The contextual interview (German: kontextuelles Interview) is a user research method in which users are interviewed and observed at the same time at their real workplace. It reveals how a product is actually used instead of how its use is described, and thus provides the context of use that IEC 62366-1 requires as the basis of every use-related risk analysis.
Principle and insights gained
The contextual interview combines two forms of data collection. The user works, and the researcher watches and asks questions at the points where something unexpected happens. This brings up things that never surface in a pure interview, because the user is no longer aware of them.
Asked about their workflow, people describe the workflow as it is meant to be. Observed at work, they show the workflow as it really is. In between lie the shortcuts, the sticky notes on the device and the handling habits someone has picked up because the intended operation does not work in everyday practice.
These deviations are decisive for the usability of a medical device. They are the origin of a considerable share of use errors and cannot be asked about, only observed.
Contextual interview, contextual inquiry and field research
The terms are often used interchangeably, but they cover different scopes.
Contextual inquiry denotes the complete approach of Beyer and Holtzblatt, including the subsequent modeling. The contextual interview means the individual data collection on site. Field user research is the umbrella term for all methods that take place in the real environment, including pure observation without questioning.
For practice in medical technology, this distinction matters less than the question of whether the data collection took place in the real context of use or in a meeting room.
Classification in IEC 62366-1 and ISO 9241-11
IEC 62366-1 requires the context of use to be determined before requirements for the user interface are defined. This includes the intended user groups, the use environment and the use environment factors acting there.
The contextual interview is the method by which this information is collected reliably. If the context of use is instead derived from assumptions, the entire use-related risk analysis built on it rests on an unverified premise.
The link to ISO 9241-11 is the same: there, usability is explicitly defined as dependent on context. The same operation can work in one environment and fail in another.
When the method fits and when it does not
It fits when the context of use is unknown or complex, when a product is used in several very different environments, or when use errors occur whose cause is unclear.
It does not fit when a specific design variant is to be evaluated. For that, formative usability evaluation is the right tool. Nor does it replace a summative evaluation, which provides the evidence of usability.
What an AI assistant can contribute
Language models are increasingly used to prepare such studies, for example to structure an interview guide or to organize observation notes. This makes sense in preparation and follow-up. At USE-Ing., for example, we use AI in the development of context-of-use analyses.
A model cannot replace the data collection itself. It was not in the room, it did not see the shortcut and it does not know the sticky note on the device. A generated guide reflects what has been written about a domain, not what happens in this specific clinic.
Who conducts contextual interviews in medical technology
USE-Ing. conducts user observations and contextual interviews for manufacturers of medical devices and laboratory technology, in clinical settings as well as in home use. The data collection is documented so that it enters the usability engineering file as evidence of the context of use according to IEC 62366-1. Recruiting suitable users, from nurses to medical specialists, is part of this.
The contextual interview combines interviewing and observation at the real workplace and shows how a product is actually used, not how its use is described. It provides the context of use that IEC 62366-1 requires as the basis of the use-related risk analysis. For evaluating a specific design variant, by contrast, formative usability evaluation is the right tool.
Frequently asked questions (FAQ)
What is the difference between a contextual interview and contextual inquiry?
Contextual inquiry denotes the complete approach of Beyer and Holtzblatt, including the subsequent modeling. Contextual interview means the individual data collection on site, that is, the conversation with simultaneous observation at the real workplace. In practice, both terms are often used interchangeably.
Why is an ordinary interview not enough?
An interview in a meeting room yields the workflow as the user describes it. Observation at the workplace yields the workflow as it actually takes place. In between lie shortcuts, workarounds and practiced handling habits that the user is no longer aware of and that explain a considerable share of use errors.
How does the method relate to IEC 62366-1?
The standard requires the context of use to be determined, with user groups, use environment and use environment factors, before requirements for the user interface are defined. The contextual interview is the method by which this information is collected reliably and documented for the usability engineering file.
Can an AI assistant replace a contextual interview?
No. A language model can support the preparation of a guide and the organization of notes. It cannot replace the data collection itself, because it has not seen the specific environment. A generated guide reflects what has been published about a domain, not what happens in this clinic.
Do you want to examine the context of use of your medical device systematically and transfer the results traceably into the use specification, use-related risk analysis and evaluation planning? We support you with field studies, contextual inquiry, workflow and task analyses and other human factors methods.
More about our usability engineeringSources
- IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
- ISO 9241-11:2018, Ergonomics of human-system interaction, Part 11: Usability: Definitions and concepts
Related terms
- Context of use
- Representative users
- Formative usability evaluation
- Think-aloud method
- Use error
- Use environment factors