A medical app,
through FDA clearance.
Development leadership from the first proof of concept through regulatory milestones and clinical use.
Real-time measurements for clinicians
The MY01 app connects to a medical device over Bluetooth so clinicians can monitor muscle compartment pressure. Its development began with my internship proof of concept; I later led the React Native application’s development through FDA clearance and into clinical use.
The app also received FDA Breakthrough Device designation. MY01 products are used daily across hundreds of U.S. sites, including major trauma centres, as of October 2026.
Communication across the device boundary
My work spanned most of the Bluetooth communication protocols between the app and medical device, including mutual authentication, time synchronization and data export.
I designed app/device mutual authentication, validated through multiple rounds of third-party penetration testing.
Keeping live charts responsive
Pressure measurements had to appear in real time while charts remained fluid as recordings grew. Much of a React Native app’s logic runs on a single JavaScript thread, where expensive computation can delay interactions and JavaScript-driven animations.
The challenge also involved the quality of the displayed trace. Simplifying each new reading as it arrived needed to preserve detail comparably to processing the complete recording in one pass, while keeping computation fast enough for live use.
My work addressed these constraints through charting-performance improvements and incremental data simplification.
Architecture through software qualification
My responsibilities covered user needs, technical architecture, design outputs and software verification and validation under ISO 13485. I led 2 developers, mentored the team and stayed hands-on, including native modules in Swift, Kotlin and Java for charting and network time synchronization.
I established GitLab checks, unit and Detox end-to-end tests, release branches, version tags and app distribution. Responsibility for the team’s adherence to IEC 62304, the medical-software lifecycle standard, extended beyond implementation to how software was tested and released.
- React Native
- TypeScript
- Swift / Kotlin / Java
- Bluetooth
- Detox