Earlier this week, SFC Fluidics and JDRF announced a new Industry Discovery and Development Partnership to accelerate the development and regulatory submission of an open protocol, fully interoperable patch pump. The two-year funding commitment (size not disclosed) will support SFC’s participation in JDRF’s Open-Protocol Automated Insulin Delivery Systems Initiative, as it aims to deliver a patch pump system that, on the back of a published communication protocol, seamlessly integrates with interoperable CGMs and third-party AID algorithms, which “may include solutions developed in recent years by the DIY community, a following which is steadily gaining traction.” Nice!
SFC is the third pump manufacturer to publicly climb aboard JDRF’s open protocol automated insulin delivery initiative following Roche in February and SOOIL last month. At ADA, SOOIL announced bold plans to submit its smartphone-controlled Dana RS insulin pump to the FDA/CE Mark with an open communication protocol and a registered version of the OpenAPS algorithm – whether it can actually execute on this remains to be seen. The SFC-JDRF press release does not confirm plans to incorporate an algorithm, but an open patch pump that patients can buy brand-new (and in-warranty!) for use in systems like Loop and OpenAPS is certainly compelling!
In January, SFC and JDRF announced a separate two-year Industry Development and Discovery Partnership to support the development of a single pod automated insulin delivery device (patch pump + CGM + algorithm in one on-body device). At the time, the project was in “early stages of development,” with an anticipated FDA submission in three to four years (~early 2021-early 2022). The two JDRF-funded projects certainly have synergies, but also have differences – a single pod with integrated CGM would have no use for integrating other iCGMs, and possibly even for integrating algorithms (it’s unclear if the on-pump algorithm would be interchangeable). We certainly chalk the multiple approaches up as a smart move – single pod AID faces significant barriers, and multiple irons in the fire are a win for patients (more options) and the company (diversification in the face of market and/or possible regulatory uncertainty).
SFC has been under the radar for over three years following our initial coverage in May 2014. As of that 2014 update and this subsequent post, the circular device has a small on-body footprint, a 300-unit reservoir, basal/bolus delivery via a wireless control, and dosing in 1/100 of a unit using a non-mechanical microfluidics technology.
Where the pump field stands today, Roche, SOOIL, Diabeloop, and SFC Fluidics have all signaled interest in open communication or incorporation of DIY algorithms. As always, huge thanks go to Dr. Courtney Lias’ FDA team and Dr. Kowalski’s JDRF team for their always-forward-looking approach to regulation and funding – suffice it to say that without these two amazing organizations and their top-notch leadership, the automated insulin delivery landscape would look very different.
-- by Maeve Serino, Brian Levine, Adam Brown, and Kelly Close