Human Factors Engineering & Usability

Human factors engineering (also called usability engineering) is becoming increasingly important to global regulatory bodies—and increasingly central to the Kapstone offering. Our design & engineering process forces the project team early on to account for human behaviors, plausible errors, and biological interactions to reduce clinical risk of the medical device. Our team is fully trained in the overlap between human factors engineering (HFE) and device development and prepared to integrate our expertise from the project get-go.

The Benefits of Integrating Human Factors Engineering

Early Assurance of Device Usability

Incorporate user research and formative testing into the early stages of device development to ensure that the device is actually designed to meet the needs of its ultimate users. We assess all potential user population types and take the diverse needs of those users into account, optimizing the product design for all potential use cases to increase adoption rates and decrease error rate.

Reduced Cost of Changes to Design

Proactive consideration and testing for human factors protects the project team from having to make costlier changes later down the line. By integrating appropriate formative testing in a low stake environment, the team can learn before design freeze and improve the design before it becomes too late.

Risk Reduction

Product risks are difficult to anticipate—unless you actually use and test the device. By identifying the critical tasks with users early in the process, we establish a user risk assessment that complements a traditional design risk assessment to capture the entire risk portfolio. We leverage our broad expertise to predict, assess, and design for product risk factors, safeguarding the project from unpredictable revision costs.