OrphaDev4Kids 3rd General Assembly Highlights Progress in Advancing Paediatric Orphan Medical Devices
On 27- 28 July 2026, TEDDY Network, together with the other partners of the OrphaDev4Kids project gathered at the Children’s Memorial Health Institute in Warsaw, Poland, one of the project consortium partners, for the 3rd General Assembly. The meeting brought together consortium members to review the progress achieved across the project, discuss ongoing activities, and define the next steps for the implementation of the project objectives.
OrphaDev4Kids project (EU4H-2023-PJ, Grant Agreement No. 101161377), is a European Union co-funded initiative running from 2024 to 2027 and coordinated by the European Paediatric Transnational Research Infrastructure (EPTRI). The project aims to address critical unmet needs in the field of orphan medical devices for paediatric patients through multidisciplinary research and innovation across Europe. Throughout the General Assembly, each Work Package leaders and involved partners presented achievements, current activities, and future plans, highlighting the collaborative efforts driving the project forward. Users from the paediatric community supported through the project also presented their innovative medical devices, with experts from the Clinical Expert Committee contributing their expertise and support. In addition, a representative of the EU-funded DeCODe project participated in the meeting and shared lessons learned from the project.
Within this framework, TEDDY Network aims to implement a complex innovation ecosystem in the orphan and paediatric Medical Devices. TEDDY Network is actively participating by engaging in ethical and legal activities and being responsible for creating a dedicated paediatric Patient Experts Committee (PEC) to support the definition of the therapeutic needs related to the project’s case studies. Learn more about the PEC and its activities within OrphaDev4Kids [here].
During the General Assembly, the progress of Work Package 3 (WP3), Case Study 1: “Wearable multiplexed biosensor for cyanotic congenital heart diseases” was presented, including the contribution of the Paediatric Experts Committee (PEC) to the patient survey developed for Cyanotic Congenital Heart Disease. The survey was reviewed by the PEC during its kick-off meeting in Bologna, Italy, 2025, providing valuable feedback to ensure that the questions reflected the perspectives and priorities of children and young people across different countries and languages, including countries beyond those represented by the OrphaDev4Kids consortium partners. Read the survey here.
The meeting also highlighted the valuable contribution of POLPEDNET KIDS Warsaw to WP4, Case Study 2: “Medical Device for Non-Invasive Cardiac Assessment in Patients with Tetralogy of Fallot” which is one of the YPAGs included in TEDDY KIDS Network and the PEC.
The group supported the review and adaptation of the clinical protocol and study documentation for children, helping to ensure that the research materials are age-appropriate, easy to understand, and better aligned with the needs of paediatric participants.
The 3rd General Assembly reaffirmed the consortium’s commitment to advancing innovation in orphan medical devices through multidisciplinary collaboration and meaningful patient involvement. TEDDY Network remains dedicated to ensuring that the voices of children and families continue to shape the development of medical devices that address the specific needs of paediatric patients with rare diseases.