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Objectives:
Complete early stage development of a device which is capable of regulating dosages of narcotic or other controlled medications to patients in an FDA-approved device. |
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Key Features:
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Consistently and accurately delivers a single dosage on a timed schedule.
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Resists tampering and provides evidence of intrusion.
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Capably communicates with a base station through wireless and GSM, providing a last-known location obtained through GPS in the event of theft or misplacement.
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Delivers a full range of pill sizes and geometries without loss of function.
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Maintains a portable size and weight.
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FDA Design Controls:
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Maintained a Design History File (DHF) documenting each step of the design process.
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Regularly conducted design reviews to evaluate the design process and obtain approval to continue.
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Tracked document and design revisions from initial release to project completion using an established system.
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Conducted traceability activities to ensure requirements were met as specified in the product specification.
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Prototype Evaluation:
A prototype delivery mechanism was constructed with the following features and advantages:
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Low-cost combination of machining and rapid prototyping.
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Allows for physical manipulation and changes.
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Offers a modular mechanism capable of delivering single-pill doses of varying size.
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