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I say Validation, you say Summative. I say Contextual Inquiry, you say Ethnographic Research.
By Elizabeth Roche, Director, Research & Strategy
If you’ve been in the Human Factors field for even a meager month or two you have likely encountered some degree of terminology muscle-flexing.
It might go something like this—one side insists on using the term ‘Human Factors Validation Testing’ while others argue for ‘Summative Usability Testing’. The first person is citing the FDA Guidance on applying human factors while the second quotes ANSI/AAMI’s HE75. Before long, a third points out that IEC 62366-1:2015 prefers the term ‘Summative Evaluation’. So is it an evaluation or a test? Should we use the descriptor ‘human factors or ‘usability’? While the former aligns with the FDA, the latter is more ubiquitous.
In truth the terminology doesn’t matter as long as those involved agree on the method being employed. In fact, as a discipline do ourselves a disfavor by engaging in such banter. Not only does it decrease efficiency, but it alienates our cross-functional team members by making us look pedantic and our discipline unnecessarily confusing.
With this in mind, Ximedica has taken on the task of standardizing the vocabulary we use to refer to our human factors work. In some cases, we followed IEC 62366-1:2015, in other cases the FDA Guidance and, as in the above instance, HE75.
Our criteria for selection were simple: ubiquity and accuracy.
We started with the term that is more widely used and understood, and then asked ourselves if we were losing anything in accuracy by choosing it over a parallel term.
The case of ‘Usability Testing’ is an example of ubiquity winning out. Our products go to the FDA for submission so of course we follow the FDA Guidance (and are aware of footnote #8 in the FDA’s Guidance about these terms), but for planning and discussion purposes nothing is lost by saying ‘Summative Usability Testing’.
In the case of ‘Contextual Inquiry’ versus ‘Ethnographic Research’, the former trumps on accuracy and we chose it over the more commonly used term ‘Ethnographic Research’. After all, spending 2 to 8 hours in someone’s home is a far cry from true ethnographic research, as any anthropologist will tell you. To top off the debate on this one, ‘Contextual Inquiry’ is the term of choice for all three standards sources, the FDA, IEC 62366-2 and ANSI/AAMI HE75.
Once we had selected our primary terms, we wrote short disambiguation paragraphs for related terms. The resulting document serves as internal training and feeds into our Standard Operating Procedures, which means we can bypass the arm wrestling over who can better map terms to standards, and get to work on the things we are truly passionate about.