Medical Device Manufacturing

Prototype to Production Capabilities

We utilize a variety of 3D printing and medical additive manufacturing processes and materials that stand up to the requirements you need in designing and producing medical devices and equipment components. Processes like stereolithography (SLA), Carbon Digital Light Synthesis (DLS), HP Multi Jet Fusion (MJF), fused deposition modeling (FDM), and metal 3D printing are used to create highly complex and intricate parts in a short timeframe.

Our in-house capabilities are not limited to just 3D printing prototypes and production parts. We also have the capacity, equipment, and expertise to drive your production projects forward. We operate EDM, CNC turning, 3-axis and 5-axis CNC machining, and medical injection molding and urethane molding. We supply component parts for original equipment manufacturers (OEMs) of medical devices and diagnostic equipment, such as MRI and X-ray equipment, as well as parts for surgical devices. Our team will work with you to help design, develop, and control the most efficient manufacturing process to fit your timetable, quality requirements, and cost-of-production objectives.

CNC Machining

Reduce production costs and lead times by cutting out costly setups and operations with high-speed milling, turning, and 5-axis CNC machining services for rapid prototyping and production.

Materials: Our CNC machining equipment can handle a wide variety of materials, including copper, brass, titanium, stainless steel, Inconel® alloys, polycarbonate (PC), polyvinyl chloride (PVC), acrylonitrile butadiene styrene (ABS), and polyetheretherketone (PEEK).

Injection Molding 

Medical device injection molding is used for applications such as implantable components, breakers, test tubes, imaging equipment, surgical equipment and components, orthopedics, and more.

Materials: Some of the more common injection molding materials we use include nylon, PC/ABS blends, PC, polypropylene (PP), polyethylene (PE), high-density polyethylene (HDPE), and more.

Urethane Molding 

The medical industry relies on plastic and polyurethane products to meet accuracy, decisiveness, scratch resistance, tear protection, stability, and insulating properties.

Material Considerations for Medical Devices and Medical Equipment Components

Our prototype and production experts will help you find an economical, high-quality material solution for your medical device manufacturing applications. Here are a few materials we use for medical, life sciences, and healthcare components:

• Aluminum: Combination of good thermal properties, non-ferrous and low weight
• Stainless Steel: Precise, high corrosion resistance, sterilizability, and durability
• Titanium: Combination of high mechanical properties and low specific weight
• PC: Rigid, MRI clear with UL94V2 and UL94V0 ratings
• Acetal: Durable, high strength, low friction, low moisture absorption, chemically resistant (often referred to as Delrin)
• PEEK: Outstanding mechanical strength, creep, and fatigue resistance make it ideal for demanding air-freight applications
• HDPE: Low moisture absorption, high impact and corrosion resistance
• PP: Best for chemical and corrosion resistance, tough with high strength-to-weight ratio
• TD-277/RC-79D/PT-8958: PEs with UL94V0 rating and MRI clear, tough, durable
• TD-277/RC-79D/PT-8958: Rigid Polyurethanes with UL94V0 rating and MRI clear 
• SIL: Grey Carbon DLS silicone-like additive material, 20 shore A, biocompatible
• MPU: White medical-grade Carbon DLS ABS-like plastic additive material, biocompatible
• Whipmix Surgical Guide: Clear Carbon DLS additive material, biocompatible, sterilizable, rigid
• Keysplint: Clear Carbon DLS additive material, low shore D for soft/flexible, biocompatible
• Nylon PA 12: HP MJF plastic additive material (available in gray or white), biocompatible and chemically resistant
• PC-ISO: White Stratasys FDM plastic additive material, biocompatible, sterilizable, rigid PC
• Ultem 9085: Stratasys FDM plastic additive material, UL94V0 rated, chemically resistant, high heat

Quality and Value-Added Services

Whether your project requires custom-colored materials, textured paints, or final part assembly, our team can manufacture all custom finishes under one roof while following the highest-quality industry standards. 

We’re Certified

We have extensive experience with medical device manufacturing applications—ranging from helping manufacturers of large diagnostic systems find new, more cost-effective parts to delivering high-precision 3D printed prototypes for custom surgical implants in a matter of hours.

Understanding that medical devices demand specialized expertise and require stringent industry standards, we’re certified to ISO 13485:2016, a comprehensive quality system standard for the design and manufacture of medical devices. This international certification shows our commitment to the customer and regulatory requirements necessary for the production of medical devices, including those used in diagnostic imaging and surgical instruments. 

We also hold quality standards for WBENC (National Women’s Business Enterprise Certification) and WOSB (Woman-Owned Small Business) for successfully meeting WBENC’s standards for a Women’s Business Enterprise as a woman-owned, operated, and controlled business.