What is a Usability Study Protocol?
A formative Human Factors (HF) protocol is a written structured plan used to evaluate the usability and safety of a product during its early development stages. It outlines the objectives, methods, and procedures for conducting usability testing, focusing on identifying potential user errors and improving the design before finalization.
Tips on writing a Usability Study Protocol:
Writing a Human Factors Formative Study Protocol can be intimidating. Below are four actionable steps to help you get started.
Define the top 3 study objectives: Start by identifying the most challenging use steps to ensure these are prioritized for analysis during the study.
Define participant criteria for recruitment: Clearly outline the characteristics required for participants, including factors like age, gender, mobility, and prior experience with the device or a predicate device.
List all use steps: Create a table that outlines each step of device use, including columns for observed issues and user feedback.
Include data collection methods: Specify how you will collect qualitative and quantitative data, such as observation, interviews, and error tracking, to inform future design iterations or regulatory submissions.
OPEN QMS
Want Access to an Editable Version?
Better yet, want access to all the forms in our ISO 13485 Certified Quality Management System? Join our Open QMS community for forms, feedback, and more.
> DOWNLOAD
GOT QUESTIONS?
FAQ About Human Factors Studies
Here are some answers to frequently asked questions about Human Factors Studies.
Who participates in human factors studies?
What are formative human factors studies?
What is a use related risk analysis (URRA)?
What are summative human factors studies?
LET'S CONNECT
Want help with Human Factors Studies?
Contact us through the form below. One of our team leaders will follow-up with you directly.