Medical Device Daily Washington Editor

ALEXANDRIA, Virginia – Very often – certainly too often – medical device development for pediatrics is overlooked because many companies consider it too small a market to justify the expense of product design, testing and then launch.

According to Joanne Less, PhD, associate director of clinical research and government affairs in the FDA’s Center for Devices and Radiological Health (CDRH), a mixture of these factors is keeping companies from actively pursuing device development in the pediatric market.

Less spoke during last week’s 15th annual Device Submissions Workshop sponsored by the Advanced Medical Technology Association (AdvaMed; Washington).

As part of last year’s Medical Devices Technical Corrections Act, which came out in April and clarified language in the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the FDA was asked to issue a report to Congress on barriers of availability to devices intended for treatment and diagnosis of diseases that affect children.

“This was a significant piece of work for us to do,” Less said. “We ultimately concluded that it is still too early for policy, regulatory, or legislative changes.”

After publishing a notice in the Federal Register asking industry for comments on what the sector needed, the agency determined that further study would be required to determine problems and possible solutions.

“I think it is safe to say that we really do not know the scope of unmet pediatric needs, and we need to link barriers to solutions,” she said.

Beginning last fall, the FDA began meeting with professional organizations, healthcare providers, academia, consumers and other stakeholders, including a series of meetings sponsored by AdvaMed.

Less said the barriers overwhelmingly identified by participants fall into three categories: economic, clinical and regulatory.

Companies feel that the development costs are much too prohibitive, Less explained, adding that companies perceive considerable added liability issues in the pediatric market.

“Some of the smaller manufactures would say that if they could make a million dollars, they’d be interested in exploring the market,” she said. “Some of the larger companies would say that they weren’t even interested for a million.”

Other issues include a lack of reimbursement from Medicare and Medicaid, combined with an absence of a mechanism for patent exclusivity.

Drug companies often are able to take advantage of the Pediatric Research Equity Act, or PREA. If a company conducts studies to show how its drug works in a pediatric population, PREA allows FDA to grant some level of exclusivity on the drug’s indication – for both adult and pediatric populations.

“As a result, so many companies feel that it is not worth their time or money cost to bring pediatric devices to market,” Less said.

On the clinical side, she said there is a belief that pediatric trials are unethical and that enrollment is limited by parental reluctance, concerns about testing exposure – X-rays and blood samples, for example – and geographic constraints because the populations are so small and so spread out around the country. “It is much harder to get pediatric patients to come back on a regular schedule when they’re not hospitalized.”

When it comes to government’s role, Less said companies think that regulatory requirements aren’t clear and there needs to be more device-specific guidance for new devices and modifications to existing devices.

Frequent size changes are needed for smaller anatomy, requiring additional regulatory activity, retooling and manufacturing.

Some of the proposed solutions include more government grants for research and development for companies deciding to enter the market. Also mentioned as a possible incentive are tax credits, as well as expedited reimbursement decisions from the Centers for Medicare & Medicaid Services (Baltimore).

In the regulatory arena, industry says it is looking for more guidance from FDA and perhaps even revised regulatory requirements in the form of new 510(k) applications specifically for pediatrics.

Less said the FDA currently is working on a targeted survey to see what can be done to facilitate development under current laws and how to encourage invention through changes to policy.

CDRH recently formed a pediatric intra-center working group to help with pre-market review consultation, coordinating pediatric-related device activity within the center. She said that, as part of the effort, a list of needed devices is being developed and reviewed to see if there are companies that would be interested in pursuing development.

Encouragement of pediatric devices should come “without unduly increasing the burden on industry or the FDA and delaying device approvals for adults,” Less said. “Our challenge is to do it right and do it smart.”