| | Usability
& Safety Bench Test™
FDA and other
regulatory bodies have taken steps in recent years to have device manufacturers
incorporate human factors into their risk
management practices. To assist companies with risk
assessment we've created a unique, analytical tool to help identify and address
potential use-related hazards. Our Usability & Safety
Bench Test™ provides a quick and cost-effective evaluation of potential
usability and safety issues. It can be performed at the earliest stages of your
product's development, while there is still an opportunity to introduce effective
controls. Solves These Problems
 | How
do we identify potential use-related hazards, early enough in the design process
to control for them effectively? | | How
to we identify usability issues that could negatively effect user acceptance and
satisfaction? | | We
conduct usability testing when we have a working prototype, but what can we do
earlier in the process to ensure we are on the right track? | | How
can we verify that the design we have meets our design input requirements? |
Usability & Safety
Bench Test™ The Usability & Safety Bench Test™
combines elements of three proven human factors techniques: Task Analysis, Heuristic
Review, and Failure Mode& Effect Analysis. The test is performed by multiple
human factors experts, who take the following factors into consideration:
| The
design of the user interface, instructions for
use, and packaging. | |
The specific steps (i.e., task steps) required
to use the device safely and effectively. | | The
device use environments (the environmental,
social, and organizational conditions under which the device is likely to be used). |
| Knowledge
of the motor, perceptual, and cognitive capabilities and limitations of the target
user population (i.e., what users can do relative
to the requirements of the task). | | Knowledge
of the likely predispositions of the target user population (what
users are likely to do given the expectations and experience with the device
and other devices users view as similar). | | General
human factors principles for good design (e.g.,
Provide unambiguous and timely feedback on use actions and device states, Provide
a clear conceptual model, Make things visible, Anticipate errors, Reduce memory
load). | | Use-errors
with similar devices (i.e., use-errors cited in the research literature
or in regulatory agency databases). | Potential
use-errors and usability problems are identified, and their severity, probability
of occurrence, and likelihood of detection by the user are assessed. Recommendations
for design changes aimed at addressing the problems are provided. Deliverables Written
report suitable for inclusion in a design history file or FDA submission. PowerPoint
presentation summarizing key findings and recommendations for design changes.
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