# 071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-02-08
- Length: 59m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/071---Steel-Industry-to-MedTech--Important-Quality-Systems-with-Etienne-Nichols-e1tjors

## Summary

Etienne Nichols, host of the Global Medical Device Podcast and Medical Device Guru at Green Light Guru, discusses his transition from the steel industry to MedTech and his work on combination products. He emphasizes that document control (21 CFR 820.40) is critical for preventing costly errors, illustrating this with an anecdote about saving a $100,000 steel coupling from being scrapped due to a decimal error. Nichols argues that management responsibility is the most important quality system element, as it sets the cultural tone for prioritizing quality over speed, and highlights the importance of strong purchasing controls to ensure quality flows to contract manufacturers.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols#t=0) Introduction: Etienne Nichols and Green Light Guru
- [1:10](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols#t=70) Transition from Steel Industry to MedTech
- [5:13](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols#t=313) Design Controls as Prudent Engineering
- [8:04](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols#t=484) The $100,000 Steel Coupling and Document Control
- [18:38](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols#t=1118) Combination Products: Pharma vs. Device Culture
- [26:20](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols#t=1580) UDI Direct Part Marking and Change Order Nightmares
- [34:20](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols#t=2060) Management Responsibility and Purchasing Controls
- [46:33](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols#t=2793) Building the MedTech Excellence Community

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- Green Light Guru (company)
- Global Medical Device Podcast (product)
- John Spears (other)
- Mike Drews (other)
- Baxter (company)
- Motorola (company)
- Kodak (company)
- Skip Krebling (other)
- UL (company)
- SolidWorks (tool)
- 21 CFR 820 (other)
- ISO 13485 (other)
- ICH (other)
- ASQ (other)
- J and J (company)
- Kevin Becker (other)

## Related episodes from other shows

- [#324 Management Responsibility: The most important part of a QMS](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-22-324-management-responsibility-the-most-important-part-of-a-qms) (Global Medical Device Podcast)
- [Quality Myths and Lessons Learned](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned) (Global Medical Device Podcast)
- [#352: Fundamentals of Quality & Regulatory](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-18-352-fundamentals-of-quality-regulatory) (Global Medical Device Podcast)
- [Past, Present, Future State (and World) of Quality in the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry) (Global Medical Device Podcast)
- [#367: Interviewing the Interviewer](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-16-367-interviewing-the-interviewer) (Global Medical Device Podcast)

## Citing this page

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