HEALTHCARE CASE STUDY -

HEALTHCARE CASE STUDY

Engineering Precision to Save Lives Faster

Integrating system and assay development made better diagnostics possible.

What We Did: Methods Integration Systems Engineering (MISE) for IVD Devices

Business Industry or Area: Diagnostics, Lab Automation, and Medical Device R&D

Summary

Ampcus was engaged to lead the integration between instrument system development
and assay development for advanced in vitro diagnostic (IVD) platforms. These
medical devices serve critical areas including infectious disease, oncology, and
and cardiac care, demanding precision, compliance, and innovation.

Goals

Time to Market

Improve systems, processes and workflows

Enhanced Reliability

Stabilize and enhance products and support systems

Regulatory Readiness

Create documentation frameworks driven by compliance

Real-time Performance

Integrate systems engineering and lab automation

Ampcus Strategic Impact

Systems Engineering Leadership

Delivered a unified engineering approach bridging hardware, software, and assay workflows—enabling robust V&V across prototype and production systems.

R&D Excellence

Optimized assay-instrument interactions through deep diagnostics expertise—resolving calibration errors, software bugs, and algorithm inefficiencies.

Regulatory & Technical Documentation

Developed detailed technical and compliance documentation aligned with FDA, GMP, GLP, GDP, and SAP systems.

Debugging & Testing

Built and executed semi-complex testing protocols to uncover root causes, automate quality checks, and ensure seamless product delivery.

Software & Tool Development

Enabled agile, standards-based development leveraging SDLC/CMMI ML3 practices and advanced tools like TFS.

Client Confidence

Ampcus’ cross-disciplinary expertise—from molecular biology to embedded systems—positioned us as a trusted long-term innovation partner in the healthcare domain.