OrthoPediatrics Joins Alliance for Pediatric Device Innovation

OrthoPediatrics Corp. has formed a strategic partnership with Children’s National Hospital in Washington, D.C., under the Alliance for Pediatric Device Innovation (APDI), to advise the development and commercialization of pediatric medical devices.
 
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. The company 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 U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, to host competitions and accelerator wraparound services exclusively for medical technology entrepreneurs of African American and Hispanic backgrounds.

“We are excited to join the APDI with our partners at Children’s National Hospital and John’s Hopkins University,” OrthoPediatrics President/CEO David Bailey said. “This coalition of thought leaders will help us advance all aspects of pediatric medicine for years to come. Since the inception of the company, OP has been focused exclusively on improving healthcare for KIDS, and this will further enable us to reach more patients with devices and treatment options that are designed specifically for them.”
 
The FDA has awarded a nearly $7.5 million grant to the APDI. The nonprofit group—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 children’s needs. New in this cycle, APDI will provide expertise on evidence generation, including the use of real-world evidence (RWE), for pediatric device development.
 
Pediatric medical device development continues to lag significantly behind that of adults due to various 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.
 
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. “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.”
 
Founded in 2006, OrthoPediatrics is focused exclusively on advancing pediatric orthopedics. As such it has developed a comprehensive product offering to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 52 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and more than 70 countries outside the United States.