3D Printed Prosthetic Devices: The Impact of Biocompatible Materials

Additive manufacturing (AM) technology and biocompatible materials can change how orthotic and prosthetic (O&P) clinicians help patients. These emerging advancements allow clinicians to craft devices faster and cheaper without sacrificing patient comfort and care.

Patients want functional O&P devices that are affordable, quickly available, and comfortable. Clinicians take great care to handcraft each device to best serve each person. This molding and iterating process results in beautiful, functional devices but can take weeks to perfect. This extended timeline makes these devices pricey and forces patients to wait to get outfitted for their device. AM allows clinicians to customize orthoses and prostheses in less time, reducing patient costs.

Recent efforts made by filament producers to comply with FDA recommendations have been a catalyst for the industry to adopt AM processes in clinics across the globe. As the O&P industry turns to 3D printing for orthoses and prostheses, clinicians must be able to trust the safety of the materials that come in contact with patients.

Essentium partnered with Vorum to demonstrate ISO 10993 biocompatibility for select Essentium 3D printing filaments: PCTG, PA-CF, TPU 74D, and PET-CF. These materials can be leveraged to enable unique O&P solutions. PCTG offers clarity and formability, PA-CF achieves high toughness and stability, TPU 74D is soft, flexible, and durable, and PET-CF offers structural stiffness. These four materials were proven to be non-irritating and non-sensitizing for extended skin contact. For a deep dive into the results of these tests, check out Essentium’s on-demand webinar over biocompatible materials.

Once the safety is verified, clinicians can customize devices for comfort and fit, which is vitally important for patients as a poor fit can cause discomfort, injury, or lead to infection.

“Developing a comfortable, properly fitting prosthesis is not just a science, it is also an art,” said Garrett Harmon, Applications Engineering Manager at Essentium. “3D printing has the power to take today’s bespoke, artisanal manufacturing process and transform it into a highly repeatable and consistent process, which ultimately results in more effective clinics and better patient outcomes.”

Another historical barrier to entry for clinicians is printing platform availability. A platform with the material requirements, precision, and size needed in clinics has not existed until recently.

An industrial printer like the Essentium High Speed Extrusion (HSE) 180 LT 3D Printer gets patients their devices faster. Using this printing platform, clinicians:

• Benefit from the open ecosystem, allowing them to print any material whether it is an Essentium material or not.
• Can maximize the 690 x 500 x 600 mm build volume to print devices from the smallest AFOs to the largest sockets.
• Print at speeds of up to 500 mm/sec, 1G acceleration, and 1 m/sec travel speed, to iterate faster.

Using industrial, open ecosystem 3D printers, like the Essentium HSE 3D Printing Platform, clinicians can yield devices that provide better patient outcomes through a more precise fit, faster turnaround, and reduced cost.

Material and technological advancements in the O&P industry enables clinicians to deliver devices that are more accessible and affordable for many more people around the world. To continue developing technology for this industry, Essentium is proud to partner with Vorum, a leader in the development of prosthetics and orthotics CAD/CAM design technology, to replace traditional plaster-cast prosthetic molding with 3D printing.

To learn how clinicians save time in both design and manufacturing, and significantly reduce physical part storage and discover how to bring the same cost and time savings to your clinic and ecosystem, see our on-demand webinar over how AM is changing the O&P industry or contact us today.