Academic Point-of-Care Manufacturing in Oral and Maxillofacial Surgery: A Retrospective Review at Gregorio Marañón University Hospital

TL;DR

This paper reviews eight years of on-site 3D-printed medical device production at a university hospital, showing how it improves surgical planning and patient care.

Contribution

The study presents a comprehensive retrospective analysis of academic point-of-care manufacturing in oral and maxillofacial surgery over an eight-year period.

Findings

Biomodels made up 68% of the 442 devices produced, primarily for trauma and oncology cases.

Fused deposition modeling (FDM) with PLA was the most common printing method and material.

Academic POC manufacturing enhanced surgical precision and supported translational research while maintaining regulatory compliance.

Abstract

Background and Objectives: Academic point-of-care (POC) manufacturing enables the in-hospital design and production of patient-specific medical devices within certified environments, integrating clinical practice, engineering, and translational research. This model represents a new academic ecosystem that accelerates innovation while maintaining compliance with medical device regulations. Gregorio Marañón University Hospital has established one of the first ISO 13485-certified academic manufacturing facilities in Spain, providing on-site production of anatomical models, surgical guides, and custom implants for oral and maxillofacial surgery. This study presents a retrospective review of all devices produced between April 2017 and September 2025, analyzing their typology, materials, production parameters, and clinical applications. Materials and Methods: A descriptive, retrospective study was conducted on 442 3D-printed medical devices fabricated for oral and maxillofacial surgical cases. Recorded variables included device classification, indication, printing technology, material type, sterilization method, working and printing times, and clinical utility. Image segmentation and design were performed using 3D Slicer and Meshmixer. Manufacturing used fused deposition modeling (FDM) and stereolithography (SLA) technologies with PLA and biocompatible resin (Biomed Clear V1). Data were analyzed descriptively. Results: During the eight-year period, 442 devices were manufactured. Biomodels constituted the majority (approximately 68%), followed by surgical guides (20%) and patient-specific implants (7%). Trauma and oncology were the leading clinical indications, representing 45% and 33% of all devices, respectively. The orbital region was the most frequent anatomical site. FDM accounted for 63% of the printing technologies used, and PLA was the predominant material. The mean working time per device was 3.4 h and mean printing time 12.6 h. Most devices were applied to preoperative planning (59%) or intraoperative use (35%). Conclusions: Academic POC manufacturing offers a sustainable, clinically integrated model for translating digital workflows and additive manufacturing into daily surgical practice. The eight-year experience of Gregorio Marañón University Hospital demonstrates how academic production units can enhance surgical precision, accelerate innovation, and ensure regulatory compliance while promoting education and translational research in healthcare.

Figures