Formlabs was founded by MIT researchers in 2011, when high-quality 3D printing was inaccessible for most. We’ve now shipped over 50,000 machines while cementing our mission to “expand access to digital fabrication, so anyone can make anything.”
Users in the medical industry have embraced 3D printing in new and unexpected ways. As their adoption organically grows, so does Formlabs’ demands and expectations. In order to better understand the market and the needs of this community, we’ve become active participants in relevant working groups and advisory boards led by SME and other organizations. As we continue to adapt to market needs, here are considerations that make us optimistic about the future.
Quality Assurance: Although point-of-care manufacturers are not currently subject to the same regulations as commercial medical device manufacturers, it’s important for all manufacturers to ensure their design and fabrication processes create a product that is safe and effective for patients. To this end, it is essential that the proper process and quality controls are developed and documented in a Quality Management System (QMS). QMS development often generates questions about maintenance, repairs, safety, process settings, software security, material production, and sterilization effects. This is a process that Formlabs understands, having developed our own ISO 13485 resin production facility. Formlabs recognizes that it holds information critical to formulating the answers and is committed to providing offerings such as medical-specific service plans, training services, and documentation to meet these needs while protecting our own IP.
Regulatory: Thanks to an active, transparent, and collaborative stakeholder engagement process led by the Food and Drug Administration and Radiological Society of North America (RSNA) Special Interest Group (SIG) for 3D Printing, the regulatory environment has more clarity than ever before. The FDA published technical considerations for 3D printed medical devices in 2017 and released Current Practices and Regulations for patient-specific anatomic models. Anatomical models marketed for diagnostic use are considered medical devices and should use segmentation software with a 510(k) clearance. As of this writing, Formlabs has three printers validated by software vendors to produce such models. We continue to participate in the FDA stakeholder engagement process as it develops its Conceptual Framework for point-of-care medical device production.
Reimbursement: Since patient-specific anatomical models and guides are not currently reimbursable at the national level, certain health systems have bundled them with other services or produced them at a direct loss outweighed by well-documented clinical gains and cost-avoidance implications. As a first step towards reimbursement, the American Medical Association (AMA) accepted Category III Current Procedural Terminology (CPT) codes for 3D anatomic modeling, which was led by the American College of Radiology (ACR). A joint RSNA-ACR 3D Printing Registry was also established to enable national data collection and analyses. As Formlabs sees benefit across our medical base and among RSNA SIG members, we’re proud to be an industry partner of the registry in the form of an unrestricted grant.
Workflows: Several associations are focused on workforce development as there is a shortage of qualified personnel for point-of-care manufacturing. In the meantime, new technology and entrants enable faster processes for clinical staff and more intuitive operation for technicians. After acquiring images on-premises, users can structure a route to a printed model based on resources and preferences. Some of our customers without segmentation software use off-site segmentation combined with hospital-based printing, an arrangement Formlabs Remote Printing enabled. When a hospital receives a model, it can remove supports and use post-processing solvents to turn around parts quicker and safer. Finally, we’ve partnered with sterilization vendors to advise customers who require information on this occasionally overlooked process.