health and femtech” by Women of Wearables.In this interview, Claire shares insights on navigating regulatory pathways, designing for real user needs, and building strategic partnerships to bring innovative women's health solutions to market through a direct-to-consumer approach.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 Claire Dixon.

In this episode, Liz Cumby is joined by Liana Mari-Gordon, an expert in mechanical engineering and surgical training, to discuss best practices throughout the clinical trial phase of medical devices. Liana shares her experiences of learning how what "looks good on paper" may need to be updated when the device is in the hands of a physician. They delve into the importance of standardizing training, capturing and sharing field data, and maintaining honest conversations about challenges and successes. The episode also highlights methods to implement continuous improvements and ensure best practices are disseminated across users.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:Liana Mari-Gordon is the owner of Liana Mari Gordon Consulting LLC, providing project management, training operations, and device development services to help set teams up for successful execution of training programs. She has spent her career in the medical device and pharmaceutical industries ranging from small startups to Fortune 500 companies. As a mechanical engineer designing spinal implants and surgical instruments at Globus Medical, her experience conducting hands-on training, supporting surgical cases, and evaluating product complaints from the field formed her passion for informed use of product and positive user experience. She joined Orbit Biomedical, an ophthalmic medical device startup, and became a surgical technical expert responsible for clinical trial device and procedure training. Liana's responsibilities expanded to managing the logistics and execution of training programs and surgery support for a global team and multiple clinical trials as the startup merged with Gyroscope Therapeutics. As training operations lead, Liana led communication between cross functional teams to ensure readiness of and consistency across internal team members and trial sites. When acquired by Novartis, Liana was a key member in integrating existing practices within the larger organization and facilitating process improvements when needed. Liana earned a BS and MEng in mechanical engineering from Cornell University.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: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Liana Mari-Gordon⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby 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.

Jón Ingi Bergsteinsson MedTech founder, former CTO of SMART-TRIAL and now a startup advisor and investor via LIFA Ventures. With 10+ years of hands-on experience scaling a SaaS company in regulated healthcare, Jón offers a rare blend of technical and commercial insight.In this episode, we talk about why founders should stop treating regulatory and commercial teams like separate planets, how VCs really evaluate MedTech startups, and what SaaS-style thinking can teach traditional device companies. Jón also walks us through his “founder-to-fund” journey, shares common pitfalls in clinical trial design and gives a blunt take on why copying pharma's playbook won't work in MedTech.Timestamps:[00:00:35] Why MedTech Startups Still Struggle to Scale[00:03:41] Building SMART-TRIAL Without Venture Capital[00:06:25] Regulatory & Clinical Teams Need to Talk More[00:09:50] LIFA Ventures: Investing Beyond the Spreadsheet[00:12:12] The Hidden Cost of Ignoring Commercialization[00:14:07] Copying Pharma? That's a Mistake[00:17:33] Europe vs U.S. Startup Culture: What Founders Get Wrong[00:20:45] Advice for Early-Stage Founders in Regulated Health[00:24:28] Jón's Life Beyond MedTech: Coaching, Family & Hobbies[00:26:12] One Thing He Wishes Founders Would Stop DoingGet in touch with Jón - https://www.linkedin.com/in/joningib/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwalSubscribe to the Podcast

In this episode of The H-Files, Hakeem is joined by returning guest Spencer Jones to dive into the real-world applications of AI in building and scaling MedTech businesses.From cutting regulatory prep time in half to identifying top KOLs across Europe, Spencer walks through the exact tools and workflows he uses to supercharge productivity, speed, and innovation.

Mildred Zayas, a global supply chain executive with over 25 years of experience in the medical technology industry, shares her transformative journey from her early career in Puerto Rico to leading strategic initiatives at Johnson & Johnson. She emphasizes operational excellence, supply chain optimization, and mentoring emerging leaders. She discusses the importance of continuous learning, servant leadership, and the exciting future of MedTech with advancements in robotics and AI. Mildred also highlights her passion for empowering underserved communities and her involvement in nonprofit organizations like America Needs You.    Guest links: www.linkedin.com/in/mildred-zayas/ Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium   EPISODE TRANSCRIPT Episode 054 - Mildred Zayas [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome Mildred Zayas. Mildred is an accomplished leader with extensive and global expertise in strategic planning, operational excellence, and supply chain optimization within medical technology and life sciences. Well, thank you so much for being here today, Mildred. I'm so excited to talk with you. [00:01:15] Mildred Zayas: Thank you for the invitation, Lindsey. [00:01:17] Lindsey Dinneen: Of course. Well, I would love it if you would start off by sharing a little bit about yourself and your background and what led you to MedTech. [00:01:25] Mildred Zayas: Of course. I'm a global supply chain executive with over 25 years of experience in the medical technology industry. I have had the privilege of leading transformative initiatives at Johnson and Johnson, where I optimize manufacturing network, particularly in Asia Pacific, resulting in cost savings, inventory improvements, improved customer service levels as well. We also have introduced what I call the manufacturing ecosystems, which is instead of focusing on the product design on the customer only, which is important-- I'm not saying that it isn't-- but we also want to introduce a product that, of course, is high quality and dependable, but we also enhancing the efficiency and manufacturability is what is called designing for manufacturability. Product design and manufacturing don't have to be mutually exclusive, and that is something that I definitely learned through my career. I was born and raised in Puerto Rico. I'm particularly dedicated to empowering underserved communities to achieve greater economic and career advancement. My career is driven by a commitment to operational excellence, strategic innovation, and mentoring emerging leaders to achieve their full potential. [00:02:43] Lindsey Dinneen: That's amazing. Thank you so much for sharing a little bit about that. So I would love to go back a little bit further and start. When you were young, did you have any idea that something like this was something you wanted to do? What was your dream? What were you thinking about? [00:02:56] Mildred Zayas: So I have to say yes. And I always, I'm an engineer by training and I always wanted to be an engineer. My uncle was an engineer. Even though he actually opened a university and did something different, he was pretty much, you know, I guess the big person in our family, everybody looked at him. We all wanted to be like my uncle, right? Unfortunately, he passed away. But with that, I always knew that I wanted to be an engineer. That's why I went to engineering school. Eventually, being an industrial engineer led me to the manufacturing industry. I started my career in Puerto Rico and manufacturing was big in the nineties. Do we still have manufacturing? Not as much anymore. But that's how I started in the industry and in the manufacturing industry. And then I progressed through roles of increasing responsibility and continuing supply chain in leadership roles. But yeah, everything started by my family, my uncle and seeing what he was doing as an industrial engineer. And I wanted to be like that. Yeah. [00:03:58] Lindsey Dinneen: Oh, I love that. [00:04:00] Mildred Zayas: I'm also good in math. [00:04:01] Lindsey Dinneen: That helps. Excellent. Well, you know, you mentioned during your opening how the values and the core beliefs that you hold to still came from your upbringing in Puerto Rico, and I was wondering if you mind sharing a little bit about that. [00:04:18] Mildred Zayas: Sure. I grew up in a family, my parents, they love to serve. So when I grew up, actually, my mother was always with a cause. She was always helping people. She's still serves. She's 81 years old and she still has a number of ministries and serves. So that's what I saw with my parents since I was growing up. My father used to cook for homeless people when I was a teenager. So at that time, frankly, it bothered me a little bit, but now I can appreciate because really it's about serving and giving others. It's not just about yourself. And I have to thank my parents because they actually taught me that, and not only taught me that, they model it throughout their actions. [00:05:01] Lindsey Dinneen: Yeah, absolutely. And how has that value of service and giving back impacted your own role as a leader and how you relate to other people? [00:05:11] Mildred Zayas: Absolutely. So and that's interesting that you say that because when you talked about leadership, I always say, "be present, be transparent." You need to let people know what you stand for. But I also embrace what I what is called servant leadership. Of course, leadership is about direction and to have a vision and have followers and all that. I'm not saying that it isn't. But when you look about servant leadership, when you are really helping others, collaborating, and so people can move into where they want to go. So that's pretty much the way is looking into others and empowering them to reach their full potential and fostering collaboration and where trust and growth at the core of every decision. [00:05:57] Lindsey Dinneen: Yeah, absolutely. So you've had a really long career with Johnson and Johnson specifically, and it sounds like you have had a lot of different opportunity there. And I was wondering if you could speak a little bit towards your experience and how starting where you did and then now where you are, what was the progression like? What did you learn along the way that was really beneficial in helping you achieve the next milestones? [00:06:22] Mildred Zayas: First of all, let me just say Johnson and Johnson is a big company now, of course, 90 billion dollar and all that. But nowhere I started in the mid nineties, right in the early nineties, I should say. So, so it was a different type of company, number one. Number two, J and J has always been very decentralized, meaning each company-- we call it franchises now business unit-- each business unit is kind of run independently. So I started my career with Ethicon, which is the suture manufacturing company, and that's where I grew up and I worked most of my career on and off. But I was also able to move to other sectors on other franchises as well. So I started in Puerto Rico as a second shift manufacturing supervisor shortly after I had a previous job after college in the pharmaceutical industry, also in manufacturing. But I definitely wanted to be a manufacturing supervisor. And in pharmaceutical industry, you need to have a pharmaceutical background, and it was going to be more difficult for me to be in manufacturing. So Johnson and Johnson offered me an opportunity and I took it and I started in the second shift. From there, I progressed to what now is called process excellence, but it used to be called industrial engineer. Once again, C. I. P. process improvements and all that. Then I move into the planning organization materials management, we call it at the time, all in Puerto Rico. I've worked for five years when Ethicon in Somerville, which we had the headquarters, they called me and they offered me an opportunity to move to New Jersey. And this was in, my goodness, in 1999. So, so I moved to, to, to New Jersey and started working, of course, in the planning organization, supply planning, planning inventory management and all that. But then there was a big opportunity for me, and it was a transformative initiative in Edinburgh, Scotland. It was about manufacturing consolidation and optimization. So there were difficult parts because we closed a manufacturing plant of 800 people, yet we move operations to different places. So in the end, I mean, we definitely grew. It was tremendous for me to work in that initiative. It was my first global experience. I was in a commuter assignment in Scotland. And I had a global team with different functions, different areas, people in Belgium, people in Germany, people in China, because we transfer process to a fair places, people in Puerto Rico, of course, in New Jersey and in Scotland. And I can tell you that I made good friends that still they remember my birthday and we continue connecting via Facebook and all that. So, so that experience was fantastic on gave me a good perspective. I came and talked to my boss at the time and say, "Listen, I already implemented a project. It was fantastic. It was great. But I want to work on strategies." And something that I've always done, and maybe you ask me later about an advice, just ask. You know, people can say no, but I mean, just ask for what you want. So I did! I asked and I got it. I was promoted to a senior manager at the time of my strategy development and deployment. So we were developing the five to seven year initiatives on where you want to have a manufacturing presence, whether make versus buy and those type of things. It did great. It was fantastic. And then I'm like, okay, I have work in the U. S. I have work in Europe. You know, what about Latin America? Because Puerto Rico is kind of in the middle. It's not 100 percent Latin America, especially from a work environment standpoint. We're reporting to the U. S. So I actually moved and worked for Johnson and Johnson Latin America. I was based in Miami and I supported our cardiovascular business. And I was there four years, and then the other two years, our diabetes care business. So I did that for several years and then I moved back to New Jersey where I actually continue developing strategies, was promoted into other directorship level, and work closely with Asia Pacific. That's where I created strategies in the region and help develop the network based on centers of excellence, reduce, of course, the footprint using a lot of suppliers and contract manufacturers as well. We try to optimize the model. So, it was exciting. I actually got to live in Singapore for a year and a half. So it was fantastic. I was there in an international development assignment. Then I came back and I actually went back to Puerto Rico to work in global supply planning. I mean, that's what I started. As I mentioned to you, I did a lot of planning early on, and there was an opportunity there. Even though it was based in Puerto Rico, it was a global opportunity. So I have responsibility for for team in Brussels. I have people in Juarez Mexico, of course, in New Jersey and I was based in Puerto Rico. Did that for a couple of years, and then actually I moved to consumer, to Johnson & Johnson consumer, and I was there for four years. And it was interesting because it's a very different pace, the pace of consumer goods versus medical devices. But it was a great experience. And once again, J and J is big. So I always wanted to take advantage and do different things. After that I came back, late in 2021, back to medtech. It used to be called medical devices by the way, but now it's medtech. And I came back in a strategy and project management role. I have responsibility to develop the overall strategies. But it was not for say, Ethicon, like before one of the franchises, right? It was for all of them. So I was working with orthopedics, of course, surgery, vision care, and then our interventional cardiology. So that's been my career in J and J. I always say three areas or four for me: manufacturing, obviously planning, project management, and strategy. So there's four. Well, I sometimes I put project management and strategy together, but you can call it three or you can call it four. [00:12:33] Lindsey Dinneen: Yeah. Excellent. Well, thank you for sharing more about that. It's an incredible career path you've had and taken you literally all around the world. And something that stood out to me as you were talking is, I'm so intrigued by your story, and courage seems to be a resonating theme. And so, between your willingness to step out of your comfort zone and go try and go learn and keep elevating your own knowledge and career and expertise, but then also to have the courage to ask for the things you want. I loved that advice so much. So I was wondering if you could maybe talk a little bit more about how did you have this courage to ask for what you want and how did this courage serve you as you continue to take advantage of opportunities in very new avenues for you? [00:13:22] Mildred Zayas: Sure. Once again, I have to go to my mother. I come from a pretty, pretty matriarchal family. My grandmother, my mother, they were very strong women. But she always said, "Ask, and you shall receive." [00:13:35] Lindsey Dinneen: Yeah. [00:13:36] Mildred Zayas: Quoting the Bible as well. But also you have to deliver and you have to execute. I mean, you don't have credibility if you don't do the job. So you have to do your homework. And then once you establish that credibility, once the organization knows that you add value, then you can start asking. And once again, the worst thing that can happen is that they say "no." In my experience it's never been no. The worst has been "not now," but it happened two years after. So you know what? You have to tell people what you're looking for and what you would like to do. But again, don't forget you have to deliver too, critically important. [00:14:17] Lindsey Dinneen: Yeah. Yeah. I love that. Well, and to your point, even if the answer is initially no, it's not usually "no, not ever for the rest of your life. It... [00:14:26] Mildred Zayas: Yet. Not now. [00:14:27] Lindsey Dinneen: ...Yeah, it's not yet. Exactly. So I love that, and your willingness to embrace that courage and do those things. So it looks like also, I know service is a big theme in your life, and one thing that I noticed when I was just glancing at your LinkedIn profile is that you have had opportunities to work with a lot of different interesting nonprofit organizations. America Needs You popped up and I was curious if you would speak a little bit about your experience with that. [00:14:53] Mildred Zayas: Oh, absolutely. And thank you for asking that question. America Needs You is an nonprofit organization that works with first generation college students and how they transition from college to the work environment. I'm passionate about it because I truly believe in education and upward mobility, especially in underserved communities. So what they do is definitely fantastic. And the program is a, it's an intense programs. When you commit to be a volunteer, you work two years with your student there, since they're sophomores until graduation, and we help them prepare for interviews, resumes, what to wear, and those type of things, but it is a tremendous and fulfilling program. And you need to have in mind that, for some of us, it makes sense. I always mentioned my mom, she instilled in me, she worked very hard, etcetera. But not everybody has the model, right? I mean, when you're a first generation college student, you don't know how to navigate. And I love the program because helping others navigate I, I mean, I really enjoy it and sometimes I think that I get more than what I give, for sure. When I see people succeeding and doing well in their careers. [00:16:08] Lindsey Dinneen: Yeah. That's really special. Mentorship is such a wonderful key component. I'm sure all of us have stories of these people who have come into our lives and helped lead us to the next thing or given us the crucial piece of advice at the right time. So thank you for being that person for others too. That's really special. [00:16:23] Mildred Zayas: Of course, love to do it. [00:16:25] Lindsey Dinneen: So I. Yeah. So I know one thing that's probably on everybody's mind is supply chain management, and since this is one of your areas of expertise, I was wondering if you could speak a little bit towards what should we look forward to in the future, especially, AI is such a big buzzword, but it is reality now. So I'm curious what are some of your takeaways? What are things that you're looking to as time goes on and technology changes? [00:16:54] Mildred Zayas: So, definitely robotics and digital are going to change the game. And you mentioned AI, which is part of that. But if you think about, before it was called medical devices, because really, it was developing devices, but those devices are going to become smarter now, right? And what's important, I think, understanding the robotics, we're going to transform the way we do surgery. Maybe a doctor is in Germany and is operating in a patient in the U. S., right? So those are the type of things that we need to be open and understand and definitely stay current on the new trends. I believe, again, digital and robotics is the future of medical devices or medical technology, for sure. [00:17:38] Lindsey Dinneen: Okay. Yeah. Excellent. So you've had so much incredible experience literally around the world. Were there any moments or a moment that stood out to you as just really reinforcing that you were in the right industry at the right time? "Yes, I am here for a reason." [00:17:56] Mildred Zayas: You know, I mentioned the strategy in Scotland, but that was definitely a defining moment in my career. Because I had the opportunity. I was quite young, but I led the transformation of a big team. I mentioned 22 people. It was a complex initiative, a lot of alignment from cross functional teams, aligning different regions, managing diverse stakeholders in optimizing overall operations. And there was a challenge to balance operational efficiency with the business goals. But while I was doing that, it really confirmed my passion for supply chain leadership. It was incredibly rewarding to see how our collaboration improved performance, reduced the cost, strengthened really our global manufacturing network. And that experience reinforced my belief in the power of strategic planning and teamwork to drive meaningful transformation. [00:18:53] Lindsey Dinneen: Yeah, of course. As you look towards the future for your own career and even for the future of medical devices, I know we touched on sort of your thoughts with that, but as far as your own career goes, what are you looking forward to coming up? What's your next challenge or adventure? [00:19:07] Mildred Zayas: So I'm glad you asked that question because I'm thinking more and more-- I've been 30 years with J& J again-- but I'm looking more and more into a portfolio career. So where I can definitely continue doing some supply chain strategy, et cetera, perhaps in, in, in a consulting way, but I would also like to serve on boards, participate in podcasts, for example. So I want to do a little bit more of that. I have done for many years, the kind of nine to five one thing in different scales and in different positions, et cetera. But my next step definitely is more into a portfolio career. So I'm not going to do one thing. I'm going to do more than one thing. And of course, I'm going to be using my background and my expertise for that. But I can also combine my passion for helping others [00:20:00] Lindsey Dinneen: Yeah, absolutely. Well, that's exciting. I am looking forward to seeing how that develops. I'll be cheering for you, rooting for you that whole time. Speaking of, you had a great piece of advice, and that was to just ask the question. And I'm wondering if anything else that pops into your mind, just pieces of leadership advice that you might give, especially to someone who's earlier on in their career, and might just need a little confidence boost. [00:20:26] Mildred Zayas: Yeah, obviously, ask the questions is good. But my best advice is really to focus on continuous learning and adaptability while building relationships. Relationships are critically important. The medtech industry is fast paced and constantly evolving, so it's crucial to deepen both our technical expertise and our business acumen. Sometimes you need to seek cross functional projects, mentorship opportunities to broaden your perspective. So it might be above and beyond your day to day job, but it doesn't matter. Ask for those opportunities. Also building this network is critically important, and it's going to help you, demonstrating resiliency and it's going to set you apart as a future leader. I believe Theodore Roosevelt say something that I like: "Whenever you're ask ed if you can do a job, tell them, 'Certainly I can!' Then get busy finding how to do it." So that's the way to do it. Don't stress yourself. Don't be afraid. Be excited. Fear paralyzes us while excitement allows us to move forward. [00:21:34] Lindsey Dinneen: That is such great advice. Thank you for that. I love that. And that's so great because you're absolutely right. You can use that strong emotional pull that often feels like fear, but what if you reframe it and think, "Hey, actually this means I care a lot and I'm very excited about this." So let's use that as energizing, not debilitating. [00:21:52] Mildred Zayas: Correct. Absolutely. [00:21:55] Lindsey Dinneen: Absolutely, absolutely. [00:21:57] Mildred Zayas: By the way, one of my mentors told me that. [00:22:00] Lindsey Dinneen: Ah, back to that. I love it. Full circle. [00:22:05] Mildred Zayas: Absolutely. [00:22:07] Lindsey Dinneen: Well, pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, based on your experience, but it doesn't have to be at all. What would you choose to teach? [00:22:24] Mildred Zayas: That's a very intriguing question. And it's something I don't believe they give in college these days, but something along the line of advancing through corporate structures. I would love to teach young professionals how to navigate workplace politics, negotiate promotions and manage career transitions, something along those lines. We were educated very tactically, typically. Like in my case, I was an engineer, so I could do a lot of math and I could do a lot of models. It was wonderful. But I didn't know how to navigate in the corporate environment, and it took some headaches, and it took some time. So, I would love to be able ,to do something like that for young professionals specifically. [00:23:12] Lindsey Dinneen: I love that. Well, I can sense a theme. Your heart is such a lovely heart of service and mentorship. So that is lovely. [00:23:18] Mildred Zayas: That is true. Yes, indeed. [00:23:20] Lindsey Dinneen: Yeah. Well, and sort of along those lines, how would you wish to be remembered after you leave this world? [00:23:27] Mildred Zayas: It's gonna be also very similar. I definitely wish to be remembered for guiding others toward reaching their full potential, especially those who face systemic challenges and for helping them create their own path to success. [00:23:43] Lindsey Dinneen: I love that so much, yeah. And then, final question, what is one thing that makes you smile every time you see or think about it? [00:23:52] Mildred Zayas: Well, you can probably guess this, but I'm telling you, seeing someone I've mentored or supported achieve their goals always make me smile. It reminds me of the difference we can make in each other's lives. [00:24:05] Lindsey Dinneen: Absolutely. That's just absolutely beautiful. Thank you for sharing that. So I am very excited to continue to watch your, how did you put it, portfolio career? [00:24:16] Mildred Zayas: That's what I'm trying to build. [00:24:18] Lindsey Dinneen: Okay. Unfold. So how can people maybe connect with you if they're interested in working with you as a supply chain executive or whatever else you plan to offer in this portfolio career of yours? [00:24:29] Mildred Zayas: They can follow me via LinkedIn. It's the best way. I'm there, Mildred Zayas. So, yeah, they can reach out. I'm happy to collaborate. I believe in teamwork, collaboration, and really helping each other succeed. [00:24:44] Lindsey Dinneen: Excellent. Excellent. Well, goodness gracious, this has been very wonderful. Thank you so much for spending some of your morning with us today, Mildred. Thank you for just sharing your advice and your heart for service and mentorship. And I'm so excited to see where this next step in your career takes you, so like I said, I will be rooting for you every step of the way. [00:25:04] Mildred Zayas: Thank you, Lindsey. I appreciate that. [00:25:07] Lindsey Dinneen: Of course. We are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support, and we just wish you the most continued success as you work to change lives for a better world. [00:25:37] Mildred Zayas: Thank you. Very nice. [00:25:40] Lindsey Dinneen: Yeah. And thank you also to all of our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time. [00:25:53] 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.

Are you new to the medical device industry—or mentoring someone who is? In this foundational episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Sara Adams and Chris Rush from Greenlight Guru to deliver a MedTech 101 masterclass. They unpack the roles, regulations, and realities of medical device development in a heavily regulated space. From defining what actually counts as a medical device to navigating FDA classifications and global regulations, the trio offers practical insights, industry analogies, and personal war stories that make this episode as entertaining as it is educational. Whether you're in R&D, marketing, clinical, or quality, this is the episode to bookmark and share with every new hire.Key Timestamps02:20 – What counts as a medical device? Intended use and labeling06:48 – Differentiating roles: Quality, Regulatory, Clinical, R&D, and Marketing15:40 – Understanding regulatory bodies: FDA, EU MDR, Health Canada, and more20:15 – FDA Classifications: Class I, II, III, and what determines risk26:00 – Standards to know: ISO 13485, 14971, 14155, 21 CFR Part 82033:05 – FDA pathways: 510(k), De Novo, PMA – when and why they apply41:55 – The design control matrix explained (User Needs through Validation)49:00 – Reverse engineering design controls: pitfalls and best practices55:30 – Clinical trials vs. preclinical studies: When each is required1:00:45 – Manufacturing & supplier controls: operations meets compliance1:04:15 – Final advice for MedTech newcomers: Read the regs and know the problemQuotes“Just because you don't call it a medical device doesn't mean the FDA agrees with you.” – Sarah AdamsThis quote highlights a key regulatory pitfall: your marketing claims, not just your label, determine if the FDA considers your product a medical device.“A 510(k) is like someone checking your wristband at the door—you're cleared to go in. A PMA? That's a locked door and you need full approval to enter.” – Chris RushA memorable analogy that demystifies the difference between FDA clearance and approval pathways.Top TakeawaysLabeling + Intended Use = Regulatory TriggerWhether it's software or a simple tool, if your product makes medical claims or supports medical decision-making, it may fall under FDA or other international regulatory oversight.Regulatory Pathways Are Tied to Risk and NoveltyKnow the difference between a 510(k), De Novo, and PMA. Class II “me-too” devices may avoid clinical trials, while Class III and novel devices usually require significant evidence.Understand Design Controls EarlyReverse-engineering documentation late in development is risky and inefficient. Start early with user needs and build forward through the five pillars: inputs, outputs, verification, and validation.Cross-functional Understanding Prevents Compliance GapsMarketing, clinical, and R&D all influence regulatory standing. Even social media likes can trigger off-label scrutiny—every department needs to understand their regulatory impact.Reading Regulations Is Not OptionalA strong regulatory foundation is key to faster development, better audits, and smoother market access. Resources like 21 CFR Part 820 and ISO 13485 are surprisingly readable and essential.References & ResourcesEtienne Nichols on LinkedInChris Rush on LinkedIn

Looming tariffs lead to renewed focus on transfer pricing Multinational companies have used transfer pricing as a way to reduce tax bills. Transferring a product from a lower tax jurisdiction allows profits to be taxed at the lower corporate rate, so a higher price can mean greater tax savings. But tariffs would be based on the higher price, meaning that some of the same companies using this practice to lower tax bills will also face higher levies. Travis Steed discusses what this means for medtech, the impact transfer pricing has had on tax rates, whether practices could change under a tariff regime and why the group is still a compelling, defensive investment   You may also enjoy listening to the Merrill Perspectives podcast, featuring conversations on the big stories, news and trends affecting your everyday financial life.   "Bank of America" and “BofA Securities” are the marketing names for the global banking businesses and global markets businesses (which includes BofA Global Research) of Bank of America Corporation. Lending, derivatives, and other commercial banking activities are performed globally by banking affiliates of Bank of America Corporation, including Bank of America, N.A., Member FDIC. Securities, trading, research, strategic advisory, and other investment banking and markets activities are performed globally by affiliates of Bank of America Corporation, including, in the United States, BofA Securities, Inc. a registered broker-dealer and Member of FINRA and SIPC, and, in other jurisdictions, by locally registered entities. ©2025 Bank of America Corporation. All rights reserved.

In this episode of Medsider Radio, we sat down with Vicky Demas, CEO of identifeye HEALTH (formerly Tesseract Health), who's leading the company's efforts to democratize access to retinal imaging. Using advanced algorithms and automated systems, identifeye's technology captures and analyzes retinal images to detect early signs of disease.Before joining identifeye HEALTH, Vicky led new product development at GRAIL, supporting the creation of the company's multi-cancer early detection test (Galleri). She was also a founding member of Google Life Sciences (later Verily) within Google [x], where she led teams focused on diagnostics, medical devices, and translational laboratory science. An engineer and scientist, Vicky holds over 20 patents and has authored numerous scientific publications across multiple disciplines.In this interview, Vicky challenges founders to consider: Are you building a diagnostic solution that can scale globally or a product limited to specialized healthcare settings? She also discusses why understanding real-world implementation challenges early can prevent costly missteps later.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 Vicky Demas.

Mit Prof. Dr. Angela Relógio (TimeTeller) Staffel #12 Folge #7 | #Marketing_021 Der Podcast über Marketing, Vertrieb, Entrepreneurship und Startups *** https://www.timeteller-health.com/de/ https://www.linkedin.com/in/angela-rel%C3%B3gio/ *** Dr. Angela Relógio, Professorin an der MSH-Medical School Hamburg und Mitgründerin des Startups TimeTeller, spricht im neuesten Marketing From Zero To One Podcast über ihre Forschung zur inneren Uhr des Menschen (Zirkadiane Medizin) und wie deren Messung zur Verbesserung von Krebstherapien und sportlichen Lleistungen beitragen kann. Mit einem nicht-invasiven Speicheltest kann TimeTeller den individuellen Biorhythmus bestimmen und daraus personalisierte Empfehlungen ableiten, z. B. zur optimalen Einnahmezeit von Medikamenten oder für sportliche Leistungsspitzen während des Tages. Das Startup wurde 2023 aus der Charité als Spin-Off ausgegründet und arbeitet aktuell u. a. an der Realisierung eines Pilotprojekts mit der Techniker Krankenkasse. Trotz begrenzter Ressourcen hat das Team bereits mehrere Preise gewonnen (darunter den German Startups Award) und ist in mehreren Kliniken aktiv – forschungsbasiert, wissenschaftlich fundiert, aber mit einer klaren Mission zur realen Anwendung. *** 00:00 – Was TimeTeller macht 01:53 – Startup & Gründungsgeschichte 06:14 – Von Portugal nach Deutschland 09:14 – Forschungsstart & Entwicklung von TimeTeller 12:27 – Wie funktioniert die Messung? 15:17 – Erste Durchbrüche und Highlights 17:43 – Studie mit Leistungssportlern 20:16 – Erkenntnisse aus den Sportstudien 22:09 – Anwendung bei Krebspatienten 25:29 – Pilotprojekt mit der TK & aktuelle Einsatzmöglichkeiten 27:12 – Preise & Anerkennung 28:53 – Nominierung für Deutschen Gründerpreis 30:00 – Status der klinischen Studien 33:49 – Finanzierung & Standortwechsel nach Hamburg 36:01 – Teamstruktur & Expertise 40:11 – Einsatz von KI & mathematischen Modellen 47:04 – Stabilität der inneren Uhr 48:26 – Businessmodell & Wiederholung der Messung 49:39 – Kritischer Blick auf KI als Diagnosetool 52:06 – KI in der medizinischen Praxis 53:43 – Angelas Buch "Die Chrono Strategie" 55:00 – Leben in Hamburg vs. Lissabon 56:26 – Startup-Entwicklung in Lissabon *** Die Zeitangaben können leicht abweichen.

In this episode, Dr. Hadi Saleh, CEO of CeramTec, delves into the intricacies of navigating a shifting MedTech market with the rise of weight-loss blockbuster drugs as well as the influence of macroeconomic and geopolitical tensions on healthcare product development and innovation. The discussion also explores preventive care, the significance of a healthy lifestyle, and the potential of genetic editing and personalized medicine. Tune in for an engaging and informative conversation.

S4: E168 The Weekly Update and an interview with Kathy Meis, CEO of Bublish, an AI enabled publishing platform that is growing 3x traditional publishing. She tells the story of Bublish democratizing content publishing by giving creators control of planning, editing, formatting, design, marketing and distribution with support for language translation, release as an ebook and audio book as well as support for TV and Film IP rights. Next week we will be talking with Tim Skapek, Co-founder and CTO of Protect3D, MedTech company that produces personalized protective devices for athletes. (interview recorded 4.17.25)Follow David and Paul: https://x.com/DGRollingSouth https://x.com/PalmettoAngel Connect On LinkedIn: https://www.linkedin.com/in/davidgrisell/ https://www.linkedin.com/in/paulclarkprivateequity/ We invite your feedback and suggestions at www.ventureinthesouth.com or email david@ventureinthesouth.com. Learn more about RollingSouth at rollingsouth.vc or email david@rollingsouth.vc.

In this 5-in-5 episode, I unpack my conversation with Lee Ali, MD of Expo Stars and international exhibition expert.We break down how most MedTech companies waste tens of thousands at global healthcare events—and what to do instead.From qualifying leads to energising your team, this is your no-fluff guide to making every trade show count.Five key insights. Five minutes. One smarter conference strategy.

In this episode of the Global Medical Device Podcast, Etienne Nichols speaks with renowned regulatory and reimbursement expert Karandeep Singh Badwal to uncover the complexities of medical device reimbursement across the US, EU, and Asian markets. From the influence of governmental systems to the nuances of coding, coverage, and payments, Karandeep shares real-world insights for MedTech companies developing their global market strategies. Learn why early planning for reimbursement is just as crucial as regulatory approval, and how future-proofing your strategy against political and economic changes can safeguard your device's success.Key Timestamps:00:00 – Intro and Sponsor Message (Greenlight Guru Quality)02:30 – Why Reimbursement Must Be Considered Early07:15 – US Reimbursement System: Medicare, Medicaid, and Private Insurers13:10 – EU Reimbursement: Challenges with Fragmented National Systems17:45 – Asian Market Differences: Japan, China, and South Korea23:20 – The Importance of a Reimbursement Expert28:05 – Navigating Political Changes in Global MedTech Markets33:30 – Special Challenges for AI and Software as a Medical Device40:00 – Direct-to-Consumer vs. Prescription Strategies46:20 – Integrating Real-World Evidence and Post-Market Surveillance52:00 – How Management Reviews Can Align Business and Quality Goals01:03:10 – Pros and Cons: US vs. EU Reimbursement Models01:18:20 – Final Takeaways and Closing ThoughtsStandout Quotes:"Reimbursement isn't just the final step after regulatory approval — it is a core business strategy."Why it matters: Many companies fail by not building reimbursement into their earliest development and design decisions."You can have the most innovative medical device in the world, but without a reimbursement pathway, you won't have a viable business."Why it matters: Innovation alone isn't enough; financial strategy is crucial to survival and growth.Top Takeaways:Start with reimbursement in mind: Align your product claims, indications, and market strategies with potential reimbursement pathways early.Tailor by region: US, EU, and Asian markets all have distinct reimbursement landscapes — success in one doesn't guarantee success in another.Hire jurisdiction-specific experts: Use consultants experienced in your target markets to avoid costly mistakes.Leverage post-market surveillance: Integrate real-world evidence gathering into your QMS and management reviews to support reimbursement claims.Build strategic flexibility: Political and regulatory landscapes shift — maintain backup jurisdictions and alternative market strategies.References:Etienne Nichols on LinkedInGreenlight Guru Quality Management SystemMedtech Podcast hosted by Karandeep Singh BadwalMedTech 101 Section:What is "Reimbursement" in MedTech?Reimbursement refers to how a company gets paid for a medical device after it's cleared for use. This usually involves navigating government programs (like Medicare) or private insurance, and it determines how easily hospitals, clinics, or individuals can buy and use a product.Simple Analogy: Think of it like getting a movie produced: regulatory clearance is getting your movie rated, but reimbursement is making sure theaters agree to pay you to...

A new MedTech Unboxed episode is out now with Christopher Haig, President of Efemoral Medical, a company developing bioresorbable scaffolds for treating peripheral arterial disease (PAD), affecting over 200 million globally. Here's a snapshot of our discussion: FlexStep Technology: A balloon-expandable, drug-eluting bioresorbable scaffold with inter-scaffold spaces for flexibility, made of PLLA with a co-polymer for ductility and rapid resorption (1-2 years), eluting sirolimus to prevent restenosis. Clinical Progress: The EFEMORAL I trial (33 patients enrolled across 4 sites in New Zealand/Australia) shows promise, with 20-patient results to be presented by Dr. Andrew Holden at @CXSymposium in London, April 23, 2025. Funding Update: Raised $10M+ in equity through angel investors and $2M+ in SBIR grants; targeting $20M Series B for IDE submission, including GLP animal studies and randomized trials for US PMA approval.

Rick Sherak, CEO of Exokinetics, shares his incredible journey from serving as an Air Force officer to leading a company that develops transformative mobility devices. He discusses the importance of leadership, sales psychology, and creating compassionate company culture. Rick's passion shines through as he recounts heartwarming stories of how Exokinetics' Zeen device has profoundly improved the lives of people with mobility challenges, including children with cerebral palsy.   Guest links: https://gozeen.com/ | https://vimeo.com/1011399920 | https://vimeo.com/856975581/9994ad1cb8?share=copy Charity supported: Project ELEVATE Mobility 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 053 - Rick Sherak [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, Rick Sherak. After serving as an Air Force officer, Rick spent over 25 years in the medical diagnostic industry as a commercial and product development executive. Leveraging his broad leadership and medical domain experience, he became CEO of Exokinetics in March 2024 to lead the company into its next expansion phase of market awareness and revenue growth.  Alrighty. Well, welcome, Rick, to the show. Thank you so much for joining me today. I'm so excited to speak with you. [00:01:30] Rick Sherak: Well, it's nice to meet you, Lindsey, and I'm glad to speak with you today as well. Should be fun. [00:01:36] Lindsey Dinneen: Yeah. Excellent. Well, I would love if you would start by sharing a little bit about yourself and your background and what led you to MedTech. [00:01:45] Rick Sherak: Sure. Well, so I currently live just outside of Philadelphia with my wife and our four dogs. We just recently moved here from Boston, so we've had to quickly become Philadelphia Eagles fans. Go birds. We love it here. And my background is kind of interesting, a little bit diverse. I started off my career as an Air Force officer. I tried to follow my dad in his fighter pilot footsteps. Got almost there, but I had a medical disqualification, so I had to do a land based job, but really enjoyed the Air Force. It was a great way to pay for my college and to serve my country and also to learn leadership. It was like a masterclass in leadership. Talking about getting thrown into the leadership fire, and as a young 22 year old, lead a group of people on a mission, motivate everyone, and get everyone producing at their highest capacity. So that was a great way to start. But after I got out of the Air Force, I really wanted to go back to my roots, and that's in the sciences. I've always loved the sciences, especially the biological sciences. I have a degree in biological science from Baylor University. So out of the military, I was looking for an opportunity to use my interest in something that would support my family. So I started with Abbott Laboratories. And Abbott Laboratories, back in the day, was a Fortune 100 company, one of the up and coming medtech companies, had a pharmaceutical arm, but I belonged to the medical diagnostics side of it. And it was great. They, at the time, were hiring a bunch of ex military officers to be their field sales people and none of us knew how to sell. We were all out of either the Air Force, Army, Navy or Marines, but we learned quick. We understood, you know, there's the hill we have to take, but I really respected Abbott because they trained us not only how to sell, but how to sell with integrity, right? And they also, you know, they had 200 products that we had to learn and become masters at because we were selling to hospitals and medical laboratory clinicians, etcetera. But it was a great way to start my career, and I truly found that I loved it. One, I enjoyed the sales aspect. It was fun helping people solve problems with our products, and ultimately, help the patients get the best care right from their diagnostics. But two, it also taught me that I was pretty good at it. I did very well at Abbott. I promoted several times and won some national awards. And as a result, I was recruited away by another medtech company, which was a early stage organization called Ventana Medical Systems. I intended to be there for three years and learn everything I could and then expand my career. I was there for 15 years. And we had a ball. We took this little medical diagnostic company that came up with a transformative device that would automate very complicated processes in the pathology laboratory environment. So it was disruptive technology. We were going out there with something no one had ever seen before. And I joined them pre IPO. So we went public and then we started churning and burning and impressing Wall Street every quarter so that we can up our value. 15 short years later we sold the company to Roche Diagnostics. So what a great exit and just a wonderful experience and developing my leadership cause I was management as I quickly was filling levels as we were growing. But what a wonderful ride, that's something to see, somebody with an early vision to take it step by step to a wonderful exit. But we helped a lot of people, we became a market leader in immunohistochemistry automation, and it just truly was a great experience. But after Ventana, I wanted to do something a little different. So I stepped into the world of startups. I spent about 12 years in the startup world, worked for four startups, two of which died, which happens a lot in that environment. And then the other couple did pretty well. I really enjoyed it because now I was helping people on the oncology diagnostic side of medtech. So each startup had a unique laboratory technology that would better predict the patient outcome to a particular chemotherapy or targeted immunotherapy for their cancer. So, the whole purpose was to see how can we get better predictive value so that these patients don't have to suffer unnecessarily with the wrong drug. So that, again, was just a wonderful opportunity for me because more than not, I would come into these startups and have to create the commercial organization from scratch. That means I had to hire my own national sales team, my own marketing team, my own customer service team and logistics team to handle very delicate samples. But I loved it. It, it enabled me to take everything I learned from the air force, from Abbott, from Ventana and apply it to a small company environment. And I found that it was addictive, and that's why I stayed in it for many years. But then I did another turn and I took a sidestep because I loved also, has always been kind of a frustrated engineer. I joined an engineering company that just focused on design development of medical devices, and they hired me because of my diagnostic domain experience. And I went out and found early stage companies and brought them to this engineering firm so we could take the novel technologies from these companies and make them into a product that could be commercialized. So I did that for several years. Long story short today, I'm in a completely different type of medical device environment. I'm the CEO of Exokinetics, and Exokinetics is a very unique organization in that we decided to look at the mobility device market and fill the gap, because unfortunately people with mobility challenges are basically regulated to either wheelchairs or walkers or electronic scooters, all of which have significant problems to their health because they're not using their body in many cases. And fall prevalence-- people with walkers-- oh, it's just such a shame. There's over 50, 000 emergency room visits a year of people falling with their walkers. So anyways, Exokinetics has developed a very unique mobility device that gives people a lot more freedom. and safety in their daily challenges with mobility. So, sorry, it's kind of long. [00:08:44] Lindsey Dinneen: Oh, I loved it. No, I so appreciate it. Thank you for talking us through all of that. That was great. And so many questions, but I'll try to start at the end a little bit and then probably work my way back. But yeah, so, okay. So I'd love to hear more about the company that you are now involved in and this device. But I'd love to take it back a little bit further and say, what made you aware of this challenge existing that there isn't a great solution in the marketplace, or not maybe more updated options. So what made you aware of that challenge and then decide, "Okay, I think I have the tools, resources, ideas to fix it, to address it"? [00:09:25] Rick Sherak: It's a great question. I, one, I was not aware, right? I was not aware of the challenges. However, a buddy of mine, we go to the same church, you know, we're in a men's group, we're a bunch of old guys hanging out talking about stuff. And he was doing some investment investing into early stage or startup medical diagnostic companies. A very generous individual, and he knew of my background and he goes, "Rick," he goes, "I'm looking at this company. I'm not sure I want to invest, but maybe you can look at it with me." So I did some free consulting for him, he's my friend. And then he kept dragging me to this company to their board meetings. Right. And I'm going, "Hey, this is great," and I give him my advice because, because it was new for me. And that's how I found out, Lindsey, about the challenges that people with mobility issues have, is that the status quo now is, oh, you have Parkinson's, or you have cerebral palsy, or you've had a stroke. Put those people in a wheelchair and just let them live their life at that level. And I didn't realize how horrible that is for many of these people because they still have utility of their legs, right? But when you're confined to a wheelchair for long term, your legs will naturally atrophy, right? And become so weak that they won't be able to use them anymore. So what struck me, as mission driven, was that this company invented with their own engineers, this device that not only promotes people with mobility issues to use their body, but to use their body effectively moving around horizontally around the world, but also vertically. It enables them to go from a seated position to a standing position. And for us, for you and I, we're thinking, "Well, yeah that's pretty good." For them, that is a game changer being able to go from seated position to standing and then walk from that position all without the fear of falling. So, it really touched my heart as I learned more and more about the company and I kept giving more and more time to them. So eventually I was pulled aside and they said, "Rick, what's your appetite for running this company because we need to grow it and we need to get out there and help more people." So lo and behold, I've been here for almost a year. February 1st is my anniversary and it's been a great ride. I just love it. I have a passionate team, mostly of young people. I love it. I couldn't script better people, more compassionate, more caring. All of our customers are suffering in some way or another. Even our elderly customers that are just bad knees, bad hips, bad endurance, our device is perfect for them. So, yeah, you know, we're having fun. [00:12:27] Lindsey Dinneen: That's great. Well, yeah. Thanks for sharing a little bit about that too. And so, as you've stepped into this leadership role that you weren't necessarily anticipating was your next right thing, what were some of the challenges? Because you've had an amazing career, and like you've said at the beginning, you were learning leadership skills all throughout and you've had many iterations of different ways of approaching medtech, with the industry. But now as CEO, that's another thing. And so I'm curious, how was that transition to step into this leadership role and take it on? [00:13:03] Rick Sherak: No. And it has been different in many ways, but it's also very similar in others, right? Because in my opinion, leadership, really the definition from my perspective is that a good leader motivates effectively a group of people, talented people, and usually very diverse group of people, pulls them all together to accomplish an overall mission or goal, right? And it's it. That's the part I wouldn't say that's easy about my job now as a CEO, but it's natural and I love motivating my people. I'm a big fan of management by walking around and I try to talk to all my employees at least every day or every other day just to see what's going on, not only in the business side of things, but also in their personal side of things. I, I assume that nobody's going to respect me unless I earn it. And, I just wanna make sure that I'm leading by example and I'm the guy that either gets to the office first or leaves the office last, just trying to make sure that I'm there for my people when they need me. What is different, Lindsey, is that I am struggling with delegation because I want to do it all myself, right? And I know better. It takes me a long time to dye this hair white because I'm not that old, but just know better. But it's a struggle because you have to allow others to get things done and especially in a small company like this. We were still very early stage. People are wearing a lot of hats and I just have to allow them to go and give them the best guidance I can and then press on to the next thing, right? [00:14:49] Lindsey Dinneen: Absolutely. So, it sounds like you've been very intentional building a company culture that reflects the values that you care about, of course, and also reflects compassion, because you mentioned, your customers, for instance, are all folks that are in a difficult, challenging place. So how do you feel the importance blends from really intentionally cultivating a culture that is this empathic, creative problem solving, just really good culture, it sounds like, to how that affects how you basically present to the world who you are. [00:15:28] Rick Sherak: Yeah, well, no, that's a great question. So where our challenge is that our customer base is so broad, right? And like you said, all of our customers in our DTC business-- that's about 40 percent of our business is direct to consumer, right? But we have other customers, distributors. We have hospitals that use our device, physical therapy, occupational therapy, neurological research, you know, things like that. But the key, I think, from our perspective, is we want people to realize that, hey, we don't have 20 products, right, that we've gotten from other folks. We have designed and developed a very new and transformative device that only came about because we had our own internal engineers, and we've listened to what is needed out there to help people live a better, more free, more independent and active lifestyle. So, you know, interestingly, when we broadcast ourselves out there, I hope that people realize that, "Wow, this is not just a company selling something new, they design and develop this with their own people," right? There's a lot of love in our products, and people can tell because each one of our products is handmade, and it's customized to the individual ordering it by their weight, how much they weigh, and how tall they are, so we can adjust everything for them. And I tell you it's a lot of fun because some people literally take the time when they get their Zeen-- that's the name of our product, Zeen-- but they'll write us these wonderful notes on how this device has just transformed the way that they engage with their world. And, when you sit back and you go, "Hey, what difference are we making today?" Wow. That's why I think I have such a motivated group of people because every day we're talking to these wonderful, courageous individuals that have lost a big part of their ability to live effectively in the world and they're looking for something new, something meaningful and something that's going to help them. And when we can provide that it's just wonderful, very rewarding. [00:17:52] Lindsey Dinneen: Yeah. Yeah. Of course. Just to know the impact that you're making and able to make. And so the days that get really tough or frustrating or whatever, you can still hold onto this anchor of, "But we're making a difference. We know that." [00:18:07] Rick Sherak: And we see it. We have visitors come to the factory just about every week. Maybe two or three visitors will come and they'll try it out. Try out the Zeen to say, "Hey, I saw it on social media, just want to try it. You guys are local." And that's when we really get that, that visceral customer experience, right? It's just crazy, Lindsey. I've seen people come in, bent over sitting on this little electric scooter with a joystick. And they come in and they just look broken, right? And then we get them into a Zeen, and then they're all of a sudden their spine starting to straighten, right? They start sitting up, and then we slowly and compassionately show them how the device works and everything, but we make sure that they feel safe and that they trust. And as soon as we get that go ahead, which often you just see it in their eyes, then we'll engage the levers and the Zeen will lift that person with-- it's kind of like a big bicycle seat under them. It lifts up with this non motorized lift mechanism, that we invented, up to 75 percent of a person's body weight. So now they go from the seating position to standing. Now, many of these people can't do that on their own. They can't extend their legs from seating to standing. They need other people to grab them and lift them, right? But now Zeen lifts them. Now they're standing. And again, it's just phenomenal because this person that came in on this scooter bent over is now standing. They're putting weight on their legs. They're stimulating their brain because there's weight on their legs. Right now, neural connections are starting to flow again, and their spine straightens, and they stand tall, and when they take those first steps, often it's very slow, just tiny little steps. But then we just leave them be, and we talk to their family that came with them, and we go get something to drink, get some snacks, start chatting, and just let them be. And it's amazing, you can just see their brains working, and their legs moving faster and faster. I've seen people barely moving at the beginning, and at the end, they're cruising, we call it the lap, they go around the office, around all the desks and everything, and everybody's clapping, you know. It's amazing. [00:20:28] Lindsey Dinneen: Wow. [00:20:28] Rick Sherak: It's so cool! I'm not trying to overstate it, but this is our daily life. So I'm just very happy and pleased that my background has led me here. It's a great way to finish my career. I want to stay here for as long as I can. Hopefully it'll be many years because I enjoy every day of it. [00:20:52] Lindsey Dinneen: Wow. That's incredible. Yeah, and thank you for sharing those stories. I was just imagining that, that laugh and how amazing. [00:21:00] Rick Sherak: It is so cool. [00:21:03] Lindsey Dinneen: Can't possibly get old. Just witnessing joy and hope, honestly, even hope alone is... [00:21:10] Rick Sherak: One of the best is this father comes in with his twin boys. And the boys have cerebral palsy. It's a disease that you get from birth, right? And their legs are just not good. They have no balance at all. And the father brings them in. He carries them because they don't even have a mobility device that really works for them, except for walkers, like an old person walker, right? But he carries them in, he puts them on the, in the lobby, and we bring over the Zeens, and these little boys are the cutest things you've ever seen. They're just, they're twins, they're chatty, they're so excited. We get them into the device, and their first few steps, it's like I said before, we're just tiny, tiny. But then they built their trust. And at the end of the visit, these boys were running. I mean, they were digging in with their little legs, fully supported, fully trusting the device and their hands were in the air waving. And their dad is just like tears. He's just like gushing. He's going, "One, I've never seen my sons run before. Two, they've never moved without their hands either holding a walker or crawling on the floor." He goes, "These boys are running around with their hands in there in the air." And they're saying, "Hey, look, Daddy, my hands are in the air. I don't need to use my hands." Of course, we have Kleenex boxes all over the office. [00:22:36] Lindsey Dinneen: Yeah. I'm pretty sure you'd have to, it's just part of the the office supplies. [00:22:42] Rick Sherak: Exactly. Yeah. We have a Costco membership for regular shipment of Kleenex. Yeah. [00:22:49] Lindsey Dinneen: That's amazing. Oh, thank you so much for sharing that story. That's incredible... [00:22:53] Rick Sherak: Oh, yeah. [00:22:54] Lindsey Dinneen: ...just for a father's heart. [00:22:56] Rick Sherak: Oh, it's just so amazing. Yeah, it's so amazing. [00:23:00] Lindsey Dinneen: So this is all incredibly exciting just the way it is right now, but I imagine there are future plans. Can you share a little bit about what's next? What are you excited about as you move forward? [00:23:12] Rick Sherak: Well, what's really exciting is our growth potential, right? So again, the Zeen is a very unique device, but it fits so many different segments of populations. Like we've been talking about people with chronic illness. That is our core group, right? We work with people with Parkinson's, MS, muscular dystrophy, cerebral palsy, ataxia, you know, just about anything like that where people have strength, balance, or endurance issues. The other part that we're really excited about this year is that we didn't realize until those boys, how much our Zeen would help in the pediatric environment. So now we're making a very concerted effort going after the children's hospital physical therapy groups, showing them the amazing utility of a Zeen. And also because it's so adjustable, a person, a child can get into a Zeen early, let's say at the age of seven, and it could actually stay and grow with them until they're 14 or 15 years old. The whole thing adjusts up. So we're very excited about that market space. And we're also introducing the Zeen to luxury senior centers, because so many of our Zeen customers are just elderly people that don't want to give up, that have this incredible determination to either maintain or regain their mobility. Their knees hurt, their hips hurt, their endurance is down. So that's another avenue that we're introducing ourselves to, primarily through social media and publications through PR. But we're hoping this new awareness will get more Zeens out there. Our goal is really awareness. And that's one of the reasons that you and I are talking. I want to get out there as much as possible and let people know that there's other alternatives out there for their loved ones or for themselves if they have mobility challenges. And please check us out. We have a really cool website, a lot of videos, a lot of testimonials, and we just love helping people. And we're very fair in business. Our product is not cheap, but we give most customers a 14 day minimum home trial, and we say, "Use it a lot, as much as you can to make sure it's a good fit." If you don't like it, money back. So we try to be as fair as possible to make sure it's a good fit. [00:25:39] Lindsey Dinneen: Yeah, that sounds good. Yeah. And so for any of our listeners that are, you know, going to go and check out the website, just make sure you have your own stash of Kleenex. Oh man. [00:25:54] Rick Sherak: And every time we sell a Zeen, it comes with a virtual training session. So it's a one on one with one of my specialists. And I tell you, these folks are the best. So the best trainers and they're just the most delightful people, right? And they're like you. They're virtual, but you feel like they're right there with you. So we do virtual training for every one of our customers. And, it gives us that opportunity to see people eye to eye and to ensure that they understand their new tool and how to use it and how to, like I mentioned before, how to trust it, and realize that they're not going to fall, that they can move again, and they can do it safely. [00:26:34] Lindsey Dinneen: Amazing. Well, gosh, thank you so much for sharing about the company and... [00:26:38] Rick Sherak: Yeah. [00:26:39] Lindsey Dinneen: ...the device and the lives that it's impacting. And I just, I love learning about this. I'm so excited about the work that you're doing. So thank you for putting in the work. It's not easy. Startup world is difficult and especially medtech, but you've done it. So good job. [00:26:56] Rick Sherak: Well, and this is also interesting for me because it's manufacturing. Before, I didn't have to manage manufacturing. So manufacturing is a whole different beast with getting your parts, getting them ordered in time 'cause everything has to be built just right. This is like a high end super bike, you know, has the latest in technology for aluminum framing and engineering leverage. So that's a challenge for sure. But the other thing I wanted to plug real quick, Lindsey, if you don't mind, is again, we're a premium priced product, but we're not covered under insurance plans right now. That means Medicare or Medicaid. So, part of our outreach is we've created a foundation. It's a nonprofit foundation so that if we can find donors that want to support, the money goes into our foundation, and we take applicants and we provide grants for up to half the cost of a Zeen through the foundation. The other half is on the people that are trying to buy it. And, it's so interesting. Talking about putting skin in the game, right? People call and say, "Geez, I just can't swing that amount of money." Well, let's talk about the foundation, but you have to come up with half. And that creates such a-- it's such a partnership, and they're so excited. They'll be emailing my folks going, "Hey, I was able to raise 500 through a crowdfund! I just got to keep going!" And we're going, "Yeah, keep going!" And as soon as we hit that halfway mark, the foundation kicks in and covers it. So again, I just want to put a plug out there so that we can help very deserving people that just financially need a little support. Yeah. [00:28:37] Lindsey Dinneen: I love that. So that's a great way for even listeners to get involved, even if they don't necessarily personally need the device, but donating to this incredible cause, that would be awesome too. [00:28:48] Rick Sherak: Anything would be so appreciated. [00:28:50] Lindsey Dinneen: Great. Yes, absolutely. Well, okay. So pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. It can be within your industry currently, it could be about anything. What would you choose to teach? [00:29:13] Rick Sherak: You know, that's funny that you said that. I live right next to Villanova University, and a lot of my neighbors are professors there. And one of our best friends that lives a few houses down she's in the business ethics department. And she even said, she goes, "Rick, have you ever thought about teaching?" And I said, "You know, I've never really been a teacher." But if I were to teach, the thing I would love to do would be to capture over all these years of me being in this industry, the nuances of the psychology of sales. Because people think of sales as, "Oh, you're trying to trick people into buying, right?" Turn that completely upside down to, you're trying to assist people to buy. Because people really, when they're looking at your product, they want it. But they need help. They're counting on you to help them in that process. And it's a psychological bond when you're talking to somebody and you have a product and they have a need and you're trying to find that, that perfect combination, right? So that they feel, "Hey, this is great for me. It's worth every penny because I see the value." Versus having them feel, "Oh man, I'm going to get ripped off." So I would love to go down that path. I think that's so interesting because people are people, and salespeople, the best ones I've ever seen, like I mentioned before, are compassionate and caring, but they're also pleasantly persistent, right? And they just, they go, they listen and they say, "All right, but let's keep moving down the path." And people that are on the buying side truly want that. They want that partnership, that walking side by side down that path to purchase, because sometimes they're not courageous enough to buy just by themselves. So, to destigmatize sales would be kind of fun. [00:31:13] Lindsey Dinneen: I love that. That would be great. That'd be a great masterclass too, just to really dive into some of that, and yeah, to put a different perspective on your role and you're helping somebody to achieve what their goals are, to be honest. [00:31:26] Rick Sherak: Absolutely. [00:31:27] Lindsey Dinneen: I love that. [00:31:28] Rick Sherak: Absolutely. And we've all had those good experiences, and we've all had those bad experiences. [00:31:32] Lindsey Dinneen: Definitely. Definitely. So how do you wish to be remembered after you leave this world? [00:31:40] Rick Sherak: You know, that, that's interesting because I love to read. My morning time is my reading time. That's my time. It's me and my two collies. They're also early risers. The pugs, the two pugs, no, they'll sleep in with their mother. But in my reading and in my studies, essentially, I think it all boils down to at the end of the day, when the curtain starts coming down, wouldn't it be nice, when you're out, you're no longer here and people look back and they just say, "You know what? That guy or that lady really genuinely cared about other people." I think authenticity and being genuine is something I would love to be remembered for. And it's not easy, because sometimes you're not authentic to yourself, yet to others. [00:32:29] Lindsey Dinneen: Yeah. [00:32:32] Rick Sherak: But especially at this stage in my life, I just see caring for people is just amazing. Talking about, if everybody cared a little bit more for each other, it might be a different place. [00:32:43] Lindsey Dinneen: Yeah. And having the courage to be authentic and honest can sometimes also be, it does come with a little bit of vulnerability. So I love that. [00:32:55] Rick Sherak: Oh yeah. Oh my gosh. You know, it's all about, if you're just so lucky to have a little bit of grace, a little bit of wisdom, but like you said, a lot of courage. That's when it all means something, right? Cool. Oh. [00:33:10] Lindsey Dinneen: I know. What is one thing that makes you smile every time you see or think about it? [00:33:22] Rick Sherak: Well, you know, funny because we've been talking about leadership and sales. I just got to tell you a quick story because it always makes me smile. As I mentioned before, I was an Air Force officer and all of a sudden I jump out of the Air Force into a sales role with a medical diagnostic company. And, I just went through training. I got assigned to my territory. Baton Rouge, Louisiana. I'm a Colorado boy. So Baton Rouge, Louisiana was a little bit different for me, but the company moved me down there, and I started my sales career. And my, my customers were all hospitals and clinical laboratories in Baton Rouge, Lafayette, and the Bayou South, all those little towns in there. And I didn't realize it until after I started, but my territory was made out of the accounts the other sales people didn't want. [00:34:16] Lindsey Dinneen: Oh. [00:34:17] Rick Sherak: So the guys that were there, they cherry pick the good accounts, and the ones they didn't want, they made into my territory, right? The new guy. But I went in, I was dialed in. I had my brochures. I knew all my product knowledge. And I'd make appointments and I'd sit in front of these lab managers and these clinical influencers. And these lovely people, they would sit there. They would be so kind. They'd have their arms crossed. I go through my spiel and then they just look at me and they say, "Thank you, Rick, for coming. I'm not interested at this time." I go, "Okay." So this went on, Lindsey, for six months at every single hospital or clinical laboratory. I was like on the bottom of the sales list. I couldn't get anybody to buy anything. And it was like, it was so funny. And this is what makes me laugh. I'll never forget. I was down in south of Lafayette, and I was sitting in front of this lab manager and I've seen him every three weeks like clock work, right? And I'd always bring in new information, recap what we discussed before, and asked for the business. And he'd always say, "No, I'm not interested." But about six months in, he just looked at me and I got through my spiel. And he goes, "Rick," he goes, "Are you just going to keep showing up every three weeks?" And I said, "Yes, sir." And he says, "Look," and I mean, he's going, "Well, I'm not buying anything from you." And I said, "Yes, sir. But I, I truly feel that my products are the best products that you could use in your laboratory to make you more successful and to give your patients the best diagnostic information to help them fight their disease." Because it was mostly oncology focused. And he just looked at me and he goes, "You truly believe that?" I said, "Yes sir, I truly believe and I'm going to keep coming back until you believe." And he just sits back and he, I'll never forget this, he unfolded his arms, put his hands on the table and he goes, "Well, okay, then let me see what you got." And it was awesome. Lindsey, I swear there was like some underground communication channel because every hospital or clinical laboratory started listening to me after about six months. It was weird. And then another six months, I was on top of the sales rolls, and I had turned my territory around and we were just having a ball. But it was that persistence, it was just in the caring. I just cared. I was convinced my products were better, and he appreciated that. And, it, it was a fun, it makes me smile today because there's nothing like seeing somebody say, "Well, you know what, I trust you enough to listen to you now." [00:37:06] Lindsey Dinneen: Yeah. Wow, that's awesome. They really had to go through that know, like, and trust you cycle or a journey. [00:37:15] Rick Sherak: These are long term Louisianians. I'm coming in as an outsider, too. So that was, I had to prove myself. But they are the one most wonderful people. Before I got promoted out of that territory, I used to show up at least once every, maybe two months, per hospital with all these crawfish and a big old pot and a boiler and I would be out in the parking lot. I'd be boiling crawfish and I called the lab and I'd say, "Hey guys, I got crawfish!" And they go, "Oh, Rick has crawfish!" And they all come out and we'd all eat crawfish. That's how you do it in Louisiana. It was a good time. [00:37:54] Lindsey Dinneen: Very cool. Thank you. Thank you so much for sharing about that. And just in general, being so willing to share so much of your story. I really appreciate it. I loved getting an opportunity to learn about you and your background and your heart for MedTech, your heart for the people that you're serving. So thank you. I know days aren't always a walk in the park as much fun as I know you're having, but I know you have good days and bad days. So thank you again so much for joining me. [00:38:19] Rick Sherak: Thank you, Lindsey. [00:38:20] Lindsey Dinneen: And I just wish you the most continued success as you continue to work to change lives for a better world. And just also thanks to our listeners for tuning in. And if you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time. [00:38:40] 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, 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

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

Episode Summary:In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kirk Petyo, Managing Partner at Talent Factory Recruiting, to explore the art and science of hiring in MedTech. Kirk shares strategies for building magnetic employer brands, explains the difference between competencies and capabilities in candidates, and warns about the hidden costs of bad hires or delayed recruitment. They also discuss how to attract top talent from outside traditional MedTech backgrounds, and why companies must clearly define their values to thrive in today's competitive hiring landscape.Key Timestamps:[00:02:00] – Introduction to Kirk Petyo and Talent Factory Recruiting's unique approach[00:05:30] – What makes a company a "magnet" for top talent in MedTech[00:12:20] – How to recruit candidates from outside traditional MedTech backgrounds[00:20:00] – How to differentiate between a good worker and a good interviewer[00:30:10] – The ripple effects of a single bad hire in a MedTech company[00:35:50] – The cost of leaving key roles unfilled for too long[00:44:00] – Outdated hiring practices that repel top candidates[00:50:00] – Trends in hiring and workforce planning for 2025[01:02:00] – Final advice for MedTech hiring managers and company leadersStandout Quotes:"If you treat hiring like a transaction, you'll get transactional results. But if you treat hiring as a critical strategy for growth, you'll flourish." – Kirk Petyo"Your candidate's life must be better at your organization than it was at their last job—if you can't tell that story, you'll struggle to attract top talent." - Kirk PetyoTakeaways:Define your value drivers clearly: Understand what makes your company unique before trying to attract top talent.Focus on capability, not just competency: Prioritize what candidates can learn and contribute over time, not just what they know today.Structure your interview process: Build a consistent, benchmark-driven approach to avoid gut-feel hiring mistakes.Partner with strategic recruiters: Seek recruiters who genuinely understand your company culture and goals, not just resume matchers.Act early on critical hires: Don't delay filling strategic roles; the opportunity cost and cultural risk multiply with time.References:Kirk Petyo's LinkedIn ProfileTalent Factory Medical WebsiteEtienne Nichols' LinkedIn ProfileMedTech 101 Section:Competency vs. Capability (Simplified):Think of competency like what's already in a candidate's toolbox—their current skills and experiences. Capability is their potential—the size of the projects they could build if you give them the right tools and environment.Audience Engagement Prompt:Poll Question: What's the biggest challenge you face when hiring MedTech talent?Defining clear job expectationsAttracting candidates from outside the industryAvoiding bad hiresSpeeding up the hiring...

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.

On this episode of the Next Level Idea podcast I have the honor of speaking with Omar Khateeb who is the host of the #1 podcast in the world talking about all things Medtech called the State of Medtech. Omar is also the founder of Khateeb & Co., OmniCreator, and a proud husband and father. We cover a wide range of subjects focussing on private equity investment, future happenings, and Omar's opinion on where he sees companies will be going with AI. Thank you Omar again for coming on the podcast!

In this compelling episode, Etienne Nichols chats with regulatory powerhouse Sarah Moeller about the crucial intersection between the FDA's regulatory oversight and international ISO standards development. They uncover the profound impact of FDA's participation—or absence—in shaping global standards, especially ISO 14155 and ISO 18969 updates. The conversation also tackles the shifting landscape caused by administrative changes in the U.S., the effects on clinical trials, AI-driven digital evidence, and what companies must do to stay compliant and innovative in a volatile regulatory environment.Key Timestamps:[02:30] – Introduction to Sarah Moeller and her role in ISO 18969 updates.[07:00] – Overview of ISO standards update processes and FDA's critical role.[15:20] – The impact of AI and digital evidence on clinical evaluations.[22:10] – Why FDA's temporary absence from standards writing matters.[31:45] – Resumed communications: FDA's current engagement status.[41:00] – Implications of leadership changes at the FDA.[50:15] – Strategic advice for MedTech companies amidst regulatory uncertainty.[58:00] – Passionate case for FDA's continued involvement and defense of public service.[1:12:30] – Big updates in ISO 14155 and 18969 and what they mean for clinical trials.Memorable Quotes:"Without FDA at the standards table, we risk global disharmony—and patients pay the price." – Sarah Moeller"Taking care of each other must be our number one goal in both hospitality and healthcare." – Sarah MoellerKey Takeaways:Practical Tips:Maintain proactive and open communications with your FDA reviewers.Incorporate rigorous digital evidence management to future-proof clinical evaluations.Advocate for clear regulatory processes by contacting your congressional representatives.References Mentioned:ISO 14155: Good Clinical Practice for Medical Device Trials—Updated to reflect decentralized trials and enhanced CRO oversight.ISO 18969: Clinical Evaluation Standard aligning evaluations across the total product lifecycle.MDUFA and PDUFA: Critical funding mechanisms supporting timely FDA review processes.Etienne Nichols on LinkedInMedTech 101:ISO Standards: International standards that ensure quality, safety, and efficacy in products across global markets.MDUFA (Medical Device User Fee Agreement): Agreement where companies pay fees to FDA for timely device reviews.Clinical Evaluation: Systematic process for assessing and analyzing clinical data to verify the safety and performance of a medical device.Audience Interaction:Poll Question: "Do you believe the FDA should have a permanent seat at all ISO standards committees?"

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.

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.

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  

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

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.