Medical Plastics – Basics

The use of plastics in the manufacture of a medical device requires many more considerations than the usual engineering requirements and capabilities. Learn about the basics of the material requirements and manufacturing conditions that apply to medical devices. Review the FDA’s different classifications of medical devices and the different types of construction materials used.

In addition to the testing and qualification requirements, we’ll discuss the product development process, the role of the FDA, compliance requirements, and sterilization.

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 objectives:

  • Review the FDA’s classification of medical devices
  • Learn about the different types of materials of construction
  • Understand the role of compliance in the product development process
  • Discuss the sterilization of devices for healthcare

Course Outline/Topics

1.  Market overview – polymers, medical devices, healthcare

  • U.S.
  • Global

2.  Types of medical devices

  • FDA Class 1
  • FDA Class 2
  • FDA Class 3
  • High volume disposables
  • Long term implantable products
  • Durables
  • Diagnostics

3.  Materials of construction for medical devices and components

  • Big 4 commodity polymers
  • Custom materials
  • Implantables
  • Next generation materials

4.  The product development process

5.  Testing and qualification requirements

  • Physical / functional
  • Chemical
  • Biological

6.  The role of the FDA

7.  Compliance requirements for suppliers and manufacturers

  • Molders
  • Extruders
  • Contract manufacturers

8.  Sterilization as an important part of the process

Dates and locations to be announced.

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