| Over the last decade, US medical device companies have been under tremendous pressure to release new products on time in order to gain market share and to achieve financial goals. Less than one-third of medical device development programs that are funded actually make it to the market. Of those that make it, nearly all encounter at least one crisis in the development cycle. This project discusses several factors such as risk management, reliability, biocompatibility assessment, human factors, clinical research, design control, process validation, and intellectual properties that are required during the development of medical devices. It also identifies typical problems that medical device companies may encounter during the product development. The final result of this project is in the form of an effective medical device development activity guideline that lists all the crucial activities under each of the four product development phases. |
