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

Sanger, Terence and Chang, Anthony and Feaster, William and Taraman, Sharief and Afari, Nadine and Beauregard, Debra and Dethlefs, Brent and Ghere, Tiffani and Kabeer, Mustafa and Tolomiczenko, George and Billig, Michael and Brophy, Jon and Eskandanian, Kolaleh and Espinoza, Juan and Farrugia, Sherry and Harrison, Michael and Horvat, Christopher and Hoyen, Claudia and Koh, Chester and Komiyama, Allison and Nelson, Krista and Kulkarni, Omkar and Levy, Robert and Maher, Kevin and O'Donnell, Michael and Ponsky, Todd and Richmond, Frances and Richter, Jessica and Roy, Shuvo and Samir, Shreim and Suresh, Srinivasan and Stallworth, Charlette and Thekkedath, Usha and Toman, Kara and Wall, James and West, Leanne and Wolff, Dawn (2021) Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables. IEEE Journal of Translational Engineering in Health and Medicine, 9 . Art. No. 4800105. ISSN 2168-2372. PMCID PMC8313015. doi:10.1109/jtehm.2021.3092559. https://resolver.caltech.edu/CaltechAUTHORS:20210728-222532880

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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.


Item Type:Article
Related URLs:
URLURL TypeDescription
https://doi.org/10.1109/jtehm.2021.3092559DOIArticle
http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8313015/PubMed CentralArticle
ORCID:
AuthorORCID
Sanger, Terence0000-0002-1837-6044
Taraman, Sharief0000-0003-2108-2490
Afari, Nadine0000-0002-9028-8102
Tolomiczenko, George0000-0002-3208-7572
Brophy, Jon0000-0001-5149-6649
Espinoza, Juan0000-0003-0513-588X
Harrison, Michael0000-0003-0866-7005
Nelson, Krista0000-0002-5318-1859
Roy, Shuvo0000-0002-3236-6336
Thekkedath, Usha0000-0001-6855-9685
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.
Subject Keywords:Device, FDA, guidelines, pediatric, regulatory
PubMed Central ID:PMC8313015
DOI:10.1109/jtehm.2021.3092559
Record Number:CaltechAUTHORS:20210728-222532880
Persistent URL:https://resolver.caltech.edu/CaltechAUTHORS:20210728-222532880
Official Citation:T. Sanger et al., "Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables," in IEEE Journal of Translational Engineering in Health and Medicine, vol. 9, pp. 1-5, 2021, Art no. 4800105, doi: 10.1109/JTEHM.2021.3092559
Usage Policy:No commercial reproduction, distribution, display or performance rights in this work are provided.
ID Code:110058
Collection:CaltechAUTHORS
Deposited By: Tony Diaz
Deposited On:02 Aug 2021 19:10
Last Modified:02 Aug 2021 19:10

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