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

Christel Schwartz-Lasfargues^1,2, Camille Roux-Gendron³, Pim Edomskis⁴

¹Public Health Department, CHU Grenoble Alpes, Grenoble, France.

JMIR Human Factors

|July 8, 2022

Summary

This summary is machine-generated.

User-centered design (UCD) improves usability for innovative medical devices. This case study demonstrates early-stage UCD application for a colorectal anastomotic leakage sensor, providing guidelines for future development.

Keywords:

Internet of Things IoT colorectal anastomotic leakage colorectal surgery formative evaluation innovation medical device mobile phone usability user-centered design

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Area of Science:

Medical device development
Human-computer interaction
Healthcare innovation

Background:

Innovative medical devices require both technical feasibility and practical usability for healthcare integration.
User-centered design (UCD) enhances usability but is underutilized in early medical device development.
Early-stage UCD is crucial for integrating complex devices into clinical workflows.

Purpose of the Study:

To demonstrate the application of UCD in the early design phase of a novel medical device.
To apply UCD to a connected sensor system for detecting colorectal anastomotic leakage.
To provide usability guidelines for the initial design of innovative medical devices.

Main Methods:

UCD was implemented through active involvement of healthcare professionals and industrial partners.
The study involved observations in 2 European hospitals and 4 workshops with stakeholders.
Formative evaluation included 5 usability tests with non-functional prototypes over 12 months.

Main Results:

Defined functional specifications for device components (weight, size, attachment, display) considering clinical integration.
Addressed interactions between various healthcare professionals (surgeons, nurses) and patients.
Promoted cost-effective design by avoiding unnecessary technical development.

Conclusions:

Successfully deployed UCD methodology over 12 months for an innovative medical device's early design.
The case study offers best practices for reusing UCD in future innovative medical device development.
Early UCD integration is key for developing usable and cost-effective medical technologies.