A Road Map to Commercialization of Cartilage Therapy in the United States of America.

Despite numerous efforts in cartilage regeneration, few products see the light of clinical translation as the commercialization process is opaque, financially demanding, and requires collaboration with people of varied skill sets. The aim of this review is to introduce, to an academic audience, the different paradigms involved in the commercialization of cartilage regeneration technology, elucidate the different hurdles associated with the use of cells and materials in developing new technologies, discuss potential commercialization strategies, and inform the reader about the current trends observed in both the clinical and laboratory setting for establishing clinical trials. Although there are review articles on articular cartilage tissue engineering, independent reports provided by the Food and Drug Administration, and separate review articles on animal models, this is the first review that encompasses all of these facets and is presented in a format favorable to the academic investigator interested in clinical translation from bench to bedside.