Harvard Study: FDA's Novel Med Device Approval Unnecessarily Slow

By Jof Enriquez,
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First-mover medical devices take significantly longer to earn U.S. Food and Drug Administration (FDA) approval because of administrative delays — rather than unfamiliarity with the devices’ technological novelty — according to a new study out of  Harvard University. Moreover, slow approvals have deprived patients of life-saving devices and deter small device firms from developing innovative products, the study suggests.

The study compared approval times of new drugs and high-risk medical devices between 1977 and 2007. Devices included pacemakers, coronary stents, implantable cardioverter defibrillators, tracheal and bronchial tubes, prosthetic limbs, and intraocular implants.

According to results published in the working paper Innovation under Regulatory Uncertainty: Evidence from Medical Technology, pioneer medical devices in a particular category took 34 percent, or 7.2 months, longer to gain FDA approval than the first follow-on device. In comparison, follow-on drugs typically take just 1.2 percent, or one-third of a month, longer to approve than pioneer drugs in the same class.

The study suggests that the FDA's practice of assigning new devices to new product categories and codes, along with building regulatory requirements from scratch for each new, yet similar, device is partly to blame for regulatory delays. 

"It wasn't 'wow, we've never seen this kind of product' that led to the longest delays. Rather, we observed many big regulatory delays for devices that are put in new product categories, but built on technologies the FDA is already familiar with," stated study author Ariel Dora Stern, an assistant professor at Harvard Business School. "That suggests there is something more administrative in the delays — something in the classification process that matters."

According to the paper, sluggish FDA approvals have deprived patients of innovative, life-saving therapies, and have cost device firms an average of $6.7 million on top of the $94 million average price to bring a new high-risk medical device to market. The additional cost burden is forcing smaller firms to shun development of novel technologies, unlike what is observed in the pharmaceutical industry.

"Small firms that have less financial flexibility are less likely to take on these pioneer roles," said Stern. "It's not that big firms are having all of the ideas. Bigger companies are just the ones that are more likely to take on the task of bringing a novel high-risk product to market."

While acknowledging some progress, device industry group AdvaMed has described the FDA's current regulatory framework as "still unnecessarily time-consuming and inconsistent." The group proposes a number of measures of reduce review and approval times, and to facilitate innovation.

For its part, the FDA has maintained that it needs to balance fostering innovation and protecting patient safety as part of its mandate.

In a statement read before a Congressional committee in April, Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health (CDRH), reported that the "FDA is on track to meet all of its MDUFA performance goals related to device review, and premarket performance measures of FDA’s device program show marked improvement since the start of the current decade on several measures related to how quickly devices come to market in the United States. FDA is making progress in bringing down total review times for 510(k) submissions, de novo requests, IDEs, and the higher-risk PMA applications."

Recently, the FDA implemented measures to streamline its regulatory process, including reducing PMA requirements, updating guidance on investigational device exemption (IDE) assessments, and fast-tracking approvals of TAVR devices.

The proposed 21st Century Cures Act — passed by the U.S. House of Representatives in July and pending before the U.S. Senate — aims to further speed device approvals by allowing case studies and registries, rather than rigorous clinical trials, to back device applications.