Medical Device Prototyping and Healthcare App Development for Better Patient Data Connectivity

We started by designing two custom wearables: one IoT medical device is a chest-worn ECG monitor, and the other is a bracelet-style tracker for blood oxygen and pressure.

Our hardware engineers handled the entire process in-house, from selecting components and building a fully functional prototype to running multiple testing sessions.

Once the design was approved, we connected the client with our trusted manufacturing partner for production.

In parallel, we developed a HIPAA-compliant mobile app that allows patients to view their health data live, get alerts about abnormal heart rhythm or blood pressure, track changes over time, and receive messages from their connected hospitals.

We created an accessible UI designed to meet the needs of all users, including those with disabilities, applying proper contrast, scalable font sizes, and a clear layout for readability.

Because the devices transmit patient health data via Bluetooth, the system had to meet strict FDA requirements for Class I and II medical devices. That means complying with regulations on risk management, communication protocols, and data handling.

We started working on compliance from day one and developed our own secure communication layer between the wearables and the app, specifically designed to meet FDA communication standards.

Throughout the FDA submission process, we supported the client every step of the way and helped them successfully obtain certification.

Collecting sensor data 24/7 from wearable cardiac monitoring devices can be expensive, especially with a growing user base. To help our client save on storage, we implemented custom data retention policies: recent data is stored in high-speed storage for instant access, while older data is automatically moved to a more affordable tier but remains accessible through the app and dashboards.

We built the entire data flow on AWS, using AWS IoT Core for secure device connectivity, AWS Data Streams for real-time data processing, and AWS QuickSight to power dashboard visualizations.

This setup helped reduce ongoing infrastructure costs while keeping all data accessible for both patients and doctors.

Integrating with hospitals meant using the HL7 standard, the backbone of medical data exchange in the US. But the challenge was that the client’s platform used multiple versions of HL7, with some modules on legacy versions and others on newer ones.

To solve this, we developed a compatibility layer that normalized communication across versions, ensuring reliable data flow from wearable devices to hospital EHR systems.

Now, real-time patient data is delivered directly into EHRs, allowing our client to offer hospitals medical IoT device monitoring and attract new partners across the U.S.