Medical Device Design Validation and Failure Analysis

This course provides students with a fundamental understanding of the design process necessary to make robust medical devices. Fracture, fatigue, stress analysis, and corrosion design validation approaches are examined, and real-world medical device design validations are reviewed. Further, since failures often provide us with important information about any design, mechanical and materials failure analysis techniques are covered. Several medical device failure analysis case studies are provided.

Medical device manufacturers need to prove that their products perform their intended function over a given design life. Fracture, fatigue, and corrosion performance of medical devices is critical. Millions of dollars are spent each year by medical device companies validating their designs Millions more are spent if a device has a significant problem. Unfortunately, given current university/academic interest areas, many medical device engineers do not receive sufficient instruction to fully understand the principles of fracture, fatigue, and corrosion, and how they apply to their designs. Further, many of these engineers do not have the background to be able to analyze and understand any device failures.

This is an online interactive course. During this course you will interact with the instructor and possibly other students in the course. All materials will be presented online, and the course can be taken anywhere that you have an internet connection.

You will have 12 months to complete the course from the time you register. Interactive activities may include discussions, assignments, live webinar, quizzes and exams with instructor feedback. Some or all of these features may be incorporated in the course.

Course Outline

1. Fracture Modes and Mechanisms
2. Fatigue Crack Initiation and Growth
3. Application of Fracture Mechanics-based Flaw-tolerant Design for Medical Devices
4. Stress-life (S-N) and Strain-life (Coffin-Manson) Fatigue Concepts
5. Effect of Mean Stress on Fatigue Life (Goodman-type Relations)
6. Application of Stress/Strain-life Fatigue Concepts for in vivo Fatigue Performance Validation of Medical Devices
7. Application of Stress Analysis for Medical Device Design
8. Small Crack Theory
9. Basic Corrosion Concepts
10. Pitting, Crevice, Galvanic and Fretting Corrosion
11. Stress Corrosion Cracking, Hydrogen Embrittlement
12. Application of Corrosion Testing for in vivo Corrosion
13. Corrosion Performance Validation of Medical Devices
14. Failure Analysis Investigation Procedures
15. Effect of Stress States on Fracture Planes and Features
16. Interpretation of Macroscopic Fracture Features
17. Interpretation of Microscopic Fracture Features
18. Failure Mechanisms and Identification