The Challenges and Opportunities in Pediatric Medical Device Innovation: Monitoring Devices.

Abstract

Medical device innovation and development for pediatric care lags behind that of adults. With higher technical risks, challenges in accumulating data, smaller market sizes, and limited return on investment, there is less incentive for pediatric device development. Consequently, translation of medical devices specifically designed to improve pediatric care is limited. However, a changing landscape and novel programs may support an expansion of pediatric device development. A keyword-based search was conducted in PubMed; market databases and Food and Drug Administration guidance documents were also used in this review. A total of 18,017 articles underwent a title and abstract review, and 190 articles were reviewed by the expert authors. Collectively, challenges with evidence generation and business and technical forces have disincentivized innovators from pursuing pediatric device innovation. Innovative programs such as the System of Hospitals for Innovation in Pediatrics-Medical Devices and the existing Pediatric Device Consortia, if strategically leveraged, may foster a robust national pediatric device innovation ecosystem. Whereas there is a higher opportunity cost for pediatric device development, leveraging the programs and incentives available in a "pediatric-first" approach may provide effective paths to larger total addressable markets for innovators.