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Dexcom

Continuous Glucose Monitoring (CGM) systems continuously track glucose levels so that users can see trends and patterns to help better manage their diabetes.&nbsp; The Dexcom G6 CGM system is based on a tiny, flexible sensor that's about the width of a human hair, placed just under the skin.

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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.

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<h3>The Challenge</h3>
While users of the previous Dexcom system greatly valued its enhanced ability to monitor their glucose levels, applying the subcutaneous Dexcom sensor to their bodies was an obvious pain point that was a barrier to wider adoption.
Previous generations of the Dexcom 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. 
<h3>Our Approach</h3>
Through a series of design sprints, we worked with Dexcom to rethink the experience from the ground up.

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<h3>Integrated Human Factors Put the User Experience at the Center of the New Design </h3>

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Anyone can develop diabetes and become insulin dependent.&nbsp;So, the central challenge Delve faced in designing the Dexcom G6 system was to take the mechanical guts needed to make the Dexcom CGM applicator function and encase it in a new form so intuitive that any user could operate it easily and correctly—regardless of age or education level, without special training or instructions, and regardless of their environment.

Having observed users struggle with earlier devices, <a href="https://www.delve.com/insights/a-chronically-underutilized-role-in-new-medical-device-development" target="_blank">Delve's integrated HF practitioners</a> knew the new Dexcom applicator would need to be stable on the skin and have many different grip orientations. They knew the needle and sensor would need to enter the skin at a certain angle. Insights like these enabled HF to contribute to design requirements that would set the team on the path to the right design. Collaborating with the design team from the beginning, HF made sure the entire team understood the problem the same way and had the same starting point of things we knew had to be solved.
As the design matured, 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. HF guided the creation of appropriate models for these user studies. In alignment with our principle that <a href="https://www.delve.com/insights/a-chronically-underutilized-role-in-new-medical-device-development" target="_blank">user study stimuli only need to be of high enough fidelity to get valid answers</a>, our first models were carved out of foam. They were realistically sized. The button was spring loaded to the proper force. They did leave a patch on the skin. But they had no actual internals. This is an example of creating simplified user study stimuli that are not just faster and less expensive to make, but also focus user attention on the aspects of the design that are being assessed at a given time. They enabled us to quickly gather user feedback on which designs worked best and why, so the design team could iterate as efficiently as possible.

We applied our process of designing options, creating prototypes, testing with users, and iterating on the design of the applicator, seal, and transmitter until we had a winning product. This intensive process that went from concept development to manufacturing support. 
It took many rounds of iteration to develop and refine a silicone seal for the sensor/transmitter that was reliable and easy to apply. Delve 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.&nbsp;
Then we did it again, rapidly, five times until we were sure we had a reliably functioning product.&nbsp;
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.
<h3>An Intuitive, User-Friendly&nbsp;Design</h3>
The final design of the applicator is functional and friendly, with a simple, clean form that’s easy to hold and intuitive to use.&nbsp;
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.

06 Work Case Study Dexcom G6 Applicator Transmitter

Sensor application is now a one-touch, one-hand operation, and insertion of the sensor occurs in a blink of an eye.&nbsp;&nbsp; Our engineers achieved this by creating a&nbsp;needle insertion and retraction mechanism that moves in and out of skin as fast as a hummingbird beats its wings. It effectively minimizes any sensation or anticipation of pain. Watch the video:

What had previously been an eleven-step, manual process is now a simple, automatic, four-step process. We were able to eliminate seven steps from the application process by integrating those steps into the device itself. This transformation&nbsp;required a great deal of sophisticated engineering work that is invisible to the user. The final device achieves reliability with a nearly infinitesimal failure rate.&nbsp;The team overcame challenges with&nbsp;jamming, material incompatibilities, and friction to design and engineer a&nbsp;fast, complicated motion in a disposable device that is manufactured in high volume.

06 Work Case Study Dexcom G6 Applicator G5Comparison

Users fell in love with the Dexcom G6 because it transformed what had once been an intimidating experience to one that was painless and error-proof.&nbsp;Users could figure out how to use the applicator right out of the box. Applying the sensor felt, in the words of one user, "like a&nbsp;puff of air on the skin, that's it." Another user said, "Insertion has been painless every single time."

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<h3>A Huge Leap Forward for CGM</h3>
The Dexcom G6 represents a huge leap forward for CGM. It 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 <a href="https://designawards.core77.com/health-wellness/85111/Dexcom-G6" target="_blank">2019 Core 77 Design Award</a> in the Health and Wellness category, a <a href="https://www.idsa.org/awards/idea/medical-health/dexcom-g6-continuous-glucose-monitoring-system" target="_blank">2019 Silver IDEA</a>award from IDSA in the Medical & Health category, and a 2019 <a href="https://www.good-designawards.com/award-details.html?award=35252" target="_blank">Good Design Award</a> in the Medical category.

Learn more about&nbsp;<a href="https://www.delve.com/medical-devices" target="_blank">Delve Product Development Services for Medical Devices.</a>

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Users fell in love with the Dexcom G6 because it transformed what had once been an intimidating experience to one that was painless and error-proof.

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Users fell in love with the Dexcom G6 because it transformed what had once been an intimidating experience to one that was painless and error-proof.

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