Key Considerations

• Formative Evaluation (The Iterative Engine): We use early-stage formative studies to learn. These small-scale tests allow our designers to observe how users interact with prototypes, identifying friction points before the design is "frozen."
• Summative Validation (The Regulatory Proof): The Summative study is your final exam for the FDA and Notified Bodies. Kapstone manages the entire protocol—from participant recruitment and simulated use environments to the final HFE validation report.
• Root Cause Analysis: If a user makes a mistake during a study, we don't blame the user. We perform a technical root cause analysis to determine if the error was caused by the UI, the labeling, or the physical ergonomics, and we provide the engineering solution to fix it.