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.
- 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.
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.