Your Global Compounder of Custom Engineered Thermoplastics for Healthcare Applications

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1 STRUCTURAL ELASTOMERS WEAR COLOR CONDUCTIVE FLAME RETARDANT FILM/SHEET Your Global Compounder of Custom Engineered Thermoplastics for Healthcare Applications 2013

2 MEDICAL MATERIALS EXPERTISE YOUR GLOBAL COMPOUNDER OF CUSTOM ENGINEERED THERMOPLASTICS Unmatched Resin & Additive Selection Virtually all resins Thousands of additives Unbiased material selection Biocompatibility RTP pre-tested Internal list known compounds Formulation Control and Change Management Traceability ISO 9001 Certified

3 GLOBALIZATION STRATEGY CONSISTENT PRODUCTION ACROSS THE GLOBE New German Plant New Chinese Plant China & Singapore United States Germany & France Scalability: Develop your solution on a small scale and produce your solution at larger quantities Plant-to-plant consistency ISO 9001:2008 Registered Facilities Worldwide technical support Local customer service: real people, real time Identical machinery, processing, QA testing

4 Quality Control and Analysis World-Class Quality & Capability State of the Art - Robotic Testing RTP Quality Policy Through the continual improvement of our quality system, processes and products, RTP Company is committed to delivering on-time, defect-free products which meet or exceed the requirements of our internal and external customers. RTP Company supports its commitment to quality with ISO 9001:2000 Registered Facilities in Winona, MN; South Boston, VA; Forth Worth, TX; Indianapolis, IN; Beaune, France; Singapore; and Suzhou, China.

5 CAE Design & Tech Service COMPUTER-AIDED ENGINEERING & MOLDING SUPPORT CAE Design Metal to Plastic Conversion Filling Analysis Structural Analysis Warpage Analysis Computer-Aided Engineering Technical Service Mold Trials Trouble Shooting Process Optimization More than 18 Engineers Global Service Capability Saves Time & Money

6 PRODUCT DEVELOPMENT/R&D UNPARALLELED PRODUCT ENGINEERING CAPABILITIES 30+ engineers worldwide Formulation development Regional engineers for local support Dedicated global pilot plants run and scheduled by R&D engineers

7 ULTRA CLEAN COMPOUNDING CENTER AVAILABLE FOR PRODUCTS REQUIRING ULTRA CLEAN COMPOUNDING Environmentally controlled manufacturing capability: Positive air pressure Ultra CLEAN compounding Highly controlled production process Limited materials in production area

8 QUANTITIES THAT MEET YOUR NEEDS Bags to Truckloads YOUR GLOBAL COMPOUNDER OF CUSTOM ENGINEERED THERMOPLASTICS

9 RTP REDUCES DEVELOPMENT TIME Repeat material selection and testing if you fail biologic and material availability and add > 9 12 months to development cycle. YOUR GLOBAL COMPOUNDER OF CUSTOM ENGINEERED THERMOPLASTICS Review times are > 6 12 months & Growing! Resin Selection Process Development Biologic Testing Regulatory Approval Fit Form Function Color Specification FDA or EC Submittal The FDA and EC want to see you demonstrate a pattern of concern for safety in each step. cgmp Manufacturing Early Selection of Biologic Tests RTP Early Involvement Physical Property Biologic Testing Color Anticipation Marketing and Branding Input Regulatory Review 3-6 Months Cue 3 Month Mandatory Waiting Period RTP parallel path development helps eliminate material selection and availability errors. RTP helps demonstrate a pattern of concern for SAFETY throughout the development.

10 MEDICAL MATERIALS EXPERTISE LARGEST MATERIAL SELECTION IN THE HEALTHCARE INDUSTRY Unmatched Resin and Additive Selection Virtually all base resins used for compounding Thousands of additives and colorants Unbiased material selection based on application need. Trademark agreements such as Radel R PPSU Biocompatibility Internal list of known biocompatible compounds Resin and additives that meet ISO or USP Class VI Complete RTP color palette tested to ISO Full line of TPEs pre-tested for ISO biocompatibility ISO 9001 Manufacturing Quality Certification Formulation Control and Change Management Service Lot traceability

11 RTP Company is bringing cutting edge plastics technology to the healthcare industry. The following slides are examples of how these technologies are applied in medical device development. NEW HEALTHCARE PLASTICS TECHNOLOGY

12 COLOR DEVELOPMENT REQUEST AN RTP COLOR MAKE OVER Improve Product Development or Refresh SPEED - Dual Path! Custom Color Match in 5-10 days (Industrial, consumer or medical colors) 18 Std colors available right now (Pre-color or master batch) ISO Bio Tests Include Part 5, in vitro cytotoxicity Part 10, irritation and delayed type hypersensitivity Part 11, systemic toxicity You can use bio-tested colors on your custom color! Statement of Biocompatibility provided upon request. Part of demonstrating your pattern of concern for SAFETY.

13 MEDICAL COLOR APPLICATIONS Glow in the Dark Glucose Meter Dental Chair Housing PC/ABS precolor Laser Marking and Elastomer Coloring Pass Over Humidifier Transparent PC Precolor Special Effects Laser marking Glow in the dark Marble, metallic, pearlescent Translucent FDA approved colors Masterbatch Color Standard color palate PP clarifiers High concentration Custom coloring

14 WEAR TECHNOLOGY - MEDICAL DEVICES Glucose Meter Dental Prophy Lubricated/glass filled PC cover slides low start up friction and long term wear. Eliminate 2 lubrication and improved wear performance. Lubricated glass filled nylon & acetal. Lubricated gears and screws for quiet smooth operation. Long term wear performance. Problems Solved with Wear Materials Eliminate Sticktion Reduce force to initiate movement Single use disposables, syringes, slides Tribology Data Improves Decisions Use engineering values to improve wear and friction outcomes SPEED decision making, reduce testing Long Term Wear Performance Improve lifecycle performance Reduce squeaks and wear debris TPU Catheter Force Reduction Reduce instrument friction and improve hoop strength PTFE replacement options New technology choices Reduce cost Insulin Pen

15 Main TPE Chemistries Available THERMOPLASTIC ELASTOMERS ISO PRE TESTED COMPOUNDS USED IN GRIPS, SEALS & MASKS Styrenic block copolymers (SBS, SEBS) New: Wide range of ISO pretested compounds and bondables Thermoplastic vulcanizates (TPV) New: Wide range of ISO pretested compounds and bondables Polyurethane elastomers (TPU) ISO pre-tested compounds Copolyester elastomers (COPE) ISO pre-tested compounds Polyether-block-amide (PEBA) ISO pre-tested compounds Wide Range of Pre-Tested ISO Elastomer Compounds Available Part of demonstrating your pattern of concern for SAFETY

16 THERMOPLASTIC ELASTOMERS - TPE WIDE RANGE OF TPE CHEMISTRIES SEBS, TPV, TPU, COPE AND OTHERS Insulin Pump Elastomer Seal water tight to 8 ft translucent Light curable Overmolded PC and Series 6002 TPE Durability Solvent resistance Soft touch grip Toughness Many colors Series 1500 polyester thermoplastic elastomer Elastomer Material Options Colorable and clear Enhanced mechanical adhesion to a variety of substrates Substrate Compatibly Biocompatible options ISO 10993, USP and FDA Applications Human touch zones, grip, ergonomics, ease of patient use. Medical devices, valves, gears and slides

17 BONDABLE ELASTOMER SYSTEMS WIDE RANGE OF CHEMISTRIES SEBS, TPV, TPU, COPE AND OTHERS Typical hardness range is from Shore A but can be customized for each application. Substrate and elastomer overmold can be modified to improve adhesion. Matching the elastomer chemistry with the substrate dramatically improves adhesion.

18 METAL REPLACEMENT WIDE RANGE OF FIBER FILLERS COMBINED WITH OTHER TECHNOLOGIES Short Glass Fiber high strength and tensile Impact modified Recycle content available Glass filled nylon wheels Long Glass Fiber High strength to weight Improved toughness Improved dimensional stability Enhance creep and fatigue performance Injection pin lbs of force Carbon Fiber Highest strength to weight ratio Light weight and high stiffness Carbon fiber polycarbonate replaces metal on injection pins

19 ORTHOPEDIC AND MIS TOOLS SURGICAL TOOL DEVELOPMENT AND METAL REPLACEMENT Functional Performance Super high stiffness and high strength Impact modified Recycle content available ½ the cost of metal Regulatory Performance Passes ISO testing Gamma, Eto and Autoclaveable Ability to earh 510(k) or CE Mark Branding Performance Custom teal logo colors Seamlessly passed all cadaver tests vs. original metal tools. Wright Medical s bone fixation device. Single use disposable.

20 STRUCTURAL METAL TO PLASTIC WIDE RANGE OF FIBER FILLERS COMBINED WITH OTHER TECHNOLOGIES Glass Beads (photo courtesy of Potters Industries) Glass Fiber Long Glass Fiber Surgical Tool Using High Strength to Weight Plastic Technology Video & picture courtesy of Niti Surgical Anastomosis Tool Carbon Fiber

21 Sustainability Renewable Feed Stock Meet Green Objectives Produces 60% less greenhouse gases during manufacture. Uses 50% less non-renewable energy than traditional polymers like PET. USDA Product Listings BIO POLYMERS MARKET DRIVEN RENEWABLE RAW MATERIALS ALLOW GREEN LABELING

22 GLASS FILLED PLA RENEWABLE RENEWABLE RAW MATERIALS ALLOWS GREEN LABELING

23 RADIO OPAQUE ADDITIVES X-RAY DETECTION AND SHEILDING Heart Surgical Tool PES with radio pacifiers X-ray opacity Inserts molded inside detachable template Branding Radio Opaque Fillers Virtually all resins Minerals and metal fillers Barium, Bismuth Range of metals Combinations Filler density control to preserve physical properties Autoclave capability with PPSU, PEEK and other resins Lead equivalency

24 CONDUCTIVE COMPOUNDS DISSIPATIVE, CONDUCTIVE & SHIELDING CAPABILITIES Permanent ESD Protection for improved drug dosage accuracy uses permanent non-sloughing formulations that has been evaluated for extractables. Clear and colors are available. GE Medical Heart Monitor EMI Shielding Conductive High Flow Polypro Pipettes

25 RTP COMPANY MEDICAL POLICY Contact with internal bodily tissues/fluids Temporary (<30 days) OK, if agreed to in writing Permanent (> 30 days) Not permitted For more information please request a copy of the RTP Company medical application policy. No RTP compounds have been determined as safe for contact with internal bodily fluid or tissues. Customers rely upon their own legal and medical judgment. Customers are responsible to perform biocompatibility testing required by local or applicable regulatory bodies.

26 RTP IMAGINEERING PLASTICS WE WANT TO BE AN INTEGRAL PART OF YOUR SUCCESS FORMULA We have The widest resin and additive selection in the world. We provide You with an unbiased review of proven new thermoplastic technology solutions for use in medical devices. We help you establish a pattern of concern for safety Formulation control, statement of biocompatibility and change management services preserve the integrity of your testing. We add SPEED to your product development team Years of experience in formulating plastics that meet ISO guidelines speed the development process.

27 RTP CONTACT INFORMATION Contact Details: Brice Filipczak Sales development Eastern France/Switzerland/Italy Tel:

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