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. 2021 Jun 25:9:4800105.
doi: 10.1109/JTEHM.2021.3092559. eCollection 2021.

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

Terence Sanger  1   2 , Anthony Chang  1 , William Feaster  1 , Sharief Taraman  1   2   3 , Nadine Afari  1   2 , Debra Beauregard  1 , Brent Dethlefs  1 , Tiffani Ghere  1 , Mustafa Kabeer  1 , George Tolomiczenko  4 , Michael Billig  5 , Jon Brophy  6 , Kolaleh Eskandanian  7 , Juan Espinoza  8   9 , Sherry Farrugia  10 , Michael Harrison  11   12 , Christopher Horvat  13   14 , Claudia Hoyen  15   16 , Chester Koh  17   18 , Allison Komiyama  19 , Krista Nelson  20 , Omkar Kulkarni  8 , Robert Levy  21 , Kevin Maher  22 , Michael O'Donnell  11   12   23 , Todd Ponsky  6 , Frances Richmond  24 , Jessica Richter  5 , Shuvo Roy  11   12 , Shreim Samir  25 , Srinivasan Suresh  13   14 , Charlette Stallworth  26 , Usha Thekkedath  11   12 , Kara Toman  17   18 , James Wall  26 , Leanne West  22   27 , Dawn Wolff  20
Affiliations

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

Terence Sanger et al. IEEE J Transl Eng Health Med. .

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.

Keywords: Device; FDA; guidelines; pediatric; regulatory.

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