DECODE to support the development of paediatric and orphan devices

Posted on: 03 October 2024

The EC-funded DeCODe (development of child and orphan devices) consortium, which Trinity College Dublin is a member of, aims to catalyse innovation and address the unique healthcare needs of people living with rare diseases (PLWRD), 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.  

Tom Melvin, Associate Professor of Medical Device Regulatory Affairs, School of Medicine, Trinity College Dublin, said:

“The DeCODe project is an important and timely initiative which aims to support orphan and paediatric device developers in navigating translational development of novel technologies for children and people living with rare diseases.”

There are very few medical devices 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 steps.

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

Moving forward

As a next step, DeCODE will select five developers for support via grant applications that are expected to launch 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. It is expected 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 European developer (a patient-led group, academic, or small to medium enterprise). Dr Tom Melvin, encourages applications, saying:

“If you are working on an innovative orphan or paediatric medical device, please consider an application for advice in the Spring of next year.”

For further information you can contact Tom Melvin .

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. This consortium is also linked to the US Alliance for Paediatric Device Innovation, an FDA-funded Pediatric Device Research Consortium, with whom it will collaborate throughout the project.

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