Two-thirds of small medical device companies obtain initial clearance for new devices in Europe. That was the finding of an industry-wide survey on FDA’s 510(k)  approval process conducted by a research team at Northwestern University.

It’s also a problem, says a spokesman for the Medical Device Manufacturers Association (MDMA).

“Tomorrow’s innovations are being developed today overwhelmingly by small and mid-sized medical technology companies,” says Brendan Benner, MDMA vice president of public affairs. Companies, he says, are turning to overseas markets for launch because FDA’s review process is too unpredictable. “This means that patient care and job creation are also moving in that direction,” Benner adds. “The fear is that if this continues, many of these jobs will never return, and patients are waiting months if not years longer until they have access to these innovations.”

The survey, funded by the nonprofit Institute for Health Technology Studies—whose board includes device company executives—also showed that the road to device approval is longer for small companies than for bigger players. Companies with fewer than 100 employees are more likely to seek presubmission meetings and spend more time in the pre-IDE process than their larger counterparts. Overall, small companies wait nearly twice as much time for 510(k) reviews to be completed.

It’s no surprise, then, that more small firms, which are more than twice as likely as large firms to seek approval for new products rather than existing line extentions, feel FDA requests affect time and financial resources.

“In speaking with companies of all sizes, they all face similar challenges attempting to navigate the moving goal posts at FDA,” Benner says. “However, given that larger companies already have products on the market generating revenues, they have a better ability to subsidize delays than a start-up who is working on the initial product.”

—Jamie Hartford