Pulse Articles in This Series
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Five Qualities Of A Good Use Risk Assessment (uFMEA)
5/1/2017
Not all use risk assessments are created equal. There absolutely is a right way and a wrong way to complete Use Failure Mode and Effects Analysis (uFMEA) assessments, and decisions made during the process can make or break your regulatory submission.
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Patient-Centered Design Begins At Home
10/14/2016
A home visit presents a unique opportunity to discover how a patient or caregiver manages medications, supplies, and everyday device use.
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Coming Home: Designing For Medical Device Use Environments
7/28/2016
Understanding a product’s use environment is as key a building block to designing a usable and useful medical device as understanding the end user. Where a product is used, and who is using it, are inseparable factors, and anticipating how they interplay in device use is a critical and complex task.
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The Value Of Eye-Tracking Software In Medical Device Usability Testing
2/29/2016
The easiest way to mitigate user and tester biases during usability testing is to automate the subjective portions of data collection, while eye-tracking software and other technologies can help to capture those pieces of latent data that may elude the human eye. Use of eye-tracking software in usability testing offers researchers, engineers, and designers a bird’s eye view of the user experience.
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Staying Dry: How To Limit Wet Injections In Auto-Injector Design
11/30/2015
In this article, I outline some of the most common risk controls utilized by on-market devices, as well as reveal where these solutions struggle in actual use. I’ll then describe different ways to better mitigate the risk of wet injection.
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Hacking In Medical Devices: White And Black Hats, Part 2
9/11/2015
In part one of this series, we discussed the “white hats” — programmers and engineers who have lifted the hood on medical devices to understand their underlying mechanics. Here, we will look at the “black hats” — hackers with malicious intent who threaten private patient health information and patient safety — as well as explore how the industry could benefit from new standards for risk management, safety requirements, and adverse events.
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Hacking In Medical Devices: White And Black Hats, Part 1
8/10/2015
Hacking in medical devices is a sensitive topic. In general, hacking has some deeply negative connotations but, while some hackers are dangerous, others have nobler causes. In this article — the first in a two-part series — we’ll discuss the programmers and engineers who have lifted the hood on medical devices to understand their underlying mechanics.
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Achieving Realism In Human Factors Work: How To Stay Out Of Fantasy Land
6/30/2015
In our last article, we discussed the key ingredients in a summative usability study. Here, we would like to focus more in-depth on a central issue related to usability studies — “representativeness.” One of the terms the FDA repeatedly uses in describing the requirements regarding usability studies is “representative." We interpret this as a call to infuse every step of the device-development process with as much realism as possible.
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How To Know You’ve Passed Validation Testing (And What To Do If You Haven’t)
5/27/2015
When studies are successful, human factors (HF) validation can be as straightforward as checking off the boxes on a study protocol. If all the pieces of testing don’t come together as planned, however, HF validation can be a complicated endeavor. At the recent HFES Symposium on Human Factors and Ergonomics in Health Care, we shared our thoughts on how to know whether or not you’ve cleared that last hurdle.
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4 Proposals To Accelerate The Growth of mHealth
3/11/2015
At an estimated $2.8 trillion, or roughly one-fifth of the U.S. gross domestic product (GDP), the U.S. healthcare industry is enormous — and it’s experiencing an equally enormous transition. The same information technology revolution that has transformed nearly all other aspects of modern life has finally made its way to healthcare.