Benjamin Johnson, VP, Portfolio & Regulatory, Healthcare, 3D Systems11.17.21
The manufacturing of medical devices at the point of care has a long history and is necessary to give patients the best possible care in the hands of a qualified clinical team. Additive manufacturing is a tool that can be reasonably deployed at the point of care and leveraged to create anatomic models, diagnostic tools, surgical instruments, and implants that improve surgical outcomes and enhance the patient experience. Currently, hundreds of hospitals around the world use workflows that include 3D printing to inform clinical care, enhance medical training, and transform healthcare research. The collection of capabilities and personnel that is typically assembled to operate a 3D printing function at the hospital also provides fertile ground for innovation and medical device development. However, the medical device development process, infrastructure, and manufacturing controls commonly utilized by medical device OEMs represent a shift in approach for the clinical team. In the future, several enabling solutions will facilitate easier onboarding of patient-specific workflows aligned with the collective mission of improving global healthcare.
In addition, hospital manufacturing capability can provide redundancy in the supply chain for critically needed or difficult to procure parts and assemblies to keep operations running. Institutions that have adopted software and hardware solutions typically create a workflow to convert medical imaging data into formats suitable for 3D printing to create patient-specific anatomic models and surgical instruments. Anatomic models of patient disease can be leveraged clinically to augment diagnosis, evaluate considerations in the treatment plan, align the clinical team to the surgical approach, provide a surrogate of patient anatomy in the operating room, and facilitate the conversation between provider and patient. Further, models of anatomy can be used for surgical simulation, skills training, and amplifying the availability of rare disease pathologic specimens.
Like anatomic models, surgical instruments and other devices are designed by the clinical team and printed using materials known to be biocompatible and sterilizable. These instruments help clinicians achieve precise surgical outcomes with fewer steps in the OR. Additive manufacturing capability at the hospital initially leveraged to print models and instruments quickly becomes a breeding ground for innovation and research as the convergence of clinicians, engineers, and technology takes flight.
Facilitating the workflow and printing at the point of care is a team focused on using software tools to segment medical imaging data, design medical devices, and hardware used to 3D print and process the patient-specific devices. The training of clinician, engineering, and technician team members to perform these workflow tasks successfully is not trivial. Expertise in medical imaging data, anatomy, CAD principles, surgical technique and approach, 3D printing, medical device cleaning, and medical device sterilization are just a few of the competencies required. Each step of the workflow is critical to the output, and each step presents risks of failure that span the matrix of occurrence, detection, and severity.
A significant hurdle to the successful establishment of medical manufacturing at the hospital is the acquisition and training of talent needed to staff the operation. In addition, the organizational structure of an in-hospital 3D printing operation can be a challenge with many stakeholders across clinical specialties, facilities, quality assurance, sterile processing, etc. The current point of care manufacturing operations have had common struggles with staffing that illustrate the ongoing need for workforce development and organizational guidance.
Equipment and materials currently used at the hospital to fabricate patient-specific models and instruments are varied. The printing hardware can span from inexpensive consumer-level 3D printers to state-of-the-art production systems. Accessory equipment required to post-process the printed part includes operations such as washing, blasting, UV curing, and oven drying. Improper post-processing of 3D-printed parts with small structures can result in residual raw materials in the final product and create a risk to both users and patients. More complicated additive manufacturing processes can also include stress relief, hot isostatic press, grinding, polishing, machining, marking, and etching. For any part to enter the sterile field, additional steps of cleaning and sterilization must be performed.
Similar variability exists in the materials used. Photopolymers, powders, inks, and filaments are common feedstocks for additive manufacturing. Naturally, each material has specific requirements for storage, handling, and shelf life.
When 3D printers are being used to create medical devices, the entire process must be reliable and reproducible. Each 3D printer should be properly set up and tested according to the manufacturer’s instructions, and routine maintenance of 3D printing equipment should be performed and documented. In this sense, the fabrication of 3D printed devices at the point of care is analogous to the medical manufacturing environment where processes are established to create products. Today, several gaps exist in most point-of-care 3D-printing operations for purchasing, document, and process controls. Additionally, common quality system regulation requirements such as traceability, nonconforming product, corrective and preventative action, labeling, and records handling are not proceduralized for manufacturing at the hospital, although many of the same ideas exist in the context of patient care.
Finally, early adopters of additive manufacturing at the point of care for medical device fabrication currently reside in a regulatory gray zone. In the United States, the FDA does not regulate the practice of medicine at the hospital. Similarly, organizations that may provide accreditation of healthcare like The Joint Commission have not established standards and policies for medical device manufacturing at the hospital. Therefore, it is incumbent upon the current point-of-care team to ensure medical devices are produced in a way that limits the risk of injury to patients. There are no better decision-makers than the clinicians and engineers tasked with providing tools for patient care, but the point-of-care team needs to be presented with the relevant information about the technologies they are utilizing to minimize risk to patients. Therefore, vendors of software, hardware, and materials need to ensure instructions, user manuals, and best practices are documented and made available in a digestible format.
The applications for hospital manufacturing and risk to the patient will increase over time. Therefore, the lessons learned from the early adopters will be invaluable to supporting the clinics of the future. At the heart of success will be the partnerships forged between clinicians, engineers, administration, regulators, OEMs, and technology vendors. This became readily apparent during the height of the COVID-19 pandemic when supply chains fell apart. Hospitals with additive manufacturing capability were able to quickly respond to the needs of frontline staff by leveraging printers to fabricate personal protective equipment, diagnostic accessories, or even critically needed ventilator modifications. Partnerships were immediately created between government organizations like the NIH, FDA, and VHA to help evaluate the performance and risk of products that could be printed. Connections between 3D-printing technology vendors and hospitals were called on to quickly develop printing parameters and post-processing instructions for face masks, nasal swabs, and ventilator splitters. The success of additive manufacturing as a rapid response tool was driven by these partnerships.
Onboarding of manufacturing technology at the hospital will become easier. Previously, the creation of a process to deliver a patient-specific medical device required several disparate software and hardware tools, with the onus of validation and assurance of quality placed on the clinical team. This hurdle will start to disappear as technology vendors deliver more complete and focused solutions with formal instructions on how to operate, qualify, and maintain a holistic medical device production system intended to support specific indications or devices. These systems will require regulatory clearance. Just as critical will be the service teams that ensure consistency and rapidly solve downtime issues with the manufacturing line. The service team can also support the establishment of a quality management system that is compliant with standards and aligned with guidance from regulatory agencies.
Finally, the medical device OEMs will have a significant role to play in the future state of hospital medical device manufacturing. Already, several partnerships between OEMs and hospitals exist that help hospitals accelerate the onboarding of additive manufacturing. Additionally, medical devices that are printed at the point of care will still require interface with surgical tools and instruments that will not be fabricated at the hospital and will require partnership with the device OEMs to ensure compatibility. Other opportunities also exist for distributed manufacturing of OEM products at hospital manufacturing locations to, yet again, solve ongoing supply chain delivery and cost issues.
Early Adopters Experience Both Benefits and Challenges
Academic hospitals and leading clinics involved with complex patient care have turned toward additive manufacturing as another tool in the toolbox to augment treatment. The deployment of additive manufacturing workflows for patient care has broad clinical reach across not only orthopedics, but also in oncology, dentistry, cardiology, and oral surgery. Medical device manufacturing with 3D printing at the hospital has a significant impact on healthcare costs by improving disease assessment, facilitating pre-surgical evaluation and planning, reducing operating room (OR) time, decreasing medical errors, improving surgical outcomes, and ultimately improving patient satisfaction.In addition, hospital manufacturing capability can provide redundancy in the supply chain for critically needed or difficult to procure parts and assemblies to keep operations running. Institutions that have adopted software and hardware solutions typically create a workflow to convert medical imaging data into formats suitable for 3D printing to create patient-specific anatomic models and surgical instruments. Anatomic models of patient disease can be leveraged clinically to augment diagnosis, evaluate considerations in the treatment plan, align the clinical team to the surgical approach, provide a surrogate of patient anatomy in the operating room, and facilitate the conversation between provider and patient. Further, models of anatomy can be used for surgical simulation, skills training, and amplifying the availability of rare disease pathologic specimens.
Like anatomic models, surgical instruments and other devices are designed by the clinical team and printed using materials known to be biocompatible and sterilizable. These instruments help clinicians achieve precise surgical outcomes with fewer steps in the OR. Additive manufacturing capability at the hospital initially leveraged to print models and instruments quickly becomes a breeding ground for innovation and research as the convergence of clinicians, engineers, and technology takes flight.
Facilitating the workflow and printing at the point of care is a team focused on using software tools to segment medical imaging data, design medical devices, and hardware used to 3D print and process the patient-specific devices. The training of clinician, engineering, and technician team members to perform these workflow tasks successfully is not trivial. Expertise in medical imaging data, anatomy, CAD principles, surgical technique and approach, 3D printing, medical device cleaning, and medical device sterilization are just a few of the competencies required. Each step of the workflow is critical to the output, and each step presents risks of failure that span the matrix of occurrence, detection, and severity.
A significant hurdle to the successful establishment of medical manufacturing at the hospital is the acquisition and training of talent needed to staff the operation. In addition, the organizational structure of an in-hospital 3D printing operation can be a challenge with many stakeholders across clinical specialties, facilities, quality assurance, sterile processing, etc. The current point of care manufacturing operations have had common struggles with staffing that illustrate the ongoing need for workforce development and organizational guidance.
Equipment and materials currently used at the hospital to fabricate patient-specific models and instruments are varied. The printing hardware can span from inexpensive consumer-level 3D printers to state-of-the-art production systems. Accessory equipment required to post-process the printed part includes operations such as washing, blasting, UV curing, and oven drying. Improper post-processing of 3D-printed parts with small structures can result in residual raw materials in the final product and create a risk to both users and patients. More complicated additive manufacturing processes can also include stress relief, hot isostatic press, grinding, polishing, machining, marking, and etching. For any part to enter the sterile field, additional steps of cleaning and sterilization must be performed.
Similar variability exists in the materials used. Photopolymers, powders, inks, and filaments are common feedstocks for additive manufacturing. Naturally, each material has specific requirements for storage, handling, and shelf life.
When 3D printers are being used to create medical devices, the entire process must be reliable and reproducible. Each 3D printer should be properly set up and tested according to the manufacturer’s instructions, and routine maintenance of 3D printing equipment should be performed and documented. In this sense, the fabrication of 3D printed devices at the point of care is analogous to the medical manufacturing environment where processes are established to create products. Today, several gaps exist in most point-of-care 3D-printing operations for purchasing, document, and process controls. Additionally, common quality system regulation requirements such as traceability, nonconforming product, corrective and preventative action, labeling, and records handling are not proceduralized for manufacturing at the hospital, although many of the same ideas exist in the context of patient care.
Finally, early adopters of additive manufacturing at the point of care for medical device fabrication currently reside in a regulatory gray zone. In the United States, the FDA does not regulate the practice of medicine at the hospital. Similarly, organizations that may provide accreditation of healthcare like The Joint Commission have not established standards and policies for medical device manufacturing at the hospital. Therefore, it is incumbent upon the current point-of-care team to ensure medical devices are produced in a way that limits the risk of injury to patients. There are no better decision-makers than the clinicians and engineers tasked with providing tools for patient care, but the point-of-care team needs to be presented with the relevant information about the technologies they are utilizing to minimize risk to patients. Therefore, vendors of software, hardware, and materials need to ensure instructions, user manuals, and best practices are documented and made available in a digestible format.
Partnerships Drive Success
The future vision for point-of-care medical manufacturing is an integration of technology, personnel, and processes to augment patient care and decrease healthcare costs. Medical devices that are patient-specific and target diseases or patient populations with no existing solutions will be printed and delivered at the point of care. Other therapies that require close proximity to the hospital like bioprinted constructs seeded with patient cells or even bioprinted organs will necessitate on-site manufacturing capabilities. Finally, patient-specific customized drug formulation and dose delivery will be printed at the bedside for rapid delivery to the patient.The applications for hospital manufacturing and risk to the patient will increase over time. Therefore, the lessons learned from the early adopters will be invaluable to supporting the clinics of the future. At the heart of success will be the partnerships forged between clinicians, engineers, administration, regulators, OEMs, and technology vendors. This became readily apparent during the height of the COVID-19 pandemic when supply chains fell apart. Hospitals with additive manufacturing capability were able to quickly respond to the needs of frontline staff by leveraging printers to fabricate personal protective equipment, diagnostic accessories, or even critically needed ventilator modifications. Partnerships were immediately created between government organizations like the NIH, FDA, and VHA to help evaluate the performance and risk of products that could be printed. Connections between 3D-printing technology vendors and hospitals were called on to quickly develop printing parameters and post-processing instructions for face masks, nasal swabs, and ventilator splitters. The success of additive manufacturing as a rapid response tool was driven by these partnerships.
Onboarding of manufacturing technology at the hospital will become easier. Previously, the creation of a process to deliver a patient-specific medical device required several disparate software and hardware tools, with the onus of validation and assurance of quality placed on the clinical team. This hurdle will start to disappear as technology vendors deliver more complete and focused solutions with formal instructions on how to operate, qualify, and maintain a holistic medical device production system intended to support specific indications or devices. These systems will require regulatory clearance. Just as critical will be the service teams that ensure consistency and rapidly solve downtime issues with the manufacturing line. The service team can also support the establishment of a quality management system that is compliant with standards and aligned with guidance from regulatory agencies.
Finally, the medical device OEMs will have a significant role to play in the future state of hospital medical device manufacturing. Already, several partnerships between OEMs and hospitals exist that help hospitals accelerate the onboarding of additive manufacturing. Additionally, medical devices that are printed at the point of care will still require interface with surgical tools and instruments that will not be fabricated at the hospital and will require partnership with the device OEMs to ensure compatibility. Other opportunities also exist for distributed manufacturing of OEM products at hospital manufacturing locations to, yet again, solve ongoing supply chain delivery and cost issues.