The engineers and scientists at Exponent have helped hundreds of medical device clients with failure analysis, manufacturing, litigation, recall, technology acquisition, and design validation issues. We have experience with vascular and orthopedic implants, surgical tools, instruments, and drug and device delivery systems.
Our engineers and scientists conduct medical device failure analysis investigations for both industrial and legal clients. These investigations range from analyses of relatively simple surgical tools to complicated drug delivery systems. Industrial clients ask us to help with manufacturing issues and failures, or to determine why a product failed to perform its intended function during testing or clinical trials. For our legal clients, we help determine the cause of adverse events that have resulted in litigation.
To conduct our investigations our staff utilize our in-house state-of–the-art laboratory equipment, including scanning electron microscopy, energy dispersive spectroscopy, microfocus x-ray, x-ray tomography, differential scanning calorimetry, Fourier transform infrared spectroscopy, and white light interferometry.
We are often asked by our clients to help validate medical device performance for regulatory approval (for example FDA 510(k) or PMA). In particular, our scientists and engineers conduct finite element, corrosion, fatigue, fretting, wear, fluid dynamics, material property, and fracture mechanics testing and analysis for our medical device clients. We utilize in-house laboratory equipment, including a dedicated corrosion test laboratory and high-speed fatigue testing equipment for device life validation.
Exponent’s consultants are recognized medical device industry leaders in failure analysis, polymers, metals, ceramics, finite element analysis, corrosion, fatigue, fracture, and design.