Boyan Pushes for Reauthorization of Pediatric Medical Device Legislation

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Barbara Boyan, the Price Gilbert, Jr. Chair in Tissue Engineering in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory, and director of the Atlanta Pediatric Device Consortium, traveled to Washington D.C. recently to support legislation that encourages the development of pediatric medical devices.

During her visit in February, Boyan met with several congressmen, urging them to reauthorize “The Pediatric Medical Device Safety and Improvement Act." The law provides grants to fund non-profit pediatric device consortia, such as the Atlanta Pediatric Device Consortium. The grants connect scientists and innovators with device manufacturers, providing them financial resources and regulatory guidance needed to advance the development of devices for children.

“The funding from the FDA has opened many doors and some of our small companies have been able to secure venture capital funding to pursue these devices,” Boyan said.

One of three FDA-sponsored consortia awarded last year, the Atlanta Pediatric Device Consortium is a partnership between Georgia Tech, Children’s Healthcare of Atlanta and Emory University.

The Atlanta Pediatric Consortium provides assistance with engineering design, prototype development, pre-clinical and clinical studies and commercialization for novel pediatric medical devices. It is currently composed of nine projects, three main projects and six pilot projects, which were incorporated from the first Pediatric Device Competition.

“This consortium has brought excitement to the Atlanta Community and strengthened our research partnerships to develop the future of pediatric medical devices,” Boyan said.

Passed in 2007, “The Pediatric Medical Device Safety and Improvement Act" includes important incentives that promote the development of medical devices for children, which currently lags five to 10 years behind those for adults. Significant barriers to pediatric device development exist, including physiological differences in pediatric patients and challenges with recruiting pediatric participants for clinical trial. The law helps to support the creation of more pediatric devices, with 107 device projects developed during the program’s first two years, according to a report by the General Accounting Office.

Boyan was accompanied to D.C. by consortium co-directors Kevin Maher, MD, 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, MD, PhD, a pediatric hematologist/oncologist and bioengineer with appointments at Emory, the Aflac Cancer Center of Children’s Healthcare of Atlanta and Georgia Tech.



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