A Specific Development Pathway to Help Decrease Time to Market for a Medical Device
Abstract
Because of federal regulations and clinical trials, the medical device industry is known for being one of the industries with the longest product lead times. This paper introduces a Lean-Based theory for setting up the flow for development of a medical device, assuming a premarket approval (PMA) or premarket notification (510k) project. the proposed development flow is designed to eliminate waste in the development system and decrease overall development time. the queueing theory and real options are also discussed as they relate to medical development and Stage-Gate systems. a strict Stage-Gate system does not support Lean Product Development (LDP) principals because of the many different documents and stages needs to "pass" to the next level. by eliminating strict Stage-Gate policies and using the presented development flow, it is theorized that the cycle time may be able to be lessened, thus decrease development time for a medical device. Copyright, American Society for Engineering Management, 2011.
Recommended Citation
K. M. Anderson and S. E. Grasman, "A Specific Development Pathway to Help Decrease Time to Market for a Medical Device," Annual International Conference of the American Society for Engineering Management 2011, ASEM 2011, pp. 153 - 158, American Society of Engineering Management, Dec 2011.
Department(s)
Engineering Management and Systems Engineering
Keywords and Phrases
Lean Product Development; Medical device development; Queuing theory; Real Options; Time to market
International Standard Book Number (ISBN)
978-161839361-6
Document Type
Article - Conference proceedings
Document Version
Citation
File Type
text
Language(s)
English
Rights
© 2024 American Society for Engineering Management, All rights reserved.
Publication Date
01 Dec 2011
