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Reading Time: 4 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. For handheld surgical tools, we focus on the biomechanics of the hand and the wrist, ensuring that 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: 6 minutes Instructions for Use (IFU) 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…

Reading Time: 5 minutes 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 U.S. Food and…

Reading Time: 5 minutes Healthcare Human Factors Engineering Human Factors Engineering focuses on designing products that match human capabilities and account for human limitations. This makes products easier to use, more effective, and safer. This is critical when designing…

Reading Time: 5 minutes Healthcare Human Factors Virtual Symposium As an attendee of the 2020 International Symposium on Human Factors and Ergonomics in Healthcare, as it was originally planned, you would have walked into a hotel ballroom in Toronto,…

Reading Time: 11 minutes Remote Research Overview Fundamentally, remote research involves the researcher and participant being in two separate locations. As it stands right now, remote research is undoubtedly the safest option during the COVID-19 pandemic. Video meeting platforms…

Reading Time: 9 minutes In-Person Research Overview Many people are sensitive to visiting unfamiliar businesses right now due to fears of COVID-19 exposure. This can be disheartening to researchers, especially when businesses put in considerable time and effort to…

Reading Time: 5 minutes Usability Testing Actually fielding a usability study is the moment of truth. Staying true to project goals and completing a task analysis accomplishes a ton for the seeker of usable results, but those strategies quickly…