Surgeons at the Sint-MaartensKliniek medical center in the Netherlands opt for a 3D-printed patient-specific hip implant from Materialise in a complicated replacement procedure.
Individuals requiring a new knee, hip, ankle, or jaw may find it unexpected that usual implants typically come in small, medium, and large sizes. Comparable to T-shirts, the sizes small, medium, or large do not fit everyone accurately. In the case of implants, an unfitting match could result in adverse outcomes and additional surgeries. That’s why the need and market for patient-specific, custom-3D-printed implants are on the rise.
“In the recent 24 months, we’ve witnessed a significant increase in the demand for patient-specific implants by medical device companies,” notes Daniel Crawford, the founder of Axial3D, a budding software firm that simplifies the transition from patient scan data to a patient-specific 3D model. “The industry is expanding quite aggressively regarding implants, surgical guides, and other patient-specific devices.”
The University Hospital Southampton employed Axial3D software to generate a 3D model to aid in diagnosing a pediatric heart condition.
Crawford indicates that major medical device manufacturers are viewing personalized products as the upcoming unique aspect in the competitive field of orthopedic implants.
Joint implant manufacturers, such as Stryker, Smith & Nephew, and Zimmer Biomet, are focusing resources on the creation of more individualized care lines.
One significant obstacle until not too long ago was the software portion, which involves converting patient information, like CT scans and MRI imaging, into a precise 3D model for personalized procedure planning, 3D printing of an exact model, or designing an implant for an exact fit.
Transforming data into a 3D digital model previously required 10 days to two weeks. However, platforms by Axial3D and another industry leader, Materialise, have now brought this time down to one day or even less. These companies are set on further streamlining the process with AI to make personalized options more available to more patients.
Crawford of Axial3D highlights that AI and machine learning play a supportive role in creating 3D models rather than solely relied upon without any human supervision. He shares, “Our AI algorithms are trained on five or six years’ worth of ground truth data sets validated by surgeons and radiologists, intending to establish an automated workflow. Yet, there is always room for human intervention, especially for more complex cases.”
Like many other subtle applications of AI, Axial3D utilizes machine learning to eliminate tedious manual processes that still demand the skills of highly trained professionals.
Crawford explains, “Extracting regions of interest from a bunch of CT images may take an engineer three to four hours. However, with machine learning, the algorithms can perform the same task within minutes.”
Axial3D, a start-up, is a medical technology firm in the field of healthcare. They specialize in using 3D printing and AI, particularly in personalized surgical planning.
AI considerably enhances personalization by automating the necessary processes and aiding in clinical decision making, explans Sebastian De Boodt, director of medical 3D software at Materialise. The current market shows the viable impact of AI and automation for individualized applications. However, the use of AI in clinical decision making is a process in development, due to the large amount of data required for effective treatments and outcomes, this data is currently being gathered.
De Boodt further emphasizes that the significant advantage of AI is its ability to free up time for experts and surgeons, enabling them to spend more time with patients rather than staring at screens.
Enhancing quick access to precise patient-specific digital 3D models, results in speedier processing for 3D printed surgical planning models and for designing implants. Moreover, it plays a pivotal role in emerging markets related to implants, like virtual reality surgical software, robotic surgeries, and assorted mixed-reality applications.
Dimension Inx, a start-up, collaborates with medical device companies to 3D print resorbable materials for implants, which could potentially substitute titanium in the future.
Materialise 3D prints patient-matched implants, such as hip and shoulder devices available in Europe, for enhanced surgical results.
In the case of a patient-specific surgical guide or tool, the duration from the digital model to the 3D-printed component can be just a few days. This time includes 3D printing, testing, certification, and sterilization.
Conversely, for patient-matched metal joints and similar metal devices, the timeline is considerably longer.
Currently, large medical device manufacturers need anywhere from three months to 18 months to produce a patient-specific implant. As Amy Alexander, the lead of mechanical development in Mayo Clinic’s Division of Engineering and internal additive manufacturing facility, points out, this is a substantial wait time for a patient in need of an implant, particularly when there are off-the-shelf alternatives that surgeons can utilize.
One of the main objectives for manufacturers in this field is to shorten the time taken from modeling to the final implant.
Alexander points out that there are indeed some companies able to achieve a turnaround of just seven days, but these are not commonplace.
Materialise is one firm that is able to work at this rapid pace, primarily due to their ability to oversee the entire process, from the initial patient data gathering stage right through to the 3D printing. During 2023, Materialise was able to produce in excess of 7,000 patient-specific implants and corresponding surgical guides within the U.S. They also inaugurated a new metal 3D printing facility in Michigan.
Despite these impressive figures, the reality is that demand greatly outweighs supply, a situation that has led to several hospitals, including Walter Reed and the Mayo Clinic, setting up their own bespoke 3D printing labs to create patient-specific items.
“One of the driving factors for Mayo Clinic to produce patient-matched implants in-house is to provide a level of speed that is not being met with third-party suppliers,” says Alexander. “We are essentially becoming a small medical device manufacturer and the goal is to be able to fill those gaps where the commercial entities haven’t been able to, yet.”
Mayo Clinic began 3D printing about 17 years ago focusing on models for surgical planning and has progressed to the point where it 3D prints its own surgical guides in-house, designs implants for fabrication off-site, and soon, will begin 3D printing titanium implants on large industrial metal 3D printers.
“It makes sense for Mayo Clinic to have its own facility because we are a destination medical center where people come to us on their third or fourth try at getting something right,” notes Alexander. “The whole point of having the manufacturer on site, like we do, is to be able to treat these patients very quickly.”
Belgium-based Materialise offers patient-matched implant solutions combining digital planning with 3D printed implants and guides primarily in Europe, but expanding to the U.S.
In addition to the thousands of 3D printed hips, knees, and shoulder implant surgeries a year worldwide, one of the fast-growing application of a patient-matched 3D-printed part is jaw and facial bone implants known as cranial maxillofacial (CMF) implants.
Materialise mentions it experienced significant adoption of its FDA-approved cranial maxillofacial patient-specific implants in the U.S. in 2023 for treating cancer and trauma patients.
“When it comes to patient-specific implants, the cranial maxillofacial area is really the furthest along,” says De Boodt. “CMF determines a person’s appearance, so it has a significant effect on the patient’s life. This is where there’s a strong and clear value of using a personalized device over a standard one.”
Hospitals are beginning to explore the total return on investment in personalized devices to measure the value against the cost.
Patients experience numerous benefits through customized fits. According to Alexander, patient-tailored implants ensure a more reliable osseointegration, whereby the implant and bone fuse efficiently and effectively. This significantly enhances surgical outcomes, cuts down time spent on operation, reduces post-operation hospital stay days, and quickens further surgeries to curb anesthetic duration in patients.
Even though hospitals often face higher upfront costs for patient-tailored implants, they can easily recover the expenses through reduced peripheral expenditures, increased daily patient visits, and reduced subsequent corrective surgeries when customary implants do not fit as required. As Alexander states, through further education on the subject, both hospitals and insurance firms are gradually understanding the overall long-term cost-saving advantages of patient-tailored implants.
Mayo Clinic coordinator for additive manufacturing facilities, Robbie Highet, is seen in action, tidying up an implant test build.
Currently, the broad spectrum of health insurance and reimbursement levels in the U.S can make the choice for patient-specific implants less straightforward.
“One thing I would recommend to patients is self-advocacy,” Alexander explains. “They should ask questions like, what implant size will be used, and how is it confirmed to be the correct size?” It’s important to note that insurance reimbursements are usually based on the procedure rather than the implant type. Nonetheless, “patients must always verify reimbursement possibilities with their healthcare team.”
However, according to Alexander, the reality in America right now is that very few patients have this choice. “The decision to use a patient-matched implant is usually made by the surgeon, not the patient,” she points out. This is because patient-specific implants are still rarely used, and are typically reserved for cases where standard implants are completely unworkable. Each year, the Mayo Clinic conducts a few hundred surgeries involving patient-matched implants.
“While not yet mainstream, the patient-specific implant market is gradually moving towards becoming the standard care for specific applications,” states Crawford. More than 300 hospitals worldwide use Axial3D’s cloud-based service to create thousands of 3D models every month.
“This technology isn’t new,” Crawford adds. “The issue has been its accessibility.” However, as patient-specific 3D modeling software reduces delivery time while adding more automation features, and as manufacturing technologies such as 3D printing become more affordable and accessible, scaling up patient-specific devices becomes significantly easier.
Europe has more readily accepted patient-matched implants as a new gold standard of care, says Alexander. “We are slightly behind because we don’t exactly know how to regulate hospitals that are doing medical manufacturing.” The FDA is expected to issue guidance on 3D printing of implants at the point of care in early 2024.
Although it isn’t necessary for every hospital to have its own lab, says Alexander. “What they need is a robust supply chain in order to meet the needs of every patient requiring a patient-matched implant. For this, I think the future is probably colocation because the proximity between the engineers doing the work and the surgeons telling them what to do is an important piece of it.”
One current example of an orthopedics manufacturer setting up shop at a hospital is LimaCorporate, which established its ProMade Point of Care Center for Complex Orthopedic Solutions at New York City’s Hospital for Special Surgery in 2019. The partnership’s first implant surgery was in 2022.
As more patients learn about patient-specific implants, there will be more demand for it and more hospitals considering it, experts agree.
To increase the usage of bespoke implants, Alexander emphasizes the importance of educating surgeons about this possibility, increasing patient awareness, and requiring medical device companies presently employing this method to simplify and hasten delivery.
“Our ultimate goal as a business is to be at the heart of the patient-centered surgical methodology, wherein custom implants are more widely utilized in several hundred thousand or even millions of surgeries annually,” Crawford shares. “Although the trend has been gradually progressing in that direction, we believe we are now at a significant turning point in the market given our technology and the industry’s perception of patient-focused surgery.”
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