Volume 1, Issue 2, May 2014, Pages 127–134
Mark Tamsin1 and Christian Bach2
1 Department of Biomedical Engineering, University of Bridgeport, Bridgeport, CT 06604, USA
2 University of Bridgeport, Bridgeport, CT 06604, USA
Original language: English
Copyright © 2014 ISSR Journals. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
This paper aims to review the design of medical devices and investigate its relationship among different factors that must be taken into consideration throughout the process. The theoretical foundation of this paper was formed by conducting a comprehensive literature review on medical device design. A new model is presented to illustrate the relationship between medical device design and four specific success factors. The model shows that product development, tissue modeling, training, and FDA regulations are the four primary success factors that are essential to medical device design. The proposed model clearly shows how device manufacturers must take into consideration many factors during the design process in order to have commercial success with their equipment. This paper demonstrates that medical device design is a unique and complicated process, which requires the utilization of a specialized cross-functional team to overcome the various obstacles along the way.
Author Keywords: Medical Device Design, Product Development, Tissue Modeling, Training, FDA Regulations.
Mark Tamsin1 and Christian Bach2
1 Department of Biomedical Engineering, University of Bridgeport, Bridgeport, CT 06604, USA
2 University of Bridgeport, Bridgeport, CT 06604, USA
Original language: English
Copyright © 2014 ISSR Journals. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
This paper aims to review the design of medical devices and investigate its relationship among different factors that must be taken into consideration throughout the process. The theoretical foundation of this paper was formed by conducting a comprehensive literature review on medical device design. A new model is presented to illustrate the relationship between medical device design and four specific success factors. The model shows that product development, tissue modeling, training, and FDA regulations are the four primary success factors that are essential to medical device design. The proposed model clearly shows how device manufacturers must take into consideration many factors during the design process in order to have commercial success with their equipment. This paper demonstrates that medical device design is a unique and complicated process, which requires the utilization of a specialized cross-functional team to overcome the various obstacles along the way.
Author Keywords: Medical Device Design, Product Development, Tissue Modeling, Training, FDA Regulations.
How to Cite this Article
Mark Tamsin and Christian Bach, “The Design of Medical Devices,” International Journal of Innovation and Scientific Research, vol. 1, no. 2, pp. 127–134, May 2014.
