The role of optical tissue phantom in verification and validation of medical imaging devices

Optical tissue phantoms are very important tools for the development of biomedical imaging applications. They play an important role from proof of concept to clinical trials. Optical phantoms are often used as reference materials against which instruments results can be compared. It is therefore important that the optical properties of reference phantoms be measured in a manner that is traceable to the international system of units. SI traceability insures long term consistency of results and will therefore improve the effectiveness of diffuse optics research effort more effective by reducing unwanted variability in the data produced and shared by the community. The ultimate benefit of SI traceability is the reduction of variability in the data produced by novel diagnostic devices, which will in turn increase the statistical power of clinical trials aiming at validating their clinical usefulness. SI traceability, which implies uncertainty analysis, is also relevant to traceability aspects mandated by FDA´s Good Manufacturing Practices.