Design, Development and Manufacturing Lifecycle

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.

Collaboration 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

Learn More About our Product Design Capabilities