Project Overview
The Lucira team at Pfizer contracted us to develop a specialized benchtop instrument for manufacturing QC and R&D validation of their colorimetric LAMP assays.
The instrument provides precise thermal control and real-time optical monitoring across 48 samples simultaneously, with automatic data upload to cloud infrastructure for QC lot release and validation studies required for FDA-regulated products.
Mosaic delivered the complete solution—from concept through production—including mechanical design, electronics, embedded software, cloud infrastructure, and manufacturing support.
Technical Solution
Hardware Design
- Thermal system: Peltier-based temperature control with ±0.1°C uniformity across 48 wells
- Optical system: Real-time transmission spectroscopy with 48-channel photodetector array
- Motorized lid: Automated sample loading and unloading
- Custom electronics: Mixed-signal PCB with multi-channel ADC and thermal control
Software & Cloud
- Embedded platform: Toradex Apalis iMX6 running Torizon Linux
- User interface: C++/Qt firmware with QML touchscreen UI
- Cloud integration: Automatic data upload, fleet management, and OTA updates
- REST API: LIMS integration and automation control
Key Capabilities
- Automated calibration: Traceable thermal and optical standards with self-calibration routines
- Fleet management: Remote monitoring, predictive maintenance, and usage analytics
- Data traceability: Complete audit trail for 21 CFR Part 11 compliance
- Manufacturing integration: Seamless workflow integration with existing LIMS and MES systems
Design & Implementation
Exploded view showing the modular assembly architecture
Internal view revealing the thermal control system, optical array, and custom PCB
Embedded touchscreen user interface for run configuration and real-time monitoring
Cloud-based dashboard for fleet management and QC analytics
Performance Specifications
- Capacity: 48 wells per run, up to 768 samples per 8-hour shift
- Thermal: ±0.1°C uniformity, <5 min ramp to 65°C
- Optical: Real-time monitoring at 1 Hz, <1% CV across wells
- Connectivity: Ethernet, Wi-Fi, USB with REST API
Impact
The instrument enabled Lucira to scale manufacturing during the COVID-19 pandemic, supporting high-volume production with centralized QC data across multiple sites. It accelerated R&D through real-time feedback and automated data collection for validation studies, while providing complete regulatory traceability for FDA submissions.
This project exemplifies Mosaic’s end-to-end capabilities—from understanding manufacturing requirements to delivering production-ready instruments. The relationship with Lucira, from founding team members to first client, demonstrates our commitment to supporting diagnostic innovators with world-class engineering.
Interested in developing custom instrumentation for your manufacturing or R&D operations? Contact us to discuss how we can design tools that accelerate your product development and scale your operations.