Biomerics Capabilities Website Presentation 08.02.2011

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Biomerics Capabilities Website Presentation 08.02.2011

  1. 1. Medical Polymer SolutionsConfidential. Protected under NDA
  2. 2. • Established in 1994 • Headquartered in SLC, UT • 75,000 Square Feet • 24 Hour Operations • 150+ Active Customers • Full Service Medical OEM Manufacturing Capabilities • ISO 9001:2008 • ISO 13485:2003 recommended • www.biomerics.comConfidential. Protected under NDA
  3. 3. • Established in 2004 • Headquartered in Ashaway, RI • 45,000 Square Feet – 10,000 Square Ft Clean Room • 24 Hour Operations • 130+ years Extrusion Experience • ISO 13485:2003 • www.htpmeds.comConfidential. Protected under NDA
  4. 4. Vision Partner with our customers to increase their productivity and Vision profitability through material technology and innovation, operational excellence, and market based customer service. Premier Market Based Operational Technology Mission Customer Service Excellence and Innovation •In-house Innovative •Market Focused •LEAN Manufacturing S Materials Platform Organization System T R •System Solutions •Superior Quality •Vertically Integrated A Products on Time Supply Chain T •Patentable E Technology •Value Added •ISO and FDA Quality G Development Services Systems I Roadmap E •Competitive •OEM Customer S •Portfolio Business Systems Partnerships ManagementConfidential. Protected under NDA
  5. 5. Quality Assurance • Quality Statement – Biomerics manufactures products that meet, or exceed, our customers expectations. As a team, we continually strive to perfect our processes and products to provide superior service to our customers.Confidential. Protected under NDA
  6. 6. Quality Registrations • Salt Lake City, UT – ISO 9001:2008 – ISO 13485:2003 recommended • Ashaway, RI – ISO 13485:2003Confidential. Protected under NDA
  7. 7. Quality Program Capabilities • Problem Solving Tools: – Six Sigma Problem Solving Tools (DMAIC, 8D) – Lean Manufacturing Tools (5S, SMED, 7 Wastes) – Value Stream Mapping/Work Flow Diagrams/Process Mapping – Visual Management Systems (VFM) – 5 Whys, Ishikawa Diagrams – Root Cause Analysis • Product and Process Validation – Standard Work Documentation – DFMEA / PFMEA – Control Plans/Charts – First Article Layouts and Approvals – Process Capability Studies (CpK) – Real-time Monitoring Systems – IQ, OQ, PQ Validations – Lab testing for Analysis and Compliance – Risk Analysis and Risk Assessment • Operational Tools: – Preventative Maintenance Program – Mold Maintenance Program – Clean Room Process – Calibration Program – Risk Assessment Studies – Regular Internal AuditsConfidential. Protected under NDA
  8. 8. Manufacturing Capabilities • Clean Room Manufacturing – Custom Polymerization – Custom Compounding – Pharma-Compounding – Medical Extrusions – Polyimide Tubing – Medical Injection Molding – Medical Device Assembly • Other Capabilities – Machining & Tooling – Support Services – Quality Testing and ValidationConfidential. Protected under NDA
  9. 9. Materials Thermoplastic Elastomers (TPEs) Engineered Polymers Both thermoplastic and Rigid Polymers selected fro their elastomeric properties. The most unique properties such as strength, common medical grade TPE’s are transparency, processability, TPU & PEBA biocompatibility, and impact High Performance Polymers Polyolefins High temperature and Polymers produced from a chemical resistant single chain carbon to thermoplastic polymers carbon monomers.Confidential. Protected under NDA
  10. 10. Custom Polymer Development • Biomerics has the ability to add the following to any of our materials to meet your custom polymer needs: – Radiopaque Additives – Specialty Additives – Color TechnologiesConfidential. Protected under NDA
  11. 11. Biomerics’ Proprietary TPUs Quadrathane™ Quadraflex™ Quadraplast™ •ARC, Aromatic Polycarbonate •ARC, Aromatic Polycarbonate •Rigid Aromatic Polycarbonate •ALC, Aliphatic Polycarbonate •ALC, Aliphatic Polycarbonate •Clear Grades •Custom Grades •Custom Grades •Custom Grades Complete Biomedical Polymer Provider Quadraphilic™ Quadraban™ •ALC, Aliphatic Polycarbonate •Silver based •ALE, Aliphatic Polyether •Antimicrobial •Solution Grades •CHC, Quaternary Ammonium •Extrusion Grades ChlorideConfidential. Protected under NDA
  12. 12. Medical Material Compounding • 6 Medical Compounding Machines • High Performance Pharma-Compounder • Clean Room Compounding of: – Liquids – Powders – Fibers – PharmaceuticalsConfidential. Protected under NDA
  13. 13. Medical Extrusions • 14 State-Of-The-Art Medical Extrusion Lines – 3/4” to 2” – Proprietary Take-Off Equipment – 11 pullers, 6 bump pullers – 50+ custom screws, 18+ custom heads • 2 Dedicated R&D Lines • Specialty Extrusions – Micro-extrusions – Multi-lumen extrusions – Multi material Co-extrusion – Multi-layer (2,3,4) – Profile Extrusions – Coated Wire – Taper and Bump Tubes – Fiber Optic JacketingConfidential. Protected under NDA
  14. 14. Polyimide Tubing and Coated Wire • Wire Coating Line and Co-extrusion – 0.0060-0.080 ID Range – 0.0005 – 0.010 Wall Thickness – Colors: Amber, Black, Red, Green • Specialty Polyimide Tubes – Micro-extrusions – Multi-lumen co-extrusions – Multi material co-extrusion (urethane and Pebax) – Coated Wire – Braided and Spiral reinforced • Secondary Operations – Laser Cutting – Necking – Drilling – PTFE LinerConfidential. Protected under NDA
  15. 15. Medical Injection Molding • 25 Injection Molding Machines • Clean Room Medical Molding • Support Capabilities – Closed loop material drying systems – Centralized plant cooling system – Full regrind and drying systems – Robot automation • Molding Technologies – Hot runner systems – Insert Molding – Intrusion Molding – Master Batch Colorant – Trim and Deflash • Process Control – Velocity and positional controls – Ejection sequences – Temperature profiles – PressureConfidential. Protected under NDA
  16. 16. Medical Device Fulfillment and Assembly • Clean Room Capabilities - Kitting - Light Assembly - Ultrasonic Welding - Packaging In Rigid Trays and Pouches - Solvent Bonding - Validation Testing • Additional Capabilities (not in clean room) - Pad Printing • SLC Sterilization Resources - Steris Isomedix – Gamma Sterilization 9 miles away - Sterigenics – ETO Sterilization 10 miles awayConfidential. Protected under NDA
  17. 17. Machining and Tooling • Capabilities – 2, 3, 4,5 Axis CNC Milling – Swiss Machine Turning – Live Tooling – Mill from billet • Plastics Machining Operations • Precision Metal Turning • Secondary Operations to molded partsConfidential. Protected under NDA
  18. 18. Value Added Support Services • Product Design and Development • Patent Services • Tool Design • Process Development • Rapid Prototype Services • Testing and Validation • Design for manufacturability • ISO and FDA regulatory services • IQ, OQ, PQ validationConfidential. Protected under NDA
  19. 19. Testing and Validation • R&D Material Development • Incoming Raw Material Certification • In-House Material QC • Extensive Quality Lab Testing Capabilities • Inspection and MeasurementConfidential. Protected under NDA
  20. 20. Biomerics Medical – FocusPeritoneal Dialysis Catheter
  21. 21. Medical Value Chain Raw Material Semi-Finished Goods OEM Manufacturers Suppliers Suppliers •Thermoset Elastomers •Compounders •Development •Engineered Plastics •Extruders •Manufacturing •Thermoplastic Elastomers •Molded Shapes •Testing and Validation •Fluoropolymers •Accessories •Packaging •Performance Metals End Users: OEM Device Hospital, Cath Labs, Medical Device OEM Cardiologist Distributor •3000 Practicing •Distribution •Development •Application •Packaging •Manufacturing •Cost/Performance •Marketing and Sales •Trials and Regulatory •Purchasing Groups •Fulfillment •Marketing and SalesConfidential. Protected under NDA
  22. 22. Contact Us• Travis Sessions, President & CEO• Troy Mohr, VP Business Development• Amanda Crowell, Customer Service Biomerics, LLC 2700 S 900 W Salt Lake City, UT 84119 801-355-2700 www.biomerics.com

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