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Nowhere is the opportunity to innovate as inviting as in the field of medicine, and no specialty has been as productive in the development of new technologies as cardiology. Because heart disease remains the most common cause of death in developed economies such as the United States (and is a growing threat in middle and low-income countries around the world), new developments in cardiology can affect an especially large population and have a tremendous impact. Advances in our understanding of human physiology, genetics, and molecular biology continue to define the fundamental mechanisms responsible for disease. Through these insights, we gain new perspectives and tools with which to create novel solutions. Regardless of the specific clinical problem to be solved, a common innovation process can be applied. It is this basic approach for creating new medical technologies that we hope to convey within this chapter.

Even though there are many revisions in the latest version of this book, we kept this chapter essentially intact from the first edition. This is because the skills required to innovate are enduring. They are typically not taught in medical school, yet they have been critical to the advancement of interventional cardiology. It has been difficult for people in medicine to learn formal principles of innovation, as they are usually taught only in engineering programs. However, this trend has begun to change, and numerous medical training programs have begun offering curricula targeted at this very issue. As history has demonstrated many times, clinicians and scientists make very good innovators. Although it is important for engineers to be skilled in the fundamental principles of innovation, clinicians and scientists have an essential role to play during the early stages of the innovation process (need finding and concept creation) and, as a result, they should learn these skills so they can participate fully in the important interdisciplinary work of creating new medical technologies.

Developing a new medical technology is a rewarding but often arduous process. The greatest success comes to those who understand the many necessary steps in the innovation process and can plan and execute a strategy to address each one efficiently and effectively.


Innovation is defined as the process of creating something new. As developers of a medical technology, we seek to address a real clinical need with the goal of not only creating something new, but also creating something better and/or more cost effective. The basic process of focused innovation is very simple and is summarized in Figure 75-1.


A process for innovation. Orange arrows indicate entry points; blue arrows indicate iterative loops.

Although the innovation process is one that may be used by someone new to a field (top orange arrow), you may enter this process at any stage ...

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