FDA grant to foster development of novel pediatric medical devices

The U.S. Food and Drug Administration (FDA) has awarded the Georgia Institute of Technology, Children's Healthcare of Atlanta, Emory University and Saint Joseph's Translational Research Institute (SJTRI) a two-year, $1.8 million grant to foster the development of medical devices focused on the special needs of children. The award will launch the new Atlanta Pediatric Device Consortium, which will provide assistance with engineering design, prototype development, pre-clinical and clinical studies and commercialization for novel pediatric medical devices.

"By developing, testing and refining medical devices specifically for children, we hope to produce safer, more effective devices that will improve their lives," said Barbara Boyan, the Price Gilbert, Jr. Chair in Tissue Engineering in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.

The consortium will be led by Boyan, along with consortium co-directors Kevin Maher, a cardiologist and researcher specializing in pediatrics with appointments at the Children's Healthcare of Atlanta Sibley Heart Center and Emory University, and Wilbur Lam, a pediatric hematologist/oncologist and bioengineer with appointments at Emory, the Aflac Cancer Center of Children's Healthcare of Atlanta and Georgia Tech.

Historically, devices designed for adults have been used in children. However, 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.

"There is little information as to what devices are working well for children and what complications occur," explained Boyan, who is also a Georgia Research Alliance Eminent Scholar. "In addition, the high cost of clinical trials for a small market like pediatrics has made conducting pediatric trials cost-prohibitive for many manufacturers."

The consortium will try to reduce these barriers by creating a product development pathway that will provide support for commercialization of devices for pediatric health care from initial concept to the completed product.

To do this, the consortium will build on partnerships the institutions have with the Georgia Tech Translational Research Institute for Biomedical Engineering and Science (TRIBES), which focuses on the need for engineering systems that result in commercial products; the Global Center for Medical Innovation (GCMI), which includes a prototyping design and development facility; and the Advanced Technology Development Center (ATDC) at Georgia Tech, a startup accelerator that helps Georgia technology entrepreneurs launch and build successful companies. Consortium institutions will also partner with SJTRI and the National Institutes of Health-sponsored Atlanta Clinical & Translational Science Institute (ACTSI) for pre-clinical, first-in-child testing and clinical assessments.

Additional consortium leadership will be provided by Franklin Bost, professor and director of design instruction in the Coulter Department; David Ku, a Regents professor with appointments in the Georgia Tech School of Mechanical Engineering and College of Management, and Emory's Department of Surgery; and Nicholas Chronos, president of SJTRI.

The consortium will provide assistance for pediatric medical devices from academic institutions and small businesses. The three technologies that will be investigated initially are:

• A smartphone attachment designed for at-home ear examinations
• A renal dialysis device
• A gel designed to delay the re-fusion of a child's skull bones after surgery for craniosynostosis

The first innovation is the RemOtoscope -- a smartphone attachment designed by Lam for at-home ear examinations. Ear infections result in more than 15 million doctor office visits each year in the United States because diagnosing them requires direct observation of the child's eardrum and ear canal with a device called an otoscope. Lam envisions a physician remotely guiding placement of the device and diagnosing the condition via real-time video consultation with parents at home. The smartphone capabilities will also enable the transmission of other relevant clinical information to guide the physician in making the correct diagnosis.

The second device the consortium will bring into the pipeline is a renal dialysis device designed especially for children with kidney failure. There is currently no FDA-approved continuous bedside dialysis device for children. When critically ill children need kidney dialysis, doctors are forced to adapt adult-size dialysis equipment. These adapted adult devices can withdraw too much fluid from a pediatric patient, leading to dehydration, shock and loss of blood pressure. Matthew Paden, a pediatric critical care physician at Children's Healthcare of Atlanta and Emory realized this problem and has collaborated with Ajit Yoganathan, a Georgia Tech Regents professor and the Wallace H. Coulter Distinguished Faculty Chair in Biomedical Engineering, to develop the device.

The consortium will also investigate the development of a gel designed to delay the re-fusion of a child's skull bones after surgery for craniosynostosis. Craniosynostosis affects approximately one in every 2,500 babies in the United States and is caused by the premature closure of gaps between skull bones. The gel is being developed by Boyan; Joseph Williams, clinical director of craniofacial plastic surgery at Children's Healthcare of Atlanta and clinical assistant professor in the Department of Plastic and Reconstructive Surgery at Emory University; and Coulter Department M.D./Ph.D. student Chris Hermann, senior scientist Rene Olivares-Navarrete, visiting professor Zvi Schwartz and associate professor Niren Murthy.

Future projects will be selected through the consortium's seed grant competition, which will provide awards between $25,000 and $50,000 to inventors in the partnering institutions and the business community to develop a pediatric medical device through the consortium. Entries are due Nov. 1, 2011.

Additional devices will also be identified through technology development and commercialization programs, including the Coulter Department capstone design class, the TI:GER (Technological Innovation: Generating Economic Results) program in the Georgia Tech College of Management, Georgia Tech's comprehensive center for technology commercialization called VentureLab and the Goizeuta Business School at Emory.