From Concept to Context: Evaluating Medical Device Usability Where It Matters Most

Abstract

The usability validation process of medical devices outside controlled environments such as test facilities, laboratories, or by expert groups is vital to scrutinising the viability of the developed solution. This work outlines a case study in which the Spanish emergency service 061-Andalucia took part in the validation process of a non-contact vital sign measuring device through image processing, describing the methodology, participant sample, data analysis and conclusions. The measured vital signs were heart rate, respiratory rate, oxygen saturation, temperature, and blood pressure contactless at 2 meters (6.5 ft). In the study, three emergency service teams from three different operation bases in Malaga (Spain) underwent the validation process under semi-real conditions. Each team was provided with one measurement device used during the work shift on patients who were not in a critical stage, conscious and willing to participate in the study after being informed and signing a consent form. The primary goals of the validation were to analyse the ease of the process, reliability, and robustness of the measurements against the standard measurement equipment of the emergency service in different scenarios, as well as detect errors and limitations under semi-real conditions of use. Besides providing evidence of a potential improvement in the service through this new camera system, the satisfaction of the users/ patient and reducing equipment weight. Under these harsh conditions, the measurement device with a technical readiness level 7 reached reliability and robustness between 70% and 100%, depending on the measured vital signs and a high acceptance among the professionals of 66,66%.

Keywords: Project Management, Human Factors, User Experience, Formative Evaluation

DOI: 10.54941/ahfe1005065