What type of human factors (HF) studies might be conducted?

Formative evaluation is a type of usability evaluation that helps establishing and refining the product or service design. Formative evaluations involve evaluating a product or a service during development, often iteratively, with the goal of detecting and eliminating usability problems. The objectives of formative studies are to detect and eliminate use errors and usability problems as part of risk management effort ensuring safe and efficient use of the final product.

Summative evaluation is conducted on a complete or near-complete design under realistic conditions, that can be used to determine if the design meets specific measurable performances and/or satisfaction goals, or to establish or to compare with equivalent or nearly equivalent devices. The objectives of summative studies are to validate the final design using industrialized medical devices.

When is the most appropriate time to perform HF studies during development phases?

What is the role of HF studies compared to clinical studies?

HF studies are conducted to evaluate the user interfaces of the medical device. HF studies investigate medical device usability considering human behavior, cognitive, sensorial, manual dexterity abilities and limitation of the targeted users’population according to predicted environment of use.

Clinical studies are designed to support a reasonable insurance of safety and effectiveness of the final product in the context of the marketing application. The primary focus is on the product safety to assess risk against the benefits. The second focus is the consistency and reliability of product effectiveness documenting clinical, biological and/or any measurable physiological effects.

How to design a HF development plan ensuring compliance to regulatory requirements?

HF and usability engineering plays a key role in maximizing the likelihood that the device will be safe and effective for use by the intended users, for the intended uses, and according to the intended use environments. They are part of the risk management plan, detecting and eliminating use errors and related hazards.

HF development plan is the tool proposed by MCP sas to integrate HF studies within risk management plan.

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