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May 2022
46m 33s

Bringing Medical Devices into the Home

Greenlight Guru + Medical Device Entrepreneurs
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Oct 15
#476: Part 2: FDA Guidance: What We Should Expect in 2027
In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory consultant Michael Drues, Ph.D., to examine the FDA's Center for Devices and Radiological Health (CDRH) guidance document priorities for fiscal year 2027. The dis ... Show More
52m 42s
Oct 13
#475: Part 1: Rethinking FDA Guidance: Why Non-Binding Documents Define Your Regulatory Strategy
In this episode of the Global Medical Device Podcast, host Etienne Nichols and regulatory consultant Mike Drues dive deep into the world of FDA guidance documents. They unpack what these documents truly represent—the agency's current thinking rather than binding law—and explore h ... Show More
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Sep 22
#470: The Real Cost of MedTech Innovation: From Idea to Pre-Production with Lisa Voronkova
Building a medical device rarely follows the smooth, predictable trajectory presented in investor pitch decks. While regulatory consultants often default to "it depends," medical device teams require concrete figures regarding engineering hours, calendar timelines, and budget all ... Show More
39m 49s
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