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Biodesign by Paul Yock, Josh Makower, Stefanos Zenios

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1.3 Need Statement Development

Introduction
Innovators usually grasp the nature of observed clinical problems quickly. The greater challenge is in understanding the associated clinical need and in translating problems into a meaningful clinical need statement. For example, after observing the difficulties some physicians have when transecting the sternum for thoracic surgery, a well-intentioned innovator may define a “need for a more effective cutting device to perform a sternotomy.” This need will lead him to investigate multiple solutions for cutting the skin and bone during thoracic procedures. However, if someone else is simultaneously exploring the “need for a way to access the chest to perform procedures on organs of the thorax,” the ...

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