JDRF initiative to accelerate “open protocol” automated insulin delivery; major win for DIY movement; encourages manufacturers to update devices for seamless connectivity – October 18, 2017

This morning, JDRF announced a truly exciting initiative to accelerate “Open Protocol” Automated Insulin Delivery (AID) systems – the move has enormous implications for the do-it-yourself (DIY) movement, patient choice, and diabetes technology innovation.

Pump and CGM manufacturers are specifically encouraged to apply (RFP here) with proposals to provide seamless, secure, interoperable connectivity with other devices and smartphone apps (e.g., Bluetooth). The RFP is very pro-DIY and notably expansive. Letters of intent are due by December 6, with projects to start as early as next July. JDRF sees insulin pump communication as the biggest technical barrier right now – see our interview with Dr. Aaron Kowalski below.

JDRF will contribute financial resources (more than $1 million) and coordinate with regulators and legal advisors to develop a predictable FDA pathway and frameworks for this field. While the technology exists, there are many unanswered questions and nuances to address.

Still, the ultimate vision is awesome: an ecosystem of interoperable pump and CGM devices that allow patients to mix and match different system components, including DIY apps/algorithms they may choose to use. For instance, pump and CGM companies might add an on/off switch for “DIY” or “experimental” mode – users could theoretically toggle this “on” and thereby assume all liability risks of communicating with an FDA cleared device. The nuances here will be key, as Dr. Kowalski noted in our interview.

The program is rooted in the ambitious, diverse, and highly talented DIY community, who has made tremendous progress in insulin automation, data display, and remote monitoring, but invested lots of time to reverse engineer pump and CGM communication protocols. If pumps and CGMs from different companies are updated to become interoperable and talk to apps, the DIY community’s pace of innovation and list of compatible devices will accelerate dramatically.

• Notably, Nightscout, OpenAPS, and Loop are all mentioned in JDRF’s press release, and JDRF International Board member DIY user Brandon Arbiter (Tidepool) is quoted – he notes that DIY AID systems have been “game changing”! This is a wonderfully patient-centric move from JDRF, a sign it believes in propelling the DIY community and more crowdsourced approaches to innovation. We’re not sure how many DIY AID users there are globally, but might guess it is in the thousands if not tens of thousands.
• JDRF still believes in proprietary systems (see below), but this news shows its true end game is a thriving commercial ecosystem where many products compete – DIY or proprietary. We like the vision of that and wonder how long it will be before multiple products in each category are available. At this point, the MiniMed 670G has been FDA approved for over a year, but is still far from widely commercially available.
• JDRF’s new Research Director Dr. Daniel Finan will lead this effort, formerly of Animas’ AID program. He will report to Dr. Kowalski. Coming from Animas, Dr. Finan obviously brings an appreciation of industry’s perspective on AID, particularly when the speed of industry innovation cannot keep up with what the community is used to.
• How will device companies think about this program? Who will apply? What are the implications for pump and CGM players’ business models and innovation? Is this an opportunity or a threat? On one hand, open protocol devices have potential to outsource innovation and take the burden off companies of developing complete “systems” and maintaining them in a faster-paced app world. Indeed, Mr. John Costik, a founding member of the CGM in the Cloud group, told us last year that the first pump company to open up communication will “sell a lot of pumps and drive innovation at an even quicker pace than we’ve seen so far.” We agree with that – iPhone and Android devices are far more valuable because of their app stores. Headphones that use Bluetooth obviously have a wider potential market than those using another wireless protocol. Diabetes device companies that adopt an open protocol unlock an innovation playing field that is currently non-existent, broadening their market. On the other hand, the bar may naturally rise for industry to provide differentiated, unique value, especially if proprietary AID systems continue. Competing with OpenAPS or Loop could become a tall order, something companies will have to navigate in an open protocol world. See the final section below for some thoughts on “open” from How Google Works. We’ll also be reaching out to the community for thoughts and updating this report as we hear back!
• Given JDRF’s FDA progress on the initial AP guidance document, plus Dr. Courtney Lias’ enthusiasm for component/interoperable AID systems, we have fewer doubts on the FDA front. But for companies, liability concerns will be key to figure out – if someone is in “DIY mode,” using an FDA-cleared device with an open communication protocol, and something goes wrong, who is responsible? We believe this liability question is a very solvable problem and one that other industries are tackling too – self-driving cars certainly come to mind.
  
  • What are the options for dealing with liability? We hope this is solvable with the proper disclaimers and working with the FDA and patient innovators – e.g., “By enabling experimental mode, you void your pump’s warranty and assume all liability risks.” Alternatively, we wonder if select innovator groups like OpenAPS and Loop could get “developer” access to pump communication protocols under certain terms and conditions. Then, they could obtain FDA approval for their algorithm/app, with an indication that it can be used with a portfolio of devices.
• Read our interview with Dr. Kowalski below, along with more specifics from the fascinating RFP.

Interview with Dr. Aaron Kowalski

Q: Aside from pump/CGM manufacturers, can groups like TypeZero, OpenAPS, Nightscout, and Loop apply?

Dr. Aaron Kowalski: Everything is on the table, but we see compatible pumps as being the biggest (technical) barrier right now. We fully expect algorithm manufacturers to play an important role in this ecosystem in the future. Dr. Dan Finan (who will be the lead on the project and recently joined us from Animas) and I have talked about this very question. I think the top priority is to get pumps out there that could “accept” algorithms such as these.

Q: Can you be more specific about the size of this program in terms of funding?

Dr. Kowalski: It is more than $1 million. We have not set the upper limit because we are exploring the different activities that will be needed and the level of interest in the community. JDRF is committed to seeing this through.

Q: Will JDRF provide funding to manufacturers to develop open protocol, interoperable devices, or simply to provide legal, regulatory assistance?

Dr. Kowalski: All are on the table. We expect all of the above will be needed.

Q: What does JDRF believe are the biggest financial, regulatory and legal barriers to this area?

Dr. Kowalski: There are challenges on each of these fronts. There will be dollars required to engineer the devices. We’ve have spoken to FDA, and there is work to be done on the regulatory front too. We see the legal responsibility as potentially the biggest issue. That is, who would be responsible if something went wrong? Can users “assume responsibility” if they are in DIY mode?

Q: What is commonly perceived as a barrier to DIY AID, but is not?

Dr. Kowalski: Interesting question! It used to be, “It can’t be done; it’s not safe.” Obviously, the data from DIY users now debunks that.

Q: Has FDA been consulted in the development of this initiative?

Dr. Kowalski: We’ve been in contact with the team at FDA and they’ve been great. There is obviously much more work to be done here as we are moving into some uncharted waters.

• Editor’s Note: JDRF’s vision aligns with Dr. Courtney Lias’ repeated goal for component, interoperable AID systems (Keystone 2017, ADA 2017, NIH 2016 Workshop, AADE 2016, ADA 2016). As Dr. Lias has astutely noted, the current approach of evaluating complete AID “systems” (pump+CGM+algorithm) cannot enable the rapid iteration this field desperately needs.

Q: Does JDRF imagine the existing AID FDA guidance document would need to be amended?

Dr. Kowalski: Another good question. We haven’t had that discussion and I think the guidance document has really accelerated commercial development. There is more to come on this front.

Q: What is the time horizon for projects?

Dr. Kowalski: We will accept “Letters of Intent” (by December 6) and then hope to launch projects in 2018. We don’t have a good idea yet what development plans (and the regulatory and legal plans) will look like.

Q: What would a home run look like for this in 2020?

Dr. Kowalski: Multiple commercial systems on the market with capability to do their proprietary approaches or user-driven approaches. Multiple pumps with DIY capability available for people with diabetes!

Q: Can donors direct dollars to this initiative?

Dr. Kowalski: Potentially. We don’t want to accept more dollars than we will fund. I think as we have a better idea of the commitment it will take from JDRF, this will become clearer.

Examples and Specifications from the RFP

Examples of projects include, but are not limited to:

• An insulin pump, able to be controlled (i.e., its insulin delivery manipulated) via a secure wireless protocol (e.g., Bluetooth LE or similar protocol)
• A CGM, able to interface via a secure wireless protocol
• A cell phone-based application (app) with the ability to communicate with an insulin pump and CGM via a secure wireless protocol
• A specialized, separate device with the ability to communicate with an insulin pump and CGM via a secure wireless protocol; in this approach, the separate device will also need to communicate with a cell phone-based app or otherwise be able to control the insulin delivery of the insulin pump
• Other innovative solutions will be considered

Other Specifications

• The device itself need not have a built-in algorithm, nor even a built in user interface.
• The insulin pump must have robust failsafe capabilities. That is, if it becomes separated from its external controller (cell phone or other device), it does not fail (e.g., it reverts to basal insulin delivery).
• The device must have an interface enabling it to be suspended by the user when the external controller is not available.
• The device must support reservoir-based delivery of at least one drug using commonly available reservoirs and infusion-site connectors.
• The device must allow for secure, authenticated control and programming by do-it-yourself (DIY) developers without restrictions on who may control the device, i.e., the communication protocol may not be limited to only entities that have executed business partnerships.
• The device must be intended for sale and distribution. The indication for use of the device will be to the effect of: a controllable infusion pump intended for use with an approved, external controller.
• Limitation on Liability. JDRF will work with applicant to develop a liability limitation framework that accounts for the fact that the external controller will be responsible for insulin delivery decisions.
• Regulatory Pathway. JDRF will work in parallel with the applicant and U.S. and international regulators to establish a regulatory pathway.

Notable Press Release Quotes

• “Do-it-yourself systems are innovating at a rapid pace and I, for one, have benefitted immensely from the community developing tools that leverage direct access to device protocols. It's been game changing. There is a tremendous opportunity to leverage the expertise from skilled individuals from outside the traditional diabetes space in order to drive solutions to patients.” – Brandon Arbiter, Tidepool
•  “To support innovation and enable type 1 diabetes families to use an open-protocol approach safely, we need to ensure the regulatory pathway is clear, and we will work with industry stakeholders to make devices compatible.”
• “JDRF believes that both proprietary and open-protocol development pathways can fuel innovation that improves outcomes and reduces the burden of T1D. JDRF is fully committed to continuing to support the development of traditional, proprietary commercial approaches, including both full AP systems and their individual components. At the same time, JDRF will also explore means to support the open-protocol ecosystem, with the goal of unlocking innovative and expedited pathways to market safely.”

Some Thoughts on “Open” From How Google Works

Though some companies might be worried about “opening” up their communication protocols, ultimately, we see it as a positive for innovation. Here are a few relevant quotes from the recently-published, and in our view, excellent, business book, How Google Works by Eric Schmidt and Jonathan Rosenberg.

• “The ecosystem matters a lot. The most successful leaders in the Internet Century will be the ones who understand how to create and quickly grow platforms. A platform is, fundamentally, a set of products and services that bring together groups of users and providers to form multi-sided markets.” 
• “It took the global phone network 89 years to reach 150 million phones. Facebook hit a billion users not long after its eight birthday. Android activated its billionth device in its fifth year…in the technology industry, companies always think “platforms, not products.”
• Whereas the twentieth century was dominated by monolithic, closed networks, the twenty-first will be driven by global, open ones. 
• “Default to open, not closed.” Open … generally means sharing more intellectual property such as software code or research results, adhering to open standards rather than creating your own, and giving customers the freedom to easily exit your platform…If you are attacking an entrenched incumbent, you can use its very entrenchedness to your advantage. Your porcine competitor is probably feeding at a closed trough, and you can take it on by matching your disruptive product with a disruptive business model. Open can play that part very effectively. It drives innovation into the ecosystem (new features for the platform, new applications from partners) and drives down the cost of complementary components.”

-- by Adam Brown and Kelly Close