# 055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-10-19
- Length: 50m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-19-055-critical-tasks-and-knowledge-tasks-with-alexandra-benbadis
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/055---Critical-Tasks-and-Knowledge-Tasks-with-Alexandra-Benbadis-e1pa4f6

## Summary

Alexandra Benbadis, Usability Leader at Sanofi and former Senior Human Factors Consultant at Emergo by UL, explains the regulatory distinctions between critical and knowledge tasks in combination product human factors studies. She details how the FDA's CDRH and CDR definitions of 'harm' expand the scope of critical tasks to include compromised medical care, such as underdoses in maintenance medications, requiring rigorous residual risk commentary. Benbadis also describes the evolution of knowledge task protocols, specifically the two-part approach to evaluate Instructions for Use (IFU) findability and comprehension without requiring their use during initial open-ended questioning.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-19-055-critical-tasks-and-knowledge-tasks-with-alexandra-benbadis#t=0) Introduction: Alexandra Benbadis and Sanofi
- [2:29](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-19-055-critical-tasks-and-knowledge-tasks-with-alexandra-benbadis#t=149) Alexandra Benbadis's Background at Tufts and Emergo by UL
- [9:47](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-19-055-critical-tasks-and-knowledge-tasks-with-alexandra-benbadis#t=587) Defining Critical Tasks: CDRH vs. CDR Definitions
- [18:58](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-19-055-critical-tasks-and-knowledge-tasks-with-alexandra-benbadis#t=1138) The Spectrum of Critical Tasks and Residual Risk
- [29:02](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-19-055-critical-tasks-and-knowledge-tasks-with-alexandra-benbadis#t=1742) Showstoppers, Test Artifacts, and Use Errors
- [34:42](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-19-055-critical-tasks-and-knowledge-tasks-with-alexandra-benbadis#t=2082) Knowledge Tasks: Evaluating Instructions for Use
- [45:15](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-19-055-critical-tasks-and-knowledge-tasks-with-alexandra-benbadis#t=2715) FDA Feedback on Knowledge Task Protocols

## 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)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)

## Most relevant to

large enterprises

## Mentioned

- Sanofi (company)
- Emergo by UL (company)
- Tufts University (other)
- FDA (other)
- CDRH (other)
- CDER (other)
- IEC 62366 (other)
- HG 75 (other)
- Don Norman (other)
- Design of Everyday Things (product)

## Related episodes from other shows

- [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)
- [Setting the Record Straight on Usability & Human Factors](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors) (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)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [Understanding and Handling Different Types of Feedback](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-14-understanding-and-handling-different-types-of-feedback) (Global Medical Device Podcast)

## Citing this page

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