Medical Plastics – Advanced

Gain valuable insights into the role of micro-molders and custom manufacturers and study proven best practices to avoid recalls due to regulatory compliance issues. Learn about pitfalls in the product and process development process and how to avoid them.

This course can be applied to the Plastics Technology Certificate.

Instructor

Len Czuba

Len Czuba

Len Czuba is the president of his own product development firm, Czuba Enterprises, headquartered in Chicago. His product development experience and polymers expertise assist partner firms to take products, especially medical devices, from concept to market. He has a bachelor’s ... read more

Benefits and Learning Outcomes

Learning Outcomes:

  • Understand best practices for processing of plastics for medical devices
  • Discuss testing of raw materials and role of antimicrobials
  • Evaluate the role of micro-molders and custom manufacturers
  • When to outsource
  • Hot Topics

Learning objectives:

  • Learn the FDA classification of medical devices
  • Learn the different types of materials of construction
  • Understand the role of compliance in the product development process
  • Discuss sterilization of devices for heathcare

Course Outline/Topics

1.  Best practices for injection molders for the medical device industry
2.  Role of micro-molders
3.  Testing of raw materials – a good incoming raw material evaluation program
4.  NRL (Natural Rubber Latex) – the issues and alternatives
5.  HAI (Hospital Acquired Infection) and the role of antimicrobials
6.  Custom polymer manufacturers

  • Cost of specialty polymers
  • Functional polymers

7.  Combination products
8.  Outsourcing – the pros and cons of each

  • Off-shore manufacturing
  • Domestic production

9.  Hot topics

  • DEHP (Di-Ethyl Hexyl Phthalate)
  • BPA (Bisphenol A)
  • Reprocessing of SUDs (Single Use Devices)

Dates and locations to be announced.

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