Mike Drues has a piece of advice he likes to repeat to clients of his medical device regulatory consulting business: Don’t fear FDA; fear the product liability attorneys.
“You should fear the product liability attorneys because they could impose a heck of a lot more damage on a company than the FDA ever could. And by the way, product liability attorneys are much better at finding documentation than the FDA ever would be,” said Drues – president of Vascular Sciences, a regulatory consulting outfit based outside Boston.
Following regulatory requirements isn’t good enough when it comes to liability, either, according to Drues.
“Often what we want to say or do from a regulatory or quality perspective, is … 180 degrees out of synch from what we want to do from a product liability perspective,” Drues said.
Words that shouldn’t have been spoken, emails that shouldn’t have been sent – they can come back to bite you, creating disincentives for people to ask questions that should be asked. And the shortest path to regulatory approval – trying to check off the human factors testing box as easily as possible, for example – may ignore product problems that should have been dealt with.
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.