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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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Some highlights of this episode include:
- COVID-19’s unintended consequences on the medical device industry include new and agile product development, but funding challenges for some startups.
- Emergency Use Authorization (EUA) is temporary, until the Secretary of Health and Human Services declares that the period of emergency is over.
- 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’ expectations is important.
- Quick turnaround or years to go till getting back to business as usual? There’s always a need for short- and long-term opportunities to market medical devices.
- Clinical Trials and Investigations: Healthcare providers and hospitals are shifting and reallocating resources to address perceived demand related to COVID crisis.
- EUA equates to 510(k) due to underlying assumption of safety and efficacy, but EUA is not substantially equivalent to De Novo or PMA.
- Altruistic vs. Opportunistic Attitudes: Filter motives, products, and people to accomplish post-market surveillance obligations, especially for COVID devices.
- Lessons Learned: React accordingly, be proactive, address patient needs safely and effectively, and solicit feedback to improve quality of life.
Links:
Emergency Use Authorization (EUA) 101: What Medical Device Companies Need To Know
Webinar: How Can Medical Device Companies Use the Emergency Use Authorization (EUA) to Address the COVID-19 Pandemic?
FDA: Medical Devices
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
Premarket Notification 510(k)
De Novo Pathway
Premarket Approval (PMA)
Institutional Review Board (IRB)
Mike Drues
Vascular Sciences
MedTech True Quality Stories Podcast
Greenlight Guru YouTube Channel
Greenlight Guru
Memorable Quotes from this episode:
“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
ABOUT THE GLOBAL MEDICAL DEVICE PODCAST:
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.
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