DeCODe Project Kick-off: Advancing Paediatric and Orphan Medical Devices

The European Commission co-funded DeCODe consortium, which EIT Health Belgium-Netherlands is partner of, aims to catalyse innovation and address the unique healthcare needs of people living with a rare disease, specifically children. This collaborative group, comprising clinicians, researchers, industry experts, and regulatory authorities, will develop a platform for developing safe and effective paediatric and orphan medical devices.

There are very few medical devices that are specifically developed for rare diseases and children, so-called paediatric and orphan devices. Many orphan devices provide essential functions for patients with rare diseases, their carers, and the healthcare professionals using them. At the same time, many patients and carers express a substantial unmet need for new paediatric devices for their conditions. As such, this initiative will support the development of paediatric and orphan devices via two different steps.

The platform’s methodology encompasses a multifaceted approach, beginning with mapping paediatric and orphan stakeholders and initiatives and developing a critical pathway analysis for the optimal way of developing novel paediatric and orphan medical technologies.

As a next step, DeCODe will select five developers for support via grant applications that are expected to be launched in March 2025. For each of the successful developers, it will keep track of the paediatric orphan devices that are supported, the number of prototypes that each developer has developed; the business plans that are drafted, the number of clinical data collections that have been launched, and certificates that have been obtained throughout the support process. The consortium expects that 3-5 new medical devices will be approved and implemented in rare disease care, due to this exciting new initiative.

The DeCODe platform will be available for any kind of developer (a patient-led group, academic, or small-and-medium enterprise) located in Europe.

So, if you have any great ideas for a new medical device for paediatric and orphan medical devices, please consider an application in the Spring of next year and visit the DeCODe website when it is launched.