Hardware Podcasts

How Jon Speer Met His Most Frequent Guest: Mike Drues

Global Medical Device Podcast · 26 Aug 2020 · 40m · Episode 161

What this episode covers

Jon Speer, host of the Global Medical Device Podcast and founder of Greenlight Guru, revisits his 2014 origin story with Mike Drues, president of Vascular Sciences, to discuss their past debates on medical device design controls. They analyze the tension between following the literal letter of FDA regulations versus understanding their intent, arguing that many companies fail because they treat compliance as a checkbox exercise rather than a rigorous engineering process. The conversation highlights the danger of assuming users know their own needs, which stifles revolutionary product development in favor of evolutionary improvements, and emphasizes the critical importance of validating validation methods and addressing off-label use in risk management.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
FDA, ISO 14971, 510 K

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