Effective product development process is one of the most critical issues facing medical devices manufacturing today. There is a need to search for ways to improve or solve the cross organization and company boundaries to enhance the faster release of new medical products to the market. This thesis presents an integrated set of perspectives on the process of new product development of medical devices with dual goals of achieving marketing speed and meet customer satisfaction.

The Attribute Driven Specifications approach described in this thesis, is one of the most valuable tools in the approach to effective product development in medical devices.

This thesis aims to promote effective management of product design and development of medical devices by addressing the inherent complexity and operational reality of the development process of medical devices. Also presented are approaches to product design and development employed by some successful medical device industries.