#356: Quality Myths & Lessons Learned Part II

Global Medical Device Podcast · 22 Feb 2024 · 46m · Episode 356

What this episode covers

Kevin Becker, author of 'Quality Myths and Lessons Learned' (2nd Edition), joins host Etienne Nichols to discuss the new ethics chapter, the importance of statistical rigor, and the nuances of accelerated testing in medical device development. Becker shares personal anecdotes about ethical dilemmas, such as being asked to fabricate data or lie to customers, and explains his '5 levels of knowledge' framework for professional development. The conversation highlights the necessity of understanding the underlying physics and math behind quality rules to avoid misapplication, using examples like measurement capability studies and fiber optic fatigue testing.

Mentioned

Companies
Greenlight Guru
Products
Quality Myths and Lessons Learned
Also
ASQ, University of Minnesota, University of Maryland

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