I agree with the statement that one of the flaws of design transfer occurs when there is an issue in transition of a product design to manufacturing environment. In order to ensure that the design of the medical device can be correctly translated into production specifications, particular care should be taken when the product involves new and unproved manufacturing processes, or established processes which are new to the manufacturer. It may not be possible to determine the adequacy of full-scale manufacturing on the basis of successfully building prototypes or models in a laboratory and testing these prototypes or models.