{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F2099abf9-ff57-4128-87f0-118e52beb92c","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"<iframe style=\"width: 100%; height: 200px;\" title=\"Pivoting Operations to Meet PPE Demand during Pandemic\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/2099abf9-ff57-4128-87f0-118e52beb92c\"></iframe>","title":"Pivoting Operations to Meet PPE Demand during Pandemic","description":"<p><span style=\"background-color: transparent; color: rgb(0, 0, 0);\">Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, are you a customer who has benefited from using them?&nbsp;&nbsp;&nbsp;&nbsp;</span></p><p><span style=\"background-color: transparent; color: rgb(0, 0, 0);\">In this episode of the Global Medical Device Podcast, Jon Speer talks to Alison Lee about her PPE startup Breathe99, which pivoted operations in developing its high-quality face mask product to meet respiratory needs and provide personal protection during the coronavirus pandemic.</span></p><h3><strong style=\"background-color: transparent; color: rgb(67, 67, 67);\">Some of highlights of this episode include:</strong></h3><ul><li><span style=\"background-color: transparent;\">Breathe99\u2019s mask filters 97 and 99 percent of airborne particles. It is not N95 certified, yet, but was designed based on those requirements.</span></li><li><span style=\"background-color: transparent;\">The prototype of the B1 mask offered protection with complete sealing around the mouth and nose, but allowed adequate breathing through a high-quality filter.</span></li><li><span style=\"background-color: transparent;\">The kickstarter for the B1 mask didn\u2019t reach its goal, but then came an obviously serious and urgent need for high-quality respiratory protection. So, the kickstarter campaign for the B2 mask started. A total of more than $750,000 was raised.</span></li><li><span style=\"background-color: transparent;\">Positive Feedback\u2014Doctors, teachers, volunteers, and other people feel safer wearing Breathe99\u2019s B2 mask. It\u2019s allowed them to continue doing their job.</span></li><li><span style=\"background-color: transparent;\">The FDA regulatory product approval process and NIOSH certification is not straightforward. Documenting users\u2019 needs and testing requirements is a long-term path that requires proper and realistic planning.</span></li><li><span style=\"background-color: transparent;\">Alison discusses how Greenlight has been a resource for bringing the B2 mask to market. It offers peace of mind by going step by step at an appropriate pace to navigate the design and development process.</span></li><li><span style=\"background-color: transparent;\">The bureaucratic and complicated regulatory process takes much longer than expected. It presents common challenges, such as checks and balances of medical devices, change orders, and regulatory approval.&nbsp;</span></li><li><span style=\"background-color: transparent;\">Medical Device Journey: Learn while you\u2019re learning it. Be deliberate and perform due diligence to be part of the solution. Understand your scope, users\u2019 needs, and why it\u2019s important to design appropriate, safe, and effective products.&nbsp;</span></li></ul><h3><strong style=\"background-color: transparent; color: rgb(67, 67, 67);\">Memorable quotes from Alison Lee:</strong></h3><p><em style=\"background-color: transparent; color: rgb(0, 0, 0);\">\u201cWe\u2019re a startup company based in Minneapolis that makes a high-quality face mask that filters 97 and 99 percent of airborne particles. Can\u2019t say we\u2019re N95-certified yet, but those are the requirements that we\u2019ve designed our mask around.\u201d</em></p><p><em style=\"background-color: transparent; color: rgb(0, 0, 0);\">\u201cWe love hearing about how people feel safer wearing our mask. It\u2019s allowed them to continue doing their job.\u201d&nbsp;</em></p><p><em style=\"background-color: transparent; color: rgb(0, 0, 0);\">\u201cThat stamp of approval from NIOSH and from the FDA is really, really important for people to trust our product.\u201d&nbsp;</em></p><p><em style=\"background-color: transparent; color: rgb(0, 0, 0);\">\u201cBe aware of your scope, and you can really only do that by talking to people as soon as possible before you, I guess, make an assumption. We definitely thought the regulatory process would be a lot faster.\u201d</em></p>","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/9045ffee-3e81-4634-acf6-a57e1a028b9f/279c10aa-b6c4-400b-bf3d-58036261406d.png"}