Precision Machining

West-Tech Materials represents manufacturers that provide the highest level of precision machining in the medical device industry with a specialization in Micro-Machining. Our manufacturers use the most advanced machining technologies to produce components and assemblies that, in some cases cannot be seen by the naked eye. We encourage you to challenge us with the tightest tolerance requirements and most difficult to produce applications.

Manufacturing Technologies and Capabilities

CNC MULTI-AXIS MILLING & SWISS MACHINING
Specializing in machining Platinum, Precious Metal Alloys, Titanium, Stainless Steel, Niobium, Nitinol, and Tantalum materials into precision machined components. Capacity from .010" to .625"diameter for turning,up to 6.0" x 18.0" for milling and configurations from simple to ultra complex.

CNC LASER CUTTING, WELDING,& MARKING
An alternative to EDM machining. In most cases Laser cutting is much faster and as accurate. Laser welding of most metals and dissimilar metals allows us to provide welded assemblies.

CNC MULTI-AXIS WIRE & PLUNGE EDM
EDM provides the flexibility of producing difficult characteristics at efficient costs. Wire and Plunge EDM allows us to produce a wide variety of complex components.

MICRO MACHINING
Our micromachining team specializes in manufacturing miniature and micro turned and milled components.

HIGH VELOCITY MACHINING TURNING & MILLING
The application of proprietary high velocity machining creates tremendous cost savings over conventional machining. This process allows us to be very cost-effective on components that are suited to the process.

CNC MICROGRINDING
CNC Microgrinding provides for the ability to manufacture components that are best produced by a grinding process. CNC microgrinding also allows us to control the quality of our cutting tools, which improves the quality of components produced while reducing our production cost.

WIRE COILING
We are focused on manufacturing the highest quality coils for medical applications, such as neurostimulation, cardiac rhythm management, vascular intervention and minimally invasive surgery. Our designed advanced technology coil winders allow us to meet the reqirements of the most demanding coils cost effectively. All coiling operations are performed in a Class 10,000 Cleanroom to avoid contamination.

CLASS 10,000 CLEANROOM
We perform all assembly, silicone over molding, micro laser welding and packagingin a Class 10,000 Cleanroom. Dedicated engineers and technicians provide these services.

CLEANING, ETCHING, & ELECTRO POLISHING
Fully automated CNC controlled systems are used to finish and clean components. These systems allow the process to be certified by our customers, permiting direct shipment to our customers' point of use.

COMPLETE TOOLROOM
Our toolroom allows us to control the quality, cost, timeliness, and effectiveness of the tooling we use in production. Our toolroom also allows us to support prodution and R&D tooling requirements of our customers.

CERTIFIED COMPONENTS PROGRAM
We have the ability to meet any customers' requirements for ship to stock, Kanban or any other initiative that reduces customer cost. Our certification program includes certified processes for manufacturing, cleaning, and inspection with complete documentation and supporting statistical data allowing shipment to point of customer use.

Manufacturing Processes

We can provide a complete solution to your p-recision metal components and assembly requirements. Services include:

• Precision machining, turning, and milling
• High velocity machining
• Micro machining
• Wire and plunge EDM
• Laser cutting, welding, and marking
• Multiaxis miniature component grinding
• Silicone molding
• Coil winding
• Cleaning, etching, and electropolishing
• Certifiable robotic cleaning
• Certifiable electronic inspection
• Cleanroom Assembly

Materials

We have the capability to manufacture components from a variety of materials, including:

Precious Metals:

Employing the necessary processes and systems to preserve the integrity of the materials and protect them from contamination, we specialize in manufacturing components from precious metals, especially platinum and its alloys.

Platinum/Iridium 90/10:

Coil Winding

West-Tech Materials can provide coil winding services and products for many types of medical device applications. Our custom designed and built coiling machines offer the tightest control of winding forces and winding dimensions that allow for single and multifilar coils using wires down to .00075” in diameter. We can provide quick turn prototype coils in 3-5 days and can work with you to optimize your coil design and performance. In addition, we can take your coils to the next level in design and provide complete coil assemblies using laser welding or soldering operations.

Coiling Technologies

Proprietary Coiling Equipment
We have invested in building the most technologically advanced coiling machines in the world for custom medical coiling. We have multi-axis controls with custom tensioning systems for complete coiling manufacturing control. Combined with our experienced coiling engineers and technicians.

Coil Tooling & Fixture Support
When combined with access to our world-class laser, precision turning, milling, EDM, chemical machining and robotic cleaning systems— our on-site custom tooling area provides the highest level of precision tooling required. This truly has a positive impact on product quality and final price to the customer.

Coil Finishing
We have the ability to provide a variety of precision end cuts and finishing methods to meet your coil design requirements. With our on-site availability of EDM, laser and micro grinding technologies, we have the capability to hold consistently accurate end cut profiles and tolerances. Multiple, state-of-the-art capabilities available, assure your secondary finishing machining is accomplished accurately and efficiently.

Coil Laser Welding
We have the most advanced laser welding systems for coiling applications to produce weld spot sizes as small as .002" in diameter. Capabilities include laser welding of precious materials and dissimilar materials including Nitinol and Elgiloy. These materials can easily be welded with excellent repeatability.

Rapid Response for New Product Development
We have the ability to rapidly turn your coil design into reality. We understand the importance of getting high quality functional components to our customers' development teams FAST.

Coil Specifications

Unifilar - A filar is one wire; therefore, a unifilar coil is wound with a single continuous wire.
Multifilar - Coils wound with more than one filar (wire) are called multifilar.
Left and Right Hand - Coils can be wound in either the left-hand or right-hand direction. The direction of wind may be important depending on the application.
Left Hand	Right Hand
Pitch - The distance from center to center of the wire in adjacent ciols. It is common to measure the average pitch over ten coils.
Stiffness - The amount of flexibility in a coil. We can control the stiffness of the coil. To specify stiffness, indicate the distance "D" for a given height "H."

We manufacture coils for the Neurostimulation, Cardiac Rhythm Management, Vascular Intervention and Minimally Invasive Surgery Markets.

We Provide:

• Single to Multifilar Coils
• Variable Pitch Coils
• Offset Coils
• Terminated Filar Coils
• Custom Coils
• Close Wound Coils
• Multiple Diameter Coils
• Tapered Coils
• Micro Coils
• Left-hand Coils

Coil Sizes & Tolerances

We have the ability to make coils to the tightest tolerances requird for the most stringent medical aplications. Our tooling expertise allows us to consistently develop new methods to meet or exceed our customes' tolerance requirements. We take extreme pride in our inovative abilities to creat tooling and fixtures to support our propretary coiling efforts.

• Outside Coil diameter ranges from .002" - .200"
• Inside coil diameters as smal as .001"
• Overall lengths to 80"
• Tolerances to ± .0002" on diameters

Materials Coiled

We can supply all standard and custom materials including flat and shaped wire for coiled products. Take advantage of our knowledge and history of purchasing large quantities of exotic, and precious materials.

• Stainless Steel
• Nitinol
• Platinum
• Titanium
• Tantalum
• Elgiloy
• Tungsten
• DFT
• Braided Wire
• Clad Wire
• Coated Wire- PTFE, ETFE and Hydrophilic
• Stranded Wire
• MP35N
• Shaped Wires

Nitinol Processing

The manufactures represented by West-Tech Materials are involved in many aspects of Nitinol processing from the raw materials to finished components and fabricated assemblies. We represent the premier NiTi tube supplier in Vascotube and can work with you on applications to produce products using various manufacturing processes including:

• Precision Micro-Machining
• Laser cutting, heat setting and electropolishing
• Laser welding Including Dissimilar Metals
• Coil Winding
• Grinding and Wire Edm

Soldering to Nitinol

In addition to NiTi fabrication West-Tech Materials can assist you with the selection and use of solder alloys and fluxes to meet your NiTi assembly requirements. The typical alloys supplied include: SnAg & AuSn in forms of wire, spheres and preforms. The fluxes we offer allow for the effective reduction of oxides and successful soldering of NiTi and other medical device alloys.

Medical Assemblies & Sub-Assemblies

In addition to component fabrication West-Tech Materials can work with you in the design and fabrication of complete medical assemblies and sub-assemblies. Our manufacturers are ISO certified and FDA registered for clean room manufacturing and production. The advantage to the medical device manufacturer is that you can design, develop and manufacture your finished device with One Source from concept to completion. Some of the areas where we specialize include:

• Neurovascular Leads & Devices for Pain Management, Weight Control and Other Neurological Conditions
• Cardiovascular Devices and Leads
• Orthopedic Devices
• Complete Laser Welded Sub-Assemblies Incorporating Machined Components & Coils
• Class 10,000 Clean Room Manufacturing

Laser Processing

West-Tech Materials offers extensive laser processing services that include laser cutting of tube and flat stock, laser welding, drilling and finishing operations that include microblasting, electro-polishing and heat setting. Our manufacturers have produced over 1.5 million NiTi Stents and have extensive experience and knowledge in the finishing and electro-polishing operations. In addition to metals, we can provide laser cutting and drilling services for many non-metals that include ceramics, rubber, glass, plastics and more.

Stent Cutting, Heat Setting and EP

Peripheral Stents

Cumulative to Date

• Over one hundred (100) development customers
• Over twelve (12) implant production customers
• > 3500 implantable stent designs produced
• 1,000,000+ units sold

Stent Capability and Capacity

• System Design
• Diameters from 0.25mm to 30mm
• Tube Lengths from <1mm to >150mm
• Wall thickness’ up to 0.8mm (I.D. limited)
• Materials
• 316L VM Stainless Steel
• NiTi
• CoCr (L605)
• Many others

Coronary Stents

Eight (8) precision tube cutting systems

Inspection Capabilties

• Laser Cutting
• Computerized Video System
• Visicon
• Ram Optical
• Optical Comparitors
• CMM
• Gage pins
• Dial Indicators
• Micrometers
• Laser Welding
• Low torque testing
• Micro cross sections
• Photo micrographs
• Simple leak testing
• Microscopes
• Micro hardness testing

Medical Devices and Assemblies

History

• Ceramic Substrates for Implant Hybrids
• Plastic Anaesthetic Delivery Cannula
• >1,500,000,000 holes drilled
• Metal Orthopedic Instruments
• Probe Tip, laser-cut and welded
• Grinders and Harvesters, laser-cut and welded
• Laparoscopic Instruments, laser-cut and welded
• > 750,000 Pacemakers shields cut
• > Production & R&D stents
• > IED and Pacemaker redundant contact welding
• > 3,500 Implantable tube designs produced

Applications

• Drug Delivery Components
• Electrical Contact Implants
• Bladder Control Implant Components
• Peripheral Vascular Stents
• Coronary Stents
• Catheter Delivery Components
• Non-Vascular Stents Components
• Device Stents
• Biopsy Probes
• Blood Pump Gaskets
• ByPass Valve Cutters

Metal Cutting

Ceramic Laser Processing

Hearing Aid Application

• Substrates for hearing aid amplifier circuit microelectronics
• Laser-drilled microvias
• Photo of a Beltone hearing instrument

Custom Nitinol & Specialty Metal Tubing

West-Tech Materials represents Vascotube, the premier supplier of NiTi tube for the Stent market worldwide. We are able to provide the highest quality ID & OD surface finish and tightest tolerances available for Wall Thickness and concentricity. With Vascotube precision tube products, our customers are able to realize the highest process yields and quality in all laser cutting and electropolishing operations. Some of the Vascotube highlights include:

• Materials - NiTi, 316lvm, MP35N, Ti, Ta
• Ultra-high Quality ID & OD Surfaces
• Thin Wall (+/- .0003”), Large Diameter, Up To >20mm
• Applications for Stents, Peripheral Catheters & Medical Devices
• ISO 9001 & 13485 Certified

Surface - Surface roughness of the finished tube is one of the most critical specifications for the quality and the lifecycle of your finished Medical devices. Surface defects cannot be removed by electro polishing of the finished stent. Cracks and deformations will remain. The possible honing process will reduce the wall thickness and will lose the tolerances you asked for. With our unique tube production technology we are able to produce OD surface finishes at 0,1µm (Ra).  For the ID we are able to achieve roughness as low as 0,2µm (Ra) as drawn, with a thin oxide layer

Concentricity - This specification has a great influence on the laser cutting process. Vascotube is able to reach concentricity tolerances up to 0,01mm (.0004") in regular production batches.

Wall tolerance - The tolerances on wall thickness for our tubes can be as narrow as +/- 0. 0075 mm (+/- .0003"). Vascotube can guarantee these tolerances, not only for a single tube, but for production batches. This attribute has significant influence on the lifecycle of your device and the performance in fatigue testing

Soldering for Medical Devices

Catheter Assembly

The assembly of diagnostic and therapeutic catheters, micro-catheters, and other one-time use devices requires precision solder. Indium Corporation’s solder wire, preforms, and paste with tight tolerances and micro dimensions facilitate the soldering of small structures, such as hypotubes and coils. Our precision solders include:

• SnAg and AuSn wire in diameters starting at 0.001” (0.0254mm)
• AuSn preforms that can be manufactured as thin as 0.0005” (0.0127mm) and are available in a variety of shapes and sizes
• SnAg preforms that can be manufactured as thin as 0.001” (0.0254mm), also available in a variety of shapes and sizes
• Pb-free solder pastes available in Type 4, 5, and 6 powders.

Soldering to Nitinol

Nitinol is one of the most widely used metals on the market today for implantable devices. However, this amazing shape-memory alloy has its soldering challenges. The key to soldering to nitinol is to remove the tenacious oxide layer that forms on the surface to allow for proper wetting of the solder. An aggressive flux, such as Indium Corporation’s Flux #2, works very well. Post reflow flux residue can be easily removed using water with a surfactant and mechanical scrubbing. Indalloy 121 (96.5Sn/3.5Ag) is eutectic with a melting temperature of 221°C. It is the preferred solder because it has a high tensile strength, is Pb-free, and wets well to Nitinol. Indalloy 182 (80Au/20Sn) which is eutectic at 280°C, has an even higher tensile strength and can be used to coat the Nitinol wires to create a very solderable surface.

Indium and Gold for Hermetic Sealing

Many medical applications require a seal during the assembly process to ensure proper reliability. Indium is used for hermetic, vacuum, and cryogenic seals because it is malleable and ductile, even at extremely low temperatures.

Hermetic seals ensure that delicate components are not exposed to harsh environments. Gold-tin is ideal for hermetic sealing because of its reliability and resistance to oxides, which reduce voiding.

Solder Preforms

Solder preforms provide an alternative method for applying solder to the joint and offer several advantages. They provide a specific, repeatable amount of solder that can be easily introduced into the manufacturing process with standard pick and place machines.

With the use of AuSn solder in a forming gas atmosphere, the soldering process can be done without flux to avoid flux spattering or contamination, which can sometimes damage delicate components. Since adding flux can be inconsistent and damage small sensitive components, preforms can also be flux-coated to eliminate the interim step of adding flux before reflow. Additionally, solder preforms can be used for solderfortifi cation. Many monitoring or diagnostic devices have connectors that are in constant use. Adding Solder Fortification Preforms to the solder paste when attaching the connector to the board can add strength and reliability to the joint.

Micro-Soldering Materials

Many medical devices require fine soldering. Indium Corporation solder pastes are available in Type 4 (20- 38 microns), Type 5 (20-25 microns), and Type 6 (<20 microns) powders in a variety of alloys.

Solder wire is also available in SnAg and AuSn from 25 to 300 microns in diameter. Microspheres are available in sizes from 80 to 300 microns.

Specialty Metals & Alloy Development

West-Tech Materials has a long history in assisting our customers in the selection and development of the appropriate metals and alloys used in medical devices and assemblies. We can provide recommendations of Precious Metal alloys for medical implants and devices including Platinum based alloys, Gold, Palladium and Silver alloys. We provide these precious metals in the form of:

• Fine Wire from less than .001" diameter for micro-coil applications used in pacemakers, defibrillators and other catheter devices used in endovascular treatment.
• Ribbon, Foil, Strip & Rod for stamping and machining.

Precision Stamping & Cold Forming

You can also work with West-Tech Materials for stamping and cold forming of custom metal components. Our manufacturers have multiple stamping locations in the US and Mexico to offer progressive die and four-slide stamping processes. Our micro-stamping processes offer many solutions to the medical device manufacturer for the stamping and forming of implantable grade materials such as Platinum, Platinum-Iridium, Gold, Stainless Steel and Titanium.

Cold Forming

Our technology includes cold forming and cold heading of a wide variety of metals including copper, nickel, kovar, brass, steel, stainless steel, gold, silver, platinum, palladium, tantalum and other alloys. With the cold forming process it is often feasible to make parts from difficult to machine alloys. Cold Forming technology is also well suited to the production of many medical applications.

With cold forming technology, parts can be produced at much higher speeds and therefore at lower cost than machined parts. At the same time the cold heading - cold forming process produces high quality parts. Cold Heading is a process with both cost and quality advantages.

Laser Processing of Non-Metals

• Ceramics: Fine hole drilling, cutting, scribing
• Plastic, Glass, & Quartz
• Silicone Rubber

Dental Alloys, Implants & Copings

• Raw materials in gold, platinum, palladium, Titanium and other specialty alloys.
• Screw Machined copings and dental implants

Catheter Based Delivery Systems and Components

West-Tech Materials now represents manufacturers with over 25 years experience in extrusions, product development and full scale manufacturing of Class I,II and III medical devices. We can assist you from the design and development stage all the way through to high volume low cost manufacturing of complex catheters and assemblies. We are also able to assist in the design, development and manufacture of various types of catheter components and materials. Please browse our website to see the various capabilities that we can offer you.

Catheter Sub-Assemblies

Braided Shafts

Articulating Catheters

Extrusions & Braided Shafts

The manufacturers that we represent are leaders in medical extrusion and related services.

• More Than 75 Years Combined Extrusion Experience
• 5 Extruders ranging from 1”-3”
• Specialty Engineered and Commodity Polymer Processing
• Co-extrusion Technology
• Coating Technology
• Secondary Processing
  Coiling
  Braiding
  Tipping
  Bonding
  Reflow
  

Balloon & Micro-Catheter Assemblies

Let us assist you with the design, development and manufacturing scale up of balloon and micro-catheter applications.

Full Scale Manufacturing

We have at our disposal an FDA- and ISO-regulated labor force of more than 1,100 spread between the USA, Mexico and the Slovak Republic. Our manufacturing operations are set up for high volume low cost production of Class I, II and III devices with over 75,000 sq-ft of class 10,000 clean room manufacturing. We are ready and prepared to scale your product volumes to meet market demand.

Medical Device Experience in FDA Class I, II, III Devices for:

• Endoscopy
• Cardiology
• Endovascular
• Electrophysiology
• Neurovascular
• Respiratory
• Urological
• Enteral Feeding
• Drug Delivery
• General Surgical
• Electrosurgical Devices

Dispensing & Packaging Coils

Engineering & Design Services

West-Tech Materials is anchored by an experienced engineering and design team focused on providing innovation in delivery devices. Our team leverages a comprehensive suite of software, including Solid Works (with Fluid Dynamics) and AutoCad and Minitab to ensure accurate and reliable development of new and innovative delivery devices. At the same time, the team works under a transparent project management structure meant to streamline any development process, giving customers a guaranteed quick delivery.

• Solid Works version 8
• Fluid Dynamics

Design Specifications to BOM

Design Failure Mode Effect Analysis

Testing Capabilities

• Pull Instron Testing
• Balloon Burst
• Leak
• Seal
• Continuity
• Inline Laser ID/OD testing
• Magnification
• Coordinate Measuring Machine (CMM)
• Calipers