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
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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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Episode 236 | Amy Rinaldo, Partner at Ward Law Office | Bridging IP, Branding, and Compliance for Medtech Innovators
39:37
39:37
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In this episode, Duane Mancini sits down with Amy Rinaldo, Partner at Ward Law Office, to discuss the strategic intricacies of intellectual property in the medtech industry. Amy shares her extensive experience in patent and trademark law, exploring the intersection of IP strategy with regulatory compliance and commercialization. The conversation co…
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#428: Andragogy in MedTech: Why Adult Learning Principles Beat Traditional Training
49:21
49:21
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49:21
This episode of the Global Medical Device Podcast, hosted by Etienne Nichols with guest Shannon Decker, CEO of VBC1 and an expert in healthcare transformation, dives deep into the science of how adults learn, contrasting pedagogy (child-centered learning) with andragogy (adult-centered learning). The discussion reveals why traditional training meth…
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#427: Medical Device Reimbursement - Pitfalls to Avoid
41:12
41:12
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Episode 235 | Leo Eisner, Founder and Principal Compliance & Regulatory Consultant of Eisner Safety Consultants | Navigating IEC 60601 Compliance for Medtech Innovation
39:12
39:12
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39:12
In this episode, Duane Mancini sits downs with Leo Eisner, a seasoned expert in medical device safety and compliance, as he shares his extensive experience and knowledge on the IEC 60601 standards. With a career spanning over 40 years, Leo talks about his beginnings at NASA, his role in the development of medical safety standards, and the intricaci…
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#426: Software as a Medical Device: Securing Your Digital Future
44:59
44:59
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44:59
In this episode, host Etienne Nichols sits down with Jose Bohorquez and Mohamad Foustok from CyberMed to dissect the complex world of Software as a Medical Device (SaMD) and cybersecurity. They emphasize that SaMD is first and foremost a medical device and should be treated as such from the very beginning of the development process. The conversatio…
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Episode 234 | Logan McKnight, Founder of GoodKnight Consulting | Developing Effective Leadership in the Medtech Field
38:50
38:50
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38:50
In this episode, Duane Mancini chats with Logan McKnight, a seasoned professional with a vast background in medtech. Logan shares her journey from starting in medical services and neuromonitoring to leadership roles, culminating in the establishment of her consulting firm, GoodKnight Consulting. The conversation dives into the nuances of managing c…
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#425: The "Front End" of Medical Device Innovation: From Idea to Market
41:58
41:58
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41:58
This episode with Stuart Grant of Archetype MedTech demystifies the "front end of innovation," a critical yet often overlooked phase of medical device development. Stuart, a seasoned MedTech veteran with over two decades of experience at Johnson & Johnson, shares insights from his doctoral research on this topic. He breaks down the process, definin…
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Episode 233 | Kevin Saem, Managing Director at Zapyrus | The Future of MedTech: Data-Driven Decisions & Investment Insights
54:32
54:32
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54:32
In this episode, Duane Mancini welcomes back Kevin Saem, Managing Director of Zapyrus, for an enlightening discussion on the future of the MedTech industry. The episode delves into the latest trends in medtech funding, highlighting a significant increase in investments outside the U.S., the pivotal role of diagnostic technologies, and the importanc…
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#424: The MedTech Startup Survival Guide with Steve Bell
52:03
52:03
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52:03
In this episode, host Etienne Nichols sits down with seasoned MedTech entrepreneur Steve Bell to discuss the critical lessons for starting and scaling a medical device company. With over 30 years of global experience, Steve shares insights from his work with major corporations like Johnson & Johnson and his role in building Europe’s largest MedTech…
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Episode 232 | Lisa Jacobs, US President at eCential Robotics | Founding STRIPES & Leading Innovation in Medtech
28:30
28:30
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28:30
In 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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#423: Inside the Investor's Mind: What VCs Look For in MedTech
1:11:23
1:11:23
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In this episode, host Etienne Nichols sits down with Josh Eckelberry, Principal at Solas BioVentures, for an illuminating conversation about venture capital in the MedTech and life sciences sectors. Josh shares his journey from a medical background to a career in venture capital, driven by a passion for creating "leveraged change" by helping innova…
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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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29:59
In 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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#422: ISO 14971 and the Road to Risk Management with Edwin Bills
1:03:59
1:03:59
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1:03:59
This episode takes an unexpected journey with Edwin Bills, a lead expert in medical device risk management and a key contributor to the development of ISO 14971. Edwin shares stories from his diverse career, beginning with his time as a submariner and electronics technician in the Navy, where he worked on early GPS technology and helped build missi…
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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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42:08
In 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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#421: Mastering MedTech Influence: The Power of Communication in Quality
53:27
53:27
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53:27
In 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
52:00
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52:00
In 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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#420: MedTech Synergy: The Project Manager and Quality Professional Relationship
39:01
39:01
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39:01
In 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
59:00
59:00
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59:00
In 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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#419: Essential Strategies for CRO Success in Today's Clinical Landscape
30:05
30:05
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30:05
In 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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39:48
In 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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#418: Biocompatibility Brief - What Medical Device Companies Need to Know
29:32
29:32
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29:32
This 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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#417: Evaluating EQMS: A Crucial Step for Medtech Success
43:45
43:45
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43:45
This 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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#416: Unpacking Common FDA Compliance Gaps: Pre-Market vs. Post-Market Realities
49:29
49:29
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49:29
In 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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#415: Neurotech: Accelerating Innovation in a Complex Medical Device Vertical
33:00
33:00
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33:00
In 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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#414: Why Global Certification is the Future of Clinical Research in Latin America
34:49
34:49
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34:49
As 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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54:09
In 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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#413: Budgeting Blind Spots: What MedTech Startups Miss—and How Investors See It
35:24
35:24
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35:24
In 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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55:14
In 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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#412: How to Build a QMS That Actually Works: From Startup to Scale in MedTech
16:58
16:58
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16:58
In 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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47:21
In 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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#411: Unlocking U.S. MedTech Market Access: State-Specific Compliance Pitfalls Medical Device Companies Miss
48:11
48:11
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48:11
Many 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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30:23
In 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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