Ricoh’s FDA 510(k) clearance means healthcare providers don’t have to be experts in printing 3D models

Every doctor has been in the tough spot of talking to a patient about a procedure with only a two-dimensional scan to explain complicated anatomy. Medical decisions are never easy for patients—even harder when they don’t understand what’s happening.

Having a precise replica to assist a patient in seeing inside the anatomy—so they truly understand the procedure and how it affects them—can be the difference-maker that provides peace of mind and minimizes stress even on someone's worse day.

Education promotes patient compliance, satisfaction with care, healthy lifestyles, and self-care skills.¹ Armed with a strong understanding of disease or illness, patients have a higher chance of experiencing a positive outcome.²

Ricoh’s 510(k) clearance from the U.S. Food and Drug Administration (FDA) for craniomaxillofacial, orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast applications will help organizations better educate patients, loved ones, and caregivers, so hospitals can increase their level of care and help battle ever-increasing costs.

When an organization receives 510(k) clearance from the FDA, it means that their product can be used as a medical device. FDA clearance allows Ricoh’s 3D anatomic modeling to be used for diagnostic use, such as pre-surgical planning.

The accurate replicas serve as physical simulators to help clinicians see inside anatomy for greater visibility into patient needs and insight to support surgical planning and approach. The 3D tissue and bone representations are also used to select items such as implants to fit patients prior to the operating room. 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.² With that time savings, providers can see more patients and increase revenue.

To accurately diagnose a patient, you need a deep knowledge of anatomy. There’s only so much you can understand in 2D, to get a true-to-life physical representation, anatomical models must be 3D. Therefore, you need a 3D replica that is verifiably accurate to the patient’s anatomy.

Precise replicas are also important for medical students. Anatomical abnormalities are common, but confusing for medical students. Having a precise replica to hone their skills prior to a procedure makes students more at ease and procedures more likely to succeed.

By outsourcing the printing of 3D models, teaching hospitals, medical schools and other education organizations can ensure access to the latest tools to teach students how to diagnose illness and disease, without running an on-site 3D printing center.

Students gain real-world experience with 510(k) cleared medical devices that they’ll use to diagnose illnesses and diseases in healthcare settings.

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, Director of Regulatory Affairs and Quality. “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 can leverage Merge Universal Viewer, a web-based, FDA 510(k)-cleared, HIPAA-enabled medical image viewer commonly used to view patient’s studies. Hospitals already using Merge Universal Viewer 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 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.

Work seamlessly with Ricoh’s service professionals to produce and deliver precise FDA 510(k)-cleared, 3D printed anatomical models. 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 practice, or to cut a model in half to expose the interior.

To learn more about how Ricoh is helping change the future of patient care, discover RICOH 3D for Healthcare >