Commercial challenges in developing biomaterials for medical device development

Abstract

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

Poly(glycerol sebacate)-Based Polyester–Polyether Copolymers and Their Semi-Interpenetrated Networks with Thermoplastic Poly(ester–ether) Elastomers: Preparation and Properties

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“…[5][6][7] Our recently introduced Challenges to Industry articles from industrial scientists and engineers are designed to challenge academic researchers to address fundamental technical obstacles and accelerate innovation for global impact. 8 Academic researchers will also challenge industrial scientists to provide insight to viable commercial pathways to enhance the likelihood of broader impact. Polymer International must continue to catalyze timely discourse in the literature and sustain our passion for addressing our complex international challenges.…”

“…However, researchers are often challenged to sustain their passion for the science of sustainability due to many factors, including variable economics, uncertainty in energy calculations, diversity in civil infrastructure, regionally inspired sustainable feed stocks, and the often missing yet essential industry‐university partnership . Our recently introduced Challenges to Industry articles from industrial scientists and engineers are designed to challenge academic researchers to address fundamental technical obstacles and accelerate innovation for global impact . Academic researchers will also challenge industrial scientists to provide insight to viable commercial pathways to enhance the likelihood of broader impact.…”