{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F9a09e96b-5977-425f-838d-15271dea1961","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Using the Bucket Method for Medical Device Risk Management w/ Mike Drues","description":"Risk management: It\u2019s a topic that needs to be navigated carefully by medical device companies.\n\nIt\u2019s been gaining a lot of traction in the industry, because some recent standards have focused on risk management.\n\nToday\u2019s guest has seen companies take their risk management plan directly from their design controls and paste them into their regulatory submission forms. This is not a correct way to approach risk management, because it gives an incomplete picture.\n\nMike Drues, the president of Vascular Sciences, has been a frequent guest on our show.\n\nNot only do we listen to him, but the FDA and Health Canada do, too, because Mike works with these regulatory agencies in addition to working with medical device companies.\n\nToday we\u2019re talking about risk management. Mike has a three (plus one bonus) bucket approach to dealing with this important topic.\n\nSome of the ideas that we discuss today include:\n\n\u25cf Mike\u2019s systematic approach to risk management: three \u201cbuckets\u201d he uses when developing his plans.\n\u25cf How to measure, track and present the probability of harm of not using the device.\n\u25cf Mike\u2019s thoughts on using FMEA as a tool.\n\u25cf The problem with equating misuse as off-label use, and what the difference is.\n\u25cf Mike\u2019s solution for facing the problem of liability pertaining to off-label use of a device.\n\u25cf Why it\u2019s important not to become a slave to whatever tool(s) your company is using when dealing with risk management.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/dd73bb66-55dc-4698-84d5-a976faeb34ed/f4fc5115-7d7e-45e4-bb9e-ac7639191fc6.jpg"}