Eight Hours Inside Bigfoot's Diabetes Lair

Entering the Bigfoot Biomedical headquarters is a true Silicon Valley experience -- from the exuberant youthful-startup feel of the building design to the bold decorations on the walls, an ultra high-tech "virtual simulation lab" and a manufacturing assembly floor that’s eager to start cranking out advanced diabetes devices.

This four-year-old company doesn't have a product on the market just yet, but has huge ambitions to change the D-world with its Automated Insulin Delivery (AID) systems that will hopefully be ready for market within the next couple years.

Now 110+ people strong, this startup’s in the crucial final stages of product development for its system components, which will include both an insulin pump and connected insulin pen, giving users a choice of dosing delivery method. They plan to offer a bundled subscription model, providing customers all the necessary supplies with a single prescription and order.

Until now, their future products have been referred to internally as Bigfoot Loop and Bigfoot Inject. But this past week, the startup announced the official commercial names: Bigfoot Autonomy for the pump product and Bigfoot Unity for the connected pen version, the latter planned for launch in 2020.

"Bigfoot will be successful only when our systems are in the hands of people who need them,” says D-Dad Jeffrey Brewer, Bigfoot Co-founder and CEO whose son Sean was diagnosed 16 years ago with T1D. “My journey at Bigfoot has been the most demanding and intense of my professional life. But none of that matters until our first customer is more free to live his or her life outside of the burdens of diabetes. That's what motivates all of us every day.” 

You can literally feel the anticipatory buzz when you walk through their building, with animated discussions happening everywhere around you -- in hallways, windowed meeting rooms, and desk areas, where brains are clearly hard at work. That's what I observed during a recent visit to Bigfoot's Bay Area HQ in early February. My cumulative 10 hours spent with them included a tour of the facility and lots of conversations with employees, as well as a casual chat over dinner and drinks in the evening. Here's my recap of that experience and insights gained about the next-gen diabetes management system they're creating.

A Diabetes Sasquatch Theme

Remember, this company is named after the mythical Bigfoot creature that was historically so elusive -- did he exist or not? In this case, about five years ago rumors began to spread of a guy out there somewhere who'd hacked into his diabetes devices to create a so-called Artificial Pancreas... but no one would publicly confirm his existence or real name. That changed in late 2014, when this diabetes tech-savvy "Bigfoot" outed himself and finally shared his family's story with the world. It turned out to be D-Dad Bryan Mazlish from New York, whose wife and son live with T1D, who had managed to crack the code on a CGM and insulin pump to create the first-ever homemade closed loop -- years before anyone else was openly doing this. Mazlish partnered with a trio of other D-Dads that led to Bigfoot's formation:

• Brewer, known as the "Father of the Artificial Pancreas" as he'd been JDRF's CEO for four years and helped pave the pathway for closed loop technology
• former Medtronic Chief Engineer Lane Desborough, who had helped create the data-sharing game-changer known as Nightscout
• Jon Brilliant, who'd served as CFO with WellDoc that he had also co-founded years earlier

Since the start, Bigfoot's had semi-consistent WOW! moments – from acquiring the Asante Snap insulin pump technology right after that company announced it would be shutting down in 2015, to buying digital pen cap company Timesulin, teaming up in 2017 with Abbott Libre on a next-gen iteration of that Flash Glucose Monitor, and kicking off its key clinical trial research over the past couple years.

From the moment you walk into the lobby, the Yeti theme is apparent. There is of course the large “Bigfoot's eyes" logo stamped on the wall over the front reception area, as well as on big screens displaying their vision for an AID system, to a display case with a “Sasquatch” craft beer brand along with numerous impressive medtech awards (with room to add more). On the white wall under the TVs are placards displaying just a small selection of the 100+ patents the company has secured.

Meetings seem to flow freely around the building, as you’d expect from any Silicon Valley medtech company. But here they happen in rooms called “Yeti" or "Abdominal Snowman” as well as in the hallways, cubicles and modern gathering spots sprinkled around the office. White boards and smart screens abound, and there's a game room to exercise those creative brainstorming skills over yoga or ping pong, plus a communal lunch room for on-the-go meetups and conversations inside or outdoors. And yes, a common sight for just the single day I visited was any number of people who appeared to be sprinting between desks and meetings with boundless energy.

You can just feel the energy, the ambition to grow and expand. All you have do is look around.

Bigfoot’s Business Model and Future Products

As to the product itself, here’s what we know:

Bigfoot Autonomy (aka  Bigfoot Loop): The insulin pump component is based on the tech and design by Asante Solutions for the Snap pump, before it went out of business in May 2015. The partially-disposable insulin pump has a “brains” part and a disposable piece that holds the insulin cartridge -- that snap together. What Bigfoot's developing will be a screen-less pump device with fun Bigfoot "eye" symbols, and a smartphone mobile app will be the main user interface, so you won't have to pull out the insulin pump to operate it or see data displayed. Users will enter meals on the phone app, which will then recommend a dose and allow delivery without having to touch the pump.

Bigfoot Unity (aka Bigfoot Inject): This is the injectable pen version that does pretty much what the above pump-option does, but gives a choice for those who prefer Multiple Daily Injections. It's based on the Timesulin smart pen-cap to track doses they acquired, but goes way beyond that. They envision not only a pen that will a scanning function over the future Bluetooth-enabled Libre sensor that will be able to beam all glucose and insulin dosing data directly to the smartphone app -- plus a similar function on the connected Bigfoot pen, so you could use that to scan your Libre sensor too. They have some not-yet-public prototypes floating around the office, and it was fun examining those and being able to mimic the on-arm sensor scanning capability envisioned and then pretending to pull my phone out to see glucose and dosing data. 

CGM: For both the Pump and Pen versions, Bigfoot will use a next-gen version of the Libre flash glucose monitoring sensor made by Abbott Diabetes Care. The two companies announced an agreement in mid-2017 to use a future, Bluetooth-enabled version of the 14-day Libre sensor with the Bigfoot AID systems. Remember, we're not talking about the existing Libre sensor where you must scan to get results; this would be a yet-launched iteration where the CGM data-stream would be continuous between pump or pen, and smartphone app. That contract with Abbott extends through 2021, after which we would expect Bigfoot may well collaborate with other CGM makers to offer other options to their customers (like Dexcom, which was an original Bigfoot partner prior to the G6 "no calibration" version release).

Business Model: Bigfoot plans to be its own supply vendor, meaning you order everything from them, bundled in their own branded packaging (minus the Libre, which will retain its product box and labeling). They have mock-up product boxes and labels displayed in a front area meeting room, but I wasn't allowed to snap any photos, as those are not ready to be shared publicly yet. Will a "bundled" business model really work? We talked about how Medtronic and United Healthcare have a value-based insurance design arrangement, but the connected meter isn’t covered. And how Tandem and Dexcom have an integrated product but users have to get separate prescriptions and make separate purchases for each product. Bigfoot wants to address those issues, making it a one-stop-shop for pretty much everything a user would need.

As Bigfoot’s Community Relations Director (and fellow D-peep) Melissa Lee puts it: "It’s about making it as simple as possible, and ensuring that those who want it can get it."

When? Important clinical study work is expected to go through 2019. Bigfoot's hoping for approval and launch of its connected injected pen system in 2020, with its pump-version AID tech to follow -- all dependent of course on clinical studies, regulatory review, and product development all aligning. With Bigfoot becoming one of the first to earn FDA's expedited "breakthrough device designation" in late 2017, the hope is that their regulatory process can be trimmed down.

That means right now, the company has all the expenses involved with R&D and a quickly growing staff, but no revenue being generated. Their internal focus is on fundraising and product development and working with regulators on the models that will eventually be filed for review. We anxious members of the D-Community need to keep that in mind, because it takes a heck of a lot of time and money just to get a first-gen product before the FDA for consideration.

Of course, Bigfoot isn’t alone in working towards a next-gen "Artificial Pancreas" system. Medtronic has its 670G system on the market, and Tandem Diabetes Care is close to having ready its Dexcom-integrated Control-IQ algorithm, while Lilly Diabetes, Beta Bionics and others plug ahead on developing their own closed loop tech. And of course, there are the quickly spreading open-source Do-it-Yourself projects that include OpenAPS and Loop. But significantly, Bigfoot may be the first (or only) player to offer both a pen and pump option – something the company says “meets people with diabetes where they are, whatever they may want to use.”

Getting there means collaborating with industry partners, from a CGM manufacturer to insulin companies that have signed on for their product to be utilized in the system, to Bigfoot's recent agreement with pen-needle makers Owen Mumford. More of these partnerships will materialize down the road, no doubt.

Touring the Bigfoot Manufacturing Floor

Being able to walk around the manufacturing floor was illuminating, even if it wasn't up and running yet. While the space was a bit empty feeling, seeing the guts of D-tech creation and hearing the explanation was pretty eye-opening.

Leading my tour was Operations Manager Chris Sepe, who has been with Bigfoot for about three years and is one of eight who'd previously worked at Asante prior to its closure. He took me around the area, which is 40% of the total 40,000 square feet building but may expand if the company moves to a new HQ nearby that is twice the current size.

I got to hold the Snap pump, something I haven’t done in several years since before Asante Solutions shutdown in 2015. It was like seeing an old-friend again. It was also exciting to see and hold the pen-cap prototypes for Bigfoot Inject, which all basically look the same but whose data display will will vary depending on the particular insulin pen one uses.

The base form factor of the pump still closely resembles the original Asante product. But Bigfoot has its created its own controller unit, with the black look that is unique to them. The glass cartridge inside is protected with many built-in safety features, and they're using the Ypsomed infusion sets out of Europe that have 360-degree rotation (compared to the Unomedical infusion sets that are so common). On the R&D line, I got to see the kinked tubing that's one of the safety mechanisms created to allow air into the pump, but not water. There's also a tiny sponge inside to absorb any water that could possibly soak inside, as another safety aspect.

Looking around, even at a manufacturing line that wasn’t yet operational but, I could see the future ready to roll. 

 

Bigfoot Biomedical’s Inner Workings

Other aspects of the tour that stand out in my mind showed off the inner workings of Bigfoot's technology -- from the clean "control lab" that's protected from earthquake tremors and temperature fluctuations, to the more nuanced processes of building these complex devices.

Automation Testing Platform (ATP): In one of the most secure rooms in the building, there's a huge piece of equipment that is so important and expensive that it felt like I should be walking around on my tiptoes in there. To me, it just looked like the large inside of a microwave with moving parts and gadgets and wires. The official description: a custom-built piece of testing equipment that allows Bigfoot to explore its system components, evaluating the function and quality of each one individually and in combination with other parts. Essentially, it's creating a hardware simulation of what the Bigfoot systems will do.

Poker Table Signal-Testing? Off to the side of the manufacturing floor was a round table set up the way you might envision a poker game table. There are small monitors and smartphones setup around the circular table, and in the middle rather than a deck of cards you have a Bigfoot controller. It's testing all the signals and interference possibilities. Nearby, there's also an eight-foot-long table that could be used for a similar purpose to test the linear workings on the signal front.

Virtual Clinic Simulations: One of the most innovative aspects of what Bigfoot's built so far is known as the "vClinic," a cloud-based simulation environment virtual software simulations take place. They run a simulation model in a virtual clinic testing setup, to generate endless amounts of data 4 million (!) times faster and less expensive than real-time clinical data. It takes only about three minutes to simulate a three-month, 100-person study, I was told! Their landmark Clinical Research Center trial using this method was a first-of-its-kind in the diabetes and medtech space that concluded in late 2016, and results were published the following year. While that's a virtual place you can't actually visit, I was able to explore the "Continuous Integration Automation Lab," a small room with 15 smartphones hooked up to flatscreens where Bigfoot can test out the software to make sure it works on those phones as part of the connected system. It sits next door to the "Design Assurance Lab," where the team can test out the phone-and-pump connectivity. 

That's impressive in itself, and goes to show how incredibly much work and investment is necessary long before a product is even finalized. Those are all just pieces of impressive equipment, though. The true magic is what comes from the hearts and minds of those working at Bigfoot.

Big(foot) Hearts and Minds

For me, seeing that collection of patents on display in the front lobby set the tone for everything inside. To date, Bigfoot has 127 patents secured in the U.S. and 106 others pending; as well as 80 others issued outside the country. They range from device design, pumping mechanisms, software workings, user and smartphone interfaces, control algorithms, service models, cybersecurity and distribution.

These are the accomplishments of a group of brilliant people hailing from all walks of life and various backgrounds in technology, healthcare and other fields -- including two user experience designers who'd previously worked for NASA, and another from the U.S. Navy with experience reducing errors of tired sailors manning ships!

As noted, the co-founding D-Dads are standouts and they often get the most credit and public recognition. But there are many others from the D-Community now working at this powerhouse startup as well, including the incredible HCP, researcher and T1D herself Jen Block, who's made a name for herself in the closed loop tech space. Significantly, Bigfoot is 45% female and that includes women on every team from software, manufacturing, regulatory, product management, quality, clinical, and execs; three of the VPs are women, in fact. They have a couple dozen people on staff who live with T1D themselves or have an immediate family connection, as well as others living with T2D.

There were times during my visit when I was left in a conference room, because the Bigfoot folk were called off to impromptu meetings or critical calls. I didn't mind, because it gave me a chance to just sit back and take it all in. I observed daily diabetes on display -- from devices and DIY closed loop tech attached to monitors or sitting on desks, to CGM and pump beeps that could be heard every so often from somewhere across the way. Informally, it was cool to see that fellow D-peeps who work in the office sometimes exchange supplies and meds if they happen to run out during the workday, and it was fun to explore a cabinet full of old and new diabetes supplies brought in as part of Bigfoot's historic collection.

I had a chance hallway encounter with Bigfoot's general counsel, who is clearly concerned about the regulatory and legal side of things and probably had reservations about letting this reporter into the building at all. But he was kind and generous with his time, and it was fascinating to hear him generally touch on some of the concerns they work through, such as sharing prototype images for public consumption before the product is FDA approved.

Even on the wall near the lunch room, you can see the passion for our D-Community: a huge, colorful wall mural that includes the Blue Circle for diabetes awareness.

Turns out it was created originally for Asante Solutions by artist Andreina Davila, who with her husband (fellow T1D advocate Manny Hernandez) co-founded the Diabetes Hands Foundation and TuDiabetes. That stayed on the wall after Bigfoot acquired the former Asante facility, and it remains for a key reason: "It tells the story of the diabetes community growing together and connecting in the pursuit of better lives. Using semiology, the tree represents a growing diverse community of PWDs, industry and caregivers; while the blue circle (universal symbol for diabetes) represents global unity behind a common goal; and the abstractions of insulin crystals interconnect the tree and Blue Circle, representing the hope that technology can bring to the D-Community."

Wow! Technology, art and passion coming together at Bigfoot's HQ.

What I saw was just a sneak peak of what our community will ultimately get once Bigfoot's ready for prime time. Seems to me what they're imagining to help people with diabetes will be... well, a big footprint, indeed.

Just how big and how quickly we get that real-world sighting of the Bigfoot AID remains to be seen.

"I want the diabetes community to know that we are as impatient as they are," says Lee, whose husband Kevin also works at Bigfoot in engineering and has co-authored a patent with Brewer. "We want what we're building for ourselves, for our families. But we're not just working on a single piece of hardware -- that's hard enough -- but Bigfoot will be end-to-end, integrating many devices, adding intelligence, and delivering it as a service. So we're working hard, every day, shoulder-to-shoulder, to deliver on that vision."

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Written by Michael W. Hoskins and originally published at DiabetesMine on March 25, 2019