Skip to content
All courses
BMB 370
Term 7
3 credits

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.

01Lesson 1: Introduction to Medical Device Design and Regulationlecture
02Lesson 2: Design Controls: Planning and Inputslecture
03Lesson 3: Design Controls: Outputs, Review, and Transferlecture
04Hands-on Lab: Design Input and Output Documentationlab
05Lesson 5: Introduction to Human Factors and Usability Engineeringlecture
06Lesson 6: Usability Engineering Process: Planning and Analysislecture
07Lesson 7: Usability Engineering: Design and Evaluation Methodslecture
08Hands-on Lab: Usability Heuristic Evaluation and Task Analysislab
09Lesson 9: Verification: Testing and Traceabilitylecture
10Lesson 10: Validation: Clinical and Simulated Use Studieslecture
11Hands-on Lab: Verification Test Protocol Developmentlab
12Lesson 12: Risk Management in Medical Device Designlecture
13Lesson 13: Post-Market Surveillance and Lifecycle Managementlecture
14Capstone Service Project: Medical Device Design and Evaluationassignment

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"]