JMIR Publications

ABSTRACT

Background:

A successful innovative medical device is not only technically challenging to develop, it must also be readily usable to be integrated into healthcare professionals’ daily practice. Through a user centered approach (UCD), 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 yet available. The device under study is a connected sensor system to detect Colorectal Anastomotic Leakage (CAL), the most detrimental complication following colorectal surgery, that has a high medical cost. We also aim to provide usability guidelines for the initial design of other innovative medical devices.

Methods:

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 and clinicians. Formative evaluation was carried out based on five usability tests with non-functional 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 and design, device attachment, display module. These specifications consider the future integration of the medical device in current clinical practice (usage in an operating room, patient follow-up inside the hospital), as well as interactions between surgeons, nurses, nurse assistants, and patients. By avoiding irrelevant technical development, this approach helps promote cost-effective design.

Conclusions:

This article 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 reusing this methodology for others innovative medical devices’ design we suggested best practices built from this case.