User Research Methods

So you’re designing a new medical device and you want to gain a better understanding of how it will fit into your intended users’ workflow. Where do you start? Some common tools for user research that are particularly useful during early stages of design are contextual inquiry, focus groups, and critical incident analysis. Let’s take a quick look at each method.

Contextual inquiry is basically observing users interacting with the product in the intended environment of use. Depending on when this happens in the design process, various levels of prototypes can be used or the observer can just witness the existing workflow and try to envision how the addition of the product would impact the current use scenario(s). This method is particularly helpful for development of use scenarios and task analyses, which are critical design inputs, but it can also be very enlightening as a post-market surveillance technique to investigate adverse events or complaints.

Focus groups are gatherings of project stakeholders, subject matter experts, and intended users who meet in this context for the purpose of discussing early design concepts and how the device will fit into the expected workflow. Smaller groups are often more effective, as individuals will more likely feel comfortable and have a chance to voice their opinions. Focus groups are useful because they often produce a higher order of discussion and analysis not usually achieved by one-on-one conversations. For more details on using focus groups for human factors engineering activities, including pros and cons, check out my article from earlier this year: Improving Device Human Factors Through Focus Groups.

Critical incident analysis is investigating adverse events or known issues with similar existing devices in order to identify causes of use errors or user interface design flaws. The FDA MAUDE and MedSun databases are good places to start when looking for these kinds of events. Since these databases are often very general, supporting known information about the incidents found there with contextual inquiries or interviews with relevant parties helps provide clarity around the source of the issues. This kind of investigation allows device manufacturers to learn from their own and others’ mistakes, thereby reducing the risks associated with new devices.

These are just some of the more common user research methods. Do you have other tools that work well for user research? Or do you have an interesting experience with one of these methods that you’d like to share? If so, we’d love to hear from you!

-KB