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Tag: medical device

Insights from 1,000 Participant Sessions in 2023

Reading Time: 2 minutes In the ever-evolving landscape of human factors and usability research, our research team has reached a significant milestone. We conducted over 1,000 participant sessions in 2023! And all before Halloween!  This journey has provided more…

Crash Course on URRAs

Reading Time: 4 minutes As human factors specialists in the medical device industry, our world is centered around mitigating use-related risks. Ultimately we hope to design a device that is safe and effective to use. An important aspect of…

Simplifying the 2023 FDA Guidance on Human Factors Engineering Principles for Combination Products

Reading Time: 4 minutes Like with all medical devices, the application of human factors principles is essential for the development of safe and effective combination products. On September 7, 2023, the FDA released “Application of Human Factors Engineering Principles…

Ethical Treatment of Human Factors Test Participants

Reading Time: 6 minutes As a university student, I worked in a psychobiology lab where we studied the physiology of emotions. Our lab housed rats, mice, and chickens. Because I was a lowly undergraduate, I was saddled with some…

How to Design your Injection Device from “Top to Bottom”

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…

Top 5 Eye-Tracking Myths

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 eye-tracking…

Human Factors and FDA: Instructions for Use (IFU)

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…

Five Tips for Human Factors Engineering and FDA

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…

Usable Research Reports: Using Task Analysis

Reading Time: 4 minutes Usable Research Reports When it comes to generating usable results, detail is key. What exactly did the users have trouble with? Broad statements like “5 out of 15 users did not successfully complete Task 14”…

6 Myths About Human Factors Engineering and the FDA

Reading Time: 5 minutes Human Factors Engineering and FDA Clearance Human factors validation testing and obtaining FDA clearance can be challenging. Even folks who fully understand these processes can struggle to execute efficiently. Where do these challenges come from?…