{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Ffcacea35-1950-44f3-8737-932effa24142","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson","description":"On today's episode of the Global Medical Device Podcast, we\u2019re discussing how startup entrepreneurs like you can remove the common regulatory obstacles your business faces and other tips and pointers you can use when developing new medical devices.\n\nOur guest today \u2013 Mitch Levinson \u2013 is the CEO of Cerebrotech Medical, and with over 30 years experience as a startup CEO and executive for companies that have IPO'd like ZELTIQ Aesthetics and Thermage, he knows all about the ins and outs of FDA regulation.\n\nHis Number One Tip? Mitigating risks as early as possible.\n\nWe discuss the ways you can reduce your risks and shorten your regulatory audits, and the best way to do that is to pick the right tech.\n\nMitch also says to start early and meet with the FDA board as soon as possible so you know what parameters you need to meet ahead of time. And among these parameters, we also discuss more of Mitch\u2019s insider tips, including\u2026\n\nHolding early meetings with FDA to set your parameters right away\n\nGrowing a quality system organically so you aren\u2019t struggling through auditing later down the road\n\nFinding products that financeable so you can be backed by the investors you need\n\nPursuing clearance in the US and the EU at the same time to speed up your approval process\n\nBuilding the right company culture so you have the most supportive employee team and board to keep your start-up running smooth\n\nSeeking FDA approval and mitigating risks go hand-in-hand in this industry. Tune in for Mitch Levinson\u2019s insightful tips and tricks so you can start applying his advice to your startup today.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/27b05346-490b-4a53-96c3-16bf3d597e6b/c6b377e0-b32c-4fa9-b5c1-061dedf902ea.jpg"}