The basis for the design and fabrication of new substitutes for tissue regeneration and organ replacement resides in biomaterials science and in the emerging field of tissue engineering. Three design approaches employ materials that perform as inert, biometric or biodegradable interfaces with body fluids or tissues. Biomaterials can provide the substrate integrated with tissue engineered molecules, cells, extracellular matrix, or recombinant protein. The question remains as to how we begin to address the issue of quality, safety, and efficacy issues in experimental testing of these materials when used in medical applications. As federal government funding of research has decreased, industrial support of academic research and development has grown. As the complexity of the interactions between materials and biological tissues grows, biomaterials-based emerging technologies will prosper through an overall changing approach to basic and applied biomaterials research. How to meet these needs through industry and acade-mia remain unresolved. Our priorities must include a major emphasis on quality and strict adherence to quality assurance issues in testing and analysis.
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