Ricoh 3D anatomical models gain FDA approval

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How 3D printed anatomic models improve patient experience
When an organization receives 510(k) clearance from the U.S. Food and Drug Administration (FDA), it means that their product can be used as a medical device. FDA-approved 3D printed medical devices are commonly leveraged for diagnostic use, such as pre-surgical planning.
 
The 3D anatomical models are used to select implants to fit patients prior to the operating room. The life-like replicas also serve as physical simulators to help clinicians see inside anatomy for greater visibility into patient needs and insight to support surgical planning and approach.
 
Providers can add or remove anatomical structures and observe them from different angles in a physical and tangible manner—creating new perspectives and enhancing patient and student education opportunities.
 
“By increasing knowledge of the patient’s anatomy and pathology before a surgery, we can cut down on issues during the surgery,” says Dr. Andrew Pedtke. As an orthopedic surgeon, Pedtke has seen first-hand how a precise anatomic model can better prepare surgeons for more complex procedures and reduce surgery times, which offer incredible patient impact.
 
“Furthermore, it’s powerful to not simply tell a patient about the procedure—we can show them precisely what we’re doing in the operating room. As an entrepreneur, a large hurdle facilitating innovation and novel technology is regulatory clearance and reimbursement approval. Through personal use and as reported in clinical literature, anatomic modeling has been validated as a valuable tool for the surgeon community. Gaining FDA clearance enables these innovative technologies to be implemented for the patient’s benefit.”
 
When compared to the non-use of 3D technology for open reduction and internal fixation of fractures, studies demonstrate that 3D printing yields significantly better perioperative results as well. [3]
 
In addition, medical 3D printing can reduce operating room costs as well as shorten procedure times. While resource-intensive, 3D printed constructs used in patients’ operative care provide considerable downstream value to health systems.
 
That value can be significant to many aspects of care. Studies have demonstrated an average time savings of 62 minutes—a cost savings of $3,720 per case. [4] With that time savings, providers can see more patients and increase revenue.
 
Learn how to provide seamless 3D model printing.
How did 3D model printing become so advanced?
Since its start making sensitized paper and cameras, Ricoh has successively drawn on the image processing technologies it garnered developing copiers and fax machines to transform healthcare.
The rapid development and application of imaging in healthcare combined with the parallel development in computer-aided visualization transformed 3D model printing.
From innovating in patient and provider communication to healthcare workflow management and managed services, Ricoh is uniquely positioned to consult on best practices for success.
Providers can choose a point-of-care option, where Ricoh staff works onsite at a healthcare facility to manage the entire process using Stratasys 3D printers, or an on-demand option where they submit an order to have the models processed at a Ricoh facility and sent directly to them.
“Outsourcing 3D model printing lets healthcare providers focus on patient care instead of technology, service, and the regulatory hurdles that come along with the production of medical devices” says Scott Brewer, Senior Manager of Regulatory Compliance. “By putting the job in the hands of skilled service professionals using an integrated, ISO 13485 certified end-to-end workflow solution, the burden is removed from the healthcare provider, making the development, design, and production of FDA 510(k)-cleared 3D-printed anatomic models simple and accessible.”
Clinicians don’t have to purchase expensive new software or learn unique platforms. Hospitals leverage IBM iConnect® Access (by Merative), a web-based, FDA 510(k)-cleared, HIPAA-enabled medical image viewer commonly used to view patient’s studies. Hospitals already using iConnect Access can simply upgrade to activate the tool’s FDA 510(k)-cleared 3D image segmentation and workflow features.
A range of functions empower physicians to use patient images for their specifications. Once the care team establishes the need for a 3D printed model, 3D print files are uploaded to Ricoh’s HIPAA-compliant portal. Leaning into familiar DICOM technology means healthcare providers access the same data and scans they’re accustomed to so there’s no steep learning curve.
Once the image is uploaded, providers work with Ricoh’s service professionals to produce and deliver precise FDA 510(k)-cleared, 3D printed anatomical models to their specifications. Their work includes communicating with physicians to finalize model design and to document all decisions. For instance, a physician may request to color a tumor red so it stands out, to use materials of different flexibility to simulate actual tissue or to cut a model in half to expose the interior.
By partnering with an established service provider, healthcare providers don't have to be experts in printing 3D models and can focus on improving patient outcomes.
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