Most of us have read about, observed, participated in, and spoke with healthcare providers and medical device professionals collaborating during the COVID-19 crisis.
Creativity within reason can be an opportunity. Like many things in life, it’s not what happens to us that counts, it’s how we choose to respond. COVID-19 is not an excuse to cut corners.
In 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.
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Emergency Use Authorization (EUA) 101: What Medical Device Companies Need To Know
COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
Clinical Trials of Medical Products during the COVID Public Health Emergency
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
Institutional Review Board (IRB)
MedTech True Quality Stories Podcast
Greenlight Guru YouTube Channel
“Funding today for COVID-related medical devices is obviously the priority.” Mike Drues
“Funding for devices that are already on the market that can somehow be modified or changed for a COVID indication is much easier from a funding (as well as a regulatory) perspective.” Mike Drues
“Without a doubt, the COVID situation is impacting clinical trials, both for new COVID-related devices...as well as non-COVID-related devices.” Mike Drues
“Creativity within reason can be an opportunity for these types of scenarios.” Jon Speer
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...