FDA Awards Nearly $7.5 Million to Pediatric Device Consortium

To foster the development and commercialization of medical devices designed for children, the U.S. 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 use 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 said. “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.”
 
This is the third PDC grant for Children’s National, which previously led the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) from 2013-2023. Over those 10 years, NCC-PDI provided guidance and resources to 315 pediatric device projects spanning all regulatory pathways, with more than 20 devices having received either FDA market clearance, approval, or European safety approval. Collectively, projects supported by NCC-PDI raised over $500 million in follow-on funding, and seven companies landed a successful exit via acquisition.
 
In addition to leading the FDA-funded pediatric device consortium, Children’s National hosts various other hospital-sponsored programs focused on advancing the innovation of pediatric medical products including devices, diagnostics, drugs, biologics and digital therapeutics. On Oct. 8, Children’s National will hold its 11th Annual Symposium on Pediatric Device Innovation, scheduled again this year with The MedTech Conference powered by AdvaMed. The symposium will host the “Make Your Medical Device Pitch for Kids! competition. Throughout the year, Children’s National also hosts Innovation Day programs and other events to bring together entrepreneurs, clinicians, investors, and regulatory and design experts to foster collaboration and advancement of pediatric innovation.
 
Under APDI’s scope, Children’s National will host a variety of boot camps on topics including regulatory, reimbursement and fundraising for pediatric device innovators. Children’s National also plans to host regular showcase days on Capitol Hill to raise awareness about equity and access to medical devices by all patient populations. 
 
Eskandanian said the new Children’s National Research and Innovation Campus provides the ideal environment for the collaborative work needed to advance pediatric innovation. Designed to drive discoveries that save and improve the lives of children, this one-of-its-kind ecosystem is a newly renovated research and innovation space located on a nearly 12-acre portion of the former, historic Walter Reed Army Medical Center in Northwest Washington, D.C. On this campus, Children’s National has combined its strengths with public and private partners—including industry, universities, federal agencies, start-up companies and academic medical centers—to create a collaborative campus that bolsters pediatric innovation and commercialization. 
 
Children’s National Hospital, based in Washington, D.C., was established in 1870 to help every child grow up stronger. Today, it is the No. 5 children’s hospital in the nation and ranked in all specialties evaluated by U.S. News & World Report. The Children’s National Research & Innovation Campus opened in 2021, a first-of-its-kind pediatric hub dedicated to developing new and better ways to care for kids. Children’s National has been designated three times in a row as a Magnet hospital, demonstrating the highest standards of nursing and patient care delivery. This pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty care locations in the D.C. metropolitan area, including Maryland and Virginia. Children’s National is home to the Children’s National Research Institute and Sheikh Zayed Institute for Pediatric Surgical Innovation.