The use of formal design techniques in the development of a medical device

摘要

This paper summarises work that has been carried out to date on the MedLINK funded research project 'SuPort'. The project is concerned with the development of an innovative urine drainage system which is designed to treat patients who have dysfunctional bladder problems. A key part of the system is a long-term indwelling device which is required to provide permanent access to the bladder for auxiliary devices of the system as well as providing continuous bladder drainage. The development of this novel device has presented a number of severe design challenges in order to find feasible alternative design solutions, requiring expertise from a range of disciplines including urology, materials science, hydrodynamics, ergonomics, aesthetics, surface mechanics, microbiology, surgery, nursing, manufacturing, structural design and mechanisms. The design space is highly constrained in terms of the limited range of FDA certified biocompatible materials which possess suitable engineering characteristics for use in this application. This paper identifies how the focus of the multi-disciplinary team was achieved using a comprehensive product design specification. The paper particularly illustrates the structured systematic design processes, such as the pairwise comparison matrix method, concept evaluation/selection matrices, FMEA and QED used to facilitate the final innovative medical device design. Finally, the paper reflects upon the strengths and weaknesses of these formal design methodologies in the development of this medical device and concludes by making suggestions as to how these design techniques could be modified and improved.