Top 5 Tips For Designing User-Friendly, CLIA-Waived Medical Diagnostics

 In Industrial Design, Medical Product Design, User Interface Design

Patients (and their doctors) are increasingly seeking out speedy results from medical tests. As a result, more and more medical device companies are producing streamlined versions of  complex diagnostics that were originally developed for centralized laboratories and hospitals. These new versions are being reconfigured for doctor’s offices, clinics, and even homes. In order to take a simplified diagnostic to market, device makers must first obtain a CLIA waiver from the FDA.

The process of translating a complex lab test to a relatively simple diagnostic that can be operated by a minimally trained layperson is no small feat.

But the biggest challenge of all? You must ensure that your diagnostic meets the necessary performance requirements while at the same time producing a user experience so intuitive that the average person never has to think about the sophisticated technology under the hood. It all starts with a firm understanding of your new users’ needs — and a commitment to excellent design.

If your company is considering developing a CLIA-waived diagnostic, use the following five tips to get started in the right direction.

1. Understand and empathize with your intended users

Many medical device companies that set out to produce a CLIA-waived diagnostic are simplifying a test or instrument that was originally created for use in a moderate or highly complex lab setting. These companies are accustomed to designing products for trained lab technicians. When they think of end users, these are the people they automatically have in mind.

If you take what you know about your usual users — that is, highly trained lab technicians — and apply it to the medical assistants and home health aides who will likely be using your CLIA-waived product, you’re already in hot water. You must pay attention to your actual users and learn from them. You must discover what it is that they need from your product.

Thus, the critical first step is to map your users’ experience and identify all the factors that will influence the way they interact with your product. This can take the form of basic observation of their work as well as contextual inquiries. However you go about it, your goal is to get a real sense of your intended users’ environment, workflow, routines, and pain points, as well as any concerns that need to be taken into consideration through the development process. Ultimately, your fully articulated understanding of your users’ needs should be mapped to your product’s Design Inputs.

For example, a medical assistant in a busy doctor’s office may have many responsibilities beyond just performing diagnostics. They may need to perform multiple tests in one visit to the lab, and the lab may contain many different instruments and diagnostics. Complexity and multitasking may be the name of their game.

If you want to design a product that actually works for your users (rather than against them), you must understand their context, motivations, and challenges —and create solutions that make their lives easier.

2. Create intuitively obvious design solutions for your CLIA-waived diagnostic

In the laboratory setting, technicians may receive extensive training on a piece of equipment or a diagnostic test. The same generally isn’t true of the users of CLIA-waived diagnostics. For example, in many point of care (POC) doctor’s offices, the medical assistant does it all: They weigh-in patients, set up testing equipment, perform diagnostics, and clean up. They’re a one-person crew.

In order to create a winning product, you must use intuitive design to your users’ advantage. Everything from the unboxing experience through end of use should feel easy. Your product should give your users confidence that they can successfully perform the necessary tasks from start to finish without any problems.

Pay attention to the following key interactions to make sure they are no-brainers:

  • Unboxing and setup. Your product should be packaged in a tidy and organized fashion. You can even use the packaging itself to indicate the right order of operations. For example, you might organize all the materials from left to right according to the order in which they are used. Use clear color-coding and labeling to eliminate users’ confusion about what to look at or interact with first.

  • Performing a test. This is typically the most complex interaction, which requires the vast majority of a user’s time and attention. Wherever possible, use design thinking to simplify this interaction and reduce the total number of steps required to perform a test.

  • Obtaining accurate test results. Make sure test results are delivered in a straightforward manner that leaves no room for confusion or misinterpretation.

  • Cleaning or decontaminating and preparing for the next test (for doctor’s offices or lab use). What steps must your users take to clean or decontaminate your diagnostic?

  • Storing away. What do your users need to do in order to safely stow away your CLIA-waived diagnostic? How can you design your product for maximum simplicity when it comes to storage?

3. Pay special attention to your diagnostic’s user interface and quick reference guides

The typical point-of-care medical assistant has very little extra time to read through fine print instructions or navigate text-rich UI functions. Depending on the setting, they may not even know where to find the instruction booklet at any given time.

Too often, the user interface for complex lab instrumentation has an outdated, DOS-like interface requiring convoluted commands and multiple passwords. That same sort of UI, which is already less than ideal in a lab setting, simply won’t fly when it comes to POC offices and home health environments.

Instead, take care to adopt a simple, graphic-driven approach. Your quick reference guide should be illustration-rich with clear visuals that graphically demonstrate each step of the process.

At the same time, your user interface should be big, bold, and straightforward with clear, simple icons. As much as possible, you want your users to be able to quickly and easily navigate your tool — even without the instruction manual handy.

Consider the smartphone in your pocket. Now see if you can make your CLIA-waived device’s UI more like that. The end result should be something your users are already familiar with, not a frustrating new puzzle to decipher.

4. For home health diagnostics, keep it discreet

Devices designated for home use by the FDA don’t need to be CLIA waived.  The home use designation already implies compliance and a level of simplicity.  Individuals generally don’t like to broadcast that they have a medical condition. So when it comes to home health medical devices and diagnostics, discretion is key. In fact, it can play a big role in patient compliance.

For example, let’s say you’re producing a home use blood glucose test for diabetic patients to check their blood sugar after meals. Your users will likely need to use your diagnostic tool in a variety of settings, from the privacy of their home to more public arenas, such as at the office or a dinner party.

Everything about your home health diagnostic’s design should be crafted with discretion in mind. That means dialing down any unnecessary alerts, visible indicators, and bright colors as much as possible.  You might consider creating an MVP or minimum viable product that only has the required functions.

5. Design your CLIA-waived medical diagnostic with safety in mind

Of course, in order to be granted a CLIA waiver, you must design a device that minimizes your users’ risk — both in terms of their personal safety and the likelihood of producing inaccurate test results. Build in failsafes wherever possible. For example, your diagnostic should include built-in alerts in the event that a user makes a mistake (such as leaving a sample on a slide for too long) that might invalidate their test results.

The good news? By sticking with the safety measures already built into the FDA’s Design Controls process, you should set your product on the right course. Namely, you must conduct and review a risk and hazard analysis throughout the project, using a Use Failure Modes and Effects Analysis (uFMEA) and Risk Management plan.

CLIA-waived versions of complex lab products can open up whole new markets — and help patients obtain speedier medical care, too. Plan for success by ensuring that your CLIA-waived diagnostics are built with your new users (and their safety) in mind.


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