With successful outcome of the testing phase, commercialization of the device will begin. Methodology - The evaluation and final development of the device will take part in two phases. In the first phase, various enhancements to the device are being explored and evaluated while at the same time the laboratory prototype of the machine is being used for remote manufacture of sockets for clinical fittings. In the second phase, three beta prototype machines are being designed, manufactured and placed in clinical settings for on-site production of sockets. The device uses a technique of plastic deposition to fabricate sockets.
Plastic material is melted and extruded through a shape forming die as a ribbon of melted plastic.
The chief focus for device enhancements has been mechanisms for cooling of the melted plastic after deposition. Liquid cooling is more efficient than air cooling and can be implemented more simply. The efficiency has led to a reduction in fabrication from 1 hour to less than 30 minutes for a typical trans-tibial socket. Clinical trials of sockets have been ongoing with the longest socket in use for almost four years. Furthermore, we are putting the finishing touches on three new prototype machines which will be placed in the clinical environment for further evaluation.