Design, Manufacture and Testing of Prosthetic Devices

Abstract

The scatter diagram shown as Fig. 1 illustrates how the subjects of manufacturing, testing and design are interlinked and how they can be reduced into many subheadings for the purposes of analysis and discussion. Regulatory affairs, which is an administrative aspect of manufacturing, places significant demands on testing, design and quality control and thus will be described. Marketing is shown on the scatter diagram, as much product testing and all product design are conducted in order to satisfy marketing objectives, namely, to expand or maintain the usage of a product. In this sense, the product could be, very specifically, a certain design or knee replacement or it could be the general product group of total-knee prostheses. Testing is performed to gain confidence in designs, new or old. The results may be used to promote the use of an implant or to satisfy regulatory requirements that it is suitable for, say, introduction into limited clinical trials.