Advanced prosthetic limbs can cost anywhere from $5,000 to $50,000. This is a high price even in industrialized countries, and is well beyond the means of many amputees in poor, developing nations where war and disease often take a greater toll. Frost & Sullivan has researched the potential of 3-D printing prosthetics and has identified several companies that stand out in the health care space.
Prosthetic devices have become more sophisticated, enabling amputees to accomplish more of the tasks that were once difficult or impossible because of missing hands, feet, or limbs. Additional functionality, however, comes at a price: advanced prosthetic limbs can cost anywhere from $5,000 to $50,000. This is a high price even in industrialized countries, and is well beyond the means of many amputees in poor, developing nations where war and disease often take a greater toll.
3-D printing can make prosthetics more affordable because the production method is inherently less costly than traditional machining. 3-D printers use a computer-aided design (CAD) program to apply layers of material to create a highly precise finished part. Cost is an especially important because most prosthetics only last about five years—even less when designed for a growing child. Another advantage is that 3-D printing is much faster than conventional manufacturing, which could take weeks or months: a 3-D printed limb can be completed in as little as a day.
CAD programs allow for customization for appearance or function. A 3-D printer can use the precision of CAD programming combined with anatomical data of the wearer to make the limb more comfortable.
Frost & Sullivan has researched the potential of 3-D printing, which is also known as additive manufacturing, in multiple industries. Automotive and aerospace applications also are rapidly developing. Further advances in printing technologies and materials will result in higher-quality, more durable devices at much lower costs in the near future. Frost & Sullivan has identified several companies that stand out in the health care space.
Mecuris GmbH (Munich, Germany)
Mecuris is a recent market entrant, founded in 2016. It develops prosthetics using the SolidWorks 3-D printing solution of Dassault Systemes. Mecuris has reported that it has reduced prosthetic limb production times by 75 percent by merging 3-D design and printing technologies into a single, intuitive platform. Physicians or orthopedic technicians upload a digital file based on computed tomography, magnetic resonance imaging, or 3-D scan of the patient with measurements into Mecuris’s proprietary, analytical, and cloud-based artificial intelligence design software. The software analyzes the images to generate an accurate 3-D anatomical picture of the patient’s body. A software algorithm automatically develops a tailored prosthetic design and sends it to a Mecuris technician who confirms its compatibility and feasibility.
Mecuris also prints orthoses (devices used to correct spine alignment or provide support) and other equipment, such as covers for below-knee prostheses. Durable materials help Mercuris’s medical products survive stress and load capacity tests simulating more than four times’ a patient’s body weight. This was key to it gaining CE medical certification in Europe for its NexStep prosthetic foot. Its similar FirStep product is specifically designed for children. A young patient even has a say in its design by being able to choose its color.
Stratasys (Eden Prairie, Minn.)
Founded in 1988 at the dawn of additive manufacturing, Stratasys Ltd. has become a global leader in manufacturing 3-D printers and production systems used in rapid prototyping and the manufacture of high-value components including Formula 1 race cars. More recently, Stratasys launched its F123 Series of rapid prototyping solutions that can be used to produce implants and prosthetics.
F123 Series printers are equipped with Stratasys’s proprietary Fast Draft Mode feature, which allows users to quickly produce conceptual prototypes at a low cost per part. They also can be remotely operated and monitored. Compatible materials include polylactic acid, production-grade acrylonitrile styrene acrylate, plastic, acrylonitrile butadiene styrene (ABS), and high impact-resistant polystyrene ABS.
Stratasys has 15 new patents in relation to the F123 design, process, and technology. The printers use the GrabCAD Print Add-In software platform, which the company also developed.
Naked Prosthetics Inc. (Olympia, Wash.)
There are already signs of specialization in the 3-D printing of prosthetics, such as in the line of digital devices designed and manufactured by Naked Prosthetics to replace fingers lost to accidents, military service, or infections.
The company’s MCPDriver replaces the metacarpophalangeal (MCP) joint—or knuckle— to mimic the extension and flex of the finger. Its MCPThumb restores opposition and strength to people who have lost thumbs, and its PIPDriver serves people whose proximal interphalangeal (PIP) joint is intact, providing the wearer with articulation, dexterity, grip strength, and protection from further injury. All of the devices consist of nylon components and a stainless steel frame that is easy to strap on, and silicone rubber tips for a sure grip.
The Road Ahead
The American Board for Certification in Orthotics and Prosthetics reports more than 1 million limb amputations around the world each year, translating into an amputation about every 30 seconds. Frost & Sullivan believes that in the long term, manufacturers will focus more on providing patients in need of prosthetics with home-based 3-D printing solutions with open-source designs for the convenience of printing new prosthetics as a young wearer grows or a device wears out. Current technology cannot accommodate large-scale manufacturing, although this is not as much of a concern for this area’s customized products.
In the meantime, U.S. Food and Drug Administration approval and certification for 3-D printed prosthetics remains a major hurdle. The agency in December released technical guidance about the emerging technology and said it is working to establish a regulatory framework.
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