Using 3D printing in medicine has a longer history than most people realize. Pioneered in the mid-1980s with the invention of stereolithography by Chuck Hull, the 3D printer has been a tool to help clinicians deliver better care to patients since at least the early 1990s. Today, several medical specialties leverage 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.
One problem anyone can relate to is that one size doesn’t necessarily fit all, especially in medical solutions. Additive manufacturing opens the door to creating unique items designed for a patient that aren’t commercially available. At the Veterans Health Administration (VHA), three hospitals led the way by using AM to create assistive technology devices, custom surgical tools, and jigs and fixtures for critical hospital equipment for which spare parts could not be readily found. These hospitals established the basis for what would become the VHA 3D Printing Network, a group of hospitals united in the common goal of providing veterans uninterrupted, best-in-class care.
The medical specialties that can be transformed with AM include clinical services in radiology, cardiology, orthopedics, oncology, craniomaxillofacial, and dentistry. Therefore, the potential to augment care for a patient within the hospital network is not trivial.
The business case for AM at the point of care (POC) is its ability to swiftly address improving patient care and reducing spending. Manufacturing at the hospital reduces costs through better disease assessment, surgical planning, and improved surgical outcomes. Other impacts include cost avoidance by controlling the supply chain and rapidly pivoting to meet unforeseen demands at the hospital—as demonstrated with the COVID-19 pandemic. Indirect value is added by improving medical education with simulation models for surgical training, complex and rare anatomy samples, and pathologic specimen surrogates. Finally, technology innovation accelerated with AM at the POC also gives value through technology transfer and licensure.
At the VHA, medical manufacturing is embraced from front line staff to leadership as a transformative technology. Initially, the funding for these capabilities came from the VHA Innovations Ecosystem, which enables the discovery of mission-driven healthcare innovation to advance care delivery and service. The capitated reimbursement system within the VHA favors technologies that deliver better quality care, so investment in AM makes sense. Other hospital networks need to consider how such a resource will be reimbursed.
The costs of POC AM can be reduced to the capital needs across hardware, software, and facilities. Then, there are the recurring costs for labor, materials, hardware maintenance, and other consumables. The barriers to entry can be very low with “prosumer” level 3D printers (for entities that both produce and consume a product) and part-time staff attention to part production.
However, complexity grows exponentially as true medical manufacturing capability is established. Safety programs, quality management, regulatory affairs, part sterilization, and formal technical staff training are all necessary. Additionally, 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 address the many needs in medical manufacturing is to consult with vendors that have experience in deploying AM technologies in healthcare. These relationships help the VHA quickly tap expertise that would otherwise take years to develop independently. Access to established additive medical manufacturing facilities and processes helps the VHA understand the needs while also helping address the significant training and know-how gaps.
The VHA recently implemented the Agile Design And Production Transformation (ADAPT) program to respond to COVID-19. Through ADAPT, the VHA rapidly expanded its AM capabilities at three sites: Charleston, N.C.; Richmond, Va.; and Seattle, Wash. VHA ADAPT is actively building infrastructure to meet 21CFR820 requirements. This is needed to ensure the safety and efficacy of 3D printed medical models and devices produced within the VHA. Concurrently, curricula are being built to train existing staff in 3D printing. Establishing a team not housed within a medical specialty has allowed for rapid evolution and the ability to address all clinical needs within the hospital.
Looking ahead, as AM technology improves, becomes less expensive, and is used to address even more clinical needs, the upfront investment into a medical manufacturing establishment will pay dividends for the hospital. The same considerations for quality management, regulatory compliance, and trained staff provide the groundwork for acquiring additional capability when it becomes available.
The future vision for POC medical manufacturing includes printing patient-matched implants where no existing devices are available. Further out, 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 survival of patient cells and tissues. Patient-matched pharmaceutical compounding and customized oral tablet printing at the hospital may allow for rapid responses to patient needs. Finally, advanced therapy medicinal products that leverage 3D printed bioreactors offer the promise of yet another treatment modality for patients that will rely on medical manufacturing competency at the point of care.
The investments required for this transformation are commensurate. Costs associated with establishing these capabilities at the hospital go far beyond the costs of 3D printers and materials. Quality management systems, facility expenses, staff, training, and regulatory compliance are required for a proper medical manufacturing focus for patients where they need it most.
Ultimately, the trend of medical manufacturing enabled by AM solutions at the POC will transform how healthcare is delivered. Improved patient outcomes, reduced surgical error, innovative therapies, and on-demand bedside delivery will drive this transformation.
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