Sunday, September 30, 2007

Exploring Summative Usability Testing

Summative usability in the medical device industry ...

"Summative usability testing can quickly reveal whether a manufacturer has effectively addressed users’ needs. With input from an FDA expert, a human factors consultant weighs in on how to do it right.

The term summative usability testing recently entered the lexicon of medical device manufacturers as they faced the new requirement to validate their product’s suitability for its intended use. According to IEC 60601-1-6, Medical Electrical Equipment—Part 1–6: General Requirements for Safety—Collateral Standard: Usability, manufacturers must demonstrate that their device enables users to perform tasks with little or no chance of an error that could cause harm to patients or themselves.1 The new requirement is a keystone in the overall movement toward reducing risk to patients by ensuring that medical devices reflect good human factors engineering practices.

Summative usability testing differs from formative usability testing in terms of its timing and purpose. Developers might perform several formative usability tests during the product development process to identify opportunities for design improvement (i.e., to help form the product). By contrast, they will usually perform just one summative usability test to validate a user interface design prior to “freezing” it and applying for regulatory approval.

When performed appropriately, summative usability testing, which FDA considers as a form of design validation, quickly reveals whether a manufacturer has effectively addressed users’ needs through the application of established human factors processes and principles. Typically, such testing calls for representative users (e.g., physicians, nurses, therapists, or technicians) to perform frequent, urgent, and critical tasks with the given device, without assistance and possibly without prior training. For example, a nurse serving as a test participant might prepare a generally familiar but new hemodialysis machine as if it were to be used on an actual patient. Or, an untrained layperson would respond to a simulated cardiac arrest by setting up and applying a lifesaving shock to a mannequin with an automated external defibrillator.

Summative usability testing is a high-stakes exercise, akin to a high school exit examination. Failure can send designers back to their computers—formerly their drawing boards—to rectify hardware and software user interfaces, which is an expensive and disruptive outcome. Therefore, developers have approached such tests with understandable trepidation because of the associated risk or failure as well as the methodological uncertainties addressed in this article."    (Continued via Medical Device Link)    [Usability Resources]

Operating Room Simulator - Usability, User Interface Design

Operating Room Simulator


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