- 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
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.