FDA Clears Ricoh Healthcare Solution to 3D Print Personalized Anatomical Models

Japan-based multinational Ricoh revealed that its RICOH 3D for Healthcare solution, which integrates with IBM iConnect Access from IBM Watson Health to fabricate 3D printed anatomic models, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its craniomaxillofacial (CMF) and orthopedic patient-specific anatomic modeling.

Ricoh’s integrated platform is an end-to-end workflow that makes 3D printing anatomic models easy. The 3D printed anatomic models, produced with Stratasys technology, include very complex replicas of patient-specific anatomy.

Experts at Ricoh’s facilities work with surgeons to create lifelike representations of tissue and bone that can be used as physical simulators with biosimilar materials. They can also help clinicians see inside a patient’s anatomy with transparent and clear materials that complement the full-color models to provide a more accurate perspective of the patient’s needs.

Providers can select from one of two options based on their preferred work styles or needs. They can choose a point-of-care option, where a Ricoh Managed Services team works onsite at a healthcare facility to manage the entire process using Stratasys 3D printers. Or, they can select an on-demand option where they order and have the models printed at a Ricoh facility and shipped directly to them.

The end-to-end workflow leverages the existing enterprise imaging solution used to view patient studies. So, once the care team establishes that they want a 3D model, the 3D print files can be uploaded to Ricoh’s HIPAA (Health Insurance Portability and Accountability Act)-compliant portal. After the digital file is sent to Ricoh’s staff of biomedical engineers, IBM iConnect Access works seamlessly with Ricoh’s 3D Case Management portal and manufacturing service professionals to produce and deliver precise models.

Leaning into familiar DICOM technology means healthcare providers access the same data and scans they’re accustomed to, as many hospitals already rely on IBM Watson Health’s zero-footprint universal viewer. With IBM iConnect Access, DICOM (digital imaging and communications in medicine) files can quickly be turned into a 3D printed model, which Ricoh then prints thanks to its partnership with Stratasys.

Making a difference

This is Ricoh’s first 510(k) clearance and a crucial step in what the company describes as a long journey to bring simplified access to precision solutions and personalized healthcare to patients and physicians.

Commenting on the FDA approval, Ricoh’s Managing Director for North America’s Additive Manufacturing division, Gary Turner, says the company is committed to healthcare innovation that will “turn the tide” on patient engagement and precision medicine.

“RICOH 3D for Healthcare does just that—offering a model matched to the unique anatomy of each individual patient. One of our goals is to address the needs of doctors and patients in specific areas with particularly high demand for 3D-printed anatomic models; the 510(k) clearance for CMF and orthopedic models moves us further toward reaching this goal.”

3D printed models are becoming more prevalent in the medical field. In line with a report by the Radiological Society of North America (RSNA) 3D Printing Special Interest Group, patient-specific anatomical models are the baseline in the craniomaxillofacial (CMF) arena. But although the use of 3D printing technologies to aid clinical care in CMF has been used since the advent of 3D printing in the late 1980s, surgeons, engineers, and researchers were designing more manual ways of converting medical imaging datasets into 3D models. Today, companies like Ricoh, through its multiple partnerships, make these processes much easier and quicker.

According to the RSNA, a growing body of work supports the benefits of 3D printed models, including increased comprehension of anatomy and pre-surgical planning for complex surgical cases, reduced operation times, and improved patient outcomes. With so many benefits for patients and doctors, Ricoh says it plans to solicit 510(k) clearance for additional treatment regions in the future.