The U.S. Food and Drug Administration announced today that it has awarded five grants totaling up to $6 million per year over the next five years to Pediatric Device Consortia (PDC) across the country that will provide advice and support services to innovators of children's medical devices. The program aims to enhance the development, production and distribution of pediatric medical devices and has awarded $37 million to various consortia since 2009.
The PDC grant recipients and their principal investigators for 2018 are the following:
Philadelphia Pediatric Medical Device Consortium, Matthew Maltese, Ph.D.
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National Capital Consortium for Pediatric Device Innovation 2.0, Kolaleh Eskandanian, Ph.D., M.B.A.
Southwest National Pediatric Device Consortium, Chester Koh, M.D.
University of California San Francisco-Stanford Pediatric Device Consortium, Michael Harrison, M.D.
West Coast Consortium for Technology and Innovation in Pediatrics, Juan Espinoza, M.D.
“We recognize the unique health needs of children, and we’re committed to advancing new policies to encourage the development of safe, effective medical devices designed specifically for pediatric patients,” said FDA Commissioner Scott Gottlieb, M.D. “We know that developing products specifically for pediatric patients can present unique challenges to device developers and there are still many unmet needs for children with serious, debilitating or rare diseases. This is why we continue to work to encourage device innovation for medical conditions that impact young populations. Our Pediatric Device Consortia Grant Program is one of a number of initiatives underway to foster the development and approval of safe and effective pediatric-specific medical devices. This year’s awards have been granted to consortia that each bring together teams with expertise that will benefit children and their families.”
Specific areas of expertise provided by the consortia to medical device innovators include advising on issues related to: intellectual property, prototyping, engineering, laboratory and animal testing, grant-writing and clinical trial design to help foster and guide the advancement of medical devices specifically for children.
Of the estimated $6 million granted this year, approximately $1 million will be used for the Real World Evidence (RWE) Demonstration Project, in which three of the consortia will conduct RWE projects in the pediatric space that develop, verify and operationalize methods of evidence generation, data use and scalability across device types, manufacturers and the health care system. The FDA intends to use the information gathered through this initiative to further efforts to incorporate RWE into the agency’s work.