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B M E 640

MEDICAL DEVICES ECOSYSTEM: THE PATH TO PRODUCT

3 credits.

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.

Prerequisites & course information

Requisites: B M E 402 or concurrent enrollment, graduate/professional standing, or member of Engineering Guest Students Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Spring 2026 Learning Outcomes: 1. Develop an evolving competitive landscape analysis Audience: Both Grad & Undergrad 2. Identify common issues in manufacturing/supply chain Audience: Both Grad & Undergrad 3. Describe key aspects of clinical trial design Audience: Both Grad & Undergrad 4. Discuss intellectual property both In theory and in practice Audience: Both Grad & Undergrad 5. Articulate the differences between regulatory pathways in Europe and the United States Audience: Graduate 6. Define key aspects of pre-clinical testing, including Quality Systems, Good Laboratory Practices, and Good Manufacturing Practices Audience: Graduate Learning Outcomes: 1. Develop an evolving competitive landscape analysis Audience: Both Grad & Undergrad 2. Identify common issues in manufacturing/supply chain Audience: Both Grad & Undergrad 3. Describe key aspects of clinical trial design Audience: Both Grad & Undergrad 4. Discuss intellectual property both In theory and in practice Audience: Both Grad & Undergrad 5. Articulate the differences between regulatory pathways in Europe and the United States Audience: Graduate 6. Define key aspects of pre-clinical testing, including Quality Systems, Good Laboratory Practices, and Good Manufacturing Practices Audience: Graduate

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