# 095 - How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN's, pFMEA's and making it simpler with Naveen Agarwal

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-07-26
- Length: 43m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-26-095-how-fmea-fits-into-iso14971-probabilities-severity-of-harm-rpns-pfmeas-and-m
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/095---How-FMEA-fits-into-ISO14971--Probabilities--Severity-of-Harm--RPNs--pFMEAs-and-making-it-simpler-with-Naveen-Agarwal-e279b5t

## Summary

Naveen Agarwal of Creative Analytics Solutions explains that ISO 14971 does not mandate FMEA, arguing that industry misuse of the tool for compliance rather than engineering reliability creates gaps in patient safety. He distinguishes between the 'one-to-many' nature of FMEA and the 'many-to-one' reality of patient harm, advocating for the use of Fault Tree and Event Tree analyses to bridge this gap. Agarwal emphasizes that severity in FMEA should prioritize engineering outcomes beyond just safety, and that process FMEAs must link directly to design FMEAs to ensure comprehensive risk control.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-26-095-how-fmea-fits-into-iso14971-probabilities-severity-of-harm-rpns-pfmeas-and-m#t=0) Introduction: Naveen Agarwal and Creative Analytics Solutions
- [2:33](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-26-095-how-fmea-fits-into-iso14971-probabilities-severity-of-harm-rpns-pfmeas-and-m#t=153) The Confusion Around ISO 14971 and Risk Management
- [6:15](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-26-095-how-fmea-fits-into-iso14971-probabilities-severity-of-harm-rpns-pfmeas-and-m#t=375) ISO 14971 Does Not Mandate FMEA
- [12:31](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-26-095-how-fmea-fits-into-iso14971-probabilities-severity-of-harm-rpns-pfmeas-and-m#t=751) Severity in FMEA: Safety vs. Engineering Outcomes
- [18:41](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-26-095-how-fmea-fits-into-iso14971-probabilities-severity-of-harm-rpns-pfmeas-and-m#t=1121) The Gap Between FMEA and Patient Harm
- [24:32](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-26-095-how-fmea-fits-into-iso14971-probabilities-severity-of-harm-rpns-pfmeas-and-m#t=1472) Linking Failure Modes to Hazards via Hazard Analysis
- [31:54](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-26-095-how-fmea-fits-into-iso14971-probabilities-severity-of-harm-rpns-pfmeas-and-m#t=1914) Using Fault Tree and Event Tree Analysis for Multifault Scenarios
- [36:20](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-26-095-how-fmea-fits-into-iso14971-probabilities-severity-of-harm-rpns-pfmeas-and-m#t=2180) Linking Process FMEA to Design FMEA
- [40:04](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-26-095-how-fmea-fits-into-iso14971-probabilities-severity-of-harm-rpns-pfmeas-and-m#t=2404) Building Competence Through Ongoing Dialogue

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [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)

## Most relevant to

established companies

## Mentioned

- ISO 14971 (other)
- ISO 14971 TR 24971 (other)
- Creative Analytics Solutions (company)
- FDA (other)
- Medtronic (company)
- iRhythm Technologies (company)

## Related episodes from other shows

- [#325 The Role of dFMEAs in Risk Management for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-medical-devices) (Global Medical Device Podcast)
- [#422: ISO 14971 and the Road to Risk Management with Edwin Bills](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills) (Global Medical Device Podcast)
- [Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-10-inside-look-into-iso-14971-2019-iso-tr-24971-2020-from-the-authors-point-of-view) (Global Medical Device Podcast)
- [#450: Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling) (Global Medical Device Podcast)
- [Human Factors & Risk Management: What's Needed & Why?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-02-human-factors-risk-management-whats-needed-why) (Global Medical Device Podcast)

## Citing this page

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