Human Factors & Usability Testing
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Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps
by Elyse Hallett Posted Feb 20, 2023 In Human Factors & Usability Testing, Medical Product Design
A human factors validation study is conducted to demonstrate that your medical device can be used by its intended users without serious use errors or problems. It’s required testing for most products as they’re finalized — before they go to market. And its results must be inc [...]
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3 Steps to an FDA-Worthy Human Factors Validation Study
by Elyse Hallett Posted Nov 01, 2022 In Human Factors & Usability Testing, Medical Product Design
A human factors validation study is an exercise to prove a market-ready product’s usability and safety in the hands of representative end users. You may know this as summative usability testing. However, the FDA dislikes this term as it can “omit essential components of human factors validati [...]
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Whitepaper: Medical Device Leaders’ Comprehensive Guide to Human Factors Engineering
by Elyse Hallett Posted Jul 29, 2022 In Human Factors & Usability Testing, Medical Product Design
Developing a medical device is already a long, involved, and often expensive process. Adding time and personnel to conduct human factors engineering (HFE) seems like a high cost addition, and for what benefit? HFE actually serves two immensely valuable purposes and vastly benefits the medical dev [...]
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Human Factors Engineering vs. UX: Are They Really All That Different?
by Chris Ross Posted May 30, 2022 In Design Strategy, Human Factors & Usability Testing, Medical Product Design
From a medical device development perspective, the goal of human factors engineering, usability, and user experience activities is the same: To release a product that meets users’ needs in a safe, effective, straightforward, and delightful way. But the technical definitions of these terms can v [...]
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Designing an IFU for Usability – Not Vanity
by Carmen Cumming Posted Aug 11, 2020 In Human Factors & Usability Testing, Industrial Design, Medical Product Design, User Interface Design
Consider a time when you opened up a new product. Maybe you just bought an IKEA desk, and you are super excited to get to using your new "FOLUBAN." You open the box, pull out the pieces, and a paper falls out with drawings of tiny people guiding you on how to assemble your desk. This is probably [...]
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Reducing Risk of Medical Products Through Prototyping
by Ryan Held Posted Jul 10, 2020 In Human Factors & Usability Testing, Medical Product Design
Prototypes are the cornerstone of medical device development. They are powerful and important tools that transform ideas, thoughts and theories into something real. Prototypes also become a catalyst for deep collaboration and clear communication. It can be overwhelming, however trying to keep tra [...]
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Don’t Just Listen to Your Users — Watch Them, Too
by Paul Klock Posted Jan 28, 2020 In Human Factors & Usability Testing, Medical Product Design
It goes without saying that medical devices should be both safe and effective. But those qualities are really just the baseline. If a product is safe and effective but doesn’t actually solve users’ problems, it won’t matter. To put it another way, the real measure of a medical device’s succe [...]
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Webinar: How to avoid the common mistakes of formative evaluations to meet user needs
by Chris Ross Posted Oct 21, 2019 In Human Factors & Usability Testing, Medical Product Design
You want the healthcare products that you design to improve people's lives. But that extends beyond the patients you aim to heal. Other than clinical efficacy, a medical device’s ability to meet its users’ needs is the most important predictor of success. For that reason, medical device developm [...]
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Human Factors and Usability Summary Report: Why You (& the FDA) Need a Good One
by Chris Ross Posted Mar 13, 2019 In Human Factors & Usability Testing, Medical Product Design
The last thing a medical device manufacturer wants to receive in response to their FDA filing is a “request for additional information.” It’s usually not a deal killer, but at the very least it’s going to delay the approval process and ultimately your product launch. Delays mean substanti [...]
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White Paper: Formative Testing—Your Medical Product Design Strategy Can’t Work Without It
by Chris Ross Posted Oct 09, 2018 In Human Factors & Usability Testing, Medical Product Design
Have you ever said to yourself of a product, “WOW, it feels like they designed this just for me!” or “I didn’t even know I needed one of these?” It’s a great feeling. Some company out there cared enough to solve your problem and put a smile on your face. In the healthcare world, that [...]
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Balancing Market & Technology Product Needs by User Testing Early and Often
by Andy Moulds Posted Aug 21, 2018 In Human Factors & Usability Testing, Medical Product Design
After months of allocating resources to your new product development project, it has moved into the validation process and user testing. There is the knock on your door and your team approaches you with a major problem. The product has missed the mark by being too large, too heavy, or too complicate [...]
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How to Break the Curse of Habit
by Chris Ross Posted Sep 29, 2017 In Human Factors & Usability Testing, Medical Product Design
Our brains are like a GPS mapping app, automatically adapting to a constant stream of information and only occasionally asking us to choose an alternative route. That automatic decision-making process driven by our subconscious is both a blessing and a curse for medical product companies. The [...]
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