Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

Global Medical Device Podcast · 29 Apr 2020 · 32m · Episode 144

What this episode covers

Sanjay Vakil, Executive Director of the non-profit MasksOn.org, and Devon Campbell, a medical device regulatory expert, discuss their rapid development and distribution of reusable PPE masks during the COVID-19 pandemic. They explain how they retrofitted off-the-shelf scuba masks with hospital-grade anesthesiology circuit filters to create a safe, sanitizable solution for healthcare providers. The team highlights their user-forward design process, involving beta testing with physicians, and their strategy for navigating FDA Emergency Use Authorization (EUA) guidance to bypass traditional regulatory hurdles.

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