That was the question floated by Nadim Yared, president of CVRx and the current chairman of AdvaMed, during this week’s Medtech Conference powered by AdvaMed. Yared made the suggestion during a talk with Tamara Syrek Jensen, director of the coverage and analysis group at CMS, and Dr. Jeff Shuren, director of CDRH.
Yared focused on industry’s responsibility to ensure better predictability from payers. He discussed the evolution of MDUFMA, the user fee payment system with FDA that many have credited with a significant turn-around in the ability for medtech companies to get better access and measurable decision-making from CDRH.
“With MDUFMA, we fought it,” Yared noted. “We didn’t want to pay. And it took four iterations and 10 years to get it right.” But, he said, FDA took those resources and made changes to create a more inclusive and available FDA.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.