Hardware Podcasts

049 - "What Does the Data Say?" with Shannon Hoste

Let's Combinate · 7 Sept 2022 · 46m

What this episode covers

Shannon Hoste, President of Agilis Consulting and former FDA reviewer, explains the regulatory framework for combination products, detailing the distinct roles of CDRH, CDER, and DMEPA in human factors reviews. She clarifies the critical distinction between design validation and human factors validation, emphasizing that the latter focuses specifically on safe and effective use rather than all user needs. Hoste also discusses the methodology for summative evaluations, including the rationale for the N=15 sample size per user group and strategies for recruiting representative participants to identify use errors.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Agilis Consulting, FDA, Stryker, Intel, Enable Injections, Alumina, Patel
Also
CDRH, CDER, DMEPA, ISO 13485, IEC 62366, ISO 14971, ISO 82030, ASTM

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