The Project Medtech podcast is interview-style podcast on the Medtech Industry where guests share stories, advice, pitfalls, trends and innovations produced by Project Medtech.
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Project Medtech Podcasts
Join Sunrise Labs on the Making Bright Ideas Work podcast to discuss the ins and outs of bringing medical devices to life, and their impact on the industry and beyond.
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Global Medical Device Podcast powered by Greenlight Guru
Greenlight Guru + Medical Device Entrepreneurs
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
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The Being An Engineer podcast is a central repository in which we collect and share industry knowledge & best practices associated with the discipline of engineering. We hope that engineers throughout the world will benefit from this content as they connect with the companies, technologies, people, resources, and opportunities that are relevant to their engineering or engineering-adjacent roles. Contact us at [email protected]. Intro and Outro music by John Martell
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Episode 232 | Lisa Jacobs, US President at eCential Robotics | Founding STRIPES & Leading Innovation in Medtech
28:30
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28:30In this episode, Duane Mancini chats with Lisa Jacobs, US President of eCential Robotics and Founder of STRIPES. With over 20 years of experience in orthopedics, robotics, and spine, Lisa delves into her motivations, challenges, and significant career milestones, including her personal connection to orthopedics through her brother's medical conditi…
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S6E38 Wally Waldron | How to Successfully Exit A Manufacturing or Industrial Services Business
55:01
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55:01Send us a text Jason “Wally” Waldron is the founder and CEO of Exitology, a company dedicated to helping custom manufacturers, industrial services, and supply chain firms scale their businesses rapidly and exit with maximum value—on their own terms. With nearly two decades of experience advising business owners and engineering-driven teams, Wally s…
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S6E37 Duann Scott | Computational Design & The Best File Format for 3D Printing
41:01
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41:01Send us a text Duann Scott is a globally recognized leader in computational design, additive manufacturing, and the emerging intersection of software and fabrication. With a background in industrial design and a PhD research foundation from the University of South Australia, Duann launched BITS to ATOMS in 2009 to explore how digital tools would re…
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Episode 231 | Walter Haydock, Founder of StackAware | Navigating AI Risk & Compliance in Healthtech Startups
29:59
29:59
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29:59In this episode, Duane Mancini sits down with Walter Haydock, founder of StackAware and former Marine Corps intelligence officer, to explore the intersection of AI, cybersecurity, and startup leadership in the healthcare and life sciences sectors. Walter shares how his military background informs his approach to risk, decision-making, and company b…
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S6E36 Tessa Axsom | Casting, Metallurgy, & Finishing with Fictiv
42:46
42:46
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42:46Send us a text Tessa Axsom blends deep mechanical engineering know‑how with the craft of product marketing. Today she serves as Product Marketing Manager – CNC at Fictiv, the on‑demand manufacturing partner known for its robust CNC resources and design guides. In this role, she translates shop‑floor realities into crisp messages, actionable guidanc…
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Episode 230 | Eduardo Palma, Senior Analyst at 415 Capital |Investing in Lifesaving Innovation & Strategies for Startups' Success
42:08
42:08
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42:08In this episode, Duane Mancini welcomes to the show Eduardo Palma, a senior analyst at 415 Capital, a VC firm specializing in cardiovascular medtech investments. Eduardo shares insights on his background, the emergence of Portugal as a VC hub, and the strategic advantages of their Munich base. The conversation explores 415 Capital’s origin, investm…
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S6E35 Spencer Jones | AI for Engineers, Finding Venture Capital, & Accelerating Medtech Development
57:31
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57:31Send us a text Spencer Jones began his healthcare career as a registered nurse in Little Rock, Arkansas, where he witnessed firsthand the clinical need that sparked his first device: SafeBreak® Vascular, a patented solution to prevent IV line dislodgement. As a nursing alumnus of the University of Arkansas, Spencer led SafeBreak from idea to FDA ap…
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#421: Mastering MedTech Influence: The Power of Communication in Quality
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53:27
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53:27In this episode, host Etienne Nichols sits down with Lesley Worthington, an executive coach with a background in psychology, law, and over 20 years in quality and regulatory affairs. They explore the critical, yet often overlooked, role of communication in building a robust culture of quality. Lesley explains that while quality professionals posses…
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Episode 229 | Jessica Richter, Medtech Executive & Board Member, MedtechWOMEN | Navigating the Medtech Landscape: Sales, Leadership, and Women in Medtech
52:00
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52:00In this episode, Duane Mancini welcomes to the show Jessica Richter, a seasoned medtech executive and board member of MedtechWOMEN. With over 20 years in the industry, Jessica shares her extensive career journey from a medical device sales rep, through various leadership roles at companies like Medtronic, to her current independent consulting role.…
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S6E34 John Lembke | Best Practices for Hiring Engineers
39:42
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39:42Send us a text Join us for an in-depth conversation with John Lembke, a manufacturing engineering manager with over a decade of experience in factory digitization, lean manufacturing, and ERP integrations. John shares his proven strategies for hiring high-performing engineering teams, scaling production rapidly, and building effective manufacturing…
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#420: MedTech Synergy: The Project Manager and Quality Professional Relationship
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39:01In this episode, host Etienne Nichols sits down with MedTech quality expert Beth Waring to explore the often-overlooked but crucial relationship between project managers and quality professionals. They tackle the common friction points and misunderstandings that arise when these two roles intersect, and discuss why this relationship is so vital for…
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Episode 228 | Dasha Tyshlek, Founder & Chief Strategic Officer, StratCraft | Empowering Biomedical Innovation: From Customer Discovery to Building Ecosystems
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59:00In this episode, Duane Mancini welcomes to the show Dasha Tyshlek, Founder & Chief Strategic Officer of StratCraft. An innovator who's bridging the gap between groundbreaking research and market-ready technologies, Dasha shares her fascinating journey from a science-loving student to a leader in the medtech, biotech, and defense industries. Learn h…
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S6E33 Bryant Foster | Design for Human Factors & User Experience
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51:30Send us a text Join us for an in-depth conversation with Bryant Foster, a human factors expert who's worked with industry giants like Google to make complex products simpler and safer. With a background in cognitive psychology, Bryant shares insights on designing user-friendly products, from surgical systems to smart thermostats, all while keeping …
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#419: Essential Strategies for CRO Success in Today's Clinical Landscape
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30:05In this episode, host Etienne Nichols speaks with Greenlight Guru's Christine Wilbert, an expert in Electronic Data Capture (EDC) systems for Clinical Research Organizations (CROs). They discuss the critical factors CROs must consider when selecting an EDC solution. Christine highlights that the biggest mistake is a lack of due diligence and not pl…
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Episode 227 | Aaron DeGagne, Senior Healthcare Analyst at PitchBook | Medtech Investment Insights & The Future of Health Innovation
39:48
39:48
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39:48In this episode, Duane Mancini welcomes to the show Aaron DeGagne, Healthcare Senior Analyst at PitchBook. From quarterly reports to market dynamics, Aaron sheds light on significant healthcare investments, including the rise in surgical tools, devices, and the blurring lines between healthtech and medtech. They delve into the impact of global mark…
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S6E32 Josh Zarecky | How To Travel The Country While Working As A Full Time Engineer
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47:01Send us a text In this engaging episode of Being An Engineer, Josh Zarecky shares his unique journey of running an engineering business while traveling across the United States in an RV. He discusses his background in mechanical engineering, the challenges and joys of remote work, and his innovative approach to developing industrial automation solu…
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#418: Biocompatibility Brief - What Medical Device Companies Need to Know
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29:32This episode offers a "biocompatibility brief" with guest Marina Daineko, a MedTech expert and chemist specializing in biological evaluations. Marina shares her perspective on the critical role of chemistry and critical thinking in assessing the safety of medical devices. The discussion highlights the need to look beyond simple pass/fail tests and …
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S6E31 Camden Shuman | Building a Second Brain, Co-ops, & Tools for Developing Your Network
45:12
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45:12Send us a text In this episode, Camden Shuman discusses his experiences as a co-op student at Siemens Healthineers, where he has gained valuable hands-on experience in mechanical design work. He also shares insights about his entrepreneurial venture, "The Engineering Way" newsletter, which aims to help engineering students and professionals develop…
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#417: Evaluating EQMS: A Crucial Step for Medtech Success
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43:45This episode features host Etienne Nichols and guest Andy Rogantino, who discuss the critical timing and process for evaluating and implementing an Electronic Quality Management System (EQMS). They challenge the common "wait until something breaks" approach, emphasizing that the most effective MedTech teams integrate an EQMS early in the product li…
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S6E30 Jake Whinnery | Resources for Interviewing & Landing Engineering Jobs
53:14
53:14
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53:14Send us a text Jake shares his engineering journey, insights into technical interviews, and strategies for young engineers to succeed in the hardware industry. He discusses his experiences at companies like Tesla and Relativity Space and how he created Hardware is Hard to help mechanical engineers land top-tier jobs. Main Topics: Importance of inte…
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#416: Unpacking Common FDA Compliance Gaps: Pre-Market vs. Post-Market Realities
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49:29In this insightful episode, Mike Drues joins host Etienne Nichols to dissect the FDA's most frequently cited compliance issues, challenging the notion that many are strictly "pre-market" concerns. They delve into the nuances of software changes, design creep, and off-label marketing, providing a critical look at how companies can avoid common pitfa…
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S6E29 Joshua Tarbutton | Lessons From the Military Applied to Engineering
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50:33Send us a text Joshua Tarbutton shares his journey from military service to engineering entrepreneurship, discussing how military discipline and leadership principles can transform engineering culture and workplace dynamics. Main Topics: Military influence on engineering leadership Restoring dignity in engineering workplaces Creating psychological …
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Send us a text Sign up for a free account at https://www.thewave.engineer/ Then, access your 50% discount code for PDX 2025 here: https://www.thewave.engineer/product-development-expo/dfm-days/ About Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with…
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#415: Neurotech: Accelerating Innovation in a Complex Medical Device Vertical
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33:00In this episode, Etienne Nichols and Matt Stratton, Director and Principal Consultant at Coalition, delve into the dynamic and complex world of neurotechnology. They discuss the expansive definition of neurotech, the significant challenges in accelerating innovation—particularly concerning regulatory frameworks and cross-functional collaboration—an…
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S6E28 Paul Vizzio | Engineering Naval Submarines, Pet Products, & Elite Sports Training Machines
50:01
50:01
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50:01Send us a text In today’s episode, Paul will explore how he scales hardware teams, builds for manufacturability, navigates supply chain complexity, mentors engineers, and embraces community‑driven innovation. Get ready for insights on leadership, prototyping, and bringing hardware to life from idea to market. Main Topics: Proteus Motion's V1 and V2…
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Send us a text Sign up for a free account at https://www.thewave.engineer/ Then, access your 50% discount code for PDX 2025 here: https://www.thewave.engineer/product-development-expo/dfm-days/ About Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with…
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What Every Engineer Should Know About Contract Manufacturers
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0:55Send us a text Webinar: What Every Engineer Should Know About Contract Manufacturers Register here: https://www.thewave.engineer/store/product/31-what-every-engineer-should-know-about-working-with-a-contract-manufacturer/ About Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers …
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#414: Why Global Certification is the Future of Clinical Research in Latin America
34:49
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34:49As global clinical trials become more competitive and data-driven, Latin America is stepping up with a new global standard in clinical trial quality. In this episode, Etienne Nichols speaks with Julio Martinez-Clark, CEO of BioAccess and a key advocate for clinical site certification in Latin America. They discuss the launch of the GCSA certificati…
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Episode 226 | Bob Roda, President & CEO at HemoSonics | Leveraging Experience & Vulnerability for Medtech Leadership
54:09
54:09
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54:09In this episode, Duane Mancini welcomes Bob Roda, President and CEO of HemoSonics, to discuss the essential components of building a successful and purpose-driven career in the medical device industry. The conversation explores Bob's formative experiences at Johnson & Johnson and Becton Dickson, the critical need for purpose as a guiding principle,…
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S6E27 Stephen Hinch | Lessons from HP & Disruptive Innovations
56:40
56:40
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56:40Send us a text Join Aaron Moncur as he interviews Stephen Hinch about his remarkable career in innovation, discussing how companies can foster breakthrough technologies, overcome corporate innovation barriers, and create a culture that supports creative thinking. Main Topics: From Engineering to Leadership: Steve's Career Journey Turning Innovative…
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#413: Budgeting Blind Spots: What MedTech Startups Miss—and How Investors See It
35:24
35:24
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35:24In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with seasoned MedTech founder and investor Jon Bergsteinsson to unpack a critical—but often overlooked—topic: budgeting in early-stage medical device startups. Drawing from his deep regulatory, clinical, and investment experience, Jon shares the red flags investors look…
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Episode 225 | Brian Morley, Chief Marketing Officer at Native Orthopaedics & Tino Chow, CEO at Giant Shoulders | Crafting & Aligning Your Medtech Brand for Growth
55:14
55:14
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55:14In this episode, Duane Mancini welcomes Brian Morley, CMO of Native Orthopaedics, and returning guest Tino Chow, CEO and Founder at Giant Shoulders, to discuss the critical aspects of building and growing a medtech brand. The conversation explores Brian's journey into Native Orthopaedics, the importance of a clear, operationalized vision for startu…
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S6E26 Katie Karmelek | How You Can Accelerate Med Device Development with Chamfr
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47:57Send us a text In this episode of the Being an Engineer podcast, host Aaron Moncur interviews Katie Karmelek, a mechanical engineer and co-founder of Chamfr. Katie shares her journey from engineering to entrepreneurship, discussing her passion for medical device innovation and how Chamfr is revolutionizing component sourcing for medical device engi…
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Send us a text Sign up for a free account at https://www.thewave.engineer/ Then, access your 50% discount code for PDX 2025 here: https://www.thewave.engineer/product-development-expo/dfm-days/ About Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with…
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#412: How to Build a QMS That Actually Works: From Startup to Scale in MedTech
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16:58In this live episode from the LSI conference in California, Etienne Nichols is joined by Ashkon Rasooli to break down what it really takes to build a high-performing quality management system (QMS) in medtech—from startup chaos to post-market scale. Ashkon shares a phased approach to aligning QMS implementation with product development, explains th…
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Episode 224 | Joseph Mocanu, Managing Partner at Verge HealthTech Fund | Rethinking Venture Capital & Achieving Global HealthTech Impact
47:21
47:21
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47:21In this episode, Duane Mancini reconnects with Joseph Mocanu, Managing Partner at Verge HealthTec Fund, for a follow-up to their insightful conversation in episode 103. Joseph shares the significant milestones Verge HealthTec Fund has achieved since their last discussion and offers a glimpse into what we can anticipate in the coming years. The conv…
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S6S25 Andy Thompson | Practical Applications of GD&T
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45:30Send us a text In this episode, Andy Thompson discussed his journey from machinist to expert in GD&T (Geometric Dimensioning and Tolerancing). He highlighted the importance of understanding GD&T for effective design, manufacturing, and quality control. Thompson shared examples of how GD&T improved manufacturing processes, such as aerospace parts an…
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#411: Unlocking U.S. MedTech Market Access: State-Specific Compliance Pitfalls Medical Device Companies Miss
48:11
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48:11Many MedTech companies focus heavily on FDA clearance but overlook a critical layer of U.S. market entry: state-level compliance. In this episode, Etienne Nichols speaks with Adam Steadman, CEO of MDD Options, to unpack the real-world challenges that derail commercialization after regulatory approval. From navigating state-specific registration, sa…
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Episode 223 | Harrison Lands, Director, Translational Sciences at UPMC Enterprises | Investing in Innovation: Inside UPMC's Payer/Provider Model & Life Science Strategy
30:23
30:23
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30:23In this episode, Duane Mancini is joined by Harrison Lands, Director of Translational Sciences at UPMC Enterprises. Harrison brings a unique perspective, shaped by his background as a physician, MBA, consultant, and now investor. We delve into the workings of UPMC Enterprises, exploring their investment thesis – the who, what, how much, when, and h…
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