WASHINGTON (Oct. 10, 2024) -- To support the global need for innovation in pediatric medical device development, 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 that creates a platform for developing safe and effective pediatric and orphan medical devices. Kolaleh Eskandanian, Ph.D., M.B.A., vice president and chief innovation officer at Children’s National and APDI principal investigator and program director, is serving as the advisor and U.S. partner to DeCODe. She participated in the program launch on Sept. 9-10 in Brussels.
“Partnering with DeCODe represents a crucial step toward addressing the unmet medical needs of children, particularly those with rare diseases. By leveraging the expertise and resources from both sides of the Atlantic, DeCODe will lead the way to develop a robust 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 innovative 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 over 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 the authorization in the form of registration, clearance and approval of more than 20 medical devices in the U.S. and European Union. She has facilitated successful exits for eight portfolio companies via 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 said.
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 the development of pediatric and orphan devices. The process begins with mapping pediatric and orphan stakeholders and initiatives, 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, whether a patient-led group, academic or small-to-medium enterprise. Applications for the DeCODe grant program will be accepted in spring 2025.
Media contacts: Jhanae Kelley | jhanae@carbonaragroup.com | 713.524.8170 x111
Cherri Carbonara | cherri@carbonaragroup.com | 713.524.8170 x114
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About Children’s National Hospital
Children’s National Hospital, based in Washington, D.C., was established in 1870 to help every child grow up stronger. Today, it is one of the top 10 children’s hospitals in the nation and ranked in all specialties evaluated by U.S. News & World Report. Children’s National is transforming pediatric medicine for all children. 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 times in a row as a Magnet® hospital, demonstrating the highest standards of nursing and patient care delivery. This pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty care locations in the D.C. metropolitan area, including Maryland and Virginia. Children’s National is home to the Children’s National Research Institute and Sheikh Zayed Institute for Pediatric Surgical Innovation. It is recognized for its expertise and innovation in pediatric care and as a strong voice for children through advocacy at the local, regional and national levels. As a nonprofit, Children's National relies on generous donors to help ensure that every child receives the care they need.
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About DeCODe
DeCODe is financed by the European Commission’s EU4Health programme (Grant Agreement ID: 101160939). The University of Twente will coordinate this project, which is focused on supporting the development of orphan devices.
The researcher involved at the University of Twente is Dr Anneliene Jonker. Dr Jonker is an assistant professor in the health technologies and services department (Faculty of BMS). Her work focuses on the interface of rare disease therapy development and policy development.
This consortium is also linked to the US Alliance for Pediatric Device Innovation, an FDA-funded Pediatric Device Research Consortium, with whom it will collaborate throughout the project.