Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the many challenges with developing devices for children and infants.
Published Jan. 2, 2025 - Elise Reuter, Reporter
A collaboration between a children’s hospital and the Food and Drug Administration aims to address challenges in developing medical devices for children and infants.
Children’s National Hospital in Washington, D.C., struck a five-year research collaboration with the FDA’s Office of Science and Engineering Laboratories (OSEL) to build regulatory science tools to help evaluate pediatric devices.
The partners will use de-identified clinical data, multimodal imaging and machine learning to develop open-source tools that can be used to design and test devices more efficiently.
Currently, few high-risk devices are labeled for pediatric use, leading to devices being used off-label in younger patients or limited treatment options.
Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, hopes the partnership will help pediatric devices come to market faster and contribute to their safety and efficacy.
MedTech Dive spoke with Eskandanian about the challenges of bringing pediatric devices to market and the partnership’s initial focus.
This interview has been edited for length and clarity.
MEDTECH DIVE: Why did you embark on this partnership with the FDA?
KOLALEH ESKANDANIAN: It boils down to the fact that innovation in pediatric medical devices lags behind that of adults by at least 10 years.
The pediatric market is small, and there are simply not enough incentives for the industry and innovators of medical devices to focus on the pediatric market. We don’t see enough devices specifically evaluated in children and labeled for the pediatric population.
Part of the challenge is that when we conduct studies, we have to work with very limited datasets.
What incentives are pediatric device developers missing?
Drug developers are asked by the FDA whether their drug was also tested in the pediatric population, but the equivalent of that does not exist for medical devices.
The type of incentives that have been made available for drugs and biologics developers have contributed a lot to reducing off-label use. In devices, we don’t have those types of incentives, and therefore the off-label use of devices has become so widespread that often we don’t even think about it.
Often clinicians have no choice but to use the device off-label, but that’s not ideal in terms of safety, because if there is an adverse event, they are not obligated to report that.
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