Know Your Material Debris for Implantables
Elaine F. Schumacher
Medical Design Technology - February 7, 2014
McCrone Associates is a consulting laboratory with extensive experience in materials analysis, much of it in the area of medical device development. Growing use of joint prostheses, combined with introduction of novel materials and coatings, requires ongoing research into mechanisms that generate wear particles, and the long-term physiological effects of these particles on tissues and organs. The benefits for patients are tremendous, but liability issues related to failed devices can pose serious consequences for manufacturers. Characterization of debris on both as-manufactured and explant devices is required to fully understand wear processes and potential risks to patients. The unique capabilities of McCrone Associates for isolation and characterization of small particles, and our experience in application of these capabilities to medical device wear debris can provide needed insights. Our ongoing culture of continuous quality improvement and cGMP certification underlie our approach to particulate analysis and guarantee the reliability of our services in this critical area of medical device design and manufacture.