Commercial challenges in developing biomaterials for medical device development

From initial conceptualization through to market adoption, the introduction of new technology into a commercial market is often fraught with challenges. In the field of biomaterials these challenges manifest themselves at every step of the commercialization process. As the understanding of the mechanobiologic relationship in tissue engineering has progressed, there is greater emphasis being placed on the engineering of specific properties into new biomaterials. During this early development, intellectual property is a critical factor in determining commercial feasibility as patent protection establishes the property lines around the technology and helps define future market segments. Once developed, a new biomaterial then enters the next series of challenges including commercial‐scale manufacturing and addressing regulatory concerns. Synthesis of the biomaterial must be economically and technically scalable to meet market demands and the new biomaterial must be designed to stand up to regulatory scrutiny with regards to safety and efficacy. However daunting, a robust understanding of the design elements and the commercial requirements will aid the researcher in overcoming the challenges of bringing a new biomaterial to the market.