Usability Inspection

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Usability Evaluation

A quick and effective way to evaluate the usability of a medical device in development, including the IFU and training materials, is to perform a usability inspection. Two popular inspection techniques are heuristic evaluation and cognitive walkthrough.

Usability inspections contribute to 'usability verification' activities as detailed in ISO/IEC 62366:2007, and can be referenced in the 'formative evaluations' section of the FDA's Human Factors Engineering report.

These techniques are particularly useful early in design, as they can uncover many usability issues or defects quickly and cost-effectively (without involving end-users). Our services in relation to those techniques are described below.

 

Heuristic Evaluation

Two or more of our usability analysts can independently inspect and evaluate the User Interface of your medical device, including the IFU and/or training materials, according to best practice principles (or heuristics). Prior to the evaluation, we will select heuristics that are most relevant to your medical device.

A heuristic evaluation report can be prepared consisting of a consolidated and prioritised list of key findings. If preferred, we can also present findings as a series of presentation slides.

 

Cognitive Walkthrough

We can facilitate a cognitive walkthrough workshop with key members of your design team to identify usability issues. This involves walking through the device use process and asking pre-determined questions about the likelihood of intended users being able to understand and perform each step.

As preparation for a cognitive walkthrough evaluation, we are able to assist with developing task flow diagrams using Hierarchical Task Analysis software (also typically conducted in a workshop). We also have a set of pre-determined questions that can be used to prompt discussion at each step in the process.

A cognitive walkthrough report can be produced detailing a list of success and failure stories for key steps of a device use process.