Medical Device Developers: Give IFUs and Information Design Details Their Proper Due

 In Medical Product Design

To shape a positive medical device user experience, it’s critical for you to strategize how users will interface with every element of your product. And yet this type of product information design is often an afterthought. For instance, developers too frequently procrastinate their Information for Use (IFU) documentation.

Here we’ll discuss why you should focus on product information design throughout your medical device development process. In doing so, you’ll set your product on a smoother path to FDA approval and subsequent market success.

Why Product Information Design Isn’t Always Top of Mind for Medical Device Developers

It’s easy to get caught up in ensuring your product’s hardware is sound, which is critically important. But safeguarding your hardware’s operation is one reason product information details — like IFUs, packaging design and training materials — are relegated to the back burner.

Another reason? The IFU is sometimes seen as a bandaid to “fix” latent user experience issues. Imagine user testing reveals that people think an element of your product is a button when it’s not. They continually try to press the “button,” so it becomes a barrier to efficient product use. You decide to use your IFU to inform users the element is not in fact a button.

If multiple users are having the same challenge when operating your device, you have a design problem on your hands. One that you should go back and ameliorate. Instead, it often becomes the job of the IFU to mitigate design deficiencies.

The FDA’s IFU guidance might be an incognito culprit when it comes to explaining why designers sometimes delay IFU completion. Why? Because it’s incredibly prescriptive. The FDA even includes formatting rules you must follow. As a result, it’s possible that medical device professionals think completing the IFU is merely a fill-in-the-blank exercise (wherein the FDA has already done much of the work) they can save for the end of development. But that’s problematic thinking. Here’s why.

The Ripple Effects of Overlooking Medical Device Information Design

Quality user experience doesn’t happen by accident. So product information design — including thoughtful IFU completion — can’t take place at the last minute. The information needed to operate your product successfully should be designed with intent and specific, proven processes.

Aside from fostering a good user experience, focusing on product information design throughout development matters to:

  • Your marketing team. They expect your device’s hardware, GUI, IFU, packaging, and training materials to have a consistent, branded look and feel.

  • Your engineering team. They need users to operate your product correctly with information design that drives the user toward desired behaviors.

  • Your business management team. They depend on the user experience and intuitive design to aid your medical device in passing testing and securing a spot in the crowded market.

  • Your associates in the field. They want the training materials product management gives them to sufficiently explain how to use your product so they don’t have to create their own.

In short, product information design matters to everyone who touches your medical device — whether they realize it or not.

How to Better Incorporate Product Information Design Into Your Medical Device Development Process

The importance of solid information design is evident. So how do you improve yours before you start your next medical device project?

First, you must use the same source of truth to create every piece of information connected to your medical device, including IFUs. Even though it’s common for medical device and diagnostic instrument manufacturers to craft IFUs after all other development work is done, as discussed, it leaves your company vulnerable to last-minute summative test failures. Not to mention it results in IFUs that present a different user experience.

Therefore, be sure your IFU, GUI, hardware, etc. look like the same company created them using a single library of source materials. After all, the customer experience includes everything that your customer, users, and patients experience — from the concrete aspects of technical performance to the abstract aspects of simplicity and ease of use. It should all be seamless.

We’ve also established that you should spend time creating a good IFU. But since the FDA is so prescriptive about what is and isn’t included in IFUs, and since IFUs are just one big document, you should consider creating supplemental information to help users operate your product and thereby improve their user experience. For example, you might consider writing a quick-start guide for your medical device. Or labeling product parts pertinent to proper operation.

Above all, it’s crucial that you strategize for the creation of information design elements right from the start — from your IFU to your GUI and product labels.

Launch Your Next Medical Device with IFU Experts

In the medical field, only firms specializing in information design for medical devices and diagnostic instruments are equipped to help your product meet regulatory requirements, reduce risks and provide a top-notch user experience.

At MPE (Formerly Mindflow Design) : An MPE Company, we have specialists devoted to creating IFUs and other information design documentation. We even have visual designers on staff who can streamline the aesthetic of these materials. Most importantly, we work exclusively on medical devices, so you’ll get that regulatory expertise missing from generalist product development firms. Contact us for more information.


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