Formative Evaluation

Formative usability evaluation(s) is an Human Factors tool designed to explore the product’s UI design strengths, weaknesses, and uncover use errors.

These evaluations are conducted at various stages during the development process with prototypes of any fidelity to identify areas for improvement in the products user interface. These evaluations inform adjustments early in the project with major design decision that focus on use safety and improved usability. 

There are various methods to ensure it is tailored to your product’s needs, including but not limited to expert reviews, cognitive walkthroughs, and usability testing.

Satisfies IEC-62366-1 and FDA Guidance for HFE/UE.

Performing formative usability evaluation early and often can help you evolve products with an proven user-centered approach. Some ways include, but not limited to:

• Conducting rapid prototyping studies to verify concepts and labeling
• Target high ROI use of questionnaires, surveys and structured interviews
• Apply true performance testing, not just focus group and preference surveys
• Employ an efficient mix of part / full task simulation customized to product needs
• Use cognitive walkthrough evaluations

In this way, design recommendations for decisions can be based on evidence gained directly from observing users interacting with the product, rather than on assumptions. This makes your product more usable, more robust, and more likely to pass through HF validation and FDA submission.