ALS 425
Device and Diagnostic Product Development

This course covers technical and managerial aspects involved in the development of medical devices and diagnostics through a combination of lectures, classroom labs, and a team design project. Students will solve specific tasks from the perspective of a product manager, development engineer, industrial designer, or manufacturing engineer. Related aspects of market research, quality control, and the FDA approval process are emphasized in other complementary courses at KGI. The design project leads students through: (a) preparation of a problem statement and product design specification; (b) design and prototyping; (c) testing; (d) design for manufacture and assembly; and will conclude with (e) the preparation of a design master record. Specific technical skills necessary for the team project are each introduced using a combination of a concept video, brief lecture, and classroom lab. Students will receive an overview of general industry standards, quality systems, and certification processes.

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• Students will be familiar with and able to compose standard product development documentation
• Students will be able to apply methods for project planning and product development
• Students will be able to apply basic technical skills common to the design of medical devices and diagnostics such as data acquisition, associated hardware, and software processing
• Students will be familiar with several COTS subcomponents used in medical devices and diagnostics, and be able to provide technical and financial comparisons of those components
• Students will be able to discern the limitations and capabilities of common prototyping and manufacturing methods
• Students will be able to specify appropriate quality and manufacturing standards for specific instrumentation types