Accelerating Emergency Diagnostics: Inflammatix and Revolutionizing Point-of-Care Testing

Aggressive Timelines: Align software and hardware development with SEPSIS-SHIELD clinical study deadlines (1,222 patients, 22 sites).

Regulatory Complexity: Comply with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304 for a Class II device.

Cybersecurity Compliance: Address evolving FDA guidance released mid-project.

HIPAA & Data Protection: Secure sensitive patient data with strong encryption and access controls.

30-Minute Runtime Goal: Achieve actionable diagnostic results in ~30 minutes to enable real-time care.

Team Scaling: Avoid delays from building an in-house FDA-compliant software team.

Go-to-Market Risk: Any delay or failed submission could derail funding, partnerships, and military contracts.

Integrated Development Approach: Tight software-hardware-assay coordination achieved performance and runtime goals.

User-Centric Design: Intuitive touchscreen UI, guided workflows, and barcode scanning optimized for emergency room workflows.

Regulatory Alignment: Proactively adapted to 2023 FDA cybersecurity updates without derailing the project timeline.

Cybersecure Architecture: Built-in HIPAA-compliant encryption and access control from the start.

Streamlined Clinical Integration: Enabled LIS connectivity and remote notifications for seamless hospital workflows.

First-Pass FDA Clearance: Delivered a compliant Design History File (DHF), avoiding 6–7 months of internal effort.

Future-Proof Platform: Modular software accommodates future assays without core system changes.

Operational Excellence: Supported Inflammatix in winning a military contract and achieving market readiness.