Description of manufacturing process
The Orthopedic Brace Manufacturing Process at IDL Orthopedics follows a structured and quality-controlled workflow from medical referral to final product delivery.
Licensed physicians or EOPYY issue official referrals that act as work orders. These documents allow our Orthopedic Center to plan and prepare the required brace according to each patient’s medical needs.
Our production manager reviews the diagnosis and clarifies any details directly with the attending physician when necessary. Once we confirm the medical specifications, the digital scanning operator begins the body casting procedure.
Our administrative team verifies that all required documentation is complete. For EOPYY cases, we follow the official national protocol and submit the necessary electronic records to the system while forwarding original forms to the accounting department.
Below, we describe each stage of the Orthopedic Brace Manufacturing Process step by step.
Orthopedic Brace Manufacturing Process – Step by Step
Taking Measurements
During this stage of the Orthopedic Brace Manufacturing Process, we perform a full digital scan of the patient’s body using a white light digitizer and specialized software. We also take additional manual measurements with a tape measure and caliper.
The patient stands on a rotating platform while wearing a tight-fitting T-shirt. Once the scanning process begins, the platform rotates and captures a full 360-degree scan of the body. The system displays the scan in real time on the computer screen.
After completing the digitization, the software generates a three-dimensional model of the patient’s body. We save this digital file for further processing and design adjustments.
We then record additional measurements manually to verify accuracy. Our team completes the official Measurement Form (EN 8.2-01.1 or EN 8.2-01.2) and includes the patient’s personal details, clinical condition, X-ray findings, physician comments, and technician observations.
Design
We use the same digital scanning software to prepare the initial form of the patient’s model. The system allows us to refine the scan by removing unnecessary points, smoothing surfaces, and eliminating digital noise. This preparation ensures that we can work on a clean and accurate digital model.
We then process the patient’s digital cast using Rodin4D CAD/CAM design software. Based on the physician’s prescription and the technician’s evaluation, we apply the necessary corrections and adjustments according to the specific characteristics of each case.
During this stage, we perform the following tasks on the digital model:
• Balance the model according to its central axis.
• Adjust the radius or diameter where required.
• Elongate specific areas or zones between planes if needed.
• Define correction zones and apply filling or indentation.
• Smooth the modified areas.
• Compare digital measurements with manual measurements taken using a tape measure and caliper, and adjust when necessary.
After completing the corrections, we store the processed digital model and transfer it to the CNC cutting machine for mold production.
Cast Cutting
To produce the mold, we select the appropriate size of polyurethane block and place it in the CNC cutting machine. The system then cuts the mold according to the digital design specifications.
After cutting, our technicians inspect the mold carefully. If needed, they perform manual corrections to ensure accuracy and dimensional precision. Once the mold meets all requirements, we begin constructing the brace.
Please note the following:
• We maintain a digital archive of every patient’s scan.
• We store molds for potential future use when appropriate.
If two patients share the same body dimensions and the same type of scoliosis or kyphosis, we may reuse an existing mold within a permissible deviation of +2 to 3 cm.
When necessary, our technicians manually adjust molds to achieve precise dimensions. They may sand the surface to reduce size or add foam material (plastazote) to increase volume.
Construction of Initial Guardian Form
Once the patient’s body cast is ready, we begin constructing the brace. If a ready-made cast fits properly, we may use it at this stage.
We calculate the overall dimensions of the cast and cut a corresponding sheet of thermoplastic material. We then place the plastic sheet in a special oven to heat and soften it. The temperature typically reaches approximately 187–192°C, depending on the thickness of the material.
Once heated, we remove the plastic sheet from the oven and mold it directly onto the patient’s cast using heat-insulating gloves. We join the two ends at the back surface (or at the front, depending on the brace type).
After the material cools and stabilizes, we trim the excess plastic and refine the edges. At this stage, the brace takes its initial form.
Rehearsal
When the patient returns for fitting, we place the molded and cooled brace around the body. The plastic material remains slightly flexible, which allows us to open it easily from the back and position it correctly.
We apply the brace securely to the pelvis and temporarily fasten it with straps. Our technicians then mark the cutting points at the armpits and above the pubic symphysis.
Through continuous testing and adjustments, we trim the brace at the groin area to allow full thigh flexion and comfortable sitting. We shape the front section to leave the chest free and adjust the back section to properly cover the shoulder blade corners.
Once the brace fits correctly without causing discomfort while sitting or walking, we smooth and refine the edges to remove any rough surfaces or protrusions.
We then reinforce the structure with aluminum supports in areas exposed to strong forces. These typically include the vertical back opening and one side of the front chest wall. The opposite side is reinforced using the same frame material.
Next, we place counterpressure pads made of duralumin in the required locations. Depending on the case, these metal components measure approximately 7 cm in height and 15–18 cm in width.
We create small ventilation holes across the brace surface to improve airflow and comfort.
We attach foam material (plastazote) at the pressure points to enhance corrective force. We also place this material in the armpits and on the inner surfaces of reverse pressure areas to prevent discomfort.
We engrave a unique six-digit serial identification number (S/N) on each brace. If the same patient requires a new brace in the future, we retain the original serial number and add a distinguishing suffix (e.g., -2, -3). This ensures full traceability and precise patient-device matching.
For front-closing braces such as Cheneau models, we follow the same manufacturing procedure. However, these braces do not include metal supports at the back. Instead, they feature two supports at the front.
We cut metal supports and pressure plates to the required dimensions from aluminum rods and sheets. Our technicians smooth the edges to prevent injury and rivet the components securely to the brace.
We sew the straps on site according to the required dimensions and fasten them with rivets.
Finally, we document every stage of production in the Orthopedic Product Production and Control Order Form EN 8.5-01.1. This documentation ensures complete traceability of materials, operators, and procedures for each orthopedic device.
Delivery of Final Product
Our production laboratory technicians complete all manufacturing stages under the supervision of the production manager.
Before delivering the final product, the patient wears the brace for a final fitting. During this stage, the production and quality control manager carefully checks that the brace fits correctly and does not cause pain or discomfort while standing, sitting, or walking.
Once the brace passes the final inspection, we provide the patient with detailed instructions for proper use. The patient receives both verbal guidance and written instructions, along with a practical demonstration on how to wear and adjust the brace correctly.