The Challenge
With concept-to-pre-market-approval costs averaging $30-100 million dollars, how do you ensure that you get your product to clinical testing? Go to the people who "wrote the book" on it.
Ä¢¹½tv's MULTIDISCIPLINARY Solution
Our client selected Ä¢¹½tv because of our expertise in high-performance polymers and bioengineering — as well as our familiarity with FDA regulatory requirements for novel devices. We formed a multidisciplinary team to help the manufacturer bring their advanced cervical disc replacement to market and develop a superior product that could successfully meet FDA pre-market approvals for clinical testing.
EXPONENT's Impact
Ä¢¹½tv's test program and the insights obtained from it allowed our client to bring to market a next-generation cervical disc replacement device that helps patients preserve mobility and reduce pain. The new device has been successful in clinical trials.
Ä¢¹½tv also continues to evolve standards for PEEK — thanks to our broad support of multiple material suppliers, medical device manufacturers, and extensive regulatory experience. Our publishing and standards-setting work in the biomedical field drives transparency, technical rigor, and efficiency for other medical device companies.
