Design of Medical Devices with Usability in Mind: A Theoretical Proposal and Experimental Case Study Using the LEPRE Device

Abstract

Usability is a critical product feature and is required for widespread market adoption. Standards on usability are highly focused on evaluation procedures and specific aspects, such as software issues or human–machine interaction, whereas the relative scientific literature is very normative oriented. The few methodological works dealing with usability either consider it as one of the many attributes that a particular project must satisfy or present very general methods. No design methods systematically oriented toward the integration of usability and usability-related constraints have been developed to date. This paper presents a usability-oriented model for the design of medical devices and its application to the design of LEPRE, a medical device for upper- and lower-limb robotic rehabilitation. Two methods were used to assess the device’s usability: interviews with experts to outline qualitative evaluations and System Usability Scale (SUS) questionnaires on eight physiotherapists, two physiatrists, and 12 patients, enabling a quantitative assessment. Results support the intention of providing an integrated methodological approach to be applied from the early stages of the project, thus saving time and costs, leading to a more linear product development for this application.

Application of Social Robots in Healthcare: Review on Characteristics, Requirements, Technical Solutions

“…Identifying the user is not so easy, so it is more reasonably proposed to put the disease at the center of the therapeutic experience, in which all these individuals participate according to their specific roles. More generally, a usability-based design approach has recently been proposed for the healthcare environment [ 196 ], but this needs to be reworked to meet the social aspect of the robot we are focusing on. Usability and sociality must be held together precisely by placing disease at the center of the design.…”

Holistic Human-Serving Digitization of Health Care Needs Integrated Automated System-Level Assessment Tools

“…The quality of output and accuracy of many DHTs are highly dependent on the correct use of the device. SaMD developers must carry out extensive HF research to minimize the amount of training or help required when using DHTs [ 23 , 24 ]. Once the tool is on the market, developers typically conduct internal automated testing before releasing new versions.…”

Soft, Rigid, and Hybrid Robotic Exoskeletons for Hand Rehabilitation: Roadmap with Impairment-Oriented Rationale for Devices Design and Selection

“…The second component (I) defines the intervention (e.g., physical therapy, pharmacological treatment) under consideration for the specific population, whereas the third element (C) focuses on the comparison between the proposed intervention and possible alternatives (e.g., from placebo to surgery). Both of these aspects can offer interesting insights for the researcher: the analysis of the intervention can, for instance, highlight additional unexpected but relevant requirements for the design of new devices [19]. The comparison with competitors can instead provide precious hints for the development of a device, for example in the demonstration of equivalence, which represents a mandatory step of the clinical evaluation of a medical device for marketing in European countries [20].…”