# #422: ISO 14971 and the Road to Risk Management with Edwin Bills

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-09-01
- Length: 1h 03m
- Episode: 422
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills
- Listen: https://podcast.greenlight.guru/episode/from-military-to-medtech-the-unexpected-path-to-iso-14971-risk-management-with-edwin-bills

## Summary

Edwin Bills, a lead expert in medical device risk management and key contributor to ISO 14971, explains how his background as a submariner and manufacturing quality engineer informs his approach to patient safety and cost of quality. He details the critical link between manufacturing process capability (CPK), supplier quality, and financial risk, arguing that quality failures directly impact a company's bottom line and reputation. Bills critiques common industry practices, such as late-stage FMEA and manual spreadsheet-based traceability, advocating for early hazard analysis, industrial statistics, and integrated software solutions to manage complex risks in medical devices and combination products.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills#t=0) Introduction: Edwin Bills and his background
- [1:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills#t=112) Edwin's military service and submarine electronics experience
- [4:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills#t=267) Transition to manufacturing quality and training under Joseph Juran
- [10:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills#t=658) Supplier quality lessons: die casting fires and motor suppliers
- [15:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills#t=938) Kaizen projects and Just-in-Time delivery resilience
- [18:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills#t=1126) Connecting manufacturing quality to patient safety and cost of quality
- [25:28](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills#t=1528) Applying industrial statistics and process improvement to medical devices
- [29:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills#t=1788) Edwin's role in developing ISO 14971 and risk management standards
- [36:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills#t=2177) Critique of FMEA and the importance of early hazard analysis
- [46:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills#t=2816) Challenges in risk management: FMEA gaps, traceability, and software

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

established companies

## Mentioned

- ISO 14971 (other)
- IEC 60601 (other)
- Greenlight Guru (company)
- Cincinnati Millicron (company)
- Motorola (company)
- Toyota (company)
- Abbott (company)
- AAMI (company)
- FDA (other)
- HY 80 steel (material)
- FMEA (other)
- PHA (other)

## Related episodes from other shows

- [025 - “The Frying Pan to the Fire” with Edwin Bills](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills) (Let's Combinate)
- [202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin](https://hardwarepodcasts.com/podcast/lets-combinate/2025-08-20-202-becoming-an-expert-in-the-work-nobody-wants-to-do-design-risk-and-the-messy) (Let's Combinate)
- [161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products](https://hardwarepodcasts.com/podcast/lets-combinate/2024-11-06-161-iso-14971-and-ich-q9-explained-risk-management-frameworks-in-medical-devices) (Let's Combinate)
- [095 - How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN's, pFMEA's and making it simpler with Naveen Agarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-26-095-how-fmea-fits-into-iso14971-probabilities-severity-of-harm-rpns-pfmeas-and-m) (Let's Combinate)
- [073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-22-073-anatomy-of-a-hazard-clifton-ericcson-iso-14971-24971-risk-management-with-na) (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/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills. 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.