MDx Assay Cartridge: Manufacturing Line

Outome of this project was a validated manufacturing line for a small, room-temperature stable in-vitro-diagnostic assay cartridge with assay for diagnosis of an infectious-disease. The cartridge is launched as CE IVD in Europe, and FDA trials in the USA are ongoing.
My role in this project:

  • Planning facility layout & capital investment
  • Manufacturing cost analysis as basis for transfer price negotiations
  • Smooth know-how transfer from the international project partner & Project Management
  • Specifying manufacturing equipment & support in selecting specific part/components
  • Manufacturing layout according lean manufacturing principles
  • Annual capacity calculation & Expansion planning
  • Proposals for cost optimization
  • Guidance & support in ensuring compliance to applicable quality regulations (ISO13485 & FDA 21 CFR 809)