Devarsh Vyas, 3D Systems, and Patricia (Trish) Weber, Clarkson College11.13.23
Hospitals are continuing to embrace the adoption of additive manufacturing (AM) at the point of care (POC). With the increase in demand and use cases of 3D-printed devices, there is also an increasing demand for flexible solutions that can overcome roadblocks to implementing AM at the POC and leverage the full potential of what AM technology has to offer to clinicians and patients. Device manufacturers are devising programs to enable on-site printing of models and guides to meet this demand for quicker, cost-effective access to a broad portfolio of patient-specific devices.
In this article, we explain the various advantages of having on-site capabilities for 3D-printed devices and how a collaborative effort between device manufacturers and health systems is emerging as a preferred solution for implementing AM technology at the POC.
This also drives innovation by immersing technologists, engineers, and clinicians in a collaborative environment. Having the engineer and clinicians in the same room discussing patient cases together makes it easier to generate new and better ways to solve complex clinical problems.
With growing demand, health systems are relying on device manufacturers to enable this collaborative environment by deploying trained engineers and advanced technology closer to clinicians and at the POC. Having engineers trained on device manufacturers’ established workflows and procedures on-site gives health systems access to surgical planning and a broad portfolio of patient-specific devices on demand, thereby leveraging the full potential of AM technology.
In December 2021, the FDA released a discussion paper on how hospitals could use 3D printing technology to manufacture medical devices such as models and guides on-site to address this need. In the discussion paper, the FDA proposed three different scenarios for adopting POC AM.
Collaboration between health systems and AM device manufacturers can help overcome this hurdle. AM device manufacturers often have a central facility that houses a broad range of the latest AM technologies and materials with continuous upgradation of them. Device manufacturers are subject to stringent compliance requirements to quality standards and regulations they meet to manufacture devices at scale using AM. By collaborating with device manufacturers, health systems can take advantage of the broad range of technologies, materials, and compliance to offer scale and backup for high-volume production at their site or to serve multiple centers needing patient-specific devices. This in turn will enable greater accessibility and adoption of patient-specific devices.
Omaha is renowned for its rich healthcare ecosystem, and the Clarkson College COE serves as a central hub for approximately 15 local hospitals to access AM technologies and personalized healthcare solutions. Through its Center of Excellence, Clarkson College will have the ability to execute surgical planning on-site and offer a range of FDA-cleared, 3D-printed patient-specific devices such as diagnostic anatomic models, surgical planning, and 3D-printed instruments of orthopedic oncology procedures and personalized radiotherapy accessories.
This collaboration between 3D Systems and Clarkson College to establish the COE is an example of a hybrid form of the co-location scenario where 3D Systems will deploy its trained personnel and technology on-site to execute patient-specific device workflows. The clinical engineers will be trained on 3D Systems’ workflows and procedures to execute virtual surgical planning on-site at Clarkson College with manufacturing support from 3D Systems’ facility in Littleton, Colo., an ISO 13485-certified and FDA-registered facility.
With the increase in adoption and continuously growing demand, the POC AM landscape will continue to evolve at a rapid pace. Soon, we will see innovative POC AM programs and more collaborations between health systems and device manufacturers to bring AM technology into the POC to leverage its full potential for better patient care and outcomes.
Devarsh Vyas is a senior product portfolio manager at 3D Systems, Healthcare. He is an experienced engineer in the healthcare 3D printing industry with subject matter expertise in successfully implementing 3D printing solutions at the point-of-care for medical devices manufacturing.
Trish Weber, with 28 years of expertise in medical imaging, is the assistant director of Radiography/Medical Imaging and Technology at Clarkson College. Her visionary leadership led to the creation of the Medical 3D Printing and Visualization Specialist Certificate and the establishment of a cutting-edge 3D Printing & Training Center, inspiring innovation in healthcare.
In this article, we explain the various advantages of having on-site capabilities for 3D-printed devices and how a collaborative effort between device manufacturers and health systems is emerging as a preferred solution for implementing AM technology at the POC.
Collaboration Between Engineers and Healthcare Professionals
A patient-specific device workflow involves a great deal of collaboration between engineers and healthcare professionals, including radiologists, surgeons, and sometimes even patients. It requires engineering experts who understand the process of medical device manufacturing using AM technologies, including regulatory and quality system requirements, and clinical expertise to help interpret medical images, perform surgical planning, and understand what the treatment options are. By having engineers and technology at the POC, clinicians and engineers can work together on complex cases to create high-quality, clinically relevant solutions for patients.This also drives innovation by immersing technologists, engineers, and clinicians in a collaborative environment. Having the engineer and clinicians in the same room discussing patient cases together makes it easier to generate new and better ways to solve complex clinical problems.
With growing demand, health systems are relying on device manufacturers to enable this collaborative environment by deploying trained engineers and advanced technology closer to clinicians and at the POC. Having engineers trained on device manufacturers’ established workflows and procedures on-site gives health systems access to surgical planning and a broad portfolio of patient-specific devices on demand, thereby leveraging the full potential of AM technology.
Quality System Requirements & Regulatory Compliance at the POC
Quality system requirements and regulatory compliance have been a discussion topic for POC AM use cases. With increased adoption and a variety of use cases, health systems often find it challenging to fulfill the quality and regulatory requirements to meet the demand of rising use cases. With few exceptions, most hospitals are currently limited to producing anatomic models at the POC, which also limits what AM technology has to offer to clinicians and patients.In December 2021, the FDA released a discussion paper on how hospitals could use 3D printing technology to manufacture medical devices such as models and guides on-site to address this need. In the discussion paper, the FDA proposed three different scenarios for adopting POC AM.
- The POC uses a medical device production system (MDPS), which is a validated and approved turn-key solution that can be used at the POC to manufacture specific medical devices.
- The medical device manufacturer co-locates at the POC as one of its satellite sites to manufacture approved devices.
- The POC chooses to be a legal manufacturer itself by getting approval from the FDA to manufacture its own devices at the POC.
Scale and Backup for High-Volume Production
Most POC AM facilities are limited in terms of the scale and range of technologies available on-site. This limits the health system to meet the rising demand and/or offer advantages of on-site AM capabilities to other hospitals/health systems in the network or region. Moreover, to meet the demand of growing use cases, hospitals need to have various AM technologies that can print in a broad range of materials with specific properties. It is a big hurdle to acquire dedicated space for housing AM technologies in hospitals. While desktop/consumer-level AM technologies are a good starting point, they lack the scalability aspect and are limited to the use cases they can serve. Production-level AM technologies that offer scalability require space and special infrastructure, and have significant cost associated. This is often a roadblock that a POC AM lab faces with increasing demand and limited technology and resources on-site.Collaboration between health systems and AM device manufacturers can help overcome this hurdle. AM device manufacturers often have a central facility that houses a broad range of the latest AM technologies and materials with continuous upgradation of them. Device manufacturers are subject to stringent compliance requirements to quality standards and regulations they meet to manufacture devices at scale using AM. By collaborating with device manufacturers, health systems can take advantage of the broad range of technologies, materials, and compliance to offer scale and backup for high-volume production at their site or to serve multiple centers needing patient-specific devices. This in turn will enable greater accessibility and adoption of patient-specific devices.
Center of Excellence Revolutionizing Healthcare in Omaha
In September 2023, Clarkson College (Omaha, Neb.) became the latest institution to take a pioneering role in POC AM. Partnering with 3D Systems, the college is establishing its 3D Printing and Training Center of Excellence (COE) on its campus. The COE will include access to the latest AM technologies, advanced software, and trained clinical engineers to offer personalized healthcare solutions to health systems across the region.Omaha is renowned for its rich healthcare ecosystem, and the Clarkson College COE serves as a central hub for approximately 15 local hospitals to access AM technologies and personalized healthcare solutions. Through its Center of Excellence, Clarkson College will have the ability to execute surgical planning on-site and offer a range of FDA-cleared, 3D-printed patient-specific devices such as diagnostic anatomic models, surgical planning, and 3D-printed instruments of orthopedic oncology procedures and personalized radiotherapy accessories.
This collaboration between 3D Systems and Clarkson College to establish the COE is an example of a hybrid form of the co-location scenario where 3D Systems will deploy its trained personnel and technology on-site to execute patient-specific device workflows. The clinical engineers will be trained on 3D Systems’ workflows and procedures to execute virtual surgical planning on-site at Clarkson College with manufacturing support from 3D Systems’ facility in Littleton, Colo., an ISO 13485-certified and FDA-registered facility.
Future Workforce Development Through Education and Training
Clarkson College started one of the nation's first medical 3D printing certificate programs. This trailblazing program laid the foundation for structured education in medical 3D printing, anticipating the critical need for a highly skilled workforce in this evolving field. Clarkson College’s strategic partnership with 3D Systems signifies a pivotal step toward enhancing workforce development through education and training, setting the stage for a future where 3D-printing professionals are not just competent but pioneering forces of innovation and progress. The partnership leverages the combined strengths of a reputable healthcare education institution and an AM industry leader, uniting to create a transformative educational experience. Notably, the partnership will keep its finger on the pulse of the industry to drive curriculum and customized workshops, ensuring education remains relevant and up-to-date while creating the workforce to propel the industry forward to meet the growing demand for skilled professionals. This collaborative endeavor promises to elevate individual careers and drive positive change in the broader landscape of medicine and additive manufacturing.With the increase in adoption and continuously growing demand, the POC AM landscape will continue to evolve at a rapid pace. Soon, we will see innovative POC AM programs and more collaborations between health systems and device manufacturers to bring AM technology into the POC to leverage its full potential for better patient care and outcomes.
Devarsh Vyas is a senior product portfolio manager at 3D Systems, Healthcare. He is an experienced engineer in the healthcare 3D printing industry with subject matter expertise in successfully implementing 3D printing solutions at the point-of-care for medical devices manufacturing.
Trish Weber, with 28 years of expertise in medical imaging, is the assistant director of Radiography/Medical Imaging and Technology at Clarkson College. Her visionary leadership led to the creation of the Medical 3D Printing and Visualization Specialist Certificate and the establishment of a cutting-edge 3D Printing & Training Center, inspiring innovation in healthcare.