# 142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-06-26
- Length: 30m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-26-142-material-qualification-in-drugs-vs-devices-ppap-apqp-quality-tools-and-purch
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/142---Material-Qualification-in-Drugs-vs--Devices--PPAP--APQP--Quality-Tools-and-Purchasing-Controls-with-Ben-Locwin-e2lah80

## Summary

Ben Locwin, Executive SME at Black Diamond Networks, discusses material qualification in regulated industries, contrasting the approaches of pharmaceuticals and medical devices with the automotive industry's PPAP and APQP frameworks. He argues that the life sciences sector is too insular, resisting the adoption of proven quality tools like 6 Sigma and Lean that have been used in automotive and aerospace for decades. Locwin emphasizes that regulations are merely the floor for compliance, not the ceiling, and advocates for a skeptical, testing-driven approach to supplier qualification and material compatibility to ensure patient safety.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-26-142-material-qualification-in-drugs-vs-devices-ppap-apqp-quality-tools-and-purch#t=0) Introduction: Subi Sade and Ben Locwin on Material Qualification
- [2:29](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-26-142-material-qualification-in-drugs-vs-devices-ppap-apqp-quality-tools-and-purch#t=149) Defining Material Qualification: Drugs vs. Devices and Automotive Standards
- [4:25](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-26-142-material-qualification-in-drugs-vs-devices-ppap-apqp-quality-tools-and-purch#t=265) The Insular Nature of Life Sciences and Resistance to Cross-Industry Tools
- [8:54](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-26-142-material-qualification-in-drugs-vs-devices-ppap-apqp-quality-tools-and-purch#t=534) Critique of Common Quality Tools and the Need for Skepticism
- [11:35](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-26-142-material-qualification-in-drugs-vs-devices-ppap-apqp-quality-tools-and-purch#t=695) Applying PPAP-like Processes and GMQ to Medical Devices
- [16:01](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-26-142-material-qualification-in-drugs-vs-devices-ppap-apqp-quality-tools-and-purch#t=961) Distinguishing Design Validation from Process Validation in Qualification
- [21:12](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-26-142-material-qualification-in-drugs-vs-devices-ppap-apqp-quality-tools-and-purch#t=1272) Supplier Management, Auditing, and the Limits of Inspection
- [27:45](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-26-142-material-qualification-in-drugs-vs-devices-ppap-apqp-quality-tools-and-purch#t=1665) Closing: Regulations as the Floor and Future Industry Trends

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Materials & manufacturing processes](https://hardwarepodcasts.com/topic/materials-and-processes)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

large enterprises

## Mentioned

- Black Diamond Networks (company)
- AIAG (other)
- PPAP (other)
- APQP (other)
- ISO 10993 (other)
- IEC 62304 (other)
- ISO 13485 (other)
- ISO 14971 (other)

## Related episodes from other shows

- [What are the Opportunities for Improvement (OFI) for Quality?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality) (Global Medical Device Podcast)
- [Meet a Guru: Erica Loring](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring) (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)
- [FDA is Expanding its Case for Quality Program... Should Your Company Participate?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-fda-is-expanding-its-case-for-quality-program-should-your-company-participate) (Global Medical Device Podcast)
- [Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices) (Global Medical Device Podcast)

## Citing this page

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