While users of the Dexcom system greatly valued its enhanced ability to monitor their glucose levels, applying the subcutaneous sensor to their bodies was an obvious pain point that was a barrier to wider adoption.
The Dexcom G6 Continuous Glucose Monitoring (CGM) System is based on a tiny, flexible sensor that's about the width of a human hair, placed just under the skin. The sensor takes a glucose reading every five minutes for up to 10 days at a time, providing dynamic glucose data that can be accessed and shared safely and conveniently through a smart device. The sensor is coupled with a small, reusable transmitter that shares the glucose readings wirelessly with an accompanying handheld reader or smartphone application.
Previous generations of the system required using a manual sensor applicator that resembled a large, plastic syringe. The user needed to push a plunger to drive a needle into the skin to insert the sensor and then pull up on a collar to pull the needle back out. The process was painful, intimidating and error prone for many users, particularly for parents using the system with young children.
As Dexcom researched these user pain points they developed a concept for an “automatic” applicator that required only a simple press of a button. While the concept showed promise, early prototypes had high failure rates and were unreliable.
Through a series of design sprints, we worked with Dexcom to rethink the experience by applying our process of designing options, creating prototypes, testing with users, and iterating on the applicator, seal and transmitter until we had a winner. This was an intensive process that went from concepting to manufacturing support.
Designing a one-touch, one-hand sensor application was a top priority. A positive user experience required a blink-of-the-eye insertion of the sensor. To minimize any sensation or anticipation of pain, our engineers created a needle insertion and retraction mechanism that moves in and out of skin as fast as a hummingbird beats its wings.
Success also required achieving reliability to a nearly infinitesimal failure rate. Taking what was an 11-step manual process and making it into a simple, automatic four-step process required a great deal of sophisticated engineering work that’s invisible to the user. Basically, the team had to design and engineer a fast, complicated motion in a disposable device that’s manufactured in high volume. Issues with jamming, material incompatibilities and friction were among the biggest challenges to overcome.
We developed several options and built prototypes that our human factors engineers tested with users to identify the best forms and safety features for easy, intuitive use.
The applicator's design is functional and friendly with a simple, clean form that’s easy to hold and intuitive to use. We also redesigned the wearable transmitter, making it smaller, stronger, more attractive and easier to insert. It’s now smooth and sleek, with nothing that can catch on clothing.
It also took many rounds of iteration to develop and refine a silicone seal for the sensor/transmitter that was reliable and easy to apply. Design Concepts did the research and development on the seals and Dexcom tested the many variants until we found a reliable option.
Out of several applicator concepts fully designed in CAD, the team down-selected to one design that was tooled and thousands of applicators were made in a pilot production line for testing. Then we did it again, rapidly, five times until we were sure we had a reliably functioning product. Our team built test fixtures and a pilot assembly line that informed the manufacturer of a simple automation pathway. A lot of the work for the pilot line made it into the final manufacturing process.
The Dexcom G6 represents a huge leap forward for CGM. That means healthier lives for the people who rely upon it and continued market growth for Dexcom.
The design of the G6 has earned the 2019 Silver Medical Design Excellence Award in the Testing and Diagnostics category, the 2019 Core 77 Design Award in the Health and Wellness category, and a 2019 Silver IDEA award from IDSA in the Medical & Health category.
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