Originally Published MD&DI November 2009
FDA Grants Put Kids First
James Geiger holds a pediatric pyloric clamp that he invented with the help of a mechanical engineer at the University of Michigan. The clamp is licensed to Karl Storz. Photo courtesy of the UNIVERSITY OF MICHIGAN.
In an effort to fuel medical device development specifically for children, FDA is awarding $2 million in grants to three organizations across the country.
Innovation in pediatrics faces significant challenges. Device development has fallen behind comparable adult devices by nearly a decade, and there are several reasons for the lag. Design hurdles include dealing with the differences in size, body chemistry, and activity level. There’s also a perceived increased risk of liability in developing medical devices for children, along with hesitancy to involve them in a clinical trial, says Brenda Jones, managing director of the Medical Device Innovation Center at the University of Michigan (Ann Arbor).
Manufacturers must go through the same rigors for product approval but the device, if approved, will most likely hold a much smaller market share than its adult counterparts. “The market size on any kind of device [for children] is going to be very small, but the burden of regulatory approval is the same, and doing the clinical trials is the same,” says Jones. “You have the same cost structure for getting a device developed, approved, and marketed, [but it’s] spread across a smaller number of sales.”
Two years ago, Congress passed legislation to establish grant funding for nonprofit groups to encourage the development of pediatric devices. A panel of six experts reviewed 16 grant applications and recently chose the following three recipients:
• James Geiger, MD, and the Michigan Pediatric Device Consortium (M-PED; University of Michigan) for $1 million.
• Pedro DelNido, MD, and the Pediatric Cardiovascular Device Consortium, Children’s Hospital (Boston) for $500,000.
• Michael Harrison, MD, and the University of California at San Francisco Pediatric Device Consortium for $500,000.
Geiger is enthusiastic about working with his team at the University of Michigan as well as any medical device companies that have ideas or are interested in developing pediatric technologies. Devices that are on M-PED’s agenda include a nonthrombogenic antiseptic catheter for neonates and a bowel-lengthening device for children suffering from short bowel syndrome. M-PED is also working on other pediatric devices.
“With more money, we can direct other exciting research projects, at an earlier stage, towards trying to commercialize a product that could impact pediatric disease,” says Geiger. “I personally think that more companies will play with us in this space and will find huge benefits. If you solve a problem for extreme conditions like those encountered in pediatrics, you’re likely to have a product that might meet some really unique needs for adults.” He adds that one of the crucial barriers to overcome involves finding funding early in the product development process.
The grants, which will be administered by FDA’s Office of Orphan Products, have been congressionally mandated for two years. However, the second year of the grant award is contingent upon available funding, according to an FDA spokesperson.
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