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Giving surgeons the ability to treat trauma patients with solutions that are designed specifically for their injury or bone reconstruction needs is closer to becoming a reality than ever before thanks to continuing advances in 3D printing and artificial intelligence (AI).
Nathan Evans, M.D., Senior Vice President of Product Development at restor3D, said the company’s additively manufactured solutions allow surgeons to print personalized implants modeled off CT scans that replace damaged bone in patients who suffer traumatic injuries. “There was no solution like this just a handful of years ago,” he added.
Although the widespread availability of on-demand trauma implants won’t be possible until significant changes take place within healthcare settings and 3D-printing technology itself, encouraging advancements are underway.
“The core belief of our company is that every patient deserves personalized care,” Dr. Evans said. “The rise of additive manufacturing and AI development has opened up a new frontier for making on-demand devices for individual patients.”
Printing at the Point of Care
Significant advancements in 3D printing capabilities include the ability to produce scaffolding that acts as a bone substitute, according to Dr. Evans. He pointed out that restor3d manufactures an array of orthopedic implants that can be used in trauma surgeries. The company prints its own devices using biometric data derived from its internal research and collaborations with Duke University and other institutions.
Trauma is unique compared to other orthopedic specialties because of the urgency involved and the frequent need to treat patients immediately, Dr. Evans noted. He acknowledged that printing personalized implants hours after trauma injuries occur is not yet possible with restor3d’s technology, but the company can provide ready-made implants in a matter of weeks instead of months.
“The ability to 3D-print on-demand implants for trauma use will increase as digital workflows, auto segmentation and AI-driven designs improve,” Dr. Evans said. “These advancements will shorten lead times and open up new possibilities for surgeons to treat increasing numbers of patients in a timelier manner.”
The practicality of producing 3D-printed implants on an as-needed basis is getting closer to reality. Clinicians at two Switzerland hospitals used 3D Systems’ point-of-care additive manufacturing technology to create a PEEK patient-specific cranial implant and patient-specific implants for use after decompressive craniectomy.
“We are proud to be at the forefront of this medical revolution, leveraging our expertise in 3D printing to benefit patient care,” said Stefan Leonhardt, Director of Medical Devices at 3D Systems. “Our collaboration with hospitals in Europe demonstrates the potential of 3D printing to transform healthcare, and we are excited to continue advancing this technology to address a broader range of medical needs.”
The progress made by 3D Systems is promising, but Dr. Evans predicts that the industry is about a decade away from the widespread printing of patient-specific trauma implants at the point of care. More R&D work is needed, and the digital front-end production of 3D printing processes needs to be automated so that it contains very few human touchpoints, he said.
Current processes used for translating a CT scan into a 3D-printed implant require a great deal of engineering work, Dr. Evans explained.
“Even when automated workflows exist on the digital side, engineer verification is necessary. FDA requires human verification of the processes,” he added. “Additive manufacturing companies in the trauma space must show FDA that a completely automated digital workflow with no human touchpoint is safe and effective, and that it can be completely validated.”
Multi-laser direct metal printing is speeding the production of orthopedic devices and will continue to unlock opportunities in trauma care, according to Dr. Evans. “But printed parts need to be heat-treated, machined polished and cleaned and sterilized. Hospitals aren’t currently set up to complete many of those steps,” he said. “A lot of advancements need to happen on the post-processing side before point-of-use printing becomes commonplace.”
Modeling Improved Outcomes
Orthopedic surgeons who treat trauma patients with personalized 3D-printed implants need access to accurate images of anatomy. That’s just one complex step out of many that are necessary to provide quicker and better treatment options.
Software company Synopsys develops image segmentation and model generation technologies for converting CT scans into 3D models of patient anatomy. Simpleware, the company’s 3D modeling platform, is used for a variety of clinical applications, including trauma.
Additively manufactured patient-specific medical devices make up a fraction of the trauma market due to current 3D printing limitations, according to Kerim Genc, Ph.D., Product Manager at Synopsys. “The more you can automate the processes to make them more scalable, the better,” he said.
Companies that want to produce patient-specific implants must be able to quickly convert image data from patients into 3D models. “We use AI-driven tools to build customized single-click solutions for our customers,” Dr. Genc said.
Synopsys and other companies like it are working to streamline image-to-model technologies in trauma care. “We’re seeing more traction from orthopedic companies that need help with producing personalized trauma implants because their focus is on medical device design, not software development,” he said. “We’re very focused on that area to help them build personalized patient care solutions.”
Dr. Genc highlighted successes on this front, but he also acknowledged challenges. “The biggest current bottleneck is the time it takes to engineer these designs,” he said. “We need to get it to the point where it can be done quickly and efficiently. The major need is improving engineering workflows and automating them as much as possible.”
Converting CT images into 3D models that are used to produce medical devices is only part of Simpleware’s application in trauma care. The software is also used on the R&D side for computer simulations that identify and minimize potential risks throughout a product’s lifecycle. Simpleware converts CT images into 3D models that run simulations during which mechanical properties are tested virtually before being validated physically.
The Synopsys team has collaborated with surgeon researchers at the Royal National Orthopedics Hospital in London, Yale University and Cleveland Clinic to improve workflows and refine their 3D modeling technology.
“The researchers we work with are constantly in the O.R. and developing complex personalized hip implants for patients, some of whom have lost half of their pelvis,” he said. “These researchers are pushing the envelope of what’s possible in trauma care and urging medical device companies to provide better solutions for patients.”
Communication among clinicians, researchers and medical device companies is the key to encouraging innovation, according to Dr. Genc. He said that product engineers must ensure workflows are accurate and done in short enough timelines to benefit trauma patients.
Medical device companies tend to work in isolation, which makes collaboration and communication among researchers and companies like Synopsys especially important, Dr. Genc noted. “We work with surgeons who provide us with a great deal of help and useful information,” he said. “In the end, they just want better tools and better clinical outcomes for patients.”
Dr. Kell Gall believes the pieces are in place to achieve mass scalability in 3D printing. Photo credit: Duke School of Engineering
Four Keys to Scaling Personalized Implant Production
Producing high volumes of 3D-printed personalized orthopedic implants demands tapping into the capabilities of advanced technologies, according to Ken Gall, Ph.D., Co-founder of restor3D.
Dr. Gall views patient care in orthopedics as a range, with revisions and intricate cases on one end and anatomical primary reconstructions on the other. “A continuum of personalized options spans the entire spectrum, and we firmly believe the necessary tools are already in place to achieve mass scalability,” he said.
These four factors as keys to scaling the production of personalized 3D-printed implants, according to Dr. Gall.
- Internal manufacturing. This is crucial, especially with the use of quad lasers for faster build plate creation. Performing heat treatments and other post-processing steps in-house helps to avoid delays in personalized product delivery.
- Employing the Right Technology. Unlike many companies that produce trust structures, which are difficult to make in various thicknesses and don’t print well if orientations are changed on the build plate, restor3D focuses on use of triple periodic minimal surfaces for scalability, easy printing and versatile thickness of porosity. “This allows engineers to make modifications without worrying about alignment issues,” Dr. Gall said. “You cannot scale without a true digital material.”
- Digital Design Automation. Dr. Gall said restor3D uses AI-based segmentation and automated design processes, which significantly reduce the time to generate implant designs. “This not only improves efficiency, but also facilitates quick design iterations based on surgeon preference,” he said.
- Digital Health Integration. restor3D developed an app to enhance the company’s communication with surgeon customers, who can schedule product design calls and approve designs with ease.
Maximizing the Fit and Function
Optimizing the speed and delivery of 3D-printed implants represents a significant opportunity in trauma, according to Sean P. Curry, Chief Commercial Officer at Onkos Surgical, a company that develops innovative treatments for complex orthopedic conditions related to bone loss within the space of musculoskeletal oncology and revision procedures.
“The industry is doing impressive work collaborating with leading surgeons, institutions and regulatory agencies to expand indications, applicability and accessibility of additive manufacturing,” he said.
Onkos Surgical’s Precision Orthpaedics platform features a wide array of products, from navigation and workflow tools to 3D implant modeling, design and printing capabilities. According to Curry, the platform provides insights into patient-specific clinical challenges and helps surgeons perform more precise bone reconstructions.
The company’s My3D Personalized Pelvic Reconstruction system, which is part of the Precision Orthopaedics platform, is the first of its kind to include 3D-printed implants, instruments, models and an advanced planning service for the treatment of deformity, trauma, disease and revisions when other treatments have failed. My3D, which is powered by 3D Systems, includes patient-specific implants for acetabular reconstruction, which is often associated with pelvis instability and a high degree of bone loss and cup migration.
My3D’s planning service includes access to the company’s Onkos uDesign Digital Ecosystem. Surgeons can send patients’ CT scans through a secure cloud-based portal, and Onkos Surgical renders the anatomical images into 3D models. Surgeons use the models to collaborate with 3D Systems’ biomedical engineers on virtual surgical planning sessions to discuss optimal ways to resect diseased bone or decide on the implant size that would precisely match the patient’s unique anatomy.
Curry credited improved imaging modalities, ease of data transfers and 3D modeling for accelerating innovation and the speed of delivery of 3D-printed trauma implants. He highlighted Onkos Surgical’s personalized implants that are designed for complex acetabular reconstruction. “Bone loss in the acetabulum can be attributed to post-traumatic complications and fracture,” he said. “Our suite of planning capabilities helps surgeons understand the severity of bone loss and provide a simple, precise solution tailored to the specific defect.”
Curry mentioned other benefits of the My3D platform for trauma surgeons and their patients, including porous construction for improved bone conformity, advanced heat mapping tools to aid the planning and design phase, and optimal positioning and screw placement trajectories for cup and flange fixation.
“The alternative to our approach often relies on modular, off-the-shelf components –– cups, cages, augments, screws and cement — that are fit together in the O.R.,” he said. “Constructing these components during acute surgery introduces additional time and complexity to the procedure.”
Advanced planning tools like My3D help surgeons maximize the fit and fill of personalized implants, Curry noted. “We optimize these attributes in every patient design,” he said. “Developing devices for hundreds of these cases over the years has provided our team with a deep library of component designs and options to evaluate during the planning process.”
Onkos Medical’s dedicated Patient Solutions Engineer helps the company deliver personalized implants in two to six weeks. “We believe that cancer patients and individuals with complex orthopedic conditions that require surgery deserve solutions designed specifically for them,” Curry said.
Orthopedic companies are buying into this wave of innovation in personalized trauma care. It’s an exciting movement worth monitoring that dovetails with advancements in additive manufacturing that will ultimately benefit what matters most — patient outcomes.
