# Quality Myths and Lessons Learned

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-01-19
- Length: 45m
- Episode: 301
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned
- Listen: https://podcast.greenlight.guru/episode/quality-myths-and-lessons-learned

## Summary

Kevin Becker, author of 'Quality Myths and Lessons Learned' and Director of Quality at a med device component manufacturer, discusses common pitfalls in medical device quality engineering. He explains how misaligned incentives can lead to unethical behavior, such as falsifying data or hiding defects during FDA audits, and emphasizes the need for principle-based decision-making to overcome peer pressure and 'normalization of deviance.' Becker argues that management support is the most critical component of a Quality Management System (QMS) and shares lessons on statistical misconceptions, effective flowcharting, and the importance of integrity in engineering.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned#t=0) Introduction and Guest Background
- [8:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned#t=509) Incentives and Unintended Consequences
- [10:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned#t=637) Ethics, Falsified Data, and FDA Audits
- [16:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned#t=973) The 'Wrong but Believable' Answer in Statistics
- [22:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned#t=1337) Quality's PR Problem and Competence
- [26:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned#t=1569) Flowcharts and Process Efficiency
- [29:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned#t=1741) Principle-Based Decision Making and Normalization of Deviance
- [40:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned#t=2411) Management Responsibility as the Core of QMS

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- Hutchinson Technology (company)
- ASQ (other)
- FDA (other)
- ISO 13485 (other)

## Related episodes from other shows

- [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)
- [215 - Why Aren’t Technical People Leading Drug-Device Audits?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-26-215-why-arent-technical-people-leading-drug-device-audits) (Let's Combinate)
- [179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-12-179-quality-is-not-everyones-job-why-thats-a-good-thing) (Let's Combinate)
- [123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a) (Let's Combinate)
- [100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m) (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/2023-01-19-quality-myths-and-lessons-learned. 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.