COVID-19 stalled clinical trials, halted elective surgeries, and body slammed many med-tech companies’ revenues. Despite that, an industry report released by Ernst & Young (EY) finds that the pandemic also drove some positive changes in the med-tech industry including long-neglected attention to enterprise-wide business continuity.

The U.S. FDA will no longer review lab-developed tests (LDTs) for the SARS-CoV-2 virus under the emergency use authorization (EUA) program, a change that will eliminate any prospect of immunity from liability for these tests. The FDA’s Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, announced the news on the weekly COVID-19 testing town hall, but the change was simultaneously unveiled in the FDA’s Q&A for testing.

U.S. FDA commissioners must rely on legal counsel for advice on a number of matters, but attorneys who sign on for work at the agency bring with them different views on the limitations of the agency’s powers. This consideration came up during a panel discussion hosted by the Food and Drug Law Institute (FDLI).

The COVID-19 pandemic has been a bump in the road for developers of digital surgical systems that include robotics, but the technology is still in demand. That was the message from industry leaders at the Advanced Medical Technology Association’s Virtual Medtech Conference.

As with many conferences, the Cleveland Clinic’s 2020 Medical Innovation Summit went virtual this year. Still, the event featured the hotly anticipated top 10 list of innovations for 2021 that saw a range of therapies. Ranked in order of expected importance, the list was led by gene therapy for hemoglobinopathies. The top three innovations, including a novel drug for primary-progressive multiple sclerosis and smartphone-connected pacemaker devices, were highlighted in a special presentation.

The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology.

Device makers have wondered in the past whether they like the idea of the Centers for Medicare & Medicaid Services (CMS) peering over the U.S. FDA’s shoulders in premarket applications, which might be a concern as well for the Medicare program for coverage of breakthrough devices. Tamara Syrek Jensen, director of the Coverage and Analysis Group at CMS, declined to say whether her office has any influence over what would be designated as a breakthrough device by FDA, stating little more than that “we will constantly be talking with the FDA” about breakthrough devices.

What is the future of med-tech innovation in the wake of COVID-19? That was the question addressed during the Advanced Medical Technology Association’s Virtual Medtech Conference, with members of industry providing some insight. “I think … that this is going to be in many ways a turning point,” changing the way stakeholders look at devices and the evidence supporting them, said Tom O’Brien, of Johnson & Johnson’s (J&J) Ethicon unit.

In a fireside chat at the Advanced Medical Technology Association (Advamed)-sponsored Virtual Medtech Conference on Oct. 5, U.S. FDA Commissioner Stephen Hahn addressed questions that have been circulating for months about the political pressure that the agency is facing to quickly approve a vaccine for COVID-19 by reiterating that any decisions will be “completely dependent on when data is mature” from phase III trials.