Why Your Medical Device Company Should Develop Accessible Products — and How

Medical device designers often overlook accessibility when creating products. Getting a medical device to market is complex, costly, and time consuming — there’s simply no bandwidth to consider accessibility in the midst of an already rigorous process.

What’s more, many people think accessibility is synonymous with physical disabilities, which limits the kinds of medical devices designed to be accessible. But accessibility encompasses physical barriers to care and so much more.

A medical device might be inaccessible if it:

• Isn’t available in rural areas

• Requires technological literacy

• Isn’t cost effective

• Only provides instructions in one language

The list goes on.

All to say, there’s so much opportunity to design medical devices that are accessible to a wide array of patients, not just those with physical disabilities.

It’s time to stop overlooking medical device accessibility. Consider the tangible benefits of designing inclusive products and how your company can do it right.

Expand Your Company’s Reach with an Accessible Medical Device

Quality medical devices are desperately needed all across the world. Yet many medical device companies limit their reach to the United States, Canada, and Europe.

You have the opportunity to expand your market to other countries — and even within the U.S. —  if you design accessible products. For example, consider how well a portable device might do in Africa where you can’t easily ship bulky equipment. Or even in a rural U.S. hospital that shares medical devices with a neighboring hospital and, therefore, requires portability.

It goes beyond adding to the list of countries or regions you reach, too. You can also appeal to new groups of customers with accessible devices.

One of our clients, GreatCall, offers health and safety services to seniors who, in general, are resistant to clunky Life Alert-like technologies. At the same time, this group needs accessible, easy-to-use tech options.

Because of their accessible device, GreatCall has cornered a target audience.

Take User-Friendliness to the Next Level and Appease the FDA

Designing a medical device that passes FDA inspection can be onerous. There are so many regulations to consider, and they’re changing all the time. You’d do anything to smooth the path to FDA approval, right?

Good news: Accessible medical devices might just have a better chance of appeasing the FDA.

The FDA values usability — devices that are as safe and easy to use as possible. And they require medical devices to have design controls to mitigate potential user errors. If your device doesn’t meet the FDA’s usability standards, it won’t make it to market.

Designing a device with accessibility in mind forces you to consider usability more in-depth and from many perspectives. Why? Because you’re trying to create a device that’s safe and effective for diverse populations, not just “ideal” users. If someone with a disability can use your product, so can someone with typical abilities.

In sum, your device might be more usable in the FDA’s eyes if it’s accessible to many kinds of people. You could be more prepared for the FDA’s process.

An added benefit: The FDA issues Humanitarian Device Exemptions. Essentially, these get products through the FDA’s ranks faster if they promise to have significant social impact — like accessibility to vulnerable populations.

Capitalize on the Rise of Home Health Devices with an Accessible Product

The COVID pandemic has permanently changed the medical industry in many ways. For one, home health devices are more prominent than ever before. Patients have been urged to stay home as much as possible amid the pandemic, so the more monitoring and care completed from home, the better.

You should take advantage of the rise of home health devices by designing your own. But you will need to keep accessibility in mind.

Products created specifically for use in medical settings will only be used by doctors, nurses, and other individuals with certain training and abilities.

On the other hand, you can’t really control who uses your at-home devices. So the message is simple: The more accessible you make your home health device, the more customers you’ll attract.

Don’t Dismiss the Value of Altruism for Your Medical Device Company

Generally speaking, there’s not a lot of brand recognition in hospital or healthcare settings. Patients don’t know which brand of tongue depressor the doctor is using on them, for instance.

But the same can’t be said of home health devices. In some cases, customers will actually go to a store to purchase your product — and they’ll have a choice between brands.

Say you develop home pregnancy tests. Your primary customer base is in the U.S., but you also send tests to in-need clinics overseas. Customers care when brands are altruistic. This could be the differentiator that compels them to choose your brand over others.

Also, we’d be remiss not to mention there’s something to be said for being altruistic — for centering accessibility — because it’s the right thing to do. Period.

How to Design an Accessible Medical Device

There are many compelling reasons to design accessible medical devices. But how can you do so successfully?

Discover Your Medical Device’s Access Limitations

To start, you need to think about what might stop users from getting to your device in the first place. That way, you can work against these barriers to get your product into the hands of those who need it most.

There are many factors that can impede access, including:

• Location. How might patient or medical facility location affect who can access your product? Take an example we already mentioned. Rural hospitals might not have access to the latest technologies, or they might share resources with neighboring medical facilities. How can you design a product that gets to more people?

• Age. Elderly people have varying levels of technology skills. If your product is for older patients, what will you do to make sure they know (or can learn) how to use it?

• Culture. There’s so much to think about in terms of culture. For example, colors don’t imply the same connotations everywhere. If you’re selling your product overseas, be sure it’s culturally appropriate and meaningful there, too.

• Cost. Healthcare providers spend a lot of money on medical devices. As technology advances, there’s even more need to buy and replace products regularly. Not to mention many devices come with consumable components that need to be purchased many times over for sanitary reasons. All to say, it’s not all about ergonomics and design. Some devices don’t need to be fancy; they just need to be economically accessible.

• Physical and mental disabilities. These are what most people think of when accessibility comes up — and they are important. Where possible, adapt your product to work for varying ability levels.

Identify Potential Usability Errors and Create a Human Factors Plan

We’ve already discussed the importance of usability (to the FDA and to ensure accessibility). Usability is simply the ability for someone to operate your device safely and effectively.

One of the keys to developing an accessible device (and any medical device, really) is identifying potential usability errors as early as possible. In other words, what could go wrong while someone’s using your product, and what design controls can you put in place to mitigate those errors?

Moreover, you will most likely have to submit a human factors engineering and usability (HFE/UE) validation report to the FDA proving your device is as safe as possible and that you’ve accounted for known usability issues.

By addressing possible usability issues upfront, you’re both creating a device that’s easier to use for all sorts of people and paving the way for a strong HFE/UE submission that gains FDA approval.

Conduct a Formative User Evaluation

Once you’ve identified potential users and usability issues, you should test an early version of your product (perhaps a prototype) to verify your usability findings and uncover other challenges users have with your device.

This kind of testing — when you ask end users to use and interact with your proposed product — is called a formative user evaluation or formative testing.

It’s always important to bring together a diverse set of test users for formative user evaluations. But it’s even more critical for accessible devices. Be sure your test group encompasses many kinds of users — short, left-handed, pregnant, old, male, etc. How will you know your device is truly accessible if you don’t ask the end user to try it first?

You Can’t Go Wrong When You Focus on Accessibility

At the end of the day, don’t you want your device to be available to the most number of people possible?

That’s exactly what you’re doing when you evaluate your medical device design through an accessibility lens.

And realistically, the process for creating an accessible device outlined here — identifying usability errors, conducting testing, and so forth — is essentially the same as the process for creating any worthwhile medical device.

The only difference is you’re expanding your knowledge of new groups of people, and thereby expanding your company’s reach. It’s a win-win.