Background A successful innovative medical device is not only technically challenging to develop but must also be readily usable to be integrated into health care professionals’ daily practice. Through a user-centered design (UCD) approach, usability can be improved. However, this type of approach is not widely implemented from the early stages of medical device development. Objective The case study presented here shows how UCD may be applied at the very early stage of the design of a disruptive medical device used in a complex hospital environment, while no functional device is available yet. The device under study is a connected sensor system to detect colorectal anastomotic leakage, the most detrimental complication following colorectal surgery, which has a high medical cost. We also aimed to provide usability guidelines for the initial design of other innovative medical devices. Methods UCD was implemented by actively involving health care professionals and all the industrial partners of the project. The methodology was conducted in 2 European hospitals: Grenoble-Alpes University Hospital (France) and Erasmus Medical Center Rotterdam (the Netherlands). A total of 6 elective colorectal procedures and 5 ward shifts were observed. In total, 4 workshops were conducted with project partners and clinicians. A formative evaluation was performed based on 5 usability tests using nonfunctional prototype systems. The case study was completed within 12 months. Results Functional specifications were defined for the various components of the medical device: device weight, size, design, device attachment, and display module. These specifications consider the future integration of the medical device into current clinical practice (for use in an operating room and patient follow-up inside the hospital) and interactions between surgeons, nurses, nurse assistants, and patients. By avoiding irrelevant technical development, this approach helps to promote cost-effective design. Conclusions This paper presents the successful deployment over 12 months of a UCD methodology for the design of an innovative medical device during its early development phase. To help in reusing this methodology to design other innovative medical devices, we suggested best practices based on this case.
BACKGROUND A successful innovative medical device is not only technically challenging to develop, but must also be readily usable for it to be integrated into healthcare professionals’ practice. Usability is studied and enhanced via a user-centred approach, the advantages of which have been demonstrated. However, this type of approach is not widely implemented from the early stages of medical device development. OBJECTIVE This case study presents a user-centred approach applied to the design of a connected sensor system to detect Colorectal Anastomotic Leakage (CAL) at an early stage. CAL is the most detrimental complication following colorectal surgery. METHODS User-Centred Design (UCD) was implemented by actively involving healthcare professionals and all the industrial partners of the project. The methodology was conducted in two European hospitals: Grenoble University Hospital (France) and Erasmus Medical Centre Rotterdam (the Netherlands). Six elective colorectal procedures and five ward shifts were observed. Four workshops were run with project partners. Formative evaluation was carried out based on five usability tests with non-functional prototypes. The case study was completed within 12 months. RESULTS Functional specifications were defined for the various components of the medical device. These specifications take into account the future integration of the medical device in current practice, as well as interactions between surgeons, nurses, nurse assistants, and patients. CONCLUSIONS The UCD methodology was relevant in the early stages of development of this innovative medical device. The results improved the functional specifications of the device by considering the context of use. The implementation of the methodology in a hospital environment is discussed, as is the utility of presenting future users with a non-functional device. By avoiding irrelevant technical development, this approach helps promote cost-effective design.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.