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MECH_ENG 395: Design and Manufacturing of Medical Devices Keys

Description

Medical devices play an essential role in improving the quality of human life. Consequently, their design poses unique engineering challenges. Designers must address high standards of reliability, risk-mitigation, and biocompatibility necessary to perform these essential life-supporting functions. In this course, students will learn how to translate these requirements into design specifications, manufacturing processes, and quality controls necessary for the mass production of medical devices. This course will cover:

• case studies on the design and manufacturing of medical devices currently on the market
• analysis of differing economic and user-centered needs of medical device stakeholders (especially healthcare providers, clinicians, and patients)
• a review of FDA standards (and other global regulations) on medical device manufacturing and testing
• development and analysis of plans for clinical trials
• strategies for the selection of biocompatible materials

Students will synthesize these learnings into a project where they will work in teams to design, manufacture, and test a tool set for performing an orthopedic surgical procedure.