For those who've been pushing for more support of do-it-yourself diabetes technology over the last five years or so (crystallized as the #WeAreNotWaiting movement), a huge endorsement came last week when JDRF announced a new initiative encouraging the pharma and device industry to be more collaborative with patient innovators.
On Oct. 18, JDRF announced this new initiative calling for open protocols in emerging Artificial Pancreas (AP) technology as part of its ongoing aim to accelerate the development and commercialization of AP systems that automate insulin delivery. This will include both legal support and financial incentives to motivate the industry to follow Dexcom's recent lead in taking steps toward opening their back-end tech, so that innovators from around the Diabetes Community can build the functionality and apps best suited to patients' lives.
OK, that all may sound like mumbo-jumbo to a lot of people... we get it.
Why Do 'Open Protocols' Matter?
Think of it this way: Instead of the closed systems we have now, where each company makes their own "proprietary" devices that work only with their own hardware, software and apps, companies would go open-source and create code and documentation freely available to the public. This would allow partners and independent developers to build upon their tech, and encourage interoperability of devices and data systems.
Many in our community have been championing this cause for years now, and while JDRF's initiative is focused specifically on closed loop systems, it's a great step forward.
In the official press release, JDRF's Chief Mission Officer and longtime type 1 himself Dr. Aaron Kowalski explains: “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. By making this approach more accessible to a wider group of people with diabetes, users of insulin delivery devices will be able to manage their blood glucose levels better, and in a way that works best for them.”
When we spoke with him directly, Kowalski mentioned that he uses a do-it-yourself closed loop system himself. "This (DIY technology) train has left station, but it's operating under the radar mostly. What if we could make it become more mainstream, make it safer and better and have this as a resource available to more people? That's a win."
While much of the detail will depend on individual proposals and associated needs, JDRF tells us the basics of their new initiative include:
- Helping to establish clear financial, regulatory and legal frameworks for open protocols
- Exploring ways to overcome potential challenges in the use and adoption of open-protocol systems
- Contributing resources, and coordinating with regulators and legal advisors to develop a predictable pathway to FDA review, and encouraging device manufacturers to update communication protocols on their devices to enable seamless, secure connectivity with other devices (e.g., by using Bluetooth tech)
- Upholding a timeline for industry to submit proposals as follows: letters of intent are due Dec. 6, 2017; applications are due Jan. 31, 2018; then after the JDRF announces the nomination awards in June, the earliest start time for projects will be July 2018
Leading up to this new initiative led by Kowalski, JDRF recently hired Dr. Daniel Finan as the org's new Research Director -- on the heels of his role as principal algorithm developer for Animas up until the JnJ decision to shut down the Animas pump division.
"Ultimately we’d like to see a reality in which there are multiple commercial systems on the market – some taking a ground-up, proprietary approach and some a user-driven approach," Finan tells us.
This is a big deal for all the Nightscout and OpenAPS fans in our D-Community, Folks!
We're thrilled to see the JDRF take this step, and given DiabetesMine's involvement in hosting the bi-annual D-Data ExChange forum where the #WeAreNotWaiting movement was born, it feels like a personal milestone for our team too!
#WeAreNotWaiting Community Responses
Longtime type 1 and OpenAPS founder Dana M. Lewis says: "This announcement from JDRF that they are funding companies to work on open-protocol development of pumps and AP systems is a much-needed start. It’s important that JDRF is now actively acknowledging the innovation and activity in the DIY communities (Nightscout, OpenAPS, etc.), and the valuable innovation coming from everyone outside of traditional companies. It’s also significant to have financial incentives for diabetes companies to move in this direction, and to begin working to remove the excuses around liability, regulatory uncertainty, etc. that have been put forward by companies as reasons to not document and open their protocols for use."
Dana adds, "Is this a silver bullet to solve all of the Diabetes Community's problems? No. But it is a much-needed step in a positive direction, and one we’re very excited about."
President of the Nightscout Foundation James Wedding is also happy to hear this news, as it’s long overdue, though he does feel the JDRF timeline is a bit aggressive for industry to meet.
"We are excited to see JDRF showing up to the open source, open protocol party. Many of their most ardent supporters, staff members, and even Board members have been using solutions like Loop, Nightscout, and OpenAPS for years, and it is great to see them come around to pushing to make these technologies more widely available. I had a great conversation with Aaron Kowalski last night, and I'm looking forward to exploring how JDRF can support our efforts and our interactions with the established industry."
Wedding also says, "We are hoping that there are some other ways to bring the resources of JDRF to bear more directly on the patient-led innovation side to drive work forward while the manufacturers work to open their protocols."
He says Kowalski was "very open to getting more information about all these systems at JDRF Summits," and that the Foundation will be looking at how to make that happen. The information sessions held at the annual Children with Diabetes Friends for Life Conference have been incredibly well-attended, and they expect overflow capacity at local events "if people knew (Nightscout) was on the agenda."
Wedding says the group had an early framework of a Speaker's Bureau "that got mothballed," but they are looking to revive that, especially now given this official support.
Brandon Arbiter, VP of Product at the open source diabetes data platform startup Tidepool, who's also a type 1 himself and serves on JDRF's international board, says:
“Do-it-yourself systems are innovating at a rapid pace and I, for one, have benefited 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.”
The Corporate Conundrum
Kowalski says insulin pump and glucose monitoring manufacturers have definitely expressed an interest in this in the past few years, but most have had serious concerns about liability; they've wondered if there is a pathway for patients to waive their rights to sue a particular company if something should go wrong -- i.e., once you go into DIY mode, you need to take personal responsibility for how a system performs.
That remains the big question right now, that JDRF aims to help explore and clarify in discussions with regulators and legal experts as part of this new initiative.
Meanwhile, the fact that a former Animas exec is now helping lead this push at the JDRF brings up the issue of non-profit money going to industry and what happens if the supported technology never makes it past R&D and into patients' hands.
The Animas closure highlights that issue specifically, as the JDRF-funded Animas Hyper-Hypo Minimizer in development is now scrapped. JnJ still owns the intellectual property, and no one seems clear on whether that project can be revived in the public domain.
So what is the protocol in cases like this, where the JDRF invests money into developing commercial technology, but the manufacturer ends up going bust?
A form of refund has been worked into the agreements, the JDRF's Kowalski tells us.
"We have provisions in every contract that if projects do not move forward that JDRF funding is paid back in some form," Kowalski explains. "We include development milestones and termination clauses that allow us to recoup funding if projects do not move forward for non-technical reasons. Hopefully it doesn’t come to this – but again, all of our contracts have payback mechanisms if the project doesn’t move forward for non-technical reasons."
For Finan's part, coming directly from the now-defunct Animas, he says, "It is bittersweet, indeed, but I’m so happy and fortunate to have landed at JDRF. I do think I can offer a unique perspective in my new role, especially with respect to the 'development' aspect of medical devices. In the R&D world at Animas, I spent my first few years focusing on the 'R' and my next few on the 'D.' After all my years in industry, I have a better idea of how they fit together."
Thanks, JDRF, for making this move. It's been long needed.
We are hopeful that industry engages in this initiative, sooner rather than later.
As the saying goes, #WeAreNotWaiting. And neither should they. Now, they don't have to, thanks to JDRF upping the ante.