Guiding pediatric medical devices to market with a little help from the FDA

March 27, 2011 by MassDevice

While scientists and entrepreneurs can find a lot of assistance and advice for bringing medical devices for adults to market, help for devices intended for infants and children is hard to come by, but that could be changing, thanks — in part — to the FDA.

By Tom Ulrich

Imagine: You're a pediatric cardiologist who for years has worked on the design of a device that could revolutionize the treatment of a severe atrial arrhythmia.

But while you can find a lot of assistance and advice for bringing devices for adults to market, you find little help for devices intended for infants and children. What can you do?

VSD heart patch

A biodegradable patch for repairing ventral septal defects (VSDs).

The Food & Drug Administration could be your best friend. Better known for its role in establishing and enforcing regulations for drug and device safety and information, the agency is also an advocate, helping bring innovative devices for pediatric treatment into clinical practice. Pedro del Nido, chief of cardiac surgery at Children's Hospital Boston, outlined the FDA's advocacy role last week at the monthly Innovators' Forum hosted by the Children's Innovation Acceleration Program.

Pediatric devices come out years after analogous devices for adults reach the market. del Nido spoke of the unique challenges behind this delay: Children differ in size, growth, and body chemistry; their activity levels vary greatly; the market for pediatric devices is small; reimbursement is limited. And because there are fewer patients, it can be difficult to gather the data required for FDA approval of high-risk devices.

"Designers often end up adapting the designs of adult devices for pediatric use," he noted, "even though those designs may not be appropriate for use in kids."