# Pivoting Operations to Meet PPE Demand during Pandemic

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-04-14
- Length: 27m
- Episode: 196
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-14-pivoting-operations-to-meet-ppe-demand-during-pandemic
- Listen: https://podcast.greenlight.guru/episode/pivoting-operations-to-meet-ppe-demand-during-pandemic

## Summary

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.

## Chapters

- [0:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-14-pivoting-operations-to-meet-ppe-demand-during-pandemic#t=20) Introduction and Breathe99 Origin Story
- [2:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-14-pivoting-operations-to-meet-ppe-demand-during-pandemic#t=156) Pivoting from Pollution to Pandemic PPE
- [5:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-14-pivoting-operations-to-meet-ppe-demand-during-pandemic#t=330) User Feedback and Market Impact
- [7:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-14-pivoting-operations-to-meet-ppe-demand-during-pandemic#t=426) Navigating NIOSH and FDA Regulatory Paths
- [11:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-14-pivoting-operations-to-meet-ppe-demand-during-pandemic#t=707) Challenges of Regulatory Compliance for Startups
- [14:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-14-pivoting-operations-to-meet-ppe-demand-during-pandemic#t=851) Defining User Needs and Scope
- [19:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-14-pivoting-operations-to-meet-ppe-demand-during-pandemic#t=1180) Design Challenges: Sizing and Fit
- [23:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-14-pivoting-operations-to-meet-ppe-demand-during-pandemic#t=1428) Future Outlook and Call to Action

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Crowdfunding & preorders](https://hardwarepodcasts.com/topic/crowdfunding)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies

## Mentioned

- Breathe99 (company)
- Greenlight Guru (company)
- B1 mask (product)
- B2 mask (product)
- NIOSH (other)
- FDA (other)
- University of Minnesota (other)

## Related episodes from other shows

- [Episode 1 - The Hardware Story of Inito w/ Aayush Rai | Building a B2C medical hardware company](https://hardwarepodcasts.com/podcast/the-hardware-story/2024-06-26-episode-1-the-hardware-story-of-inito-w-aayush-rai-building-a-b2c-medical-hardwa) (The Hardware Story)
- [017 - "Feet First" with Ahmed Zobi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-26-017-feet-first-with-ahmed-zobi) (Let's Combinate)
- [008: Temporary Face Masks & Surviving Shark Tank, Doug Marshall of The Game Face Company](https://hardwarepodcasts.com/podcast/product-startup/2016-05-17-008-temporary-face-masks-surviving-shark-tank-doug-marshall-of-the-game-face-com) (Product Startup)
- [HIBT Lab! Armbrust American: Lloyd Armbrust](https://hardwarepodcasts.com/podcast/how-i-built-this/2022-04-28-hibt-lab-armbrust-american-lloyd-armbrust) (How I Built This)
- [16 - Ogden's Own CEO Steve Conlin](https://hardwarepodcasts.com/podcast/people-of-packaging/2020-04-27-16-ogdens-own-ceo-steve-conlin) (People of Packaging)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-14-pivoting-operations-to-meet-ppe-demand-during-pandemic. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.