Department - Author 1

Industrial Technology

Degree Name - Author 1

BS in Industrial Technology

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



Primary Advisor

Louis Tornatsky


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.