The field of health care is often considered to be one of the most dynamic. The speed at which innovation is occurring—from the way surgeries are performed, to the development of new therapies—is ever more rapid. Health care providers are relying more on innovative technologies to improve patient care. With the advent of the global pandemic, timely delivery of health care was put to the test, and additive manufacturing demonstrated its power.
As the number of COVID-19 cases grew, health care workers needed more personal protective equipment (PPE) to treat patients. Additionally, the need for ventilators grew exponentially and production lines came to a halt as raw materials were unavailable. It was apparent how the pandemic disrupted supply chains and additive manufacturing (AM) was highlighted for its ability to rapidly adapt with new designs to produce the necessary items. When it came to manufacturing of nasopharyngeal swabs, for example, AM enabled rapid innovation via multiple design and material iterations to launch a product that could be mass-produced cost-effectively. As a result, several contract manufacturers were able to adapt their shop floors overnight to produce these swabs. Similarly, multiple hospitals worldwide were able to bring the technology on-site to produce swabs and achieve greater control of their supply chain in a pandemic challenged world.
Yet with all the advances in health care, findings by the World Health Organization suggest that globally, surgery still results in high rates of illness, disease, and death. Unsafe surgical care procedures cause complications in up to 25 percent of patients. Almost seven million surgical patients suffer significant complications, one million of whom die during or immediately following surgery. Long before the pandemic, additive manufacturing was recognized for its ability to enable the creation of personalized surgical plans and tools, thus helping improve patient outcomes.
Virtual surgical planning combines expertise in medical imaging, surgical simulation, and 3D printing to enable personalized surgery—allowing surgeons to perform digitally before entering the operating room. Following an online planning session between biomedical engineers and the surgeon, patient-specific models, personalized surgical tools, and instruments are designed and 3D printed for use within the sterile field. As the pandemic brought into focus, any sort of distance between where the models, tools, and instruments are created, and where the surgery is performed has a direct impact on patient treatment. If these capabilities could be located within the healthcare institution—at the point of care—the planning and delivery time could be condensed.
This is already occurring at some of the world’s elite hospitals where clinicians can create customized solutions for patient care by using AM solutions available to them on campus.
Professor Samer Saruji leads the Craniomaxillofacial Surgery unit at Galilee Medical Center in Nahariya, Israel, which includes a 3D printing lab. This is the first—and currently, the only—center in Israel that has an in-house end-to-end surgical planning workflow, in which physicians have the knowhow for using 3D Systems’ surgical planning applications and 3D printing. As Saruji has said, “the surgeon is becoming a designer.”
“We have just started to use this workflow in our daily practice and we already see the great progress in our patient outcome. The errors are dramatically reduced and the surgical ability of the surgeon is constantly improving. In addition, having those capabilities in-house helps us to reduce procedural cost,” said Prof. Saruji.
Another great example of 3D printing at the point of care can be found within the Veterans Health Administration (VHA). Prior to the pandemic, the VHA was already using 3D printing for manufacturing. However, COVID caused the VHA to ramp up its capabilities in order to produce tens of thousands of face shields, face masks, and diagnostic swabs. In November 2020, the VHA announced it had entered into a contract with 3D Systems to take their efforts further by establishing FDA-compliant manufacturing facilities within their hospitals for the production of additively manufactured devices. As a result, the VA network will streamline its supply chain and accelerate innovation to enhance personalized care for their patients—U.S. veterans.
To create patient-specific models and tools, the clinician must first begin with scans of the patient anatomy. Today, FDA-cleared software is available that relies on unique automatic segmentation tools driven by deep learning enabling medical practitioners to quickly create accurate, digital 3D anatomic models from medical imaging data. Some of these software packages also include a volumetric virtual reality solution enabling instant views of patient scans in a 3D environment—facilitating surgical planning and conversations between medical staff and their patients.
The models, in combination with the pre-surgical plan, allows clinicians to also design patient-specific tools and guides to be used during the procedure. This can be accomplished using organic 3D design software that includes advanced design tools for working with complex, organic shapes like patient anatomy. This software—in combination with a haptic device—facilitates user-friendly interaction with the modeling shape to create precise devices. Having a 3D printer at the point of care allows efficient production of tools and models which can be used within the sterile field.
Complex surgical procedures are stressful for patients and their families due, in part, to not having a good understanding of what will occur in the operating room. Employing virtual surgical planning at the point of care arms surgeons with all the tools needed to improve pre-surgical planning with their staff, and thereby execute on the plans more effectively and accurately during the surgery. Moreover, using the 3D models, surgeons can use visual tools to simplify the discussion and take the patient and their family through the steps that will be taken in the operating room—providing necessary information that facilitates a more informed decision process for treatment planning conversations.
Additionally, pre-surgical planning in combination with patient-specific tools and guides allows the surgeon to focus on the precise surgical field, helping to reduce time in the operating room. In clinical applications where 3D Systems’ VSP is used today, the solutions have been shown to improve surgical accuracy and outcomes—saving time in the operating room which benefits the patient, the surgeon, and the hospital. Designing the optimal surgical plan also includes conducting the procedure in a way that is the least invasive as possible, helping to reduce the length of stay, and ultimately overall healthcare costs.
Additive manufacturing continues to accelerate health care innovation, yet at the point of care, I believe the technology is still in its infancy. As the technology becomes more user-friendly for medical professionals, a larger number of hospitals will be able to implement end-to-end solutions for personalized care—making strides in innovation, and enhancing their R&D efforts. This includes hospitals being able to print their own patient-specific implants, surgical guides and instruments to improve surgical outcomes and the patient experience. From here, the scope could expand into additional clinical streams such as instrumentation to support radiotherapies for cancer treatment. Within a strong regulated framework and quality management, there are opportunities for 3D printing applications to produce customized drugs for patient-specific outcomes.
Beyond all of these applications is bioprinting. There is real potential for 3D printing at the point of care to create advanced therapy products through producing bioreactors and tissue constructs. These solutions will be the ultimate in personalized medicine by using patient cells and gene therapies to restore health.
Point of care manufacturing will quickly go beyond improving accuracy and efficiency of surgical procedures. There is tremendous potential for additive manufacturing to shape the future of healthcare by disrupting existing models to provide better quality and less expensive care.
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