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Investigating the Relationship Between Product Design Complexity and FDA for Medical Device Development

[+] Author Affiliations
Lourdes A. Medina

University of Puerto Rico at Mayaguez, Mayaguez, Puerto Rico

Marija Jankovic

Ecole Centrale Paris, Chatenay Malabry, France

Gül E. Okudan Kremer

Pennsylvania State University, University Park, PA

Paper No. DETC2013-13309, pp. V03AT03A015; 10 pages
  • ASME 2013 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference
  • Volume 3A: 39th Design Automation Conference
  • Portland, Oregon, USA, August 4–7, 2013
  • Conference Sponsors: Design Engineering Division, Computers and Information in Engineering Division
  • ISBN: 978-0-7918-5588-1
  • Copyright © 2013 by ASME


Product complexity has been studied as an important factor to decrease the cost and time of the development process. With this purpose, prior research has included the development of design complexity metrics as a method to assess and decrease complexity. Recent studies have also focused on the comparison of complexity metrics for the particular case of medical devices development (MDD). However, the major issue relevant to MDD has not been addressed; the relationship between FDA regulations and the device complexity is not clarified. Therefore, to increase MDD safety and decrease the time to market, we must understand the regulatory decision process and rules. In this paper, we investigate the relation between different complexity metrics and FDA’s decision time using a sample of 100 hip replacement devices. Bayesian network learning is used to explore in detail local relationships between different variables, both complexity measures and product variables. This relationship was found significant for the first two clusters of the analysis. However, for a third cluster it is speculated that FDA decision time does not depend solely upon the degree of medical device complexity. Company or organization relevant variables could be playing a greater role than just complexity. Additional questions are drawn based on the results that must be investigated.

Copyright © 2013 by ASME



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