An Effective Design Process for the Successful Development of Medical Devices

Abstract

The most important point in the successful development of a medical device is the proper overall design. The quality, safety, and effectiveness of a device are established during the design phase. The design process is the foundation of the medical device and will be the basis for the device from its inception till the end of its lifetime. There are domestic and international guidelines on the proper steps to develop a medical device. However, these are guides; they do not specify when and how to implement each phase of design control. The guides also do not specify to what depth an organization must go as it progresses in the overall developmental process. The challenge that faces development organizations is to create a design process plan that is simple, straightforward, and not overburdening.

This chapter gives an overview of the design and development of a medical device. It also gives some guidance and advice about the developmental process. Finally, it gives some case examples of pitfalls that real companies have experienced in their medical device development.