DESIGN AND DEVELOPMENT OF MEDICAL ELECTRONIC ...

EPILOGUEOut of clutter, find simplicityfrom discord, find harmony.In the middle of difficulty lies opportunity.—Albert EinsteinThink you have a great idea for a new medical device? You’re not alone. Every year, manyphysicians and engineers try to develop their ideas and market them commercially. With aprototype in hand, you may be thinking about how to turn it into an actual product that canbe commercialized. As a first step, you may proceed to conduct some preliminary safetyand functional bench testing on your prototype device. Concurrently, you may invest a littletime visiting the library to research for possible patent infringement. Then you mayshow your prototype to a physician, who may help evaluate your idea by testing the devicein animals and human subjects. If all goes well, and testing shows that your idea wouldtruly constitute an advancement to medicine, you may be tempted to start investing in theinfrastructure, tools, and materials required to mass-produce and commercialize yourdevice. Well, don’t, at least not yet.REGULATORY PATHUnlike many other high-tech businesses, the medical devices industry is highly regulated.Especially in the United States the level of regulation is so extreme that compliance concernsoften outweigh all other technical and financial considerations. In fact, even if youcould build your device out of your own garage at a cost that you could afford to coverfrom your own pocket, the extensive clinical trials and lengthy submission process that areneeded to satisfy the Food and Drug Administration’s (FDA) requirements would probablymake the home-based venture completely nonfeasible. To give you an idea of theDesign and Development of Medical Electronic Instrumentation By David Prutchi and Michael NorrisISBN 0-471-67623-3 Copyright © 2005 John Wiley & Sons, Inc.441