Date

6-2010

Degree Name

BS in Industrial Technology

Department

Industrial Technology

Advisor(s)

Louis Tornatsky

Abstract

This project examined the use of process mapping as a tool to show the process of developing medical devices from a broad perspective that includes research, innovation, development, regulation, and marketing. The medical device development cycle, on a broad scope, is not well defined. The lack of a universal language with which to describe this process has made it difficult to understand and communicate. In this project, data was collected from peer-reviewed sources, summarized in a literature review, drawn out by hand into a series of lower-level process maps and finally assembled into a single process map. This project is an attempt to work towards establishing a general framework that can be used to better understand how medical devices are developed and marketed. It supports that process mapping may have potential for being used on a higher level than it is traditionally used. The final process map produced in this project has limitations. The map gives a basic understanding of the broader development process. The level of detail and accuracy of the process map is limited by the time and cost of process mapping.

Medical Device Development Flowchart.pdf (102 kB)
Medical Device Development Flowchart.pdf

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