Medical devices like implant, surgical tools, and other equipment provide the tools that make our modern medical system so successful. However, when these components fail, it is important to correctly determine the cause to prevent future failures and improve patient outcomes. According to the FDA, “failures in product design and manufacturing process control caused more than half of all product recalls. The root causes of quality issues are tied closely to device type.”
The scientists and researchers at G2MT Labs have been identifying and solving medical device failures for years, including implants, operating tools, medical devices, and other medical equipment. We look forward to helping you find the root cause and select appropriate actions to remediate the problems.
Value of Medical Device Failure Analysis
When medical devices fail, you need a thorough and accurate investigation to determine the root cause of the failure (1). The ‘good’ news is there are far more adverse reactions to drugs (235,000) than implant failures each year (80,000); however, once you know the root cause it is possible to improve designs and reduce future failure rates.
Our medical device analysis experts work closely with our metallurgical analysis and consulting team to provide every facet of the investigation needed to rapidly and accurately determine the cause of the failure. Through years of experience in the development of medical devices and tools, our medical device failure analysts can help isolate and identify the cause of the failure, and then provide effective recommendations to prevent recurrence.
Medical Device Failure Analysis Process
The medical device failure analysis process [2, 3] includes visual inspection, photography, and measurements of the samples, typically followed by microscopy (optical, SEM, EDS, and other measurements) to analyze the material and the fracture surfaces. Generally we follow the practices of the ASM Handbook for Medical Device Failure Analysis.
Final reports from G2MT Labs include pertinent background information, results (including photographs, micrographs, mechanical testing results, corrosion analysis, and other testing data, as needed) and discussion of the root cause, conclusions, and recommendations for additional steps to be taken. Our team of failure analysis experts works hard to provide a clear and thorough explanation that is accessible to the layman but substantial enough to satisfy our colleagues and/or critics. When necessary, we are available for expert witness testimony and consulting cases.