I have recently come across another example of a challenge in the global regulatory involvement and that involves continuous improvement. When a product is launched, often times the manufacturing process or product quality or cost are not as efficient and cost effective as it could be. So we go through the process of improving the product over years by evaluating where we can improve quality, process and cost. This is done on a continuous basis through the lifecycle of the project. The problem we have encountered recently is that the global regulatory submissions required as a result of the product or process change will be so cost prohibitive that it prevents us from implementing product improvements. This prevents us from lowering the cost of products. This is a really interesting problem. How can companies improve products considering the cost of all the regulatory submissions? We often will try bundling changes to maximize the benefit, but on older products even this is rarely enough. Anyone have any other thoughts?