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Budget Phase I Amount Research and Development $ 40,000.

00 Research includes the production of the analytes, compound immobilization methods, electrode fabrication methods, circuitry design, as well as the necessary testing. Enclosure development and analysis is included in this category. Monthly salary figures are factored from this amount. Materials $ 10,000.00 Includes analyte production, synthesizing, and disposing chemicals. Enclosure and LOD device circuit elements, electrode components, and manufacturing materials are included in this category. Manufacturing $ 30,000.00 Outsourcing costs required for software design, enclosure construction and circuit elements (centrifuge motor, potentiostat, power source), and GUI development are included. Legal (Consultant) $ 10,000.00 FDA, patenting, and contractual issues would be handled by a consultant. Patenting would include software and hardware designs of device. Miscellaneous $ 10,000.00 Lab space and equipment rental and travel considerations are estimated in the amount Total $ 100,000.00 Phase II budgets would be provided through separate granting as well as investor capital. The costs considered would include: Further FDA and Patenting approval as required by Phase I prototyping and development of assays Market research to expand or concentrate assay development into specific fields or sectors Clinical trials testing the devices analytic procedure, ease-of-use, and general compatibility with the desired market. Research into expanding markets and potential demand Distribution and investor recruitment

Device Fabrication The fabrication of the LOD device is a simple, relatively common procedure divided into 3 parts: Microfluidic Cartridge Fabrication, Bio senor Fabrication, and layer assembly. The microfluidic cartridge is made from a polymer mold fabricated on silicon wafers through standard photolithography methods. The mold is designed from a photo mask printed on an acetate sheet. The photo mask from which the mold is designed is created digitally though CAD software. The polymer mold is then used to make the cartridges using Polydimethysiloxane (PDMS). Several cartridges can be produced from a single mold/photo mask design. The dimensions of the 8 parallel sections can be adjusted to fit the specific analyte to be used, depending of the amount of blood needed to be analyzed. A standard sizing is as follows: a depth of 100 L for the sample inlet, inner/outer reservoir, and vent with a volume of 6.5 L for the inner reservoir and 9.5 L for the outer reservoir. The electrochemical Bio sensor fabrication is more complicated requiring specific enzymes to be added depending on the desired analysis. The bio sensor contains 3 separate electrodes each made using photoresist layers and an alloy/dealloy process. The electrode patterns, leads, and conductive pads are all made using Au, Zn, and Ag deposits, multiwall carbon nanotubes (MWCNT), and enzyme/catalyst layers. The biosensor layer includes the valves between reservoirs. The layers are then assembled through a 15 minute UV-Ozone cleaning process and a 2 hour pressure bonding of 10 N method. Enclosure The design of the enclosure is a major factor of improvement to the previous device. Aside from the protective aspects a case would offer the centrifuge and microprocessor device, the case would house both the motor and potentiostat that powers the circuit. A power source is also integral to the portability intention to the design; this would also be included in the enclosure in the form of a AC adaptor. Though the design and functionality of the enclosure would stem from the initiative research the manufacturing of prototypes as well as further models are likely to be outsourced. Options as to the structure could include 3D printing to be modified and fitted by hand in the lab.

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