An exclusive Tech Tribune Q&A with Jeffrey Brewer, the founder and CEO of Bigfoot Biomedical, which was honored in our:
Tell us the origin story of Bigfoot Biomedical – what problem were you trying to solve and why?
There are 6 million people in the United States living with insulin-requiring Type 1 and Type 2 diabetes, and those numbers are growing. With insulin-requiring diabetes, the person is managing their own dosing of insulin to control the body’s glucose level, a job previously held by the pancreas. This dosing happens around the clock, 365 days a year either by MDI (multiple daily injections) or with an insulin pump. The real challenge, and danger, for people with insulin-requiring diabetes is determining how much insulin to take throughout the day. What and how much you eat goes into the dosing decision, as do things like exercise and stress level. At Bigfoot, we’re using algorithms, artificial intelligence, and automation to develop solutions that simplify and optimize insulin delivery and dosing decisions. Diabetes is a huge burden on families and on our health care system. We believe technology can play a huge role in lifting this burden and helping people with insulin-requiring diabetes live their healthiest and fullest lives.
I reference the burden of diabetes on families because it played a huge role in the founding of Bigfoot Biomedical. Both I and my co-founder Bryan Mazlish have sons with type 1 diabetes (T1D), and we know on a very personal level the challenges and dangers of managing diabetes.
Bryan and I come from technology backgrounds, and both of our career paths changed when our families received their diabetes diagnoses. At the time, we did not know each other. Bryan was in finance and automated stock trading, and I had founded a number of early dot-com startups, including CitySearch and Overture/GoTo.com, before joining JDRF (Juvenile Diabetes Research Foundation) as its CEO.
Even prior to joining JDRF, I had worked alongside the organization to fund and launch the Artificial Pancreas Project. I saw the huge potential for harnessing technology to create an automated insulin dosing device or what was then commonly referred to as an “artificial pancreas”. I was aware of emerging ideas coming out of the diabetes community, including Bryan’s work. He was using his experience with quantitative trading algorithms to create models to predict future blood sugar trends, which he paired with remote glucose monitoring tools and an insulin pump, effectively building the first DIY artificial pancreas device.
In 2014, Bryan was ready to take his DIY device and create a new paradigm of care for those with insulin-requiring diabetes. We joined forces and founded SmartLoop Labs. That year, Wired Magazine published a piece detailing the legendary story of an elusive figure who’d successfully hacked their own automated system, dubbing him “Bigfoot”. The name stuck and we renamed the company Bigfoot Biomedical, Inc. in February of 2015. Today, we have approximately 80 employees working at our Bigfoot facility in Milpitas, Calif.
What was the biggest hurdle you encountered in your journey?
Since we are a medical device company, it’s not surprising that our biggest hurdles are the important and necessary steps in the FDA approval process. The FDA is a tremendous partner of Bigfoot. Currently, we’re in the final stages of product development and FDA submission for our first offering, the Bigfoot Unity™ Diabetes Management Program, a real-time, dose-decision support system for people using multiple daily injection (MDI) therapy and those wanting to take a break from their insulin pumps. FDA submission of Bigfoot Unity is anticipated in 2020, with a target launch soon after clearance. The clearance we’re getting for this first-generation of Bigfoot Unity, a Class II device, requires no clinical data because any changes in the patient’s underlying insulin titration settings must be initiated by the clinician, so it has a lower regulatory threshold.
What does the future hold for Bigfoot Biomedical?
The future will be busy for Bigfoot! Certainly, we’re excited about the anticipated launch of our first-generation Bigfoot Unity™ Diabetes Management Program, with development of a second-generation Bigfoot Unity system close on its heels. Our program is much more than just a medical device; it leverages many of the advances happening today in digital health and, in particular, opportunities for telehealth engagement. With Bigfoot Unity, the patient and the health care provider can view and share glucose readings and dosing decisions to better refine daily diabetes management, which we believe will lead to better overall health outcomes.
Our program also uses a subscription model to make it convenient and easy for users to manage their inventory of diabetes supplies. If you have someone with insulin-requiring diabetes in your household, you know the difficulties of keeping track of so many items and prescriptions. Users will still get their own insulin, and our subscription service will take care of everything else. We think this service will not only reduce the burden of families becoming their own supply chain managers, but also help to reduce costs.
Bigfoot’s product portfolio also includes the Bigfoot Autonomy™ Diabetes Management Program with a pump-based, closed-loop, automated insulin delivery system. Bigfoot Autonomy’s loop system, which received the FDA Breakthrough Device designation, will require a pivotal clinical trial and subsequent regulatory approvals. Right now, we’re laser focused on validating and launching the technology for Bigfoot Unity. Breaking ground with this initial MDI product offering provides us a better commercial foundation for launching an automated insulin delivery system, like Bigfoot Autonomy, in the future.
What are your thoughts on the local tech startup scene in Milpitas?
Milpitas has been our home since 2015 when we acquired the assets of another diabetes medical device company, Asante Solutions, which was based in Milpitas. Prior to that acquisition, our team had been working from different locations, and then we had a facility and a community in which we could all put down roots. Just this year, we deepened those roots by moving to a much larger facility in Milpitas. Looking back, I can’t imagine having Bigfoot located anywhere else. The tech startup community has been tremendous and the talent here is phenomenal.
What’s your best advice for aspiring entrepreneurs?
Founding and growing a startup is one of the hardest yet most rewarding challenges you can take on. That being said, what makes the lows a bit easier to swallow and the highs a bit sweeter is that this startup, Bigfoot Biomedical, is personal for me. I want every family that has someone with insulin-requiring diabetes to have their burden eased when it comes to managing this very difficult disease. I’ve been an entrepreneur all of my adult life and I can tell you that it has never been more satisfying than with the work we’re doing at Bigfoot. It’s because I know what a difference our efforts will have in the lives of people with insulin-requiring diabetes.