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It can be tricky for a product’s instructions to communicate to end-users how to use the product safely and effectively. People interpret text differently from each other; some people have a higher or lower reading level; some people skim, or think they don’t need all the instructions, or only look at the pictures, or ignore the pictures, or are colorblind, or … etc. Core Human Factors meets this challenge by infusing the instruction-writing process with a human factors perspective, aiming to incorporate knowledge of the range of human characteristics throughout the entire instruction-writing process. To help explain how we go about producing broadly understandable, safe, and effective instructions, we have been iteratively developing a “fictional” set of instructions for an insulin pen that does not exist. Below are some of the human factors processes that we put into instructions. However, heuristics, principles, and knowledge are not enough. Conducting formative empirical testi...

Core Human Factors, Inc., is proud to announce the formation of a new IRB, Institutional Review Board. IRBs are responsible for reviewing research plans to ensure that they are ethical, in particular that the planned research protocol protects subjects (research participants). Approval from an IRB is either a necessary or an optional step in research depending on who is conducting the research, who is funding the research, and how the research may eventually be used. The new Core Human Factors IRB#1 is registered with the U.S. Department of Health and Human Services, and is comprised of approximately  6 ethically interested scientists and non-scientists, men and women from a variety of backgrounds. We aim to provide fast, high-quality, and inexpensive IRB review as a for-profit service for low-risk behavioral (non-drug) research. To our knowledge, no other for-profit IRB focuses on this subtype of research, and the overhead involved for them in processing high-risk drug-orient...

Core Human Factors recently completed a usability study of a new injection device and ran into a phenomenon that stresses the importance of clearly conveying headings and illustrations in a product’s instructions for use (IFU). During this study, numerous users stated that they performed a certain step a particular way because of what they read in the heading and/or saw in the illustration; oftentimes users said that they did not bother to read the instruction’s captions. If captions contain additional important information on how to properly use a product (as these captions did), then only viewing an instruction’s heading and/or illustration  can lead to product misuse and potential safety risks. The purpose of the study we conducted was to learn about the usability of an injection pen and its accompanying IFU, while the product was still in development. Sixty-nine representative users participated in the study; some participants had experience with similar devices currently o...

Before a medical device can be sold in the U.S., the manufacturer needs to demonstrate that it can be used safely and effectively. Do people hurt themselves by mistake when they try to use it for the first time? Can people pick it up and hold it so that it doesn’t slip and fall? Can people read its display and know what the display is telling them? Does the device resemble another device that is used differently, leading people to use the new device incorrectly? Do the instructions make sense to a wide range of people coming from different backgrounds? Core Human Factors, Inc. specializes in testing new medical devices for just these sorts of issues, by having representative users come in and use new devices in a variety of scenarios designed to represent real life. This blog post is not intended as an advertisement for the firm. Rather, it is a “slice of life” from our niche in applied psychology, where careful simulations of reality are necessary to capture “use events”--instance...

By Adam R Shames Core Human Factors recently completed an injection pen study and came across an interesting phenomenon that stresses the importance of clearly conveying headings and illustrations in a product’s instructions for use (IFU). During this study, numerous users stated that they performed a certain step a particular way because of what they read in the heading and/or saw in the illustration; often users stated that they did not bother to read an instruction’s subtext. Only viewing an instruction’s heading and/or illustration can lead to product misuse and potential safety risks if the subtext contains additional important information on how to properly use the product. The purpose of this formative study was to examine the usability of an injection pen and its accompanying IFU. Sixty-nine representative users participated in the study; some participants had experience with similar devices currently on the market, while others were inexperienced. The study took place in ...

By Marc Egeth Egeth, M., Fink, N., Soosaar, J., Margolies, R. & Shames, A. (2014). If you can read this, you’re too close: Human factors in human factors standards for font sizes. Human Factors and Ergonomics Society: International Symposium on Human Factors and Ergonomics in Health Care: Leading the Way, 2014.