If a product, especially a medical product, is to be truly successful in increasingly competitive markets, it needs to be accepted and adopted by regulators and users alike, being safe to use while delighting the target audience. The barriers are made increasingly more difficult if your product is going to achieve success on a global platform. In this talk we examine what is required to develop a product that takes account of the needs of multi-markets and the range of cultural and social issues you will encounter when creating a product that can achieve success in both Japan and New Jersey.