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Commercial challenges in developing biomaterials for medical device development
Author(s) -
Harris Jeremy J,
Lu Steven,
Gabriele Peter
Publication year - 2018
Publication title -
polymer international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.592
H-Index - 105
eISSN - 1097-0126
pISSN - 0959-8103
DOI - 10.1002/pi.5590
Subject(s) - commercialization , biomaterial , scrutiny , conceptualization , medical device , risk analysis (engineering) , engineering , computer science , nanotechnology , business , biomedical engineering , marketing , materials science , artificial intelligence , political science , law
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. © 2018 Society of Chemical Industry