Regulatory Uncertainty Slows Approvals of Novel Devices

August 14, 2015

Pioneer entrants for medical devices face a steeper hurdle than their drug counterparts in gaining approval, according to research from a Harvard professor.

“[I]n contrast to the early entrant advantages observed in drug regulation, first entrants in medical device markets experience a strong disadvantage in the regulatory approval process,” says Ariel Stern, an assistant professor of business administration, in Innovation under Regulatory Uncertainty: Evidence from Medical Technology.

Stern notes that pharmaceuticals “are a relatively homogeneous category of products,” with decades of regulation. “By comparison, medical devices and other non-drug medical products are far more heterogeneous and have a much shorter history of FDA oversight.”

The problem isn’t technological novelty or a lack of scientific knowledge on the part of reviewers, according Stern, but a lack of regulatory guidelines — particularly when it comes to devices with new product codes.

Stern points to implantable cardioverter defibrillators, which were first approved in 1983. Starting in 1998, some ICDs obtained a new product code as a result of modifications to the device. These later ICDs still experienced a regulatory delay, even though the FDA had years of experience evaluating them. Indeed, Stern says it takes 34 percent longer for pioneer medical device entrants with new product codes to go through the approval process than successive applicants.

While the lack of explicit evaluation criteria for devices contributes to this uncertainty and lengthy delays, the issuance of guidance explaining approval criteria for specific device types often reduces approval times, Stern says. Following issuance of guidance on drug-eluting stents, intravascular stents, heart valves and catheter ablation devices, approval times dropped by approximately 6.6, 5.5, 2.8 and 4.9 months, respectively.

While large firms are facing delays, the burden is worse for smaller companies, which have fewer resources and face prohibitive capital costs trying to get novel products to market.

Many smaller companies avoid innovative work because it’s too risky. Stern found that small devicemakers make up just 6.9 percent to 17.2 percent of pioneer entrants, compared with 36.4 percent to 54.5 percent in the pharmaceutical industry.

Suggestions for Improvement

Based on her research, Stern recommends the faster release of product-specific guidance documents. Earlier meetings between the FDA and sponsors could also lead to evaluation standards or guidelines before a submission is formally made.

She sees the 21st Century Cures Act as a potential avenue for restructuring the device approval process. Under the proposed legislation, devicemakers developing advanced technologies that either have no alternative or offer a significant improvement over existing alternatives could apply for a priority review designation before submitting an application (IDDM, May 1).

The legislation was approved by the U.S. House of Representatives last month in a 344-77 vote. The Senate is working to develop similar legislation (IDDM, July 10).

Stern tells IDDM that her research focuses broadly on the field of health economics and the economics of innovation. “The medical device industry is a place where the two fields meet, but very little academic health economics research is done,” she says. “My hope is to change that a bit with a few papers on the medical device innovation/regulatory process, and this is the first one in that effort.”

To read the report, visit www.fdanews.com/08-17-15-innovation.pdf. — Elizabeth Hollis