The introduction of an extracellular matrix–based scaffold to the marketplace

Continuous application of new scientific knowledge is a central characteristic of modern medical practice. The current pace of medical innovation creates an environment of rapid change, and the introduction of innovative treatments in the area of regenerative medicine in orthopaedics prompts health care providers, medical device companies, patient advocacy groups, and health insurance payors to study the most optimal method for introducing these treatments to clinical practice. Questions regarding the role and value of preclinical testing, clinical trials, and postmarketing surveillance are pertinent to this discussion, and answers to these questions should culminate in a strategy that benefits patient care.