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 requirem...