The use of 3D printing in medicine has a longer history than most people realize. Launched in the mid-1980s with the invention of stereolithography by Chuck Hull, the 3D printer has been a tool to help clinicians provide better patient care since at least the early 1990s. Today, several specialties medical professionals are leveraging 3D printing to facilitate clinical decisions and more precise patient treatment. However, implementing additive manufacturing capabilities within a hospital network requires careful consideration of several issues that can make or break success.

AM’s value at the point of service

One issue that everyone can relate to is that one size does not necessarily fit everyone, especially in medical solutions. Additive manufacturing opens the door to the creation of unique items designed for a patient that are not commercially available. At the Veterans Health Administration (VHA), three hospitals have led the way in using AM to create assistive technology devices, custom surgical tools, as well as jigs and accessories for essential hospital equipment for which parts spare could not be easily found. These hospitals laid the foundation for what would become the VHA 3D Printing Network, a group of hospitals united in the common goal of providing veterans with the best, uninterrupted care.

Medical specialties that can be transformed with AD include clinical services in radiology, cardiology, orthopedics, oncology, craniomaxillofacial, and dentistry. Therefore, the potential to increase care for a patient within the hospital network is not negligible.

The business case for point-of-care (POC) PA is its ability to rapidly improve patient care and reduce expenses. Manufacturing in the hospital reduces costs through better disease assessment, surgical planning and better surgical outcomes. Other impacts include cost avoidance by controlling the supply chain and pivoting quickly to meet unforeseen demands in the hospital, as demonstrated by the COVID-19 pandemic. Indirect value is added by improving medical education with simulation models for surgical training, complex and rare anatomy samples, and pathological sample surrogates. Finally, technological innovation accelerated with AM at POC also provides value through technology transfer and licensing.

Considerations for healthcare facilities

At the VHA, medical manufacturing is embraced from frontline staff to leadership as transformative technology. Initially, funding for these capabilities came from the VHA Innovation Ecosystem, which enables the discovery of mission-driven healthcare innovations to advance care delivery and services. The capitation reimbursement system within the VHA favors technologies that provide better quality care, so it makes sense to invest in AM. Other hospital networks must ask how such a resource will be reimbursed.

POC AM costs can be reduced to capital requirements for hardware, software and installations. Then there are the recurring costs for labor, materials, equipment maintenance, and other consumables. Barriers to entry can be very low with “prosumer” level 3D printers (for entities that produce and consume both a product) and part-time staff attentive to parts production.

When implementing point-of-care AM, safety programs, quality management, regulatory affairs, parts sterilization, and formal training of technical personnel are all required. (All images provided by the Veterans Health Administration)

However, the complexity increases exponentially as true medical manufacturing capacity is established. Safety programs, quality management, regulatory affairs, parts sterilization, and formal training of technical personnel are all required. In addition, facility and space requirements become an important consideration. Large platform printers require a large footprint, special power sources, compressed gases, ventilation, and space for post-processing needs. The varied needs can quickly become overwhelming.

One strategy the VHA has used to meet the many needs of medical manufacturing is to consult with vendors experienced in deploying AM technologies in healthcare. These relationships help the VHA quickly harness expertise that would otherwise take years to develop independently. Access to established additive medical manufacturing facilities and processes helps the VHA understand needs while helping to fill critical training and know-how gaps.

Transforming Healthcare

The VHA recently implemented the Agile Design And Production Transformation (ADAPT) program to respond to COVID-19. With ADAPT, the VHA quickly expanded its AM capabilities to three locations: Charleston, North Carolina; Richmond, Virginia; and Seattle, Washington. VHA ADAPT is actively building an infrastructure to meet 21CFR820 requirements. This is necessary to ensure the safety and efficacy of 3D printed medical models and devices produced within the VHA. At the same time, programs are being developed to train existing staff in 3D printing. The establishment of a team that is not part of a medical specialty has allowed rapid development and the ability to meet all clinical needs within the hospital.

As AM technology improves, becomes cheaper, and is used to meet even more clinical needs, the initial investment in a medical manufacturing facility will pay dividends for the hospital. The same considerations of quality management, regulatory compliance and skilled personnel form the foundation for acquiring additional capabilities when they become available.

The global COVID-19 pandemic has provided valuable insight into the value of using AM to address supply chain shortages.

The future vision of POC medical manufacturing includes printing patient-friendly implants where no existing device is available. Further down the line, therapies that use rapidly developing technologies in bioprinting will need to be deployed at or near the point of care due to logistical requirements and the survival of patients’ cells and tissues. Pharmaceutical preparation tailored to the patient and printing of personalized oral tablets in the hospital can enable rapid responses to patient needs. Finally, advanced therapy drugs that exploit 3D printed bioreactors hold the promise of another treatment modality for patients that will build on medical manufacturing competence at the point of care.

The investments required for this transformation are up to the task. The costs associated with bringing these capabilities to the hospital go far beyond the costs of 3D printers and materials. Quality management systems, facility expenses, personnel, training, and regulatory compliance are necessary for proper concentration of medical manufacturing for patients where they need it most.

Ultimately, the trend of medical manufacturing enabled by AM solutions at POC will transform the way healthcare is delivered. Better patient outcomes, reduced surgical errors, innovative therapies and on-demand bedside delivery will drive this transformation.

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