Accelerating Time to Market for Your Life-Saving Innovations

Our engineering and process expertise includes capabilities to support your early design efforts, design and development of the final design, manufacturing process development to support scale manufacturing and post launch services.

Partnership Value

Early Design

  • Market insight and understanding of therapy dynamics
  • Technology understanding related to drug complexities
  • Take a product from idea into manufacturing and scale production
  • Comply with regulatory requirements and pathway
  • Create the full roadmap and investment plans
  • Facilitate or assist decision process

Design & Development

  • Strong innovation and design-driven DNA; recipient of multiple design awards
  • Human-centered design (patient/therapy focused)
  • 20+ years of integrated mechanical and electronic design
  • ~10 years of connected health experience
  • Systems engineering, risk management documentation (DHF, DMF)
  • Project/program management, scaled to size

Manufacturing Development

  • Manufacturing strategy
  • Design for manufacturing (DfM), Design for assembly (DfA), covering both mechanics and electronics
  • Deep experience with cleanroom manufacturing (class 7, 8)
  • Robust and phased QMS to allow for flexibility and speed
  • Integrated tool, packaging, sterilization, automation, test engineering
  • Project/program management, dependent on size

Clinical Manufacturing

  • Manufacturing strategy experience from low to high volume
  • Drug handling at selected sites
  • Deep experience with cleanroom manufacturing (class 7, 8)
  • Robust and phase QMS to allow for flexibility and speed
  • Integrated tool build (both internally and externally)
  • Project/program management, dependent on size

Commercial Manufacturing

  • Dedicated facilities and staff globally, covering both mechanics and electronics
  • 2.5+ million sq. ft. of facility space with 30 locations around the globe
  • Drug handling and final packaging at selected sites
  • Cleanroom manufacturing (class 7, 8)
  • Robust QMS to secure stable quality and timely delivery

Post Launch

  • Legal manufacturing and post-market surveillance services
  • Connected health solution hosting and maintenance
  • Lifecycle management of your product
  • Finish good handling and logistics