Usability‑Engineering Projects: What Are the Common Misunderstandings?

At the beginning of this month, Ilkka Juuso and Ilpo Pöyhönen published a book entitled Medical-Device Usability: Human Factors for Medical Device Development, which simplifies the process regarding the application of usability to medical devices for new developers by providing a thought-out walkthrough of what is involved and how the expectations from the essential standards affect their work and why.

When I spoke with Ilkka this past week, I asked him, "What are the most common misunderstandings developers encounter when starting a usability‑engineering project?" Here is his complete answer:

By far the easiest mistake to make is to think that usability in medical devices is just about an interface that is pleasant to look at and use. That will be a part of it, but far more important is the safety of that interface. An aesthetically appealing user interface is nice, an interface with all the controls in intuitive places is a great start, but what actually matters the most is that it is difficult to use the interface in the wrong way, leading to real harm to patients. That may sound counterintuitive from a general usability perspective – after all, usability typically talks about the ease of all use – but safety and the safe use of a device really is paramount when it comes to health. In an optimal situation, of course, all these rings align so that a safe interface is also intuitive and appealing, and thus hopefully even safer to use. In our book, we approach usability engineering from the viewpoint of safety, but also bring in lessons from the field of general usability engineering, which is useful to a discussion of medical devices.

The second mistake to avoid is keeping usability engineering as an isolated activity, run once and then forgotten about, without much impact on the development or maintenance of the medical device. In the book, we show how usability connects to the overall quality management and risk management activities of the organization, and how usability can actually inform the whole path from an initial product concept to a finished device and beyond. Our message here is that usability engineering is not just something you have to do, it’s something you should want to do because of how it can add to your knowledge of your user, use environment, and the use of your device – and bring benefits to all of these.

For those working in the medical device industry, do you agree with Ilkka's perspective regarding common mistakes? In your organization, does usability connect directly to quality and risk management?