Lake Region Medical
 
 
 
EXPERTISE: ASSEMBLY
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Device Assembly Finished Device / Sterile Packaging Joining
Device Assembly

Assembly

Partnering with Lake Region provides our customers with access to an extensive suite of assembly capabilities. With 200,000 square feet of manufacturing space and locations across the globe, Lake Region can assure complete business continuity to our customers. Within this space, Lake Region leverages the expertise of over 200 manufacturing and process experts to provide an efficient, seamless solution for the production of thousands of unique components, subassemblies and complete devices. Lake Region is flexible and will support our customer's requirements—whether they are for a subassembly or a finished device. Several customers begin with a subassembly only to realize that it is both more cost-effective and faster to engage Lake Region to build the final assembled device—including packaging, labeling and sterilization.

Lake Region recognizes quality is the most important factor for medical device companies. Our engineers leverage tremendous expertise in producing quality products. Lake Region's focus on medical devices means we can bring extensive resources to bear, improving designs, quality and speed to market. Lake Region conducts manufacturing assessments early in the process to tailor our solutions to our customer's needs. We provide a unique solution for every customer, reducing time to market and increasing ROI. Click below to discover more about the breadth of Lake Region's offerings.

 

Device Assembly

Lake Region offers manual and semi-automated device assembly in controlled and highly-efficient environments. Methods range from bonding, ultrasonic, laser and induction welding to imprinting, molding, packaging and sterilization. In medical device markets, quality and consistency are key to product performance. Lake Region uses continuous improvement techniques to produce devices at competitive costs. Drawing from experience in design, process and multiple technologies, Lake Region turns a customer's vision to a marketable and saleable product.

Subassembly
Lake Region offers a wide range of competencies for manual and automated production of subassemblies including bonding, ultrasonic, laser and induction welding, imprinting, molding and lubrication. Subassemblies are most often produced in controlled environments to eliminate risk to the end user or patient. Lake Region utilizes experience in multiple technologies and in design and established production processes to turn a customer's idea into a salable product.

Device Testing
Ensuring that a device will perform as expected is of the utmost criticality when serving medical device markets. To verify that a device meets all of its functional and performance requirements, Lake Region uses testing equipment dedicated to specific designs, ensuring 100% compliance to regulatory requirements.

Sterile Barrier Packaging
Lake Region provides tray and pouch vacuum sealing of devices in preparation for sterilization. It is critical that packaging designs maintain integrity from the point of manufacture to the surgical field. Lake Region utilizes processes that guarantee the integrity of product packaging, ensuring compliance to world-wide regulatory requirements.

Device Labeling
Device labeling, including product, customer and/or manufacturing data, is routinely performed by Lake Region. Control of the label quality, including quantity and relevant manufacturing data, is critical to the medical device marketplace and Lake Region deploys a team of experts to ensure 100% compliance.

Sterilization Services
Lake Region ensures that products are sterilized in accordance with all applicable standards to prevent contamination and infection in the medical device environment. Lake Region regularly provides oversight and trending of sterilization data, drawing from extensive experience with all types of sterilization.

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Finished Device / Sterile Packaging

Lake Region regularly performs final packaging and labeling, is well-versed in several packaging methodologies and employs strict label control systems.

Lake Region also provides tray and pouch vacuum sealing of devices in preparation for sterilization. Lake Region understands the criticality of packaging designs, ensuring seal integrity from the point of manufacture to the surgical field.

Lake Region uses proven packaging equipment and techniques to provide consistent sterile barrier packaging, meeting or surpassing US and OUS regulatory requirements.

Lake Region’s expertise in working with a wide variety of metals and polymers ensures that your packaging needs are met.

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Joining

Joining

Lake Region leverages years of experience with a variety of proprietary systems and knowledge to form a complete and efficient joining solution. From crimping and swaging to UV bonding, Lake Region provides world-class solutions to challenging design requirements.

Laser Welding

Laser Welding
Utilizing a wide array of laser welding techniques, Lake Region is well-versed in developing platforms for hundreds of product joining applications. Lake Region leverages its vast laser welding technologies to develop, validate and implement solutions for all medical device applications as well as critical non-medical applications.

Resistance Welding
Resistance welding is a process in which localized, electrically-generated heat and pressure are applied to create bonds between materials. This is a cost-effective method for joining certain materials without inducing significant stresses to assembly or subassembly. Lake Region utilizes strict process controls to minimize process variability and maximize robustness.

Soldering
Lake Region typically solders medical materials with tin or antimony alloys as an economical method for joining components that will not operate under stress or elevated temperatures. Soldering uses a low enough temperature to leave joined components unaffected by heat. Lake Region has the materials process expertise to identify the proper solders, fluxes, thermal cycles and cleaning processes to ensure a sound solder joint.

Brazing
Brazing is the process of flowing a melted metal alloy, typically copper or silver, across two metal components to join the materials. This is an economical joining method for components that do not realize high stresses or temperatures in service. Lake Region has the materials process expertise to identify the proper brazing alloys, fluxes or atmospheres, thermal cycles and cleaning processes to ensure a sound braze joint.

UV Bonding
UV bonding is an adhesive process that cures materials using Ultra Violet light. This rapid process creates shorter cycle times. Lake Region leverages its experience in UV bonding at multiple facilities.

Adhesive Bonding
Adhesive bonding is a process used for joining any number of materials. It is often used in applications to join dissimilar materials in which typical bonding technologies are not possible. Lake Region utilizes a great number of technologies and is well-versed in adhesive bonding for medical device applications.

Crimping
Crimping is the joining of components via mechanical means, often a bending or deforming process. Crimping is a common method for joining components into a functional assembly or subassembly and is ideal for small medical devices that have minimal joining options. Lake Region is experienced with exceptionally complex and small diameter crimped connections and offers in-house testing for strength and fatigue.

Swaging
Swaging is a rotary hammering process used to reduce the diameter of tube and wire ends, which are then formed into a customer-defined shape with enhanced mechanical properties. This process does not produce chips or metal loss and can achieve very high deformations without intermediate annealing, producing the net shape in one operation. Common swaging applications include attaching radiopaque marker bands to polymer catheters. Lake Region leverages its strong expertise in swaging with in-house tool manufacturing, process experts and process automation. Lake Region can produce a highly capable, cost-effective swaging process for your end shaping needs.

Induction Welding
Induction welding uses electric induction energy and forging pressure to join two materials, either metal or plastic. Induction welding can be controlled to quickly heat small areas, avoiding heating of adjacent material.

Ultrasonic Welding
Ultrasonic welding is a process for joining similar and dissimilar polymer based components using ultrasonic energy and pressure. This process creates strong, reliable and potentially hermetic seals by melting the materials together. Lake Region is well-versed in process optimization and tooling development to achieve the desired joint performance with minimal flash and particulate generation. Additionally, Lake Region provides material selection and component design support to achieve the product performance at the lowest possible manufacturing costs.

RF Welding
Radio frequency (RF) welding utilizes radio frequency energy to melt and bond polymers, typically for large-volume film products such as blood bags and colostomy bags.

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