2011 Design of Medical Devices Conference Abstracts

Concept Selection in the Development of Medical Devices: The Case of the Smart Stent-Graft OPEN ACCESS

[+] Author and Article Information
Isa C. T. Santos, João Manuel R. S. Tavares

Faculty of Engineering,University of Porto

Luís A. Rocha

I3N/IPC,University of Minho

J. Med. Devices 5(2), 027510 (Jun 09, 2011) (1 page) doi:10.1115/1.3589826 History: Published June 09, 2011; Online June 09, 2011

During product development, ideas are narrowed down to a single one by the designers in order to satisfy the customers’ needs. This process is called concept selection and is crucial to the development of new products because, from this point onward, the design team is committed to a concept whose modification implies delays and additional costs. Decisions made during the concept selection phase are often difficult due to the uncertainty caused by the lack of objective data. However, it is possible to reduce this uncertainty assessing each concept’s expected costs and benefit. Medical devices, before entering the market, are scrutinized by several agencies around the world to assess their clinical- and cost-effectiveness. In order to reduce the uncertainty associated with concept selection, the parameters evaluated by the multiple agencies should be used to support the idea to pursue. However, as that data are not available yet, in this paper, several parameters were identified to evaluate each concept and, for each metric, the most adequate measurement technique was described. This paper also presents a specific implementation of the design process for a new stent-graft.

Copyright © 2011 by American Society of Mechanical Engineers
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