From Design Freeze to Production: AM in Regulated Medical Device Manufacturing

A successful application is one thing. Moving it into a controlled, repeatable production environment is another. What questions should you be asking before making that transition?

In this practical session, the Stratasys Medical team will explore the questions and considerations that come into play when moving an additive application from design freeze toward production—from validation and design transfer to process control, repeatability, and manufacturing readiness.

We'll discuss:
• What questions to ask before moving an additive application into production
• What needs to be defined and controlled after design freeze
• Design transfer and manufacturing readiness considerations
• Material and process validation
• Repeatability, traceability, and quality considerations
• Production volume, capacity, and scalability
• When to manufacture in-house, outsource, or consider a hybrid approach
• Common implementation challenges and lessons learned
• Where additive may or may not make sense for production.

The goal is simple: help you understand the questions to ask and the considerations to evaluate when moving an additive application toward production—so engineering, manufacturing, quality, and other stakeholders can make informed decisions together.