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The pre-treatment of patients with clopidogrel before primary percutaneous coronary intervention (PCI) has been shown to lower the risk of complications that could lead to heart attack or stroke during the procedure. However, the proper administration of clopidogrel requires the measurement of the patient’s drug resistance due to its inherent variation across the population. Approximately 1.1 million PCIs were performed in the US alone in 2008. As the patient population is becoming increasingly aware of the benefits of clopidogrel treatment prior to PCI, there is an ever-expanding market potential for clopidogrel resistance screening devices. As most of the existing devices utilize traditional test-tube-scale bench-top technology that usually sets limitations on the throughput and applicability of the test itself, the market demands a device that not only minimizes the cost per test but also produces consistent and comprehensive results. In this report, guided by the innovation map, we are able to link soft lithography in combination with micro-patterning technology to the customer’s requirements, and come up with a higher-throughput system that meets the market demand. Our system consists of two parts: the chip and the device. We focus our design effort primarily on the chip, in which micro-channel layout, dry reagent dissolution, reagent mixing and reservoir volume design are carefully worked out. On the other hand, the design of the device is discussed briefly, but production is assumed to be outsourced. With the cost estimates from suppliers and the assumed expected market share to be 50%, the net present value is computed to be about 45 million, indicating a lucrative return to investors.



Date Posted: 22 January 2010