비침습적 호흡 케톤 측정기의 사용적합성 평가 : 시나리오 기반 오류 분석과 휴리스틱 접근

Abstract

This study aims to evaluate the formative usability of a breath-based ketone measurement device to verify its performance and user interface (UI) effectiveness, and to identify areas for improvement. Based on international standards IEC 62366 and ISO 14971, usage scenarios were developed during the prototype phase, and formative eval- uation was conducted with five intended users in a simulated use environment. A combined evaluation framework was applied, incorporating Zhang’s heuristic principles for medical devices and mHIMSS principles for mobile usabil- ity. For high-risk tasks, both quantitative (5-point Likert scale) and qualitative (open-ended responses) data were col- lected. The results showed that while participants expressed high satisfaction with the product’s non-invasive ketone measurement and mobile app integration, multiple usability issues were observed during breath initiation, ketone value confirmation, and measurement history retrieval. These stages also received lower heuristic scores. Key areas for improvement included insufficient feedback, inconsistent use of user language, and visual information overload. This study presents a practical case of applying international standards to a product not yet clearly categorized under domestic medical device regulations, and it may serve as foundational data for product refinement and future reg- ulatory approval processes.