Design for Simplicity to Earn the CLIA Waiver

When we’re ill, a speedier diagnosis will help you get better faster by shortening the time between seeing a doctor and receiving treatment.

To meet rising patient expectations for instant test results, diagnostic device makers are moving tests from hospitals and centralized laboratories to clinics, doctor’s offices, and even into our homes. Device makers are challenged to simplify products or design entirely new ones that are easy enough for average nonclinical people to use.

For medical companies that normally create devices for laboratory use, this task is not at all straightforward. Burdened with mindsets and processes established over many years designing complex devices

Take in vitro diagnostic (IVD) tests used to detect disease or monitor health, for example. Such tests add a human blood or tissue sample to a disposable kit that is inserted into a device for analysis. These devices are often designed specifically for use in a laboratory environment by a highly trained clinician. For similar testing in a doctor’s office, the FDA requires that it must be usable by someone with a seventh-grade reading level or less.

Companies wishing to migrate diagnostic products away from the laboratory are asking themselves one of two questions:

1. What are the minimum changes we must make to an existing product so we can move from the laboratory to point of care?

2. How do we design a new device so simple that anyone can use it?

In either case, the path to building simplicity into products starts with understanding the Food and Drug Administration’s requirements as well as user needs and abilities.

What is a CLIA Waiver? And how is the Waiver Earned?

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). CLIA regulations describe three levels of test complexity, designating them as either waived tests, moderately complex, or highly complex.

Earning a waiver saves device makers considerable time and money. Companies seeking to prove that their test is simple must submit an application to the FDA. If successful, they’ll receive the coveted CLIA waiver, which gives them permission to sell into markets that require one. It’s important to note that only devices already cleared or approved by the FDA are eligible for CLIA waiver. Tests cleared for “home-use” or “OTC (over the counter)” are automatically categorized as waived and no application is necessary.

Receiving a CLIA waiver requires much more than simply sending in an application. To get an FDA stamp of approval, the FDA Guidance suggests a one-month clinical study with a minimum of 360 patient samples from a minimum of three independent testing sites representative of both the intended patient population and the intended operators. And that’s just the beginning.

The current guidance issued in 2017, updated from 2001, places greater emphasis on intended users (which may include medical assistants, nurses or doctors, and lay people, as appropriate) during these studies. As defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.”

What makes a medical device “simple”?  How do you achieve it simplicity?

A murky unknown stands between your technology and the people who use it. That murky unknown is the user’s experience – how people physically and mentally interact with your device.

The mistake that many companies make is not spending enough time designing the experience they want people to have with their system. Or they do, but from the perspective of a technologist, business person, or scientist rather than who really matters. Achieving true simplicity requires an experience that is designed through the lens of your user, who in the CLIA waived environment, is now a different person.

Harkening back to our example, let’s look at the steps an office manager named Mary of a small doctor’s office might go through to run an in vitro diagnostic test.

It starts with the first impression of the overall system. The appearance of both the device and consumable sample kit should build Mary’s confidence in two ways. First, is the system approachable and does it invite Mary to use it? Ensuring she feels capable of easily running the test is important. Second, does it look like it’s going to give an accurate result? The design language of the device should speak to Mary and tell her that this is a sophisticated, state of the art, high-quality system. One that will deliver accurate results. Perception is everything!

After the doctor orders a test, Mary needs to locate the right test kit. Where is it? How can she be sure she’s choosing the right test kit for the right device? Some are stored on shelves and others in refrigerators. It would help Mary if the branding and style of kit-boxes for all different tests were consistent and recognizable. Once located, help her easily choose the right test by using large font types or color coding. Remember she may be looking high up on a shelf or through to the back of a crowded refrigerator.

Mary takes the kit to a sample preparation area and opens it. What does Mary’s and all other doctor’s offices’ sample preparation areas look like? Finding that out and designing your test to work in that space is the device maker’s responsibility. It will probably look more like your kitchen at home or an office desk than a clinical laboratory bench.

Preparing the kit and then the sample are two of the most important tasks in determining a system’s complexity. What Mary is asked to do and the way she is asked are critical. While recently benchmarking a competitive IVD test system for a client, our team at MPE (Formerly Mindflow Design) found that their competitor required 38 steps for the first task and 34 for the second. Remembering 72 steps would be tough for Mary or anyone else.

The final steps toward a diagnostic’s device’s moment of truth

Beyond simplicity, creating a great packaging insert or quick reference instructions (QRI) and test kit packaging labels are important. When applying for a CLIA waiver, the FDA determines a test’s complexity by reviewing the package insert test instructions, which uses a criteria “scorecard” to categorize a test as moderate or high complexity. The FDA looks at it as a non-clinician in the same way that a new user will.

To continue with the example, Mary takes her fully prepared test kit over to the IVD device. What does that look like? In the engineering lab during development, a single test is usually prepared about a foot from the prototype device and then inserted by a design engineer. In Mary’s real world case, she might transport the test to a different room where the device resides. Or she might prepare and carry multiple patient tests at the same time, needing them to remain organized so as not to mix up patient data. Making Mary’s life easy goes beyond the kit and device themselves.

All these tasks lay the foundation for the moment of truth. Mary’s final interaction with your product and brand: inserting the test sample into the device and receiving an accurate result. Did it remind Mary of simply putting bread in a toaster and receiving the perfect piece of toast? Or of her Christmas tree’s blinking lights as she reaches for the quick reference instructions to build confidence in proceeding?

Moving closer to point of care is not about your company, device, or the FDA. It’s about Mary. If you simplify her life and build her confidence, the rest will fall into place.