OrphaDev4Kids

The OrphaDev4kids initiative focuses on improving the development of orphan medical devices (MDs) for paediatric use. Developing these devices is challenging because children have unique physical and medical needs that require devices specifically tailored to them. However, few medical devices are designed with children in mind, and most are adapted from adult versions.
This project aims to provide specialised services to help bring these paediatric devices to the European market. The areas covered include device design, quality control, non-clinical and clinical studies, and regulatory guidance. Additionally, the initiative provides tools to connect innovators with manufacturers and funding. Specialised support will be tailored to three specific paediatric case studies, each representing different needs and developmental stages.
In summary, OrphaDev4kids aims to address critical gaps in paediatric healthcare by making specialised, child-specific medical devices more accessible and ensuring they meet the highest standards.

ROLE OF THE FOUNDATION

The Foundation leads the ethical and regulatory activities of the project. Through this key role, the Foundationis responsible for:
- Monitor the ethical and regulatory compliance of both the project activities and the services provided by the project, including for example authorisations, ethics approvals, informed consent/assent, GDPR compliance.
- Address any issues regarding ethics and regulatory compliance that may arise during the project.
- Provide ethical and regulatory advice and document preparation for clinical studies to test the paediatric MDs developed under the project.
- Inform and update the interested stakeholders about relevant ethics and regulatory documents on orphan and paediatric MDs at national, European and international level.
Moreover, the Foundation coordinates a matching service allowing the connection between relevant players (e.g. academia, scientific societies, users) with orphan device ideas to potential manufacturers (SMEs and companies). With this aim, the Foundation maintains a ‘Research Inventory’, consisting of the following instruments:
- Repository of projects and needs submitted by researchers
- Funds and Opportunities database
- Regulatory database

FUNDED BY: This Project has received funding from the European Union’s Horizon Europe Framework Programme under grant agreement No 101161377.