Exactech Transitions from EBM to Laser 3D Printing Implants for Shoulders

Orthopedic implant device maker Exactech wants to scale up the production of its Equinoxe Stemless Shoulder implant by switching from electron beam metal additive manufacturing to direct metal 3D printing with high precision lasers. In an official statement released on July 21, 2020, the Florida-based company announced plans to transition all US stemless shoulder procedures to its laser-printed devices throughout the rest of the year.

As the latest addition to the company’s extremities product line, the Stemless Shoulder, launched in 2018, is a bone conserving prosthesis designed for anatomic total shoulder arthroplasty. Comprised of a stemless cage, humeral head, and cage glenoid, the device offers intraoperative flexibility which is ideal for conserving the bone, said the company. Furthermore, to enhance the probability of biological fixation, it incorporated a laser 3D printed porous bone cage structure that allows bone-through growth, and without the need for a stem, there is more ease of implantation, reduced operating time, and blood loss. Exactech indicated that the innovative combination of 3D porous material and bone cage technology is what differentiates it from competing products on the market.

The new Equinoxe Stemless Shoulder uses laser-printed AM (Image courtesy of Exactech)

Currently, there is a growing trend towards minimally invasive orthopedic surgeries, like stemless shoulder implant procedures mainly led by experts in Germany and France. However, US surgeons also took notice of the benefits of using stemless implants to perform arthroplasties with less bone removal and fewer complications than more conventional anatomic shoulder prosthesis.

Driven by an upsurge in the aging population, longer life expectancy, and rising prevalence of arthritis, the global shoulder arthroplasty market is expected to reach $2.4 billion by 2023, and that includes increased demand for stemless shoulder implants, as forecasted by Koncept Analytics last year. In the US alone, over 53,000 people have shoulder replacement surgery each year, according to the Agency for Healthcare Research and Quality, and with only a handful of stemless shoulder implants cleared by the US Food and Drug Administration (FDA) since 2015 (including the Equinoxe Stemless Shoulder), there is a wide-open market opportunity for medical device manufacturers to exploit. Expecting to become a leading force in the stemless implant market, Exactech is switching technologies to deliver quick solutions for patients and surgeons.

“We have been incredibly pleased with our original EBM [electron beam melting] Stemless Shoulder implant and the early positive clinical feedback we received from our surgeon customers. The new laser-printed device is built on this solid foundation while also giving us the ability to ramp up production to serve even more patients, which drives us and fulfills our mission,” said Exactech Vice President of Extremities, Chris Roche.

Orthopedic surgeons Curtis Noel, of the Crystal Clinic in Akron, Ohio, and Stephanie Muh, of the Henry Ford Health System in Detroit, Michigan, were the first shoulder specialists to perform the surgeries with the Equinoxe Stemless Shoulder implant earlier this month. As a member of the design team, Noel expressed how proud he was to be one of the first to implant the laser-printed Stemless Shoulder, mainly due to the bone conserving design, along with its compatibility to the Equinoxe Shoulder Platform System.

Laser 3D printed porous structure designed to promote bone-through growth (Image courtesy of Exactech)

Muh described that “one of my favorite features of the Stemless implant is its bone cage structure that is designed to provide initial press-fit fixation while also allowing for bone-through growth. That intentional design element, along with the porous structure being designed to mimic the trabecular nature of cancellous bone, differentiates it from competitors.”

In order to design the Stemless Shoulder implant, Exactech engineering researchers collaborated with orthopedic surgeons that combined their knowledge, expertise, and background to come up with a final design structure that could be additively manufactured with optimized pore size, porosity, and count. The design team included Noel; shoulder and elbow surgery expert’s Felix Henry Savoie, from Tulane University, and Joseph Zuckerman from New York University (NYU)’s Langone Orthopaedic Hospital; Pierre-Henri Flurin, from the Clinique du Sport in Bordeaux-Mérignac, in France; Ryan Simovitch, the Director of the Shoulder Division at the Hospital for Special Surgery (HSS) in West Palm Beach, Florida, and Thomas Wright, Director of Interdisciplinary Center for Musculoskeletal Training at the University of Florida.

Pre-operative X-ray (left) and postoperative X-ray (right) showing the laser-printed Stemless Shoulder and Equinoxe Cage Glenoid. (Image courtesy of Stephanie Muh)

As a developer, and producer of innovative implants, instrumentation, and computer-assisted technologies for joint replacement surgery, Exactech targeted clinical evaluations of the Stemless Shoulder immediately after release and has been aggressively expanding and upgrading its product ever since. Just like other manufacturers of stemless implants, the goal here is to try to reproduce the native shoulder anatomy and minimize humeral bone removal. Recent studies. have outlined the numerous advantages – as well as a few disadvantages – of stemless shoulder implant arthroplasty, and although its use is still emerging outside of Europe, the implant is gaining ground with surgeons and patients and is expected to surpass stemmed implants by 2025.

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Fraunhofer ILT: Making Tungsten Carbide-Cobalt Cutting Tools with LPBF 3D Printing

Obviously, the Fraunhofer Institute for Laser Technology ILT does a lot of work with lasers, and, in the same vein, with metal 3D printing processes that use lasers. Now, it’s teaming up with scientists from the Institute for Materials Applications in Mechanical Engineering IWM and the Laboratory for Machine Tools and Production Engineering WZL, both at RWTH Aachen University, to investigate laser processes for the 3D printing of cutting tools made of tungsten carbide-cobalt (WC-Co).

The new AiF project – “Additive Manufacturing of Machining Tools out of WC-Co – AM of WC-Co” – began on October 1st 2019 and will last for 30 months; funding is provided by the Otto von Guericke e.V. working group of industrial research associations.

Cutting tools made of WC-Co are very heat- and wear-resistant, which is what one generally wants in this type of application, but it’s not easy to use conventional methods of manufacturing to create them. Complex sintering processes are currently used, but it’s not ideal, as only a restricted amount of geometrical freedom is possible, and it’s expensive and difficult to introduce complex cooling structures into the tools as well.

The process development aims to generate a homogeneous, almost dense structure of the WC-Co-composite, as shown here in this SEM measurement. [Image: Institute for Materials Applications in Mechanical Engineering IWM, RWTH Aachen University]

One of the project goals is to create cutting tools with integrated complex cooling geometries in order to ensure longer tool life. That’s why the Aachen researchers are looking into Laser Powder Bed Fusion (LPBF) 3D printing for WC-Co cutting tool fabrication, which offers near-net-shape production for generation of cooling structures within these tools, and far more design freedom. This technology requires users to carefully choose their process and material parameters in order to create components with strength that’s comparable to what could be achieved with conventional manufacturing methods.

For the past few years, Fraunhofer ILT scientists have been researching a major problem in the LPBF process – temperature distribution in the part. Conventional systems slow down the cooling process with a heated base plate, but with LPBF, the metal powder is melted where the laser touches it and cools down quickly, which can cause cracks and tension.

Fraunhofer ILT has been working with adphos Innovative Technologies GmbH on this issue, and together the two created a system which uses a near-infrared (NIR) emitter to heat the component from above to over 800°C. This system is what Fraunhofer ILT and its fellow Aachen researchers are using to process tungsten carbide-cobalt material for cutting tools in the “AM of WC-Co” project.

Under the scope of the project, the researchers are investigating the process route all the way from powder formation and 3D printing to post-processing and testing the components. Together, they will qualify the materials and processes that will replace complex sintering processes in fabricating these cutting tools.

Preheating the machining plane with the NIR module significantly reduces stresses in the laser-manufactured component. [Image: Fraunhofer ILT]

3D printed WC-Co cutting tools will have a hardness comparable to those made with conventional manufacturing methods, but because of the cooling structures that the LPBF process can be used to create, they will have a longer service life. Additionally, the NIR emitter system developed by Fraunhofer ILT and adphos can lay the groundwork for processing refractory alloy systems in the future.

At formnext 2019, in Frankfurt from November 19-22, you can stop by the Fraunhofer Additive Manufacturing Alliance booth D51 in Hall 11 to learn more about the collaborative “AM of Wc-CO” project.

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[Source: Fraunhofer ILT]

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Aconity3D to Set Up North American Base of Operations for 3D Printing at UTEP

Bottom, L-R: Diana Natalicio, UTEP President; Yves Hagedorn, Aconity3D, managing director; Florian Sondermann, AconityUS, managing director. Top, L-R: Ryan Wicker, PhD, Keck Center director; Zia Uddin, student researcher; Alfonso Fernandez, powder bed manager; Francisco Medina, director of technology and engagement; Mireya Flores, Keck Center manager; Philip Morton, applications manager. [Image: UTEP Communications]

The University of Texas at El Paso (UTEP) has long been a 3D printing advocate, and a lot of this important work takes place at the university’s W.M. Keck Center for 3D Innovation, which is also the first satellite center for America Makes. Now, UTEP has made an agreement with Germany-based Aconity3D GmbH, which develops laser powder bed fusion 3D printers, to be its base of operations in North America.

“We are pleased to establish a relationship with UTEP. This is an excellent example of how research universities can partner with private industry to advance the educational opportunities afforded to students and also attract economic development to the region,” said Yves Hagedorn, PhD, the Managing Director of Aconity3D. “We are confident that the combined expertise of the Keck Center and Aconity3D will yield innovative approaches to 3D printing and offer world-class research opportunities for students.”

Aconity3D was founded in 2014 as a small startup, though it now boasts over 50 employees, and makes 3D printers capable of manufacturing complex metal parts for medical implants, airplanes, and cars, among others. It was eager to set up camp at UTEP due to the Keck Center’s expertise and prominence in the industry, as well as its commitment to increase economic development.

“This exciting collaboration is very well aligned with UTEP’s access and excellence mission. UTEP is committed to providing our students with exceptional educational opportunities, many of which are advanced through the ground-breaking research underway on our campus,” said UTEP President Diana Natalicio. “This agreement with Aconity3D will enhance UTEP’s research environment, broaden the range of experiences available to our students in the Keck Center for 3D Innovation, and attract new business development that will enable UTEP graduates to remain in this region to pursue their career goals.”

This agreement will not only give Aconity3D a home in the US, but it will also attract high-end jobs for the community’s engineering students, increase UTEP’s production and service operations, and advance 3D printing through important research investigations with government agencies and industry.

“The Keck Center is a natural fit for Aconity3D as it is a recognized leader in additive manufacturing. This collaboration will enhance our technical knowledge base and expand our expertise,” said Theresa A. Maldonado, PhD, the dean of UTEP’s College of Engineering. “We can also work collaboratively toward our model to incubate startups and provide them a pool of highly qualified graduates.”

The company’s 3D printers have an open architecture system, which is different from most commercial approaches in that users can modify the parameters themselves in order to find the optimal way to 3D print a customer’s specified material. The equipment is great for research, as one needs plenty of knowledge about the technology in order to operate the 3D printers. This helps feed Aconity3D’s corporate philosophy of locating near high-tech research organizations – for instance, its German headquarters are near the Fraunhofer Institute for Laser Technology (Fraunhofer ILT). Aconity3D’s model of supporting the institute’s interns and students will continue at UTEP.

Aconity3D will begin its North American operations with only a CEO, but plans to hire up to three employees within a year. The hiring process will focus first on Keck Center graduates who have experience working with the company’s technology, as one of Aconity3D’s laser powder bed machines is already housed there.

“We have long worked on leveraging our expertise in 3D printing to build a new economy in El Paso around additive manufacturing. Our partnership with Aconity3D is a major milestone in that direction and is validation of all of our combined efforts,” said Ryan Wicker, PhD, the founder of the Keck Center. “The only way a company like Aconity3D would decide to come here is because of our technical strength in additive manufacturing, access to our graduating talent to meet their workforce needs, and the tremendous opportunities available for commercial success through collaborations with UTEP. We can apply this economic development model to build other businesses around their technologies, recruit other 3D printing businesses to our region and create new businesses from our own 3D printing technologies coming out of UTEP. As a research university, UTEP must be – and is excited to be – fully engaged in stimulating economic development for the benefit of our region.”

The long-term goal of this agreement is to set up a technical center and research space in the Keck Center, which will work with Aconity3D’s German headquarters to sell and service its 3D printers in North America. Its US base of operations will be located at UTEP’s University Towers Building.

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