After the patient is referred by the treating physician and the patient’s file is completed and the down payment is received, the necessary coordination is made for CT scan imaging or other types of medical imaging if needed. After conducting the initial review and approving the received images, a 3D model of the patient’s limb is extracted, and the initial treatment plan is implemented based on the physician’s request at the referral stage. The design is sent to the treating physician for approval. At this stage, if necessary and according to the physician’s request, modifications will be made; otherwise, the finalized design will be sent for the manufacturing process.

During the manufacturing process, the custom-made prosthesis will be printed by a 3D printer. After the required thermal operations based on the protocol, depending on the prosthesis’s usage, the part will be sent for final processing. Final processing includes secondary machining, coating, anodizing, or polishing the part at this stage. Finally, the part is sent to the cleanroom for sanitizing and packaging operations. In the last step, the packaged part is sterilized with gamma radiation and sent to the operating room with a technician.

The design and manufacture of custom-made prostheses, as indicated by the name, involves two phases. In the design phase, the time required depends on the patient’s promptness in completing the necessary imaging, as well as the time needed by the treating physician to approve or modify the design. Additionally, if the design undergoes changes, it is evident that more time will be needed.

In the manufacturing phase, the time required can vary depending on the dimensions of the piece and the urgency of the prosthesis’s use. The number and type of final processing operations also impact the time needed to manufacture and prepare the designed prosthesis.

On average, the design and manufacturing process for custo-made prostheses can take about 10 weeks from the time of referral by the physician. However, in most cases, the delivery time to patients has been shorter.

Currently, basic insurance plans do not provide coverage for custom-made prostheses. For supplementary insurance, it depends on the insurance company. In many cases, the insurance company, based on the physician’s request and an official invoice from the company, has covered part of the cost of the custom-made prosthesis according to the contract between the insurer and the insured.

Custom prostheses made using 3D printing technology are similar to those produced by traditional mass production methods. The main difference is that they are individually made and designed based on the patient’s anatomy. Therefore, in terms of risks and complications, these custom prostheses are exactly the same as conventional prostheses and plates.