Children affected by cyanotic congenital heart disease (CCHD) often require lifelong monitoring due to the risk of sudden clinical deterioration and serious complications. However, continuous monitoring outside hospital settings remains challenging, creating a significant unmet medical need for patients, families and healthcare providers.
A new study published in the journal Frontiers in Medicine highlights how clinician expertise can help shape the development of innovative medical devices for children living with these rare and complex heart conditions. The research, conducted within the framework of the OrphaDev4Kids project, coordinated by EPTRI, gathered insights from healthcare professionals across Europe to guide the early development of a wearable multiparametric biosensor for children with CCHD.
The paper, 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,” explored the needs, expectations and concerns of healthcare professionals regarding the use of wearable monitoring technologies in children with CCHD.
The survey revealed strong clinical interest in non-invasive, multiparametric, and child-friendly wearable devices capable of continuously monitoring multiple physiological parameters through a non-invasive, child-friendly design. Experts emphasized that successful devices must provide meaningful and actionable information rather than overwhelming clinicians with large volumes of raw data.
Among the key priorities identified were:
- Early detection of clinical deterioration during high-risk periods;
- Comfortable and unobtrusive designs suitable for children;
- Easy integration into existing clinical workflows;
- Clear data visualisation and targeted alerts;
- Robust data governance and privacy protections.
The findings also highlighted the importance of involving clinicians early in the development process to ensure that future technologies address real-world clinical needs and can be successfully adopted in practice.
Funded under the EU4Health Programme (2021–2027), OrphaDev4Kids aims to accelerate the development of orphan and paediatric medical devices by providing access to expertise, regulatory guidance, technical support and innovation services. The project focuses on overcoming the unique scientific, regulatory and market challenges that often limit the availability of medical devices specifically designed for children with rare diseases.
The newly published study exemplifies the project’s patient-centred approach, generating evidence that will guide the development of technologies tailored to the needs of paediatric populations rather than adapting solutions originally designed for adults.