This report considered what the medical device industry is facing issues and trends,analyzed from two broad perspectives: changes in social needs and technological innovation. As a result of the analysis, three issues and trends were extracted. The first one is the movement to “strengthen regulations” to ensure security against new technological innovations. The second one is a move to “strengthen ethics”, or “compliance”, to make the relationship between the medical device industry and healthcare professionals and organizations more transparent. Third,technological innovation has increased the entry of new competitive companies, and there has been a move to “smart healthcare”, including the impact of disruptive technological innovation. These three trends examined using the most significant medical device manufacturer in Japan as an example case. Finally, it concluded the issues and trends in the medical device industry as a bird’s-eye view using the Five Forces framework.