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.

Key Features:

• Consistently and accurately delivers a single dosage on a timed schedule.
• Resists tampering and provides evidence of intrusion.
• 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.
• Delivers a full range of pill sizes and geometries without loss of function.
• Maintains a portable size and weight.

FDA Design Controls:

• Maintained a Design History File (DHF) documenting each step of the design process.
• Regularly conducted design reviews to evaluate the design process and obtain approval to continue.
• Tracked document and design revisions from initial release to project completion using an established system.
• Conducted traceability activities to ensure requirements were met as specified in the product specification.

Prototype Evaluation:

A prototype delivery mechanism was constructed with the following features and advantages:

• Low-cost combination of machining and rapid prototyping.
• Allows for physical manipulation and changes.
• Offers a modular mechanism capable of delivering single-pill doses of varying size.