What is formative testing?
Formative testing is continuous evaluation during product development. Its goal is to identify problems and improve the user experience as the development process progresses. In health technology, this means regular usability testing with prototypes and development versions.
It helps ensure that medical devices and software meet user needs already during the development phase.
Formative testing should be used at all stages of product development, from concept to prototype. It is most effective when changes are still possible and affordable to implement.
What is summative testing?
Summative testing, in turn, is performed on the final product before market release. It measures the product’s overall performance and usability in its finished form. In health technology, summative testing is often a regulatory process that demonstrates the product’s safety and efficacy.
How do they complement each other?
Both testing methods are essential in the development of medical devices and software. Formative testing prevents costly errors and ensures user-centered design, while summative testing verifies the product’s readiness for the market and for regulatory approval.
When is each required?
Summative testing belongs to the final stage of product development, when the product is essentially complete. Regulatory requirements often determine the timing and scope of summative testing. For medical devices, summative usability testing is a mandatory part of the CE marking process and FDA approval.
The device’s risk analysis plays a decisive role — particularly use-related risks. If use errors could cause serious harm to a patient or user, summative usability testing and its documentation are required more rigorously, regardless of the device class.
In short: formative testing builds the foundation for good usability throughout development, while summative testing proves that the final product is safe and effective for regulatory purposes.
