The concept of a "one size fits all" medical device sounds attractive in theory, but in practice, it isn't very likely that one device can be developed to meet every patient's unique needs. This is particularly true when it comes to pediatric devices, which may not receive as much attention or funding as devices that were developed with an adult demographic in mind. In comparison to adults, children exhibit not just differences in body size, but also different immune response reactions.
Help may be on the way. The FDA recently awarded the Georgia Institute of Technology, Children's Healthcare of Atlanta, Emory University, and Saint Joseph's Translational Research Institute a two-year, $1.8 million grant to foster the development of medical devices focused on the specific needs of children. The award will launch the Atlanta Pediatric Device Consortium, which will provide support for commercialization of devices for pediatric health care from concept to finished product. One of their goals is to reduce cost-prohibitive barriers that prevent manufacturers from focusing on pediatric trials, which are seen as a small market.
The consortium plans to provide assistance for pediatric medical devices from academic institutions and small businesses. It is investigating three technologies, intially: a smartphone attachment for at-home ear examinations, a renal dialysis device, and a gel designed to delay the re-fusion of a child's skull bones after surgery for craniosynostosis.
The renal dialysis device will help address the needs of children with kidney failure, who, up to this point, have had to make do with adult-size dialysis equipment, as there is currently no FDA-approved continuous bedside dialysis device for children. These adapted devices can withdraw too much fluid from pediatric patients, leading to dehydration, shock, and loss of blood pressure.
A gel is being developed to help re-fuse a child's skull bones after surgery for craniosynostosis. Craniosynostosis is a congenital condition caused by the premature closure of gaps between skull bones; it affects approximately one in every 2,500 babies in the U.S.
