Advanced diabetes data tracking

About the project

Innovation Zed is an Irish MedTech company known for developing hardware solutions to improve diabetes self-management. Their latest project created an ecosystem available through a mobile app for patients to monitor insulin dosage data from a connected pen accessory.

To support this goal, we joined the project as their digital partner – building an intuitive app intended to be a medical device, from design to delivery. Our work focused on usability, scalability, and readiness for future MDR compliance.

What did our client need?

Innovation Zed approached us with a Bluetooth device that fits on an insulin pen and tracks insulin administration. What they needed was an intuitive mobile application.

Key requirements included:

• Support for iOS and Android

• Visually clear and usable design

• Data visualisation, onboarding, and daily support features

• Seamless user experience tailored to real users

• Future-readiness for medical device certification

Initial deliverables included wireframes and functional requirements.

How did we approach it?

User-centric Product Design

We launched the project with research interviews involving people with Type 1 diabetes, who were insulin-dependent. These interviews helped us understand their daily challenges, habits, and tools for managing glucose levels–crucial for adjusting insulin doses. On that basis, we:

• Analysed client requirements and early wireframes to capture key features and business needs

• Conducted follow-up workshops to refine app flows and functionality

• Prepared initial wireframes and reviewed with client to validate flow and UI

• Defined a high-level feature set and technical feasibility

• Validated the design through several iterative workshops using Figma

The design process remained flexible but focused, allowing Innovation Zed to stay close to the vision while benefiting from UX validation and refinement.

Technical architecture & development

Once the flows and wireframes were agreed, we transitioned to development, involving multiple integrated components:

• Mobile application: Built with React Native to ensure a seamless cross-platform experience on both iOS and Android.

• Bluetooth communication: To avoid challenges with background Bluetooth communication and connection stability, we resolved it through SDK implementation and iterative testing. We introduced two main capabilities:
  One dedicated to stable Bluetooth connection handling
  Another specifically designed for communicating with the DOSE device – a wrapper around its commands and features

• Backend platform: Built using NestJS, PostgreSQL, and hosted on AWS to manage user data and secure communications.

• Apple Watch support: Developed and bundled alongside the iOS app to provide a simplified companion experience on watchOS.

• Advanced features: Widgets, push notifications, insulin statistics,CGM data integration (Dexcom and Abbott), and a first-use onboarding flow were developed and deployed.

All features were designed with usability and modular scalability in mind.

Ensuring regulatory readiness

Although the initial version wasn’t launched as a medical device, this project was intended to be a medical device – and was built with that goal in mind from day one.

Risk and development documentation strategy

• Conducted early-stage risk analysis to assess design decisions

• Defined how feature changes affect regulatory boundaries

• Implemented a development process aligned with IEC 62304, IEC 82304, ISO 13485 and ISO 14971, including structured documentation, traceability, and risk control measures integration

• Monitored compliance with IEC 62304 SOUP requirements, ensuring risk and regulatory documentation processes were followed by the appropriate teams

• Maintained development documentation that could be reused in future MDR Technical Documentation

Post-launch privacy and data management

• Ensured GDPR compliance through privacy-focused design and data anonymisation

• Collected minimal anonymised data to support system health and product enhancements

These regulatory measures were embedded from the start and sustained throughout the development life cycle.

Communication & Workflow

We maintained close alignment using Slack, Jira, Confluence, Meet, and Figma. Designers, developers, QA, and regulatory leads collaborated in real time. All work was tracked in Jira with clearly documented requirements and decisions.

Innovation Zed also played an unusually active role in testing, reviewing each new release alongside our QA team. This rare level of involvement not only sped up iterations but also helped to raise the overall quality of the product. It proved how valuable close client collaboration can be in achieving the best outcome.

What did we deliver?

We transformed Innovation Zed’s concept into a polished digital solution — intuitive, connected, and built with certification in mind. From mobile to wearables, every layer was crafted to support users and meet medical standards.

Key Deliverables:

• Hybrid mobile app for iOS and Android, built with React Native

• Apple Watch companion for iOS app

• DOSE SDK

• Cloud backend with secure user data storage

• Regulatory documentation and risk analysis

• Privacy & anonymisation mechanisms

• UI/UX design based on real user research

The result? A seamless experience grounded in user needs and ready for MDR and relevant ISO standards compliance – scalable, secure, and future-proof.