3D Printing Workflow for Orthotics and Prosthetics

The prosthetic and orthotic (O&P) industry is at a pivotal crossroads. On one side, the traditional fabrication method relies on manual craftsmanship, involving plaster casting, hand molding, and extensive trial-and-error adjustments. While effective to some degree, this approach is time-consuming, labor-intensive, and prone to inconsistencies. Conversely, you have “off-the-shelf” O&P products that adopt the “one-size-fits-all” approach. As we all know, no two patients are the same; therefore, each medical situation requires different needs and demands.

However, a new era is emerging—one driven by digital workflows and additive manufacturing (AM). The two solutions are not only viable options for overcoming the constraints of traditional O&P fabrication, but tools for fundamentally shifting the way these devices are designed, manufactured, and delivered.

The digital manufacturing process for orthotic and prosthetic devices using additive manufacturing follows a streamlined and precise workflow, ensuring that the final product is custom-designed, durable, and optimized for patient needs. Here’s a step-by-step guide to how this process works:

The process begins with capturing an accurate digital representation of the patient’s affected limb or body part. Using advanced 3D scanning technology, the limb is scanned to create a precise digital model. This digital representation is crucial because it allows the design to be tailored specifically to the patient’s unique anatomy, eliminating the inaccuracies that often come with traditional molding techniques. Research indicates that 3D scanners can provide lower limb measurements with similar accuracy to manual methods but with better repeatability, boasting an intraclass correlation coefficient between 0.99 and 1.0 and a mean difference of 0.15%. This level of precision ensures a consistent, reproducible foundation for designing effective orthotic and prosthetic devices.

Once the scan is completed, the data is processed and converted into a CAD (Computer-Aided Design) file. For customers who have a 2D drawing or file that needs to be converted into a 3D model, Endeavor 3D can help. Through our partnership with CADmore, an industry-leading design team specializing in 3D-printed parts, we ensure precise and efficient file conversions.

With a CAD file in hand, we can apply our expertise to optimize the design, ensuring it meets both functional and aesthetic patient requirements. This may include adjusting the material properties or modifying the part’s lattice structure to enhance comfort, durability, and weight. We work closely with our partners to ensure the design aligns with the patient’s individual needs and medical considerations.

Before moving into the physical production stage, the optimized CAD file undergoes simulations to test its performance. Using tools like Finite Element Analysis (FEA), we simulate stress distribution, movement, and potential wear over time. These simulations help ensure that the device will perform as expected in the real world—durable, lightweight, and capable of withstanding the forces it will experience in everyday use.

With the design validated through simulation, the next step is fabricating the part using HP Multi Jet Fusion (MJF) 3D printing—a technology uniquely suited for orthotic and prosthetic (O&P) applications due to its precision, strength, and scalability. Unlike traditional subtractive manufacturing, which can be time-consuming and wasteful, MJF enables high-throughput, repeatable production of custom O&P devices.

MJF 3D printing utilizes a fine detailing and fusing agent, which plays a critical role in part strength by selectively binding plastic powder particles at a microscopic level. This ensures that the final part has near-isotropic mechanical properties, meaning uniform strength and durability across all axes.

Beyond strength, MJF delivers exceptional accuracy. The process achieves tolerances of ±0.012 inches (0.30mm) plus 0.1% of the nominal length for each additional inch, making it one of the most precise additive manufacturing methods available. This level of precision ensures a consistent, snug fit for custom prosthetic and orthotic devices, reducing the need for manual adjustments and increasing patient comfort.

After the 3D printing process is complete, the customer has the option to employ additional post-processing steps. Depending on the requirements of the device and the material used, we may apply vapor smoothing to enhance the surface finish, bead blasting for texture, or coloring and dyeing to match the patient’s preferences. These post-processing techniques further refine the appearance and functionality of the device.

The final step in the workflow is rigorous quality control. At Endeavor 3D, every device undergoes a 24-point defect inspection to ensure it meets the highest standards. We inspect 100% of the parts produced for cosmetic defects, ensuring the patient receives a fully functional and aesthetically pleasing device. With our quality control process, our customers can be confident that every part meets strict quality assurance standards.

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With the digital manufacturing process in place, three primary benefits stand out: scalability, quick design iterations, and improved patient outcomes.

Traditional O&P fabrication often involves the creation of one-off devices, each requiring individual time and effort. This can be inefficient and limiting, particularly for small-volume to large-volume production runs. With MJF 3D printing, however, we can easily scale production. Multiple parts and projects can be placed on the same print bed, allowing for efficient production of several devices at once. Moreover, with 3D printing, devices can be produced on demand, reducing the time between design and delivery. This scalability makes it easier to meet high-volume needs while maintaining personalized customization, all without sacrificing quality or time.

Patients’ needs can change over time due to factors such as weight fluctuation or changes in the affected body part. The digital workflow supports quick iterations, allowing Endeavor 3D to adjust the design of the O&P device without starting from scratch. By storing the digital files, we can quickly modify and reprint the device as needed. This flexibility reduces lead times and ensures that the device continues to meet the patient’s evolving needs.

One of the most significant advantages of digital manufacturing, particularly with MJF 3D printing, is the consistency and repeatability of the process. MJF printing produces parts with isotropic properties, meaning they have uniform strength in all directions, ensuring durability and functionality. Additionally, the intricate design capabilities of 3D printing allow for the creation of lightweight, breathable devices. For example, using materials like thermoplastic polyurethane (TPU), we can create devices with varying rigidity and flexibility. In areas requiring more structure, we can use a dense lattice, while areas needing more flexibility can have an open, lightweight design.

The digital manufacturing workflow for orthotic and prosthetic (O&P) devices seamlessly combines customizability and accessibility, ensuring that each patient receives a tailored solution without the delays and inconsistencies of traditional methods. Leveraging Multi Jet Fusion (MJF) 3D printing provides a clear roadmap for efficient and scalable production. With faster development cycles, enhanced durability, and improved patient outcomes, digital workflows are setting a new standard in O&P manufacturing.

Endeavor 3D is committed to driving this transformation with high-quality 3D printing technologies, materials, and expert support. Ready to explore how digital manufacturing can enhance your O&P solutions? Contact us today to get started.