The major challenges are the fact that the vocal fold vibrates, so that anything we make has to mimic the biomechanical properties of the vocal fold, she said. It is difficult because most biomaterials that can mimic vocal fold properties also quickly degrade, and we want the materials to stay around for a while.
She is hoping that they will have a first product for FDA approval within three years.
Success of Tissue Engineering Products
According to Dr. Nussenbaum, experts from multiple disciplines will need to work together to make tissue engineering a success; these include clinical scientists, biologists, biomedical engineers, industry sponsors, and government agencies. To help expedite the developmental process and monitor both safety and efficacy, an international registry of clinical trials for tissue engineering products is now being developed by the Tissue Engineering and Regenerative Medicine International Society (TERMIS), a society formed in 2004.