eNews October 13, 2020

The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association

How is COVID-19 affecting your business, your people, your customers? IMDA is a membership organization, and in times like these, we can all use some camaraderie. If you have a COVID story to share, advice to offer, or a warning to sound, send it to Mark Thill, IMDA’s communications director, at mdthill1913@gmail.com, with the subject line “IMDA COVID story.” We’ll compile them and send them back out to you.

On the rebound

Medical technology manufacturers have taken a hit in 2020 due to COVID-19, but the industry is likely to see a quick rebound, according to the 2020 EY medical technology report, Pulse of the Industry. “The shift toward digitalization, telehealth and remote-operated business models is accelerating as a silver lining to the tragic impact of COVID-19, but executives will have to adapt to operating in a highly uncertain environment in the foreseeable future,” said Arda Ural, PhD, EY Americas Industry Markets Leader, Health Sciences and Wellness. The pandemic forced companies to go beyond norms and collaborate to overcome critical challenges, according to the report. Many sectors of the industry experienced financial losses, but some — the diagnostics segment, for one — have surged.

FDA must change its creaky ways

The FDA must embrace the same regulatory flexibility going forward that it has shown in response to the coronavirus crisis, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, told attendees at AdvaMed’s recent Virtual MedTech Conference, reports MedTech Dive. FDA fully leveraged its emergency use authorization authority during the pandemic to “maximize timely availability” of diagnostics and medical devices with “some assurances of the safety and effectiveness” of these products, he said. But he acknowledged the regulatory paradigm established for medical devices is more than 40 years old and is “not well suited for many modern-day technologies.”

Top 10 innovations

Cleveland Clinic has named its Top 10 Medical Innovations of the Year: 1) gene therapy for functional hemoglobin molecules, 2) a monoclonal antibody that is the first and only MS treatment for the primary-progressive MS population, 3) smartphone-connected pacemaker devices, 4) a new combination drug to provide relief for 90% of individuals living with cystic fibrosis, 5) a new combination medication which improves hepatitis C treatment, 6) bubble CPAP, a noninvasive ventilation strategy delivering continuous positive airway pressure to newborns, 7) increased access to telemedicine, 8) vacuum-induced uterine tamponade device for postpartum hemorrhage, 9) PARP inhibitors to delay the progression of prostate cancer, and 10) immunologics for migraine sufferers.