A new scientific publication has been published in the journal Frontiers in Medicine, contributing to the advancement of innovation in orphan medical devices for paediatric populations.

The article, titled “Clinical perspectives on wearable devices for pediatric cyanotic congenital heart disease: an expert survey to inform the early development of a multiparametric wearable biosensor”, presents the results of an expert consultation aimed at informing the early development of an innovative wearable biosensor for children affected by cyanotic congenital heart disease (CCHD).

Developed within the framework of the OrphaDev4Kids (EU4H-2023-PJ) project, co-funded by the European Union, the survey was carried out as part of Work Package 3 (WP3) activities. Using a structured anonymous questionnaire, the study gathered perspectives from paediatric cardiology experts across Europe to identify unmet clinical needs, expectations, and practical requirements for the adoption of wearable monitoring technologies in paediatric care. Experts highlighted the need for child-friendly, non-invasive, and multiparametric wearable devices capable of supporting early detection of clinical deterioration, particularly during infancy and high-risk phases of care.

The publication also underlines the importance of integrating technological innovation with usability, clinical workflow integration, training, and robust data governance to ensure future implementation in real-world healthcare settings.

The Fondazione per la Ricerca Farmacologica Gianni Benzi-ETS contributed to this work as a partner of the OrphaDev4Kids consortium and co-author of the publication, supporting the ethical and regulatory aspects of the study and contributing to the development, methodological review, and refinement of the expert survey.

The publication is available here