In-Vitro Diagnostic Product Development – Hemostasis Systems

Executive summary

The client is a leading global supplier of specialty In-vitro Diagnostics (IVD) serving the acute care and autoimmunity markets. The portfolio of hemostasis products includes blood analyzers, reagents, and automation solutions along with a data management platform and supporting services that diagnose and guide treatment of thrombotic and bleeding disorders.

The client was challenged by high development and maintenance cost as a result of a fully onsite delivery model, longer release cycles due to manual testing and legacy driven development processes. High effort and risk in maintaining undocumented and legacy FPGA-based systems resulted in impact to time-to-market, scalability, and long-term sustainability of the products.

eInfochips delivered end-to-end product engineering services including hardware design, firmware development, and OS-porting, to help the client bring its hemostasis analyzer to market faster. We advised and worked closely with the team to re-architect their analyzer platform, modernize test automation, and put in place a scalable and sustainable offshore delivery model, while closely adhering to FDA and medical regulatory compliance requirements for their IVD products.

Key Highlights

Medical Devices
  • Hardware architecture and design
  • Firmware development
  • Performed porting and customization of Linux Board Support Packages (BSP) for Intel i7 and ARM-based platforms
  • Ensured robustness and portability of the platform for long-term scalability
  • Test automation and simulation 
  • Regulatory documentation support
  • Technology stack
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