Funded by the Food and Drug Administration (FDA), the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) solicits proposals from medical device companies with FDA-cleared or approved medical devices that may address an unmet need in the pediatric population, and therefore seeking pediatric market clearance in the US. If chosen, the partnering team will provide technical expertise where needed and include (1) access to mentors, (2) design study protocol implementing RWE methodologies, (3) facilitate IRB submission, (4) facilitate study implementation, (5) furnish cloud services and data science support, and (6) provide regulatory, reimbursement, and supply chain consultation. The partnering team will facilitate meetings with the device sponsors and FDA. The pediatric population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or younger at the time of diagnosis or treatment.