Lake Region Medical
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Device, Component, and Material Design Testing Analysis Idea Center Prototyping
Engineer at a Computer


From ideation to prototyping to testing, Lake Region's design capabilities are available to bring your vision to the market. Lake Region's expertise in design for manufacturing, experience with unique materials and testing and analysis capabilities combine in a comprehensive solution for any design challenge.

Engineer at a Computer

Device, Component, and Material Design

Lake Region offers unique, comprehensive solutions to design challenges by utilizing a phased approach—compressing the design process to achieve rapid, high-quality design solutions. Click below to learn more about Lake Region’s design capabilities.

Design for Manufacturing and Assembly
Design for Manufacturing & Assembly (DFMA) is a systematic method of analyzing a design to achieve the lowest total cost. Lake Region is a DFMA leader. Our engineering services group utilizes BDI DFMA software to analyze designs and leverage core manufacturing technologies to produce superior reductions—at times up to 80% in costs and 50% in cycle time. Generally, a substantial portion of the product cost is locked in by the design of the product. DFMA focuses on individual component design optimization for cost reduction and process robustness. It is typical to achieve product cost reductions of greater than 50% and reduce product development cycle times by 40%.

Alloy and 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.

Application Specific Materials
Whether designing a pacemaker, catheter or endoscopic cutter, Lake Region's material engineers have the expertise to provide guidance in material selection for hundreds of product applications. This often translates to increasing speed to market, improved product quality and greater profitability.

Materials Consultation
By choosing Lake Region, our customers realize the benefit of partnering with industry-leading metal and polymer experts. Lake Region's engineers are available to provide guidance and expertise from initial design consideration to full commercialization.

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Lake Region brings vast expertise to perfecting your product through a battery of tests, offering a complete suite of analytical tools to ensure your device succeeds at the clinical trial phase.

Biocompatibility Testing
Biocompatibility testing ensures that adverse reactions—due to materials or processes performed on a device—will not occur for patients or clinicians. Lake Region has extensive knowledge of the ISO procedures that govern biocompatibility testing and maintains strong partnerships with leading biocompatibility testing houses.

Packaging Testing
Lake Region performs tensile and burst testing on packages to ensure a robust, sterile barrier is in place to maintain sterilization of devices. Lake Region is experienced in testing many types of packages and seals—leveraging this experience across all product packaging.

Sterility Testing
Sterility testing determines if a product is free of viable micro-organisms. This is generally achieved by testing biological indicators (BI) that are inoculated with types of bacterial spores—an important step in the sterilization validation process, dose audits and continuous monitoring of sterility cycles.

Transit Testing
Distribution simulation (transit testing) evaluates the robustness of a package. This ensures the product will not be damaged during shipping and will perform as expected upon reaching its destination. Lake Region has a broad understanding of the different standards that encompass distribution testing. We have developed numerous resources to perform this testing for all aspects of a product's life cycle—from prototype packaging to established production.

Corrosion Testing
Corrosion testing examines various metals and their resistance to oxidation, most typically in metallurgy.

Fatigue Testing
In fatigue testing, a material or product's resistance to cyclic loading is tested to predict the service life of a component. Lake Region has strong materials testing capabilities and expertise in evaluating fatigue data to characterize and improve component materials, manufacturing methods or design.

Fourier Transform Infra-Red (FTIR) Testing
Analysis of chemical compounds can be performed through Fourier Transform Infra-Red (FTIR) spectroscopy to identify organic compounds. Lake Region works in partnership with multiple chemists—including analytical, polymer and PhD chemists—on FTIR testing.

Hardness Testing (Micro/Macro)
Micro and macro hardness testing determines the resistance of a material to penetration by a loaded indenter. Macro methods can be used to test the outer surface of a product. Micro methods can test a section within the product's interior. Hardness values obtained from this test method can be used to determine the strength of products that have geometries or sizes too small for tensile testing. Lake Region has strong materials testing capabilities and expertise to accurately determine hardness.

High Potential Testing
High Potential Testing (or Hipot Testing) is performed to verify that no current will flow from one point through a dielectric barrier to another point—signifying good insulation. This helps to guarantee the safety and quality of electrical circuits and evaluates the quality of an insulator. This process also identifies weaknesses in electrical design. Lake Region is committed to continuous improvement in Hipot Testing and performs these tests on several of its devices.

Lubricity Testing
Lubricity testing determines frictional interactions between mating parts and the efficacy of lubricity level on parts. This determines manufacturing process limits used to control lubrication application. Lake Region is experienced in characterizing frictional forces between parts with a sub-assembly to determine lubricious coating efficacy.

Nitinol Bend and Free Recovery Testing
Nitinol bend and free recovery testing determines the active transformation temperature of a Nitinol component or material. This process determines the component's behavior in a service temperature environment. Lake Region leverages its expertise with Nitinol and is equipped to perform a wide range of tests on Nitinol—ensuring specification compliance and proper component performance.

Tensile Testing
Through tensile testing, the mechanical properties of a material or component can be determined. In this process, a tensile load is applied and the material is pulled to failure. This generates data that can be used to determine the amount of cold work in a component or the effectiveness of hardening heat treatments that can be applied and can be interpreted for process control or product acceptance purposes. Lake Region has strong materials testing capabilities and expertise.

Coating Durability Testing
Coating durability tests are performed to determine the coating's resistance to degradation over time and exposure to various environments—ensuring that the system performs appropriately. Lake Region can measure friction and perform visual inspections for coating durability tests.

Verification and Validation
Verification is the examination and provision of objective evidence that specified requirements have been fulfilled. Validation is established by objective evidence that a process consistently produces a result or that a product meets its predetermined requirements. Lake Region understands the importance of process verification and validation to ensure sound process development—maximizing manufacturing yields and minimizing product failures in the field. Process verification and validation are required to meet U.S. and International Regulatory standards that assure predictable manufacturing outcomes and high quality products.

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Lake Region's engineers excel at performing analyses to identify inefficiencies and flaws in existing products. Our broad testing capabilities allow us to scrutinize a design from all angles before the manufacturing process even begins.

Failure Analysis
Failure analysis is performed to find the root cause of the failure and identify corrective action on parts or materials that have failed in manufacturing, product testing or in field service. Lake Region's multiple failure analysis labs practice a wide range of metal testing and diagnostic techniques including Scanning Electron Microscopy (SEM) and Energy Dispersive Spectroscopy (EDS). This equipment is used to view fractures and other surface failures at up to 100,000 times magnification and to perform semi-quantitative chemical analyses on very small surface regions.

Finite Element Analysis
Finite element analysis is a mathematical technique that analyzes stress by breaking down a physical structure into substructures called finite elements. Finite elements and their interrelationships are converted into equation form and solved mathematically in problems where analytical solutions are not easily obtained due to complex geometries, loadings and material properties.

Materials Analysis
Analyzing materials to determine their nature and properties enhances the capabilities to use materials appropriately, to reverse engineer products and to analyze failures. Lake Region has years of experience in metallic and non-metallic material evaluations—utilizing top organic chemists, polymer chemists and metallurgists to perform these analyses.

Moldflow Analysis
When performing moldflow analysis, a computer simulation of a plastic molding process is performed to help lean out the physical molding process—speeding up the development effort with fewer tooling iterations. Lake Region has numerous plastics engineers who conduct, understand and apply the results of these analyses.

Shelf Life and Aging Studies
Shelf life and aging studies are performed to ensure a medical device and its packaging will perform as expected throughout the life cycle of the product. Aging tests can be performed in real time or with elevated temperatures to simulate aging.

Tolerance Studies
Tolerance studies assess the fit of components in an assembly at all ranges of dimensional value to determine proper part tolerances. Proper tolerance will reduce incidence of future problems while minimizing part costs. Lake Region understands the capability of many part manufacturing processes, and can more accurately predict part dimensional variance.

EDS Analysis
In energy-dispersive X-ray spectroscopy (EDS), X-ray analysis is performed to gain information about the nature and condition of materials used in Lake Region products.

SEM Analysis
Using SEM analysis, Lake Region examines and evaluates small objects at high magnification. Lake Region draws on over 25 years of experience in the field of SEM analysis.

Thermal Analysis
Thermal analysis is utilized to determine the melting points, glass transition points, and any other heat-related properties of non-metallic materials to predict how the material will behave when incorporated into a particular device. Lake Region utilizes the latest equipment in its thermal analysis laboratory.

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Idea Center

Idea Center

The birthplace of cutting edge, creative innovations. Our engineers are passionate about developing best-in-class solutions to bring customer projects to life quickly and efficiently. When companies partner with Lake Region, they partner with a dedication to perfection. Lake Region's Idea Center engineers are adept at testing and examining potential devices and processes for flaws and inefficiencies. Our engineers have the know how to test devices so you don't have to—eliminating costly iterations and increasing ROI.

The Lake Region Idea Center focuses on creative concept development and innovative design to accelerate new medical device product launches for our customers. By integrating knowledge, experience and the latest technology, we rapidly transform ideas into successes. Partner with the Lake Region Idea Center to extend internal design resources and start realizing the benefits of increased idea generation.

Jumpstart your company's product concept development with enhanced creativity. Deliver on development timelines and bring innovative products to market faster. Maximize resources through increased focus and improved portfolio management. Lake Region's design and engineering experts have a proven track record of providing solutions to the marketplace, while meeting and overcoming design challenges.

The Lake Region Idea Center ensures:

  • Speed to Market: Early involvement in the design phase—facilitating innovation, generating more creative ideas and speeding results.
  • Intelligent Designs: Advanced methods and tools enable Lake Region's design teams to predict process capability early on—ensuring targets are met without sacrificing functional requirements, speed to market or cost goals.
  • Reduced Costs: Efficient processes help drive down product costs by providing feedback early in the design process—ensuring a smooth transition from design to product manufacturing.
  • Reduced Risk: Focused on the medical device industry, Lake Region is a trusted partner—employing FDA-audited design controls and providing regulatory submissions support.

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Our technical experts will guide customers through the process of taking their concept for product innovation and converting it to a marketable device. Lake Region's Idea Center engineers are experts in bringing design concepts to reality—providing fast and efficient solutions. Our rapid prototyping capabilities allow fast and efficient product development, enabling faster speed to market.

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