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Making the Grade: A Testing and Analysis Roundtable

Published In: Orthopedic Design & Technology

This roundtable discussion examines the technological and regulatory factors affecting the third-party testing and analysis services industry.

Medical and orthopedic devices are becoming smaller and more complex. Manufacturing technologies are advancing, new materials are frequently being created, and regulations are becoming more stringent. All of these factors working in concert have ensured a healthy medical device testing and analysis market—one that Research and Markets forecasts to reach $13.4 billion by 2025 with a CAGR of 11.5 percent.

Orthopedic products have more to examine than ever before. Regulatory bodies expect polymeric materials to be screened for low molecular weight impurities and additives like residual monomers and solvents, light stabilizers, and antioxidants. For 510(k) submissions, the U.S. Food and Drug Administration (FDA) demands more detailed material compatibility and device cleaning studies. Testing isn’t limited to the device themselves either—packaging is subject to increased scrutiny, including usability and environmental impact.


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Featuring: Thor Rollins and Matthew Jorgensen

Thor Rollins

Thor Rollins

Biocompatibility Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...