Human Factors Engineering vs. UX: Are They Really All That Different?

 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, straightforward, effective, and delightful way.

But the technical definitions of these terms can vary. As a result, the terms are often perceived as being markedly different — to the detriment of medical device developers like you.

The best case scenario is that this misperception causes confusion. And the worst case scenario? You develop a product that falls short in one of two ways:

  1. It doesn’t meet users’ standards and tastes because you’re too focused on the technology and the FDA hurdles, or

  2. It doesn’t meet the FDA’s guidance because you’re too focused on the user experience and aesthetic design.

To avoid both of these scenarios, stop getting caught up in the terminology. Instead, employ a robust development process that aims to deliver a superior user experience as your number one objective while at the same time meeting the FDA’s guidelines and IEC standards.

Defining Human Factors Engineering, Usability, and User Experience in the Medical Device Industry

Before we discuss strategies to get out of the terminology weeds to create a user-centric product, it’s helpful to define the terms at hand:

Human Factors Engineering

The 2016 FDA human factors guidance defines human factors engineering (often shortened to HFE) as:

The application of knowledge about human behavior, abilities, limitations, and other characteristics of medical device users to the design of medical devices including mechanical and software driven user interfaces, systems, tasks, user documentation, and user training to enhance and demonstrate safe and effective use.

In simpler terms, HFE focuses on providing a safe and effective user experience with a medical device.

Also note that the FDA recognizes IEC 62366-1 as the prevailing international standard that should guide HFE efforts for medical device R&D teams.

Usability and Usability Engineering

Usability (aka usability engineering or UE) is exactly the same as HFE. HFE is simply the term the United States uses, while Europe and most other countries refer to it as usability.

Even the FDA  concedes, “Human factors engineering and usability engineering can be considered to be synonymous.”

User Experience

User experience (UX) is a broader, catch-all term and is widely used beyond the medical device industry.

For our purposes, according to one of the general ISO definitions, UX includes all the users’ emotions, beliefs, preferences, perceptions, physical and psychological responses, behaviors and accomplishments that occur before, during, and after use. The ISO also lists three factors that influence user experience: the system, the user, and the context of use.

In a sense, usability nests under the much broader UX umbrella since —  at an absolute minimum — a user requires sufficient usability to accomplish a task. UX goes a step further than usability in that it also considers the more qualitative aspects of your users’ feelings and opinions during development.

Why Most Medical Device Companies Neglect UX in Favor of FDA Guidance

The FDA only asks that medical devices adhere to the guidance outlined in IEC 62366-1. This document talks exclusively about the safety and effectiveness of a product, neglecting additional information on delivering an exceptional user experience.

Because getting a medical device to market is time-consuming and difficult, most R&D teams — perhaps yours included — only have the bandwidth to consider this one requirement. They think as long as we check all of the FDA’s boxes, we’ll be fine. This IEC standard is what the FDA cares about, so this is what we’ll use to guide our usability efforts.

And honestly, the technical mindset that prevails within most medical device companies means R&D teams don’t mind that IEC 62366-1 reduces usability to an achievable regulatory checklist that can be completed and validated. More often than not, they don’t have experience focusing on those fuzzy, qualitative aspects — and, therefore, they’d rather not.

Why Neglecting UX Doesn’t Work

A company solely focused on aligning with the FDA guidance in IEC 62366-1 is likely to check the FDA’s safety and effectiveness boxes and gain their clearance or approval. But just because the final product is safe to use and works doesn’t mean it’ll please or delight users.

You may think pleasing users doesn’t matter in the medical device industry. In reality, it’s an increasingly competitive space. It’s no longer enough to differentiate your product based on its technology alone. Another company will come along with that same technology — and a better UX.

What’s more, the COVID-19 pandemic has accelerated the popularity of home health products. Regular, everyday users in their homes expect an even easier, more pleasant experience than a seasoned doctor or nurse in a hospital setting. It’s only a matter of time before this trend informs UX expectations — and demands — for non-home health medical devices in an even bigger way.

The most compelling reason to look beyond the FDA’s guidance? A medical device that is safe and effective should be table stakes.

Think of it this way: If you were looking to buy a new hair dryer, you’d assume that anything on the market wouldn’t electrocute you. Again, product safety is the expectation. Instead, you’d make your purchasing decisions on differentiating qualities including ease of use.

The bottom line? You can meet the usability requirements, receive FDA approval, and still offer a sub-optimal user experience to your customers. Usability must be more than a regulatory requirement.

Neglecting Your Regulatory Duties Doesn’t Work Either

Although it’s arguably less common, it’s also possible to focus too much on UX.

If you concern yourself with pleasing users above all else, you may miss important FDA guidance and, as a result, your device might not gain approval.

No medical device company wants to re-work their product and re-seek FDA acceptance. It’s extremely costly to backtrack in your development process, to say the least.

So, how do you mitigate these two, equally important facets of medical device design to ensure your product is not only approved, but provides its end users with a first-rate experience?

3 Tips for Navigating Your Medical Device’s Usability and UX Journey

The key to creating a medical device that checks the right regulatory boxes and meets users’ increasingly demanding expectations is finding the right balance between the technical and UX aspects of development.

1. Use This Overlooked IEC Standard as Your Guide to a User-Friendly Medical Device

IEC 62366-1 is followed by a related, but separate, document: IEC 62366-2. It’s titled Technical Report Part 2: Guidance on the application of usability engineering to medical devices.

The standard states “it also helps manufacturers produce medical devices that have well designed user interfaces that satisfy users. As such, it can propel a manufacturer beyond a common sense approach to user interface design to an approach that fully embraces usability engineering as an essential step toward design excellence.”

Clearly, this document provides powerful, valuable information about satisfying users and even design excellence, which are expected by your customers — but not required by the FDA. And because the information in IEC 62366-2 isn’t part of the FDA’s recognized guidance, it’s too often overlooked by medical device developers.

It’s not enough to do the minimum to satisfy the FDA and hope a superb UX will follow. Instead, review this guidance in the early stages of development. We’d wager to say it’s an even better, more holistic guide than IEC 62366-1.

2. Plan and Time Your Human Factors Activities Right

To create a successful product, you need to have a strong focus on usability during two phases of development:

  1. At the beginning while creating requirements, before your product is designed, and

  2. During the design process.

At the beginning of your development process, you must clearly define user needs and understand the problem you’re trying to solve for your prospective customers. A robust HFE plan is non-negotiable. It ensures that the proper process, resources, and funding are in place for the duration of the project.

Focusing on usability during your design process is arguably even more important. The user needs will begin to manifest into conceptual solutions and design concepts. This phase will include many cycles of design and build — with ever-important formative evaluations. The cyclical nature of this portion of development is vital. It establishes the connection between your technology and the end user.

The takeaway? Don’t wait to incorporate usability into your medical device development process. After all, summative usability testing is the time to confirm that your product is safe and effective, not the time to react to user feedback and make changes.

3. Trade Your Tech-Driven Culture for a User-Centered Design Philosophy

The R&D department is typically run by a chief technology officer and/or an engineering VP — very technically-minded individuals.

Of course, you have human factors and marketing professionals on your team, too. But they’re often working beside or under your R&D leaders. Meaning all decisions are driven by R&D and, therefore, inherently tech-focused.

What does this mean? Your company may need a culture shift.

If your culture considers usability a mere regulatory box to check, you’ll need to work to include broader UX in that definition or you may never design a truly user-centric medical device.

Don’t Just Define Usability, Incorporate It

The terms human factors engineering, usability, and UX do sound different — but you can’t get stuck analyzing the terminology.

When you focus instead on delivering an exceptional user experience to everyone who interacts with your medical device, you create loyal customers who not only commit to that single product, but to your brand as a whole.

And remember, terminology aside, your ultimate goal as a medical device developer is to connect people with the technology they need in a way they can use it.


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