Three researchers in Michigan, Massachusetts, and California, have been awarded $2 million by the FDA for development of implants for children who face increased risks during surgery because so few of these devices are designed for their use. 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 currently find themselves jury-rigging adult-sized devices to fit smaller patients. This practice has limits and may put patients at risk. Problems with using adult devices in children range from oversized oxygen masks to 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 to invest.
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," says 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.