When it comes to government approvals of medical devices—including those submitted by Indiana companies—the sky is just about the limit these days.
The Food and Drug Administration approved 98 percent of all applications for high-risk medical devices submitted for the fiscal year ending Sept. 30. That was the highest rate in at least 15 years.
The approvals include vascular stents made by Cook Medical of Bloomington, prosthetic knees made by Zimmer of Warsaw and immunoassays for testing hepatitis C by Roche Diagnostics of Indianapolis.
Obviously, the medical device industry loves this. The approvals could translate into billions of dollars in revenue and profit. Indiana’s medical-device industry is one of the largest in the nation, employing more than 20,000 people and generating more than $10 billion a year in revenue.
But why is the FDA on such a tear? Well, just remember the higher approvals come as the FDA is facing the prospect of reform legislation in Congress based on the criticism that the agency’s approval process is too slow and unresponsive, according to an analysis by PricewaterhouseCoopers.
“The approval percentages could help regulators combat that narrative,” the consulting firm said in a recent report.
Medical device manufacturers successfully advocated for premarket-approval reforms to be placed into the 2012 FDA Safety and Innovation Act, including more and earlier feedback about problems that might cause an application to be rejected. (Premarket approvals are used by the FDA to approve high-risk and novel devices. )
Lower-risk devices are benefiting from FDA decisions, as well. The agency approved 85 percent of all lower-risk devices in fiscal 2015, its highest percentage since 2010.
But it’s the figures for high-risk devices (think heart-replacement valves and surgical instruments) that really got a booster shot. Check out these numbers from recent years: