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

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...

Full description

Bibliographic Details
Main Authors: Raffaele Formicola, Cinzia Amici, Maurizio Mor, Luciano Bissolotti, Alberto Borboni
Format: Article
Language:English
Published: MDPI AG 2023-01-01
Series:Designs
Subjects:
Online Access:https://www.mdpi.com/2411-9660/7/1/9
_version_ 1797621495210442752
author Raffaele Formicola
Cinzia Amici
Maurizio Mor
Luciano Bissolotti
Alberto Borboni
author_facet Raffaele Formicola
Cinzia Amici
Maurizio Mor
Luciano Bissolotti
Alberto Borboni
author_sort Raffaele Formicola
collection DOAJ
description 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.
first_indexed 2024-03-11T08:57:44Z
format Article
id doaj.art-36ca2287130c47619f2e8d7283f5f8f2
institution Directory Open Access Journal
issn 2411-9660
language English
last_indexed 2024-03-11T08:57:44Z
publishDate 2023-01-01
publisher MDPI AG
record_format Article
series Designs
spelling doaj.art-36ca2287130c47619f2e8d7283f5f8f22023-11-16T19:59:32ZengMDPI AGDesigns2411-96602023-01-0171910.3390/designs7010009Design of Medical Devices with Usability in Mind: A Theoretical Proposal and Experimental Case Study Using the LEPRE DeviceRaffaele Formicola0Cinzia Amici1Maurizio Mor2Luciano Bissolotti3Alberto Borboni4Department of Mechanical and Industrial Engineering, University of Brescia, Via Branze 38, 25123 Brescia, ItalyDepartment of Mechanical and Industrial Engineering, University of Brescia, Via Branze 38, 25123 Brescia, ItalyPolibrixia s.r.l., Via Branze 43, 25123 Brescia, ItalyDomus Salutis Rehabilitation Clinic, Teresa Camplani Foundation, Via Lazzaretto 3, 25123 Brescia, ItalyDepartment of Mechanical and Industrial Engineering, University of Brescia, Via Branze 38, 25123 Brescia, ItalyUsability 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.https://www.mdpi.com/2411-9660/7/1/9usabilitydesign processmedical devicerobotic rehabilitationnormative frameworkproduct development
spellingShingle Raffaele Formicola
Cinzia Amici
Maurizio Mor
Luciano Bissolotti
Alberto Borboni
Design of Medical Devices with Usability in Mind: A Theoretical Proposal and Experimental Case Study Using the LEPRE Device
Designs
usability
design process
medical device
robotic rehabilitation
normative framework
product development
title Design of Medical Devices with Usability in Mind: A Theoretical Proposal and Experimental Case Study Using the LEPRE Device
title_full Design of Medical Devices with Usability in Mind: A Theoretical Proposal and Experimental Case Study Using the LEPRE Device
title_fullStr Design of Medical Devices with Usability in Mind: A Theoretical Proposal and Experimental Case Study Using the LEPRE Device
title_full_unstemmed Design of Medical Devices with Usability in Mind: A Theoretical Proposal and Experimental Case Study Using the LEPRE Device
title_short Design of Medical Devices with Usability in Mind: A Theoretical Proposal and Experimental Case Study Using the LEPRE Device
title_sort design of medical devices with usability in mind a theoretical proposal and experimental case study using the lepre device
topic usability
design process
medical device
robotic rehabilitation
normative framework
product development
url https://www.mdpi.com/2411-9660/7/1/9
work_keys_str_mv AT raffaeleformicola designofmedicaldeviceswithusabilityinmindatheoreticalproposalandexperimentalcasestudyusingthelepredevice
AT cinziaamici designofmedicaldeviceswithusabilityinmindatheoreticalproposalandexperimentalcasestudyusingthelepredevice
AT mauriziomor designofmedicaldeviceswithusabilityinmindatheoreticalproposalandexperimentalcasestudyusingthelepredevice
AT lucianobissolotti designofmedicaldeviceswithusabilityinmindatheoreticalproposalandexperimentalcasestudyusingthelepredevice
AT albertoborboni designofmedicaldeviceswithusabilityinmindatheoreticalproposalandexperimentalcasestudyusingthelepredevice