CGM Mobile App That’s Changing Lives
Building an FDA Approved Continuous Glucose Monitoring (CGM) App for Better Health Management
Company Summary
Our client is a San Diego based biomedical company that is developing and marketing continuous glucose monitoring (CGM) systems for ambulatory use by people with diabetes. Instead of a finger prick several times a day, the company has developed a simple one touch auto-applicator that sends data wirelessly to a mobile app for easy monitoring of blood sugar levels. The initiative required us to quickly become agile and remain bulletproof in mobile testing, utilize our Food and Drug Administration (FDA) compliance expertise, and fluent in the realm of wearable technology.
Services
Mobile Application Development, Mobile Application Testing, FDA Compliance, Solution Architecture, Hardware Testing
Technologies
Swift, Kotlin
Project Locations
San Diego, CA, US | Cairo, Egypt
Industry
Life Sciences, Biotech, Medical Device
Size
10,000+ employees
Customer Since
2019
Drawing upon years of experience in engineering, agile, and scrum methodologies, we delivered to the client a best-in-class solution that enables patients, caregivers, and clinicians alike to take control of diabetes once and for all.
Challenges
Those living with Type 1 or Type 2 diabetes must continually monitor their blood sugar to avoid the potentially dangerous consequences of hyperglycemia (too-high blood sugar) and hypoglycemia (too-low blood sugar). Building an FDA-compliant mobile application for a wearable sensor that helps diabetes patients avoid fingerstick required us to overcome and navigate a number of complex business and technical challenges.
Navigating Mobile Architecture
Historically, Integrant has been known for its .NET full-stack expertise, which meant we had a bit of an uphill climb to prove our mobile app development expertise and ultimately demonstrate the caliber of our engineers along with our problem-solving and grit. This meant we had to quickly pivot and apply our engineering and agile best practices to onboarding the right team of mobile development experts – in parallel with understanding and interpreting the client’s unique requirements.
The technical components of the project were particularly complex since we had to develop the native mobile architecture and coordinate how the various sub-modules would communicate with the this sublayer. Previously the client used a software framework that required uniform communication with all the different submodules. One of our tasks was to create a layer within the architecture that would talk to the various submodules and also act as a bridge to the client applications. This new architecture also required full integration with cloud service and authentication, both built from scratch.
Gaining Client Trust
The most important and critical challenge was to gain client trust immediately. To instill confidence in our ability to deliver a client ready application on time, we had to complete a number of important actions in parallel. First, we had to hire a new mobile development team, which required extensive interviews and onboarding. This process was made particularly difficult during the pandemic since hiring and onboarding had to be done remotely without the option to meet the client onsite and interact with them directly.
The second major challenge is that we had to properly understand the complex code base, so we would make recommendations, perform test cases, and optimize as much of the base as possible. It was also very important that we communicated frequently and kept in close alignment with the client’s own development team. This initiative was a collaborative effort from the start and so we had to ensure we could fit in seamlessly and work efficiently within their culture.
It’s noteworthy to mention that our development work required the integration of a scrum master who would help us to achieve our project goals and benchmarks. We hoped that this additional resource would endear us to the client’s team and ensure a smooth working relationship and strong project oversight each step of the way.
FDA Compliance
Since we were working on a medical application, it had to meet rigorous FDA approval. This meant we were expected to provide high levels of testing to ensure the mobile software meets full standards for the consumer market. The FDA has identified a set of published standards for manufactured medical devices. Our testing processes had to align closely with these standards, which is another way of saying that all security and data integration had to be flawless. These steps were all critical to winning the complete trust of our client. (You can read more about our high-level best practices to FDA approval here.)
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Solution
We began this engagement in a modest capacity by taking tickets, analyzing code, and then offering feedback. However, the client soon realized that we brought a high degree of technical expertise to the table and finished tasks quickly. This served us well and resulted in getting assigned to more tasks. In fact, it wasn’t long before we migrated from one small project to three major projects, each with an iOS and Android team. The client has come to value our work – not just as a second set of hands but as a highly regarded consultancy that is very quick and versatile. In fact, we’re already collaborating on the next release of the CGM monitoring system.
Below are some of the major solutions and characteristics that helped us deliver outstanding value to our client.
Relationship-Building
As with all of our client engagements over the past three decades, the core value we brought to the table this time was an attitude of rapid trust building. We demonstrated this by taking on each task with a high degree of ownership and expertise along with a continual forward-looking approach in the areas of architecture, security, testing, and more. This meant no difficulty was ever overlooked nor was there ever a moment’s hesitation to go the second mile to fully understand our client’s business. We strove for continuous improvement by seeking ways to make each process more efficient and cost-effective for our client.
One way in which we set ourselves apart was by hiring and onboarding the mobile development team. This involved searching for the most qualified developer candidates, interviewing and hiring the best matches, and providing gap analyses and feedback to ensure everyone was in complete alignment with the client’s requirements and expectations. All of this happened remotely, due to the impacts of the global health pandemic.
Technical Expertise
Our client looked to us to develop a complex architecture that would communicate real-time updates of patient blood sugar readings to a mobile application. This required us to develop a robust, FDA-approved architecture that could scale easily and communicate effectively with the client’s various internal and external applications. Through this rigorous process of development and testing, we accomplished:
- Discovery of a set of commonalities between the different applications – both logic and software-based.
- Construction of an architecture layer that could speak with the various Git submodules and be imported to any one of the client applications. The analogy drawn here was of trying to unravel a tangle of wires while deciphering where each one goes.
- Ensuring that each submodule is created for both iOS and Android.
- Development of a modern cloud service from scratch with authentication features also built in, which will provide more scalable, easier communications down the road.
- Some of our self-acknowledged future challenges are:
- How to version or level-up our new architecture?
- The best way to “ship” our architecture to customers
Testing, Automation, and Security
To ensure full FDA compliance of our client’s medical mobile app, we had to strive to ensure every function in the system allows only authorized people to access the data they need. This, in turn, required a considerable amount of security testing – especially important for medical apps where the correct functioning of the application can be a life and death matter.
Our team worked carefully and efficiently to ensure the highest levels of trust and transparency as we abstracted the code base and went through our QA processes. By designing various security tests, we continually explored ways to automate more components, write better code, and reduce redundancies within the architecture.
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Outcome
When first approached by a reputable San Diego biomedical company to take on a project, we jumped at the opportunity to make a difference. After investing in a rigorous process of trust-building and technical deep dives, we soon developed a great partnership, showcasing our technical expertise and our ability to problem-solve. One project quickly grew to three and these projects have stretched us in new directions by introducing us to the complexities of mobile architectures integrated with cloud-based systems.
Our next challenge? Figuring out how to further leverage the architecture we’ve already built and continue to improve our processes and level-up our solutions to create the most accurate and impactful products and software to serve our customer and the end-user. Thanks to our partnership with the client, we’re now making a direct impact on improving the lives of diabetes patients around the world.
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