Observations on medical device design, Part I: Current practice.
Medical devices must be designed and proven to be fit for the purpose that they were intended. Good design practice ensures this fitness for purpose and is reflected in the commercial success of products. This two-part article focuses on current industry design practice and proposes that there are significant benefits to be obtained by defining good design practice: better products and reduced development costs.
Clarkson
J
J
Cambridge Engineering Design Centre, Department of Engineering, University of Cambridge, UK.
Alexander
K
K
Bishop
D
D
D004867:Equipment Design / Q000145:classification / Q000379:methods / Q000592:standards; D004869:Equipment Safety; D005060:Europe; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D008389:Marketing of Health Services; D011785:Quality Assurance, Health Care; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration