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