Plastics devices and materials play a critical role in the growing health care industry. A great number of prosthetics, implants, tools, devices, and packaging could not exist without advanced plastics and materials. Furthermore, the use of plastics in medical applications is growing rapidly and the medical plastics market is expected to increase. We offer a Medical Plastics Certificate, taken in conjunction with the Plastics Engineering Technology baccalaureate degree, for students who are interested in careers in medical product development. Topics include advanced materials, new product design, manufacturing, and FDA regulatory issues. All are necessary to have an understanding how to design and bring new medical products to the market.
The following courses are required to obtain the certificate (14 credits):
- BI SC 004 – Human Body Form and Function (3 credits)
MICRB 106 – Elementary Microbiology (3 credits) AND MICRB 107 – Elementary Microbiology Laboratory (1 credit)
- PLET 380 – Medical Plastics Industry Overview (1 credit). This introductory course will provide students with an overview of the medical plastics industry and the implications of designing and manufacturing products in a regulated environment. Topics such as an introduction to the FDA, device levels, quality control methods, and current events relating to plastics in medical devices will be covered.
- PLET 481 – Plastics Product Development (3 credits). Covers product/business development process including researching user needs, writing specifications, testing requirements, concept creation and selection, working with industrial design, marketing, and finance.
- PLET 482 – Medical Product Development (1 credit). This course is taught in parallel with PLET 481 and shares a common semester project. In this course, students learn specific documentation and design requirements for plastic medical devices. Topics such as design history files, marketing requirement documents, product requirement documents, standard medical device components, and medical packaging requirements are covered.
- PLET 483 – Advanced Materials in Medical Applications (3 credits). Topics include plastics materials in medical applications and devices. This focus is on the properties that are important to medical devices such as chemical resistance, sterilization and bio-compatibility. A broad range of polymers are reviewed including commodity resins, such as polyolefins, engineering resins such as polycarbonates, acrylics, nylons and advanced polymers including polysulfones, polyetherether ketones and aramids. The synthesis, production and structure property relationships will be studied with particular emphasis on the effect on sterilization, bio-compatibility and FDA regulatory requirements. The effect of additives, stabilizers, fillers and blends will also be reviewed.
- PLET 484 – Medical Manufacturing Methods (3 credits). This course provides instruction in the methods and practices used in the manufacturing of plastic devices in the medical industry. The course includes both manufacturing and regulatory requirements.