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Reading Time: 5 minutes Top-down and Bottom-up Cues: Using Perceptual Process in Injection Device Designs Human Factors Engineers are often intrigued by peoples’ candid reactions to new devices. Recently, my friend received a new medication that needed to be…

Reading Time: 3 minutes We commonly get questions about what we do and what it’s like to work with us. So, we’ve put together a brief list of frequently asked questions and their answers. Of course, give us a…

Reading Time: 5 minutes Eye tracking provides valuable insights into the cognition of healthcare providers, patients, caregivers, and medical device users. Recent advancements have made this technology more accessible and affordable. Yet, despite its growing popularity, numerous misconceptions about…

Reading Time: 4 minutes Medical products have text (groundbreaking news, right?). From labels on devices, to results on a screen, to IFUs, there is a lot of text to consider when designing medical devices and software. However, the text…

Reading Time: 3 minutes Usable instructions for use (IFUs) for medical devices are more than step-by-step processes for users. Equally important is explaining why the product should be used as described. Naturally, the ultimate goal of most readers of…

Reading Time: 5 minutes In December of 2022, FDA released its latest guidance on human factors in medical device marketing submissions. The purpose of the new document is to complement and provide some clarifications to the existing guidance document,…

Reading Time: 5 minutes People often ask us, “What are the most important human factors in healthcare?” Well, it depends. If it is a handheld surgical tool, we often focus on the biomechanics of the hand and the wrist,…

Reading Time: 5 minutes Two nurses were caring for a 15-day-old baby with a congenital heart defect and a rapid heart rate. As is routine, they administered digoxin, a common drug for slowing heartbeats. Tragically, however, they made a…

Reading Time: 5 minutes Instructions for use (IFU) are essentially the user manual for a medical device, providing information such as: How to use the device Why and when the device should be used Technical specifications Maintenance requirements Troubleshooting…

Reading Time: 5 minutes Healthcare Human Factors Human factors engineering focuses on researching, designing, and evaluating products to make them useful, usable, desirable, and safe. Healthcare human factors engineering emphasizes safety. In fact, during the premarket submission process, the…