Hardware Podcasts

#332: Regulatory Strategy and the Advantage of Diversity in MedTech

Global Medical Device Podcast · 17 Aug 2023 · 50m · Episode 332

What this episode covers

Nada Hanafi, SVP of Regulatory Strategy at Veranex and co-founder of Medtech Color, discusses the critical importance of diversity in medical device design and regulatory strategy. She highlights how historical biases in validation, such as pulse oximeters failing on darker skin tones due to testing on Caucasian men, led to dire health outcomes. Hanafi explains how the FDA has evolved to prioritize transparency, health equity, and user-centered design, urging companies to define clear intended use and indications for use early in the development process. She emphasizes that incorporating diverse patient perspectives and data into AI training and clinical trials is no longer optional but a regulatory requirement for safety and efficacy.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Veranex
Tools
Greenlight Guru
Also
Medtech Color, FDA, CDRH

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