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 Sales Culture Podcast shares real conversations on how growth teams stay human as they scale with AI. Hosted by Joe Lemon, the show explores how sales, marketing, and revenue leaders are using AI to work smarter—without losing empathy, creativity, or trust. Each episode dives into what’s actually working in the field: from building better teams and customer experiences to redefining what “human connection” means in a digital world. It’s not about replacing people. It’s about helping peop ...
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Episode 240 | Panel Discussion at Ohio VC Fest | AI-Driven Healthcare: The Heartland Advantage
48:16
48:16
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48:16This special episode of the podcast is a recording of a panel discussion that took place at the 2025 Ohio VC Fest powered by @JumpStart Inc. entitled "AI-Driven Healthcare: The Heartland Advantage." Panelists include Michael Dalton (CEO & Founder at @Ovatient), Kaleigh Gallagher (VP of Tech Services & Network Management at @JumpStart), Matthew Zenk…
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#434: ICYMI (In Case You Missed It!) Project Management In Medtech
1:02:20
1:02:20
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1:02:20This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management within the MedTech sector. Host Etienne Nichols and Perry delve into the challenges and opportunities facing medical device development, emphasizing the critical role of agile pract…
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#436: Do ISO 13485's Production Controls apply to SaMD?
43:05
43:05
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43:05This episode tackles the complex challenge of applying the hardware-centric clauses of ISO 13485 to Software as a Medical Device (SaMD). Adnan Ashfaq, founder of Simply Medica, joins Etienne Nichols to dissect how traditional standards intended for physical manufacturing must be creatively interpreted for the virtual world of software development, …
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#435: ICYMI (In Case You Missed It!) Becoming a Regulatory Affairs Professional
44:35
44:35
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44:35In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices. Together, they delve into how new regulatory affairs professionals can get started in a career of medical device regulations and the …
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Episode 239 | Holly Cotter, Co-Founder of indieMedTech | Building Community & Innovation in Medtech
29:19
29:19
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29:19In this episode, Duane Mancini chats with Holly Cotter, a seasoned regulatory quality and clinical consulting expert in MedTech and co-founder of indieMedTech. Holly discusses the inception of indieMedTech, a platform designed to support MedTech professionals, especially independent consultants and startups, with a robust community and marketplace.…
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Episode 238 | Allison Komiyama, Founder of Bluestocking Health | From the FDA to Regulatory Consultant to Medtech Entrepreneur
42:03
42:03
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42:03In this episode, Duane Mancini interviews Allison Komiyama, a former FDA reviewer turned successful entrepreneur, who shares her journey from her early passion for biology, through her academic achievements in molecular cell biology and neuroscience, to landing a role at the FDA. She recounts the challenges and lessons learned starting her own regu…
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Episode 237 | Tino Chow, Giant Shoulders & Lindsey Dinneen, Project Medtech | Building Authentic Relationships & Memorable Pitches
49:50
49:50
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49:50In this episode, Duane Mancini, Tino Chow, and Lindsey Dinneen dive into the intricacies of pitching, focusing on both the technical and emotional aspects. The conversation highlights the importance of authenticity, building relationships, and the critical role a cohesive and credible team plays in attracting investors. They share strategies for ma…
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#433: ICYMI (In Case You Missed It!) Climbing the Medtech Ladder - How to Get to the Top
1:10:28
1:10:28
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1:10:28In this episode of the Global Medical Device Podcast, we’re joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Elena delves into what it takes to climb the career ladder in the medtech industry, whether you're early or late in your career journey. Our host, Etienne Nichols, engages in a rich discussion on career paths, levera…
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178. Trend Towards Project-based Work in AI Era (AUDIO)
4:10
4:10
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4:10Adapting Sales Strategies in the AI Era In this episode of Sales Culture, host Joe Lemon delves into the evolving landscape of work, sales, and human connection in the AI age. Joe discusses how automation and AI are transforming the workplace and highlights the importance of integrating old-school sales principles with new AI-driven approaches. He …
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#432: China MedTech Compliance: Regulatory Risks, Rewards, & Strategy with Elaine Tan
40:20
40:20
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40:20This episode dives into the complex and often misunderstood MedTech market in China, featuring Elaine Tan, creator of MedTech Chopsticks, who translates the nation’s stringent regulatory language into actionable insights. Elaine and host Etienne Nichols discuss the substantial risks and rewards of bringing a medical device to China, highlighting th…
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#431: Meet Alex Naber: Insider Insights on Quality Systems, Design Quality, and MedTech's Patient-First Ethos
26:07
26:07
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26:07This "Meet the Guru" episode introduces Alex Naber, a seasoned medical device consultant at Greenlight Guru, offering listeners a deep dive into his background and expertise. Alex shares his journey, beginning in bioengineering and progressing through roles in complaints, field action, design quality, and post-market quality management at a major o…
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#430: MedTech Language: Patient, Customer, or Partner?
32:49
32:49
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32:49In this episode, host Etienne Nichols and guest Dr. Allison Komiyama, CEO and Founder of Blue Stocking Health, dive into a fascinating dialogue about the language used in healthcare and MedTech, particularly the terms patient, customer, and user. They explore how these words influence the perception of care, service, and the entire medical device d…
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#429: MedTech Regulatory Risk: Navigating the FDA During a Government Shutdown
22:16
22:16
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22:16This episode, hosted by Etienne Nichols, delves into the critical impact of a U.S. government shutdown on the medical device industry, specifically focusing on the Food and Drug Administration (FDA). Guest Michael Nilo, President and Principal Consultant of Nilo Medical Consulting Group and a former FDA Scientific Reviewer, offers an insider's pers…
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#428: Andragogy in MedTech: Why Adult Learning Principles Beat Traditional Training
49:21
49:21
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49:21This 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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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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39:37In 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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#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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39:12In 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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44:59In 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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38:50In 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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41:58This 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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54:32In 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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52:03In 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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28:30In 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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#423: Inside the Investor's Mind: What VCs Look For in MedTech
1:11:23
1:11:23
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1:11:23In 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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29:59In 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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#422: ISO 14971 and the Road to Risk Management with Edwin Bills
1:03:59
1:03:59
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1:03:59This 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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42:08In 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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#421: Mastering MedTech Influence: The Power of Communication in Quality
53:27
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
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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#420: MedTech Synergy: The Project Manager and Quality Professional Relationship
39:01
39:01
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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
59:00
59:00
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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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#419: Essential Strategies for CRO Success in Today's Clinical Landscape
30:05
30:05
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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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