Develop Child and Orphan Device Evaluation Support

The Challenge

Developing medical devices for paediatric and orphan conditions comes with major hurdles—limited dedicated support for developers, fragmented regulatory pathways, and restricted access to high-quality scientific data. These challenges slow down innovation and leave vulnerable patient groups without the medical solutions they need.

Project Overview

DeCODe is a collaborative initiative designed to bridge these gaps. By bringing together clinicians, researchers, industry experts, and regulatory authorities, the project will provide expert guidance, scientific insights, and structured support for developers. A key outcome of DeCODe will be a platform that maps key stakeholders, highlights existing initiatives, and delivers a critical pathway analysis to streamline the development of paediatric and orphan medical devices.

Objectives

• Provide expert support to medical device developers.
• Generate high-quality scientific insights to guide development.
• Strengthen collaboration between key stakeholders.
• Launch targeted funding calls to accelerate innovation.
• Develop a critical pathway analysis for device development.
• Offer technical and regulatory guidance tailored to paediatric needs.

EIT Health’s Role

EIT Health Belgium-Netherlands plays a key role in bringing together a network of stakeholders across Europe, ensuring a broad and inclusive perspective in the project. We engage experts from research, healthcare, patient organisations, and industry to contribute their insights and expertise. Additionally, we support the practical implementation of DeCODe’s findings by working directly with medical device developers to test and refine the project’s critical strategies. Through this, we help create an environment where innovation can thrive and life-changing medical devices can reach patients faster.

Project Partners

The DeCODe consortium includes:

• University of Twente (Netherlands)
• Trinity College Dublin (Ireland)
• InSilicoTrials (Italy)
• EIT Health Belgium-Netherlands (Belgium/Netherlands)
• eUROGEN / Radboud UMC (Netherlands)
• MetabERN / Azienda Sanitaria Universitaria Friuli Centrale (Italy)
• Connect4Children (Netherlands)
• Ludwig-Maximilians-Universität München (Germany)
• KU Leuven (Belgium)

Contact Information
For more information, contact Akvile Zalatoryte or visit DeCODE website

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