Accelerating smart diabetes care with a secure digital foundation

Key outcomes:

• Faster access to smart diabetes care for patients
• Reduced development and verification time for Ypsomed and partners
• Stronger governance and compliance across the digital ecosystem 
   

The challenge: Building towards global leadership in closed-loop care

Ypsomed set out to lead in closed-loop diabetes care - a field where secure, timely, and scalable digital solutions are essential. But delivering mobile applications across global markets was slowed down by integration complexity and strict regulatory requirements.
To unlock their vision, Ypsomed needed a way to enable partners to build safe, connected apps quickly-without compromising on compliance or quality.

The solution: A future-ready SDK, co-created from the ground up

We began with a shared roadmap and co-developed a Class C Software as a Medical Device (SaMD) software development kit (SDK) for iOS and Android. Designed to support fast, secure integration, the SDK simplifies development for Ypsomed’s partners while ensuring device-cloud-app connectivity at scale.

To accelerate onboarding, Zühlke built bespoke emulators that simulate device integration and enable early testing. We also operate the SDK on an ongoing basis, ensuring it aligns with Ypsomed’s evolving governance and compliance requirements - including MDR and FDA 21 CFR Part 11 standards.

The results: Accelerated timelines, improved safety, greater confidence

The SDK has given Ypsomed and its partners a future-ready foundation for innovation in diabetes care.

• Development cycles have shortened, enabling faster market delivery
• App safety and reliability have improved through better testing and simulation
• Partner teams now build with greater confidence, clarity, and control

By making it easier for developers to create secure, connected apps, the SDK accelerates access to digital insulin therapy-delivering tangible benefits for both healthcare professionals and people living with diabetes.
 

Conclusion

This project marks a significant step forward in Ypsomed’s journey to lead in closed-loop diabetes care. With a clear vision and strong focus on scalability and safety, Ypsomed is enabling its partners to bring secure, connected digital health solutions to market faster.
The secure mobile SDK now serves as a backbone of their digital ecosystem-supporting third-party partner onboarding, improving integration quality, and ultimately helping people with diabetes access smarter care sooner.