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Atlanta Network to Boost Pediatric Medical Devices

Barbara Boyan (Gary Meek/Georgia Tech)

Barbara Boyan (Gary Meek/Georgia Tech)

The Food and Drug Administration (FDA) has awarded four Atlanta-area institutions a $1.8 million grant to encourage development of new medical devices to meet the special needs of children. Georgia Institute of Technology, Children’s Healthcare of Atlanta, Emory University and Saint Joseph’s Translational Research Institute will take part in the Atlanta Pediatric Device Consortium.

Barbara Boyan (pictured left), a professor of biomedical engineering at Georgia Tech and Emory University, will serve as the consortium’s director. The network will provide help with engineering design, prototype development, pre-clinical and clinical studies, and commercialization of new pediatric medical devices.

Medical devices designed for adults have traditionally been used with children, but differences in physiology between adults and children may call for more specialized equipment. Differences in body size and immune system responses between adults and children, and the lack of appropriate models to assess how a device might function in a growing child, can result in poor device performance and responses that are less than optimal.

The consortium, funded by FDA for two years, aims to encourage technologies that recognize these differences. The network plans to create a product development process for academic institutions and small businesses that supports commercialization of devices for pediatric health care from initial concept to the completed product. The group has targeted three technologies for development.

The first device is a smartphone attachment for at-home ear examinations. More than 15 million doctor-office visits each year in the U.S. are attributed to ear infections, because diagnosing them requires direct observation of the child’s eardrum and ear canal with a device called an otoscope. The smartphone-based device could make it possible for physicians to help parents conduct the examination at home.

Another technology identified by the network is a renal dialysis device designed for children with kidney failure, for which no FDA-approved device now exists. When critically ill children need kidney dialysis, doctors are forced to adapt adult-size dialysis equipment, which can withdraw too much fluid from a child, leading to dehydration, shock, and loss of blood pressure.

A third project the consortium will undertake is development of a gel to delay re-fusion of a child’s skull bones after surgery for craniosynostosis, a disorder that affects about one in every 2,500 babies in the U.S. and is caused by premature closure of gaps between skull bones.

The network has established a seed grant competition, which will provide grants of $25,000 to $50,000 to inventors in participating institutions and businesses to develop other pediatric medical devices through the consortium. The deadline for entries in the competition is 1 November 2011.

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2 comments to Atlanta Network to Boost Pediatric Medical Devices

  • .FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death..Use the yearly lists to find information about Class I medical device recalls and some Class II and III recalls of interest to consumers. The links give details about what to do if you own or use one of these products..Please note that FDA now lists medical device recall notices by the date that it posts the recall rather than the recall initiation date.

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