Regulatory & Compliance

Developing Next-Gen Medical Implants

Neck Pain Women Holding

Guiding a Client Through the Total Product Life Cycle

A cutting-edge medical device company wanted to use an innovative material for the next generation of their cervical disc replacement — one with the potential to improve radiological imaging and better evaluate patient outcomes.

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. 

Exponent's MULTIDISCIPLINARY Solution 

Our client selected Exponent 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 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.

Exponent 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.