Hardware Podcasts

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

Global Medical Device Podcast · 9 Mar 2026 · 53m · Episode 450

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
GenUX, Medtronic, Abbott
Tools
ChatGPT, Gemini, Fathom
Also
ISO 14971, FDA

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