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?    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.Some of highlights of this episode include:Breathe99’s mask filters 97 and 99 percent of airborne particles. It is not N95 certified, yet, but was designed based on those requirements.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.The kickstarter for the B1 mask didn’t 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.Positive Feedback—Doctors, teachers, volunteers, and other people feel safer wearing Breathe99’s B2 mask. It’s allowed them to continue doing their job.The FDA regulatory product approval process and NIOSH certification is not straightforward. Documenting users’ needs and testing requirements is a long-term path that requires proper and realistic planning.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.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. Medical Device Journey: Learn while you’re learning it. Be deliberate and perform due diligence to be part of the solution. Understand your scope, users’ needs, and why it’s important to design appropriate, safe, and effective products. Memorable quotes from Alison Lee:“We’re a startup company based in Minneapolis that makes a high-quality face mask that filters 97 and 99 percent of airborne particles. Can’t say we’re N95-certified yet, but those are the requirements that we’ve designed our mask around.”“We love hearing about how people feel safer wearing our mask. It’s allowed them to continue doing their job.” “That stamp of approval from NIOSH and from the FDA is really, really important for people to trust our product.” “Be 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.”