ME EN 573

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Design of Medical Devices

Mechanical Engineering Ira A. Fulton College of Engineering

Course Description

This interdisciplinary course aims to provide a comprehensive and practical understanding of the design, development, and deployment of medical devices. Rooted in mechanical engineering, the course integrates key principles from biomedicine, materials science, quality assurance, and intellectual property law. With a focus on real-world application, students will engage in case studies, a hands-on project, and team-based design exercises that simulate the challenges and opportunities within the medical device industry.

When Taught

Fall

Fixed/Max

3

Fixed

0

Recommended

BIO 100

Title

Medical device design life cycle

Learning Outcome

Explain in detail each step of the medical device design life cycle and apply it correctly to a course project.

Title

Ethics, standards, regulation, and quality control

Learning Outcome

Correctly navigate ISO standards, safety, ethical, the regulatory frameworks, and quality controls and apply them correctly to design case studies or scenarios.

Title

Innovative approaches

Learning Outcome

Apply innovative approaches such as bio-inspired design and adaptive design for specific populations (e.g. male, female, age-specific populations) in case studies and/or a course project.

Title

Intellectual property

Learning Outcome

Understand intellectual property (IP) considerations involved in medical device design and estimate an IP pathway and timeline for an example project.

Title

Practical experience

Learning Outcome

Demonstrate competence in device specification, execution, validation, and verification on a medical industry-relevant project.