# 098 - MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-08-16
- Length: 40m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-16-098-medtech-vs-aerospace-risk-management-afap-vs-alarp-alara-quantifying-benefit
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/098---MedTech-vs--Aerospace-Risk-Management--AFAP-vs--ALARPALARA--Quantifying-Benefit--Risk-Control-Measures--and-Risk-Management-Reports-with-Bijan-Elahi-e2842r0

## Summary

Bijan Elahi, a Technical Fellow and Medtronic corporate Advisor on safety risk management, explains the fundamental differences between MedTech and Aerospace risk management, noting that MedTech balances risk against benefit while Aerospace focuses on elimination. He details the challenges of quantifying risk using ISO 14971, advocating for quantitative methods over qualitative guesswork to provide objective evidence of safety. Elahi also discusses the regulatory requirements of the EU MDR, specifically the 'as far as possible' (AFAP) standard, and how companies determine when risk reduction is sufficient without adversely affecting the benefit-risk ratio.

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-16-098-medtech-vs-aerospace-risk-management-afap-vs-alarp-alara-quantifying-benefit#t=1) Introduction: Bijan Elahi and Medtronic
- [1:28](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-16-098-medtech-vs-aerospace-risk-management-afap-vs-alarp-alara-quantifying-benefit#t=88) Aerospace vs. MedTech Risk Management Philosophies
- [8:31](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-16-098-medtech-vs-aerospace-risk-management-afap-vs-alarp-alara-quantifying-benefit#t=511) Challenges in Predictive Risk Management and Quantification
- [16:32](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-16-098-medtech-vs-aerospace-risk-management-afap-vs-alarp-alara-quantifying-benefit#t=992) Quantitative vs. Semi-Quantitative Risk Analysis
- [23:58](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-16-098-medtech-vs-aerospace-risk-management-afap-vs-alarp-alara-quantifying-benefit#t=1438) Risk Control Measures and AFAP vs. ALARP
- [31:39](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-16-098-medtech-vs-aerospace-risk-management-afap-vs-alarp-alara-quantifying-benefit#t=1899) Quantifying Benefit and Benefit-Risk Ratio
- [36:02](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-16-098-medtech-vs-aerospace-risk-management-afap-vs-alarp-alara-quantifying-benefit#t=2162) Components of a Good Risk Management Process

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)

## Most relevant to

large enterprises

## Mentioned

- Medtronic (company)
- NASA (company)
- ISO 14971 (other)
- EU MDR (other)
- ISO 31000 (other)
- IEC 62304 (other)

## Related episodes from other shows

- [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)
- [#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)
- [#362: Managing Risk in Clinical Investigations](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-25-362-managing-risk-in-clinical-investigations) (Global Medical Device Podcast)
- [How AI Can Help You Manage Risk](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-26-how-ai-can-help-you-manage-risk) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-16-098-medtech-vs-aerospace-risk-management-afap-vs-alarp-alara-quantifying-benefit. 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 Let's Combinate.