1. Concept development

• 'Black box' development
• Value-engineering of customer concept or existing product
• Creating ideas
• DFM (Design for Manufacture)

2. Product specification

• Drawings
• 3D models
• Critical criteria
• Cleanliness
• Special surface finish or treatments
• Special packaging
• Product testing

3. Feasibility analysis

• FEA simulation
• Manufacturing feasibility
• Tool design models
• Supply chain considerations
• Feed-to-line concepts

4. Concept validation

• Flow simulation
• Quick prototyping (additive manufacturing)
• Quick sampling
• Material evaluation

5. Testing and validation

• Dimensions
• Material properties
• Functional product testing
• Surface cleanliness
• Special testing, e.g. bioburden

6. Product optimization and design freeze

• Pre-serial trials
• DOE (Design of Experiment)

7. Industrialization

• Construction of molding and demolding tools and automated handling units
• Closed loop fully automated cells for high volumes
• Finalization of serial process in suitable environment: Cleanroom, White room, Gray room, Food safe cells

8. Serial validation

• Part and material validation package to suit customer requirements
• Run@Rate studies
• Dimensional capability
• In-line inspection
• Process audit

9. Scale-up production

• Scaled-up tools
• Scaled-up production cells
• Advanced automation techniques
• Direct Line Feed (DLF) programs
• Ready-to-use product packaging and supply systems