OrphaDev4Kids
The OrphaDev4Kids (EU4H-2023-PJ, N°101161377) 2024/2027 is a European Union (EU) co-funded, three-year project aiming to address the issue of orphan Medical Devices (MDs) intended for use in the paediatric population.
TEDDY Network aims to implement a complex innovation ecosystem in the orphan and paediatric MDs. TEDDY Network is actively participating by engaging in ethical and legal activities and being responsible for creating a dedicated Paediatric Experts Committee (PEC) to support the definition of the therapeutic needs related to the project’s case studies.
The PEC plays a central role in ensuring that the voices and needs of paediatric patients are integrated into the development and evaluation of medical devices through different activities, including:
- Providing Feedback from PEC Perspective
- Identifying Unmet Need
- Shaping Research and Development Plans
- Promoting Patient-Centred Approaches
- Collaborating with Researchers and Developers
Kick-off Meeting - 19 July 2024, Italy
On 19 July 2024, the OrphaDev4Kids project held its Kick-Off Meeting at the Hotel Excelsior in Bari, Italy, marking the official launch of a European initiative dedicated to developing orphan medical devices for paediatric patients.
The TEDDY Network presented its approach to building the PEC, a group that will give children and young people a direct voice in the development of medical devices designed for them. The PEC will be composed of representatives from Young Person Advisory Groups (YPAGs) across Europe, working together to ensure that the perspectives of children and families shape research from its earliest stages.
At this founding stage, TEDDY Network outlined three core commitments to the project: supporting the identification of unmet needs in paediatric medical devices, providing ethical and social feedback on each of the project’s three case studies, and co-developing age-appropriate materials alongside the young members of the PEC.
As a first concrete step, TEDDY Network announced the preparation of a survey addressed to all stakeholders, healthcare professionals, patients, families, and researchers to systematically uncover the real-world needs of children living with rare and complex conditions.
The presesntation is available here.
General Assembly, 6 November 2024, Online
On 6 November 2024, during the OrphaDev4Kids project’s General Assembly held online, TEDDY Network presented the list of candidates for the PEC, comprising representatives from KIDS Albania, KIDS Bari, KIDS Kosova, KIDS Rare Hellas, POLPEDNET KIDS Warsaw. The proposed candidates were officially appointed, confirming the committee’s central role in ensuring that the perspectives of children and young people guided the development of orphan medical devices.
The presentation is available here.
Kick-off Meeting of the Patients Experts’ Committee (PEC), 15 March 2025, Italy
On 15 March 2025, the kick-off meeting of the PEC of the OrphaDev4Kids project was held in the Poeti Hall of Hercolani Palace at the University of Bologna.
The event was organised in a hybrid format, enabling active participation both in person and online, and fostering open dialogue among children, families, researchers, and healthcare experts on the development of orphan medical devices (MDs) for the paediatric population.
The TEDDY Network established the PEC, comprising representatives from ANDO Portugal, KIDS Albania, KIDS Bari, KIDS Umbria, KIDS Kosova, KIDS Rare Hellas, POLPEDNET KIDS Warsaw.
During the meeting, the PEC provided valuable feedback by reviewing a survey designed for patients with Cyanotic Congenital Heart Disease, developed as part of Work Package 3 (WP3) of the OrphaDev4Kids project.
WP3 aims to design a wearable multiplex biosensor to:
- Prevent lactic acidosis in children with unrepaired congenital heart defects
- Monitor and evaluate physiological responses to pulmonary valve replacement in children with repaired congenital heart defects
The objective of the survey review was to ensure that, from the earliest stage of question design, the survey reflected the perspectives and priorities of patients and young people.
More broadly, the purpose of the kick-off meeting was to create a collaborative space for the exchange of ideas between young patients and project stakeholders, with the aim of developing more effective and patient-centred medical devices.
This collaboration was essential to strengthen young patients’ health rights and to help ensure that future medical technologies are genuinely designed around their needs.
| Speakers | Presentation |
| Emilia Biffi | Towards the Development of Paediatric Medical Devices: Identifying and Gathering User Needs |
| Roberta Nossa | Survey for patients on Cyanotic Congenital Heart Disease (CCHD) |
| YPAGs | Presentations |
| KIDS Bari | Who are we? |
| POLPEDNET KIDS Warsaw | Building the POLPEDNET KIDS Warsaw |
| KIDS Albania | KIDS Albania |
General Assembly, 5 June 2025, Austria
The second General Assembly was held on 5 June 2025 at the Medical University of Graz, Austria. The meeting underscored the importance of engaging young patients within the OrphaDev4Kids project, bringing together consortium members and clinical experts to directly appreciate the value of their perspectives in shaping research and innovation activities.
Coordinated by TEDDY Network, the PEC comprises 17 members representing seven YPAGs. This diverse body plays a critical role in the project by identifying unmet clinical needs, providing input on device design and usability, and ensuring that the lived experiences of young patients are systematically integrated throughout the innovation process.
The presesntation is available here.