Design validation is important because this is the step where you have to essentially prove that your project was successful. The fundamental purpose behind your project is to develop a product or service that will fulfill a need to a customer, whether it be management or consumers. In the design validation, you have to show that all of your inputs into the product design are met and that they all ultimately will fulfill the needs of your customer. The customer is the one whom the company depends on for revenue and survival; therefore, fulfilling the need of the customer is the most important reason behind any project. In Design Validation, you basically prove that the device that you are introducing to the market can be used by customers and it will perform as expected. As Dr. Simon mentioned, the validation step may not be required if the medical device you have produced through your project is similar to devices already on the market. Another way to think about Design Validation is that you are trying to prove the integrity of your devices, that it will perform as expected and that it meets all of the requirements of not only the customer, but the company and the government.