Pediatric Device Innovation: An Analysis of Food and Drug Administration Authorizations Over Time.

Abstract

Background: Despite a tremendous increase in the number of orthopaedic devices authorized by the U.S. Food and Drug Administration (FDA), novel devices designed specifically for the pediatric population remain sparse. Surgeons frequently repurpose adult implants for "off-label" use in pediatric patients, with both legal and technical ramifications. This study seeks to objectively quantify and characterize the nature of pediatric device innovation over time.

Methods: The FDA employs 4 pathways for assessing safety and effectiveness of novel devices prior to authorization. Perceived device risk and novelty determine the pathway. Orthopaedic devices were identified from the FDA's online database. All devices approved since inception via the Humanitarian Device Exemption, Pre-Market Approval, and De Novo regulatory pathways were included and grouped as "highly innovative." Because of their number and the rapidity of their development, the evaluation of 510(k) devices was limited to those cleared from January 1, 2018, to December 31, 2022. Such 510(k) devices make up ∼97% of devices and by definition are less risky and less novel. Approval statements were assessed for pediatric indications within the approved labeling. As a secondary analysis, the impact of company size on developing a product with a pediatric indication was analyzed.

Results: Of the 1,925 devices cleared via the 510(k) pathway, 9 (0.5%) were designed exclusively for pediatrics and 160 (8.3%) included pediatric indications. Five of the 9 pediatrics-only devices were for spine and 4 were for trauma indications. Of the 97 highly innovative devices, only 2 (2%) were exclusively pediatric and another 2 (2%) included pediatric indications. The 2 pediatrics-only devices were for the spine. Large and medium-sized companies were 1.9 times and 1.6 times more likely to bring to market a device with pediatric indications than a small company, respectively.

Conclusions: Innovation for pediatric orthopaedic devices lags substantially behind that for adult orthopaedic devices. These findings are consistent with clinical experience and the common practice of modifying adult implants for "off-label" use in pediatric patients. Despite long-standing efforts to stimulate innovation for this vulnerable population, our results suggest little progress.