{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F9ab40180-bed7-4140-8c02-bee4b2dd067c","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions","description":"The topic of\u00a0Real-World Evidence\u00a0is generating a lot of discussion lately, especially after the draft guidance was issued last summer and the final guidance was issued in August. So what does Real-world Evidence mean for you and from a regulatory perspective? \n\nToday we speak with Mike Drues, President of Vascular Sciences, about how real-world evidence can help you develop products that will improve and save lives. \n\nSome of the highlights of the show include:\n\n\u25cf\tWhy medical device companies should care about real-world evidence and why it\u2019s as important and more realistic than the \u201cgold standard\u201d of randomized clinical trials.\n\u25cf\tReasons that a clinical trial can be less informative than real-world evidence and how the FDA is beginning to change its thoughts on accepting real-world evidence. \n\u25cf\tThoughts on why the quality of the real-world data is important when it comes to getting FDA to accept it.\n\u25cf\tThe mechanism of going down the path of using real-world evidence in regulatory matters.\n\u25cf\tHow real-world evidence might be used even after a device or product is already on the market, either in lieu of a clinical trial or as a reason to use a smaller clinical trial.\n\u25cf\tThoughts on the future of credible real-world evidence.\n\u25cf\tExamples of how real-world evidence can be used.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/d5388e1e-1209-4d63-9a2b-b854cb7854e3/4859e249-1328-4d90-8bd4-ed6b4d9713a9.jpg"}