Accepted for/Published in: JMIR Human Factors
Date Submitted: Jun 24, 2021
Open Peer Review Period: Jun 24, 2021 - Jul 8, 2021
Date Accepted: Mar 21, 2022
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Early User Centred Design during development of an innovative medical device: case study of a connected Sensor System in colorectal surgery
ABSTRACT
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.
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.