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.
Highlights
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
ON August 5, 2020, a group of innovators, engineers, and clinicians met to discuss challenges and opportunities for the development of new devices for pediatric health and the importance of creating a regulatory environment that encourages the development of such devices
Some pediatric medical devices are designed for children, while others are derived from products designed for adults
Summary
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 August 5, 2020, a group of innovators, engineers, and clinicians met to discuss challenges and opportunities for the development of new devices for pediatric health and the importance of creating a regulatory environment that encourages the development of such devices. The challenges associated with designing medical devices for use in pediatric patients include smaller body size and higher activity level compared with adults, changes in body structures and functions throughout childhood, and the fact that pediatric devices may be used over the long term, necessitating additional research on device longevity and long-term exposure to implanted materials [1]
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