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.