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Biomedical Device Plastics and Design

This course reviews the biomedical product development process and explains how it helps in the design of the biomedical device as well as guides the selection of the polymer for the application. A brief “how-to” on preparing a product requirement definition is reviewed. Then we cover sterilization and discuss its effects on the polymer and the product, explaining why one method is used rather than another in some applications.

You leave with a good overview of the process needed to make superior biomedical devices.

This course can be applied to the Plastics Technology Certificate.


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

  • 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 health care

Course Outline/Topics

1. Biomedical device industry overview
Historical review putting current industry into perspective
Focus on improved patient outcomes including ease of use and cost of care
Pressure on industry for better, lower cost products
How polymers were the enabling technological breakthrough

2. Product requirements definition
New product must be safe and effective
Cost of product must suited to market need

3. Type of biomedical device
Commodity – single-use disposables
Specialty product
Durables or diagnostics

4. Polymers of construction and design of product or component
When to use and why
High volume, low cost commodity polymers
Thermoplastic elastomers
Liquid silicone rubber

High performance polymers which carry inherently higher cost
Polyamides and copolymers
Polyether imides
Thermoplastic urethanes
Liquid crystal polymers
Specialty polymers for long-term implantable devices, etc., for highest performance with as high a price
Polyamide imide
Silicone rubber
Durable products for permanent equipment, repeated cleaning and/or sterilization
Diagnostics – usually disposables

5. Processing for quality, low cost and safety
Thermoplastic processes:
Extrusion & coextrusion
Injection molding
Rotational molding
Joining of plastics
Heat sealing
Heat welding
Laser welding
Friction welding
RF or induction heating
Ultrasonic welding
Hot bar or impulse welding
Solvent bonding or using adhesives
Assembly, packaging and sterilization

6. Extra topics if time is available
Explain how the FDA works
The important reimbursement process by CMMS
The effect of buying groups or organizations on new or emerging technologies

Dates and locations to be announced.