Technologies Catalog to Support the Identification of User Behavior During Usability Tests

Abstract

IEC ISO 60601-1-6:2015 is the regulatory standard for Medical Device (MD) and directs to ISO IEC 62366:2015 as a technical standard. However, due to the general nature of this standard, it does not provide details about criteria to guide usability testing of MD. In this way, the manufacturer deals with the unpredictability of the user according to the subjective convenience that he deems necessary to the type and class of the device. Objectives: To present a Catalog indicating technologies that can be used to detect the ergonomic or biomechanical behavior of the user. So that the test team has support for the follow-up of the experiment and for assistance in interpreting the test results. Method: A bibliographical review on technologies used to detect human behavior, and a technical survey of the market for products capable of capturing such behavior, were carried out in 2017 to establish and create the Catalog. Results: Findings allowed to list technologies that can be used to analyze the behavior of the user, assisting the execution of usability tests (UT) of the MD, being effective to detect the behavior and generate data to support the analysis and generation of reports. Conclusion: The Catalog classified technologies that can generate information about the usability of the MD, considering the analysis of the user’s behavior. The Catalog contains the association between the technology and behavioral possibilities that can be identified, serving as support to choose the technology most appropriate to the UT.