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Presentation
Validating Design Complexity Metrics for Medical Devices
IIE Annual Conference (2014)
  • Giovanni Cruz
  • Maricarmen Collet
  • Ismael A. Garcia
  • Lourdes A. Medina, University of Puerto Rico, Mayaguez
  • Gül E. Kremer, Iowa State University
Abstract
When measuring design complexity (DC) in the field of medical devices, some of the aspects to consider are the
number of components, interactions between components, part variations and the product’s overall functionality.
Taking into consideration these aspects, several authors have developed metrics in an effort to quantitatively
measure DC. While these metrics consider DC from different perspectives, there is an underlying relationship
between each one. This paper presents a study of seventy-five knee replacement devices in an effort to understand the connection between these factors and complexity. To achieve this, product information and surgical techniques were gathered to analyze the devices’ complexity using six DC metrics. Furthermore, a correlation analysis was performed to unravel the relationships between these metrics for knee replacements and in contrast to previous results with hip replacements. This research provides a framework for future developments with an understanding of complexity metrics in the field of medical devices.
Keywords
  • Medical Device;,
  • FDA;,
  • Metrics;,
  • Correlation;,
  • Complexity
Disciplines
Publication Date
2014
Comments
This is a proceeding published as Cruz, Giovanni, Maricarmen Collet, Ismael A. Garcia, Lourdes A. Medina, and Gül E. Okudan Kremer. "Validating Design Complexity Metrics for Medical Devices." In IIE Annual Conference. Proceedings, p. 3574. Institute of Industrial and Systems Engineers (IISE), 2014. Posted with permission.
Citation Information
Giovanni Cruz, Maricarmen Collet, Ismael A. Garcia, Lourdes A. Medina, et al.. "Validating Design Complexity Metrics for Medical Devices" IIE Annual Conference (2014)
Available at: http://works.bepress.com/gul-kremer/131/