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Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint

Terence Sanger1,2, Anthony Chang1, William Feaster1

  • 1Children's Hospital of Orange County (CHOC)OrangeCA92868USA.

IEEE Journal of Translational Engineering in Health and Medicine
|July 30, 2021
PubMed

Insights

Pediatric device development needs regulatory pathway revisions to encourage investment. Strategies focus on removing barriers and increasing incentives for pediatric medical device innovation.

Area of Science:

  • Biomedical Engineering
  • Regulatory Science
  • Pediatric Healthcare

Background:

  • The development of medical devices for pediatric populations faces unique challenges.
  • Current regulatory pathways may not adequately incentivize pediatric device innovation.
  • Stakeholder input is crucial for improving the pediatric medical device ecosystem.

Purpose of the Study:

  • To gather insights from pediatric stakeholders regarding regulatory pathways for pediatric healthcare devices.
  • To identify challenges and opportunities in developing new medical devices for children.
  • To propose revisions to the United States regulatory framework for pediatric devices.

Main Methods:

  • Convened a group of innovators, engineers, professors, and clinicians on August 5, 2020.
  • Held a follow-up meeting with regulatory experts on January 6, 2021.
  • Discussed challenges, opportunities, and strategies for pediatric device development.

Main Results:

  • A key issue identified is the need to shift the return-on-investment (ROI) balance to favor pediatric devices over adult devices.
  • Current investment in pediatric medical devices is insufficient.
  • Decision-makers need compelling opportunities to invest in pediatric innovations.

Conclusions:

  • Proposed strategies aim to remove barriers and increase incentives for pediatric device innovation.
  • Revising regulatory pathways is essential for accelerating the development of pediatric healthcare devices.
  • Collaborative efforts between innovators, clinicians, and regulatory experts are vital for progress.
Abstract

Keywords:
DeviceFDAguidelinespediatricregulatory

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