# Greenlight Guru
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Top podcast episodes featuring greenlight guru.
#376: FDA's Proposed Wound Dressing Rule: Industry Impacts and Regulatory Insights
In this episode, host Etienne Nichols is joined by Mark DuVal, President and CEO of DuVal & Associates, and Kathy Herzog, Senior Regulatory, Quality, and Compliance Associate at DuVal & Associates. They delve into the recent FDA proposed rule for wound dressings, addressing the classification and r…
#377: Designing a Medical Device for a Global User
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Matthew Wettergreen, Director of the Global Medical Innovation Master of Bioengineering program at Rice University. Dr. Wettergreen shares his extensive experience in developing client-based engineering design …
Turning Roadblocks into Milestones with Jon Speer
What happens when your passion collides with a bigger challenge?
Join host Kevin Bailey and Max Yoder as they dive deep into conversation with Jon Speer, a remarkable founder who knows the highs and lows of entrepreneurship like the back of his hands.
Jon shares his story of how an investor's de…
#381: MedTech Advice from an Accidental Entrepreneur
In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, about her path from a biomedical engineer to an "accidental entrepreneur."
Dr. Parekh shares how her desire to create impactful medical devi…
#382: Design of Experiments - How and When to Use DOE
In this episode, Etienne Nichols interviews Perry Parendo, an expert in Design of Experiments (DOE), about the practical application of DOE in medical device development.
They discuss how DOE can be used to better understand systems, reduce risk, and solve complex problems, especially in R&D and m…
#383: What Standards Apply to My Device?
In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development.
Leo shares his journey into the world of medical device standards, offering a detai…
#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator.
Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on …
#386: The Danger of In-Home Use Medical Devices, Pt. 2
In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory expert Mike Drues in part two of their series on home use medical devices.
The discussion centers on critical topics such as labeling, usability challenges, and the future of medic…
#387: The case for Real World Evidence Studies
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation.
Simon breaks down NEST'…
#388: Elements of an Effective CAPA Program
In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Georg Digel, a seasoned expert in Corrective and Preventive Action (CAPA) systems.
Georg shares insights into setting up an effective CAPA program, discussing essential topics like identifying CAPA triggers, executing root…
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