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Biodesign by Paul Yock, Josh Makower, Stefanos Zenios

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5.3 Clinical Strategy

Introduction
Human device testing is at the pinnacle of the medtech innovation process. The stakes are high. Two to three years to perform patient recruitment, enrollment, investigation, and follow-up. Costs as great as $100,000 per patient studied. Regulatory approval and reimbursement hanging in the balance. The credibility and commercial viability of the company on the line. And, most importantly, patient lives in the innovator’s hands. These are the types of issues that make human device testing a risky and challenging (yet essential) element of the biodesign innovation process. For these and many other reasons, a clinical strategy is essential not only for planning human testing, but for the entire clinical development ...

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