"Through an example, led at a leading medical device company, this dissertation will demonstrate that by applying certain lean principals and tools to the development of a medical device, shortened development times can be obtained. The two papers presented in the dissertation will fill a gap in current literature. Literature presents lean techniques and applications used in many different industries. But, due to the uniqueness of the medical device industry, these general techniques are not ideal. New methods will be used and validated at a medical device company, Covidien. Instead of trying to implement many general lean principals to their projects, these new methods will give medical device companies a step-by-step way to use these principals in a valuable way.
The first paper presented in this dissertation uses value stream mapping, Kaizen events, and other lean tools to create a new artwork process for new medical devices going through the product development process. By following the process and methods presented in this paper, a company can rank and select the sub-processes in their product development process that are most important to revamp.
The second paper in the dissertation introduces a lean-based theory for setting up the flow for development of a medical device. This theory was designed to be used for either of the U.S. Food and Drug Administration's (FDA) medical device regulatory paths: a premarket approval (PMA) (Class III device) or premarket notification (510(k)) (Class II) project. The proposed development flow is designed to eliminate waste in the development system and decrease overall development time. The methodology behind the theory will be validated through trials at a leading medical device development and manufacturing corporation, Covidien"--Abstract, page iv.
Grasman, Scott E. (Scott Erwin)
Cudney, Elizabeth A.
Grantham Lough, Katie, 1979-
Murray, Susan L.
Engineering Management and Systems Engineering
Ph. D. in Engineering Management
Missouri University of Science and Technology
Journal article titles appearing in thesis/dissertation
- Applying value steam mapping and Kaizen events in R&D to the medical device industry.
- Specific development pathway to help decrease time to market for a medical device
x, 117 pages
© 2012 Kelly Marie Davis, All rights reserved.
Dissertation - Restricted Access
Library of Congress Subject Headings
New products -- Management
Medical instruments and apparatus -- Marketing
Time to market (New products)
Print OCLC #
Electronic OCLC #
Link to Catalog Record
Electronic access to the full-text of this document is restricted to Missouri S&T users. Otherwise, request this publication directly from Missouri S&T Library or contact your local library.http://laurel.lso.missouri.edu:80/record=b9552595~S5
Davis, Kelly Marie, "Decreasing time to market for a medical device: new methods for the product development process" (2012). Doctoral Dissertations. 15.
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