CYP2C19 UI

Medical devices can be challenging to design for. There are numerous concerns and regulations that must to account for, and they require a great deal of rigor in documentation. It's also critical to get the design right before submission to a regulatory body (like the FDA), since any changes to the design after that can have major regulatory impact, and impose a huge burden of work across the organization. The core team working on this interface was myself, another designer, and a Windows developer.

The CYP2C19 UI is the software component of Spartan Bio's CYP2C19 Test and allows a user to run a DNA test on the Spartan Cube, a rapid DNA analyzer.

One of the goals was to eventually get the Spartan CYP2C19 Test to a "CLIA waived" designation from the FDA. This would mean that just about anyone could run the test. For reference, many DNA analyzers—like the Spartan RX CYP2C19 System, the product's predecessor—are designated as high complexity. This means they can only be run in a lab by qualified technicians. An example of a waived device that anyone can use would be a blood glucose meter. Waived devices must be incredibly robust, and be usable with minimal training. This drove us to take great care to make instructions and training materials simple and user-friendly.

Features this interface includes are:

• Guided workflows for running a test, or a control
• A searchable log of test and control results
• User logins and permissions to protect potentially sensitive patient data
• An optional, time-based lock
• An optional training module

As this was for a medical device, design of the UI fell into Spartan's design control process. The features above were determined in the concept and feasibility stages, along with a number of low-level requirements. These were based on regulatory, technical, and end-user requirements.

Once the initial requirements were set, we moved on to design and development of the UI, continually refining the requirements. We built the prototypes in XD, then used its handoff features and a tight feedback loop with our developer.

Guided workflows

Ensuring users could successfully run our test every time was critical to gaining FDA clearance, let alone CLIA waived status. One of the features we implemented were guided workflows for tests and controls. Users never had to guess what to do next since they were provided with instructions and illustrations. For the critical and more complex task of tapping and mixing, we even included a video of how this process in the UI. You can see what we did for the text workflow in the video below.

Searchable log

We included a log so users would be able to go back and check results of a given test at any point in the future. Since there could potentially be many records in the log, we included a search function to help users find results more easily. Click on a result in the log would show extended information about the test result.

Since many of our users would have their own record keeping systems, we also included an export feature to facilitate entering our results in their systems.

Logins and lock outs

Although users of this system should be following HIPPA guidelines, we also took steps to protect patient data. A key step was to implement user logins in order to access the system.

The login form was designed to provide clear feedback in a secure way. Instead of entering credentials, users also had the ability to scan a barcode. This is common in hospital settings where users are able to scan their ID badges to access equipment.

An optional setting was included to lock the system after a certain amount of time, so users could be confident the system had not been tampered with. This lock was able to occur while a test was running, so we also added test status to the lock screen. The system works with 1 laptop controlling 1 Cube, so it was important to show when the system is busy.

The lockout time and users could only be configured by the system's administrator.

Training Module

To help ensure our users' success in running the system, we included a training module. This module outlined the entire workflow, from sample collection, to running the analyzer. It included clear instructions on how to perform each test. In addition to the main instructions, it also provided some additional pointers.