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

Abstract

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 followup 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.

Paediatric heart transplantation: life-saving but not yet a cure

“…The Federal Drug Administration's Real-World Evidence programme provides a new path to their clearance/approval for device trials in children. The Real-World Evidence programme has demonstrated how existing healthcare systems can collect, store, and curate data that can be utilised 42 bypassing traditional randomised controlled trials, which are costly and pose challenges for complete data collection. Philanthropic organisations such as Enduring Hearts, often in collaboration with dedicated professional societies, such as the Pediatric Heart Transplant Study Group, International Society of Heart Lung Transplantation, and the American Heart Association, are providing important research funding for paediatric heart transplant recipients.…”

What to Do When Your Preferred Right Atrial Venovenous Cannula for Neonates Is Pulled From the Market: Choosing Between Scylla (Bicaval Venovenous) and Charybdis (Venoarterial)*

“…Other studies such as another report using a computational study of fluid dynamics showing that the Avalon performed better than the OriGen catheter, with lower recirculation fraction than the OriGen catheter also found that further optimization of the Avalon catheter could be achieved (15). In the case of small populations, there is a need for decreasing barriers and increasing financial and nonfinancial incentives for more active device innovation based on such reports and studies (16). The Cresent cannula, a new bicaval-right atrial catheter for V-V ECMO, was recently introduced, and initial reports in adults have been favorable but experience in neonates have not been published (17).…”