• Device design management and governance from pilot scale clinical volumes through to industrialisation, commercial scale-up and launch
  • Integration across technical functions and systems with manufacturing organisations and equipment suppliers
  • Technical input and collaboration with toolmakers, injection moulders, device manufacturers, automated assembly, packaging and test equipment suppliers
  • Technical project management creating a clear development pathway to product launch
  • Device and component design for manufacture (DFM) for commercial scale-up suitability
  • Navigation through complex and demanding equipment qualification and validation processes Including technical support for complex multi cavity tooling and automated assembly
  • Troubleshooting and device performance optimisation
  • IFU and final packaging design and development