Abstract

Developing advanced medical devices and treatments within affordable costs and expediting patients' access to such medical therapies are expected in worldwide.

In the development of medical devices, identification, evaluation, and reduction of individual risks are indispensable in parallel with evaluation of probable benefits. Effects of patent characteristics and doctor's skill should be considered to maximize device performances and reduce risks. Clinical trials for market approval of innovative and first-in-human medical devices are limited in inclusion criteria, number of patient enrollment, and monitoring period. Thus, we have been challenging to develop innovative patient-oriented testing methodologies to accelerate medical device development, to evaluate safety and probable efficacy of medical devices, and to support scientific-based approval decision, which, we believe, will contribute to the acceleration of patients' access to new technologies. We are also engaged in developing guidance and standards to evaluate innovative medical devices and driving those global expansions.