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The form factor for insulin pumps hasn't really changed dramatically over the years, other than one traditional tubed pump now featuring a touchscreen and one groundbreaking tubeless pump that was introduced nearly 15 years ago.

But recently, we've had a glimpse of the potential next evolution for insulin pumps: an ultra-thin Band-Aid like tubeless patch pump that sticks onto your skin, is flexible enough to bend and curve with your body, and has multiple reservoirs not only for insulin but for other medications like glucagon to boost blood sugars when necessary.

The product is called Evopump, under development by Boston-area medical device startup Cam Med. Founded in 2014, the company specializes in microfluidic-based drug delivery, and won an innovation award from the T1D Exchange in 2017 and then partnered with JDRF a year later to create this future multi-reservoir flexible patch pump.

In early November of this year, Cam Med demo'd its Evopump tech at our own DiabetesMine D-Data ExChange event in San Francisco, renewing excitement about what it's building.

The company envisions its Evopump becoming an essential component in new "closed loop" glucose control systems, paired with any number of different CGM (continuous glucose monitor) devices, or smart algorithm of your choice.

Let's be real here: This is a few years out from hitting market, at least. Even if the company starts key clinical trials in 2021, it could still be a while before it even gets to regulators for evaluation. Nonetheless, the Evopump is an exciting concept.

"With the Evopump’s low profile, flexible form factor and the ability to deliver more than one medication, we are poised to not evolve the on-body insulin delivery market, but to revolutionize that market," says Cam Med's Chief Commercial Officer Richard Spector, who lives with type 1 diabetes himself and formerly worked at Insulet (creators of the Omnipod tubeless pump). "We are thinking very much outside the box with the Evopump technology -- all the while keeping the user experience as the foundation of our efforts."

 

What is the Evopump?

Flat, Ultra-Thin, and Soft: The insulin-holding part of the device is rectangular and thin like a bandage, less than one centimeter in height. The company markets it as being able to "disappear underneath clothing." It's also soft and can contour to a particular person's body more naturally than existing plastic devices that don't bend. Similar to the Omnipod, the Evopump is a one-piece disposable device that cannot be reconnected or reused once disconnected from the body.

Fill and Stick On: A user will fill up the Evopump with insulin (up to 300 units) and then peel off the back adhesive, before sticking it onto the body. It has a circular spring-loaded applicator, that the user twists to remove and dispose of, so only the thin patch pump remains on the body. The flexible design allows it to be placed on more spots on the body than existing pumps, especially helpful for children and those who may be thinner and have less "real estate" to work with -- meaning areas with fatty tissue that infusion sets / injected pumps require.

Driven by Currents: The Evopump works differently than anything available now. Instead of using a mechanical process within the pump, it's driven by an electro-chemical reaction -- electrical currents generating gas bubbles inside, allowing for a precise amount of medication (insulin / glucagon / etc.) to be delivered through the structural membrane via the cannula underneath the skin.

Multi-Reservoir: Rather than the single large reservoir found in most pumps, Evopump contains an array of tiny reservoirs with small electro-chemical actuators at each, and a microfluidic tubing network connecting the reservoirs to a soft, subcutaneous cannula. This allows the Evopump to deliver multiple medications as and when needed, for a variety of health conditions. For diabetes, the idea of course is to add stable liquid glucagon in one reservoir to offset low blood glucose when needed.

Wireless BLE Tech: The Evopump uses built-in Bluetooth Low Energy (BLE) tech to beam data directly to either a smartphone app or a separate handheld retriever. This will also enable Evopump to be interoperable, something Cam Med likes to call "bring your own device and algorithm" when building a closed loop system.

Access and Affordability? It's too early for Cam Med to provide pricing specifics, but the company says the unique design of the Evopump enables it to be manufactured at a fraction of the cost of existing pumps, enabling "much more affordable pricing." In fact, Cam Med believes it can mass produce the Evopump for what it currently costs to create a traditional insulin pen.

 

Excitement over the flexible patch design

For decades, people with type 1 diabetes have been vocal about longing for an insulin pump that could be smaller, more comfortable and more discreet. At our Nov. 8 #DData event in fact, a whole discussion popped up about the need for devices that work better for the bodies and apparel choices of women with T1D. So Cam Med's demo was met with much enthusiasm.

In choosing to financially support Cam Med, JDRF has described this type of miniaturized, user-centric design as one that could "substantially reduce the burden of living with type 1 diabetes and remove obstacles preventing some people, particularly children, from using devices that could improve their glucose management."

The 2018-announced JDRF-Cam Med partnership supposedly quickened the pace of R&D and potential commercialization for the Evopump, though its not clear just how much.

In Cam Med's view, their Evopump design and ease-of-use can help many people using multiple daily injections (MDI) more easily transition to a more powerful wearable insulin delivery device. The company notes how few people with T1D actually use pumps on the whole; some sources put the numbers at less than 40%. Reasons may vary, but they include bulkiness and less-than-ideal design, along with affordability and access.

Their COO Spector sees the Evopump as nothing short of revolutionary. He was diagnosed at age 11 back in 1981, when injections were the norm and home glucometers were in their infancy. He started using an insulin pump in his 20s after college, and says he never questioned that experience until being exposed to the Omnipod when he eventually joined Insulet's drug delivery group in 2015. That's when "the light went on" about what was possible, he says.

"Very much like the introduction of the iPhone, where the smartphone market appeared to be well established, there was a pioneer device that redefined that market... And now, I feel honored and privileged to be part of Cam Med, where with the EvoPump we are redefining the insulin pump market and beyond," he says.

Cam Med has had a working prototype since 2017. They hope to get a so-called investigational device exemption (IDE) from the FDA in 2020 to allow them to start initial investigational trials, and then to launch larger human clinical trials in 2021 that would set the stage for regulatory submission.

We're fascinated to see what happens with the notion of a thin, flexible patch pump design as it moves forward. This would certainly offer a quality of life boost to anyone whose life depends on insulin, and wants the best possible glucose control with the least bulky and uncomfortable treatment option.