There’s the recent International Consortium of Investigative Journalists’ “Implant Files” report, as well as the documentary “Bleeding Edge” on Netflix. Both paint a picture of lax medical device regulation resulting in patients exposed to poorly tested implants.
Veteran regulatory consultant Michael Drues thinks the problems outlined in the reports echo concerns going all the way back to when the FDA started regulating medical devices in 1976.
They raise similar questions, too. “What do we do to prevent them? How do we prevent more from happening?” Drues said during his newest podcast with Medical Design & Outsourcing.
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.