Medical Polymer Solutions
Confidential. Protected under NDA
• 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.com
Confidential. Protected under NDA
• 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.com
Confidential. Protected under NDA
Vision
MissionPremier Market Based
Customer Service
Operational
Excellence
Technology
and Innovation
S
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G
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•Market Focused
Organization
•Superior Quality
Products on Time
•Value Added
Services
•Competitive
Business Systems
•In-house Innovative
Materials Platform
•System Solutions
•Patentable
Technology
Development
Roadmap
•Portfolio
Management
•LEAN Manufacturing
System
•Vertically Integrated
Supply Chain
•ISO and FDA Quality
Systems
•OEM Customer
Partnerships
Vision
Partner with our customers to increase their productivity and
profitability through material technology and innovation,
operational excellence, and market based customer service.
Confidential. Protected under NDA
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
Quality Registrations
• Salt Lake City, UT
– ISO 9001:2008
– ISO 13485:2003 recommended
• Ashaway, RI
– ISO 13485:2003
Confidential. Protected under NDA
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 Why's, 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 Audits
Confidential. Protected under NDA
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 Validation
Confidential. Protected under NDA
High Performance Polymers
High temperature and
chemical resistant
thermoplastic polymers
Materials
Thermoplastic Elastomers (TPEs)
Both thermoplastic and
elastomeric properties. The most
common medical grade TPE’s are
TPU & PEBA
Engineered Polymers
Rigid Polymers selected fro their
unique properties such as strength,
transparency, processability,
biocompatibility, and impact
Polyolefin's
Polymers produced from a
single chain carbon to
carbon monomers.
Confidential. Protected under NDA
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 Technologies
Confidential. Protected under NDA
Biomerics’ Proprietary TPUs
Confidential. Protected under NDA
Complete Biomedical Polymer Provider
Quadraflex™
•ARC, Aromatic Polycarbonate•ALC, Aliphatic Polycarbonate•Custom Grades
Quadrathane™
•ARC, Aromatic Polycarbonate•ALC, Aliphatic Polycarbonate•Custom Grades
Quadraplast™
•Rigid Aromatic Polycarbonate•Clear Grades•Custom Grades
Quadraphilic™
•ALC, Aliphatic Polycarbonate•ALE, Aliphatic Polyether•Solution Grades•Extrusion Grades
Quadraban™
•Silver based•Antimicrobial•CHC, Quaternary Ammonium Chloride
Medical Material Compounding
• 6 Medical Compounding Machines
• High Performance Pharma-Compounder
• Clean Room Compounding of:
– Liquids
– Powders
– Fibers
– Pharmaceuticals
Confidential. Protected under NDA
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 Jacketing
Confidential. Protected under NDA
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
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
– Pressure
Confidential. Protected under NDA
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 away
Confidential. Protected under NDA
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 parts
Confidential. Protected under NDA
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 validation
Confidential. Protected under NDA
Testing and Validation
• R&D Material Development
• Incoming Raw Material Certification
• In-House Material QC
• Extensive Quality Lab Testing Capabilities
• Inspection and Measurement
Confidential. Protected under NDA
Biomerics Medical – Focus
Peritoneal Dialysis Catheter
Medical Value Chain
End Users:Hospital, Cath Labs, Cardiologist
•3000 Practicing•Application•Cost/Performance•Purchasing Groups
OEM Device Distributor
•Distribution•Packaging•Marketing and Sales•Fulfillment
Medical Device OEM
OEM ManufacturersSemi-Finished GoodsSuppliers
•Thermoset Elastomers•Engineered Plastics•Thermoplastic Elastomers•Fluoropolymers•Performance Metals
•Compounders•Extruders•Molded Shapes•Accessories
•Development•Manufacturing•Testing and Validation•Packaging
•Development•Manufacturing•Trials and Regulatory•Marketing and Sales
Raw Material Suppliers
Confidential. Protected under NDA
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