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Medical device companies need to worry more about liability: Here’s why

January 3, 2018 By Chris Newmarker

medtech liability gavelMike 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.

Find out more from Drues in MDO’s latest podcast.

About The Author

Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

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