Bridging gaps in pediatric device development: The power of ACTION – a collaborative learning network

Abstract

Progress in the field of pediatric ventricular assist devices (VAD) have revolutionized the care and management of young patients with end-stage heart failure. However, innovation in pediatric medical devices is limited by financial and regulatory barriers due to the small and heterogenous target population. The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) was established in 2017 as a learning network to improve outcomes of pediatric patients supported on VAD. Here we describe how intentional design of the ACTION registry has mitigated regulatory and financial barriers to pediatric VAD innovation through the use of real-world evidence gathered through a learning network.