An information model to support user-centered design of medical devices

Journal of Biomedical Informatics
Thomas J HagedornIan R Grosse


The process of engineering design requires the product development team to balance the needs and limitations of many stakeholders, including those of the user, regulatory organizations, and the designing institution. This is particularly true in medical device design, where additional consideration must be given for a much more complex user-base that can only be accessed on a limited basis. Given this inherent challenge, few projects exist that consider design domain concepts, such as aspects of a detailed design, a detailed view of various stakeholders and their capabilities, along with the user-needs simultaneously. In this paper, we present a novel information model approach that combines a detailed model of design elements with a model of the design itself, customer requirements, and of the capabilities of the customer themselves. The information model is used to facilitate knowledge capture and automated reasoning across domains with a minimal set of rules by adopting a terminology that treats customer and design specific factors identically, thus enabling straightforward assessments. A uniqueness of this approach is that it systematically provides an integrated perspective on the key usability information that drive desig...Continue Reading


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Jun 16, 2004·Journal of Biomedical Informatics·Jiajie ZhangEdward H Shortliffe
Oct 20, 2004·International Journal of Medical Informatics·Mark J GrahamVimla L Patel
Dec 20, 2005·Applied Ergonomics·Patricia MarcosH Feussner
Apr 7, 2007·Journal of the American College of Radiology : JACR·Michael M Raskin
Dec 7, 2007·Applied Ergonomics·Jennifer L MartinJohn A Crowe
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Mar 2, 2011·BMC Medical Informatics and Decision Making·Arthur G MoneyTerry Young
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May 10, 2015·Journal of Biomedical Informatics·Thomas J HagedornSundar Krishnamurty

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