{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fd81baba0-516a-4109-9fc6-1708b5c2de4b","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Understanding the Blurred Lines Between Consumer Tech and MedTech","description":"Did you know that the Apple Watch was recently granted de novo classification requests by the FDA? Pretty exciting news for the medical device industry, which is experiencing a crossover of traditionally consumer goods and technology. \n\nFor example, health insurance providers and wellness programs are starting to adopt such wellness products. So, expect more technologies to enter the medical device realm in the near future. \n\nIn this episode, Mike Drues and I discuss this trend and related programs.\n\nSome of the highlights of the show include:\n \n\u25cf\tMedical devices being used in a non-traditional clinical setting and by non-clinical professionals, which creates challenges for medical device developers.\n\u25cf\tUsability is a concern because more medical devices are being used by untrained users with a lack of expertise.\n\u25cf\tWhat\u2019s the difference between a consumer vs. medical device? Regulations don\u2019t distinguish a difference; what matters - intended use and who uses it.\n\u25cf\tRegulations shouldn\u2019t be technology specific, but broad. More regulations aren\u2019t needed, what\u2019s needed is a simpler definition of a medical device.\n\u25cf\tFDA is challenged to keep up with the evolution of technology, but most regulations and the way people think tend to be timeless. \n\u25cf\tProducts need to be reliable and accurate, or more regulations will be implemented to address irresponsible companies.\n\u25cf\tPrograms are in place, including the Breakthrough Device Designation and Opioid Addiction Initiative, to enable non-traditional medical device technology.\n\u25cf\tDoes a product do what it claims to do to improve your quality of life? Regulatory risk can include weak medical claims.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/611cdffe-ef37-4264-98f6-dcc4d1bfa8ea/92669169-6f61-44bc-a4a3-fa3e36c9ad84.jpg"}