TY - JOUR
T1 - Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States
T2 - Joint Recommendations from Pediatric Innovator Roundtables
AU - Sanger, Terence
AU - Chang, Anthony
AU - Feaster, William
AU - Taraman, Sharief
AU - Afari, Nadine
AU - Beauregard, Debra
AU - Dethlefs, Brent
AU - Ghere, Tiffani
AU - Kabeer, Mustafa
AU - Tolomiczenko, George
AU - Billig, Michael
AU - Brophy, Jon
AU - Eskandanian, Kolaleh
AU - Espinoza, Juan
AU - Farrugia, Sherry
AU - Harrison, Michael
AU - Horvat, Christopher
AU - Hoyen, Claudia
AU - Koh, Chester
AU - Komiyama, Allison
AU - Nelson, Krista
AU - Kulkarni, Omkar
AU - Levy, Robert
AU - Maher, Kevin
AU - O'Donnell, Michael
AU - Ponsky, Todd
AU - Richmond, Frances
AU - Richter, Jessica
AU - Roy, Shuvo
AU - Samir, Shreim
AU - Suresh, Srinivasan
AU - Stallworth, Charlette
AU - Thekkedath, Usha
AU - Toman, Kara
AU - Wall, James
AU - West, Leanne
AU - Wolff, Dawn
N1 - Publisher Copyright:
© 2013 IEEE.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Device
KW - FDA
KW - guidelines
KW - pediatric
KW - regulatory
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U2 - 10.1109/JTEHM.2021.3092559
DO - 10.1109/JTEHM.2021.3092559
M3 - Article
C2 - 34327067
AN - SCOPUS:85111640161
SN - 2168-2372
VL - 9
JO - IEEE Journal of Translational Engineering in Health and Medicine
JF - IEEE Journal of Translational Engineering in Health and Medicine
M1 - 9465164
ER -