Orthotics & 3D Printing

Additive manufacturing is ideal for products such as splints, braces and insoles that require a custom fit to the human body

Manufacturing bespoke Orthotics

As you can imagine, the body of every person requiring an orthotic device can differ in size and shape - the effectiveness of an orthotic as part of a medical treatment is therefore heavily dependent on designing the device to fit the patient. This leads to one of the major headaches with designing and manufacturing custom products, it’s both time consuming and expensive. Traditionally manufactured orthotics often require multiple in-person fitting sessions, several months of waiting and even then, potentially an imperfectly fitting device that doesn’t perform its function as well as it could. 

Additive manufacturing provides a clear solution to the longstanding issues within both the design and manufacturing process for orthotic devices. For each patient, a process of capturing specific measurements, converting this into digital data and modifying the form can be done in just a few hours. The printing process is also fast, with the ability to print parts within hours and have them ready for fitting within days and crucially, without the need for any process of iteratively improving the fit of the device to the patient. 

3D scanning is an established solution that quickly and accurately capture millions of data points across the body and digitise it in a format that can then be imported into CAD software and modified. Most hospitals already have the equipment (MRI and CT equipment) required to obtain the 3D scan data from the patient in just a few minutes required to start the digital design and manufacturing process.

Software solutions can streamline the computer modelling and design stages when developing a new orthotic, to simplify and semi-automate the process of conversion of your human body data into a functional device. The customised, perfectly fitting solution can then be sent to be 3D printed on a medically approved multi jet fusion 3D printer in as little as a few hours. Twikit is one of a number of companies working to develop more automated workflows for this stage of the process, to allow data to be fed into fully constrained models which automate the output of the personalised, custom-fitting orthotic device ready for 3D printing using multi jet fusion technology.

Manufacturing orthotics using Multi Jet Fusion (MJF)

HP’s multi jet fusion (MJF) is one of the leading 3D printing technologies within the orthotics market, and for a good reason. HP has undertaken extensive testing on both their technology and primary material, PA12 Nylon, to drive adoption within the medical sector. It has been able to secure biocompatibility certification, a key requirement for any material being used in skin-contact applications through rigorous testing under a variety of environmental conditions.

The material PA12 Nylon is certified biocompatible by the FDA, is near 100% dense, watertight and chemically inert. MJF PA12 Nylon also has the perfect balance of toughness and rigidity for a homogeneous orthotic structure.

Key benefits of using MJF PA12 Nylon in Orthotics

Multi Jet Fusion (MJF) AND Orthotics - INDUSTRY EXAMPLES

There are some clear advantages to using MJF technology during the manufacturing of orthotic devices, with some promising developments taking place across the world. We explore some of these in more detail below.

HeyGears - Orthotics & Prosthetics

HeyGears is an innovative medical applications company that has been utilising HP multi jet fusion technology to produce fully customised and tailored orthotic devices. The company explains that in traditional orthosis manufacturing, materials like plaster can cause complications and often result in parts with poor precision, causing uneven pressure on the tissue. This can cause friction and lead to redness and blisters on the skin. To ensure proper treatment and recovery from injuries, patients need orthotic devices that are both static and dynamic, as well as breathable and comfortable.

HeyGears has been able to develop and bring to market an orthotic using MJF PA12 Nylon, with a unique adjustable design that easily positions a patient’s wrist at different angles, ensuring easy wrist joint movement and gradual correction over time, in addition to joint protection.

Traditional materials such as plaster and some polymers resulted in heavy orthotic devices that did not breathe well, making it difficult for the physician to adjust and clean. But 3D printed orthotics made with MJF PA12 can be adjusted by the patient, reducing the number of necessary visits with the physician.

HeyGears values the design freedom and quality of materials that PA12 Nylon brings. "Design freedom (with HP multi jet fusion) allows us to think differently and put multiple functional parts into one product, which also saves on assembly costs," Huang states.

"The personalised design, fixing method, and the additional adjustable structures can effectively prevent problems such as muscle atrophy, skin discomfort, and nerve and blood vessel compression," said Dr. Zhao. "The use of 3D printing technology to create 3D printed custom orthotics and replacing traditional methods enable patients to obtain the latest treatment options and the best medical experience."

Materialise Phits Suite - Orthotics

The shoe insole is one of the most common orthotic devices in the world today. Shoe insoles can reduce foot pain by relieving pressure on the most painful areas. Every person has a different way of walking relating to both posture and gait, leading to the need for custom insoles to suit an individual's walking style. A well-designed insole can not only reduce foot pain but also correct misalignment, tackling the root causes of the issue at the same time.

Traditional methods of manufacturing shoe insoles have revolved around beginning with a standardised insole, which needs to be fitted to a patient's foot, commonly through being heated in position - this method has a number of imperfections and limitations, however. 

Materialise has developed an end-to-end digital toolkit, from 3D scan to custom orthotic. Customers can scan and obtain a dynamic gait analysis by using high quality pressure plates and 3D scanners. Phits Suite can automatically generate the insole required to reflect the different pressure variations across the patient's foot before sending this to 3D printing using MJF technology.

The end result is a robust, long-lasting insole perfectly designed for the patient's individual needs. The use of 3D printing is ideal for this application because of the design freedom and zero-cost additional complexity that the technology offers. The Materialise Phits Suite software can alter the flexibility and rigidity of different areas of the insole by varying the lattice structures within it, according to the patient's dynamic weight and pressure distribution.

MJF PA12 Nylon is the perfect material for this application, being inert, chemically stable and offering the right combination of flexibility and robustness to solve a patients long term pain management needs.

The 3D printed custom orthotics market is predicted to sustain impressive growth in the coming years. Digitisation of medical care, in addition to an ageing world population, means the need for fit-for-purpose, high quality orthotics is only going to increase. Individualised care plans that solve the long term root causes of chronic issues can help relieve pressure on national medical services, with 3D printed orthotics being one of the most promising solutions for the future.

At 3D People, we offer medically-certified multi jet fusion (MJF) technology with PA12 Nylon. We undertake partnerships with a variety of medical device and equipment suppliers, don’t hesitate to get in touch for a quotation today.

3D printing has been quietly taking over a number of areas across the medical industry to become the primary method of manufacturing. It is becoming an indispensable tool to help support patient care and recovery, especially within the Orthotics sector. In this blog post, we find out why.