Career Center



Medical Device Failures–  Lessons Learned
Date: March 17, 2009
Time: 8:30am


Sunnyvale City Council Chambers
456 West Olive Ave

Sponsor: Bio2Device Group

Event details:

It has been said that we learn more from our failures than our successes.  Given this, the medical device industry has historically provided ample learning opportunities to enable better designs.  This presentation will review case studies of famous and not-so-famous medical device failures, and examine lessons learned.  Design validation approaches to minimize failures (and get FDA approval) will also be presented.

Dr. Brad James is a Principal Engineer with Exponent Failure Analysis Associates, specializing in failure analysis, metallurgy, fracture, fatigue, corrosion and material degradation issues.  Dr. James has conducted hundreds of medical device failure analysis investigations for both industrial and legal clients. He also helps medical device companies with general materials and/or metallurgical issues, as well as design validation for fatigue, fracture and corrosion performance.  Dr. James is an adjunct professor at the Santa Clara University School of Engineering, where he teaches graduate-level fracture mechanics and failure analysis courses.  He has also served as a guest lecturer at Stanford and San Jose State Universities.  A registered Professional Metallurgical Engineer, Dr. James received his Ph.D. in Metallurgical and Materials Engineering from the Colorado School of Mines in 1994.

Additional information and/or registration:

Bio2Device Group

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