{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fb0a21991-3481-4167-947b-cb69c0dbfcff","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"<iframe style=\"width: 100%; height: 200px;\" title=\"The Intersection of Medical Device Usability and Risk Management\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/b0a21991-3481-4167-947b-cb69c0dbfcff\"></iframe>","title":"The Intersection of Medical Device Usability and Risk Management","description":"Today we\u2019re going to be talking to our good friend Mike Drues from Vascular Sciences about the intersection of usability and risk management. There are so many tips and great pointers that you will not want to miss this show. Have a pen and paper or your note-taking device available, because this episode is chock-full of information that you won\u2019t want to forget.\n\nSome of the highlights of the show include:\n\n\u25cf What usability means and how it applies to the medical device production process. \n\u25cf Where the FDA stands on the topic of usability and what types of guidance documents are available.\n\u25cf How the topic is handled by international and world agencies in addition to the FDA, as well as how cultural differences can impact usability studies.\n\u25cf The difference between a usability study and a clinical trial. A usability study is focused on the user and a clinical trial is focused on the patient, but today, the two are often one and the same.\n\u25cf Why usability needs to be more \u201creal-world.\u201d Many times, what the engineer intends is not how the doctor or surgeon will actually use the device.\n\u25cf The importance of instructions for use and labeling, and how that relates to risk management.\n\u25cf The relationship between usability and product liability.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/b23593a1-cf93-4afe-9d9c-47f664e80568/0f26ab82-44ea-48ce-bc4e-4eb089e8ed8b.jpg"}