Abstract
Background/Objectives: Preterm and critically ill neonates in neonatal intensive care units (NICUs) require multiple medical devices, including incubators, radiant warmers, phototherapy systems, and patient monitors. The coexistence of standalone devices without interoperability increases cognitive and operational burdens for healthcare providers and leads to spatial inefficiency. This study aimed to develop and evaluate a multi-functional neonatal incubator integrating these core functions into a single platform, using user-centered design (UCD) and usability engineering principles. Methods: By synthesizing and analyzing international standards (ISO 13485, IEC 62366-1, IEC 62366-2, and ISO 9241-210), a four-phase design process was established. Following the development of the monitoring system, the design was iteratively refined and validated through repeated formative usability evaluations. A summative usability evaluation was then conducted with 20 NICU clinicians in a simulated NICU environment, using 13 scenarios comprising 39 tasks. Outcome measures included task success rate, the After-Scenario Questionnaire (ASQ), the NASA Task Load Index (NASA-TLX), and the System Usability Scale (SUS). Results: The overall task success rate was 95.64%. When analyzed by function, success rates were 94.63% for incubator-related tasks, 98.33% for patient monitoring, 96.67% for radiant warmer tasks, and 98.33% for phototherapy tasks. The mean SUS score was 78.63, exceeding the benchmark score of 68 that indicates good usability. In addition, no statistically significant differences were observed in workload (NASA-TLX) or usability (SUS) scores according to clinical role or length of clinical experience. Conclusions: The multi-functional neonatal incubator developed in this study demonstrated high usability despite the integration of multiple medical device functions. The findings suggest that this integrated system has the potential to enhance clinical workflow efficiency, optimize spatial utilization, and improve patient safety in NICU settings.