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OPM Licensed for Marketing & Manufacturing 3D Printed Medical Devices in Asia

Oxford Performance Materials Inc. is a Connecticut-based company we have followed for years as they continue to forge ahead in the realm of 3D printed implants. Their proprietary OsteoFab technology has propelled them into the industry of medical devices in both materials sciences and manufacturing. Now, this will also include the Japanese market as well.

OPM was just recently accredited as a foreign medical device manufacturer by the Japanese Ministry of Health, Labour, and Welfare. With this international development, they will also be creating OPM Asia in partnership with JSR Corp. of Tokyo. JSR is known for their strength in the life sciences industry in Asia, including a personalized medicine ecosystem, 3D software, drug discovery, and more.

The license will allow the new partners to market and manufacture medical devices in the following countries, with products expected to be on the Asian market by 2019 in:

  • Japan
  • China
  • Taiwan
  • Korea
  • Brunei Darussalam
  • Cambodia
  • Lao PDR
  • Malaysia
  • Myanmar
  • Philippines
  • Singapore
  • Thailand
  • Vietnam
  • India

“OPM has a broad technology platform built on PEKK polymer,” Scott DeFelice, the CEO and Chairman of Oxford Performance Materials, told 3DPrint.com. “With our establishment of OPM Japan we can now exploit our technology in a highly attractive market.”

“PEKK is a true high-performance polymer with highly unique attributes such as biocompatibility, purity, osteoconductivity, antibacterial properties and of course we have developed a proprietary method to 3D print with it. In our view as a materials company everything starts with having a polymer with the right attributes and PEKK does this uniquely.”

3D printed PEKK OsteoFab implant

With their ongoing use of PEKK, the OPM team produces implants very similar to bone that are osteoconductive and encourage the growth of natural bone once implanted. It is also radiolucent—meaning that it works well for patients having MRIs as well.

“If a material has the same modulus as bone, it does less damage and is healthier for the bone. For instance, metal can damage the bony interface,” said DeFelice, who will also be OPM Asia’s CEO, as well as one of their board members.

OPM offers comprehensive services around the world, also serving as an OEM and regulatory filer. When PEKK was originally created by DuPont, OPM was approved to make their own OXPEKK material, and since then they have patented OXPEKK LTS for 3D printing medical implants.

“We can go from a proprietary polymer to device to distribution,” continued DeFelice. “It’s sort of what you have to do with something so fundamentally different, something disruptive. In medtech, there’s so much vested cost in development, so it’s really hard to buy in to new materials and processes. You have to do a lot of it yourself.”

“Companies don’t always have the capability and infrastructure to innovate. We have to develop proof and go to companies with a good package.”

With the OPM and JSR partnership in place, they also intend to expand into other areas:

“Independent surgical centers are growing, and we are building a business model around those models,” said DeFelice. “They offer clinical efficacy at a lower cost, which is core to our business model.”

“You’re catching us as we are internationalizing our technology,” he said. “We’ve established a global best-in-class technology that made it through the rigorous U.S. FDA regulatory system. We are already selling implants globally, and now we are ready to expand.”

What do you think of this news? Let us know your thoughts! Join the discussion of this and other 3D printing topics at 3DPrintBoard.com.

[Source: MDDI; Images: OPM]

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Patient-Specific 3D Printed Spinal Solutions by Anatomics

3D printed anterior cervical cage

Australian medical device company Anatomics has a very prolific 3D printing portfolio in the healthcare industry, from assisting with a 3D printed heel bone to 3D printing the first titanium sternum and set of ribs and vertebrae. Anatomics founder Paul D’urso, MD, a neurosurgeon at Epworth Healthcare, began his medical 3D printing research way back in 1991, four years before starting the not-for-profit Anatomics, which has since helped over 5,000 patients with its custom 3D printed medical solutions.

D’Urso said, “Anatomics has lead the world in custom 3D printed spine technology for over 20 years and is proud to have developed numerous world first applications.”

3D printed occipito-cervical plate

D’Urso has a particular interest in developing spinal applications for biomodeling, and at the recent 3DHEALS conference in San Francisco, reported that he’s used 3D printing in nearly 700 spinal fusion procedures, including what D’Urso tells us is “the world’s first custom occipito cervical plate.”

“In the future Anatomics plans to create disruptive Spinal Solution Centres that will enable Community Based Personalised Healthcare allowing surgeons and hospitals to 3D print a range of spinal implants and share designs through-out the world,” D’Urso told 3DPrint.com.

The success of some of the innovative 3D printed solutions that D’Urso and Anatomics have developed, including 3D printed custom spinal implants, have recently been described in articles and research papers printed in various publications, such as the European Spine Journal and the Journal of Clinical Neuroscience.

The latter paper, titled “Designing patient-specific 3D printed devices for posterior atlantoaxial transarticular fixation surgery,” discussed how biomedelling and 3D printing are both useful tools for pre-surgical planning, developing titanium implants and patient-specific tools, and intraoperative stereotaxy – a minimally invasive surgical procedure which uses a 3D coordinate system to locate small targets inside the body and then perform an action, like an ablation, biopsy, injection, or implantation, on them.

The abstract reads, “Atlantoaxial transarticular screw fixation is an effective technique for arthrodesis. Surgical accuracy is critical due to the unique anatomy of the atlantoaxial region. Intraoperative aids such as computer-assisted navigation and drilling templates offer trajectory guidance but do not eliminate screw malposition. This study reports the operative and clinical performance of a novel process utilising biomodelling and 3D printing to develop patient specific solutions for posterior transarticular atlantoaxial fixation surgery. Software models and 3D printed 1:1 scale biomodels of the patient’s bony atlantoaxial spine were developed from computed tomography data for surgical planning. The surgeon collaborated with a local medical device manufacturer using AnatomicsC3D to design patient specific titanium posterior atlantoaxial fixation implants using transarticular and posterior C1 arch screws. Software enabled the surgeon to specify screw trajectories, screw sizes, and simulate corrected atlantoaxial alignment allowing patient specific stereotactic drill guides and titanium posterior fixation implants to be manufactured using 3D printing. Three female patients with unilateral atlantoaxial osteoarthritis were treated using patient specific implants. Transarticular screws were placed using a percutaneous technique with fluoroscopy and neural monitoring. No screw malposition and no neural or vascular injuries were observed. Average operating and fluoroscopy times were 126.0 ± 4.1 min and 36.7 ± 11.5 s respectively. Blood loss was <50 ml per patient and length of stay was 4–6 days. Clinical and radiographic follow up data indicate satisfactory outcomes in all patients. This study demonstrates a safe, accurate, efficient, and relatively inexpensive process to stabilise the atlantoaxial spine using transarticular screws.


The paper also explained how operative ergonomics and the placement of atlantoaxial transarticular screws can both be simplified using 3D printing. Authors include Ganesha K. Thayaparan, with Epworth’s Department of Neurosciences, and Anatomics’ Mark G. Owbridge, Robert G. Thompson, and D’Urso.

Discuss this and other 3D printing topics at 3DPrintBoard.com or share your thoughts in the comments below. 

[Images provided by Anatomics]

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3D Printing News Briefs: June 29, 2018

In today’s 3D Printing News Briefs (the last one this month, how is the summer going by so quickly?!), a few companies are announcing special honors and recognitions, and then we’re sharing stories stories about some interesting new 3D printing projects, and finally wrapping things up before the weekend with some business news. Renishaw’s Director of R&D has been honored by the Royal Academy of Engineering, while MakerBot earned an important designation for its 3D printing certification program for educators and Renovis Surgical Technologies received FDA approval for its new 3D printed implant. Festo is introducing three new bionic robots, one of which is partially 3D printed, and CINTEC is using 3D printing for its restoration of a famous government house. GE wants to use blockchains for 3D printing protection, and ExOne announced a global cost realignment.

Royal Academy of Engineering Honors Renishaw’s Chris Sutcliffe

Earlier this week, the Royal Academy of Engineering (RAE) awarded a Silver Medal to Professor Chris Sutcliffe, the Director of Research and Development of the Additive Manufacturing Products Division (AMPD) for global metrology company Renishaw. This award is given to recognize outstanding personal contributions to British engineering, and is given to no more than four people a year. The Silver Medal Sutcliffe received was in recognition of his part in driving the development of metal 3D printed implants in both human and veterinary surgery, and also celebrates his successful commercialization of 3D printed products with several companies, including Renishaw, and the University of Liverpool.

“Throughout my career I’ve worked hard to commercialise additive manufacturing technology. As well as AM’s benefit to the aerospace and automotive sectors, commercialisation of AM and associated technologies has been lifechanging for those with musculoskeletal diseases,” said Sutcliffe. “The award celebrates the successes of the engineers I have worked with to achieve this and I am grateful to receive the award to recognise our work.”

MakerBot’s Certification Program for Educators Gets Important Designation

One of the leaders in 3D printing for education is definitely MakerBot, which has sent its 3D printers to classrooms all over the world. Just a few months ago, the company launched a comprehensive, first of its kind 3D printing certification program, which trains educators to become 3D printing experts and create custom curriculum for STEAM classrooms. An independent review of the program showed that it meets the International Society for Technology in Education (ISTE) standards, and it has earned the prestigious ISTE Seal of Alignment from the accreditation body. In addition, a survey conducted over the last three years of over 2,000 MakerBot educators shows that the percentage of teachers reporting that MakerBot’s 3D printers met their classroom needs has doubled in just two years.

“This data shows that MakerBot isn’t just growing its user base in schools. We’re measurably improving teachers’ experiences using 3D printing,” said MakerBot CEO Nadav Goshen. “Much of this impressive teacher satisfaction is thanks to the effort we’ve put into solving real classroom problems—like the availability of 3D printing curriculum with Thingiverse Education, clear best practices with the MakerBot Educators Guidebook, and now training with the new MakerBot Certification program.”

Earlier this week, MakerBot exhibited its educator solutions at the ISTE Conference in Chicago.

FDA Grants Clearance for 3D Printed Interbody Spinal Fusion System 

California-headquartered Renovis Surgical Technologies, Inc. announced that it has received 510(k) clearance from the FDA for its Tesera SA Hyperlordotic ALIF Interbody Spinal Fusion System. All Tesera implants are 3D printed, and use a proprietary, patent-pending design to create a porous, roughened surface structure, which maximizes biologic fixation, strength, and stability to allow for bone attachment and in-growth to the implant.

The SA implant, made with Renovis’s trabecular technology and featuring a four-screw design and locking cover plate, is a titanium stand-alone anterior lumbar interbody fusion system. They are available in 7˚, 12˚, 17˚, 22˚ and 28˚ lordotic angles, with various heights and footprints for proper lordosis and intervertebral height restoration, and come with advanced instrumentation that’s designed to decrease operative steps during surgery.

Festo Introduces Partially 3D Printed Bionic Robot

German company Festo, the robotics research of which we’ve covered before, has introduced its Bionic Learning Network’s latest project – three bionic robots inspired by a flic-flac spider, a flying fox, and a cuttlefish. The latter of these biomimetic robots, the BionicFinWave, is a partially 3D printed robotic fish that can autonomously maneuver its way through acrylic water-filled tubing. The project has applications in soft robotics, and could one day be developed for tasks like underwater data acquisition, inspection, and measurement.

The 15 oz robot propels itself forward and backward through the tubing using undulation forces from its longitudinal fins, while also communicating with and transmitting data to the outside world with a radio. The BionicFinWave’s lateral fins, molded from silicone, can move independently of each other and generate different wave patterns, and water-resistant pressure and ultrasound sensors help the robot register its depth and distance to the tube walls. Due to its ability to realize complex geometry, 3D printing was used to create the robot’s piston rod, joints, and crankshafts out of plastic, along with its other body elements.


Cintec Using 3D Printing on Restoration Work of the Red House

Cintec North America, a leader in the field of structural masonry retrofit strengthening, preservation, and repair, completes structural analysis and design services for projects all around the world, including the Egyptian Pyramids, Buckingham Palace, Canada’s Library of Parliament, and the White House. Now, the company is using 3D printing in its $1 million restoration project on the historic Red House, which is also known as the seat of Parliament for the Republic of Trinidad and Tobago and was built between 1844 and 1892.

After sustaining damage from a fire, the Red House, featuring signature red paint and Beaux-Arts style architecture, was refurbished in 1904. In 2007, Cintec North America was asked to advise on the required repairs to the Red House, and was given permission to install its Reinforcing Anchor System. This landmark restoration project – the first where Cintec used 3D printing for sacrificial parts – denotes an historic moment in structural engineering, because one of the reinforcement anchors inserted into the structure, measuring 120 ft, is thought to be the longest in the world.

GE Files Patent to Use Blockchains For 3D Printing Protection

According to a patent filing recently released by the US Patent and Trademark Office (USPTO), industry giant GE wants to use a blockchain to verify the 3D printed parts in its supply chain and protect itself from fakes. If a replacement part for an industrial asset is 3D printed, anyone can reproduce it, so end users can’t verify its authenticity, and if it was made with the right manufacturing media, device, and build file. In its filing, GE, which joined the Blockchain in Transport Alliance (BiTA) consortium in March, outlined a method for setting up a database that can validate, verify, and track the manufacturing process, by integrating blockchains into 3D printing.

“It would therefore be desirable to provide systems and methods for implementing a historical data record of an additive manufacturing process with verification and validation capabilities that may be integrated into additive manufacturing devices,” GE stated in the patent filing.

ExOne to Undergo Global Cost Realignment

3D printer and printed products provider ExOne has announced a global cost realignment program, in order to achieve positive earnings and cash flow in 2019. In addition to maximizing efficiency through aligning its capital resources, ExOne’s new program will be immediately reducing the company’s consulting projects and headcount – any initial employee reductions will take place principally in consulting and select personnel. The program, which has already begun, will focus first on global operations, with an emphasis on working capital initiatives, production overhead, and general and administrative spending. This program will continue over the next several quarters.

“With the essential goal of significantly improving our cash flows in 2019, we have conducted a review of our cost structure and working capital practices. We are evaluating each position and expense within our organization, with the desire to improve productivity. As a result, we made the difficult decision to eliminate certain positions within ExOne, reduce our spending on outside consultants and further rely on some of our recently instituted and more efficient processes,” explained S. Kent Rockwell, ExOne’s Chairman and CEO. “Additional cost analyses and changes to business practices to improve working capital utilization will be ongoing over the next several quarters and are expected to result in additional cost reductions and improved cash positions. All the while, we remain focused on our research and development goals and long-term revenue growth goals, which will not be impacted by these changes, as we continue to lead the market adoption of our binder jetting technology.”

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