Material jetted anatomical models of hearts, eyelids, and the lower skull.Medical 3D printing, also known as additive manufacturing (AM), is used for its rapid production, complex geometries, and customization to produce healthcare products, including implants, surgical tools, and anatomical models. AM allows for the creation of form factors that are difficult or impossible to manufacture using traditional methods, supporting personalized designs and enhanced osseointegration in implantable devices. Additionally, this type of medical manufacturing enables production at the point of care for applications where its personalization and speed are most needed, such as preoperative planning models and surgical guides. Medical 3D printing can be accomplished through processes from powder bed fusion to material jetting, and it uses a range of both metals and plastics, as well as ceramics.This manufacturing method introduces challenges related to regulatory compliance, process validation, and insurer reimbursement. In the United States, 3D printed medical devices are regulated under existing FDA medical device frameworks, with additional considerations outlined in the FDA’s 2017 guidance. Depending on device classification and risk, manufacturers may pursue 510(k) clearance, Premarket Approval (PMA), or other FDA-recognized pathways such as De Novo classification. Reimbursement for 3D-printed medical devices remains an evolving challenge. Particularly for applications only recently enabled by medical 3D printing, such as devices manufactured at the point of care, current reimbursement pathways remain inconsistent, though preliminary CPT and HCPCS codes have been established with further development expected as 3D printing continues to grow.Below, we cover:What Is Medical 3D Printing?Pros and Cons of Medical 3D PrintingApplications for Medical 3D Printing3D Printing Medical Devices at the Point of CareTypes of Medical 3D Printer ProcessesMedical 3D Printing MaterialsRegulatory Considerations for 3D Printing Medical DevicesMedical 3D Printing ReimbursementThe Future of Medical Additive ManufacturingWhat Is Medical 3D Printing?Medical 3D printing is the use of AM to prototype and produce healthcare products, including anatomical models, surgical guides, prosthetics, and implants. AM builds objects by joining materials, typically layer by layer, from a design file. Compared to traditional manufacturing methods – such as machining, casting, and molding – AM enables rapid production of complex geometries that can better match a patient’s anatomy, reduce device weight, and, for implantable devices, promote osseointegration (bone growth onto the device surface).Pros and Cons of Medical 3D PrintingMedical 3D printing benefits include the rapid production of patient-customized devices with complex geometries; however, challenges remain in quality consistency and navigating complex regulatory and reimbursement landscapes. Additive manufacturing can be a strong fit for medical applications because healthcare’s inherent need for personalization aligns with AM’s ability to rapidly create cost-efficient patient-customized devices. Additionally, the overall lead times are greatly reduced, since AM eliminates the need for specific tooling and can be implemented at the point of care. At the same time, medical 3D printing creates challenges such as ensuring consistent quality, additional post-processing steps, and navigating relatively rigid reimbursement and regulatory landscapes. The tables below summarize the key benefits and limitations of medical 3D printing.Table 1: Benefits of Additive Manufacturing for Medical Applications 1–3Benefits of AMPatient customizationEnables patient-matched models, guides, and devices from imaging/scan data; improves fit; and can support better clinical outcomes in a more economical manner.Complex geometries (lattices, porous structures, and internal channels)Allows lightweight designs and porous/rough surfaces that can support osseointegration in implants; enables features difficult or impossible to create with conventional methods.Rapid iteration and short lead timesSpeeds up design iteration and validation cycles; supports time-sensitive workflows (e.g., pre-op models/guides) by avoiding long lead times typical with other manufacturing processes.Point-of-care (POC) and on-demand productionOn-site printing can provide rapid-turnaround models and select surgical aids, improving coordination with care teams and reducing logistical complexity during procedures.Material efficiencyMinimizes material waste, resulting in reduced part cost compared to subtractive machining.Digital workflow integrationNaturally fits into the modern clinical planning and device creation workflow: Medical Imaging → Segmentation → CAD → Print Table 2: Limitations of Additive Manufacturing in Medical Applications1,3,4Limitations of AMUnclear regulatory requirementsAM introduces additional process variables such as patient-specific designs, build parameters, orientation effects, and post-processing without established guidelines from regulatory bodies.Reimbursement ambiguity (especially for POC outputs)Some printed items (e.g., models/guides) may not fit clearly with billing pathways, complicating hospital adoption even when clinical value is clear.Quality inconsistency and process variabilityPart properties can vary by machine, build orientation, input material properties, and post-processing steps, driving higher quality assurance needs and concerns around repeatability and accuracy.Post-processing complexity and sterilization concernsMany AM parts require extensive post-processing; powder/residue removal and sterilization process compatibility can be nontrivial, especially with complex internal/porous structures. Economics at scaleUnit costs can remain cost-prohibitive for high-volume, standardized components where traditional manufacturing is more economical due to amortized tooling costs and higher throughput.Upfront investment and specialized staffingIndustrial systems, validation infrastructure, and trained personnel (especially for POC labs) require significant capital and operational commitments.Applications for Medical 3D PrintingApplications for medical 3D printing include rapid prototyping, anatomical models, and production of regulated 3D printed medical devices – including everything from implants to prosthetics to surgical guides. Additionally, AM is actively applied for emerging applications like the printing of human tissues (bioprinting) and pharmaceutical drug printing, often with a focus on personalized treatment plans.3D Printing Medical Device Prototypes3D printing medical device prototypes enables rapid iteration and design changes without the cost or lead times required for traditional manufacturing processes, such as casting and injection molding. This flexibility is particularly useful in early development of medical devices, when frequent adjustments are required to optimize form, fit, ergonomics, and function. Producing prototypes quickly can help identify design issues earlier, streamline verification processes, and reduce overall development time and cost. In some cases, prototypes can be fabricated from materials that approximate the mechanical or sterilization properties of final devices, supporting more realistic bench testing. For example, Raise3D (IMTS booth 338370) digital light projection 3D printers are used to produce high-precision medical prototypes.53D Printed Medical ImplantsPatient specific cranial-maxillofacial implants.3D printed medical implants are used for orthopedic, cranial-maxillofacial, and spinal applications, where patient-specific design, osseointegration, and stiffness tuning help reduce complications and improve outcomes.4 The complex geometries enabled by AM drive functional advantages for implantable medical devices, including:6Patient-specific design: Implants can be tailored to a patient’s anatomy from medical imaging data for better fit and positioning.Osseointegration: Built-in porous surfaces and controlled surface roughness encourage bone to grow into the implant, improving long-term fixation and stability.Stiffness tuning for reduced stress shielding: Lattices and other topology-optimized structures maintain strength while tuning stiffness across the implant to better match bone properties, improving load transfer and reducing stress shielding, which results from an overly stiff implant carrying too much load.Collectively, these advantages reduce complications, such as loosening or misalignment, and have led to improved patient satisfaction and quality of life.7 This has led to an increasing number of 3D printed implants.8 For example, EOS’s (IMTS booth 338450) laser powder bed fusion systems are used to produce titanium cranial implants, and 3D Systems (IMTS booth 338466) produces implants as a manufacturing service provider using polymer extrusion and laser powder bed fusion systems, including PEEK cranial implants, titanium acetabular hip cups, and titanium spinal cages.9–12More 3D Printed Medical DevicesBeyond implants, additional 3D printed medical devices include anatomical models, surgical guides and instruments, orthotics, and prosthetics.Anatomical Models3D printed anatomical models enable patient-specific modeling, and include both regulated and unregulated devices depending on the context. The 3D printing process enables straightforward transformation of medical imaging data into patient-specific anatomical models, including replicating imaging characteristics:13Regulated Models: Anatomical models can be produced as regulated devices to support preoperative planning and practice, helping clinicians anticipate access, sizing, and fit considerations prior to a procedure.14Unregulated Models: Models can also be used in unregulated educational contexts for patient awareness and clinician training, including leveraging materials that can mimic tissue properties.15 For example, Stratasys (IMTS booth 338460) uses its PolyJet material jetting systems to produce eyelid surgical training models.16Surgical Guides and Instruments3D printed surgical guides and instruments are patient- and procedure-specific devices designed to reduce intraoperative variability and improve surgical accuracy. These are typically designed from preoperative imaging or scan data and printed within days to support surgical procedures:Surgical Guides: Guides are commonly used to transfer a surgical plan into the operating room by constraining alignment and placement variability for steps like drilling, cutting, and device positioning. AM enables the rapid production of personalized guides to support repeatable execution of planned angles, depths, and locations and reduces time spent on intraoperative trial-and-check.4,12,17 For example, Formlabs (IMTS booth 338260) provides an application workflow for producing 3D printed surgical guides using its stereolithography systems.18Instruments and Accessories: Custom instruments and accessories (e.g., scalpel handles, forceps, retractors, alignment aids, and custom grips) improve surgeon comfort and allow for procedure-specific modifications. AM enables this workflow through fast turnarounds – often at the point of care, incorporating surgeon-driven improvements – and the ability to print feature-rich, personalized structures.Orthotics and Prosthetics (O&P)A group of thermoplastic prosthetics and orthotics.3D printed orthotics and prosthetics enable patient-specific devices from patient measurements and body scans, to supporting improved fit and rapid iteration: Orthotics: Orthotic devices, which support an existing body part (e.g., insoles, braces, and supports), can be produced with tuned stiffness and lightweight structures for improved comfort and fit.19Prosthetics: AM is used for prosthetic devices and components (including sockets), which replace missing body parts, where rapid iteration and geometry flexibility are important, supporting customization and improved functional comfort.20 For example, Formlabs (IMTS booth 338260) selective laser sintering printers are used for prosthetic fingers, finger sockets, elbows, and shoulders.21Emerging Applications for Medical 3D PrintingEmerging applications for medical 3D printing include printing living cells (bioprinting) and printing pharmaceuticals, and often fall under different regulatory pathways. While these applications are still in early development stages and face significant scientific and regulatory challenges, they illustrate the broader potential of AM to influence future approaches to tissue engineering, physiologically relevant tissue models, and printed pharmaceuticals. Because these technologies are not yet widely adopted for commercial use, they have been excluded from subsequent sections on 3D printing processes, materials, and regulations.BioprintingBioprinting is the 3D printing of living cells in combination with biomaterials, which are cell-compatible materials that provide scaffolding structures to form living tissue. While this process remains largely at the research stage, bioprinting has shown potential for applications such as tissue replacement, including patient-specific cartilage repair, skin grafts, and – long term – fully functional organs to address tissue donor availability and enable individualized engineered tissue solutions.2 Another popular research application for bioprinting is printing tissue models for drug development and disease research. These models provide physiologically accurate testing platforms – compared to conventional two-dimensional cultures and many animal models.22 The FDA updated its requirements in April 2025 to remove mandatory animal testing for certain drugs in favor of methodologies such as lab-grown human-derived tissues.23 As a result of this change, bioprinted tissue models may become an increasingly common alternative or supplement to animal testing in future drug development.Pharmaceuticals3D printing pharmaceuticals enables custom drug-delivery systems (often tablets) with with controlled release profiles and dosages by leveraging AM-enabled complex internal geometries. These capabilities may expand availability of personalized medicine approaches by simplifying treatment regimens. In particular, patient-specific dosing or combination pills can be composed of multiple active ingredients with distinct release characteristics that reduce the number of tablets and maximize dose efficacy.1,24,253D Printing Medical Devices at the Point of Care 3D printing medical devices at the point of care (3DPOC) is the practice of using a 3D printer in medical industry locations – such as hospitals or clinical facilities – rather than at an external manufacturing site. In practice, items such as anatomical models, patient-specific surgical guides, and custom orthotics can be designed and printed in the same building where the patient will receive treatment. This approach significantly shortens the traditional manufacturing timeline from weeks or months to hours or days, and it enables closer coordination among clinicians, engineers, and patients. By bringing manufacturing closer to the patient and doctor, 3DPOC supports more informed and timely personalized treatment options and elevates the standard of care available.2,3 Common 3D Point of Care ApplicationsThe most common instances of point-of-care 3D printing fall into low- to medium-risk categories (Class I and Class II devices), where the combination of personalization, fast turnaround, and lesser regulatory requirements make onsite production both feasible and valuable. These include:Anatomical models for surgical planning and patient communicationPatient-specific surgical guides and positioning aidsOrthotics and prosthetic componentsCustom instruments that support planning or intraoperative workflowPros and Cons of 3DPOC Table 3: Benefits and Limitations of 3D Printing at the Point of Care (3DPOC)1,2 Benefits of 3DPOCLimitations of 3DPOCSignificantly faster turnaroundEnables rapid iteration of designs, if neededEnhanced collaboration between clinicians and engineers to achieve better patient outcomesImproved patient communication using anatomical guides/models to clarify treatment plansTraditional hospital staff are not device manufacturers, requiring training or hiringExtensive regulatory documentation and part tracing requirementsInconsistent insurance coverage and reimbursement for 3DPOC-produced devicesHospital facilities are not set up for manufacturing; high startup costs with equipment purchases and facility improvementsHow Is 3DPOC Implemented?Point-of-care 3D printing can be implemented in several ways including, internal hospital labs, co-located manufacturers on hospital premises, or through a third-party developed medical device production system (MDPS) operated by hospital staff. Each model carries different regulatory responsibilities, staffing needs, and operational considerations. In 2021, the U.S. Food and Drug Administration outlined three distinct implementation models.261. Fully Internal Hospital 3D Printing LabsSome hospitals run their own additive manufacturing labs, staffed by biomedical engineers, imaging specialists, and dedicated technicians who design and print devices entirely in-house. Early adopters such as the Mayo Clinic in Rochester, Minnesota, and the U.S. Department of Veterans Affairs (VA) health system use this model to produce anatomical models, surgical tools, and select Class II devices such as surgical guides.32. Co-Located Manufacturer on Hospital PremisesIn this model, an external medical device company places equipment and specialized staff inside or adjacent to the hospital. The manufacturer remains responsible for regulatory compliance and device production, while the hospital benefits from rapid access, reduced logistical hurdles, and closer collaboration.3. Medical Device Production Systems A third approach uses manufacturer-designed production systems. The hospital operates the hardware and software, but the device company retains responsibility for ensuring that the system as a whole meets regulatory requirements. This concept comes from early FDA discussion papers and is not yet a formal regulatory pathway, but it illustrates a potential hybrid model for future POC manufacturing.These three configurations reflect the FDA’s evolving, but not yet formalized, thinking on point-of-care manufacturing. They illustrate likely paths hospitals may take to integrate additive manufacturing into clinical practice, while the regulatory landscape continues to develop.2Types of Medical 3D Printer ProcessesThe most common medical 3D printer processes include, powder bed fusion (PBF), material extrusion (ME), vat polymerization (VP), material jetting (MJ), and binder jetting (BJ). Each process differs in how they process materials, material compatibility, available build volumes, and the end part characteristics they can produce. AMT – The Association For Manufacturing Technology – recognizes 16 distinct 3D printing processes plus hybrid combinations of AM with other manufacturing technologies in order to increase visibility and specificity towards commercially available processes. The ISO/ASTM 52900 standard defines seven primary 3D printing process categories to standardize terminology and help streamline qualification pathways.27 The commonly used AM processes by ISO/ASTM category for 3D printing in medical field applications include powder bed fusion (PBF), material extrusion (ME), vat photopolymerization (VP), and material jetting (MJ). Table 4: Summary of Medical 3D Printer Processes Commonly Used in Medical Applications with Their Associated Materials, Example Use Cases, Select Benefits, and Notable Limitations for Medical Applications4,12,28–30 ProcessMaterialsUse CasesBenefitsLimitationsLaser Powder Bed Fusion (LPBF)(Metal) Titanium (Grades 1-4, 5, 23), CoCr, Stainless steelsImplants, surgical instrumentsHigh strength, high resolutionHigh cost, lower build volume utilization due to limited support-free printingElectron Beam Powder Bed Fusion (EBPBF)(Metal) Titanium (Grades 1-4, 5, 23), CoCrImplants, surgical instrumentsFaster printing and improved build volume utilization (no supports) compared to LPBF, low residual stressLower resolution, high costSelective Laser Sintering (SLS)(Polymer) PA11/PA12, PEEK/PEKKOrthotics and prosthetics, surgical guides, implantsHigh resolution, no supportsSterilization challenges and implant regulatory requirements, unequal mechanical properties in all directions (anisotropic)Material Extrusion (ME)(Polymer) ABS, PLA, TPU, Silicone, PEEK, and carbon fiber-filled compositesPrototypes, orthotics and prosthetics, surgical guides, select implantsAffordable, easy to useLow resolution, porosity, unequal mechanical properties in all directions (anisotropic)Vat Photopolymerization (VP) – Digital Light Projection (DLP), Stereolithography (SLA) (Polymer) Photopolymer resin; (Ceramic) HydroxyapatiteAnatomical models, prototypes, hearing aids, bioresorbable implantsHigh resolution, smooth surfaceBrittle or otherwise limited material properties, polymer material biocompatibility concernsMaterial Jetting (MJ)(Polymer) Photopolymer inksAnatomical modelsHigh resolution, multi-colorHigh cost, limited material propertiesBinder Jetting (BJ) – High Speed Sintering (HSS)(Polymer) PA11, PA12, TPUOrthotics and prostheticsHigh resolution, no supports, equal mechanical properties in all directions (isotropic)Limited materialsPowder Bed FusionThe powder bed fusion process selectively fuses polymer or metal powder layer-by-layer to create parts based on a design file.Metal Powder Bed Fusion (LPBF, EBPBF)The inner workings of a laser powder bed fusion printer.Metal PBF is further categorized based on the energy source used. Laser powder bed fusion (LPBF) uses a laser in an inert gas environment, while electron beam powder bed fusion (EBPBF) uses an electron beam in a vacuum. There are numerous trade names created by companies to describe metal forms of powder bed fusion including Selective Laser Melting (SLM) and Direct Metal Laser Sintering (DMLS) for LPBF-type processes, and Electron Beam Melting (EBM) for EBPBF-type processes. Both LPBF and EBPBF can produce precise, complex geometries with mechanical properties suitable for load-bearing medical implants, while maintaining relatively high productivity in meter-scale build volumes. LPBF generally offers higher resolution and smoother surfaces, making it well suited to intricate features and fine detail. EBPBF, on the other hand, lightly sinters the entire powder bed each layer, forming a semi-sintered “powder cake” that supports parts so they can be built free-floating and vertically stacked, significantly improving build-volume utilization. Combined with EBPBF’s characteristically rougher as-printed surface, which can enhance osseointegration, these attributes make it particularly attractive for standardized implants such as acetabular cups.31Polymer Powder Bed Fusion (SLS)An SLS or polymer powder bed fusion printer's interior.Polymer powder bed fusion, most commonly known as selective laser sintering (SLS), produces functional polymer components with complex geometries, no support structures, consistent mechanical properties, and efficient part nesting for low- to mid-volume production.SLS is widely used for orthotics and prosthetics, surgical guides, and spinal fusion or cranial-maxillofacial implants. It is particularly well suited to applications where patient-specific customization, strength, consistency, and fast turnaround are more important than ultra-fine surface finish or cosmetic detail.30Material Extrusion (ME) The inside of a material extrusion printer.The material extrusion (ME) process selectively deposits material through a temperature-controlled nozzle, also known as a hot-end, onto a build platform, following the toolpaths defined by a digital design file. Also known as fused filament fabrication (FFF) or fused deposition modeling (FDM), ME most commonly uses thermoplastic materials in medical applications, though metal, ceramic, and thermoplastic composite filaments or pellets can also be processed with certain systems.ME is the most prevalent 3D printing technology due to its affordability and accessibility, making it a staple for rapid prototyping throughout the medical device development cycle. Beyond prototyping, ME is used for surgical guides, orthotics and prosthetics, and spinal fusion and cranial-maxillofacial implants.30 However, in general, ME end-use applications are limited by its low resolution, porosity, and unequal mechanical properties (anisotropy) leaving parts weaker perpendicular to the layer lines.Vat Photopolymerization (VP)Inside an SLA (stereolithography) printer.Vat photopolymerization (VP) is a group of additive manufacturing processes that selectively cure liquid photopolymer resin layer by layer with a controlled light source to create finely detailed solid parts. Stereolithography (SLA) is a type of VP that uses a scanning ultraviolet or visible wavelength laser to trace each layer, offering excellent surface smoothness, high accuracy, and consistent mechanical properties. Digital light projection (DLP) is another common form of VP, which, in contrast, cures an entire layer at once using a projected image, enabling faster build speeds than SLA and in some cases, sharper feature edges on smaller part sizes. However, DLP may exhibit pixelation effects or reduced consistency over large build areas. Vat photopolymerization is used for surgical guides, anatomical models, and ceramic bioresorbable implants.4 However, it is worth noting that photopolymer resins used in VP are highly sensitive to printing and post-processing conditions: incomplete curing is associated with cytotoxicity and irritation, while overcuring can embrittle the material and compromise mechanical performance. These unique challenges to VP may make broader adoption more difficult in some medical applications.29Material Jetting (MJ)Interior of a material jetting printer.Material jetting (MJ) deposits photopolymer droplets using inkjet heads and cures each deposited layer with ultraviolet light. This process builds parts with exceptionally smooth surfaces, fine detail, and – in many systems – in full-color. Alternative names for material jetting include Stratasys’ PolyJet and 3D Systems’ MultiJet Printing (MJP). MJ is especially valuable for anatomical models in surgical planning and educational contexts, where visual clarity and realistic appearance are critical.4Binder Jetting (BJ)Binder jetting (BJ) is a powder-bed 3D printing process in which an inkjet printhead selectively deposits liquid agents onto a spread layer of powder to define each cross-section of a part, with surrounding loose powder acting as a self-supporting medium. Within BJ, high-speed sintering (HSS) is a very similar process that is commonly used for medical applications. HSS, also referred to as Multi Jet Fusion (MJF) by HP or Selective Absorption Fusion (SAF) by Stratasys, uses infrared heating to directly sinter each layer of thermoplastic powders rather than relying on a separate post-sintering step. Inside an HSS (high-speed sintering) printer.HSS is increasingly used for orthotics and prosthetics (O&P) because it can produce parts with relatively isotropic mechanical properties, meaning that strength and stiffness are more uniform in all directions rather than being weaker perpendicular to the build (layer) direction. This is particularly important for O&P devices, which experience complex, multi-directional loading during gait and daily activities; more isotropic behavior reduces the risk of premature failure perpendicular to layer lines and supports more predictable, durable performance in patient use.28Medical 3D Printing MaterialsMedical 3D printing materials include metals such as titanium, polymers like PA12 and TPU, and ceramics. Material selection is critical for medical 3D printing. It influences everything from patient safety to mechanical performance and long-term clinical viability. A primary constraint for medical applications is a material’s biocompatibility – its ability to perform its intended function in contact with the body without provoking harmful local or systemic responses. Other key factors include mechanical properties (i.e., strength, stiffness, and fatigue resistance), stability under sterilization and clinical use, and surface characteristics, which can all affect wear, tissue interaction, osseointegration, and patient outcomes.Materials used in medical 3D printing generally fall into three primary categories: metals, polymers, and ceramics. Each class brings distinct advantages and limitations: metals provide strength, durability, and surface properties required for load-bearing implants; polymers offer an affordable option for rapid prototyping, surgical guides, and anatomical models; and ceramics enable highly stable or bioresorbable implants.Metals A comparison between two metal 3D printed knee prosthetics: Ti-64 Grade 23 vs. CoCrMo (titanium alloy vs. cobalt chrome).Metallic materials offer a balance of strength, durability, and biocompatibility ideal for implants – especially load-bearing – and surgical instruments. TitaniumTitanium is one of the most common materials in medical 3D printing due its combination of biocompatibility, high strength, corrosion resistance, and lightweight profile. Plus, it naturally bonds to bone (osseointegration), which is essential for long-term implant stability. Titanium materials are classified by ISO/ASTM standards into grades depending on purity and alloying elements.For medical 3D printing, the commonly used grades are Grades 1-4 (commercially pure titanium, known as CP-Ti), Grade 5 (Ti-6Al-4V), and Grade 23 (Ti-6Al-4V ELI). CP-Ti is more ductile and easier to shape, making it well-suited for non-load-bearing plates. Grades 5 and 23 are widely used for load-bearing implants due to their high strength and excellent fatigue resistance.Grade 23 is a high-purity version of Ti-6Al-4V (called ELI, for extra-low interstitials). It has lower amounts of oxygen, nitrogen, and carbon – smaller atoms that usually occupy the spaces between titanium atoms in the metal’s structure. This improves ductility and fracture toughness, which is important for implants that may endure millions of loading cycles over a patient’s lifetime. Its cleaner chemical composition also supports better long-term biocompatibility, making it the preferred choice for most patient-specific, load-bearing implants. Vanadium-free alloys such as Ti-6Al-7Nb are being explored to avoid toxicity concerns related to long-term vanadium ion release from grade 5 and grade 23 titanium. At the same time, ductile β-titanium alloys are being explored to further improve biocompatibility and better match the flexibility of bone to mitigate stress shielding.32Other MetalsOther metals used in medical 3D printing applications include cobalt-chromium (CoCr) alloys and stainless steels, although these are much less common than titanium.8 CoCr alloys provide exceptional strength and wear resistance, making them suitable for high-load, articulating components such as joint replacements. However, their use has declined in recent years due to toxicity concerns about cobalt ions leaching from implants over time, particularly in metal-on-metal joint systems. Medical grade 316L stainless steel is valued for its toughness, corrosion resistance, and cost-effectiveness. It’s often used for surgical instruments and implants, however its stiffness disparity to bone can lead to stress shielding.33PolymersPolymeric materials provide a wide range of options for biocompatibility, strength-to-weight ratio, tunable stiffness, and overall cost-effectiveness. This ability to tailor material properties aligns with medical applications ranging from anatomical models and surgical guides to prosthetics and implantable devices. Medical 3D printing polymers can be organized into three functional groups based on how they form and behave: thermoplastics, which can be melted and reshaped; thermosets, which undergo a permanent chemical change into a fixed form; and elastomers, which provide rubber-like flexibility for patient-contact and soft-tissue uses. Each group aligns with specific AM processes and comes with distinct tradeoffs in strength, detail resolution, sterilization compatibility, and long-term performance.ThermoplasticsThermoplastic materials – which can be remelted – are used with material extrusion, including selective laser sintering, and high-speed sintering (a form of binder jetting). Everyday AM thermoplastics such as PLA and ABS remain staples for cost-efficient, rapid prototyping of medical devices. Engineered thermoplastics, including nylons such as PA11 and PA12 and PAEKs (polyaryletherketones) such as PEEK, provide a balance of strength, toughness, chemical resistance, and dimensional stability, making them suitable for end-use medical devices.PEEK additive manufacturing implants.Engineered thermoplastics are commonly used for orthotics, prosthetics, and surgical guides and instruments due to their durability and processability. PAEKs – most commonly PEEK – offer even stronger mechanical performance, making them uniquely applicable for select implants. Polymer implants offer a compelling alternative to traditional metal implants because they don’t block X-rays (radiolucent), making post-operative assessment easier, and because they have mechanical properties more alike to bone than metal alloys do, which can reduce stress shielding.18,34 ThermosetsThermoset photopolymers used in material jetting (MJ) and vat photopolymerization (VP) cure irreversibly via light-initiated reactions and are widely used for medical 3D printing applications. These materials excel in dimensional accuracy, providing smooth surface finishes and fine feature details. Translucent photopolymers are often used with VP 3D printers, while multi-material, multi-color output is possible with MJ. Additionally, a common indirect approach involves casting the liquid thermoset into a 3D printed mold or form (e.g. urethane casting). This makes photopolymers the preferred material class for anatomical models, including for surgical planning and clinical training models. However, their limited mechanical performance, biocompatibility concerns, and long-term instability restrict their use in load-bearing or implantable devices.18Elastomers3D printed silicone prosthetic and orthotic inserts.Elastomeric polymers are flexible, rubber-like materials used in medical 3D printing applications when compliance and comfort are critical. Standard and specialized versions of material extrusion are common approaches to print with elastomers. Elastomers can fall under both polymer classes: thermoplastic elastomers such as TPU (thermoplastic polyurethane) and thermoset elastomers such as medical-grade silicone. Elastomeric polymers are commonly used for soft-tissue models, prosthetic liners, and custom-fit wearable devices where cushioning, flexibility, and patient-specific fit are important. Elastomeric materials can also support soft-tissue implants and tissue-engineering scaffolds in select applications, where a flexible structure is needed to better match the mechanics of soft tissues and guide healing.35CeramicsCeramic materials are used in medical 3D printing applications when extreme wear resistance, chemical stability, and long-term biocompatibility are required. Many advanced ceramics are bioinert, meaning they are highly stable in the body and resist corrosion and ion release, which makes them attractive for applications where material stability is critical. A second, growing category is bioresorbable ceramics, designed to gradually dissolve and be replaced by bone growth.Bioinert ceramics such as zirconia and alumina are most common in dental restorations, select implant components, and wear-critical surfaces. Bioresorbable ceramics such as hydroxyapatite (HA) are used for bone repair and patient-specific scaffolds, where bone growth and controlled resorption are desired. Compared with metals and polymers, ceramics remain rare in commercial AM applications due to their brittleness and difficulty to additively manufacture – often requiring debinding and high-temperature sintering, pre-planning for extensive part shrinkage during sintering, and specialized handling to avoid cracking.36Regulatory Considerations for 3D Printing Medical DevicesRegulatory considerations for 3D printing medical devices depend on the devices intended uses and how risky they are, as well as, the required documentation standards, and regulatory pathways based on where the device is manufactured. For 3D printing specifically, it is important to understand the necessary regulatory considerations due to the device’s material properties often being inseparable from the manufacturing process: design files, software, materials, printer settings, and post-processing steps can all change final performance. This interdependence between material properties and the process is particularly evident due to the chemical and physical changes 3D printed materials experience. In the United States, the FDA regulates medical devices to help ensure they are safe and effective for patient use. However, it’s important to note that the FDA has not created a standalone, AM-specific regulatory framework; instead, its primary AM-specific direction is provided through the agency’s preliminary 2017 guidance.37 It is therefore critical to understand what the FDA regulates, how devices are classified, and the regulatory pathways used to bring 3D-printed products to market. This section provides a practical overview of how regulations apply to medical 3D printing and what manufacturers must control to ensure safety, consistency, and compliance. Unless otherwise noted, this overview is written from a U.S. (FDA) regulatory perspective.What Is a Medical Device for Regulatory Purposes?A medical device is any instrument, implant, or tool intended for diagnosing, treating, preventing disease, or for affecting the structure or function of the body. The complete statutory definition is found in Title 21 of the United States Code, Section 321 (h)(1) (the definition of “device”).38 In practice, regulation hinges on the intended use, as illustrated by the following examples. Regulated Medical Device Examples:ImplantsSurgical guides and positioning aidsProsthetics and orthoticsSurgical intraoperative toolsAnatomical models used for planning or diagnosisNon-Regulated Medical Device Examples:Generic educational or training anatomical modelsResearch and development prototypes not intended for patient useFDA Medical Device ClassificationsTable 5: The FDA’s Three Risk-Based Device Classification Levels, Device Examples, and General Requirements39Class I (Low Risk)Examples: non-critical surgical tools, select orthotic components Most are exempt from premarket review, though they must follow “general controls” such as labeling, complaint handling, and basic quality system requirementsClass II (Moderate Risk)Examples: Surgical guides, orthopedic instruments, most implants Typically require a 510(k) premarket notification showing the device is substantially equivalent to a legally marketed predicate deviceClass III (High Risk)Examples: life-sustaining implants such as heart valves, certain neurological implants, innovative/new devices Require Premarket Approval (PMA), which involves robust clinical evidence and a more intensive reviewFDA Regulatory Pathways for 3D Printing Medical Devices FDA regulatory pathways for 3D printing medical devices require following an FDA-defined pathway, such as 510(k) clearance, pre-market approval, or alternative pathways, depending on risk, intended use, and whether a suitable predicate device exists.510(k) PathwayThe 510(k) pathway is a premarket submission process in which manufacturers demonstrate substantial equivalence to an existing, legally marketed medical device. It is the most common route for bringing most moderate risk (Class II) devices and certain low risk (Class I) devices to the market. Instead of proving safety and effectiveness from scratch, manufacturers show that their device is substantially equivalent to a legally marketed predicate device – an existing device that is already on the U.S. market (typically through clearance or prior classification) that has the same intended use. “Substantial equivalence” means the new device has the same intended use and either the same technological characteristics or differences that do not raise new questions of safety or effectiveness.40A typical 510(k) submission includes:A structured comparison to the predicate device, explaining intended use, design features, and performance characteristicsBench testing, mechanical and accuracy data, and material characterization to show the device performs at least as well as the predicateInformation on sterilization, biocompatibility, labeling, and manufacturing controls, demonstrating consistent and safe productionPre-Market Approval (PMA) PathwayThe Premarket Approval (PMA) pathway is a premarket approval process in which manufacturers provide independent evidence demonstrating the safety and effectiveness of a high-risk medical device. It is the FDA’s most rigorous review pathway and is required for most high-risk (Class III) devices. PMA is rarely used for today’s 3D-printed devices, but it remains a pathway for future high-risk or breakthrough AM medical devices that cannot rely on a predicate. Because these devices pose the highest potential risk, the FDA requires significantly more evidence than for 510(k) submissions.41 A PMA application generally includes:Robust clinical evidence, often from prospective clinical trials demonstrating a reasonable assurance of safety and effectivenessDetailed manufacturing, process validation, and sterilization data, showing that every device can be produced consistently and safelyExtensive scientific review, including biocompatibility, mechanical performance, shelf-life, and post-market surveillance plansAlternative PathwaysAlternative pathways such as De Novo classification and the Humanitarian Device Exemption (HDE) address regulatory scenarios where predicate devices or traditional clinical evidence are not available. A De Novo classification is used for novel devices with no suitable predicate device, but whose risk profile does not warrant PMA.42The HDE supports devices intended for rare conditions affecting 8,000 or fewer patients per year in the United States. Because traditional clinical studies may be impractical in very small patient populations, HDE allows marketing authorization with a lower evidentiary burden than PMA.43 In 2021, the FDA approved a 3D printed talus (bone in the ankle joint) implant to treat a rare bone disease via the HDE pathway.44Common Regulatory Misconceptions of Medical 3D PrintingCommon regulatory misconceptions of medical 3D printing arise from misinterpreting FDA terminology and regulatory concepts related to device approval, clearance, customization, and clinical use. Below are four common misconceptions, each followed by the more accurate interpretation.Misconception #1: The FDA regulates the practice of medicine.Reality: The FDA regulates the manufacturing, labeling, and marketing of medical devices. Decisions about how clinicians use devices in patient care generally fall under the practice of medicine, which is overseen by state medical boards.45Misconception #2: The FDA “approves” materials and 3D printers.Reality: There is no universal “FDA-approved material” or “FDA-approved 3D printer.” The FDA evaluates specific medical devices for a specific intended use, including the device design, materials, manufacturing process, and validation. The same material or 3D printing process may be appropriate in one application and not another depending on risk, exposure, and performance requirements.1Misconception #3: FDA-approved and FDA-cleared mean the same thing.Reality: They refer to different pathways. FDA-approved devices go through the rigorous Premarket Approval (PMA) pathway reserved for the high-risk Class III devices that require extensive clinical evidence. FDA-cleared devices are reviewed through the 510(k) or De Novo pathway, which have a lower burden of proof for safety and effectiveness.1Misconception #4: 3D printed medical devices are “custom devices,” so they are exempt from premarket requirements.Reality: “Custom device” has a narrow legal definition and is applicable only in rare cases. To qualify, a device must meet a unique clinical need, be made in very small quantities, and lack a suitable commercially available alternative. Most individualized 3D-printed products are better described as patient-matched (or patient-specific) devices and still must follow appropriate regulatory requirements – even if the geometry varies patient to patient.46Quality, Process Validation, and Documentation AM quality and documentation requirements follow FDA Quality System Registration, 2017 FDA guidance, and several ISO standards, among others. For 3D-printed devices, the FDA expects manufacturers, including providers using a 3D printer in medical industry locations (3DPOC), to comply with standard quality and documentation requirements.46Core regulations and standards:FDA Quality System Regulation (21 CFR Part 820)47 Often referred to as current Good Manufacturing Practice (cGMP) for devices. This covers design controls, process validation, corrective actions, complaint handling, and more.2017 FDA Guidance: U.S. Food and Drug Administration. Technical considerations for additive manufactured medical devices37ISO 10993-1: Medical Device Biocompatibility48ISO 13485: Medical Device Quality Systems49ISO 14971: Medical Device Risk Management50AM-specific FDA expectations: 37Control of starting materials and any reuse of powder or resinValidation of build parameters and printer settingsEffects of orientation and build location on performanceCleaning, depowdering, and post-processing verification (especially for powder and resin processes)Sterilization compatibilityEuropean Regulatory Considerations (EU MDR)European regulatory considerations for 3D printed medical devices are governed by the EU Medical Device Regulation (MDR), which applies a risk-based framework for classification, quality systems, clinical evidence, and post-market surveillance. At a high level, the MDR framework is similar to the U.S. FDA framework. They both classify devices based on risk into class I–III (with the MDR splitting class II devices into class IIa and class IIb), expect a robust quality management system (commonly aligned with ISO 13485), and require clinical evidence and post-market surveillance scaled to device risk. For most 3D printed devices, that means the same core principles apply – define intended use, control the manufacturing process, validate performance, and monitor real-world outcomes.Key differences show up in who does the review and how ongoing evidence is maintained. Unlike the FDA, the EU relies on independent Notified Bodies rather than a single centralized regulator to review and certify most devices. The MDR generally has stricter expectations for ongoing clinical evaluation and post-market follow-up, which, combined with a limited Notified Body capacity, has slowed approvals and renewals across Europe. For organizations working to develop 3D-printed devices for multiple markets, these structural differences mean regulatory planning must accommodate both FDA and MDR pathways, even when the underlying AM technology is the same.51Medical 3D Printing ReimbursementMedical 3D printing reimbursement is the process by which healthcare providers are paid by insurers (e.g., private payers, Medicare, or Medicaid) for a service or device. For AM, payers usually don’t pay for the “3D printing” itself – they pay for a covered medical service or device when it is medically necessary, properly coded, and supported by required documentation.Providers have faced reimbursement challenges as 3D printing enabled new clinical applications, including patient-specific anatomical models, surgical guides, and orthotics and prosthetics. These challenges often stem from (1) proving and documenting the clinical value payers require, and (2) the design and personalization work not fitting cleanly into established billing and payment pathways. As a result, reimbursement remains limited or inconsistent, leaving organizations to absorb costs or pass them on to patients – slowing broader adoption, especially at the point of care.What Are CPT and HCPCS Codes?Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) are standardized coding systems used in the United States to describe medical procedures, services, and products for billing and reimbursement. CPT is maintained by the American Medical Association and used to describe services and procedures and bill for clinical services. CPT codes are organized into three categories; these two are relevant for reimbursement:52Category I CPT codesEstablished, widely used clinical services/proceduresGenerally the most reimbursement-ready and consistently recognized by payersCategory III CPT codesTemporary tracking codes for new and emerging technologies or servicesGather data on use and effectiveness to support potential Category I conversionCoverage and payment are often inconsistent and payer-dependentHCPCS is a broader coding system – maintained by the Centers for Medicare and Medicaid Services – used to bill for services and products, split into two levels:53HCPCS Level IThis level is literally the CPT code setHCPCS Level II Used to bill for products, supplies, equipment, and certain services that aren’t well captured by CPT Commonly includes things like medical devicesAnatomical Models and Surgical Guides ReimbursementPatient-specific 3D-printed anatomical models and surgical guides are reimbursed through Category III CPT codes, but reimbursement still varies. These have historically faced reimbursement hurdles because coverage is inconsistent and many payers treat these services as integral to the primary imaging study or surgical procedure, rather than reimbursable on their own. To address the lack of a clear pathway, the AMA established Category III CPT codes (0559T–0562T) for 3D-printed anatomical models and surgical guides, enabling standardized reporting and data collection to support potential future Category I CPT codes.54 However, because Category III codes do not guarantee coverage, reimbursement is still limited and varies widely by payer and site of care.Orthotics and Prosthetics ReimbursementOrthotics and prosthetics are frequently reimbursed as products under HCPCS Level II codes. A key recent development is that Medicare’s prosthetics and orthotics coding and policy bodies (DME MACs, and PDAC) have explicitly stated that 3D printing is an acceptable way to manufacture an orthotic or prosthetic – given that the finished item matches an existing code description and meets the same coverage rules as traditionally fabricated devices. This clarification mitigates concerns about potential reimbursement impacts associated with the use of additive manufacturing in these contexts.55,56The Future of Medical Additive ManufacturingMedical 3D printing is rapidly expanding from prototyping into real clinical production because it uniquely enables patient-specific designs, complex functional geometries, and faster turnaround – especially when deployed at the point of care. At the same time, success in medical 3D printing depends on more than choosing a 3D printer. Organizations and manufacturers need to match the right process and material to the clinical use case and build the quality, post-processing, and documentation discipline required for regulated, reimbursable products. Adoption is also shaped by broader systemic factors, especially point-of-care implementation, evolving regulatory expectations, and the pace at which reimbursement catches up to clinical value. As standards mature and evidence accumulates – supported by clearer regulatory expectations and more predictable coding – medical 3D printing is positioned to become a routine, scalable tool for personalized care rather than a niche capability.To stay current on where medical 3D printing is headed next and the latest medical 3D printing technology developments, attend IMTS 2026, the largest manufacturing technology trade show in the Western Hemisphere, taking place September 14–19, 2026, in Chicago. Register here: https://www.imts.com/attend/registration/If you’re interested in other deep dives into additive manufacturing, check out our sister article on this topic, Additive Manufacturing in Aerospace: Applications, Materials & Trends.Matthew Foulk is an analyst on AMT’s Research team, contributing to in-depth market research and strategic analysis of emerging manufacturing technologies, with an emphasis on additive manufacturing. His background spans startup development – including as a Venture for America fellow – data analysis, and hands-on engineering work across software, robotics, and industrial design. Matthew holds a B.S. in Mathematics from the University of Maryland. Learn more about Matthew, and see how your company can benefit from the insights of AMT’s Research team.Further ReadingAdditive Manufacturing in Aerospace: Applications, Materials & TrendsAdaptive Robotic Finishing Raises the Bar for Medical ManufacturingAdditive, Digital, Generative: Emerged and Emerging TechHow to Get Started in Additive ManufacturingReferences(1) Di Prima, M., Coburn, J., Hwang, D., Kelly, J., Khairuzzaman, A., & Ricles, L. (2016, Dec. 1). Additively manufactured medical products— The FDA Perspective. 3D Printing Medicine , 2(1). Retrieved January 7, 2026, from https://doi.org/10.1186/s41205-016-0005-9 (2) Pew Charitable Trusts. (2022, July 27). FDA’s regulatory framework for 3D printing of medical devices at the point of care needs more clarity. Retrieved January 7, 2026, from https://www.pew.org/en/research-and-analysis/issue-briefs/2022/07/fdas-regulatory-framework-for-3d-printing-of-medical-devices-needs-more-clarity (3) Society of Manufacturing Engineers. 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