Basic Concept for Evaluating the Safety and Efficacy of Medical Devices Using Diagnostic and Therapeutic Data of Diseased Animals

Abstract

Model animals, artificially induced with a specific disease, are used in general non-clinical studies in the development of medical devices for human. Moreover, companion animals with spontaneous diseases such as cancer (diseased animals) are useful for more accurate evaluations on the safety and efficacy of applications in humans because they retain immune functions and may reflect pathological conditions of chronic diseases on target-affected areas and other organs. Therefore, pilot studies using diseased animals may be used as valuable test methods before First-in-Human trials for the devices with innovative techniques. However, for its implementation, it is necessary to be fully considered from the perspective of regulatory science regarding ethical basis, related laws and regulations, applicable cases, risk assessments, safety and efficacy evaluation methods, testing systems. Considering this background, and to establish a revolutionary state-of-the-art test method, we developed the basic concept of safety and efficacy assessments of the devices using diseased companion animals, with the cooperation of relevant academic societies, industry organizations, and regulatory authorities.