# 073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-02-22
- Length: 19m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-22-073-anatomy-of-a-hazard-clifton-ericcson-iso-14971-24971-risk-management-with-na
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/073---Anatomy-of-a-Hazard--Clifton-Ericcson--ISO-1497124971-Risk-Management-with-Naveen-Agarwal-e1v9nkc

## Summary

Naveen Agarwal of Creative Analytics Solutions explains the 'Anatomy of a Hazard' using Clifton Ericcson’s HS-IM-TTO model to clarify ISO 14971 risk management for medical devices. He argues that hazards are non-linear system properties rather than simple linear sequences, requiring a distinction between hazard source, initiating mechanisms, and target-threat outcomes. Agarwal advocates for separating failure analysis (FMEA) from hazard-harm analysis to manage complexity and improve completeness in risk files.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-22-073-anatomy-of-a-hazard-clifton-ericcson-iso-14971-24971-risk-management-with-na#t=0) Introduction: Naveen Agarwal and the Anatomy of a Hazard
- [2:25](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-22-073-anatomy-of-a-hazard-clifton-ericcson-iso-14971-24971-risk-management-with-na#t=145) Critique of ISO 14971 and ISO TR 24971 Definitions
- [6:55](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-22-073-anatomy-of-a-hazard-clifton-ericcson-iso-14971-24971-risk-management-with-na#t=415) System Safety and the Non-Linear Nature of Hazards
- [9:31](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-22-073-anatomy-of-a-hazard-clifton-ericcson-iso-14971-24971-risk-management-with-na#t=571) Clifton Ericcson’s HS-IM-TTO Model Explained
- [13:41](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-22-073-anatomy-of-a-hazard-clifton-ericcson-iso-14971-24971-risk-management-with-na#t=821) Separating Failure Analysis from Hazard-Harm Analysis
- [17:49](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-22-073-anatomy-of-a-hazard-clifton-ericcson-iso-14971-24971-risk-management-with-na#t=1069) Case Study: Intra-ocular Lenses and Managing Complexity

## Topics

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

## Most relevant to

established companies

## Mentioned

- Creative Analytics Solutions (company)
- ISO 14971 (other)
- ISO TR 24971 (other)
- Clifton Ericcson (other)
- FMEA (other)

## Related episodes from other shows

- [#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)
- [#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)
- [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)
- [3 Systems of Risk for Medical Devices from FDA](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-07-3-systems-of-risk-for-medical-devices-from-fda) (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)

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