Hardware Podcasts

Pivoting Operations to Meet PPE Demand during Pandemic

Global Medical Device Podcast · 14 Apr 2021 · 27m · Episode 196

What this episode covers

Alison Lee, Director of Operations at Breathe99, explains how the Minneapolis-based startup pivoted from urban pollution masks to pandemic PPE, raising over $750,000 via Kickstarter for its B2 mask. Lee details the challenges of navigating the NIOSH and FDA regulatory pathways as a team with no prior medical device certification experience, emphasizing the complexity of design controls and user needs. She discusses the technical difficulties of achieving a proper seal across diverse face geometries and the strategic decision to delay regulatory submission to improve sizing and fit before seeking approval.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Breathe99, Greenlight Guru
Products
B1 mask, B2 mask
Also
NIOSH, FDA, University of Minnesota

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