Online Registration

Purpose & Overview
This workshop is an introduction to material selection and process technologies for personnel involved in the development and processing of medical devices. The course covers the fundamentals of selecting the right polymer for the application. It reviews compliance with regulatory systems in the development and manufacturing processes. It reviews sterilization methods used for medical devices and explains how this post-assembly process affects the choice of polymers. Attendees also learn the background of some of the “hot topics” in the industry.

Who Should Attend?
Engineers, product designers, technicians, procurement and quality professionals, and managers involved in developing and manufacturing medical devices and products for the healthcare industry.

Course Overview

1. Commitment to quality — so what else is new?
2. A look at the new specialty materials and a review of the “traditional” polymers.
3. Adapting latest processing technologies to differentiate capabilities.
   • The shift toward micromolding and what is driving it
   • Automation
   • Clean-room manufacturing
4. The evolution of sterilization technologies for medical devices and how the sterilization process affects your devices or components.
5. Hot topics.
   • DEHP and phthalates as well as PVC in medical devices
   • The BPA issue and how it will affect existing products and future devices
   • The need for “Green”
   • Cost-containment pressures and the healthcare industry’s response

Len Czuba
Len Czuba is president of his own product-development firm, Czuba Enterprises, Inc., headquartered in the greater Chicagoland area. He uses his product-development experience and polymers expertise in working with partner firms to take products, especially medical devices, from concept to market.

Mr. Czuba holds a bachelor’s degree in biosciences from Southern Illinois University. He has more than 30 years of experience in polymer synthesis, compounding, and material development in the medical-device industry. From the 1970’s through the 1990’s, he was with Baxter Healthcare Corp., where he was involved in device engineering, blood and IV container work, and product development. He was responsible for several new material replacements for PVC and holds 15 U.S. patents. He has worked on a wide variety of devices, both implantable and external accessories, used in the healthcare industry.

In 2004, Len Czuba was honored as one of the 100 MD&DI Notable Persons in the medical-device industry. He is a frequent seminar instructor both in the U.S. and around the globe. A member of the Society of Plastics Engineers since 1975, Mr. Czuba is active in the Chicago Section, has been on the Board of Directors of the Medical Plastics Division since 1985, and has twice served as Division Chair. In 2000, Mr. Czuba became an SPE Honored Service Member; he was the Society’s President in 2005–06 and is now a Distinguished Member of SPE.