Development of a Connected Sensor System in Colorectal Surgery: User-Centered Design Case Study (Preprint)

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.