3D PRINTING ORTHOPEDICS
3D Printed Scoliosis Brace with Embedded Wearable Tech Showcased at White House Event
By Business Wire | September 16, 2016
UNYQ Align uses sensors to detect how long a user wears the device, and monitors pressure points to ensure fit and function.
UNYQ, the San Francisco- and Seville-based pioneer in personalized prosthetics and orthotics, today showcased their new scoliosis brace, UNYQ Align, and their personalized prosthetic cover, UNYQ Performance, at a White House event hosted by the White House Office of Public Engagement and Office of Science and Technology Policy. UNYQ Align combines 3D-printing and digital design, powered by the Intel Curie module, into a stylish, customized, and lightweight medical device that assists scoliosis sufferers.
For this special White House event, UNYQ teamed up with Studio Bitonti, led by famed designer, Francis Bitonti, to imagine a brand new type of UNYQ Align brace. The result is not only fashionable, but, through innovative topology optimization technology, Studio Bitonti and UNYQ were able to reduce the material significantly to create their most breathable and lightweight scoliosis brace yet.
“It was a privilege to collaborate with UNYQ on this solution. These are the kinds of projects designers need to be paying very close attention to,” said Francis Bitonti, CEO of Studio Bitonti. “UNYQ Align demonstrates how innovative technologies, designers, and technologists can combine to revolutionize treatment of medical conditions and dramatically improve the lives of the people who rely on assistive devices.”
Around 7 million US citizens suffer from scoliosis, a curvature of the spine that afflicts both young and old. Bracing is the most common treatment for children and teens, with prescribed usage of up to 16-18 hours a day. Traditional braces make it difficult for patients to reach the minimum recommended bracing period per day because they are constricting, bulky and perceived as unattractive.
UNYQ Align uses sensors to detect how long a user wears the device, and monitors pressure points to ensure fit and function. A mobile app collects the data for use by clinicians to make adjustments based on empirical data. At 3.5mm thick, the new brace is lightweight and slim enough to wear under a shirt, and comes in a wide variety of colors and patterns. These innovations dramatically improve the patient’s experience and impact their willingness to wear the brace.
“We are thrilled to have been invited to feature 2 of our products, UNYQ Performance and UNYQ Align at the White House Event Celebrating Inclusive Design, Assistive Technology & Prosthetics,” said Eythor Bender, UNYQ CEO and Co-Founder. “I’m continually inspired by people who have overcome personal barriers, and am proud we have developed products that allow them more opportunities to do so.”
UNYQ Align will be launched to a limited number of the top clinics in the U.S. in October. The UNYQ Align App will be available in the spring of 2017.
3-D Printed Prosthesis Gives Paralympian a Leg Up
- By P.M.FORNASARI on May 20, 2016
German Paralympian Denise Schindler tests a 3D-printed prosthesis, hoping to use it at the Rio Olympics in summer.
German paralympic cyclist Denise Schindler is training hard for Rio
But these Olympics will be different for her : she plans to use a 3D-printed leg prosthesis instead of a conventional one.
GERMAN PARALYMPIC CYCLIST DENISE SCHINDLER:
"It feels different when I cycle due to its quality. But we are on the right path to reach the right stiffness and aerodynamic. The new prosthesis is also lighter and that is also an advantage when competing. "The manufacturing process starts with the scanning of the stump followed by the design of the prosthesis through a special computer program called Fusion 360. The software is designed by American company Autodesk which says the 3D prosthesis is a revolutionary step forward
MICKEY WAKEFIELD AUTODESK APPLICATIONS ENGINEER, MICKEY WAKEFIELD:
"The advantage of having data is that we can send this digital information to another prosthesis maker who can correct things without the presence of the person. When it is ready it can be printed relatively easy everywhere in the world with a 3D printer."
Schindler, who lost the lower part of her leg in an accident when she was two, recently presented the new prosthesis to US President Barack Obama and German Chancellor Angela Merkel: "I was surprised to see how informed the president was about the issue. He was very positive about it,"
Those behind it say the idea of the new method of production is to make sports-prostheses cheaper and more accessible for everyone.
And Denise Schindler's new 3D-printed prosthesis is set to get the ultimate test when she hits the velodrome in Rio.
3D Printing Offers Patients ‘Life-Changing’ Option
for Talus Replacement Surgery
By P.M.FORNASARI | May 12, 2016
Orthopedic surgeon pioneers unique new approach to treating avascular necrosis of the talus. High impact injuries like falls or traffic accidents can cause the talus bone to be fractured, and a high percentage of these injuries result in avascular necrosis. Related Breaking News DJO Global Reports 12.7 Percent Spike in Q1 Sales Repair Cartilage Can Potentially Heal Horribly Broken Bones Hope for Injured High School Football Player Wright Medical's Sales More Than Double in First Quarter The talus is the part ankle that allows the foot to move in all different directions. High impact injuries like falls, or traffic accidents can cause the talus bone to be fractured, and a high percentage of these injuries result in avascular necrosis (AVN)—the death of the bone. In a first-of-its-kind procedure using 3D printing technology, internationally renowned orthopedic surgeon Dr. Mark Myerson, Director, The Institute for Foot and Ankle Reconstruction at Mercy Medical Center, explains how a talus replacement, tailored to the patient’s specific dimensions, can result in a “life-changing experience” for the patient. “The talus has limited blood circulation, and when it is fractured, that blood circulation is commonly lost. The result is avascular necrosis. Over time, the bone will crumble and collapse, like a squashed orange. You’re left with a flattened, painful and arthritic ankle. When you remove the dead bone from the ankle you are left with a massive hole. The treatment offered to patients to date has been to fuse the heel to the leg (the tibia) and these results are particularly poor. The patient is left with a stiff ankle without any movement at all. However, we have a new method of treatment which is truly unique,” Dr. Myerson said. The patient’s healthy ankle is imaged by a CAT scan; then using computer engineering, the image is reversed and becomes a blueprint for creating the new talus, “to be a match for the abnormal talus with AVN which is removed. 3D printing technology (provided by 4Web Medical) is used to create a new talus to take the place of the dead bone,” Dr. Myerson said. Several trial implants, made of plastic, are provided to be inserted to determine the best fit. “Once we decide on the one that fits, we then select the appropriate matched size to insert in to the patient,” Dr. Myerson said. The final prosthesis to be inserted is made of cobalt and chrome. “This is not an ankle replacement. An ankle replacement may be appropriate for a patient with ankle arthritis, but it cannot be done with patients with avascular necrosis of the talus,” Dr. Myerson explained. Patients who receive the 3D-printed talus replacement may regain up to 75 percent of normal ankle function. “If you have a fusion, there is no movement. The talus replacement allows for the movement of both the ankle and subtalar joints, which make moving the foot up and down and side to side possible. The talus replacement helps move these joints because it replaces both surfaces. The final result is truly unbelievable, the mobility it affords the patient, enhancing their quality of life. I’ve been practicing orthopedic surgery of the foot and ankle for 32 years and it is rare that something like this comes along that help patients in this way,” Dr. Myerson said.
Additive Manufacturing Status in the
By P.M. FORNASARI | May 11, 2016
Implants expo organizer offers a brief synopsis of the sector.
Zimmer, one of the major orthopedic companies, penetrated this market 15 years ago with a proprietary technology acquired from Implex, thereby opening the trabecular structure market with an investment of several hundred million U.S. dollars.
In 1997, Zimmer used clinically trabecular metal based on the tantalum vapor deposit process for the hip cup. In 2007, Adler Ortho (Italy) used its first trabecular titanium cup—Fixa Ti-Por. Between 2008-2011, 109 Lima Delta TT cups were implanted in 98 patients. In 2009, Medtronic launched the Fuse Lumbar PLIF Cage made via additive manufacturing. In 2011, Exactech was the first U.S. company to offer FDA-cleared implants made via additive manufacturing technology; its Intergrip porous metal acetabular represented the first implantation.
The main benefit of additive manufacturing for orthopedics is the bone ingrowth capabilities. It also enables the manufacture of complex metal parts simultaneously for different sizes, shapes, and design. In the industrial field (mainly aeronautics), the additive manufacturing users are looking for weight reduction or advanced cooling.
Additive manufacturing is now a mature technology in orthopedics as it has been used for more than 15 years in the industry. With additive manufacturing, Italy offers the most advanced market; following Zimmer, the historical player, challengers like Lima Corporate and Adler Ortho have invested heavily in this technology. The main trabecular products are hip cups (several thousand are sold in Italy each year) followed by other products such as shoulder implants, knee tibial plates, and mini-hip stems.
Spinal cages manufactured via additive manufacturing represents one of the most dynamic orthopedic segments. For example, in Europe, PEEK cages are expected to lose market share (-4.5 percent CAGR by 2018) and titanium cages are anticipated to see a decrease of 2 percent in the five main countries. Meanwhile, additive manufacturing and trabecular cages are expected to increase by 19 percent and reach 61,000 units in 2018.
Industry Invests in Additive Manufacturing
In 2014, almost 25 orthopedic products that were manufactured via additive manufacturing received 510(k) clearance in the U.S. More specifically, Stryker, another major orthopedic company, has received 510(k) clearance for several orthopedic implants manufactured with additive manufacturing technologies. Stryker’s CEO, Kevin Lobo, announced that an additive manufacturing facility was being built in 2016, which partially accounted for a high level of planned capital expenditure (approximately $400 to $450 million). During the company's Q4 2015 earnings call, the company’s CEO also said additive manufacturing knee implants bolstered sales of the company's orthopedic devices. An additive manufacturing spinal implant is scheduled for launch this year, and the company has a "huge line-up of other divisions with ideas and prototypes to get into 3D-printed titanium products."
In early 2016, Smith & Nephew announced the launch of the Redapt Revision acetabular fully porous cup manufacturered using additive manufacturing technology. The Redapt gained FDA clearance in November 2015.
In 2015, if the orthopedic industry used 1,500 to 2,000 tons of titanium, additive manufacturing required less than 50 tons (<3 percent of the total). This year, Lima Corporate will need almost 2 tons of titanium for additive manufacturing and Adler Ortho will require 0.7 tons.
From 2014-2021, the market growth for additive manufacturing in metal will be between 18 and 30 percent, according to several industry forecasts. Orthopedic applications will be one of most dynamic segments.
Since 1990, Ali Madani, the managing partner at Avicenne Consulting, has been working on strategic and marketing studies in the medical sector. He has advised major players in this industry (Medtronic, Stryker, Zimmer, Depuy, etc.) on strategy development and implementation, technical and economic appraisals, and mergers and acquisitions. Madani has also advised multiple private equities firms on acquisitions and build-up (Deals: Tecomet, Lima Corporate, Amplitude Ortho, Marle, etc.). He has also advised medium- and small-sized companies for market research and strategic partnerships in the U.S., Europe, and BRICs. In 2005, Madani founded the annual medical industry conference and exhibition, Implants, over which he has presided ever since.