# Setting the Record Straight on Usability & Human Factors

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-11-03
- Length: 36m
- Episode: 234
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors
- Listen: https://podcast.greenlight.guru/episode/setting-the-record-straight-on-usability-human-factors

## Summary

Mike Drues, a regulatory consultant for Vascular Sciences, joins host Jon Speer to clarify the distinction between usability and human factors in medical device development. They discuss how engineers often fail to test devices on actual end-users, leading to design flaws, and argue that FDA regulations are inconsistent, requiring extensive testing for simple devices while ignoring complex ones. The conversation emphasizes that usability testing should be risk-based, distinguishing between formative testing during development and summative testing after design freeze. Drues highlights the importance of realistic testing scenarios and warns against the 'tick-box' mentality that ignores off-label use risks.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors#t=0) Introduction: Usability vs. Human Factors Definitions
- [3:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors#t=219) Engineer Bias and Lack of User Testing
- [9:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors#t=561) Expanding User Base and FDA Regulatory Gaps
- [12:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors#t=755) The Infusion Pump Fiasco and Testing Mandates
- [17:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors#t=1027) Risk-Based Approach: Spit Tubes vs. Ocular Devices
- [25:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors#t=1503) Formative vs. Summative Usability Testing
- [28:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors#t=1681) Off-Label Use and Manufacturers' Objective Intent
- [32:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors#t=1942) Realistic Testing and Final Thoughts

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Debugging & failure analysis](https://hardwarepodcasts.com/topic/debugging-and-failure-analysis)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Green Light Guru (company)
- FDA (other)
- Band-Aid (product)
- 510 K (other)

## Related episodes from other shows

- [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)
- [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)
- [258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin](https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-12-258-combination-product-quality-human-factors-cdmo-scorecards-iso-14971-vs-ich-q) (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)
- [S6E33 Bryant Foster | Design for Human Factors & User Experience](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-08-15-s6e33-bryant-foster-design-for-human-factors-user-experience) (Being an Engineer)

## 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/2021-11-03-setting-the-record-straight-on-usability-human-factors. 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.