eNews July 7, 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.

Teach your sells reps well 

Sales rep training is more important than ever to address medical device litigation challenges, says Sara Thompson, a medical technology litigation lawyer with Greenberg Traurig, in a recent article in Medical Design and Outsourcing. More than a decade has gone by since the Supreme Court’s Riegel v. Medtronic decision, which found that federal medical device regulation laws provide lawsuit protections for devices with FDA premarket approval. Since then, plaintiff lawyers have focused less on a device’s design, warnings or performance, and more on a company’s conduct, particularly, sales representatives, according to Thompson. “Plaintiffs may allege the sales representative trained a doctor, and if so, did they train the doctor how to use a device in a way that led to or allegedly led to injury?” she said. “Or did the doctor have a sales representative directly interacting with a patient in some impermissible way?”

 

Startups to know

Even in the midst of COVID-19, medical technology innovation has been thriving, says Paul Grand, CEO of MedTech Innovator, a nonprofit global competition and accelerator for medical device, digital health and diagnostic companies. Grand was quoted in the article “20 medical device startups you need to know,” in Medical Design and Outsourcing. Among those 20 are: Circadia Health, for its contactless monitoring system for respiratory disease, which is designed to sense respiratory failure in patients up to 4 feet away; Forest Devices, a developer of the Alphastroke system for stroke and large vessel occlusion detection, which is intended to let first responders triage patients quickly; and LimFlow, developer of a minimally invasive technology that diverts blood around diseased arteries in the leg.

Real-world evidence

The U.S. Food and Drug Administration says it will rely even more on real-world evidence regarding the performance of approved or cleared devices than it has during the COVID-19 crisis. Real-world evidence offers a way for medical technology companies to prove safety and efficacy without necessarily conducting a clinical trial, reports Medical Design and Outsourcing. Real-world evidence has “been critical during the pandemic because we’ve had to make some pretty quick decisions with the data available,” FDA Commission Dr. Stephen Hahn was quoted as saying in a Medical Device Innovation Consortium event. “We will really work on that a lot in the upcoming years to incorporate that further. The question is, how do we do that in a robust way so that we have the right information for the decisions?”