The Food and Drug Administration is awarding $2 million to spur the development of medical devices for children, who face increased risks during surgery because so few implants are designed for their use.
The FDA said Monday it will distribute the grants among three researchers in Michigan, Massachusetts and California.
The announcement comes two years after Congress passed legislation to address the problem, which is little-known outside the medical world.
The vast majority of medical devices are made for adults. Doctors work around the problem by jury-rigging adult-sized devices to fit smaller patients. But they acknowledge that such ingenuity has limits and that the risks to patients are often high.
Problems with using adult devices in children range from the mundane — oversized oxygen masks — to the complicated — pacemaker batteries that run out because children's' hearts beat faster. There is virtually no data on the safety of using adult devices in children, though experts say the complications can be fatal.
While the U.S. market for medical devices is estimated at more than $90 billion, the demand for pediatric devices is minuscule, creating little financial incentive for companies like Medtronic Inc. and Boston Scientific Corp. to invest in the space.
Development of new pediatric devices lags about 10 years behind similar devices for adults, according to the FDA.
"Congress provided the FDA with this funding so that we could help connect innovators and their ideas with experienced professionals who assist them through development," said Timothy Cote, director of FDA's program for orphan product development.
The agency awarded $1 million to Dr. James Geiger of the Michigan Pediatric Device Consortium; and $500,000 each to Dr. Pedro DelNido of the Pediatric Device Consortium in Boston, and Dr. Michael Harrison of the University of California at San Francisco Pediatric Device Consortium.
The researchers will work with the FDA to develop prototypes and ultimately find manufacturers to build and market new pediatric devices.