WASHINGTON, D.C. (Sept.19, 2023) — To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to the Alliance for Pediatric Device Innovation (APDI), a consortium led by Children’s National Hospital. The nonprofit group, which is one of five in the FDA’s Pediatric Device Consortia (PDC) program, will utilize the five-year grant to provide a platform of services, expertise and funding that supports pediatric innovators in bringing medical devices to the market that specifically address the needs of children. New in this cycle, APDI will provide expertise on evidence generation, including the use of real-world evidence (RWE), for pediatric device development.

Along with Children’s National, APDI consortium members include Johns Hopkins University, CIMIT at Mass General Brigham, Tufts Medical Center and Medstar Health Research Institute. Publicly traded OrthoPediatrics Corp., which exclusively focuses on advancing pediatric orthopedics, will serve as APDI’s strategic advisor and role model for device innovators whose primary focus is children. Children’s National and APDI are also partnering with MedTech Color, a collaborative community that is part of FDA’s Center for Devices and Radiological Health, to host competitions and accelerator wraparound services exclusively for medical technology entrepreneurs of African American and Hispanic backgrounds.

APDI is led by program director and principal investigator Kolaleh Eskandanian, Ph.D., M.B.A., vice president and chief innovation officer at Children’s National, and principal investigator Julia Finkel, M.D., pediatric anesthesiologist and director of Pain Medicine Research and Development in the Sheikh Zayed Institute for Pediatric Surgical Innovation.

Pediatric medical device development continues to lag significantly behind that of adults because of a variety of challenges, including complexities in designing devices for growing children, small market size and lack of financial incentives. To address this health inequity, the FDA provides support through the consortia grant program to advance the development of medical devices for children.

“Children are our future, and they deserve to benefit from the best advancements that medical technology can offer,” Eskandanian says. “Children’s National looks forward to continuing our work as a champion for medical device innovation for children. Working with our distinguished consortium partners, we will build upon our collective strengths to bring more pediatric devices to patient care while minimizing the barriers to device innovation.”

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