DeviceTalks Weekly ep. 3 - Making Sense of Medtech's Regulatory Alphabet Soup
In this week’s DeviceTalks Weekly, we’ll examine how governmental effort, both foreign and domestic, are hitting the medtech industry.
Our guests include Tracy Eberly, CEO of Fang Consulting, a regulatory advisory group. Eberly will update listeners on what pushing back the MDR deadline could mean for medtech companies and why some companies may be less than thrilled with the decision.
In our second conversation, Joy Sturm, procurement expert and partner at the DC office of Law Firm Hogan Lovells, walks us through the powers contained within the Defense Production Act invoked last week by the Trump administration.
Sturm, who brings 20-years of governmental purchasing experience to the conversation, answer several key questions including:
What CAN and CAN’T the government do under the act?
Which federal agencies are responsible for executing the DPA?
Can companies secure capital to pay for DPA-supported efforts?
What player is missing on the field in the battle against COVID-19?
Also, AdvaMed is also looking for direction from the Federal government. You may be surprised by the potential source of leadership.
Finally, MassDevice Honcho Chris Newmarker talks DYI ventilators. Check out Mass Device's Sean Whooley's feature here. And what does the FDA say about these projects?