Front Med (Lausanne). 2026 May 19;13:1819360. doi: 10.3389/fmed.2026.1819360. eCollection 2026.
ABSTRACT
INTRODUCTION: Pediatric medical device development remains limited, particularly for rare and complex conditions such as cyanotic congenital heart disease (CCHD). Although advances in surgery and diagnostics have improved survival, continuous and non-invasive monitoring of metabolic and physiological deterioration is not available outside hospital settings. Wearable devices could address this gap, but their clinical adoption requires alignment with real-world needs, usability, and healthcare workflows. This study aimed to capture clinician perspectives to inform the early development of a wearable multiparametric biosensor for pediatric CCHD within the European OrphaDev4Kids project (EU4H-2023-PJ).
METHODS: A structured, web-based anonymous survey was distributed through EPTRI channels to reach pediatric cardiology experts across Europe, including members of the OrphaDev4Kids Clinical Expert Committee. The questionnaire addressed current monitoring practices in CCHD, unmet clinical needs, usability and compliance, data integration, training requirements, and data governance. Quantitative responses were analyzed using descriptive statistics, and qualitative feedback was descriptively reviewed.
RESULTS: Clinicians reported that current CCHD monitoring relies mainly on imaging and basic physiological parameters, with minimal assessment of metabolic markers and no availability of non-invasive metabolic monitoring. Infancy, both before and after heart surgery, was identified as the most critical phase for remote monitoring. Respondents strongly supported non-invasive, multiparametric wearable devices providing threshold-based alerts and longitudinal summaries rather than continuous data streams. Comfort, intuitive design, and minimal disruption to daily activities were key determinants of patient compliance, while integration with clinical workflows, training, and technical support were essential for adoption. Clinicians also emphasized the importance of secure, regulation-compliant data handling. Despite limited familiarity with advanced wearable devices, clear and consistent expectations regarding functionality and usability emerged.
CONCLUSION: This expert consultation identifies a clear unmet need and strong clinical support for the development of wearable, multiparametric biosensors tailored to pediatric patients with CCHD. The findings provide actionable guidance for device design and highlight the importance of combining technological innovation with human-centered design, workflow integration, and robust data governance to enable future clinical adoption.
PMID:42239944 | PMC:PMC13226199 | DOI:10.3389/fmed.2026.1819360
