# Human Factors & Risk Management: What's Needed & Why?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-03-02
- Length: 40m
- Episode: 248
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-02-human-factors-risk-management-whats-needed-why
- Listen: https://podcast.greenlight.guru/episode/human-factors-risk-management-whats-needed-why

## Summary

Shannon Hoste, President of Agilis Consulting Group and former lead of the FDA’s Human Factors Team, explains how human factors serves as a critical risk management activity for medical device development. She details the importance of the Use-Related Risk Assessment (URRA) in identifying potential use errors and high-disparity harms early in the design process to ensure safe and effective product use. Hoste discusses the evolution of ISO 62366, the challenges engineers face in understanding qualitative user needs, and the necessity of integrating human factors into the product development lifecycle rather than treating it as a late-stage compliance checkbox.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-02-human-factors-risk-management-whats-needed-why#t=0) Introduction and Shannon Hoste's Background
- [2:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-02-human-factors-risk-management-whats-needed-why#t=161) Human Factors as Risk Management and ISO 62366
- [6:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-02-human-factors-risk-management-whats-needed-why#t=404) FDA Review Perspective and Common Deficiencies
- [13:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-02-human-factors-risk-management-whats-needed-why#t=834) The Use-Related Risk Assessment (URRA) Process
- [18:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-02-human-factors-risk-management-whats-needed-why#t=1119) Understanding User Needs and System Boundaries
- [25:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-02-human-factors-risk-management-whats-needed-why#t=1533) Engineering Mindset and Staying Out of Solution Space
- [31:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-02-human-factors-risk-management-whats-needed-why#t=1887) Validation vs. Verification and Industry Evolution
- [38:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-02-human-factors-risk-management-whats-needed-why#t=2288) Agilis Consulting and Pathway for Patient Health

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

established companies

## Mentioned

- Agilis Consulting Group (company)
- FDA (company)
- Green Light Guru (company)
- ISO 62366 (other)
- Pathway for Patient Health (company)
- DOORS (tool)

## Related episodes from other shows

- [147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-30-147-urra-draft-guidance-ufmeas-design-validation-hf-summative-comparative-analys) (Let's Combinate)
- [104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w) (Let's Combinate)
- [049 - "What Does the Data Say?" with Shannon Hoste](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-07-049-what-does-the-data-say-with-shannon-hoste) (Let's Combinate)
- [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)
- [012 - "Asking then Seeing" with Sara Waxberg Mcnew](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew) (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/2022-03-02-human-factors-risk-management-whats-needed-why. 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.