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.
Featuring: Thor Rollins and Matthew Jorgensen