17 May Innovation at the FDA – Cultural Changes
A few weeks ago I had the pleasure of moderating the Q&A session for a Women in Bio event in DC. This installment featured Dr. Jeffrey Shuren, Director of FDA’s CDRH, which is responsible for reviewing and approving medical devices for use and sale in the US.
CDRH has come under intense criticism over the past several years for being slow to approve medical devices under both the PMA and 510(k) programs. From 2006 to 2010, the number of devices cleared through the 510(k) process has dropped steadily from 85.8% to 73.6% of submissions, while the average review period prior to clearance has steadily increased from 96 to 135 days (additional information). As a result, medical device companies are increasingly executing strategies to launch their products outside the US first and worry about the FDA (and the US market) later. This means that millions of Americans are waiting for medical diagnoses and treatments that are already benefiting the health of citizens in the rest of the world. Here at Key Tech we are seeing this trend firsthand. About 63% of our current medical device programs are being strategically positioned for approval outside the US first.
Dr. Shuren acknowledged that one of the reasons for the slow pace of approvals at the FDA is culture. He doesn’t agree, however, with the popular notion that the FDA culture is too risk-averse. He offered instead that the slow pace is due, at least in part, to an ingrained culture of self-sufficiency among FDA reviewers. The reviewers feel they should independently resolve most of the identified issues on the path to clearance themselves. They literally “get stuck” instead of reaching out to others for help. Increased collaboration among FDA reviewers and contracted outside experts, he says, should help break this logjam.
Dr. Shuren enthusiastically presented the FDA’s new Innovation Pathway program, a new review process aimed at reducing time and cost for review and clearance of higher-risk, newer-tech submittals, as well as increasing collaboration within the FDA and between FDA staff, inventors and outside experts. The program was initiated in 2010, as a pilot program focused on solutions to End Stage Renal Failure, and has been revised already to “version 2.0” in April 2012, to incorporate new methods and tools developed during the first version of the program. These tools include decision support rubrics, IT collaboration environments, and other process accelerators. Another feature of the new “Innovation Pathway 2.0” is very early collaboration between inventors and the FDA, even before pre-market submission.
It remains to be seen whether the Innovation Pathway will accelerate reviews and increase collaboration in a way that can be rolled out across the organization and to the pool of submittals seeking 510(k) approvals. However, the tenets of this program and Dr. Shuren’s passion for it surely are promising.