# #356: Quality Myths & Lessons Learned Part II

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-02-22
- Length: 46m
- Episode: 356
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-02-22-356-quality-myths-lessons-learned-part-ii
- Listen: https://podcast.greenlight.guru/episode/357-quality-myths-lessons-learned-ii

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-02-22-356-quality-myths-lessons-learned-part-ii#t=0) Introduction and Book Overview
- [5:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-02-22-356-quality-myths-lessons-learned-part-ii#t=319) Ethics in Medical Device Engineering
- [10:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-02-22-356-quality-myths-lessons-learned-part-ii#t=629) Accelerated Testing and Statistical Rigor
- [15:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-02-22-356-quality-myths-lessons-learned-part-ii#t=927) Becker's 5 Levels of Knowledge
- [18:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-02-22-356-quality-myths-lessons-learned-part-ii#t=1125) Standing Your Ground and Competence
- [24:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-02-22-356-quality-myths-lessons-learned-part-ii#t=1449) Practical Examples: Measurement and Fibers
- [33:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-02-22-356-quality-myths-lessons-learned-part-ii#t=2018) Complex Problems vs. Complicated Problems
- [44:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-02-22-356-quality-myths-lessons-learned-part-ii#t=2652) Final Advice and Closing

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- Quality Myths and Lessons Learned (product)
- ASQ (other)
- University of Minnesota (other)
- University of Maryland (other)

## Related episodes from other shows

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- [254 - Saying No Is the Easy Part of Quality](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-13-254-saying-no-is-the-easy-part-of-quality) (Let's Combinate)
- [065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-28-065-8-quality-lessons-from-losing-100-lbs-with-subhi-saadeh) (Let's Combinate)
- [071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols) (Let's Combinate)
- [004 - “Until They Know How Much You Care” with Andy Robertson](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-27-004-until-they-know-how-much-you-care-with-andy-robertson) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-02-22-356-quality-myths-lessons-learned-part-ii. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.