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Medical 3D Printing Service

ISO 13485-Certified 3D Print Services for Medical Devices & Anatomical Models

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ISO 9001 | ISO 13485 | AS9100 | DDTC/ITAR Registered
Traceability for your manufactured parts | Stratasys Direct

ISO 13485 Certified

Meeting strict safety and traceability standards for medical devices.

50+ Industrial Grade Materials | Stratasys Direct

Engineering-Grade Materials

Polypropylene, ABS, Nylon, Polycarbonate, and more. 50+ materials to choose from.

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Parts Printed

6+ Million medical 3D printed parts produced

Finishing & Assembly Full-Service | Stratasys Direct

Full-Service

25+ post process production finishing and inspection services​

3D Printed Medical Model of a Heart in someone's hands | Stratasys Direct

Why Medical Companies Use 3D Printing

The medical industry, including medical device manufacturers, equipment makers, and medical manufacturing companies, is experiencing a transformation driven by the integration of 3D printing technologies. Unlike traditional subtractive manufacturing methods, 3D printing allows for the creation of complex geometries, patient-specific customization, and lightweight designs that are otherwise difficult to achieve. This revolution spans medical devices, equipment, models, and surgical tools, enhancing innovation and efficiency.

3D Printed prototype of inhaler on display | Stratasys Direct

Why Choose Stratasys Direct

Over the years, we have gained extensive experience manufacturing medical devices and anatomical parts, supported by our ISO 13485 certification achieved in October 2024. We cater to a diverse range of healthcare providers, from local practices to leading healthcare institutions. Our commitment to quality and excellence is underscored by our dedication to meeting the highest standards in medical 3D printing. Utilizing industrial additive technology and a wide selection of healthcare-specific materials, including USP Class 6 materials known for their biocompatibility, we ensure our innovative solutions deliver precision, reliability, and exceptional performance.

Medical Materials

With a diverse range of medical manufacturing materials and advanced solutions, we meet your needs for patient-specific models, devices, and tools. We offer materials that comply with ISO 10993 and USP Class VI for Gamma, EtO, and steam autoclave sterilization. Alternatively, you could visit our materials page, use our material selection tool, or contact us to have us help you walk through the material and technology selection process.

 

Key Features
  • Produces excellent fine feature detail
  • Quickly and economically produces parts
  • Available in 27µm (0.00106”) Z resolution
  • Available in multi-color or the following single colors: white, black, clear, cyan, yellow, magenta
Applications
  • Highly accurate presentation models
  • Smaller parts with complex features
  • Medical devices and components
  • Electronic housings
  • Suitable for a wide range of industries
Ideal for presentation models, small components with complex features and anatomical models, Vero produces parts with fine feature detail and smooth surface finish. Vero can be built in a near-endless CMYKW color range and transparencies. Companies can reduce time to market by enabling designers to integrate product images in marketing materials and ensure that packaging and displays work seamlessly with end products.
Data Sheet & Additional Resources

Download Vero Data Sheet

PolyJet Design Guide

Key Features
  • Good tensile, flexural & impact strength
  • Gamma and EtO sterilizable
Applications
  • Medical handling
  • Food handling
  • Pharmaceutical handling and tools
ABS-M30i is a high-strength material well suited for the medical, pharmaceutical and food packaging industries. Parts manufactured with ABS-M30i material are biocompatible (ISO 10993 USP Class VI) and can be gamma or EtO sterilized. The material is NSF 51 food-contract certified with good tensile, flexural and impact strength. Available in sparse or solid fill.
Key Features
  • Great heat resistance vs. ABS
  • Great aesthetics
  • Easy to work with matte finish
  • Resists fading & significant mechanical degradation over prolonged UV exposure
Applications
  • Automotive, electrical housings
  • Sporting goods
  • Outdoor goods
  • Recreational vehicles
  • Tooling masters
ASA (Acrylonitrile Styrene Acrylate) is a UV-stable, production-grade thermoplastic. In addition to being UV-stable, ASA is consistent in color part to part, providing ease of finishing and a good cosmetic appearance. These features when combined with mechanical properties on par with ABS-M30 make ASA an ideal material choice for production applications. Available in sparse or solid fill.
Key Features
  • Steam autoclavable
  • NSF-51 food contact
  • Bio-compatible ISO 10993/USP Class VI FST certified per "14 CFR/FAR 25.853" & "ASTM F814/E662"
Applications
  • Aerospace applications
  • Composite tooling
  • Medical applications
  • Food contact applications
ULTEM™ 1010 Resin is a high-performance FDM thermoplastic that offers excellent strength, highest heat resistance, thermal stability and the ability to withstand steam autoclaving. NSF-51 food contact and bio-compatible ISO 10993/USP Class VI certifications for use in food production tools and custom medical applications. FST certified per 14 CFR/FAR 25.853 & ASTM F814/E662, and is ideal for aerospace and automotive applications.
Key Features
  • Glass filled Nylon 12 material
  • Excellent mechanical stiffness
  • Elevated temperature resistance
  • Dimensionally stable
Applications
  • Housings and enclosures
  • Consumer sporting goods
  • Complex prototype plastic parts
  • Form, fit, or functional prototypes
Glass Filled Nylon-12 offers increased modulus for more rigid parts with greater strength. Surface finish and fine feature details are very good and heat deflection temperature (HDT) values are the best of the SLS prototype materials.
Key Features
  • Superior impact strength and durability
  • Exceptionally versatile
  • Thermoplastic-like performance, look and feel

 

Applications
  • Tough, functional end-use prototypes
  • Snap-fit designs
  • Jigs and fixtures
  • Packaging and sporting goods
Somos® NeXt is a durable Stereolithography (SLA) resin that produces very accurate parts with high feature detail. Based on the Somos® DMX technology, Somos® NeXt is a next generation of material that facilitates the production of tough, complex parts with improved moisture resistance and greater thermal properties for most of your prototyping needs.
Key Features
  • Best surface resolution/feature details with powder bed fusion technology
  • Fully dense and nearly isotropic mechanical properties
  • Excellent chemical resistance to oils, greases and other hydro-carbons
  • Low unit cost for batches of smaller parts
Applications
  • Vehicles electronic system housings, guides, grommets, clips, connectors & covers
  • Vessels for fuel, oil housings and washer fluid
  • Environmental control system components like fan housings, plenums, ducting, valves, diverters and vents
Nylon 12 PA material is tough and chemically resistant, making it a good choice in a broad variety of applications and operating environments. Nylon 12 PA made with the Multi Jet Fusion process also delivers mechanical properties that are more isotropic when compared to Nylon 12 materials built with other 3D printing processes.

Additive Manufacturing for Medical

3D printing in the medical industry allows for the creation of customized prosthetics, surgical tools, anatomical models, and enhanced patient care through tailored and precise medical solutions.

PolyJet  for Automotive | Stratasys Direct

PolyJet™

Ideal Part Size: Small - Mid

SAF  for Automotive | Stratasys Direct

SAF™ - Selective Absorption Fusion

Ideal Part Size: Small - Mid

FDM for Automotive | Stratasys Direct

FDM® - Fused Deposition Modeling

Ideal Part Size: Small - Mid - Large

SLS for Automotive | Stratasys Direct

SLS - Selective Laser Sintering

Ideal Part Size: Mid - Large

SLA for Automotive | Stratasys Direct

SLA - Stereolithography

Ideal Part Size: Mid - Large

DLP P3  for Automotive | Stratasys Direct

P3™ DLP - Programmable Photopolymerization

Ideal Part Size: Small

MJF for Aerospace | Stratasys Direct

MJF - Multi Jet Fusion

Ideal Part Size: Small - Mid

PolyJet  for Automotive | Stratasys Direct

Ideal Part Size: Small - Mid

SAF  for Automotive | Stratasys Direct

Ideal Part Size: Small - Mid

FDM for Automotive | Stratasys Direct

Ideal Part Size: Small - Mid - Large

SLS for Automotive | Stratasys Direct

Ideal Part Size: Mid - Large

SLA for Automotive | Stratasys Direct

Ideal Part Size: Mid - Large

DLP P3  for Automotive | Stratasys Direct

Ideal Part Size: Small

MJF for Aerospace | Stratasys Direct

Ideal Part Size: Small - Mid

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Innovating Medical Practice with 3D Printed Models & Devices

The medical industry has utilized our services for innovative applications such as custom anatomical models from patient CT scans for pre-op surgery practice, medical training, and patient education.

At the Texas Cardiac Arrhythmia Institute, doctors use our 3D printing technology to create precise heart models, enhancing surgical planning and patient outcomes. Move to clinical trials faster by producing low volumes of medical devices or equipment with 3D printing, leveraging our advanced manufacturing capabilities. Read the case study here.

3D Printed Anatomical Model of Heart | Stratasys Direct

Anatomical Models

Stratasys Direct's 3D printing services create highly realistic anatomical models, replicating the feel, function, and dimensions of human tissues. These models are used for surgical planning, medical training, and device testing, providing healthcare professionals with accurate and effective tools to enhance patient outcomes.

3D Printed  Surgical Guides | Stratasys Direct

Surgical Guides

3D printed surgical guides offer improved accuracy, reduced procedure time, and potentially minimized blood loss compared to traditional freehand techniques. Creating patient-specific guides based on medical scans allows surgeons to pre-plan complex procedures and achieve better outcomes.

Surgical Instruments

Traditional reusable instruments are machined from stainless steel and sold in expensive kits. 3D printing allows for the creation of lightweight, ergonomic, single-use surgical instruments with customized features for specific procedures. This can improve surgeon comfort and dexterity, and lead to significant cost reductions for the health institution.

3D printed surgical tool sterilization tray medical prototype | Stratasys Direct

Prototypes and Device Components

3D printing enables the creation of complex and/or patient-specific medical device components and prototypes. This can lead to improved functionality, reduced weight, and potentially faster turnaround times for custom components used in surgery or device development.

 

It was suddenly a way to look at the internal organs without having to open someone up. And frankly, even if you open someone up, it’s not the same; it doesn’t look the same. […] Having this type of 3-dimensional mapping and printing of an actual heart of that particular patient is invaluable in speeding up and improving safety and efficacy of the procedure”

3D Printed Hearing Aid | Stratasys Direct

Audiology

3D printing allows for creating custom-fit hearing aids and ear molds with improved comfort, retention, and sound quality compared to traditional options. Additionally, complex geometries can be achieved, leading to potentially more discreet hearing solutions. Examples include in-the-ear (ITE), behind-the-ear (BTE), and in-the-canal (ITC) hearing aids, all tailored to the specific contours of the user's ear.

SAF 3D printed splint | Stratasys Direct

Orthotics and Prosthetics

3D printing allows for the creation of customized prosthetics and orthotics with a better fit, improved comfort, and lighter weight compared to traditional methods. This can lead to enhanced mobility, function, and quality of life for patients. Examples include prosthetic sockets, liners, ankle foot orthoses, remolding helmets, and more.

Normally we would use generic foam models or cadavers for training, but both these scenarios carry problems,” explains Stephen McDaniel, Senior Project Engineer with Sonoma Orthopedics. “For example, if I want a specific fracture and a specific bone canal, it’s impossible to achieve that at the right quality using a cadaver and difficult or costly to recreate in foam when very specific details are needed.”

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Digital Anatomy Printer from Stratasys

Digital Anatomy Printer

The Stratasys J850™ Digital Anatomy™ 3D Printer creates highly realistic anatomical models that mimic the feel, function, and dimensions of human tissues. It features pre-programmed settings for specific medical applications, such as vascular and cardiac models, which allow for precise simulation of clinical procedures. This printer uses advanced materials like TissueMatrix™, BoneMatrix™, GelMatrix™, and the radiopaque RadioMatrix™, enabling detailed and functional medical models ideal for training, surgical planning, and device testing.

Learn more about the Stratasys Digital Anatomy Printer.

Frequently Asked Questions

Yes, you can 3D print medical devices, including complex geometries and patient-specific parts, from prototyping to end-use production, with ISO 13485 certification ensuring precision and compliance.

Yes. ABS-M30i, PC-ISO, and ULTEM™ 1010 resin for FDM; Various formulations of Nylon 12 PA for Selective Laser Sintering.

Learn more about our materials

3D printing in the medical field is used for creating custom anatomical models from patient CT scans, surgical guides, prosthetics, and implants. It enhances preoperative planning, medical training, and patient education by providing accurate, tangible models. Additionally, it allows for the rapid prototyping and production of low-volume medical devices and equipment.

Medical manufacturing involves the production of medical devices, equipment, and tools used in healthcare settings. This includes the design, development, and assembly of products like surgical instruments, diagnostic devices, prosthetics, and implants. It often requires stringent compliance with regulatory standards to ensure safety and efficacy.

While fully functional 3D-printed organs are not yet a reality, 3D printing is extensively used to create highly realistic medical models. Stratasys' Digital Anatomy Printer, equipped with advanced capabilities, produces detailed models such as flexible hearts, bones with varying densities, and spines. These models allow medical professionals to practice surgeries, drill into bones, and conduct accurate surgical planning, significantly enhancing training and preparation for real-life procedures.

Medical Resources

P3 DLP 3D Printed Spine

ISO 13485-Certified 3D Printing for Medical Device Manufacturing

Stratasys Direct offers ISO 13485-certified 3D printing services, ensuring precision and compliance for medical device manufacturing. From prototyping to scalable production, we streamline the entire development process with cutting-edge additive technology.

View more
3d model echocardiography UofM Minnesota | Stratasys Direct

3D Anatomy Model

Stratasys Direct has partnered with the University of Minnesota Visible Heart Lab to offer high-quality 3D anatomy models for educational and medical applications. Explore now!

View more
3D Printed Bone Model

3D Printed Bone Models Provide True-To-Life Training For Surgeons

3D printing offered a viable, cost-effective solution to recreating accurate models with repeatable bone fracture types for multiple training scenarios.

View more
printing hearts

Printing Hearts

Hearts can be 3D printed and delivered to physicians in hours, enabling physicians to study models before performing open-heart surgery on a patient.

View more
pc iso

PC-ISO Combines Strength and Safety for FDM Medical Applications

Additive manufacturing processes like Fused Deposition Modeling (FDM) have the materials to meet medical safety requirements.

View more
3d printed medical models

New Advancements in 3D Printing Medical Models

The medical industry is rapidly embracing the cutting-edge production of 3D printed anatomical models for bettering patient outcomes.

View more
additive manufacturing top industries

5 Places Additive Manufacturing is Unstoppable

There are five industries in particular where the amazing capabilities of additive manufacturing have transformed production.

View more
3d printing medical breakthrough

3D Printing a Medical Breakthrough

Kablooe needed a cost-effective way to build, test, redesign and repeat. For this kind of breakthrough prototyping, FDM was just what the doctor ordered.

View more
agilus30

Introducing Stronger, More Flexible PolyJet Parts

To enhance parts and medical models that utilize the flexible capabilities of PolyJet, Stratasys Direct now offers Agilus30.

View more
P3 DLP 3D Printed Spine

Stratasys Direct offers ISO 13485-certified 3D printing services, ensuring precision and compliance for medical device manufacturing. From prototyping to scalable production, we streamline the entire development process with cutting-edge additive technology.

3d model echocardiography UofM Minnesota | Stratasys Direct

Stratasys Direct has partnered with the University of Minnesota Visible Heart Lab to offer high-quality 3D anatomy models for educational and medical applications. Explore now!

3D Printed Bone Model

3D printing offered a viable, cost-effective solution to recreating accurate models with repeatable bone fracture types for multiple training scenarios.

printing hearts

Hearts can be 3D printed and delivered to physicians in hours, enabling physicians to study models before performing open-heart surgery on a patient.

pc iso

Additive manufacturing processes like Fused Deposition Modeling (FDM) have the materials to meet medical safety requirements.

3d printed medical models

The medical industry is rapidly embracing the cutting-edge production of 3D printed anatomical models for bettering patient outcomes.

additive manufacturing top industries

There are five industries in particular where the amazing capabilities of additive manufacturing have transformed production.

3d printing medical breakthrough

Kablooe needed a cost-effective way to build, test, redesign and repeat. For this kind of breakthrough prototyping, FDM was just what the doctor ordered.

agilus30

To enhance parts and medical models that utilize the flexible capabilities of PolyJet, Stratasys Direct now offers Agilus30.

9085, 1010 and ULTEM™ trademarks are used under license from SABIC, its affiliate or subsidiary.