Global Medical Device Podcast powered by Greenlight Guru

Feb 20 2025 350 ep. 38 mins 168
Global Medical Device Podcast powered by Greenlight Guru artwork

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.

  Health & Fitness  Business  Technology
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#399: How To Approach Culture Differences

Feb 20 2025 22 mins  
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Olga Chashchina, a MedTech startup founder with extensive international experience. They explore how cultural differences affect communication in the medical device industry and the importance of understanding intercultural nuances. Drawing from the book The Culture Map by Erin Meyer, Olga sha

#398: Game-Changing Connections in MedTech: Inside LSI with Scott Pantel

Feb 13 2025 35 mins  
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Scott Pantel, CEO and founder of Life Science Intelligence (LSI), to explore how LSI bridges the gap between medtech innovation and commercialization. Scott shares LSI’s origin story, the evolution of its events, and the importance of cultivating meaningful relationships within the medtech e

#397: Winning Over Skeptics: the Key to Product Adoption in Healthcare

Feb 06 2025 33 mins  
In this episode, Etienne Nichols sits down with Tiffany Ryder—healthcare advocate, physician assistant, and founder of Red Flag Hero—to discuss the complexities of product adoption in healthcare. Tiffany shares her journey from rural Louisiana to the NFL cheerleading squad and into emergency medicine, highlighting how personal experience shapes her patient advocacy.The conversa

#396: Mastering Device Descriptions: The Cornerstone of Medical Device Submissions

Dec 19 2024 50 mins  
In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory consultant Mike Drues delve into the often-overlooked yet critical topic of device descriptions in FDA submissions. Discover why this foundational element can determine the success of your regulatory pathway, influence classification, and impact the required testing for your device. With actionable

#395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond

Dec 12 2024 42 mins  
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development. They unpack the upcoming revisions to the fourth edition of IEC 60601, focusing on the rationale behind these changes, their impact on medical device design, and how MedTech professionals can pr

#394: Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike Drues

Dec 06 2024 51 mins  
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices. They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the rigorous PMA pathway. Mike explai

#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko

Nov 29 2024 33 mins  
In this episode of the Global Medical Device Podcast, Etienne Nichols talks with Justin Bushko, president of Concise Engineering and founder of MedTech Man. Justin shares his extensive experience in MedTech, guiding startups and major players alike through complex engineering challenges. From simplifying prototypes to pivoting product strategies, Justin emphasizes the importance of

#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell

Nov 22 2024 58 mins  
In this engaging episode of the Global Medical Device Podcast, Etienne Nichols and Devon Campbell dive into the complexities of verification and validation (V&V) in medical device development. Whether you’re a medtech startup founder or an industry veteran, this conversation offers essential insights on creating robust V&V processes. Devon shares practical advice on defin

#391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq

Nov 14 2024 35 mins  
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Adnan Ashfaq, a seasoned quality, regulatory, and validation specialist, to explore the critical role of developing a regulatory roadmap for medical device companies. Adnan breaks down the differences between a regulatory strategy and a regulatory roadmap, highlighting how a well-designed roadmap s

#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli

Nov 07 2024 37 mins  
In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by quality and regulatory expert Ashkon Rasooli to explore the essentials of creating a high-impact, non-burdensome Quality Management System (QMS). Ashkon shares his four guiding principles for building an effective QMS—emphasizing quality over proceduralism, culture over mandate, redundancy ove