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Bigfoot Biomedical Sets its Sights on Simplifying Type 1 Diabetes Management

By Kelly Close and Adam Brown

Twitter Summary: dT interviews 3 minds behind Bigfoot Biomedical – their mission for simplifying #T1D tech, automated #insulin, + better outcomes

Three leaders in diabetes have come together to form a new type 1 diabetes technology startup called Bigfoot Biomedical and have soft-launched a teaser webpage at bigfootbiomedical.com: “Many didn't believe Bigfoot could be real. It is. And it's coming.” The quote comes from Dan Hurley’s December 2014 Wired article, in which an unknown person, dubbed “Bigfoot” at the time, had hacked together a “homebrew artificial pancreas” for his son. It turns out that “Bigfoot” is type 1 dad/husband Bryan Mazlish: his pediatrician wife and eight-year-old son have been using closed-loop automation of insulin delivery for over two years or more than 30,000 hours!  Co-founder, Mazlish, teamed up with former JDRF CEO Jeffrey Brewer and former Medtronic Chief Engineer Lane Desborough to found Bigfoot in late 2014.

From speaking with the team, we understand their strategy is to simplify diabetes technology, particularly for the majority of type 1 patients who are not on insulin pumps or continuous glucose monitors. It’s clear that their driving focus is a simple, intuitive, unified system of delivering insulin that requires less time than current alternatives and simultaneously delivers better outcomes. Given the collective experience and drive of these three leaders, we imagine some sort of automated insulin delivery system is certainly possible.

Below, we share our compelling interview with the Bigfoot Biomedical team, including the company’s mission/vision; what’s most missing in type 1 diabetes (“Empathy. No question.”); the drive to close the loop and why it hasn’t moved fast enough; why Brewer, Desborough, and Mazlish say their entire professional lives have served as an “apprenticeship” for Bigfoot Biomedical; and more. There’s a lot to accomplish, to be sure – type 1 patients and families need all the focus they can get, and they certainly have that in this group.

Table of Contents

Bigfoot Biomedical’s Mission and Vision

Q: What was the impetus to start Bigfoot Biomedical? Why did you change the name?

A: Each of us (Jeffrey, Bryan, and Lane) have extensive experience working with the existing companies, counting on others to implement, but have lost confidence that the industry is going to get there in a timeframe meaningful for our loved ones [Editor’s note – all three have children with type 1 diabetes]. So we are taking a more direct approach.

Bigfoot is a nontraditional name for a biomedical company, for sure, but it’s apt for us because we’re an uncommon biomedical company. In the press (see Dan Hurley’s December 2014 Wired article) and among T1D insiders, our technology has been nicknamed “Bigfoot.” It stuck, and we liked the moniker for several reasons. Our approach, our technology, and our team are unique, and we wanted our name to reflect that. Bigfoot is elusive and sparks our collective imaginations. Bigfoot is unexpected. Bigfoot is fast and quietly powerful. These are qualities we share with this mythical creature. Bigfoot is a name that stands apart – just like our proposed solution for T1D.

Q: That’s fascinating and a little bit audacious! We know the current form of your technology that Bryan’s wife and son have been wearing has been pretty under wraps. Please tell us more about your mission and vision behind the technology as it stands today.

A: Our vision is for a world where the burden of type 1 diabetes has largely disappeared. Unfortunately, a safe, effective and durable biological cure is going to require a multi-decade, multi-billion dollar basic and translational research effort. However, in the meantime, we believe the technology exists to take what is today an omnipresent, dangerous, expensive chronic disease, and turn it into a small nuisance requiring occasional attention. We want people to be able to take all the energy that goes into managing T1D and direct that effort to lives well lived. Our mission is to provide all people with T1D and their loved ones a reliable, trustworthy, cost-effective way to outsource most of the work, worry, and burden of managing their disease.

Q: What would be a home run for Bigfoot Biomedical in 2015? In 2016? In 2020?

By close of 2015, we’d like to see ourselves deep into our product development with a strong collaboration with FDA on how we turn our vision into a commercial product.

A home run for 2016 would be to complete our product development and be well on our way to completing a pivotal trial for FDA submission. By 2020, we would like to be in our second or third generation of development with a diversified line of hardware and software solutions, purpose-designed and built to meet the needs of different segments of the T1D population.

Q: Please tell us how would you rank the following risks: fundraising, clinical data, regulatory, reimbursement, patient adoption, provider adoption, others?

A: The predominant risk is reimbursement. That’s why we are spending so much time in that area right now. We are really focused on getting our pricing model right. If we have the right value proposition for the payers and the right product, then provider and patient adoption will happen. It’s about getting the incentives right.

Q: Can you share more about your thinking on the regulatory and fundraising fronts?

A: Sure. Big picture, we’re very impressed with what’s happening at the FDA these days. Although we’ve been passionate advocates for patient interests vis-a-vis device regulation in the past, the FDA has shown the field a pathway. Industry leadership from Dexcom has really shown us all how to get products through the regulatory pipeline.

With regard to fundraising, you’re right – we don’t see it as the gating factor at all. There is already a lot of capital queued to back Bigfoot – one of the benefits of our backgrounds. It’s about getting the right team, the right plan, and the right business model. Taking this product to market will cost north of $100 million. However, there is a huge need waiting to be filled and a substantial value creation opportunity at the other end.

Q: How do you think about value creation? In terms of the costs associated with patients avoiding the ER for severe hypoglycemia?

A: In general, we are looking to drive better outcomes for our customers - people with T1D - as well as create efficiencies and cost savings for clinicians, health care providers, and payers. Our philosophy is to create and share value. The most tangible way to do so is to drastically reduce acute adverse medical events that have a high and increasing cost to the system, namely hypo- and hyperglycemic events that lead to physician or hospital intervention. We know everyone in the space wants to do that as well - we aren’t unique in that regard. However, I think we are going to design a solution that will do so more consistently for a larger population. We are designing from the ground up to do just that.

Q: If you are the organization that is bringing everything together, can you talk about things like infrastructure and service? Will that be more about being better than what others have or will it be about needing far less of it?

A: We need to do both. What is required is smarter, more connected infrastructure. However, the ambulatory components of the system (what the customer carries around and uses every day) need to be simpler, more reliable, and easier to use. Toward that end, we have applied our collective knowledge and experience to evaluate more than a dozen paths to implement the various components of our system.  We evaluated myriad technical and commercial factors of existing and next-gen technologies. We are partnering for some components, and developing others of our own. At the end of the day, whether we build, license or partner, we will be accountable for the whole system in the eyes of the customer. Making the parts work together will be our job.

The Field of Type 1 Diabetes and Closing the Loop

Q: What do you think is most missing in the care of type 1 diabetes?

A: Empathy. No question. Some of the most important stakeholders have little idea what it’s like to live with T1D. Fortunately or unfortunately, we do. We’re swimming in the fishbowl with the other fish.  We could be sitting on a beach or exploring the world or working for a big company in a more progressive industry. But we aren’t. We have chosen to devote ourselves to reducing the burden of living with T1D.

Q: We would agree there is a lack of understanding on how to address behavioral elements of diabetes, and bring that actively into diabetes management. Until that’s done, we probably won’t see success, in our view. What other challenges will the field of type 1 diabetes face in the coming years?

A: Cost. We need to bend the cost curve, and it’s easiest to do that when your incentives are aligned to do so. Change won’t come easily. Closed-loop systems in clinical trials – Lane’s son has been in two of them – cost hundreds to thousands of dollars per hour. We need to get this down to pennies per hour in the real world setting if this has any hope of getting widespread adoption and access.

Q: So getting back to basics. What fraction of type 1 patients do you imagine will go on closed loop devices in the first years? Ultimately? How do you want to see those who won’t ever make the jump be better served?

A: We believe we need to meet patients where they are. One of our tenets is to make technology more accessible. Note, we do not state that everyone needs to wear a closed loop system. As a holistic, systemic approach we are thinking very hard how to serve a broad population with our system, some of which will use closed loop devices and others may use something between where they are now and what’s possible with the current suite of technologies.

Q: That’s terrific to hear – we’ve come to realize more and more how true it is that the population of people with diabetes, even all those with type 1, are actually pretty different! Can you tell us more about how you are thinking about the closed loop?

A: An important thing to note here is that we are not developing a solution for all types of diabetes. At this stage, we are not even developing a system for insulin dependent diabetes. Our focus is solely on T1D. We’d be thrilled if our solution ended up being more generally useful for all people on insulin therapy; however, we don’t claim to understand or be able to compete in the type 2 diabetes space. What we do know and understand best - and where a very substantial business can be built - is T1D. We will relentlessly focus on the customer we know and understand deep in our bones.

We think less about “closed loop” and more about “human centered automation.” The human needs to be in charge; they need to be able to monitor and intervene and perform maintenance at appropriate times. There’s a reason there are still pilots in cockpits and operators in oil refinery control rooms: people and computers are good at different tasks. There is so much opportunity through the use of automation and connectivity to support people with T1D more effectively. Smart devices, smart networks, and smart people working together to effectively outsource tasks, burden, and worry to us as a third party.

Q: Really fascinating. You guys are smart! Thanks for helping us think more broadly about this. So here’s another hard one. How do you set patient expectations appropriately, especially for the artificial pancreas? We’ve been thinking a lot about this, particularly as patient expectations for normal consumer electronics has increased a lot in the age of the iPhone, Android, etc.

A: This question is probably best answered by Dr. Sarah Kimball (Bryan’s wife and a leading pediatrician in New York City) who understands better than any of us how transformative these technologies will be: “Wearing an automated system is not like being cured of diabetes: you still need to bolus and test occasionally. But it is a lot easier. You don't have to do as much thinking and management between meals or to worry overnight: the system takes care of all that for you and does it better than you ever could. Suddenly, the 30% of your brain that has been forever allocated to 24/7 diabetes awareness and management is freed up, which feels amazing.”

We are looking hard at all aspects of life with T1D and how we can make it easier. Some of this revolves around the daily burden of “how much insulin do I take right now,” but as we all know, there is a lot more. Anything we can do to make life easier we will try very hard to do.

Q: Thank you. Thank you so much. We’d like to hear more. For a start, what patients are optimal for closed-loop systems?

A: That’s like asking “what drivers are best for adaptive cruise control?” Obviously you must have some driving experience, and you must be motivated and willing to service the car when it needs serving. But in the end, our goal is to make a system that is accessible to a broad T1D population so that everyone can benefit from these new technologies, not just the most engaged patients. That is the challenge in the design of our system and we are excited about where we are heading.

Q: Adaptive cruise control. In thinking about the closed loop in that way, what’s must-have and what’s nice to have, for the closed loop?

Bryan Mazlish: We have demonstrated with four people-years  - over 30,000 hours of use - that the current technologies are up to the task. We keep things simple and safe and even an eight-year-old, properly supervised, can safely benefit from automated insulin delivery. Even the algorithms we use are simple. We remotely monitor, and we are careful about carb counting and meal announcements.

Lane Desborough: If we were trying to achieve the “tightest” control possible, then we might need to include more expensive, complex, aggressive components. But we’re not. We’re making a safe, robust, cost-effective, reliable, elegantly designed system that will be accessible and will enable people to more easily live their lives. We are creating a dependable Subaru, not a McLaren engineered to win the Indy 500.

Q: How will you design the trials?

A: Lane: It is very expensive to perform exploratory clinical trials, especially for automated closed-loop systems with high user interaction, and frankly you don’t learn much which can be applied in practical real world use - the land of colds, growth spurts, overdue site changes, forgotten meals, forgotten boluses, and dozens of other safety challenges. My son Hayden has been in two of these trials now (Stanford, Yale), and in both cases the sensors, insulin, and infusion sets were new, the meals were precisely measured, everything was controlled. We believe a better way to generate knowledge and eliminate risk is to use models and simulation. With in silico clinical trials we can preferentially “recruit” the riskiest subjects (hypo-unaware, brittle, disengaged, etc.), and design a system that is robust to the real-world rigors of diabetes. Modern simulators run a million times faster than real life, without risk to any real subjects. The knowledge generation rate is enormous.

Q: How will newly diagnosed patients best use closed-loop technology? Some would ask – how will they cope with it?

Lane: For the Metabolic Control Trial at Stanford University, my son went on a Medtronic closed loop system at day seven, post-diagnosis.  He’s worn a pump and CGM ever since he walked out of the hospital five and a half years ago, and since then we’ve been using technologies like Medtronic’s MySentry and Nightscout to maintain and build skills around glucose management. We’re going into this with a great deal of direct, practical experience, and we’re doing this right:  there’s no reason a simple, reliable, transparent, human-centered type 1 diabetes management system can’t be provided right in hospital at diagnosis.

The Powerhouse Bigfoot Team – Thinking Differently

BRYAN MAZLISH (CTO)

Q: Bryan, you and your wife Sarah (a noted pediatrician and type 1 patient herself) have done some very innovative things to help your son better manage his diabetes. Can you talk about that, and even before that, could you say how it’s different having a child versus a partner with diabetes?

Bryan: Before our son’s diagnosis, Sarah managed her diabetes on her own, and I’m embarrassed to say how little I understood of what she was dealing with on a day-to-day basis. It wasn’t until our son, Sam, was diagnosed about three and a half years ago that I became involved in the daily management of type 1 diabetes – that’s when I truly came to understand what it takes to manage this disease. It is so incredibly challenging to make sense of all of the numbers that I could only imagine how hard it would be for someone not mathematically inclined. I immediately saw that there could be a better way and I was fortunate to be in a position to have the time, ability, and inclination to make a difference: first by developing tools and technology that my family benefited from, and now by bringing these types of technologies to the broader T1D community.

Q: You don’t come from the diabetes world originally; how has that novel perspective influenced the way you think?

Bryan: That’s correct – my background is in quantitative finance. As you can imagine, this is an intensely competitive business, so we dealt with some fairly complex quantitative methods to stay ahead of the pack. A rogue algorithm can take down a firm – or the entire stock exchange – in a matter of seconds, so this was an area of intense focus for us. In many ways, my automated trading business was akin to ‘closed-loop stock trading’. What is unique is that I ‘grew up’ applying these skills in a fast moving, competitive commercial setting, differentiating my experience from that of many working in the field.

Q: What has been easiest about your transition to Bigfoot Biomedical? What has been hardest? What did you not expect?

Bryan: Once I saw the real-world benefits that can be achieved by managing T1D through automation and connectivity, I immediately set out to try to bring these advances to the T1D community by partnering with existing device makers. While there was some interest from existing players, the appetite to move quickly was lacking. Having now partnered with Jeffrey and Lane, we are moving at lightning pace. What is amazing about Bigfoot is that we can make our own destiny – no waiting or convincing some other company to follow our vision. There is nothing to stop us but ourselves and I am confident that we will succeed in bringing amazing new technologies to the T1D community in the very near future.

JEFFREY BREWER (CEO)

Q: What was your biggest learning from your time at JDRF?

Jeffrey: JDRF’s success in the Artificial Pancreas Project was always based on having capable and willing industry partners to achieve its goals. The two biggest players in the space, JDRF and The Helmsley Charitable Trust, both made the bet that the partner would be there if we could provide financial support and help remove some of the other non-financial obstacles. I’m proud that at JDRF we were able to drive the early research progress and demonstrate proof-of-concept for automation of insulin delivery. Also, JDRF was fundamental in influencing and partnering with the FDA to create a regulatory roadmap that companies could access to take innovative products through the development process. We were even able to achieve reimbursement breakthroughs, such as broad coverage of CGM driven by JDRF’s health care outcomes research. However, all those achievements did not get us what we wanted. We never had a partner that would commit to true innovation. Bigfoot is committed, and we will leverage all the work JDRF and Helmsley have done.

Q: You’ve now had extensive experience in for-profit and non-profit - how do you see that playing out at Bigfoot Biomedical?

Jeffrey: My for-profit experience is with high-tech, fast growing companies that disrupted traditional business models and distribution channels. My non-profit experience has given me a deep and broad understanding of the issues involved in discovery, development, and delivery of T1D therapies, particularly medical devices. It’s almost as if my entire professional life has been an apprenticeship leading up to now. I’m lucky to have the right background and skills to deliver an amazing solution that will benefit my family and millions of others.

Q: What is demanding most of your time right now?

Jeffrey: Overcoming skepticism that things can’t change. After having been promised so much and delivered so little, many affected by T1D are really jaded. People don’t believe rapid innovation is possible when medical devices are involved, or that the FDA can be a partner and accelerator instead of an obstacle, or that healthcare can’t be made more efficient, or that insurance companies can’t be motivated to pay for life changing therapies. However, once we take a more systemic approach to all those challenges, it turns out that some fundamental innovations in automation, connectivity, and simple, intuitive design can solve those problems. We just haven’t been thinking big enough. Bigfoot will be successful by tackling all those problems at the same time. None can change until all are addressed. When the world is changing and a new venture has a very different vision for the future, it takes time to for people to understand how things can really be different. Just ask Apple.

Q: What is easiest about your transition to Bigfoot Biomedical? What is hardest? What did you not expect?

Jeffrey: I’m the luckiest guy in the world. I’m working with amazingly talented people. We’ve got the support of the T1D community behind us. We have access to capital to fund our ambitious vision. Our biggest challenge has been sorting through all the amazing offers of help and support.

Q: We’ve always been so moved by how you have given the non-shiny version of what it’s like to be a parent of a child with type 1 diabetes. Why is that so hard for so many people with diabetes and parents alike, do you think?

Jeffrey: For many it is an effective coping mechanism to deny T1D is as hard as it is. People often feel stronger if they are able to deny this disease the victory of bringing them down. The problem is that if we are always telling ourselves “It’s OKAY,” then where is the motivation to make things different in the future? I guess my approach is to say things are NOT OKAY; in fact they are intolerable and unacceptable. For me, that then leads to action. If something is not acceptable, then I won’t accept it and will fight like heck to change it. I feel like I’m getting more company in that way of thinking. It’s what drives me to challenge the status quo and commit to a very different future.

LANE DESBOROUGH (CHIEF ENGINEER)

Q: What was your biggest learning from your time at Medtronic?

Lane: My biggest learning is not specific to Medtronic but applies to the world of medical device development in general: there is a pervasive belief that things will happen slowly; that there are perverse incentives NOT to translate knowledge and experience from other domains. I’ve had the privilege of working in petrochemicals, oil refinery automation, and smart grid power generation – all hyper-competitive industries using cutting edge technology. It’s frustrating that existing medical device development processes do not mirror those of these other domains.

Medtronic is an incredible company, with devoted and skilled employees who I am privileged to count among my friends. I have the highest regard for Medtronic’s leadership team, many of whom are fellow GE alumni, and I have no doubt that they will lead Medtronic to great things in five or ten years. But my son is 16 years old – we need solutions now – and I’ve seen how fast things can change based on my experience with Nightscout.

To mirror Jeffrey’s comment, “It’s almost as if my entire professional life has been an apprenticeship leading up to now.” I thought I would be learning a lot by coming to the world of medical devices, but sadly that hasn’t been the case. It’s been like getting in a time machine and going back 20 years in my career.

Q: What is easiest about your transition to Bigfoot Biomedical? What is hardest? What did you not expect?

Lane: Well the easiest part of the transition was when my daily commute went from 35 miles to ten feet. I work from my home office and am in constant electronic contact with my colleagues in other locations. The hardest part was getting used to being actively “pulled” for my ideas and insights; the fact that there are no barriers to the flow of value. I spent 20 years living in corporate America – Honeywell, GE, and Medtronic – what Apple alumni and Nest founder Tony Fadell calls the land of “big, dumb, slow companies.” The pace of decision-making when there are only three of us at the table was completely unexpected – and welcome. #WeAreNotWaiting

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