{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fa6a2bcd9-f45e-4fcb-94d5-c5bc3315af79","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Medical Device Industry Predictions for 2019","description":"It\u2019s time to recap what happened in the medical device industry this year and start to think about what\u2019s expected to happen in 2019.\n\nSome of the highlights of the show include:\n \n\u25cf\t2018 Prediction #1: It\u2019s going to be harder for medical devices to get to market and stay in the market in EU. Still confusing; clarity to come in 2019? \n\u25cf\t2018 Prediction #2: Mad dash to update ISO 13485 certification before deadline. Resources were constrained, some came late to the party, progress was made. \n\u25cf\t2018 Prediction #3: ISO 14971 will be revised for industry comment. Draft was released in September/October to receive comments. Be on the lookout for a revision around mid-year.\n\u25cf\t2018 Prediction #4: Health Canada will back off on MDSAP deadline. Would have provided constraints for many companies, but Canada didn\u2019t back down.\n\u25cf\t2018 Prediction #5: Medical device companies shift from compliance-focused to quality-focused. FDA\u2019s been proactive, some movement, but a long way to go.\n\u25cf\t2019 Prediction #6: Wearable medical devices will become more common. A trend with more consumer good companies entering medical device market. \n\u25cf\t2019 Prediction #7: EU MDR challenges. Will still be more difficult and unclear on how to get products to market. \n\u25cf\t2019 Prediction #8: FDA QSR harmonizing with ISO 13485:2016. FDA is interested in moving away from 21 CFR Part 820 for ISO 13485. Prepare for it!\n\u25cf\t2019 Prediction #9: The FDA\u2019s Case for Quality. It\u2019ll continue and gain momentum. Initiatives include Medical Device Discovery Appraisal Program. \n\u25cf\t2019 Prediction #10: Expect FDA to continue to shake up regulatory submission processes. Modernizing 510(k) process into Safety and Performance-based Pathway.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/f554e462-90d9-487b-b066-992bee564c3b/0cf38167-deae-4781-890a-785d3819dcc7.jpg"}