Starting up an in-house 3D lab for orthopaedics: essential considerations and steps—a narrative review

Introduction

Background

3D printing (3DP) is a term that encompasses an umbrella of technologies that allow the production of physical, tangible objects starting from a computer-aided design (CAD). The working principle behind this disruptive innovation relies on the addition layer by layer of substrate materials, which is why it is also referred to as additive manufacturing. The forte of this technology lies in the rapid, cost-effective production of geometrically complex, case-specific devices that would be difficult or impossible to fabricate using traditional manufacturing methods. In a field like healthcare, where patients are affected by unique pathologies and anatomical defects, the opportunity to produce on-demand patient-specific (PS) solutions marks a paradigm shift toward personalized care (1). Over the past decade, rapid advancements in image acquisition, CAD software and 3D technology have made 3D modeling and printing more precise, accessible and cost-effective (2). These have spurred its adoption across many medical specialties, including orthopaedics, maxillofacial surgery, and plastic surgery, among others (3-7). Moreover, the advent of user-friendly desktop printers has allowed in-house adoption of the technology, leading to the establishment of hospital-based 3DP facilities (8). Healthcare institutions can now integrate point-of-care (POC) manufacturing directly into clinical workflows, addressing the limitations of external, traditional manufacturing, which tends to be costly, time-consuming, and prone to confidentiality risks (9). Centralizing 3DP units within healthcare facilities fosters interdisciplinary collaboration among engineers, radiologists, and surgeons, serving as a bridge for knowledge transfer and promoting innovations in medical care and PS solutions (9). In orthopaedics, surgeons now use 3DP in various aspects of trauma surgery, including surgical simulation, surgical guides, prosthetics, and external fixation devices (5,10-12). It contributes to improved intraoperative decision-making and has been associated with reductions in operative and turnaround time (13,14). However, despite these advantages, POC 3DP has not yet achieved widespread adoption in clinical practice. Several barriers including technical learning curves, regulatory and quality requirements, reimbursement uncertainty and the lack of standardized training, continue to slow its translation. As the clinical applications of 3DP expand, especially in orthopaedics, there is a growing need to establish structured, scalable, and compliant frameworks for implementing these services within clinical institutions.

Rationale and knowledge gap

The effectiveness of 3DP in healthcare depends on the specific application, pathology, and complexity of the case. Although existing literature has examined the development of 3DP laboratories in clinical settings (9,15-19), the elements required to create such a facility often remain fragmented (9,16,20), making the process of assembling the necessary components long and laborious. Each organization differs in clinical goals, available resources, and institutional priorities, leading to wide variability in how 3DP services are adopted and managed. Furthermore, substantial initial costs, lack of clear reimbursement frameworks, absence of standardized training programs and the need for multidisciplinary expertise, continue to hinder technology adoption (21-23). These challenges are further influenced by heterogeneous regulatory frameworks across jurisdictions such as the United States, Europe, and developing countries (15). In orthopaedic traumatology, in particular, a thorough investigation is needed to determine how to best integrate 3DP into surgical practices.

Objective

This article serves as an overview for establishing a hospital-based 3DP laboratory within the European Union regulatory context. It reflects the insight acquired from our experience involving the start-up of a recently born UNICA3D LAB within the Duilio Casula University Hospital located in Cagliari, Sardegna, Italy. Hereby, clinical benefits, workflow, resources, cost analysis, and regulatory considerations are outlined. It explores the practical challenges and opportunities associated with developing an interdisciplinary service, highlighting how these labs can support surgeons to improve patient outcomes. Special emphasis is placed on orthopaedic trauma applications, reflecting the growing demand for PS solutions in hospitals with an orthopaedic focus. We present this article in accordance with the Narrative Review reporting checklist (available at https://asj.amegroups.com/article/view/10.21037/asj-25-55/rc).

Methods

PubMed, Web of Science, Google Scholar and Scopus databases were searched for articles published between January 2015 and February 2025. The search terms included “3D printing” AND “unit” AND “in-house” AND “hospital” AND (“development” OR “orthopaedics”). The full search strategies for each database are given in Table 1. Publications identified in these searches were imported into Zotero bibliography software to identify and exclude duplicate and retracted articles. Studies were included if they explored the development, implementation, or application of 3DP in orthopaedic surgery and provided pertinent insights on cost, workflow, or regulatory frameworks within in-house hospital settings. Two authors (G.M. and C.G.P.) independently screened the articles based on title and abstract and selected those that met the inclusion and exclusion criteria. The full text of the selected articles was then reviewed to confirm that all criteria were met. The reference lists of these articles were then manually searched for other relevant articles. In parallel with database searches, a targeted grey-literature search of official hospital and university webpages, was conducted to identify and characterize European POC laboratories relevant to orthopaedics and trauma. Eligible web sources were limited to official institutional pages or peer-reviewed publications. Institutional webpages are used for descriptive attributes only (governance, scope, technologies, regulatory) and are cited with access dates. All authors agreed on the final list of articles following the full-text review process.

Clinical utility and indications

Orthopaedic surgery was among the first specialties to explore 3DP (24). Its application, once limited to complex cases, has become routine and is set to transform clinical practice (13). In the preoperative phase, 3D CAD offers significant advantages compared to traditional 2D imaging, allowing surgeons to virtually interact with three-dimensional models of the patient anatomy. With the help of an engineer, the surgeon can segment and highlight bone fragments (Figure 1A), perform virtual reductions (Figure 1B), and simulate implant positioning and sizing. This interactive planning provides a deeper understanding of spatial relationships that may lead to a change in the planned surgical approach (25), therefore influencing surgical decision-making. While a CAD model can often be sufficient for preoperative planning, the printed model can be useful to physically simulate the procedure (Figure 1C). The most commonly adopted application of 3DP is creating high-fidelity anatomical models that aid haptic feedback and provide spatial relationships that 2D imaging cannot capture (26). It has been demonstrated that it can be used to accurately predict the size of bone deformities, inducing a reduction in the implant inventory up to 60% (27-29). 3D printed models can also be used as a template for prebending reduction plates prior to surgery (30,31). In addition, the model can be handled and examined intraoperatively. In this regard, it has been shown that surgeons’ level of experience influences how helpful the anatomical model is, with less experienced surgeons benefiting significantly more from the use of 3D modeling (32). Although more experienced surgeons may not consider the model essential for a successful outcome, most still support its use to improve communication within the surgical team (33). One of the additional advantages of 3D-printed models is their role as effective educational tools. They support surgical training and improve patient understanding by offering clear visual explanations of their pathology and the planned treatment (34). Furthermore, 3DP enables the production of PS surgical instruments, such as custom guides, alignment jigs (26,32,35), PS implants and prostheses (36,37). Multiple studies confirm that 3DP adoption within orthopedics significantly reduces operating time, blood loss, and fluoroscopy usage while improving bone union and decreasing complication rates (29,37-40). Nevertheless, the start-up phase of a hospital-based 3DP laboratory is characterized by practical constraints and hurdles that must be considered by institutions. While clinical benefits are increasingly well documented, the clinical promise of 3DP cannot be fully realized without an operational framework that ensures the reliable, timely, and safe production of models within the healthcare infrastructure. Securing funding is often one of the first challenges. Initial investment may be supported through dedicated innovation grants from universities, research calls at regional or national level, or hospital development funds (22). Clinical demand can be initially modest and uneven across services, and time is required within healthcare organisations to build awareness among practitioners of the indications, capabilities, and limits of 3DP. Surgeon availability for case reviews is limited by operating-theatre schedules, and some clinicians may be slower to adopt new technologies. The technical learning curve in segmentation, print setup (orientation/supports), and post-processing can lead to print failures and rework. Since the opening of the UNICA3D LAB in March 2025, approximately 40 virtual CAD plans were completed, and 24 anatomical models were printed for pre- and intra-operative planning and education; no patient-contact devices were manufactured. This reflects a deliberately conservative scope while governance, quality procedures, and staff training are being established. The next section outlines the workflow employed in the newly established UNICA3D LAB located within the University Hospital Duilio Casula (CA, Sardegna, Italy). It includes the steps involved in the creation of 3D modeling and 3DP for orthopaedic surgery.

Figure 1 Applications of CAD and 3D-printed models in orthopaedic surgery. (A) Segmentation facilitates visualization of bone fragments in complex trauma cases. (B) 3D modeling allowed the detection of a fragment rotated 180 degrees. Following digital reduction, the surgeon decided to change the initial surgical approach. (C) A printed model supports preoperative planning. CAD, computer-aided design.

Workflow

Hospital-based 3DP units share a common workflow backbone (7,17). The process typically begins with the submission of a clinical request, which specifies the intended application of the model or device. This is followed by the acquisition of patient imaging data. The imaging data are then processed through segmentation to isolate the relevant anatomical structures. Once segmentation is complete, CAD tools are used to refine the model, make necessary adjustments, or design PS devices. If necessary, the finalized digital file is sent to a 3D printer for production. After printing, the product undergoes post-processing steps and items intended for intraoperative application are subsequently sterilized. An overview of the process of the workflow employed at the UNICA3D LAB is illustrated in Figure 2.

Figure 2 Workflow employed at UNICA3D LAB for clinical integration of 3D printing. The process starts with a clinical request raised by the treating team, followed by image acquisition of the region of interest. Data are then segmented and refined into a CAD model (e.g., anatomical models, patient-specific guides). These stages undergo clinical validation to confirm anatomical fidelity and intended use. The team determines whether virtual planning alone is adequate; if so, surgery proceeds without physical print. When a tangible device is required, 3D printing is performed in-house. If capacity, material, or regulatory constraints arise, production may be outsourced. After printing, the model goes through post-processing (support removal, washing/curing, finishing) and quality control with visual and dimensional checks. Models intended for intraoperative use are then sterilized before surgery. CAD, computer-aided design.

Request and image acquisition

The process begins with a physician, typically surgeons within our hospital from specialties such as orthopaedics, trauma and oncology, identifying the need for a three-dimensional representation to support clinical planning (9,41). The physician submits a request detailing patient information, intended purpose, 3D model specifics, and the completion date. This can be done in various ways depending on the facility’s policies. Institutions may use intranet submissions, email, or standardized order sets. However, for handling large volumes, the most efficient option is to employ a structured request form, preferably integrated into the electronic health record system (Figure 3) (17). Based on the information provided, the radiologist acquires cross-sectional volumetric images of the targeted area, which are typically stored in the Digital Imaging and Communications in Medicine format. Even if every step in the workflow contributes to the creation of the 3D models, many studies emphasize that image acquisition constitutes the backbone of the process (42-44). When performed effectively, it can save countless hours in subsequent phases. Therefore, the radiologist must be well-trained and equipped to capture images that meet the specific criteria of each case. The primary imaging acquisition methods employed for 3D modeling are computed tomography (CT) and magnetic resonance imaging (MRI) (43,45,46). CT is preferred for orthopaedic applications since it produces high-resolution 3D images that offer strong contrast that delineates bone structures. On the other hand, MRI excels at imaging soft tissues and is particularly useful for evaluating joints, cartilage, muscles, and tendons (47). MRI is radiation-free; hence, it can be a better option, especially for pediatric and young adult patients (46). However, it’s more expensive, time-consuming, and struggles to precisely delineate cortical bone, often requiring laborious manual corrections during segmentation (47). While recent MRI techniques have improved image resolution, they are unlikely to fully replace CT in the near term, especially in emergency settings (48). Currently, to minimize artifacts in bone 3D models, it is advisable to generate them from soft tissue CT reconstructions (49). However, in clinical scenarios requiring both bone and soft tissue data, models can be generated using a process of registration of both CT and MRI sequences (48). In literature, various image acquisition protocols for 3DP in orthopaedics are reported (17). Beyond selecting the appropriate imaging modality, the radiologist must consider other parameters to secure high-quality data for 3D modeling. Resolution, defined by voxel size, determines image clarity. While thicker slices can reduce scan time and radiation exposure, they may compromise the model’s accuracy, creating a “staircase” effect (41). Diagnostic CT scans typically use a 2–5 mm slice thickness (26,50). Orthopedic 3D imaging workflows commonly use CT acquisitions with a slice thickness of 0.5–1.5 mm to balance image noise and surface fidelity (19,48-50). Surveys of Spanish hospitals indicate Traumatology and Maxillofacial departments are the leading requestors for models and guides (23). In these fields metal implants are common and artifacts and image scattering often pose a challenge for diagnostic imaging and segmentation. To address this, various metal artifact reduction techniques have been developed (45,51).

Figure 3 Workflow of medical 3D printing for patient-specific models. CAD, computer-aided design.

Image segmentation and CAD creation

Once the medical image is acquired, the data is imported into dedicated software where a radiologist or biomedical engineer performs the segmentation (Figure 3). Segmentation refers to the process of isolating the region of interest from the rest of the imaged anatomy (40). The segmentation process typically begins with thresholding, a software function that filters tissues based on their density. Often, manual corrections are applied, ensuring that the borders accurately reflect true anatomical boundaries. These adjustments may include contour modifications, hole filling, and artifact removal (26). A variety of segmentation software exists, including both commercial and open-source options. The operation may be performed manually, via automated, semi-automated approaches, or by combining these methods (52). At UNICA3D LAB, segmentation is executed in Mimics Innovation Suite Software (Materialise, Leuven, Belgium) by a biomedical engineer through semi-automated approaches (18,42). However, workflows may vary depending on the facility’s structure. Radiology-anchored services typically emphasize close coordination between radiologists and surgeons to define the region of interest, optimize acquisition protocols, and often retain segmentation responsibilities within the radiology department (17,19,24,42). In contrast, department-embedded or engineering-led models (e.g., within orthopaedics or medical physics) tend to delegate day-to-day segmentation tasks to trained engineers (23,53,54). Before proceeding to the next step, it is considered best practice to obtain approval of the segmentation from the referring surgeon (34). After segmentation, the 3D model is imported into CAD software such as Materialise 3-Matic, Fusion 360 and Meshmixer for further refinement. At this stage, PS solutions, such as implants, surgical guides, and other customized medical devices, can be designed and optimized for specific cases. Finally, the model must undergo essential quality checks, including overlaying it on the original imaging to confirm anatomical accuracy, validating the design with the referring surgeon to ensure it meets its intended purpose, and labeling it with a unique identifier for traceability (52). Before the model is ready for 3DP, common issues like open meshes and non-manifold edges must be identified and resolved. The model is then converted into a Standard Tessellation Language (STL) file, a widely used format compatible with 3DP technologies (55). In many cases, virtual models and preoperative planning provide adequate information to achieve the intended clinical outcome. Hence, when virtual planning alone is sufficient, the workflow can appropriately conclude at this stage, without proceeding to physical model fabrication.

3DP and post-processing

Once the STL file is generated, it is imported into slicer software, which slices the file into horizontal layers. This software allows the user to simulate the object’s position and orientation on the 3D build platform, estimate print duration and material consumption, and configure parameters such as slice thickness and the inclusion of supports. Once this process is complete, the file is uploaded to the printer via Wi-Fi or USB, and the machine begins the printing phase. Technology selection varies across institutions, depending on clinical scope and operational needs. In the medical sector, the most common 3DP technologies are fused deposition modeling (FDM) and stereolithography (SLA) (26). A study by Valls-Esteve et al. reported that most hospital-based labs in Spain primarily use polymer-based printing, with FDM employed by 83.3% and SLA by 56.7%. Material jetting (MJ) technologies are less common, while powder bed fusion (PBF) and metal printing remains rare and is typically outsourced due to high cost, complexity and infrastructure demands (23). Many institutions adopt a hybrid model, combining in-house printing with external services when specific materials, capacity, or regulatory considerations require it (23). Within the UNICA3D LAB, Formlabs SLA Form2 machines are employed to produce resin models once finished, the printed part is removed from the platform and cleaned of the supports and residual material. Cleaning methods vary based on the specific 3DP technology used and the intended outcome. The resins employed in our lab are Formlabs Model Resin V2, compatible with Form2 printers. For non-contact applications, such as planning or educational models, standard resins are sufficient. For any patient-contact applications (e.g., surgical guides), biocompatible, sterilizable resins must be selected and adopted following manufacturer instructions and local sterilization policies (15). Once printed, models are detached from their supports, rinsed in isopropyl alcohol, and post-cured under ultraviolet light in a Formlabs Wash and Cure station. Additional finishing steps, such as sanding or polishing, are then applied to achieve the required surface quality and structural properties. During the printing and post processing phase, several challenges may arise. Print failures related to incorrect orientation, insufficient support, or material shrinkage are not uncommon and may require repeating the process, increasing time and cost. Another issue is the balance between print resolution and production time, as high accuracy often comes at the expense of longer build durations. Post-processing steps, such as cleaning and polishing, introduce additional risks of damaging fragile anatomical structures.

Quality control and sterilization

Quality control refers to the process by which 3DP models are inspected to verify the correspondence between the physical print and the digital reference model. Depending on the intended use, quality control may involve a simple visual inspection, a geometric check of dimensions and tolerances, or a mechanical evaluation (56). However, since mechanical strength is typically evaluated through destructive testing, the mechanical properties of printed devices are often not measured or verified after production (57). 3D scanners can be used to generate a CAD version of the printed object, which can then be superimposed onto the original digital model to analyse discrepancies and evaluate the dimensional accuracy of the print. 3DP models intended for direct patient contact or intraoperative use often require sterilization to ensure safety and compliance with clinical standards. The print can be sterilized through steam (autoclaving), ethylene oxide gas, or hydrogen peroxide plasma sterilization (52). Depending on the sterilization method employed by the hospital, the material used for the printed device may be subject to alterations, including warping, melting, increased brittleness, or residual toxicity (57). Among these methods, steam sterilization is the most commonly used in surgical settings due to its non-toxic nature, involving pressurized steam at high temperatures (58). However, to maintain the dimensional and structural integrity of the printed object, the material must be capable of withstanding the high temperatures typically involved in this process (59). It is documented that heat-based sterilization techniques are generally unsuitable for FDM thermoplastic filaments, as these materials tend to deform under high heat conditions (60). In this context, Burkhardt et al. evaluated the dimensional accuracy of surgical guides produced using various 3DP technologies before and after exposure to 134 ℃ steam sterilization. Their study revealed that FDM-printed guides exhibited significant warping and deformation, rendering them clinically unusable. In contrast, SLA printed guides retained high dimensional accuracy and were therefore more suitable for surgical applications (61). In any case, it is recommended to reassess the print quality after sterilization to ensure that the process has not compromised the model’s integrity or accuracy. As the last step of the clinical workflow, the finalized implant or model must typically be delivered to the hospital’s sterilization unit at least 24 hours before surgery (18).

3D service resources

Establishing an in-house 3DP lab in a hospital setting requires a well-planned integration of physical space, specialized software, and a skilled multidisciplinary team.

Personnel

The success of the laboratory depends on the coordinated efforts of a multidisciplinary team comprised of surgeons, radiologists, biomedical engineers, and technical support. A small practice focused on a single surgical discipline might be managed by only one to two individuals operating a single desktop 3D printer (33). As the laboratory expands, part-time staff may first be added, and eventually full-time specialists in each domain can be brought on board to distribute responsibilities (62). Information technology technicians are needed, especially in the initial building phase, to configure the machines, integrate the lab within the hospital’s existing network infrastructure and provide support in case of technical emergencies. Radiologists must be actively involved in the early stages, as their expertise in medical imaging is essential for proper image acquisition, optimization, and segmentation, ensuring accurate models for surgical planning. Engineers have a crucial role as they represent the bridge between surgeons’ needs and product concretization. They need to be proficient in imaging segmentation, CAD, 3DP, anatomy and pathological conditions. Since the learning curve can be steep, it is important to set up an organised training program with defined and measurable objectives (17). In Europe, several new training opportunities have recently emerged to build the skillset needed for professionals working in hospital-based 3DP units (63). Surgeons represent the end-users and therefore, without their interest and willingness to adopt the technology, its implementation is unlikely to succeed. Since engineers and surgeons’ ways of thinking may differ considerably, it is crucial to establish a synergetic relationship to allow efficient knowledge transfer. Engineers should be fully integrated within the clinical workflow, being part not only of preplanning but also of the intraoperative process, enhancing overall understanding of clinical needs. Besides physical and human resources, hospitals must evaluate the financial sustainability of their in-house 3DP services.

Physical space

The dimensional requirements for the workspace can vary widely and should be tailored to the intended scale of operations. Since 3DP processes can generate noise and particles, it is advisable to establish separate but adjacent zones for different functions (24). It is documented that 3DP can release ultrafine particles (<100 nm) and volatile organic compounds, posing occupational hazards (64,65). For this reason, the UNICA3D LAB was designed with one zone dedicated to printing equipment and an adjacent area for computer workstations used in design and model preparation (Figure 4). This spatial separation helps isolate noise, fumes, and debris from the main working area. Hence, improving overall safety and comfort. Both areas should be equipped with adequate power outlets and robust network connectivity to reliably support all printers, computers, and peripheral devices. Bastawrous et al. report the minimum space requirements to install various 3DP ecosystems, and FDM is noted as the least space-intensive, requiring approximately 29 square feet, followed by MJ and SLA, which require around 47 and 54 square feet, respectively (24). In contrast, PBF demands significantly more space, with a total footprint of approximately 400 square feet (24). A separate area or benchtop should be designated for post-processing and quality control, equipped with measurement instruments for dimensional inspection and any necessary finishing tools. Finally, the facility should include appropriate utilities such as a sink or dedicated washing station, along with a ventilation system to maintain good air quality.

Figure 4 Overview of the UNICA3D Lab. Computer workstations are located in an external area for CAD design and real-time monitoring (A), while 3D printing equipment is placed in an adjacent zone to isolate noise, fumes, and debris (B). This area also includes workbenches, fume hoods, and a sink for post-processing and quality control. CAD, computer-aided design.

Cost-effectiveness

Depending on the intended scale of implementation, the cost variations can be substantial. While a small clinic may require a desktop printer and minimal personnel, a hospital-integrated facility demands multiple advanced printers, skilled professionals, and dedicated infrastructure (22,52,66). Nevertheless, even for larger facilities, there is always the possibility to start with a smaller setup and expand progressively as needs and capabilities grow. Initial capital investment for a POC manufacturing facility can be supported through small internal or external grants (52). Funding an in-hospital 3D service can follow several routes, including establishing the facility as an independent service line with internal chargebacks or external contracts, or financing it within the local hospital system (22). In university-hospital partnerships, both parties can share capital and operating costs. At UNICA3D LAB, we used a shared-cost model. During the start-up phase the Department of Surgical Sciences purchased Materialise Mimics license and the 3D printers, while the university provided the footprint, infrastructure upgrades (power outlets, sink, fume hoods), workstation, and consumable materials. At the initial stage, POC programs are not expected to generate substantial revenue, and their implementation typically involves considerable up-front investment (52). Therefore, each institution should conduct a breakeven analysis to determine the number of 3DP models needed to offset operational costs. The breakeven point can be calculated by assuming linear cost and revenue functions, with the formula: fixed costs/(cost savings per case − variable costs) (67). To maintain consistency and avoid heterogeneous data reporting, this section excludes metal 3DP, which requires significantly higher capital investment. Fixed costs remain unchanged regardless of production volume. This includes investments in 3D printers, post-processing equipment, software licenses, quality management system (QMS), and initial staff training. Initial setup costs for a small-scale facility are reported to range between $10,000 and $30,000, covering essential components such as a printer, free software, materials, and staff training. However, other relevant expenses such as annual software fees (e.g. Materialise Mimics, up to €20,000 per year), and labour need to be considered (62). Variable costs depend on the number of printed models, including consumable materials, labour expenses, hardware depreciation, and operational overhead such as energy consumption and routine maintenance (68). Given the increasing affordability of 3D printers, the machinery and material costs associated with the technology are now relatively low (69,70). The per-unit cost of 3DP models ranges from just a few dollars to several hundred, depending on the anatomical complexity and the technology employed (41). Gómez et al. considered the overall 3DP process expenses involved in the production of surgical guides and anatomical replicas while using a free segmentation software and an SLA printer. They report an average cost of €150 for models fabricated with FDM and €200 for those produced with SLA (71). Garcia et al. detail a six-year experience developing a hospital-based 3DP unit, analyzing printing times and costs employing FDM, SLA, and MJ technologies. Average fabrication costs for hemipelvis models were €15 with FDM, €60 with SLA, and €651 with material jetting. Beyond production-related expenses, labour constituted a supplementary expense of €70 per bone model (17). Similarly, Gkika et al. demonstrated that, when excluding start-up expenses and considering only the manufacturing process, labour constituted over 90% of the total costs when employing FDM (72). Depending on the region of employment and the technician’s competencies, the hourly labour rate can vary between €20 and €80, significantly impacting overall operational costs (5,17,52,67,71,73). Time required to segment, prepare, and manufacture 3D anatomical models ranged from a few hours to three days based on the model complexity and the intended use (74). Hence, labour costs are also influenced by the technician’s level of experience and efficiency. This raises a question for many institutions: whether to invest in their own additive manufacturing infrastructure or to rely on third-party services. While outsourcing eliminates the need for internal infrastructure and staffing, it is associated with higher costs, slower production times, and potential concerns regarding data security (9). Although upfront and operational investments can be substantial, current research indicates that long-term returns justify these expenses for healthcare institutions (75). A comparative cost analysis found that internally manufactured skull models had a mean production cost of $236.38±26.17, significantly lower than the $1,677.82±488.43 associated with externally manufactured models (73). Beyond cost savings compared to outsourcing, the primary measurable factor supporting the adoption of 3DP models within healthcare infrastructures is the reduction in surgical time. The time saved in the surgical theater implementing 3D-printed models can potentially offset the associated operational costs (76-78). A systematic review and meta-analysis by Morgan et al., encompassing 17 studies and 922 patients, demonstrated that 3DP in orthopaedic trauma surgery reduced operative time by approximately 20%, intraoperative blood loss by 25%, and fluoroscopy usage by 24% (40,79). In acute lower-extremity deformity corrections in pediatric orthopaedic surgery, Trisolino et al. demonstrated that integrating virtual pre-operative planning and POC PS instrumentation reduced overall procedure time by an average of 45 minutes (37). Zheng et al. reported that employing 3DP surgical guides in proximal femoral varus rotational osteotomy halved the operative time (80). For complex head and neck reconstruction, Padilla et al. reported a mean of 65 minutes of reduced operating room time (81). Ballard et al. conducted a cost analysis showing that seven studies using 3D-printed anatomic models demonstrated an average surgical time saving of 62 minutes, while 25 studies using 3D-printed surgical guides reported an average saving of 23 minutes. Considering average operating room costs of $62 per minute, they estimated that producing 63 models or guides per year would be the minimum required to break-even and cover annual fixed costs of $150,000 (67). On the other hand, some researchers argue that 3DP has yet to demonstrate significant improvements in clinical outcomes and that having a 3D printer in every medical center is not essential (82,83). Moreover, despite economic analyses regarding the feasibility of implementing in-house 3DP laboratories, Serrano et al. highlight a notable scarcity of high-quality evaluations. Existing cost analyses remain highly heterogeneous, with many studies focusing on isolated financial aspects, thereby failing to provide a comprehensive and in-depth economic assessment. Recurring factors often overlooked in literature include initial setup costs for the laboratory, software licenses, hardware depreciation, and QMS implementation (20). Therefore, further context-specific studies are needed to strengthen the available evidence. Nevertheless, beyond purely economic considerations, developing an in-house 3D lab provides the opportunity to deliver PS treatments, foster interdisciplinary collaborations, and move closer to personalized medicine. It improves clinical understanding, supports optimal treatment strategies, and enhances overall quality of care. Yet, even with favorable economic projections, hospitals must operate within a well-defined legal and regulatory framework, especially when producing patient specific devices. The next section examines these requirements in the European context.

Regulatory considerations

Healthcare institutions intending to establish a 3DP center are required to adhere to the guidelines outlined in the European Medical Device Regulation (MDR) 2017/745 (84). A starting point is a proper understanding of what qualifies as a medical device. Under the MDR, a medical device is defined as any instrument, apparatus, software, or material intended to be used on humans for medical purposes such as diagnosis, prevention, or treatment (84). For instance, anatomical models designed for educational and training purposes are not considered medical devices. On the other hand, anatomical models used for surgical planning are increasingly recognized as important tools for operational decision making. They thus may also be considered and fall under MDR (85). For the MDR, a custom-made device represents any device designed for a specific patient, manufactured individually, and not intended for commercial distribution (84). Surgical guides and PS implants fall under this category. Medical devices are also classified based on factors such as the duration of contact with the body and the level of invasiveness, according to the Medical Device Coordination Group 2021–2024 (86). This classification determines the quality and risk management obligations that the infrastructure must meet to produce a certain device. When a healthcare institution decides to make its own POC devices, it assumes the role of manufacturer and may operate under the exemption provided by Article 5 of MDR (84). In contrast to private manufacturers that must obtain European Conformity marking before placing their devices on the market, health institutions operating under Article 5(5) may provide patient-specific devices without this requirement. This can shorten lead times and reduce costs for in-house centers. However, the distribution of such devices is restricted, as they cannot be placed on the commercial market. Consequently, some centers pursue a full manufacturer license and ISO 13485 certification to broaden their scope, for example by supplying devices to affiliated or network hospitals (15). Nevertheless, institutions must implement a QMS compliant with UNE-EN-ISO13485, conduct a thorough risk analysis in line with ISO 14971, and must assume full clinical responsibility. Custom medical devices may only be requested by a licensed surgeon who is registered with the relevant professional body and who assumes responsibility for the request. For each device produced, the healthcare institution must document the clinical necessity and absence of equivalent commercial alternatives, thus justifying internal manufacturing. The 3D lab must ensure clinical and technical data management, device traceability, and control over the production workflow. It is essential to establish standard operating procedures covering laboratory activities such as equipment maintenance and calibration, material handling, quality control, and staff training (57). It is recommended to implement an electronic document control system. As an alternative, solutions developed internally may be employed as long as they meet quality and compliance requirements (87). Special attention must also be given to occupational safety in a medical setting, particularly concerning the handling of hazardous substances (resins, solvents, powders) and the emission of volatile compounds. Adequate ventilation systems and personal protective equipment must be in place to comply with local occupational health regulations.

Overview of reported European hospital-based 3DP facilities for orthopaedic trauma

Over the past decade, hospitals and universities all over Europe have implemented POC 3DP services to support various specialties including orthopaedic and trauma surgery. These initiatives reflect a growing clinical demand for PS solutions, but they also demonstrate a wide variability in terms of organizational structure, technological adoption, and regulatory integration. Table 2 summarizes European hospital-based 3DP facilities dedicated to orthopaedic applications.

Hospital-based 3DP services are organized under diverse governance models, reflecting differences in institutional priorities and available resources. Some labs are department-embedded and serve a single specialty. Others function as central hospital facilities that are open to multiple departments. A few are branded as large institutional hubs, positioned as hospital-wide resources, while some operate as networked or distributed platforms that span several hospitals. Each model entails different degrees of integration with surgical teams, regulatory responsibility, and resource allocation. Technologies span polymer printing (FDM, SLA, MJ) for anatomical models and PS guides, with selective metal printing typically outsourced. Some centers have pursued formal ISO 13485 certification to enable regulated production, while others rely on hospital QMS under MDR Article 5(5) to provide compliant in-house devices. These inter-facility variations underscore that there is no “one-size-fits-all” model for implementing 3DP in orthopaedic trauma. Instead, local resources, regulatory contexts, and institutional priorities strongly shape service configuration. Nonetheless, the rapid expansion of these initiatives across Europe demonstrates a collective momentum towards establishing POC 3DP as a routine infrastructure. Recent efforts, including the creation of the first European 3DP in Hospitals Special Interest Group, signal a move toward a shared framework to address current gaps (104).

Strengths and limitations

This work offers a practical overview of how to establish an in-house 3DP service within an orthopaedic setting in Europe. Its strength lies in combining hands-on operational detail from a hospital implementation with a structured description of clinical workflow, resources, costs, and regulatory considerations. By situating a single-center experience within the wider European landscape, it draws comparative insights on governance models, technology portfolios, and quality-assurance approaches, translating these into actionable steps for institutions considering POC manufacturing. Several limitations should be acknowledged. This is a narrative rather than a systematic review, so selection and reporting bias cannot be excluded. The regulatory focus is specific to the European context. Institutional webpages are used for descriptive attributes only. Heterogeneous public reporting across centers constrained the depth of inter-facility comparisons. Costs vary widely by setting; metal additive manufacturing was therefore excluded from scope. Institutions should treat the figures and examples as illustrative and adapt them to local clinical governance, quality systems, and regulatory obligations.

Conclusions

This paper provides guidance to support healthcare institutions in implementing a 3DP in-house laboratory. An overview of the workflow, infrastructure, cost analysis, and regulatory considerations is presented. These insights reflect the work undertaken in recent years to start up a 3D Lab associated with the Orthopaedic Department of Duilio Casula University Hospital in Cagliari. The establishment of such a facility can reduce dependence on external providers, lower operational costs, shorten turnaround times, while delivering PS solutions directly at the POC. 3DP technologies’ rapid advancements have made implementing a 3D unit feasible, foreshadowing a future in which these infrastructures become a grounded facility within hospitals. Nevertheless, the clinical promise of 3DP can only be realized through robust operational frameworks and a multidisciplinary team trained to manage clinical challenges. Given the variability of operational costs involved in starting up, each facility should conduct a break-even analysis to evaluate the impact on the local level. In addition, regulatory requirements and the workload associated with implementing a QMS are also crucial aspects to consider. While 3D in-house labs are emerging all around Europe, further studies are needed to lay the foundation of standardized frameworks adaptable to various realities. In this regard, coordination among the 3DP healthcare community is needed to ensure quality, safety, and long-term sustainability. This work aims to support ongoing collaborative efforts to define practice guidelines for establishing in-house 3DP laboratories within orthopaedic and trauma surgery departments.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the Narrative Review reporting checklist. Available at https://asj.amegroups.com/article/view/10.21037/asj-25-55/rc

Peer Review File: Available at https://asj.amegroups.com/article/view/10.21037/asj-25-55/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://asj.amegroups.com/article/view/10.21037/asj-25-55/coif). G.M. serves as an unpaid editorial board member of AME Surgical Journal from December 2024 to December 2026. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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