Wiklund's Perspective: IFU Designers Helping Us Get Through the Pandemic

By now, many of us have used a home COVID-19 test kit. I went a long time without needing to test. But then, a heavy cold got me into the swing of testing. Later on, I tested out of an abundance of caution before and after family events. Each time, my wife and I made it a two-person job in the spirit of togetherness.

My simple job was to open the box and perform the swab-in-nostril maneuvers. Her more challenging job was to direct us through the process and perform the hands-on steps of mixing and depositing several drops—but not too many!—of “swabby” fluid onto a test plate. Things went smoothly each time, except for a near-mishap on the first occasion. Our cat jumped on the kitchen countertop that, at the time, was serving as our laboratory workbench. He caused a moment of chaos but no harm.

I credit our positive experiences, fortunately leading to only negative test results, to the high-quality instructions for use (IFUs). In contrast to the common and dubious claim that people don’t pay attention to IFUs, we did follow them with intense commitment. We did not want to mess things up and get a false negative or false positive finding, nor waste a test kit.

Sure, I could quibble with specific details of each instruction sheet, but I saw nothing of major concern. The IFUs were black and white instead of multi-colored, undoubtedly for cost control reasons. There was a lot of information to consume with many steps to follow, as there often is with test kits. While I could envision many ways to make each example better, the combination of illustrations, text, and design provided clear steps for us to follow—a pleasant surprise.

My colleagues and I routinely work with our customers to produce good IFUs—in fact, great ones. We’ve sincerely claimed that an investment in good instructions is important to a product’s use, safety, and effectiveness. We have also observed that good instructions help generate positive feelings about the product and product manufacturer.

Clearly, COVID-19 testing is no fun and comes with anxiety over the test result. However, my use experience was pretty good under the direction of decent IFU and a helpful spouse. Furthermore, it pleased me that the people who use our customers’ products likely get the same sense of satisfaction from the instructions we have designed and validated as facilitating safe and effective interaction with the given products.

I’m a fan of good instructions, and even more so of great instructions. My team did not develop the instructions that came with the COVID-19 test kits that my wife and I used. So, I can thank the anonymous document designers and evaluators who created them. Perhaps somebody else feels the same way about the instructions my teammates have developed for a wide array of other products, such as insulin pen-injectors, inhalers, nebulizers, and many others.  

Michael Wiklund is General Manager and Director, Human Factors Research & Design (HFR&D) at Emergo by UL.

Learn more about human factors engineering and usability for medical devices at Emergo by UL:

• HFE user research for medical devices, IVDs and combination products
• Human factors design and prototype development support