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Oct 23, 2026
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BMED 2100 - Design and Manufacturing in the Medical Device Industry
Credits: 3
Catalog Description
This course provides an introduction to the design and manufacturing of medical devices with special focus on the unique design manufacturing challenges that are necessary to achieve World Class Manufacturing (WCM) excellence. The course describes the fundamental systems used in the design, development, and manufacturing of medical devices and how these relate to industry regulations. Specific topics include: material and process selection considerations, aseptic processes, clean-room techniques, sterilization processes, clinical testing, lot traceability, introduction to automation and control systems, testing and instrumentation lab and manufacturing controls. BMED 1100 is strongly recommended as a first class for those with no previous biomedical device industry experience.
Additional fee to student: No
Learner Outcomes
At the conclusion of the course the student should be able to:
- Demonstrate a basic understanding of the way in which a medical device moves through the stages of production, including the following topics: development cycle, product requirements, materials selection, manufacturing strategy development and supplier selection, process selection, aseptic processes, sterility and clean rooms, instrumentation lab, testing and validation, automation and control systems, packaging and distribution.
- Demonstrate a basic knowledge of World Class Manufacturing practices.
- Describe the above processes as they apply to a local medical device company visited or researched by the student.
Major Areas of Course Content
- Understanding of medical device manufacturing with emphasis on Minnesota companies
- The development cycle of a medical device
- World Class Manufacturing practices
- Understanding product requirements
- Materials selection
- Manufacturing strategy development and supplier selection
- Process selection and monitoring-process validation
- Aseptic processes
- Sterility and clean rooms
- Instrumentation laboratories
- Design testing and validation
- Automation and control systems
- Packaging and distribution
Credit for Prior Learning Options
No credit for prior learning option is available for this course.
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