Global Medical Device Podcast powered by Greenlight Guru Podcast
1) #450: Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling
In this episode, Etienne Nichols sits down with Staci Miller, a Human Factors and UX Strategist at GenUX, to demystify the role of human factors (HF) in the medical device regulatory pathway. Staci ex...Show More
2) #449: 7 Pitfalls of International MedTech Expansion
In this episode, Etienne Nichols sits down with regulatory expert Mike Drues, President of Vascular Sciences, to discuss the "culture shock" international medical device companies face when entering t...Show More
3) 448: MedTech Investment: Outcomes, Regulations, and the Shift to At-Home Care
This episode features Ivanny Franklin, Managing Partner at MedSight Capital, who brings a wealth of experience from her background in molecular biology and her decade-long tenure at NAMSA. The convers...Show More
4) 447: Solving the Pediatric MedTech Gap with Edwin Lindsay
In this episode, Etienne Nichols sits down with Edwin Lindsay, a seasoned MedTech operator and QARA leader, to discuss the systemic challenges facing the pediatric medical device market. Following a p...Show More
5) #446: The Hidden Physics of the MedTech Life Cycle with Dr. Kristy Katzenmeyer-Pleuss
In this episode, Etienne Nichols sits down with Dr. Kristy Katzenmeyer-Pleuss, President and Founder of KP Medical Device Consulting, to unpack the complexities of the medical device life cycle. The c...Show More
6) #445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech
In this episode, Etienne Nichols sits down with Thor Rollins, a leader at Nelson Labs and the convener of the committee revising ISO 10993-1. The conversation centers on the newest 2025 version of the...Show More
7) #443: Scaling Your QMS: What the FDA Really Expects for MedTech Startups
This episode explores the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and the foundational elements required for medical device compliance. H...Show More
8) #443: Generative AI in MedTech: Quality, Risks, and the Autonomy Scale with Ashkon Rasooli
In this episode, host Etienne Nichols sits down with Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD). The conversation previews their upcoming se...Show More
9) #442: MedTech Leadership: Vulnerability & The CEC Framework with Dr. Jenny Hoffmann
Dr. Jenny Hoffmann, MedTech executive and author of Open Up: Step Into the Leader You Are Meant to Be, joins host Etienne Nichols to discuss the evolution of leadership in the medical device industry....Show More
10) #441: ICYMI (In Case You Missed It!) How Artificial Intelligence is Impacting the MedTech Industry
In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future ...Show More