The healthcare industry has long been at the forefront of additive manufacturing (AM), driving new technologies and efficiencies. To help sort out the latest advances and challenges, Manufacturing Engineering (ME) spoke with three members of SME’s Healthcare AM Technical Advisory Team:
ME: How has AM advanced in recent years?
Jakus: Technologically, the major advancement across medical applications has been in the development of new materials. Whether intended for dental applications, models or surgical guides, permanent implants or regenerative biomaterials, these new materials have permitted medical AM to begin to achieve its full potential. There have been continuing and progressive improvements in AM hardware, software and techniques, but it has been the development of these new materials that has allowed AM medical products to be manufactured better, more consistently and, very importantly, address new medical indications and open new markets not accessible by traditionally manufactured products.
Weber: I feel the most notable advancement is the integration of artificial intelligence (AI) in the process of auto-segmenting anatomy. This not only accelerates the segmentation process but also enhances precision, reducing the margin of error associated with manual methods.
Alexander: The range of printable materials has grown, with new high-performance metal alloys, polymers with biocompatible properties and, even, concrete. This allows for growing applications for AM in fields like aerospace, medicine and construction. New and interesting hybrid tech like multi-jet fusion enable the creation of objects with different material properties within the same build or part, leading to more complex and functional devices. There’s also a growing focus on sustainable materials such as recycled plastics to promote greener printing practices.
Additionally, newer AM machines offer faster print speeds, larger build volumes and improved resolution, making production more efficient and cost-effective. One thing I’m particularly excited about are machines that combine AM with other processes like machining or subtractive manufacturing, and the industry is seeing more of that. Patient-matched metal implant manufacturing can greatly benefit from such tech. Advancements in automation and support generation/slicing software are making AM more user friendly, as well.
ME: What are some of the most common and beneficial applications?
Weber: The applications of patient specific pre-surgical anatomic models and surgical guides. These innovative applications contribute to improved diagnosis, treatment planning and surgical outcomes, ultimately enhancing patient care and safety.
Alexander: In medicine, some of the most common and beneficial applications of AM are in medical device prototyping/fabrication and patient-matched devices. AM is increasingly used to create anatomic models and guides, prosthetics and implants, and bioprinting can produce tissues like vasculature or organs for research. Many AM materials have the capacity to be biocompatible when designed, printed, post-processed, cleaned and sterilized with the proper expertise in standards, regulations, design and end-use application. Mayo Clinic is engaging in all of this work across the enterprise in a variety of departments.
Jakus: There is a steadily increasing use of patient-matched implants comprised of traditionally established polymeric and metallic materials. However, perhaps the most beneficial use of medical AM, a use that is only beginning to be tapped commercially, is the use of AM technologies in combination with newly developed biomaterials and engineered cells to create tissue therapeutic technologies to treat a wide range of debilitating ailments. AM is specifically suited for the creation of complex structures that the body and transplanted cells can respond to. In combination with directed materials engineering efforts and designed microstructures and biologically relevant compositions, an entirely new wave of medical products can be achieved. CMFlex (a 3D-printed tissue regenerative device) is the first product of its kind to hit the market, but makes use of the structural intricacies enabled by AM in combination with advanced biomaterial design.
ME: What are the biggest challenges to more widespread use?
Alexander: The greatest challenges to the adoption of AM in medicine continue to be cost and labor. The capital required to invest in AM technology continues to frustrate many enthusiastic designers and engineers as budgets are cut. AM equipment, especially multi-material printers, can be expensive when working with a modest annual budget (or no promised budget at all). Like anything else, medical-grade materials for AM often have higher costs. Depending on the application, post-processing equipment and consumables, and cleaning and sterilization add to the overall cost. Smaller hospitals and clinics may struggle to justify the initial investment because it’s not just equipment, it’s people. It’s difficult to find specialized AM expertise, however this problem is improving steadily.
In many cases, if hospital leadership does decide to invest in AM, they lean on a single employee to get the facility/lab established and operational. My industry colleagues and I have had dozens of calls and meetings with people who are in just such a position, and we’ve tried to help them to choose technology and begin to establish appropriate quality management systems. Finding the right personnel, and then training said people, adds to the labor burden. Even once they are fully functional, processes need to be developed with the greater hospital ecosystem in mind, and staff will need to understand the overall technological and operational flow of the practice of care to integrate AM seamlessly into existing medical workflows.
Weber: To fully harness the potential of AM technologies, there is a need for a pool of competent professionals who are well versed in the intricacies of working with additive manufacturing in the healthcare sector. This includes skills in segmenting and designing 3D models, understanding material properties and navigating the technical aspects of 3D printing. Additionally, there is a crucial need for clinicians to recognize the value that additive manufacturing brings to improving healthcare outcomes. Bridging the gap between technological capabilities and clinical applications requires a concerted effort to raise awareness and provide education on the benefits of AM in various healthcare settings.
To address these challenges, the 3D Printing and Training Center at Clarkson College is taking a proactive approach by integrating additive manufacturing early in the curriculum across healthcare professions. By exposing students to AM technologies during their education, the center aims to produce a future workforce that is not only technically proficient but also deeply understands the value proposition of AM in enhancing patient care.
Jakus: Medical AM is being increasingly utilized. Traditional challenges such as regulatory clearances and approvals, manufacturing at scale and implementation of quality systems are being progressively addressed as well. The biggest upcoming challenge that must be overcome to unlock medical AM’s true potential is the integration of organizations, skills, people and efforts that span medical device manufacturing, pharmaceuticals, cellular therapeutics and tissue engineering—and all the newly defined and yet-to be-defined regulatory requirements that come out of the resulting technology integration and therapeutic products.
This is a major challenge, as it requires traditionally separated industries to work together, new lines of creative thinking and training, as well as significant efforts from regulatory bodies and standards bodies to create a process that does not inhibit the progression of new technologies that are distinct from anything we’ve seen before, but also allows them to be safely implemented.
ME: What would you like seen done in terms of testing and regulations?
Weber: It is imperative that everyone involved in AM for healthcare adheres to the regulations set forth by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the International Organization for Standardization (ISO). Following FDA and ISO regulations ensures that patient safety is prioritized, and products meet the necessary quality and safety standards for medical applications.
By emphasizing these initiatives and ensuring compliance with FDA and ISO regulations, the healthcare sector can establish a robust framework that supports the responsible and safe integration of AM technologies. This approach not only ensures patient safety but also fosters innovation and confidence in the application of AM within the healthcare industry.
ME: What excites you most about future applications?
Jakus: Oh, so much. I’m excited to see the further integration of AM with biomaterials design, pharmaceuticals development, and gene and cellular design. Bringing these fields together will yield commercial products that are not only able to restore and regenerate damaged and missing tissues, but also be used to treat systemic terminal conditions, such as diabetes, heart disease and cancers, as well as gene therapies that can be used to resolve hereditary conditions such as sickle cell anemia.
Alexander: In terms of future applications, I’m most excited about automation, bioprinting and patient-matched devices. AM of patient-matched devices has been a reality for decades, and I look forward to seeing where medical device companies and hospital-based manufacturing centers can take it.
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