Abstract
The process of device evolution from concept to clinical application has been called “bench to bedside”. This term is used by many to define translational research, but it must be recognized that there is much more to translational research than this. We can use the words device translation to refer to the process of moving a technology methodically along a series of measurable milestones from concept to completion. Translational research, on the other hand, is the process of doing all this while at the same time employing a functional quality management system, regulatory adherence (e.g. safety and efficacy), and methods of standardization. The purpose of these intangible enterprises in the research effort is to lower the barriers at the interface between basic science and clinical medicine. Effective translation of technology across this interface is the goal of translational research, and requires the addition of metrics of quality along with sound scientific and engineering judgment. This article reviews the nature of translational research and looks at its key components of quality management and standardization.
Keywords: Good laboratory practice, quality, standardization, translational research, validation.
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