If you work for a medical device manufacturer, you have likely felt the pain of having your device stuck in between the move from a successful product prototype to something that can be manufactured. There are risks of this no matter what type of product you’ve designed, and regardless of what industry it addresses. However, products developed for use with or as a medical device must meet some of the most stringent quality requirements of any industry. And making sure that your supply chain, manufacturing processes, packaging, labeling, and sterilization departments are all meeting regulatory requirements is no simple task. This white paper provides a summary of considerations involved in the development of a medical device that can be successfully manufactured, as well as suggestions for engaging a qualified CMO for risk minimization.