The Advanced Design and 3D Printing Unit (UTADI 3D) at the Hospital Universitario 12 de Octubre in Madrid, Spain, has strengthened its standing as a national leader in healthcare 3D-printing technology after expanding its manufacturing license and earning certification under the UNE-EN ISO 13485:2018 standard from the Spanish Association for Standardization and Certification (AENOR).

The hospital said in a press release that the milestone makes UTADI 3D the first hospital unit in Spain to hold two manufacturing licenses and product family certification across each of its device categories.

This recognition represents a significant step toward a new model of care in which hospitals not only use medical devices but can also develop and produce them, tailoring them to the specific needs of each patient.

3D Printing in Medicine

This technique is no longer a technology reserved for industry but has become a tool with increasingly relevant applications in the healthcare field. One of the most widespread applications in the hospital setting is the production of anatomic biomodels. These replicas accurately reproduce organs and anatomic structures, enabling, among other things, greater precision in surgical planning.

The use of biomodels is particularly useful in fields such as cardiac surgery, neurosurgery, maxillofacial surgery, and orthopedics, where even minor anatomic variations can significantly influence the course of a procedure. The applications of 3D printing in medicine involve a complex integration of technologies that combine medical imaging, computer-aided design, materials science, and clinical expertise.

Manufacturing Process

The 3D printing process does not begin with the printer, but rather with the acquisition of medical images — typically via CT or MRI — to study the patient’s anatomy. From there, a fundamental step begins: image processing using software and specialized professionals, who isolate the structures of interest within the image. This step is known as segmentation.

Next, a 3D digital model is reconstructed by adjusting details such as the thickness or final geometry of the object using computer-aided design. Subsequently, the most suitable material is selected, depending on whether the goal is to create an anatomic replica, a surgical device, or a biocompatible implant. Finally, the digital file is sent to the 3D printer, which builds the object layer by layer using additive manufacturing. After printing, the object typically undergoes a process that usually includes cleaning, sterilization, or dimensional validation before clinical use.

Clinical Integration

The advances in 3D printing are redefining the concept of personalized medicine. The ability to transform medical images into physical solutions tailored to each patient makes it possible to design more precise treatments, optimize surgical planning, contribute to research and innovation, improve healthcare staff training, and develop specific devices for particular needs.

Initiatives such as the one at the Hospital Universitario 12 de Octubre make it possible to integrate the entire process within the hospital itself, without the need to rely on external entities. This reduces wait times, facilitates logistics, improves communication among professionals, lowers costs, and allows for greater adaptability to complex and unforeseen cases.

The authors of the article disclosed no relevant financial relationships.

This story was translated from Univadis Spain, part of the Medscape Professional Network.