Human Factors & Usability Testing

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

[vc_row][vc_column][vc_column_text]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 [...]

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

[vc_row][vc_column][vc_column_text]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 esse [...]

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 [...]

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

[vc_row][vc_column][vc_column_text]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 [...]

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

[vc_row][vc_column][vc_column_text]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 as [...]

Reducing Risk of Medical Products Through Prototyping

by Ryan Held Posted Jul 10, 2020 In Human Factors & Usability Testing, Medical Product Design

[vc_row][vc_column][vc_column_text]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 b [...]

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

[vc_row][vc_column][vc_column_text]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 [...]

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

[vc_row][vc_column][vc_column_text]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 pr [...]

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 [...]

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

[vc_row][vc_column][vc_column_text]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 t [...]

How to Break the Curse of Habit

by Chris Ross Posted Sep 29, 2017 In Human Factors & Usability Testing, Medical Product Design

[vc_row][vc_column][vc_column_text]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 cu [...]