학술논문
Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables
Document Type
Periodical
Author
Sanger, T.; Chang, A.; Feaster, W.; Taraman, S.; Afari, N.; Beauregard, D.; Dethlefs, B.; Ghere, T.; Kabeer, M.; Tolomiczenko, G.; Billig, M.; Brophy, J.; Eskandanian, K.; Espinoza, J.; Farrugia, S.; Harrison, M.; Horvat, C.; Hoyen, C.; Koh, C.; Komiyama, A.; Nelson, K.; Kulkarni, O.; Levy, R.; Maher, K.; O'Donnell, M.; Ponsky, T.; Richmond, F.; Richter, J.; Roy, S.; Samir, S.; Suresh, S.; Stallworth, C.; Thekkedath, U.; Toman, K.; Wall, J.; West, L.; Wolff, D.
Source
IEEE Journal of Translational Engineering in Health and Medicine IEEE J. Transl. Eng. Health Med. Translational Engineering in Health and Medicine, IEEE Journal of. 9:1-5 2021
Subject
Language
ISSN
2168-2372
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.