The story of Tidepool Loop is steeped in the history of patient-led innovation in the diabetes space. Our reason for going through all of the steps it took to take do-it-yourself (DIY) Loop through the regulatory process was simple–more people living with diabetes should have access to the amazing patient-led features in Loop.
The first phase of this rollout included building Tidepool Loop for iOS because that was the code base that DIY Loop was built on. We first needed to demonstrate the safety of the tool used by so many in the community–and starting with iOS was the fastest way to get where we are today–with a patient-led system cleared by the FDA.
Getting FDA clearance means that Tidepool Loop can be loaded in the App Store - and instead of having to know how to use Xcode and know what GitHub is (let alone how to use them), and have an Apple Developer account – anyone can just download Tidepool Loop onto their phone and activate it with a prescription code.
But not just anyone–yet. Tidepool was founded to help all people with insulin-requiring diabetes safely achieve great outcomes through our expertise in diabetes technology solutions. But on a global scale, 72% of smartphone users are on Android devices. This means that expanding the Tidepool Loop footprint beyond iOS devices is a necessary and critical step to make the most innovative diabetes technology accessible to more smartphone users–ensuring we stay true to our nonprofit mission.
Expanding Tidepool Loop to Android devices also means a few things for those of us here at Tidepool:
It means growing the Tidepool team. This includes software engineers to write the code that will power Tidepool Loop for Android and QA Engineers to test each feature, following the process in our Quality Management System to ensure full auditability of our work, our requirements, and our verification and validation documentation.
It means updating the overall design and architecture of Tidepool Loop to account for the unique aspects of the Android operating system that our Designers and Product Managers will need to consider as we bring Tidepool Loop for Android to life. It will be incumbent upon our team to understand those nuances and put forward a design that is consistent with the look and feel of the Tidepool brand and the Tidepool Loop experience.
It means conducting additional rounds of usability testing as we make progress on the design and development of Tidepool Loop for Android. As a Class II medical device, usability testing is not just nice to have but necessary to demonstrate that critical tasks are just as easy to perform on an Android phone as they are on their iOS counterpart. Developing and executing that protocol requires a significant joint effort across our Product, Design, and User Research teams.
It means an additional round of risk analysis for every design and engineering decision to understand if the changes we make and features we introduce reduce the probability and severity of risk of harm to our users. Much of this work has been completed with our iOS version, but again, as we account for nuances of the Android operating system, additional analysis will be necessary.
It means updating our cybersecurity threat analysis, taking into account different ways that Android may be vulnerable to bad actors and how Android phones may interact with Blueooth-enabled iCGM and ACE pump devices. iOS and Android are very different operating systems, and we’ll need to demonstrate that we’ve thought through all of the differences thoroughly. This is especially true as the Android ecosystem is much more fragmented compared to iOS, with many manufacturers trying to differentiate their products from others.
It means an additional 510(k) submission to the FDA to fulfill our regulatory obligations. This is no small task and means being prepared to respond to questions, maintaining robust and intricately detailed documentation, and staying on top of the latest guidance, regulations, requirements, and continuing to foster the collaborative relationship we have with our friends in the Center for Devices and Radiological Health (CDRH) at the FDA.
It also means that our rounds of support documentation, user guides, and labeling will grow. As we expand the footprint of access to Tidepool Loop, being able to support those users to ensure the best experience is critical. Getting the word out and ensuring more people are aware of the wonders of Tidepool Loop will also require additional work.
Some of the tasks outlined above will become the responsibility of existing Tidepool team members. Others will almost certainly be new hires—keep an eye on https://tidepool.org/jobs for the latest opportunities to join us! We’re sharing this perspective on what it takes to fulfill this promise because we believe in the power of radical transparency. Delivering Tidepool Loop for Android is not as simple as “copying code.” Making software is tricky, and making medical software is even more so. But in the medical device world, there typically isn’t a lot of discourse and discussion about what it takes to deliver these kinds of updates. Public statements are made about intentions and objectives, and updates are given from time to time, but there’s only so much perspective that can be gleaned because there is a tendency to share as little as possible “until it’s done.”
We think there’s a different way to go about that—a way that brings the community along the journey. There will always be some things we can’t say for partner confidentiality reasons, but whenever there’s something we can say, we will say it. We believe in radical transparency and the trust and connection that can yield with our community.
Bringing Tidepool Loop to Android is another step we are taking to fill the gap in access to great diabetes technology. We are also a nonprofit organization, so building the next iteration of Tidepool Loop means we needed a little help from a generous funder who believed in expanding access to Tidepool Loop just as much as we do. We are thankful for every single one of our supporters who enable our mission of helping all people with insulin-requiring diabetes safely achieve great outcomes through more accessible, actionable, and meaningful diabetes data.
To support our ongoing work, please donate today.