American, European Medtech Specialists Partner on Pediatric Device Development

Pediatric device innovation is receiving a boost from medtech developers on two continents.

The Alliance for Pediatric Device Innovation (APDI)—a consortium funded by the U.S. Food and Drug Administration (FDA) and led by Children’s National Hospital—is partnering with DeCODe, a new European Commission-funded device consortium, to advance medical technologies that benefit children. DeCODe was formed to catalyze innovation and address the unique healthcare needs of children with rare diseases. 

DeCODe is a collaboration of clinicians, researchers, industry experts and regulatory authorities who are developing safe, effective pediatric and orphan medical devices. Kolaleh Eskandanian, Ph.D., vice president and chief innovation officer at Children’s National and APDI principal investigator and program director, is the advisor and U.S. partner to DeCODe.

“Partnering with DeCODe represents a crucial step toward addressing the unmet medical needs of children, particularly those with rare diseases,” Dr. Eskandanian said. “By leveraging the expertise and resources from both sides of the Atlantic, DeCODe will lead the way to develop a framework to accelerate the development of safe and effective pediatric medical devices. Our collaboration highlights the importance of global partnerships to ensure that children, regardless of where they live, can access medical technologies designed specifically for them.” 

On behalf of APDI, Dr. Eskandanian will provide advisory support to DeCODe by sharing best practices and lessons learned from more than 11 years of leading a similar program in the United States. Her extensive experience, reflected in the first 10 years as principal investigator of the FDA-funded consortium, includes supporting authorization through the registration, clearance, and approval of more than 20 medical devices in the United States and European Union. She has facilitated successful exits for eight portfolio companies through acquisition and helped all portfolio companies secure more than $500 million in follow-on funding. 

“We are eager to leverage this expertise to help DeCODe run a successful and impactful program for pediatric medical device innovation in the European Union,” Dr. Eskandanian stated. 

Few medical devices specifically developed for children with rare diseases are currently available, although some existing devices provide essential functions for rare disease patients, their caregivers, and healthcare professionals. Many patients and caregivers express a substantial unmet need for new pediatric devices for rare conditions. 

DeCODe will use a two-step methodology to support pediatric and orphan device development. The process begins with mapping pediatric and orphan stakeholders and initiatives, and developing a critical pathway analysis to optimize novel pediatric and orphan medical technologies.

As a second step, DeCODe will select five developers for support through grant applications, with an anticipated launch in March 2025. For each developer, the program will track supported pediatric and orphan devices, the number of prototypes developed, the business plans created, the number of clinical data collections launched, and certificates obtained throughout the support process. The DeCODe initiative is expected to lead to the approval and implementation of up to five new medical devices for rare diseases. 

The DeCODe platform will be available for any European medical device developer. Applications for the DeCODe grant program will be accepted in spring 2025. 

Children’s National Hospital, based in Washington, D.C., was established in 1870. It currently is one of the top 10 children’s hospitals in the nation and ranked in all specialties evaluated by U.S. News & World Report. The Children’s National Research & Innovation Campus opened in 2021, a first-of-its-kind pediatric hub dedicated to developing new and better ways to care for kids. Children’s National has been designated three consecutive times as a Magnet  hospital, demonstrating the highest standards of nursing and patient care delivery. Children’s National is home to the Children’s National Research Institute and Sheikh Zayed Institute for Pediatric Surgical Innovation.

DeCODe is financed by the European Commission’s EU4Health program. The University of Twente will coordinate this project, led by Dr. Anneliene Jonker, an assistant professor in the health technologies and services department. Her work focuses on the interface of rare disease therapy development and policy development. This consortium is also linked to the U.S. Alliance for Pediatric Device Innovation, an FDA-funded Pediatric Device Research Consortium, with whom it will collaborate throughout the project.