Cockpit's Template for Usability Engineering (Human Factors Analysis)
The Usability Engineering Template guides teams to reduce use-related problems that contribute to or may cause risk.
The template assists teams in defining and understanding the use of the device and identifying potential use-related risks.
Results from Formative testing can be used to improve the design.
Understand the context of use for the device you are creating. Define the intended medical indication, intended patient population, intended user profile, use environment and operating principle.
USE ERROR ANALYSIS
Understand what could possibly go wrong, which includes identification of operating functions, user activities, tasks (& sub-tasks) and possible use errors and hazard related use scenarios with subsequent risk analysis.
USER INTERFACE SPECIFICATION
What are your acceptance criteria for knowing you have a successful design? This is where you spell it out. Does your device meet the expectation of the user? During this phase, define what the user is expecting to ensure the device is designed as specified.
Formative testing is started early in the process and is used to improve the usability of the design. Summative testing, also called Validation Usability testing, is done to prove the final design performs as intended.