The Mixed Unit for Biomedical Design and Fabrication (BioFab), a collaboration between the Institute of Health and Biomedical Research of Alicante (ISABIAL) and the University of Alicante, has obtained the Custom Medical Device Manufacturing License. With this authorization, it becomes the first 3D unit in the Valencian Community accredited to design and manufacture personalized medical devices.
This license, granted by the Directorate General of Pharmacy of the Conselleria de Sanidad (Regional Ministry of Health), marks a turning point for BioFab and positions the General University Hospital Doctor Balmis as the only hospital center in the region with an authorized biomedical fabrication unit for custom designs and advanced surgical planning.
Javier Esclapés, scientific director of BioFab and researcher at the University of Alicante, highlighted that this certification "completely transforms the unit's direction," which since its creation four years ago had focused on research projects in surgical planning, medical and surgical instrumentation, orthotics, prosthetics, and support products through 3D printing.
Now, the unit "ceases to be a space exclusively oriented towards biomedical research to be fully integrated into daily healthcare activities, with full legal and clinical validity," according to Esclapés. The new authorization will allow the design and manufacturing of personalized medical devices directly from the hospital, fostering collaboration between biomedical engineers and clinical professionals to create solutions tailored to each patient's needs.
Until now, the fabrication of biomodels (three-dimensional replicas of organs or bones) and custom surgical guides depended on external suppliers. Esclapés anticipates that this new model "will significantly reduce response times, increase customization capacity, and optimize healthcare system resources".
Francisco Soriano, manager of the Alicante-Hospital General Health Department, emphasized that the license represents "an innovative organizational model within the public health system, based on multidisciplinarity, applied research, and the generation of transferable and scalable knowledge," consolidating the Doctor Balmis Hospital at the forefront of personalized medicine.
BioFab's new work will begin immediately in two key specialties: Radiodiagnostics, led by Dr. Luis Concepción, which will generate three-dimensional models from advanced medical images (CT scans, MRI); and Orthopedic and Trauma Surgery, led by Dr. Antonio García, for virtual planning of interventions and the creation of specific biomodels and surgical guides.
This integration will allow medical teams to study and rehearse interventions on exact replicas before entering the operating room, improving precision and safety. Additionally, BioFab will design custom surgical guides with biocompatible materials to enhance accuracy during surgery.
To publicize this milestone, the unit will organize the "Innovation Conference on Orthopedic and Trauma Surgery. From Planning to Clinical Practice" on Friday, October 16, 2026, at the Auditorium of the Official College of Physicians of Alicante, bringing together reference units from across Spain.
