The medical device innovation process

Developing a new medical device requires more than a good idea and good engineering. This chapter presents a structured method and best practices to guide innovators through the steps of medical device development. Practical suggestions are offered for screening an innovative medical device based on its technical, market, and financial feasibility, how to cost effectively test new medical devices for safety and efficacy, and how to protect intellectual property and navigate the patent process. The complexities of regulation, reimbursement, and financing of medical devices are discussed as well. Following best practices for new medical device development does not guarantee success, but it does minimize the risk of developing the product.