Why U.S. first may be the new medical device development strategy (Medical Design & Outsourcing)
Increased regulatory hurdles in Europe and China could mean more medical device development focusing on the U.S. market first.
That seemed to be a major takeaway from panels on regulation and reimbursement at Healthegy’s Medtech Conference, held last week in Minneapolis.
“We’re actually going to be doing more early clinical work with the FDA,” said Stacey Pugh, vice president and general manager of neurovascular at Medtronic.
New medical device requirements in Europe could make CE Mark requirements as tough as FDA requirements, Pugh said. A growing number of European countries including Spain, Portugal, Sweden and France are also requiring economic data to prove a device’s value – something the U.S. does not presently require, said Bonnie Handke, vice president of health economics, policy and payment at Medtronic.
Meanwhile, China has also seen a recent flurry of regulatory activity. “Somebody could ask me, ‘What is my requirement in China?’ … What is was 12 months ago is very different from what it is today,” Pugh said.
“The requirements in China … overlaid with economic requiremen...
