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MEDICAL DEVICES ECOSYSTEM: THE PATH TO PRODUCT

BME 640
Course Description

Development of medical devices for therapeutic or diagnostic purposes. Gap analysis, market analysis, reimbursement/distribution, regulatory approval, and manufacturing/supply chain development. Refinement and presentation of design ideas and corporate strategy within a team setting. Case studies of device design/manufacture including supply chain, intellectual property, pre-clinical testing, U.S. and European regulatory pathways and clinical trial design.

Prerequisties

BME 402 or concurrent enrollment, graduate/professional standing, or member of Engineering Guest Students

Satisfies

This course does not satisfy any prerequisites.

Credits

Not Reported

Offered

Not Reported