{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F2d4eab36-fc07-4a69-88f7-9e446cffa1a0","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry","description":"Most of us have read about, observed, participated in, and spoke with healthcare providers and medical device professionals collaborating during the COVID-19 crisis.\u00a0\n\nCreativity within reason can be an opportunity. Like many things in life, it\u2019s not what happens to us that counts, it\u2019s how we choose to respond. COVID-19 is not an excuse to cut corners.\n\nIn this episode of the Global Medical Device Podcast Jon Speer invites guest Mike Drues of Vascular Sciences to join the show. Together, they share their own COVID-19 observations and insights into what has gone right and wrong, so far, for the medical device industry.\n\nSome of the highlights of the show include:\n\u2022 COVID-19\u2019s unintended consequences on the medical device industry include new and agile product development, but funding challenges for some startups.\n\u2022 Emergency Use Authorization (EUA) is temporary, until the Secretary of Health and Human Services declares that the period of emergency is over.\n\u2022 Why is funding and regulatory pathways easier for COVID-19 medical devices? Devices already on the market can be modified or changed for a COVID indication. However, the ability to manage investors\u2019 expectations is important.\n\u2022 Quick turnaround or years to go till getting back to business as usual? There\u2019s always a need for short- and long-term opportunities to market medical devices.\n\u2022 Clinical Trials and Investigations: Healthcare providers and hospitals are shifting and reallocating resources to address perceived demand related to COVID crisis.\n\u2022 EUA equates to 510(k) due to underlying assumption of safety and efficacy, but EUA is not substantially equivalent to De Novo or PMA.\n\u2022 Altruistic vs. Opportunistic Attitudes: Filter motives, products, and people to accomplish post-market surveillance obligations, especially for COVID devices.\n\u2022 Lessons Learned: React accordingly, be proactive, address patient needs safely and effectively, and solicit feedback to improve quality of life.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/18f17900-f499-48e8-a512-ca794ab34ea3/d449230b-32ca-475b-97e6-01a83543ee71.jpg"}