Sterile Medical Device Package Development: From Concept to Market

Abstract

Developing the packaging system for medical device products is often an after thought in the product development life cycle. The sterile package is a critical part of the device, as the device must be sterile in order to be used; therefore the package provides the device with utility at the point of use. Although the packaging for a medical device is as critical to the device function as the device itself, the process and methods that must be followed to effectively design, develop, and implement a sterile package assembly are established but often misunderstood. Medical device packaging development is directly related to factors associated with the physiological and pathological environment, the development of the device, and regulatory issues surrounding the possible markets of distribution. It is critical that the proper packaging development be applied to a device to ensure that it is both safe and effective.