Bringing a POC Diagnostics Kit from Development to Scale

Case Study: Developing and Scaling a Point-of-Care Cartridge for Sepsis Pathogen Detection

Overview

SMC partnered with an innovative diagnostics company to design, develop, and scale a next-generation point-of-care (POC) cartridge used for rapid sepsis pathogen detection. The project required accelerated development timelines, complex material processing, and rigorous regulatory support. SMC delivered an integrated solution—from tooling and molding to assembly automation and FDA readiness—ensuring a high-quality consumable ready for clinical and commercial deployment.

The Challenge

Developing a high-precision diagnostics consumable demands careful coordination across engineering, manufacturing, and regulatory workflows. This program required:

  • Managing aggressive timelines for verification & validation (V&V), clinical evaluations, and FDA submissions
  • Developing robust molding processes using both thermoplastic and liquid injection molding (LIM)
  • Ensuring perfect foil sealing and achieving 100% inspection of critical functional criteria
  • Handling and dispensing sensitive reagents and proprietary components
  • Designing specialized assembly equipment capable of supporting development, scale-up, and commercial volumes

The Solution

SMC implemented a comprehensive, cross-functional manufacturing strategy tailored to the cartridge’s complexity and regulatory requirements.

Key elements included:

  • End-to-end program management through V&V testing, clinical evaluation phases, FDA submission, and product release
  • Custom tooling and molding processes for both thermoplastic components and LIM features
  • Precision foil sealing and full (100%) inspection protocols for critical product attributes
  • Controlled reagent management, including supply and dispensing of proprietary components
  • Purpose-built assembly equipment to support development and production scale-up
  • Validation protocol development and execution, ensuring compliance and reliability
  • Automation of critical assembly steps to reduce cost, increase throughput, and improve product quality

The Results

Through strategic planning, advanced materials processing, and targeted automation, SMC successfully brought the diagnostic cartridge from concept to scalable manufacturing. The solution delivered:

  • A validated, manufacturable diagnostic consumable
  • Streamlined development through coordinated V&V, clinical, and regulatory milestones
  • Improved consistency and reduced production cost through selective automation
  • A scalable manufacturing platform capable of supporting future growth
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