Navigating Regulatory Challenges: Ricoh’s Journey in 3D Healthcare Printing

By on May 22nd, 2023 in news, Service

Tags: , , , , ,

3D printed organ model by Ricoh [Source: Fabbaloo]

Ricoh seems to have found a promising niche in the 3D print world: anatomical models.

The giant Japanese multinational company has countless lines of business, but one is additive manufacturing. But even within that division there’s different organizations that target specific markets.

We recently had the chance to chat with the Ricoh team involved with their anatomical model service, an initiative they’ve aptly named “3D For Healthcare”.

3D Printing and Healthcare: A Perfect Union

3D printed hip joint model by Ricoh [Source: Fabbaloo]

Anatomical models are a growing application that has been enabled by 3D print technology. There are several reasons for producing anatomical models, including education, surgical planning, fit testing for medical devices, but there’s one that’s particularly interesting: surgery practice.

The concept is to perform a detailed 3D scan of the patient, and then produce a matching surgical model using Ricoh’s service. Surgeons can then practice complex operations using the printed anatomical model without risk to the patient. They can even attempt multiple surgical strategies to see which one is best for the patient.

3D printed bone model by Ricoh [Source: Fabbaloo]

This is enabled by Ricoh’s 3D print technology that can not only reproduce the geometry of the patient, but also involve different colors and even rigidity. Portions of a print can be soft or rigid, adding to the realism during surgical practice.

Ricoh operates their technology as a service, as doctors and others may order models from them.

Navigating Regulatory Waters in 3D Healthcare Printing

3D printed dental model by Ricoh [Source: Fabbaloo]

An anatomical model 3D print service might seem to be a relatively straightforward business: just get a 3D printer that can produce the necessary colors and textures, add some patient data and you’re good to go.

No, that’s not it.

The healthcare space is highly regulated, and before any of this can happen the provider, in this case Ricoh, must obtain a variety of regulatory certifications. Ricoh has indeed obtained FDA certification, which has allowed them to proceed.

3D printed organ model by Ricoh [Source: Fabbaloo]

However, we were told that they are currently awaiting more approvals for certifications, which could imply they could increase the scope of their anatomical service to new applications, or even add more geographies to their service. After all, you must be approved in each region by the appropriate regulatory authorities.

We had the opportunity to examine several sample anatomical prints produced by Ricoh. The results were nothing short of impressive. The breadth of their capabilities was clearly displayed in the diverse range of applications showcased in their sample set.

3D printed heart model by Ricoh [Source: Fabbaloo]

While we may be a while away from the point where 3D printed anatomical models become the norm for surgeons and other medical applications, the majority of practitioners are still relying on traditional methods. However, as more 3D printing companies like Ricoh continue to offer increasingly competent services, we anticipate a surge in usage.

Via Ricoh

By Kerry Stevenson

Kerry Stevenson, aka "General Fabb" has written over 8,000 stories on 3D printing at Fabbaloo since he launched the venture in 2007, with an intention to promote and grow the incredible technology of 3D printing across the world. So far, it seems to be working!

Leave a comment

Your email address will not be published. Required fields are marked *