FULL PAPER IN BOOKS: How a human-centred design approach can speed up market acceptance of long-term ECG monitoring devices

Abstract: Cardiovascular diseases constitute a significant portion of preventable fatalities, underscoring the necessity for early detection and diagnosis to enhance quality of life and mitigate healthcare expenses. While conventional monitoring tools are typically confined to hospital environments, limiting continuous monitoring of high-risk individuals, ambulatory monitoring devices improve the yield of detected pathologies. However, few solutions allow comfortable long-term monitoring systems and still fewer combine event monitoring and real-time access to data, limiting the potential to detect critical and sporadic events like atrial fibrillation or tachycardia, potentially resulting in sudden fatalities. This paper presents the design of an ambulatory ECG monitoring system based on wearable technology, guided by Human Factors, User Experience, and Lean methodologies for expediting market deployment and ensuring acceptance by clinicians, patients, and markets, thereby reducing time and costs. The work described covers the initial phase of the development process, including conceptual designs, dummy prototypes, detailed designs, and prototype validation with participants. In European and US body shape databases, anthropometric research was conducted to comprehend population variability and determine device shapes and dimensions for signal accuracy and comfort optimisation.An iterative design approach was employed to streamline design and development, aligning with regulatory standards required by regulatory bodies such as MDR and FDA to facilitate defining and validating functionalities, risks, ease of use, comfort, privacy, and satisfaction.

Keywords: Human-centred design approach

DOI: 10.54941/ahfe1005631

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