Philip O’Neill is the Representative Director of the Parkdale Group, a company based in Kyoto, Japan that provides market entry services to overseas companies seeking to enter the Japan health care market. Recently his firm was engaged on a regulatory project to bring a medical device into Japan. They worked for over a year with an overseas supplier of a product that they felt would be well received by medical doctors in Japan. When the time came to approach the Japanese government regulator to gain product approval for use in Japan, overseas clinical trial documentation was no where to be found. Indeed, the supplier said that this information could not be found. This is a key piece of data that must be presented to the regulator before any product can approved for use in the Japanese market. Philip’s challenge was to figure out next steps. Visit casenet.ca from Acadia University for more decision focused video business case studies and to learn how you can use our cases in your classroom.