Research Papers

Integrated Fuzzy-Based Modular Architecture for Medical Device Design and Development

[+] Author and Article Information
Celestine C. Aguwa

 Wayne State University, 4815 Fourth Street, Detroit, MI 48201celestine.aguwa@wayne.edu

Leslie Monplaisir, Prasanth Achuthamenon Sylajakumari, Ram Kumar Muni

 Wayne State University, 4815 Fourth Street, Detroit, MI 48201

J. Med. Devices 4(3), 031007 (Sep 08, 2010) (10 pages) doi:10.1115/1.4002323 History: Received June 16, 2010; Revised July 27, 2010; Published September 08, 2010; Online September 08, 2010

In this paper, we present an integrated collaborative modular architecture method for medical device design and development. The methodology is focused on analyzing the input of stakeholder data from existing products and components to achieve an optimal number of modules. The methodology starts by defining a product’s functional and physical decompositions. Product parameters are selected such as quality, reliability, ease of development, and cost. These are prioritized using analytical hierarchy process (AHP) to determine the medical device manufacturers’ focus area. The parameters’ subsequent metrics are selected for performance requirements. Next, we evaluate the candidate modules by acquiring stakeholder data and converting them to crisp values by applying the Sugeno fuzzy-based method. Finally, we determine the subsequent optimal module values using a multi-optimization goal programming model. We present here a proof of concept using a typical glucometer. The implication of this work is the determination of the optimal number of product modules based on stakeholder constraints. Hence, an original equipment manufacturer (OEM) can work on fewer components per module without adversely affecting the integrity, quality, and reliability of the final product. Next is the improved quality of patient care by enabling cost reductions in product design and development, thereby improving patient safety. This methodology helps reduce product cycle time, thereby improving market competitiveness among other factors.

Copyright © 2010 by American Society of Mechanical Engineers
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Figure 1

HDT architecture

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Figure 2

Product architecture and component process flexibility (23)

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Figure 3

Flow diagram of proposed methodology

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Figure 4

Expert Choice© output

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Figure 5

Fuzzy set definitions in MATLAB ®

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Figure 6

Rule viewer of Sugeno

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Figure 7

Surface viewer of Sugeno

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Figure 8

Quality goal function

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Figure 9

Final GP-optimal number of modules, N∗



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