Most medical devices are designed and marketed for adults so often must be repurposed and used off-label in pediatrics. The innovation gap is complex and multifactorial, and contributes to pediatric health disparities. This talk will summarize the medical device landscape, describe barriers to pediatric device development, and provide an update on current strategies to help overcome these limitations. Pediatric devices number only a quarter of those developed for adults for multiple reasons. Clinically, innovators must adjust their products to address the smaller sizes, growth, and longer duration of use in children. Smaller sample sizes and population heterogeneity also challenge the ability to obtain sufficient safety data for regulatory submissions. Financial concerns stem from lower pediatric reimbursement rates coupled with a lack of nationally standardized coverage. There are a number of promising initiatives, including the Pediatric Device Consortia program, Early Feasibility Studies, and the new System of Hospitals for Innovation in Pediatrics - Medical Devices. Finally, we will discuss how we can view this process through a health equity lens to identify opportunities to reduce disparities and improve pediatric health outcomes.