Formative evaluation

Formative work shapes the design and can use prototypes, small groups or expert reviews. It is different from human factors validation testing, which comes at the end and confirms the final design; a summary of formative work usually appears in the human factors report.

USER INTERFACE EVALUATION conducted with the intent to explore USER INTERFACE design strengths, weaknesses, and unanticipated USE ERRORS Note 1 to entry: FORMATIVE EVALUATION is generally performed iteratively throughout the design and development PROCESS, but prior to SUMMATIVE EVALUATION, to guide USER INTERFACE design as necessary.

IEC 62366-1:2015+AMD1:2020, clause 3.7

User interface evaluation conducted with the intent to explore user interface design strengths, weaknesses, and unanticipated use errors.

FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices (August 2026), Section 3, Definitions