Mahemaa Rajasekaran, R&D Engineer, EOS North America03.10.23
Inflation and supply chain snarls have left medical device makers grasping for solutions, as specialized plastics, metals, and resins needed to make devices are lacking in supply. According to purchasing and consulting organization Premier, the number of medical items in shortage is around five times higher than pre-pandemic levels.1 A partial solution for these shortages is additive manufacturing (AM)—more commonly called 3D printing—which can deliver on-demand, cost-effective, locally produced applications that can be “one of many” (mass production) or “one of one” (mass customization).
Set to grow to more than $50 billion by 2030,2 3D-printed parts are a convenient and scalable method for manufacturers to build orthopedic implants on an ad hoc basis from digital models. From spinal structures, glenoid replacements, hip implants, implants for oral and maxillofacial surgery, and more, AM combats the fragmented supply chain and reverses outsourcing mistakes that are now negatively impacting U.S.-based healthcare organizations.
Since about 2010, most orthopedic companies have been leveraging AM, especially laser powder bed fusion (LPBF). The push into AM was primarily driven by the need to get into new technological breakthroughs that simplify complex medical processes such as osseointegration as early as possible, increasing the probability of patient survival and comfort. Traditional manufacturing methods also often required the production of large quantities of a single design, leading to a one-size-fits-all approach. Similar to how there are standardized shoe or clothing sizes, patients sometimes couldn't find an exact fit and were subject to painful bone-altering procedures to fit the standardization.
However, at the time, new AM technology allowed for the creation of customized medical devices tailored to the specific needs of each patient based on anatomical data like our female stroke patient. This resulted in a better fit and increased comfort for the patient, which speeds up the healing process and gives people a better post-op quality of life.
Additionally, AM technology’s potential aimed to improve the performance of orthopedic devices by creating complex internal structures and shapes that may not be possible with traditional manufacturing methods. The ideal result would be medical devices that are stronger, lighter, and more durable.
The promise of orthopedic AM breakthroughs was that the technology could cut the cost and production of medically compatible materials by an exponential amount. What was originally four months of lead time would be cut to somewhere around a month for products with complex designs.
Traditionally, organizations would have to order castings that would then go to a different foundry and different third-party vendors to complete individual implants. Depending on the product, additional steps and manufacturing tasks would need to be taken based on factors like relative density and compression strength depending on the product.
The convenience of having a machine available to print patient-specific, single-use parts like hip shelves or small spinal cage parts right away was too good to ignore. With additive, just being able to model bone structures with computer-aided design files was a huge promise that medical industry players wanted to tap into once the technology became a manufacturing reality.
The next step would be to allow for the rapid prototyping and testing of new designs, potentially leading to shorter development times and a faster time-to-market for new products. This resulted in cost savings for manufacturers and an increased ability to bring new, innovative products to market faster than ever before. Enabling the production of more affordable medical devices eliminates the need for many of the complex and costly manufacturing steps required for traditional methods, such as tooling and machining. The significant cost savings could then be passed on to patients.
The ideal scenario for the technology is and will always remain the ability to treat trauma patients as soon as possible by bringing the supply chain closer to hospitals and other medical facilities. Yet, with orthopedic implants, unreliable supply chains potentially cause weeks of product backlogs and availability delays, increasing prices and putting patients in harm’s way due to the inability to get the life-saving items they need in time. Immediately available localized manufacturing would reduce reliance on global supply chains and save lives.
The goal across the orthopedic industry is to be able to replicate custom medical devices with low to immediate cycle time, especially for complicated medical interventions. If it’s a major additive device or item for a patient, doctors will hopefully cut down on the wait time from more than a month or so to be able to realistically produce a custom 3D-printed bone replacement in as little as three weeks. But, there are complications to this reality.
Any company launching its initial product in a certain material first has to go through the testing and approval cycle with stringent installation qualification, operational qualification, and performance qualifications. In this case, the entire shift in technology hinges on powder.
LPBF uses powdered material, then prints items on a plate using high temperatures to melt away that powder to create the final item. In a conventional model of components for hip implants, for example, liquid metal is poured into a mold and fuses to create the item. When it comes out of the mold, the liquid cleanly solidifies because the process is done above the melting point.
A major hurdle for the future of AM in the orthopedic industry is overcoming the risk of powder entrapment in a finished item or within components. It makes obvious sense; doctors don't want to endanger their patients and patients don't want loose powder floating through their bodies. So, there is a need to rethink and revamp cleaning validation processes to ensure safety and replication. For example, while additive has opened up opportunities for new materials, there are biocompatibility studies needed for FDA approval, which are costly and can take a year or longer to play out.
References
Mahemaa Rajasekaran, metals R&D engineer for EOS North America, specializes in metal material and application development, AM design implementation for customers, and customer success throughout the additive minds project lifetime. She previously was an additive manufacturing engineer for Howco Group and a product development engineer, specializing in additive manufacturing at MicroPort Orthopedics Inc. Rajasekaran also held the position of materials engineer with Materials Resources LLC, bringing years of AM and metal material experience to her projects at EOS North America. Rajasekaran holds a bachelor of technology in BTech, metallurgical and materials engineering from the National Institute of Technology, Tiruchirappalli and a master of science in materials science engineering from Carnegie Mellon University.
Set to grow to more than $50 billion by 2030,2 3D-printed parts are a convenient and scalable method for manufacturers to build orthopedic implants on an ad hoc basis from digital models. From spinal structures, glenoid replacements, hip implants, implants for oral and maxillofacial surgery, and more, AM combats the fragmented supply chain and reverses outsourcing mistakes that are now negatively impacting U.S.-based healthcare organizations.
Making Innovative Medical Technology a Reality
A female stroke patient with damage to her skull and brain was required to undergo complex surgery to repair the affected area. As a result of the stroke, she had a large defect on the left side of her skull, which needed to be filled to protect her brain and restore her cranial shape. Traditional methods of reconstruction simply could not work—it was too costly, and the implant would have arrived months after the patient needed it. By leveraging 3D printing, an additively manufactured implant was created, and her skull was restored to its natural shape, allowing her to recover from her stroke and return to her normal life.Since about 2010, most orthopedic companies have been leveraging AM, especially laser powder bed fusion (LPBF). The push into AM was primarily driven by the need to get into new technological breakthroughs that simplify complex medical processes such as osseointegration as early as possible, increasing the probability of patient survival and comfort. Traditional manufacturing methods also often required the production of large quantities of a single design, leading to a one-size-fits-all approach. Similar to how there are standardized shoe or clothing sizes, patients sometimes couldn't find an exact fit and were subject to painful bone-altering procedures to fit the standardization.
However, at the time, new AM technology allowed for the creation of customized medical devices tailored to the specific needs of each patient based on anatomical data like our female stroke patient. This resulted in a better fit and increased comfort for the patient, which speeds up the healing process and gives people a better post-op quality of life.
Additionally, AM technology’s potential aimed to improve the performance of orthopedic devices by creating complex internal structures and shapes that may not be possible with traditional manufacturing methods. The ideal result would be medical devices that are stronger, lighter, and more durable.
The promise of orthopedic AM breakthroughs was that the technology could cut the cost and production of medically compatible materials by an exponential amount. What was originally four months of lead time would be cut to somewhere around a month for products with complex designs.
Traditionally, organizations would have to order castings that would then go to a different foundry and different third-party vendors to complete individual implants. Depending on the product, additional steps and manufacturing tasks would need to be taken based on factors like relative density and compression strength depending on the product.
The convenience of having a machine available to print patient-specific, single-use parts like hip shelves or small spinal cage parts right away was too good to ignore. With additive, just being able to model bone structures with computer-aided design files was a huge promise that medical industry players wanted to tap into once the technology became a manufacturing reality.
The next step would be to allow for the rapid prototyping and testing of new designs, potentially leading to shorter development times and a faster time-to-market for new products. This resulted in cost savings for manufacturers and an increased ability to bring new, innovative products to market faster than ever before. Enabling the production of more affordable medical devices eliminates the need for many of the complex and costly manufacturing steps required for traditional methods, such as tooling and machining. The significant cost savings could then be passed on to patients.
The ideal scenario for the technology is and will always remain the ability to treat trauma patients as soon as possible by bringing the supply chain closer to hospitals and other medical facilities. Yet, with orthopedic implants, unreliable supply chains potentially cause weeks of product backlogs and availability delays, increasing prices and putting patients in harm’s way due to the inability to get the life-saving items they need in time. Immediately available localized manufacturing would reduce reliance on global supply chains and save lives.
The goal across the orthopedic industry is to be able to replicate custom medical devices with low to immediate cycle time, especially for complicated medical interventions. If it’s a major additive device or item for a patient, doctors will hopefully cut down on the wait time from more than a month or so to be able to realistically produce a custom 3D-printed bone replacement in as little as three weeks. But, there are complications to this reality.
The Reality of Innovative Development
Gradually, the initial activation energy coming off the first AM devices that achieved FDA approval took time because engineers and the industry did not know what standards to test. The FDA generally requires new technology to test for the worst-case scenario and work backward. The primary challenge with this technology was to be strong enough to surpass the strict standards associated with medical applications and work well over time without having to change significant details in the structure of the medical device being printed.Any company launching its initial product in a certain material first has to go through the testing and approval cycle with stringent installation qualification, operational qualification, and performance qualifications. In this case, the entire shift in technology hinges on powder.
LPBF uses powdered material, then prints items on a plate using high temperatures to melt away that powder to create the final item. In a conventional model of components for hip implants, for example, liquid metal is poured into a mold and fuses to create the item. When it comes out of the mold, the liquid cleanly solidifies because the process is done above the melting point.
A major hurdle for the future of AM in the orthopedic industry is overcoming the risk of powder entrapment in a finished item or within components. It makes obvious sense; doctors don't want to endanger their patients and patients don't want loose powder floating through their bodies. So, there is a need to rethink and revamp cleaning validation processes to ensure safety and replication. For example, while additive has opened up opportunities for new materials, there are biocompatibility studies needed for FDA approval, which are costly and can take a year or longer to play out.
Conclusion
Overall, the impact of 3D printing on the orthopedic industry has the potential to be significant. Customization, improved performance, and cost savings are all potential benefits of additive manufacturing for the production of medical devices in the field of orthopedics. As the technology continues to advance and become more widespread, we will likely see increasing adoption of 3D printing in the production of orthopedic medical devices.References
Mahemaa Rajasekaran, metals R&D engineer for EOS North America, specializes in metal material and application development, AM design implementation for customers, and customer success throughout the additive minds project lifetime. She previously was an additive manufacturing engineer for Howco Group and a product development engineer, specializing in additive manufacturing at MicroPort Orthopedics Inc. Rajasekaran also held the position of materials engineer with Materials Resources LLC, bringing years of AM and metal material experience to her projects at EOS North America. Rajasekaran holds a bachelor of technology in BTech, metallurgical and materials engineering from the National Institute of Technology, Tiruchirappalli and a master of science in materials science engineering from Carnegie Mellon University.
