FDA Awards Five Grants to Advance Development of Pediatric Medical Devices

Rare Daily Staff

The U.S. Food and Drug Administration said that it has awarded five grants totaling up to $6 million per year over the next five years to Pediatric Device Consortia across the country that will provide advice and support services to innovators of children’s medical devices.

The program, which is intended to enhance the development, production, and distribution of pediatric medical devices, has awarded $37 million in grant to various consortia since 2009.

The PDC grant recipients and their principal investigators for 2018 include:

• Philadelphia Pediatric Medical Device Consortium, Matthew Maltese
• National Capital Consortium for Pediatric Device Innovation 2.0, Kolaleh Eskandanian
• Southwest National Pediatric Device Consortium, Chester Koh
• University of California San Francisco-Stanford Pediatric Device Consortium
• West Coast Consortium for Technology and Innovation in Pediatrics

“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. “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.”

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.

The consortia have assisted or advised more than 1,000 medical device projects since the program began. There are now 19 pediatric medical devices available to patients as a result of this grants program, including a needle-free blood collection device that attaches to peripheral IV systems for use as a direct blood draw device; a surgical vessel sealing system for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles and a rapid infusion device that delivers fluids to a patient’s vascular system.

“The consortia support a mix of projects at all stages of development and bring together individuals and institutions whose expertise and collaboration is essential to furthering our goal of bringing more pediatric medical devices to patients,” said Debra Lewis, acting director of the FDA’s Office of Orphan Products Development. “Each of the consortia will coordinate projects with the FDA, medical device companies, and the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development to facilitate research and any necessary applications for device approval or clearance.”

September 13, 2018
Photo: FDA Commissioner Scott Gottlieb