Experts Examine Challenges to Developing Pediatric Devices
Even as the FDA and industry collaborate to champion development of pediatric devices, it is clear that more work must be done.
That was the conclusion of experts speaking at a panel on pediatric and rare disease device development at AdvaMed 2015 in San Diego, Calif. They cited a lack of incentives, smaller market size, the specialization of pediatric device development and the cost of conducting clinical trials as barriers industry faces.
“Children are not just small adults,” said Charles Berul, division chief of cardiology and co-director of the Children’s National Heart Institute at the Children’s National Health System in Washington, D.C.
Berul demonstrated just how acute the need showing photos of children with implanted pacemakers and defibrillators visible from outside their bodies.
Mark Carlson, vice president of global clinical affairs and chief medical officer at St. Jude Medical, cited Centers for Disease Control and Prevention statistics indicating that about 120,000 babies are born each year in the U.S. with any one of 45 types of birth defects, including about 40,000 with congenital heart defects.
Despite this need, the demand for pediatric medical devices doesn’t cover R&D investments. Carlson said his company’s size allowed it to dive into the pediatric arena. “If we were smaller, we wouldn’t necessarily have the same ability,” he said.
Berul noted that it is often individual laboratories and universities trying to innovate in this area, rather than industry.
Eric Chen, director of the FDA’s humanitarian use device program, said the agency has taken steps to address this complicated area, particularly when it comes to testing devices in children.
Chen added there are incentives for studies of pediatric and orphan drugs on the pharmaceutical side, including user fees. Opportunities do exist on the device side, including the Pediatric Device Consortia Grants Program, which has provided advice on the development of more than 500 devices since 2009.
In a report accompanying its fiscal 2016 funding bill, the Senate Appropriations Committee praises the grants program and calls on the agency to fund it “at the highest possible level,” and at least at the same level as last year ().
Chen also cited a device needs assessment that the FDA launched two weeks ago via a web-based clinician survey, which is getting good response.
The survey will close by the end of the month and will be followed by a report demonstrating the need for devices to address pediatric and rare diseases.
A symposium organized by the Children’s National Health System’s Sheikh Zayed Institute for Pediatric Surgical Innovation is set for Oct. 23, in Washington, D.C. Participants will examine incentives to stimulate pediatric device development; more information is available at www.pediatric-surgery-symposium.org. — Elizabeth Hollis