IEEE Journal of Translational Engineering in Health and Medicine (Jan 2021)
Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables
- Terence Sanger,
- Anthony Chang,
- William Feaster,
- Sharief Taraman,
- Nadine Afari,
- Debra Beauregard,
- Brent Dethlefs,
- Tiffani Ghere,
- Mustafa Kabeer,
- George Tolomiczenko,
- Michael Billig,
- Jon Brophy,
- Kolaleh Eskandanian,
- Juan Espinoza,
- Sherry Farrugia,
- Michael Harrison,
- Christopher Horvat,
- Claudia Hoyen,
- Chester Koh,
- Allison Komiyama,
- Krista Nelson,
- Omkar Kulkarni,
- Robert Levy,
- Kevin Maher,
- Michael O'Donnell,
- Todd Ponsky,
- Frances Richmond,
- Jessica Richter,
- Shuvo Roy,
- Shreim Samir,
- Srinivasan Suresh,
- Charlette Stallworth,
- Usha Thekkedath,
- Kara Toman,
- James Wall,
- Leanne West,
- Dawn Wolff
Affiliations
- Terence Sanger
- ORCiD
- Children’s Hospital of Orange County (CHOC), Orange, CA, USA
- Anthony Chang
- Children’s Hospital of Orange County (CHOC), Orange, CA, USA
- William Feaster
- Children’s Hospital of Orange County (CHOC), Orange, CA, USA
- Sharief Taraman
- ORCiD
- Children’s Hospital of Orange County (CHOC), Orange, CA, USA
- Nadine Afari
- ORCiD
- Children’s Hospital of Orange County (CHOC), Orange, CA, USA
- Debra Beauregard
- Children’s Hospital of Orange County (CHOC), Orange, CA, USA
- Brent Dethlefs
- Children’s Hospital of Orange County (CHOC), Orange, CA, USA
- Tiffani Ghere
- Children’s Hospital of Orange County (CHOC), Orange, CA, USA
- Mustafa Kabeer
- Children’s Hospital of Orange County (CHOC), Orange, CA, USA
- George Tolomiczenko
- ORCiD
- Caltech, Pasadena, CA, USA
- Michael Billig
- Experien Group, San Diego, CA, USA
- Jon Brophy
- ORCiD
- Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA
- Kolaleh Eskandanian
- Children’s National Hospital, Washington, DC, USA
- Juan Espinoza
- ORCiD
- Children’s Hospital of Los Angeles, Los Angeles, CA, USA
- Sherry Farrugia
- Global Center for Medical Innovation, Atlanta, GA, USA
- Michael Harrison
- ORCiD
- University of California at San Francisco, San Francisco, CA, USA
- Christopher Horvat
- University of Pittsburgh, Pittsburgh, PA, USA
- Claudia Hoyen
- University Hospitals Rainbow Babies and Children’s Hospital, Cleveland, OH, USA
- Chester Koh
- Texas Children’s Hospital, Houston, TX, USA
- Allison Komiyama
- Acknowledge Regulatory Strategies, San Diego, CA, USA
- Krista Nelson
- ORCiD
- Children’s Mercy Hospital, Kansas City, MO, USA
- Omkar Kulkarni
- Children’s Hospital of Los Angeles, Los Angeles, CA, USA
- Robert Levy
- Children’s Hospital of Philadelphia, Philadelphia, PA, USA
- Kevin Maher
- Children’s Healthcare of Atlanta, Atlanta, GA, USA
- Michael O'Donnell
- University of California at San Francisco, San Francisco, CA, USA
- Todd Ponsky
- Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA
- Frances Richmond
- International Center for Regulatory Science, University of Southern California, Los Angeles, CA, USA
- Jessica Richter
- Experien Group, San Diego, CA, USA
- Shuvo Roy
- ORCiD
- University of California at San Francisco, San Francisco, CA, USA
- Shreim Samir
- Cactus Medical, Irvine, CA, USA
- Srinivasan Suresh
- University of Pittsburgh, Pittsburgh, PA, USA
- Charlette Stallworth
- Stanford Children’s Health, Lucile Packard Children’s Hospital, Palo Alto, CA, USA
- Usha Thekkedath
- ORCiD
- University of California at San Francisco, San Francisco, CA, USA
- Kara Toman
- Texas Children’s Hospital, Houston, TX, USA
- James Wall
- Stanford Children’s Health, Lucile Packard Children’s Hospital, Palo Alto, CA, USA
- Leanne West
- Children’s Healthcare of Atlanta, Atlanta, GA, USA
- Dawn Wolff
- Children’s Mercy Hospital, Kansas City, MO, USA
- DOI
- https://doi.org/10.1109/JTEHM.2021.3092559
- Journal volume & issue
-
Vol. 9
pp. 1 – 5
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
