Lake Region Medical
 
 
 
EXPERTISE: MANUFACTURING
line blend
Metalworking Metal Secondary Processing Wire Processing Machining Plastics Processing Finishing
Device Assembly

Manufacturing

Lake Region offers component manufacturing with a "finished product" mindset. Our engineers take the time to understand your end goals when producing a product component, and our broad metals-and plastics-based component solutions mean that you can rely on Lake Region to produce exactly what you need.

With over 1,000,000 square feet of manufacturing space and 19 locations across the globe, Lake Region can assure business continuity throughout the component production process. Within that space, we leverage the expertise of over 200 manufacturing and process experts to provide efficient, seamless solutions for the production of thousands of unique component parts in a lean manufacturing environment. Partnering with Lake Region provides our customers access to an extensive suite of component capabilities. Select a manufacturing capability below to learn more about Lake Region's offerings.

Device Assembly

Metalworking

Lake Region brings a comprehensive suite of metalworking capabilities and processes to the medical device industry.

Alloy & Clad Development
Lake Region's metallurgical experts bring a comprehensive suite of custom alloys and clad materials to the medical device marketplace, including precious metals. The Company's highly experienced materials engineers guide our customers through the process of material specification, sourcing, selection, development, validation and commercialization—creating application-specific solutions to meet the needs of the medical device marketplace.

Device Assembly

Metal Tube Drawing
Lake Region's metal tube drawing capability ranges in size from 0.010 inch (.25mm) OD to 0.625 inch (16mm) OD in both seamless and welded and drawn types. Drawn tube can be delivered in coil, random straight lengths and dead cut lengths from 0.25 inch (6mm) to 20 feet (6,100mm). Tube drawing is performed with hard tooling on ID and OD surfaces to allow precise dimensional control and smooth surfaces. The drawing process design includes intermediate anneals and variable drawing reductions, allowing precise control of mechanical properties and microstructural quality. Lake Region offers a wide range of stainless steel, precipitation hardenable, nickel, cobalt, titanium, zirconium, niobium, and tantalum alloys and precious metals. Lake Region will provide sample quantities as low as 25 feet and production quantities up to 1,000,000 feet. Lake Region will source material and develop drawing processes for your custom alloy needs. Lake Region's drawn tube products are manufactured locally in North America, Europe and Asia. 

 

Device Assembly Metal Tube Fabrication
Metal tube fabrication uses specific deformation, punching, cutting, machining and laser processing operations to create customer-specific features and functions on tubular products. Tube forming processes can be used to create expansions, reductions, corsets, bulges and bends. Laser cutting, punching and shearing can be used to create windows, lances, notches and other through-the-wall features, greatly enhancing the functionality of a tubular component. Lake Region's integrated tube drawing enables a streamlined supply chain, insuring product quality, short development and delivery timelines.
Device Assembly Marker Band Fabrication
Marker band fabrication is the production of metal cut tubing—typically gold, platinum and their alloys, Tantalum, MP35N, Elgiloy® and L605—for use as radiopaque markers during angioplasty and other minimally-invasive catheter procedures. Lake Region was one of the earliest players in this market and quickly attained market leadership status in quality, delivery, service and capability—providing the complete integration of supply chain from virgin materials to finished product.
Device Assembly

Stamping
The stamping process produces parts at a significant cost advantage over machining and can include piercing, forming, coining to varying or precise thicknesses and extruding sheet metal, tubing or wire. Lake Region offers in-house design/build tooling with machine capability to stamp flat stock up to .080" x 12" wide and perform wire forming up to .125" diameter.

Forging
Hot forging is a forming process that takes advantage of the linear grain flow of a rolled bar by contouring it to the final shape. This produces a stronger part while reducing raw material and final machining costs. Lake Region supplies cobalt chrome, titanium and stainless steel forgings with automated and manual forging operations—as well as post-forging operations such as annealing, machining, polishing, clean room packing—to deliver a finished component.

Laser Welding
Laser welding is a non-impact, low-heat repeatable process for joining similar and dissimilar metals. Lake Region offers lasers of multiple power levels to suit a variety of applications.

Metal Injection Molding
Metal injection molding (MIM) is a process in which fine metal powders are mixed with a polymer binder to create a flowable mixture, producing net or near net metal parts. The metal injection component may be used as molded or may require further densification, machining, surface finishing or heat treatment. Current alloys include 316L and 17-7PH stainless steels. MIM produces metallic parts at much lower costs than conventional machining from wrought metal forms. Lake Region compounds our own proprietary feedstock—formulated for low viscosity and reduced shrinkage, along with an eco-friendly water-soluble debinding system. Lake Region's R&D group is focused on the development of implantable MIM materials and is actively engaged in the development of ASTM standards for implantable MIM materials.

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Device Assembly

Metal Secondary Processing

Lake Region's metal secondary processing expertise covers a range of capabilities. Click on a link below to learn more about Lake Region’s expertise in these processes.

Heat Treating
Heat treating, such as annealing, is the thermal processing of metals, designed to achieve specific characteristics in the finished component. This can enable more efficient machining to produce a specific shape and super elastic properties, enhance spring properties, or reduce movement during grinding. Lake Region has in-house heat treatment capabilities to ensure process control and reduced supply chain cycle times.

Passivation
Passivation is the process of making a material "passive" usually by the deposition of a layer of oxide on its surface—most commonly an acid treatment (nitric and citric). It removes deposits of corrosive metals left by material forming processes and restores the passive oxide layer to the surfaces of metals such as stainless steel or titanium alloys. Lake Region offers in-house passivation to ensure process control and reduced supply chain cycle times.

Electropolishing
In its simplest definition, electropolishing is the controlled removal of surface metal using a combination of chemicals and electrical current. While plating deposits metal on a surface, electropolishing is a reverse plating process. This leaves no coating to chip, peel or flake off. Lake Region's in-house electropolishing capabilities are state of the art, and include the ability to polish Nitinol products.

Laser Marking
Laser marking chars metal to leave a mark and is used in a wide variety of applications, including part identification, scale and measurement marking, bar coding, material lot control, and customer name and logo marking. Lake Region has years of laser marking experience and can mark a wide range of product sizes with varying types of laser markers—all in the manufacturing facility to lower costs and increase product throughput.

Polishing
Lake Region's polishing capabilities allow us to produce extremely fine mirrored finishes for a variety of medical products, including hip, knee, spinal and extremity implants. Articulating surfaces of orthopedic implants require fine finishes to prevent premature failure. Surface finishes of less than four microinches are common on titanium, cobalt chrome and stainless steels.

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Device Assembly

Wire Processing

Lake Region provides a wide array of wire processing capabilities including wire drawing, forming, coiling, straightening, grinding, cabling, braiding, welding and polymer coating.

Alloy & Clad Development
Lake Region's metallurgical experts bring a comprehensive suite of custom alloys and clad materials to the medical device marketplace, including precious metals. The Company's highly experienced materials engineers guide our customers through the process of material selection, development, validation and commercialization—creating application-specific solutions to meet the needs of the medical device marketplace.

Wire Drawing: Precious Metals & Alloys
Wire drawing reduces wire and rod sizes by pulling the material through a series of dies to reach a desired diameter. In-process and final heat treatments are completed to target specific mechanical properties such as ultimate tensile strength, yield strength, break load and elongation. Lake Region is a fully-integrated precious metal producer, including platinum, gold, silver, palladium and their alloys. With fully integrated melting capabilities and a metallurgical staff, Lake Region works with our customers to develop specific material properties or custom alloys.

Wire Drawing: Clads
Clad wire is formed when two or more distinct metal materials combine into a single wire, creating properties not provided by a single material. Typical properties include corrosion resistance, biocompatibility, radiopacity, electrical conductivity and tensile strength. Lake Region's metallurgical staff can provide guidance in selecting materials and processing options to help customers meet specific design needs.

Device Assembly

Wire Straightening & Cutting
Lake Region offers wire straightening and precision cutting for a wide range of materials including all medical-grade stainless steels, MP35N and nitinol with diameters from .0030” to .070” and lengths with tolerances as tight as ±.005”. Lake Region also offers various end configurations including deburring, radiusing or pointing.

Wire Forming
In wire forming, precision drawn, and straightened or precision ground straight wires are mechanically cold worked to impart flats, angular bends or radiused bends. Wire formed distal curve shapes are important features to aid navigation for the distal end of guide wire devices and can impart tip flexibility for device movement in one plane while simultaneously stiffening another plane. Lake Region has a wealth of experience developing a range of automated and manually-operated wire forming, and understands the complex relationship between wire forming process input variables and the process outcome.

Device Assembly Nitinol Wire Forming
Lake Region regularly forms both nitinol tube and wire for a multitude of product applications. Forming is followed by a thermal set process that optimizes the super elastic properties of nitinol. Lake Region has extensive experience in thermal setting and also secondary processing of nitinol tube and wire products with state-of-the-art processing equipment and expertise that is among the best in the industry.
Device Assembly Coil Winding
Coil winding is the forming of a single filament or multiple filaments in the shape of a helix to function as electrode coils for implantable conductors (including fixation helixes). It is commonly used in catheter applications for tube reinforcement or strain reliefs. Lake Region is constantly investing in advanced coil winding technologies to solve ever-increasing design challenges presented by today's medical device marketplace. Combining coil winding technologies with Lake Region's other core competencies—such as wire drawing, laser ablation and coating—allows our customers advanced design flexibility and increased speed to market.
Device Assembly Wire Plasma Tip Forming
Lake Region offers plasma tip forming, a process in which the parent material is melted to form a ball on the end of a wire. Diameters can be achieved up to 3x that of the base wire.
Device Assembly

Wire Braiding
Braiding is the interweaving of filaments—typically stainless steel—to form an interlocking reinforcement for polymer tubing. This process helps meet performance requirements such as high torque, high push, kink response, and related requirements that can only be attained with reinforced polymer tubing. Other fibers and materials such as NiTi, tungsten, and monofilaments can also be used in the braiding process. Lake Region has decades of experience working with reinforced polymer tubes and can predict the performance of these reinforced composites with our Virtual Tubing Model to adjust the design for specific customer needs.

Wire Cabling
Wire cabling is a process through which multiple wires are stranded concentrically together in a helical arrangement to form a cable or wire rope—increasing flexibility and resistance to bending fatigue or abrasion, and creating multiple conductor paths for implantable leads. Lake Region specializes in small-diameter filaments and can manufacture multiple cable designs with capabilities to process solid/alloy and clad materials with a wide range of mechanical/tensile properties.

Device Assembly

Wire Coating
Lake Region has extensive wire coating capabilities including Hydrophilic, Silicone, PTFE, ETFE, Parylene and Polyimide.

Centerless Grinding
Lake Region is a fully-integrated supplier of ground wire based components and products with a full complement of centerless, profile and micro grinding technologies. Capabilities include thru feed and plunge centerless grind, profile grinding and micro OD grinding with ground diameters to .0015” and tolerances to ± .0002".

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Joining

Machining

Whether you require CNC, Multi-axis, Swiss, EDM or Laser machining, Lake Region provides a comprehensive solution from design to development to component production.

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Swiss Machining
Swiss machining is a simultaneous multi axis automated lathe that can be used to produce highly-precise complex components. The Swiss design allows for the production of long, small diameter components that are difficult to produce on conventional lathes. Lake Region employs more than 250 Swiss style machines with varying capabilities depending on the complexity of the part and continuously upgrades its Swiss machining centers as new technologies become available.

CNC Milling / Turning
CNC Milling is a versatile process that enables complex machining of a vast array of products, often with very complex geometries. Starting stock is affixed to the machine and material is removed using rotating tools, endmills, drills and reamers on multiple axes. Lake Region's 100+ CNC milling and turning centers offer the latest programming technology, improved cutting performance, decreased cycle time and improved quality output.

Electrical Discharge Machining (EDM)
Electrical Discharge Machining (EDM) is an erosion process that allows machining of intricate shapes with close tolerances that are burr-free. EDM uses a rapid series of repetitive electrical discharges, while eroded particles are flushed away with a continuous flow of dielectric fluid. Lake Region has embraced EDM technology since its introduction to the machining industry and is adept at producing very complex geometries in extremely small sizes—many with profiles only visible with magnification. Lake Region is a leader in driving innovative EDM solutions to the most difficult product design challenges.

Laser Machining
The Laser Machining process allows repeatable cutting of high-precision patterns, typically creating features that can't be produced via conventional machining methods. This process enables tighter tolerances and extremely intricate features without the tool pressure of traditional machining. Lake Region processes a wide range of medical-grade alloys, including precious metals and shape memory alloys.

Multi-Axis Grinding
Multi-axis grinding technology enables Lake Region to produce a wide range of medical components and products, most often requiring complex flute geometries, trocar points and sharpened edge components with extremely high-quality surface finishes. Lake Region has utilized multi-access grinding—including products with shanks from .040" to 1/2" in diameter and group surfaces up to 11" long—utilizing fully-automated 2-axis robotic technology.

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Plastics Processing

Lake Region brings a comprehensive suite of plastics processing capabilities to the medical device industry including molding, extrusion, filmcasting and custom catheter development and production.

Joining Insert Molding
Insert molding is the process in which a polymer is molded over a sub-component, often metal but increasingly another molded product. Overmolding, or two shot molding, is helpful in molding complex geometries that would otherwise create surface imperfections and high tooling costs. It eliminates downstream assembly steps and produces a strong mechanical bond by incorporating interlocking overmolded features. Lake Region leverages its fully-integrated supply chain capabilities to produce a wide array of both metal and molded components, many of which are later overmolded to produce a finished assembly or device. Specialized vertical presses are outfitted with rotary tables to eliminate injection cycle time and minimize cost.
Joining Injection Molding
With plastic injection molding, molten resin is injected into a closed mold under high pressure to efficiently produce a complex shape in a cost-efficient manner. As an alternative to machining, this process offers significant piece part savings and delivers otherwise impossible-to-achieve component or product features.
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Implantable Molding
For products designed as long-term implantables, high precision and extremely finite tolerances are the standard. Lake Region brings a vast array of technical expertise to ensure compliance to all regulatory requirements. Our engineers are extremely well-versed in providing highly valued solutions for all facets of molding, including mold design, product design, and process control.

Header Molding
Headers are used to contain electrical receptacles for pulse generation leads in pacing and neurostimulation applications. They are attached to the pulse generator, usually made of polyurethane or epoxy, and used to make the connection between the implantable device circuitry and the implanted lead. Lake Region's header molding capability is world-class. When coupled with a suite of the Company's implantable conductor solutions, it provides our CRM/ICD/CRT and Neuro Stimulation customers with more complete supply chain solutions—lowering overall product costs.

Joining Extrusion
Polymer extrusion is a process in which a polymer is melted and forced through a die/mandrel to produce a desired shape. It is a high-speed, low-cost method to produce polymer tubing used in medical device applications. Lake Region offers a broad range of materials and sizes in a variety of constructions including single lumen, multi-lumen, co-extrusion and wire reinforcement. Combined with our in-house film cast capabilities, extrusion contributes to Lake Region's vast array of material combination offerings to serve your product needs.
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Film Cast Tube Fabrication: Polyimide, PTFE, etc.
In film cast tube fabrication, polymer tubing is manufactured by applying layers of polymers over a mandrel. The process allows broad customization of tubing properties to fit specific applications with options such as lubricous liners, braid reinforcement, thermoplastic outer layers, lubricious outer layers and varying flexibility along the tube length. Lake Region offers the broadest range of materials, sizes and constructions in the market and is a world leader in braiding capability. With in-house extrusion capabilities, Lake Region offers a vast array of material combinations to serve your product needs.

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Finishing

Lake Region utilizes the latest technologies to ensure our customer's finishing needs are met with the utmost quality. Our heat treating process is overseen by our material technology experts, and the Company's engineers are fully versed in the use of Nd:YAG light energy for laser etching. Lake Region's finishing solutions are the perfect complement to our design expertise.

Heat Treating
Heat treating, such as annealing, is the thermal processing of metals, designed to achieve specific characteristics in the finished component, such as:

  • Enabling more efficient machining
  • Producing a specific shape and super elastic properties
  • Enhancing spring properties
  • Reducing movement during grinding

Lake Region has in-house heat treatment capabilities to ensure process control and reduced supply chain cycle times.

Passivation
Passivation is the process of making a material "passive," usually by the deposition of a layer of oxide on its surface. This is most commonly an acid treatment (nitric and citric). It removes deposits of corrosive metals left by material forming processes and restores the passive oxide layer to the surface of metals—such as stainless steel or titanium alloys. Lake Region offers in-house passivation to ensure process control and supply chain cycle times.

Electropolishing
In its simplest definition, electropolishing is the controlled removal of surface metal using a combination of chemicals and electrical current. While plating deposits metal on a surface, electropolishing is a reverse plating process. It leaves no coating to chip, peel or flake off. Lake Region's in-house electropolishing capabilities are state of the art, and include the ability to polish Nitinol products.

Laser Ablation
Laser ablation is a laser machining technique that allows the selective removal of plastic materials while leaving underlying metals unharmed, introducing very little heat into surrounding materials. This process is typically used to strip plastic coating—eliminating issues with mechanical methods such as part damage, part deflection and tolerancing, and tool wear. Lake Region can perform ablations on coils, cables and plastic tubes, utilize rotary control and hold very exact angles.

Laser Marking
Laser marking chars metal to leave a mark and is used in a wide variety of applications. These include part identification, scale and measurement marking, bar coding, material lot control and customer name and logo marking. Lake Region has years of experience and can mark a wide range of product sizes with varying types of laser markers. All these processes occur in the manufacturing facility to lower costs and increase product throughput.

Pad Printing
Pad printing is a process that transfers 2-D images—including logos or measurements, or functional materials such as conductive inks, adhesives, dyes and lubricants—onto 3-D objects via silicone pad. Properties of the silicone pad allow it to pick up the image from a flat plane and apply it to a variety of surfaces, enabling printing on objects that would otherwise be impossible. Lake Region offers expertise in developing ink mixtures and process parameters required to achieve the best possible appearance on a printing surface.

Hydrophilic Coating
Very lubricous when wet, hydrophilic coating is used on catheters for easier tracking in blood vessels and to allow passage into certain parts of the anatomy. Lake Region has designed its own coating equipment and can design custom equipment as needed. With catheter and tubing component manufacturing—as well as other coating services—Lake Region can provide complete solutions to your needs.

Silicone Coating
Lake Region offers solvent-based dip-coating of a high molecular weight silicone: polydimethylsiloxane. A very thin coating with low migration provides lubricity to various substrates, including metals, plastics and other silicones. Lake Region has developed a controlled, semi-automated process that provides uniform coating and ensures consistent application.

PTFE Coating
Lake Region applies a thin coat of polytetrafluoroethylene (PTFE) to metallic parts and mandrels on medical devices to increase lubricity and to better reach certain anatomies.

Parylene Coating
Parylene is an insulative coating applied through a vapor deposition process—producing a surface free of pin holes. This result is necessary for electrical and chemical resistance.

ETFE Coating
Ethylene tetrafluoroethylene (ETFE) coating is applied via extrusion—typically over wire or cable—as required for electrical insulation and reduced friction. ETFE coatings are often typical to implantable conductor applications.

Polishing
Lake Region's polishing capabilities allow us to produce extremely fine, mirrored finishes for a variety of medical products, including hip, knee, spinal and extremity implants. Articulating surfaces of orthopedic implants requires fine finishes to prevent premature failure. Surface finishes of less than four microinches are common on titanium, cobalt chrome and stainless steels.

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