Medical Device Design and Human Factors
BMB 370 delves into the critical aspects of medical device design, blending theoretical knowledge with practical application. The curriculum focuses on establishing robust design controls, which are essential for regulatory compliance and ensuring product quality throughout the device lifecycle. A significant portion of the course is dedicated to usability engineering, exploring methods for designing devices that are intuitive, safe, and effective for human interaction, thereby minimizing use errors. Students will learn the methodologies for comprehensive verification and validation activities, crucial steps in proving a device meets its intended specifications and user needs. Through a combination of lectures, case studies, hands-on labs, and a capstone project, students will develop a deep understanding of the interdisciplinary challenges and best practices in medical device development, preparing them for careers in this highly regulated field.
Course outline
Lectures, virtual labs, and graded assignments — completed in your browser.
Syllabus
["Week 1: Lesson 1: Introduction to Medical Device Design and Regulation","Week 2: Lesson 2: Design Controls: Planning and Inputs","Week 3: Lesson 3: Design Controls: Outputs, Review, and Transfer","Week 4: Hands-on Lab: Design Input and Output Documentation","Week 5: Lesson 5: Introduction to Human Factors and Usability Engineering","Week 6: Lesson 6: Usability Engineering Process: Planning and Analysis","Week 7: Lesson 7: Usability Engineering: Design and Evaluation Methods","Week 8: Hands-on Lab: Usability Heuristic Evaluation and Task Analysis","Week 9: Lesson 9: Verification: Testing and Traceability","Week 10: Lesson 10: Validation: Clinical and Simulated Use Studies","Week 11: Hands-on Lab: Verification Test Protocol Development","Week 12: Lesson 12: Risk Management in Medical Device Design","Week 13: Lesson 13: Post-Market Surveillance and Lifecycle Management","Week 14: Capstone Service Project: Medical Device Design and Evaluation"]