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Empowering Patients with a Groundbreaking User-Friendly CGM
Explore our collaboration with a leading medical device manufacturer to create groundbreaking technology that saves lives. Together, we developed an innovative solution that puts diabetes care at patients’ fingertips. One that seamlessly links their continuous glucose monitor (CGM) with a mobile app compatible with both iOS and Android devices.
What We Did
Product Design, Mobile Development, Cross-Platform Development, User Testing
Tech Stack
C#, .NET MAUI, BLE, Appium
Opportunity
A leading medical device manufacturer, wanted to create an app to help people manage diabetes with a Continuous Glucose Monitor (CGM). They needed a software team they could trust. And, they wanted to provide patients with 24/7 access to their health data via a wearable patch, moving away from traditional manual blood sugar tests. Enter: a groundbreaking user-friendly CGM.
They chose SEP because of our strong history of working with medical technology, medical mobile apps, and our ability to meet strict safety standards. Since its founding over 125 years ago, our client has grown into one of the world’s largest biotech companies, a leading provider of in-vitro diagnostics, and a global supplier of transformative digital health solutions.
Solution
This story isn’t just about technical milestones; it’s about trust, expertise, and the shared commitment to enhancing patient health through innovation.
A Partnership Born from Trust
When our client aimed to design a continuous glucose monitoring (CGM) solution, they needed a software partner who not only had technical expertise but could navigate the complex regulatory environments of medical device software. They turned to us, drawing on our long standing reputation for meticulous attention to detail. This, paired with our proven track record in delivering solutions that meet critical safety standards, meant SEP fit the bill.
The solution included a mobile app to collect data from the sensor. The app needed to function seamlessly across different platforms while running in the background continuously for weeks—essential for real-time monitoring of glucose levels. Our task was formidable, requiring a deep understanding of both iOS and Android ecosystems to ensure reliability and compliance.
For uninterrupted data transmission from the glucose sensor, the mobile app leveraged Bluetooth technology. Recognizing the critical nature of this function, our team innovated a robust connection strategy that would later become a cornerstone of the app’s reliability.
Exceeding Expectations: Clinical Studies and Regulatory Milestones
In addition to the design and technical work for the mobile app, SEP supported them
- in clinical evaluations and
- preparing for the regulatory submissions required for medical software.
Our team responded quickly when adjustments were needed to prepare and configure the system to support clinical studies. Our team also created comprehensive documents and records needed for a smooth regulatory submission.
“The team performed above my expectations. Anytime we needed a new configuration built, they’d jump right in and deliver earlier than I expected. Their ability to innovate—particularly in ensuring continuous Bluetooth connectivity—has set our app apart in the competitive market. ”
— Diabetes Director of Development
— Diabetes Director of Development
Solving Problems and Enhancing User Experience
The solution showcased our commitment to iterative improvement and patient safety, keeping the user experience and regulatory requirements at the forefront. Examples of significant milestones in our collaboration to develop the user-friendly CGM:
- integration of the Apple Watch app, enabling users to monitor glucose levels conveniently on their wrists
- development of a tailored solution for the complexities of alarm systems and user notifications, a feat that balances critical alerts with user control
- quick adaptation to Apple’s new account management requirements, integrating the ability to delete accounts seamlessly and enhancing user autonomy and trust
Results
The new cross-platform mobile app secured both MDR approval and the CE mark signifying its compliance with stringent EU medical device regulations and its efficacy for patient use.
Continuous Innovation and Future Prospects
Throughout this partnership, our team has not only responded to immediate challenges. We also anticipated future needs. The adoption of the FHIR standard for medical data is a prime example. In addition to proactively enhancing the app’s capabilities, we also streamlined the user experience. Plus, it ensures that our client remains at the cutting edge of medical technology.
More Than Just a Vendor, a Trusted Partner
Looking ahead, our involvement in this partnership goes beyond just being a software developer. We are advisors, innovators, and, most importantly, trusted partners in a mission that touches the lives of thousands. Each challenge we’ve overcome and every milestone we’ve reached has reinforced the trust our client places in us. This isn’t just a project; it’s a commitment to bettering lives through technology, demonstrating the profound impact of a partnership built on trust, expertise, and a consistent drive for improvement.
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