IU Health opens FDA-cleared 3D print studio for faster surgery planning

IU Health has opened an enhanced 3D Print Studio at the 16 Tech Innovation District in Indianapolis, giving surgeons an in-house way to produce patient-specific anatomical models for pre-surgery planning, medical education and family consultations. The program is among the first hospital-based, FDA-cleared 3D printing operations in the United States, and some models can now be produced in as fast as 24 hours.

The studio is built around a regulated clinical workflow, not a casual maker setup. Physicians can order a model based on a patient’s scan, have it printed inside IU Health instead of through an outside vendor, and use the finished part to study complex anatomy before a procedure. The FDA-cleared process is designed to support diagnostic accuracy and communication with patients and families, while also reducing the lag that comes with outsourcing.

IU Health’s 3D Innovations Lab started in 2017 with one person and two 3D printers in the basement of IU Health University Hospital, then moved to 16 Tech in 2023. The new studio has five printers, and senior clinical engineer Hannah Cahill said imaging is converted into a “glorified Photoshop rendering” before it becomes a physical model. Depending on the case, printing can take anywhere from 30 minutes to four days.

Avinash Mantravadi, MD, said cancer surgery often has to move quickly because surgery is frequently the first treatment option. Christopher Collier said bringing the work in-house should create “tremendous cost savings” for both IU Health and patients. Jeremy Herrmann, MD, said 3D-printed, patient-specific models can change conversations with parents because hands-on anatomy is easier to understand than a scan on a screen. IU Health CEO Dennis Murphy said the technology gives patients access to treatments they cannot get elsewhere in Indiana, the region or the United States.

The U.S. Food and Drug Administration calls 3D printing additive manufacturing, a layer-by-layer process built from digital files, and has been building guidance around medical use for years, including a 2017 technical guidance and a 2021 point-of-care discussion paper.