Human Factors and Usability Engineering for Medical Technology

A context of use analysis, also known as User Research, marks the beginning of the user-centered development process. The goal is to thoroughly understand the future users, their workflows, and work environments. Within the requirements analysis, our experts derive relevant User Requirements & User Needs from this context of use. In accordance with normative requirements, we offer our customers the use of observing, interviewing, and testing techniques. The method spectrum includes basic techniques such as protocols, audio and video recordings, as well as the use of advanced technologies such as eye tracking & motion tracking. Through observation and interviews, we collect both qualitative and quantitative data for our customers, such as context interviews, user surveys, or focus group interviews.

The information collected during the analysis is systematically consolidated in the subsequent specification process. This process concludes in the regulatory-relevant use specification document and is the basis for deriving user requirements and user interface specifications. These requirement categories are then bundled and specified in the form of a functional and technical specification document. Workflow analyses make the workflow visible for the project team and help to optimize the medical device through intelligent product design. The derived task models, are transferred into regulatory-required use scenarios, that represent the basis to identify usability strengths and weaknesses of the medical device in later evaluation activities.

Wondering how to bridge the gap between qualitative research and technical specification?
Our experts will assist you in developing your requirement specification.