How does Exponent's multidisciplinary approach provide objective answers regarding the safety, quality, and performance of medical devices and tools?
Exponent's multidisciplinary teams work collaboratively to solve complex challenges related to vascular and orthopedic implants, surgical tools, instruments, and drug delivery systems.
We provide rigorous science and engineering with data-backed evidence to help next-gen medical device manufacturers meet and exceed compliance and safety expectations. Exponent's materials and corrosion engineers conduct fatigue, fretting, wear, fluid dynamics, material properties, and fracture mechanics testing and analysis to help evaluate medical device performance for regulatory approval (e.g., FDA 510(k) or PMA).
State-of-the-art laboratories, testing equipment, and proven methodologies assist you throughout each stage of the medical product lifecycle.
Exponent evaluates medical device materials at our in-house, state-of-the-art laboratories, equipped with scanning electron microscopy (SEM), energy dispersive X-ray spectroscopy (EDS), microfocus X-ray, X-ray computed tomography (CT), differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), and white light interferometry. With high-speed fatigue testing equipment, we offer device life-expectancy evaluation. We also have significant finite element analysis (FEA) expertise to support the evaluation and potential failure analysis of medical devices.
We've supported hundreds of clients with manufacturing, disputes, recall, technology acquisition, and design validation issues related to materials in their medical devices and tools. With over 50+ years of experience with failure analysis, we apply lessons from the past to ensure a safer, healthier future.
Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.