# #450: Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-03-09
- Length: 53m
- Episode: 450
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling
- Listen: https://podcast.greenlight.guru/episode/human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling

## Summary

Staci Miller, a Human Factors and UX Strategist at GenUX, explains why medical device submissions stall when human factors (HF) is treated as a late-stage box-checking exercise rather than an integrated part of ISO 14971 risk management. She distinguishes between Use-Related Risk Analysis (URRA) for novel devices and User Failure Mode and Effects Analysis (uFMEA) for established products with post-market data, emphasizing that clinical trial efficacy data cannot replace usability validation unless premeditated in the study protocol. Miller warns that ignoring the 'use environment' and design inputs leads to FDA rejections, as regulators require a cohesive safety story that maps user interactions across diverse contexts like ambulances or radiology suites.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling#t=0) Introduction and AI Note-Taking Tools
- [7:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling#t=454) Human Factors in ISO 14971 Risk Management
- [11:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling#t=689) URRA vs. uFMEA: Choosing the Right Analysis
- [12:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling#t=722) The Lifecycle of HF Documentation from Phase 0 to Market
- [17:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling#t=1037) System Errors vs. Use Errors in Summative Studies
- [23:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling#t=1388) The Clinical Trial Myth: Efficacy vs. Usability
- [29:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling#t=1771) Design Inputs vs. Outputs and the 'Blueprint' Analogy
- [32:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling#t=1926) Impact of Use Environment on Validation
- [35:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling#t=2121) Post-Market Data and Predicate Device Risks
- [42:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling#t=2544) Three Essential HF Documents for Submission

## 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)

## Most relevant to

early-stage companies

## Mentioned

- GenUX (company)
- Medtronic (company)
- Abbott (company)
- ISO 14971 (other)
- FDA (other)
- ChatGPT (tool)
- Gemini (tool)
- Fathom (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)
- [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)
- [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)

## Citing this page

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