Your Global Compounder of

Custom Engineered Thermoplastics

for Healthcare Applications

2013

CONDUCTIVE • FLAME RETARDANT •FILM/SHEET

STRUCTURAL • ELASTOMERS • WEAR • COLOR

MEDICAL MATERIALS EXPERTISEYOUR 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

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

• Identical machinery, processing, QA testing

• ISO 9001:2008 Registered Facilities

• Worldwide technical support

• Local customer service: real people, real time

CONSISTENT PRODUCTION ACROSS THE GLOBE

GLOBALIZATION STRATEGY

New

German

Plant

New

Chinese

Plant

State of the Art - Robotic TestingWorld-Class Quality & Capability

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.

Quality Control and Analysis

Technical Service

•Mold Trials

•Trouble Shooting

•Process Optimization

•More than 18 Engineers

•Global Service Capability

CAE Design

• Metal to Plastic

Conversion

• Filling Analysis

• Structural Analysis

• Warpage Analysis

• Computer-Aided Engineering

• Saves Time & Money

COMPUTER-AIDED ENGINEERING & MOLDING SUPPORT

CAE Design & Tech Service

PRODUCT DEVELOPMENT/R&D

•30+ engineers worldwide

•Formulation development

•Regional engineers for local

support

•Dedicated global pilot plants –

run and scheduled by R&D

engineers

UNPARALLELED PRODUCT ENGINEERING CAPABILITIES

Environmentally controlled manufacturing capability:

• Positive air pressure

• Ultra CLEAN compounding

• Highly controlled production process

• Limited materials in production area

ULTRA CLEAN COMPOUNDING CENTERAVAILABLE FOR PRODUCTS REQUIRING ULTRA CLEAN COMPOUNDING

QUANTITIES THAT MEET

YOUR NEEDS

Bags to Truckloads

YOUR GLOBAL COMPOUNDER OF CUSTOM ENGINEERED THERMOPLASTICS

YOUR GLOBAL COMPOUNDER OF CUSTOM ENGINEERED THERMOPLASTICS

RTP REDUCES DEVELOPMENT TIME

Resin Selection

Fit Form Function

Process Development

Color Specification

Biologic Testing

FDA or EC Submittal

Regulatory Approval

Repeat material selection and testing

if you fail biologic and material availability

and add > 9 – 12 months to development cycle.

RTP Early Involvement

• Physical Property

• Biologic Testing

• Color Anticipation

cGMP Manufacturing

Marketing and

Branding Input

Early Selection of

Biologic Tests

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.

The FDA and EC want to see you demonstrate a pattern of concern for safety in each step.

Review

times are

> 6 – 12

months

& Growing!

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 10993-1 or USP Class VI

– Complete RTP color palette tested to ISO 10993

– Full line of TPEs pre-tested for ISO 10993 biocompatibility

ISO 9001 Manufacturing Quality Certification

– Formulation Control and Change Management Service

– Lot traceability

MEDICAL MATERIALS EXPERTISELARGEST MATERIAL SELECTION IN THE HEALTHCARE INDUSTRY

NEW HEALTHCARE PLASTICS

TECHNOLOGY

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.

COLOR DEVELOPMENTREQUEST AN RTP COLOR MAKE OVER

ISO 10993 Bio Tests Include

• Part 5, in vitro cytotoxicity

• Part 10, irritation and

delayed type hypersensitivity

• Part 11, systemic toxicity

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)

• 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.

MEDICAL COLOR APPLICATIONS

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

Laser Marking andElastomer Coloring

Glow in the DarkGlucose Meter

Dental Chair HousingPC/ABS precolor

Pass Over HumidifierTransparent PC

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

Glucose Meter

Dental Prophy

Insulin Pen

Lubricated/glass filled

PC cover slides – low

start up friction and

long term wear.

Lubricated gears and

screws for quiet smooth

operation. Long term

wear performance.

Eliminate 2°lubrication

and improved wear

performance. Lubricated

glass filled nylon & acetal.

WEAR TECHNOLOGY - MEDICAL DEVICES

THERMOPLASTIC ELASTOMERSISO 10993 PRE TESTED COMPOUNDS USED IN GRIPS, SEALS & MASKS

Main TPE Chemistries Available

• Styrenic block copolymers (SBS, SEBS)– New: Wide range of ISO 10993 pre-

tested compounds and bondables

• Thermoplastic vulcanizates (TPV)– New: Wide range of ISO 10993 pre-

tested compounds and bondables

• Polyurethane elastomers (TPU)– ISO 10993 pre-tested compounds

• Copolyester elastomers (COPE)– ISO 10993 pre-tested compounds

• Polyether-block-amide (PEBA)– ISO 10993 pre-tested compounds

Part of demonstrating your pattern of concern for SAFETY

Wide Range of Pre-TestedISO 10993 Elastomer

Compounds Available

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

Elastomer Seal

• water tight to 8 ft

• translucent

• Light curable

• Overmolded

• PC and Series

6002 TPE

Insulin Pump

Durability

• Solvent resistance

• Soft touch grip

• Toughness

• Many colors

• Series 1500 polyester

thermoplastic elastomer

THERMOPLASTIC ELASTOMERS - TPEWIDE RANGE OF TPE CHEMISTRIES – SEBS, TPV, TPU, COPE AND OTHERS

• Typical hardness range is from 45 – 75 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.

BONDABLE ELASTOMER SYSTEMSWIDE RANGE OF CHEMISTRIES – SEBS, TPV, TPU, COPE AND OTHERS

Short Glass Fiber

• high strength and tensile

• Impact modified

• Recycle content available

Long Glass Fiber

• High strength to weight

• Improved toughness

• Improved dimensional stability

• Enhance creep and fatigue performance

Carbon Fiber

• Highest strength to weight ratio

• Light weight and high stiffness

Glass filled nylon wheels

WIDE RANGE OF FIBER FILLERS COMBINED WITH OTHER TECHNOLOGIES

METAL REPLACEMENT

Carbon fiber polycarbonate

replaces metal on injection pins

Injection pin

10 – 15 lbs of force

ORTHOPEDIC AND MIS TOOLSSURGICAL TOOL DEVELOPMENT AND METAL REPLACEMENT

Wright Medical’s bone fixation

device. Single use disposable.

Functional Performance

• Super high stiffness and high strength

• Impact modified

• Recycle content available

• ½ the cost of metal

Regulatory Performance

• Passes ISO 10993 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.

WIDE RANGE OF FIBER FILLERS COMBINED WITH OTHER TECHNOLOGIES

STRUCTURAL – METAL TO PLASTIC

Surgical Tool Using

High Strength to Weight Plastic TechnologyVideo & picture courtesy of Niti Surgical Anastomosis Tool

Glass Beads (photo courtesy ofPotters Industries)

Glass Fiber

Long Glass Fiber

Carbon Fiber

• 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 POLYMERSMARKET DRIVEN RENEWABLE RAW MATERIALS ALLOW GREEN LABELING

GLASS FILLED PLA – RENEWABLERENEWABLE RAW MATERIALS ALLOWS GREEN LABELING

RADIO OPAQUE ADDITIVESX-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

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

CONDUCTIVE COMPOUNDSDISSIPATIVE, CONDUCTIVE & SHIELDING CAPABILITIES

• 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.

RTP COMPANY MEDICAL POLICY

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 10993 guidelines speed the development process.

WE WANT TO BE AN INTEGRAL PART OF YOUR SUCCESS FORMULA

RTP IMAGINEERING PLASTICS

Contact Details:

Brice Filipczak

Sales development Eastern

France/Switzerland/Italy

bfilipczak@rtpcompany.com

Tel: 06 07 11 29 13

RTP CONTACT INFORMATION