Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables
- Creators
- 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
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.
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.Attached Files
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Additional details
- PMCID
- PMC8313015
- Eprint ID
- 110058
- Resolver ID
- CaltechAUTHORS:20210728-222532880
- Created
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2021-08-02Created from EPrint's datestamp field
- Updated
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2021-08-02Created from EPrint's last_modified field