Lake Region Medical
 
 
 
EXPERTISE: LOGISTICS
line blend
Quality Assurance Sterilization Warehousing Delivery
Raw Material Outsourcing Metallurgical Laboratory Capabilities Lean Materials Management & Analysis

Logistics

Our customers' needs don't end with assembly and packaging—and neither do Lake Region's services. Please review the information below to learn about our offerings for the final logistical stages of our customers' supply chain.

Quality Assurance

Lake Region engineers are adept at identifying quality improvement opportunities throughout the product lifecycle, from early concept design stages to ongoing manufacturing processes. The Company is constantly training and equipping our engineers with industry best practices, Lean Engineering principles and Six Sigma methodologies. Quality control is embedded in Lake Region's culture. Our Quality Management System touches all employee functions to ensure every step in the supply chain is held to the highest standards.

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Sterilization

Lake Region leverages multiple partner relationships to provide a complete sterilization management solution. Furthermore, our engineers are adept at providing industry-standard sterilization validation solutions for our customers.

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Warehousing

Lake Region's warehousing solutions are a valued asset to our customer base. Lake Region's locations in North America and throughout Europe and Asia enable the Company to meet our customers' warehousing needs across a number of geographies. Lake Region is well-versed in managing any number of materials management systems, including EDI, Kanban and consignment arrangements.

Vendor Managed Inventory
Lake Region is well-versed in executing Vendor Managed Inventory (VMI) programs. VMI allows our customers to ensure continuity of supply with minimal management of demand fluctuations.

Kanban
Kanban arrangements enable Lake Region's customers to better manage inventories while ensuring absolute continuity of supply. Customers will typically maintain a minimum amount of product on-site, while Lake Region carries the bulk of inventory needs within our facilities. As customer inventories are drawn down, Lake Region typically ships replenishment product within a pre-arranged timeframe, typically within 72 hours.

Consignment
Lake Region's consignment solutions place inventory in the possession of our customers, while Lake Region continues to hold title to the product. Title is transferred as the products are built (or in some cases sold) essentially eliminating any inventory costs to our customers.

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Delivery

When you partner with Lake Region, you are partnering with an international company that can deliver products to customers across the globe. The result? Efficient distribution, on-time delivery and meeting all commitments. Lake Region's customers typically choose the method of shipment based on specific logistical requirements. The Company frequently ships products via UPS, FedEx, DHL or common carrier. Lake Region works with customers on a purchase order-to-purchase order basis or through supply agreements, utilizing forecasts to better meet our customers’ delivery needs.

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Raw Material Outsourcing

Lake Region's customers often leverage the Company's expertise in securing raw materials typically used in medical device applications. Lake Region's material processing and testing professionals assure the material used in your product application meets industry-wide regulatory requirements.

Polymer Material List (generic names)

  • PTFE
  • FEP
  • ETFE
  • PFA
  • Polyimide
  • PTFE Doped Polyimide
  • PEEK
  • Polyester
  • Polyurethane
  • Tecothane (Implantable Polyurethane/ Polycarbonate Blend)
  • PP (including glass filled and mineral filled)
  • ABS
  • Nylon 6 and 6,6 (including glass filled)
  • PE (including HDPE and LDPE)
  • PC (including glass filled)
  • PC/ABS
  • Nylon 12
  • HIPS
  • TPE
  • TPR
  • TPU
  • Acetal
  • PPS
  • PES
  • PBT
  • PET
  • UHMWPE

Polymer Material List (some specific brand names)

  • Pebax®
  • Tecoflex®
  • Vestamid®
  • Grilamid®
  • Zytel®
  • Aesno®
  • Besno®
  • Bionate

Metals List – generic

  • NiTi
  • Stainless Steel
  • Tantalum
  • Pt
  • Pt-Ir
  • Gold
  • Silver
  • Copper
  • Co-Cr alloys (MP35N, Elgiloy®, L605)
  • Titanium alloys (CP-Ti, Ti3Al2.5V, Ti6Al4V)

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Metallurgical Laboratory Capabilities

The Metallurgical Laboratories at the Lake Region facilities in Collegeville, PA and Salem, VA are fully equipped laboratories set up for materials testing and evaluation. The lab’s capabilities cover a wide range of functions including mechanical testing, metallographic evaluation, corrosion testing, failure analysis and scanning electron microscopy (SEM) and energy dispersive x-ray spectroscopy (EDS). In addition, other tests not performed directly by the laboratories, such as non-destructive testing, salt spray corrosion testing, and elevated temperature tensile testing can be supplied as needed.

Mechanical Testing

  • Tensile Testing (Room Temperature) – ASTM A 370, ASTM E 8
  • Ultimate tensile strength 0.2% and 0.5% offset yield strength
  • Elongation @ 2”, 1”, 0.5”, 0.25” and 4D gage lengths
  • Cyclic tensile testing (hysteresis losses)
  • Hardness Testing
  • Macrohardness testing (Rockwell) - both standard (Ra, Rb, Rc, etc.) and superficial (15T, 30T, 30N, etc.)
  • Microhardness testing (DPH, Vickers)
  • Hardness profiles
  • Case depth determination
  • Tube Flare Testing
  • Expansion over a 60° anvil
  • Expansion over a 74° anvil
  • Tube Flattening Testing
  • To any required “T” value
  • Nitinol Testing - Mechanical
  • Tensile testing for UTS, upper plateau stress and Elongation. All strains are measured utilizing an extensometer at room or elevated temperature
  • Cyclic testing for determination of permanent set and lower plateau stress
  • Nitinol Testing – Thermal
  • Bend and free recovery testing for active transformations
  • Differential Scanning Calorimetry for ingot transformations
  • Fatigue Testing
  • Rotary beam fatigue testing for wires and cables
  • “Bell-mouth” bend fatigue testing for wires, cables, and coils
  • Device Testing
  • Alternating bend fatigue testing
  • Pull strength (the load required to separate two or more components)
  • Break load (the load required to break an assembly)

Non-Destructive Testing

  • Hydrostatic Pressure Testing
  • Up to 10,000 psi applied pressure
  • Burst testing (pressurized to failure) can also be performed on the lower strength materials such as copper and aluminum
  • Pneumatic Pressure Testing
  • Up to 1,000 psi applied pressure
  • Air under water
  • Nitrogen under water
  • Surface Finish
  • Quantitative RMS, Ra, or Rq measurements via a non-contact laser surface profilometer
  • Eddy Current Testing
  • Capability to detect defects down to 0.002”

Metallographic Evaluation

  • Microstructural examination and evaluation
  • Grain size measurement (ASTM E 112)
  • Weld bead evaluation
  • Characterization of internal and surface contamination
  • Qualitative surface roughness determination
  • Tubing wall thickness measurements
  • Evaluation and measurement of surface and internal defects and discontinuities
  • Micro cleanliness determination and inclusion rating (ASTM E 45)
  • Alpha-case determination
  • Corrosion/oxidation evaluation
  • Examination for intergranular attack
  • Determination of susceptibility to stress corrosion and general or pitting corrosion
  • Preparation of potted Samples for examination of internal characteristics (e.g., electrical connectors, small machined or formed parts, small diameter tubing,
    etc.)

Image Analysis

  • Measurements for length, diameter, area, longest dimension, perimeter and percent of area
  • Measurement of plating or composite layer thickness
  • Measurement of defect length or depth
  • Grain size measurement
  • Determination of weld bead width and thickness

Scanning Electron Microscopy (SEM) - LEO EVO 40 ASPEX PSEM

  • Micro examination of features of interest at up to 200,000X magnification
  • Comparison of surface finishes and topographies
  • Fractography – Examination of fracture surfaces
  • Elemental differentiation through the use of backscatter emissions

Energy Dispersive Spectroscopy (EDS) - EDAX Genesis & Sirius 10/2.8

  • Elemental bulk qualitative and quantitative chemical analysis
  • Electron probe microanalysis
  • Line scans
  • X-Ray mapping
  • Particle analysis
  • Microvoid size determination
  • Identification of foreign materials or corrosion products and possible sources

Corrosion Testing

  • ASTM G 36 (stress corrosion cracking)
  • ASTM A 262, Practice “A” (susceptibility to corrosion)
  • ASTM A 967, Practices “A” and “D” (confirmation of passivation)
  • ASTM F 1089, Procedures 6.1 and 6.2 (resistance to corrosion)
  • AMS-STD-753, Test Methods 100, 102, and 103 (confirmation of passivation)
  • Immersion Testing (corrosion susceptibility in a specific environment)

Analysis of Product Failures and Customer Complaints

  • Visual examination
  • Preparation of photographic record of failure/defect
  • Optical and electron optical microscopic evaluation
  • Metallurgical examination
  • Preparation of detailed reports including source of problem or cause of failure and, when applicable, provide corrective action.

Consultation

  • Consult with raw material vendors to work out any technical issues regarding Lake Region requirements and the product available from the vendor.
  • Consult with customers over any issues or concerns of a metallurgical nature regarding Lake Region products. When appropriate, provide any additional technical support to the customer that they might require.
  • Provide consultation of a metallurgical/technical nature to the various companies and departments within the Lake Region organization. This could include process or material development, cleaning issues, and fabrication procedures.

Outside Support
In addition to the capabilities described above the Collegeville Metallurgical Laboratory works closely with at least six other independent laboratories. These labs perform the additional testing required to be able to provide complete analytical services both to the Lake Region facilities and Lake Region customers. Some of these procedures include:

  • Complete or Interstitial Chemical analysis
  • Elevated temperature tensile testing
  • Stress-rupture testing
  • Extended exposure elevated temperature corrosion testing (e.g., ASTM A 262, Practice E and Practice C)
  • Potentiodynamic corrosion testing
  • Non-destructive testing/evaluation (fluorescent penetrant and ultransonic testing)
  • Auger electron spectroscopy (AES)
  • X-ray photon spectroscopy (XPS) for evaluation of cleanliness and surface layers

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Lean Materials Management & Analysis

Lake Region's engineers excel at identifying inefficiencies and flaws in both new and existing manufacturing and supply chains. The Company's broad testing capabilities allow our experts to scrutinize complex designs for waste and inefficiencies, developing solutions to ensure a streamlined and robust manufacturing process.

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