{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fdad60d9a-1ea2-46f0-bd87-2579650481be","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"How to Construct an Effective Regulatory Strategy","description":"What is a regulatory strategy? What are the components involved? \n\nIn this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues of Vascular Sciences to provide listeners with practical and pragmatic tips on how to construct a meaningful, not misunderstood, misapplied, and misused regulatory strategy. \n\nSome of the highlights of the show include:\n \n\u2022 Pro Tip: Regulatory strategy is not synonymous with Pathway to Market (element), or 510(k) and De Novo (tactics).\n\u2022 Regulatory Strategy Executive Summary: Living artifact that serves as a communication tool to articulate pros, cons, benefits, risks, and options.\n\u2022 Executive Summary components may include device description, labeling matrix, classification and risk, and potential pathways to market.\n\u2022 Investor Pitch Deck: Demonstrate medical device idea by knowing all options, and possessing knowledge and experience of fluid and dynamic environment. \n\u2022 Conventional Wisdom: Easiest, fastest, cheapest path to market to get through regulatory challenges doesn\u2019t always make sense for products and technology. \n\u2022 Future Features List: What do you want added to a medical device in the future? Start with the ultimate end in mind and work backwards to build strategy and plan.\n\u2022 Product Development Process: Bring in regulatory sooner than later, earlier the better. Changes after a design freeze are difficult, time consuming, and costly.\n\u2022 Summary, Recommendations, and Takeaways: Who is your audience? Will they understand the purpose? Offer proof.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/9a91b157-e653-4ecf-b3f8-958ad2bf5cf7/39fab247-4b08-458f-8b2b-3aac89b7c85f.jpg"}