Making It Simple: Bigfoot’s Approach to the Artificial Pancreas

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Jeffrey Brewer is no stranger to the diabetes community. Known by many in the diabetes space as the enterprising CEO of JDRF who launched JDRF’s Artificial Pancreas Project in 2005 at the same time that JDRF also created programming to bring adult type 1s back into the fold, Brewer has been a pivotal figure in bringing a sense of modernity and urgency to type 1 diabetes. Already a tech entrepreneur when his son Sean was diagnosed in 2002, Brewer worked with the existing industry players in his time at JDRF to try to advance technological solutions for type 1 diabetes, but, like his fellow Bigfoot Biomedical co-founders, grew frustrated by the excruciating pace of development. He feels that his time spent working in the diabetes space has served as a “13-year apprenticeship” to bring him to where he is now, heading up a team of passionate individuals committed to seeing a simpler solution for type 1 diabetes.

That’s a sense you hear echoed by many of the employees you’ll speak to from Bigfoot – that their past experiences in industry prepared them for this opportunity. Many on the team have type 1 themselves or a child with type 1 diabetes. They know the customer already, and, like their infamous co-founder Bryan Mazlish (aka Bigfoot) who invented a working prototype of an artificial pancreas that his wife Sarah and son Sam have been using for nearly three years, the team embraces the culture of the #wearenotwaiting movement. Indeed, roughly 10% of their force came from the Nightscout / CGM in the Cloud developer community.

Bigfoot Staff

So what are they not waiting for? And how long do we have to wait? I recently had the opportunity to sit down with Jeffrey Brewer, the company’s co-founder and CEO, to discuss some of the burning questions we have about the product and service they are developing. *Disclosure: my husband is a software engineer for Bigfoot Biomedical.

The diabetes community has had insulin pumps available to us for decades and continuous glucose monitors available for over a decade, and yet, these therapies still suffer under the burdens of high cost, accessibility factors, clunky training protocol, poor human factor engineering, and spotty payor reimbursement. And we necessarily had to wait for pumps to get smaller, sensors to become more accurate, and advancements in encryption and battery life and platforms like Bluetooth LE (Low Energy) for us to arrive where we are today. We have only recently entered the era of pumps and sensors communicating with one another.

Bigfoot’s goal is to make pump-sensor therapy simpler than the pump companies before them have. They envision themselves as a service provider rather than a hardware or device company. Their service will be to “do a better job delivering insulin,” automating your between-meal insulin therapy, the communication between your pump and your Dexcom CGM, even so far as serving as a single point of contact for all of your supply and prescription inventory management, sending you supplies when you need them, “connecting everything, making it intuitive,” says Brewer. “We want to have our systems fit into the way you live, not have you have to live your life according to how devices work. Between meal times you don’t need to think about it because it’s constantly protecting you.”

Given his tenure at JDRF, an organization who has proven itself a champion of coverage battles where CGM is concerned, I asked him for his thoughts on whether low utilization of CGM or the reimbursement process was an area of concern for the Bigfoot system’s eventual rollout. He stated unequivocally that he doesn’t expect CGM to be a problem. “When someone is approved for the Bigfoot system,” he explained, “they’ll be approved for the system as a whole, not a piece of it,” and to that end, the Bigfoot team is considering the providers and payors as they design their service and software.

First, he expects that the coordination of the therapy, the supply management, and the data will be of benefit to both providers and payors, as redundancy will be eliminated in the process and certain identifiable healthcare economic outcomes will be able to be measured by payors so that they’re going to be incentivized to reimburse it. The company is designing its service in such a way that a primary care provider in a remote location could prescribe and deliver the system to a patient as easily as an endocrinologist at a high-tech facility might, making wearing an insulin pump “orders of magnitude simpler than it is today” and “cheaper than the sensor-enabled pumps today.”

And, excitingly, tying it all together on a smartphone. Brewer describes how the system should be as intuitive to use as a smartphone, without requiring extensive training by an educator or mentor. The average person with type 1 diabetes and his or her primary care physician don’t want to get in the weeds about micro-adjustments to insulin sensitivity factors, multiple basal insulin rates, insulin to carb ratios – “this isn’t scalable,” says Brewer. The user should have to enter as little information as possible and the system should be a “learning system,” making adjustments as it learns the user’s physiology and behaviors.

Bigfoot system

With all of these elements to bring together – and a savvy team assembled to get it done (I disclosed my partiality, right?), Brewer explained that their focus is not on being the first to market, but on “getting the whole package right” with a focus on “quality of life, health, and safety.” They want to tailor everything – the device, the app, the software – to how people live. “We’re going to help you deliver this drug called insulin in a safer, more effective way that requires less of your time and energy and worry. People with diabetes don’t want another feature [on a pump]. They want a different way of living.”

YES.

And that, perhaps, is where Bigfoot’s approach to bringing an artificial pancreas system to market veers distinctly from that of its peers. They’re considering that more goes into truly “closing the loop” and freeing the burden of living with type 1 diabetes than just getting the pump and CGM to respond to one another.

“The algorithm isn’t the hardest part. It may not be sexy or exciting, but the hard work of bringing a solution like this to market is the product development. And we’re doing that,” he explained.

Brewer shared his belief that startups that thrive have a moment where they seize an opportunity. For him and his three co-founders, that moment came when they were fortunate enough to swoop in and purchase the pre-existing, FDA-approved, Snap pump platform as Asante Solutions closed its (brand new facility’s) doors in May of 2015. That catapulted them forward (and across the country from Manhattan to Milpitas, California) in their product development and gave them a foundation on which to build their system. For Snap devotees who had to retire our pumps, it’s heartening to see the easy-to-fill pump bodies re-imagined with a smartphone controller!

Having just celebrated their first anniversary in November, the Bigfoot team is already preparing for a Clinical Research Center study in the second quarter of 2016. They plan for a pivotal trial in 2017 and Brewer has hinted at “precursor solutions” and “opportunities short of a closed loop” coming to market before the Bigfoot system launch planned tentatively for 2018.

Though I clearly let my fangirl flag fly where this enterprise is concerned, I think it’s safe to say that we will all be waiting to catch the next glimpse of Bigfoot.

*Melissa Lee is currently a consultant with Bigfoot Biomedical. She was not consulting for the company at the time of writing this article.

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