Scaling a proven design into high volume production.
We utilize a proven and rigorous approach to define and implement the ideal process and industrial approach for your product based on our long-standing experience across device categories. This ensures that control, quality, safety, and effectiveness are integrated into your eventual commercial manufacturing.
Implementing Your Manufacturing Plan
Supporting your small series supply requirements
Industrialization begins with updating your manufacturing strategy based on lessons learned up to this point. A diverse team of expert updates this strategy to ensure learnings from the development to date are integrated most effectively. This includes aligning with your business and ramp up requirements including any interim supply you may require.
Custom Solutions for Your Product
The right process and assets for your device
We ensure that our approach for your process development and requirements for pilot production leading to high scale manufacturing is aligned to your goals. This includes definition and selection of the proper assembly and automation approach as well as a global approach to mold development and sourcing with a proven supply base.
Integrating Quality by Design
Systemically reducing risk throughout scale-up
We apply Quality by Design principles and FMEA throughout of the whole of the industrialization process. This is driven by a diverse team who integrate design for manufacturing with all aspects of quality management. This includes verification and validation testing leading to all of the controls necessary to ensure reliable production.