US patients wait on average a full two years longer than their European counterparts for many lifesaving and life-enhancing technologies made by US medical device and diagnostics companies because of growing regulatory delays and inefficiencies, according to a new study.

“The data show that the US is at risk of losing its global leadership position in medical technology innovation,” said Josh Makower, MD, a consulting professor of medicine at Stanford University and a medical device entrepreneur. Makower, who is one of the co-authors of the study, said that the unpredictability and inefficiencies in the US regulatory process are making it difficult for companies to get life-changing medical products into the hands of clinicians and patients.

“The global financial crisis has created a tremendous pressure on small companies in the United States. Venture Capital funding is very difficult to get right now. And the challenges that have been reported on the regulatory process are making this worse and really pose serious threats to medical innovation and therefore threats to advancing patient care,” said Makower.
Makower and coauthor Aabed Meer, with the support of the Medical Device Manufacturers Association and the National Venture Capital Association, surveyed more than 200 small- and medium-sized medical technology companies to evaluate the impact of the current FDA regulatory processes on innovation.

Speaking at the annual FDA update at the Mass. Medical Society sponsored by Massachusetts Medical Device Industry Council, CDRH Director Jeffrey Shuren discounted the results of the findings, calling the sample too small and the assessment of the agency unfair.

For more on this study, see the Dec. 7 Medical Edge.