Using Modeling and Simulation in the Manufacturing of Medical Devices

Abstract:

This paper examines the importance of modeling and simulation in manufacturing, specifically medical device manufacturing. While the use of simulation analysis is steadily gaining acceptance in many industries, medical device manufacturers are still apprehensive of its use and value. It is seen as a non-value added approach given the widespread acceptance of other approaches like lean manufacturing, six-sigma, just-in-time manufacturing etc. Here we will explore the potential benefits of simulation in the manufacturing of medical devices and highlight how it can complement the other process improvement approaches and techniques. When a valid and credible model of a system is established it can be a very effective tool which manufacturers can use to address numerous challenges they face every day - broadly classified into Resource Allocation, Performance Evaluation and Operations Excellence. For manufacturers who are serious about remaining competitive in the 21st century, they cannot afford to ignore this powerful approach. The industry is well positioned to embrace this technology and can leverage key ingredients from existing systems. The US Food and Drug Administration (FDA) sees a lot of benefit in simulation technology and recommends its use to device manufacturers through a series of guidance documents. The relative benefit of using this approach along with other established approaches of process analyses and improvement like lean cannot be overemphasized. Towards the end of this study, a comprehensive simulation model of case in point manufacturing facility has been developed and its results demonstrate how effective this technology can be in solving real life manufacturing problems in a systematic manner, with a data driven approach.

• Periodical: Advanced Materials Research (Volumes 488-489)
• Pages: 1032-1038
• DOI: https://doi.org/10.4028/www.scientific.net/AMR.488-489.1032
• Online since: March 2012
• Authors: Sulaiman Hussaini, Gregory Lahrman
• Keywords: Manufacturing, Modeling and Medical Devices, Simulation

References

[1] M. Schrage: Serious Play: How the World's Best Companies Simulate to Innovate, Harvard Business School Press Boston, MA. (2000).

[2] F. Chance, J. Robinson, and J. Fowler: Supporting manufacturing with simulation: model design, development, and deployment, Proceedings of the 1996 Winter Simulation Conference, San Diego, CA, 1996, pp.1-8.

DOI: 10.1145/256562.256586

[3] J. Banks: Handbook of Simulation: Principles, Methodology, Advances, Applications, and Practice, John Wiley and Sons, New York, NY (1998).

[4] P.L. Knepell and D.C. Arangno: Simulation Validation: A Confidence Assessment Methodology, IEEE Computer Society Press (1993).

[5] M. Rohrer, and J. Banks: Required Skills of Simulation Analyst, IIE Solutions (1998).

[6] A. Law and W. Kelton: Simulation Modeling and Analysis, McGraw-Hill, Boston, MA, 2000, pp.296-297.

[7] G Nystedt: Production Logistics Improves Productivity in the Medical Device Industry, FlexLink White Paper (2007).

[8] E. Yücesan, and J. Fowler: Simulation Analysis of Manufacturing and Logistics Systems, Encyclopedia of Production and Manufacturing Management, Kluwer Academic Publishers, Boston (2000).

DOI: 10.1007/1-4020-0612-8_881

[9] N. E Ozdemirel, G. T Mackulak, and J.K. Cochran: A group technology classification and coding scheme for discrete manufacturing simulation models, International Journal of Production Research, Vol. 33, No. 3(1993).

DOI: 10.1080/00207549308956745