The Atlantic Pediatric Device Consortium (APDC) is the product of collaborations between the Atlanta institutions of Children’s Healthcare of Atlanta, the Georgia Institute of Technology, and Emory University Medical School and now the Virginia Commonwealth University. The collaboration began with the Laboratory for Pediatric Craniofacial Plastic Surgery Research formed in July 2005 and then developed into the Center for Pediatric Healthcare Technology Innovation (CPHTI) in June 2010. The Laboratory combined the expertise of scientists and engineers at Georgia Tech with surgeons at Scottish Rite to define, research, and develop novel diagnostic and therapeutic regimens for the critical problems in treating craniofacial anomalies in children. CPHTI employed this same combination of expertise to develop new technologies that will “grow as children grow” as well as novel surgical, diagnostic and point-of-care technologies for the pediatric patient population.
In 2010, collaborators from CPHTI formed the Atlanta Pediatric Device Consortium and APDC became the first research center to be awarded funding from CPHTI. In April 2011 the members of the APDC applied for a P50 grant from the FDA Office of Orphan Products Development and the APDC was the only engineering based consortium of three pediatric device consortiums awarded that year. A goal of the FDA-sponsored Pediatric Device Consortia, of which there are now seven nationwide, is to provide a center of expertise focused on the specific needs of children that is available to inventors, entrepreneurs, and business.
In November 2011 APDC held the first annual Pediatric Device Competition where six technologies were awarded funding and support from the Consortium. In 2012 an additional nine device projects received funding and by the end of that year over 45 pediatric medical device projects had been assisted through funding or advising by APDC. In early 2013 Dr. Barbara Boyan left Georgia Tech to become the Dean of Engineering at Virginia Commonwealth University (VCU). Renewal funding from the FDA was awarded in the Fall of 2013, and with that APDC extended its borders to include VCU as a part of the consortium where Dr. Boyan continues in a leadership role.
The fifth annual Pediatric Device Innovation Competition was held in October 2015, and the next call for proposals will be in September 2016.
FDA Pediatric Devices Consortia Background
In 2007, Congress passed the Pediatric Medical Device Safety and Improvement Act as part of the Food and Drug Administration Amendments Act of 2007. Administered by the FDA Office of Orphan Products Development, this act provides grants or contracts to promote pediatric device development. The development of pediatric medical devices is currently five to ten years behind the development of devices for adults. The challenges involved with pediatric devices include the fact that children differ from adults in terms of their size, growth, development, and body chemistry. There currently exists both a need for medical devices designed specifically for children as well as the specific adaptation of existing adult devices for children. This grant program which APDC is a part of is intended to encompass devices used in all pediatric diseases and for all patients 21 years of age and younger at the time of diagnosis or treatment according to the FDA definition of “pediatric” devices.
