Production-Equivalent Units

• FDA summative testing requires devices built to production-equivalent specifications. Through our integrated Kapstone Manufacturing facility and network, we rapidly produce low-volume, high-fidelity pilot runs specifically for summative usability testing, eliminating the need to source a third-party manufacturer just for test units.

FAQ

When is a Summative Usability Study required by the FDA?

The FDA requires a Summative (Validation) Usability Study for any medical device where a use-error could result in serious harm to the patient or user. This study must be conducted with representative users performing "critical tasks" in a simulated use environment to prove the device interface is safe and effective.

What is the difference between Formative and Summative Evaluation?

• Formative evaluation is used in the early stages of the design process. These evaluations form and shape the direction of efforts, ensuring that the right device is being designed for the intended purpose.

• Summative Evaluation is used in the later stages of the development process to evaluate the end product. These evaluations summarize and explain how the device meets all of the requirements it set out to achieve regarding functionality and user interaction.