Good design practice for medical devices and equipment, Part I: a review of current literature

Abstract

Changes to the medical device regulations within the past few years have forced medical device manufacturers to take an integrated approach to design and validation in order to ensure that their products are reliable and fit for purpose. Good design practice encourages fitness for purpose within commercial reality. This paper contains a review of the current literature that is relevant to good design practice. The results show that there is inadequate guidance regarding the integration of validation with design. Thus, there is a need for good design practice to include 'design for validation' which is aimed at designing medical devices to make them easier and more economic to validate. Research has been carried out at the Cambridge Engineering Design Centre in order to develop an approach that provides guidance in order to help designers achieve integrated design, development and validation. This will be reported in part II of this paper.