How does Exponent leverage our unique multidisciplinary approach to help you understand your real-world performance and provide feedback on the product lifecycle?
Exponent has extensive expertise in creating and managing international multicenter programs to collect and analyze components from explanted orthopedic, spine, and cardiovascular implants, including total joint replacements, artificial discs, surgical tools, pacemakers, implantable cardioverter-defibrillators, and stents. With a team of multidisciplinary experts highly trained in failure analysis, our team has the experience to diagnosis the cause when a failure occurs.
We are well-versed in the Food and Drug Administration's expectations for clinical studies and post-market surveillance. Both require attention to retrieval analysis procedures that support a manufacturer's complaint handling process.
With accredited ISO 17025 (A2LA Certificate 2561.01, 2561.03) facilities for retrieval protocols based on ASTM F561, "Standard Practice for retrieval and analysis of medical devices and associated tissues and fluids," and ISO 12891, "Retrieval and analysis of surgical implants," Exponent's staff and laboratories are well-positioned to serve the global community.
We have participated in the development of the standards and use them to create custom protocols to ensure appropriate collection, shipping, and analysis of retrieved devices, tools, and tissues. Our team employs validated analysis techniques to assess wear and damage modes; evaluate fracture surfaces and material degradation; and quantify wear, deformation, and penetration of biomaterials. The results are compiled into reports suitable for direct submission to regulatory agencies.
Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.