The regulatory and reimbursement environment is creating great interest and anxiety in the Medtech space, says Stacy Pugh, vice president and general manager of Medtronic Neurovascular. “Companies who figure this out and figure it out well will have an incredible advantage.”
R&D budgets have changed, with the requirement for clinical evidence significantly increasing. That means tough choices on innovation, she says. “The stairs don’t seem to have a door at the top in terms of clinical requirements.” That’s good for value-based healthcare, because knowing that technology will be held to that bar means focusing beyond iterative change. “You can’t afford a hurdle like that unless the technology is a meaningful innovation,” adds Pugh.
But the ever-changing landscape isn’t slowing down Medtronic, already one of the world’s leading medical device makers. “The pace of innovation, despite the challenges on the horizon, is so incredible,” Pugh says.