Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables
Terence D. Sanger, Anthony Chang, William Feaster, Sharief Taraman, Nadine Afari, Debra Beauregard, B Dethlefs, Tiffani Ghere, Mustafa H. Kabeer, George Tolomiczenko, Michael Billig, Jon Brophy, Kolaleh Eskandanian, Juan Espinoza, Sherry N. Farrugia, Michael Harrison, Christopher M. Horvat, Claudia K. Hoyen, Chester J. Koh, Allison Komiyama, Krista Nelson, Omkar Kulkarni, Robert J. Levy, Kevin Maher, Michael O’Donnell, Todd A. Ponsky, F.J.R. Richmond, Jessica Richter, Shuvo Roy, Shreim Samir, Srinivasan Suresh, Charlette Stallworth, Usha Thekkedath, Kara Toman, James Wall, Leanne L. West, Dawn Wolff
Abstract
OBJECTIVE: The purpose of this report is to provide insight from pediatric stakeholders with a shared desire to facilitate a revision of the current United States regulatory pathways for the development of pediatric healthcare devices. METHODS: On August 5, 2020, a group of innovators, engineers, professors and clinicians met to discuss challenges and opportunities for the development of new medical devices for pediatric health and the importance of creating a regulatory environment that encourages and accelerates the research and development of such devices. On January 6, 2021, this group joined regulatory experts at a follow-up meeting. RESULTS: One of the primary issues identified was the need to present decision-makers with opportunities that change the return-on-investment balance between adult and pediatric devices to promote investment in pediatric devices. DISCUSSION/CONCLUSION: Several proposed strategies were discussed, and these strategies can be divided into two broad categories: 1. Removal of real and perceived barriers to pediatric device innovation; 2. Increasing incentives for pediatric device innovation.