Individual Usability™ Solutions

Individual Usability™ Solutions focus on understanding how users interact with a product at specific stages of development. These studies are used to explore design decisions, identify risks early, and confirm usability before regulatory submission.

We support manufacturers across early-stage exploration through to pre-market confirmation, using structured, defensible methods aligned with regulatory expectations.

  • Formative or Investigational Usability Studies

    Formative (or investigational) usability studies are used during development to explore how users interact with a product and to identify usability issues before they become costly or high-risk.

    These studies help teams understand:

    Where users struggle or hesitate

    How design choices affect task performance

    Whether assumptions made during development hold up in practice

    What we do:

    Design task-based usability studies tailored to your product and users

    Observe and analyse user interactions in realistic use scenarios

    Identify use-related risks, errors, and design opportunities

    Provide clear, actionable feedback to support design refinement

    Formative studies are particularly valuable when designs are evolving and decisions still need to be made.

  • Actual Use and Summative Usability Studies

    Actual Use and Summative Usability Studies are conducted to confirm that users can safely and effectively use a product as intended. These studies are typically performed later in development and often support regulatory submissions.

    They are used to demonstrate that:

    Critical tasks can be completed successfully

    Use-related risks have been adequately mitigated

    The final design performs as expected with representative users

    What we do:

    Plan and execute structured summative usability evaluations

    Develop realistic, risk-based task scenarios

    Capture and analyse performance data in line with regulatory guidance

    Produce clear, defensible study outputs suitable for technical documentation

    Our approach focuses on clarity, traceability, and confidence in the final usability evidence.

Let’s Work Together