Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables

Sanger, Terence; Chang, Anthony; Feaster, William; Taraman, Sharief; Afari, Nadine; Beauregard, Debra; Dethlefs, Brent; Ghere, Tiffani; Kabeer, Mustafa; Tolomiczenko, George; Billig, Michael; Brophy, Jon; Eskandanian, Kolaleh; Espinoza, Juan; Farrugia, Sherry; Harrison, Michael; Horvat, Christopher; Hoyen, Claudia; Koh, Chester; Komiyama, Allison; Nelson, Krista; Kulkarni, Omkar; Levy, Robert; Maher, Kevin; O'Donnell, Michael; Ponsky, Todd; Richmond, Frances; Richter, Jessica; Roy, Shuvo; Samir, Shreim; Suresh, Srinivasan; Stallworth, Charlette; Thekkedath, Usha; Toman, Kara; Wall, James; West, Leanne; Wolff, Dawn

doi:10.1109/jtehm.2021.3092559

Published June 25, 2021 | Version Published + Accepted Version

Journal Article Open

Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables

1. Children's Hospital of Orange County
2. University of California, Irvine
3. California Institute of Technology
4. Cincinnati Children's Hospital Medical Center
5. Children's National Health System
6. Children's Hospital of Los Angeles
7. University of California, San Francisco
8. University of Pittsburgh
9. Children's Hospital of Pittsburgh
10. Rainbow Babies & Children's Hospital
11. Case Western Reserve University
12. Texas Children's Hospital
13. Children's Mercy Hospital
14. Children's Hospital of Philadelphia
15. Children's Healthcare of Atlanta
16. University of California, Berkeley
17. University of Southern California
18. Lucile Packard Children's Hospital

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.

Additional Information

© 2021 IEEE. This work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/. Received 10 April 2021; revised 14 June 2021; accepted 18 June 2021. Date of publication 25 June 2021; date of current version 22 July 2021. These Joint Recommendations were not supported by any source of funding.

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Accepted Version - Opportunities_for_Regulatory_Changes_to_Promote_Pediatric_Device_Innovation_in_the_United_States_Joint_Recommendations_from_Pediatric_Innovator_Roundtables_August_5_2020_amp_January_6_2021.pdf

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