CareLink SmartSync: designing an app experience to replace 17-year old technology

Because of confidentiality I’m only able to share a high level overview and describe the process and value I brought to these projects.

Apps for Medical Devices - Not your typical app

Medical device apps require additional testing and rigor around the safety and efficacy of the products to meet FDA approval. These apps prioritize safety, effectiveness and ease of use. Once met, the NEXT STEP Is to FIND WAYS TO delight the user

CareLink SmartSync Product Timeline: 2015-2019

My Team:
Lead Human Factors Engineer
*Lead UX/UI Visual Designer (Me)
Lead Industrial Designer
Supporting Human Factors Engineers
Supporting UX designers

How might we modernize the programmer?

Because of out-dated technology and parts, the 17-year-old Medtronic cardiac device programmers could no longer be supported or maintained and were in need of replacement. These programmers are used in the OR/ER to analyze the placement of leads for pacemakers and defibrillators, as well as program the settings once the device has been implanted.

The Challenge:

Design an app-based system to replace the 2090 and Encore Programmers, keeping top of mind they had been in daily use by cardiac physicians, device nurses and clinical specialists for 17 years. It was clear when interviewing these users that they wanted minimal change and training with the new system. Many of them could navigate the existing programmers without even looking - just based on muscle memory of where buttons were located - and did not want to be slowed down when it came time to switch to an app with Bluetooth connected hardware.

Prototypes

Joining the project at the prototyping stage was advantageous in many ways. There was a baseline for using the existing UI screens/flows from the 2090 and Encore programmers, and it was my job to transfer that design to a mobile app experience. My goal was to create a balance of matching the existing layout for familiarity of placement, but simplifying the UI as much as possible. The screen size was much smaller than the existing programmers, so a lot of thought was put into prioritizing what needed to be accessible from the Home Screen and what could be 1-2 taps away.

Testing

Accompanying the prototypes, I created discussion guides to facilitate monthly user testing on the different feature sets of the app. I met with both experienced and new users to the 2090 (about 5-10 per month), who gave me valuable feedback on the usability of the new system. Since this was prior to handing off the designs to Dev, it was an effective way to bring an iterative process of design into a big corporation, where it’s difficult to be agile and make frequent updates. Using this feedback I incorporated design improvements and enhancements. Once these flows were solidified through testing, I held reviews with the cross-functional team members (systems engineering, software, safety, quality, regulatory, tech comm, clinical education, marketing) for their approval.

This project presented many challenges to overcome because of its scope and timeline. We met with 150+ users, which provided an opportunity to observe and record feedback on system use on a regular basis. The feedback had a significant impact on showing the rest of the team the importance of the improvement requests and shed light on issues that didn’t arise during internal testing. The enhancement requests were prioritized and tracked for future releases. During the user testing process many of the team members were able to observe the product in use. Hearing the feedback from the users themselves helped create fellow advocates for good usability.

Insights

There were countless findings from multiple rounds of usability testing over several years. A couple pleasantly surprising insights came to light later in the development process. These were discovered once we started testing with the visual design style and elements we planned to implement.

Insight: Use of Color
In the initial prototypes of the app, the background color of the waveform was white. We started to get feedback from users that it was problematic for them not to have a clear visual separation between the waveform and the rest of the app area. This also lead to a learning that an all-white background was particularly hard to look at for long periods of time in an OR or ER environment. We made the update to the waveform background color to black and re-met with users to show them the update. We found that it was much more usable and easier to use.

A note about designing with color in a regulated app: color is especially important to consider when following medical design standards, for example system status needs to be defined in more than one way; it cannot just be color. There needs to be a secondary indicator, like a symbol or animation that will help clarify the level of importance a message or status is when using the system.

Insight: Printing vs Saving a PDF Report
Although one of the goals was to create minimal burden to the user when learning this new system, it was important for us to understand the impact of sacrificing a built-in printer for a smaller size programmer. We listened to users concerns on how this would impact their workflow. This was not a minor request - we were asking them to change their mental model of having a print button directly on the programmer vs. viewing the report in a digital PDF and then having to connect to a BT printer or email the document. It became clear that the Reps would need additional support for working with IT in hospitals and clinics since this change to workflow would have a much bigger impact than initially estimated. There was a work stream created to help with this effort and support these users. There was also additional consideration given to the carrying case to include an external printer, if the user needed time to transition from print to digital reports.

Visual Design:

On top of the prototyping, user testing, and UI enhancements, I also created the visual design following the Medtronic branding guidelines. This included a style guide and design assets. This was one of the largest projects at Medtronic during that time, involving over 300 developers to help complete this work, so clear communication for delivering the design specs was key.

Conclusion:

I participated in a limited release cycle, which provides an opportunity to test the system with a small number of clinicians to use the product in its intended environment before it’s fully released into the market. Traveling to various sites in Europe to help train and observe the system in use provided meaningful insights that were immediately applicable. I was able to report back usability issues to the team to address as needed.