teleflex incorporated - medica

Teleflex Incorporated

Work With The Experts™

2

This is Teleflex Medical OEM

Our Common CauseA relentless obsession for providing solutions

to our customers’ needs.

Our PurposeAs a trusted co-development partner, we support industry

leaders in the design and development

of medical devices with the unparalleled expertise

that improves speed, flexibility, and value.

3

Global Network of FacilitiesEight state-of-the art facilities

Trusted partner with decades of experience in outsourcing

45+ Years

Global Leader in Device Innovation and Manufacturing

EPIC Medtec®

CentersThree purpose-built facilities for innovation and product development

4

Global Network of SupportSales and customer care network, manufacturing facilities, and EPIC Medtec® Centers

United States• Coventry, CT• Jaffrey, NH• Gurnee, IL*• Mansfield, MA**• Maple Grove, MN**• Plymouth, MN• Trenton, GA

Mexico• Nuevo Laredo• Tecate

Republic of Ireland• Limerick**

*OEM Headquarters**EPIC Medtec™ Center

Teleflex OEM Facility

Sales and Customer Care Support

5

Fluoropolymer, Polyimide, Thermoset,and Thermoplastic Tubing and Extrusions

Diagnostic and InterventionalCathetersBalloon Catheters

Sheath/Dilator Sets

Specialized Sutures and Performance Fibers

Bioabsorbable Sutures, Yarns, and Resins

Product PortfolioBroad product offering from raw materials to components to finished devices

Film-Insulated Fine Wire, Mandrel Wire, and Conductors

6

Our Advantage: Single Source Solution

Unlike some manufacturers who deliver only components or will outsource projects to multiple vendors, we can do it all because of our comprehensive, in-house, vertically-integrated capabilities

7

Product Concept Development

Engineering

Film Cast Tubing, Mandrels, Fine Wire,

and Catheters

Material Selection

Design for Manufacturability

Extrusion

Finishing Operations

ProductionProcess Development

Manufacturing

Conductors

Prototyping

Testing and Validation

Custom Tooling

Vertically-Integrated Capabilities

Private Labeling

Assembly & Packaging

Balloon Blowing

8

Mandrels | Tubing | Extrusions | Catheters

9

Catheter Construction

Braid/CoilReinforcement

Outer Layer

Hydrophilic Coating

Liner

Mandrel

10

Mandrel Wire: Coated and Uncoated

Uncoated • Silver-plated copper wire• Size range ~0.004” to 0.051”

Spring Coil

Coated PD-Slick™ (Polyimide and PTFE composite)• Size range ~ 0.006” to .090”• Low friction polymer coating over most base

metals• Gamma radiation resistant• Chemically resistant

PTFE• Lubrious material• Chemically resistant

Core Wire

Artist’s ConceptNot to Scale

We Can Take Your Project from Pellets to Tubing to Finished Device

11

Thermoplastic and Thermoset Resins

Tubing and Extrusion

Components Finished Devices

12

Micro-Diameter, Film-Cast Tubing

• Global leader for medical tubing• As small as .0020” (.0508mm) up to

.0910” (2.31mm) ID• Ultra-thin walls with tight tolerancing• Polyimide, PTFE, PD-Slick™, Pebax®,

and other hybrid materials

• Reinforced (coil and braid) tubes• Conductor embedded tubes• Drilling, flaring, tipping, forming, pad

printing, and cut-to-length options

13

Precision Extrusions

• Global leader for medical tubing• Facilities in Jaffrey and Limerick• Full in-house compounding

capabilities• Horizontal and vertical fluoropolymer

extrusion • High-performance thermoplastic

extrusion• Key materials : PTFE, FEP, PEEK,

and thermoplastics

14

Extrusion Capabilities

• Single and multi-lumen tubing• Heat-shrink and spiral heat-shrink

tubing• Co-extrusion and multi-layer• Beading• Profiles• Encapsulated tips• Multi-durometer• Ultra-thin walls • Radiopaque filler • Color match and custom color

compounding

16

Catheter Reinforcement

Braiding

Braid-Reinforced Polyimide Tubing

Coiling Longitudinal

Coil-Reinforced Polyimide Tubing

Embedded Conductor

17

Balloons and Balloon Catheters

Balloon Blowing Capabilities• Plymouth facility• Non-compliant, semi-compliant,

and compliant balloons• Diameters: 1mm to 19mm,

Lengths: 4mm to 200mm• Wide range of balloon shapes

Balloon Catheter Capabilities• Plymouth and Limerick facilities• 0.014”, 0.018”, and 0.035” balloon

catheter dilation and delivery systems

• Over-The-Wire (OTW) and Rapid Exchange (RX) designs

• Hydrophilic coating services

18

Hydrophilic Coating Services

• Limerick facility• Customizable, fully-automated application and

curing technology • May reduce required insertion force, resulting in

improved device control, placement, and tracking• Low particulate count (meets USP 788 standard)• Proven biocompatibility, sterilization and three-

year shelf life

19

Comprehensive Finishing Operations

Soft Tips

Marker Bands

Tipping

Molding

ShapingSteerable Tips

DrillingVariable Pitch

Coiling Pad Printing

20

Sheath/Dilator Sets

• Rotator lock introducers• PTFE micro-introducers with peelable sheath• Fluoropolymer-lined, reinforced introducers• OTN peelable introducers• Hydrophilic coating services

21

Fine Wire | Conductors

22

Film-Insulated, Fine WireConstruction• Single strand• Multi-filar wire• Single thermocouple,

parallel wire• Single thermocouple,

twist wire• Multi-thermocouple,

twist wire• Stranded wire• Hybrid/custom

constructions available

• 30 to 46 gauge with single, heavy, triple and quad coatings

• Our optimized, polymer coating process uses a variety of insulation and wire materials

• Laser stripping process

23

Film-Insulated, Fine Wire

Insulation and Bonding Materials• Polyimide• PD-Slick™ (PTFE/Polyimide blend)

• Polyester• Nylon• Polyurethane

Wire Materials• Copper/Copper alloys• Stainless Steel• Monel• Alumel• Chromel• Copper-clad steel• Titanium• Nitinol

• Silver • Constantan• CS95• DFT• Nickel/Nickel alloys• Nichrome 80/60/20

24

Conductors

• Silver- or nickel-plated, copper or copper alloy devices

• Ultra-fine wire from 44 to 52 AWG with the capability of producing 56 AWG CS-95 wire

• Environmentally friendly, cadmium-free conductor materials

• Tinsel wire in multiple conductor/fiber combinations

• Diverse, in-house capabilities including bobbin winding, bunching, stranded wire, and single-end wire

• Hybrid and custom construction available upon request

Materials• Copper/Copper alloys• Monel• Copper clad steel• Silver • Constantan• CS95• DFT• Nickel/Nickel alloys• Nichrome 80/60/20• Alumel• Chromel

25

Sutures and Fibers | Bioabsorbables

26

From Resins to Devices

Resins Fibers Components Finished Devices

27

Performance Fibers

• Proprietary braiding, tipping, and cutting capabilities

• 25+ years of multifilament braiding experience

• Device assembly and packaging• ISO13485 cleanroom assembly• Fully validated sterilization

and packaging

28

Suture PortfolioOur branded sutures are associated with a 510(k) and CE mark.

UHMWPE Sutures

Force Fiber®, OrthoTape® Braid, and Force Fiber

Fusion®

Polyester Sutures

Cottony™ II, Tevdek ®,

and Polydek®

PolypropyleneSutures

Deklene® II and Deklene® Maxx™

Nylon Sutures

SilkSutures

PDO Sutures

Monodek®

PGASutures

Bondek® Plus

Bioabsorbable

Non-Absorbable

29

Customization is Our Specialty

Materials

UHMWPE

Polyester

Polypropylene

Nylon

PGA

PDO

Silk

Processes

Coatings

Tip treatment

Dying

Hot stretching

Washing

Annealing

Needle Attachment

Twisting

Sterilization

Customization

Packaging

Processing

Materials

Needles

Assemblies

Cut Lengths

Spools

Braid Geometries

Core/CorelessLow/High Friction

Round/Flat/Combo

Bi/Tri/Quadfurcation

PIC Count

Co-braiding

Custom

30

Performance Characteristics

Braided from Ultra-High Molecular Weight Polyethylene (UHMWPE)• High-strength, non-abrasive, and lubricious fiber

Profile Reduction at Same Strength

Polypropylene PTFE Nylon Polyester Steel UHMWPEChart courtesy of DSM Biomedical

**Testing conducted on size 2, white, Force Fiber® Suture against comparable suture in sterilized form. Data on file.

31

Bioabsorbable Product Portfolio

Sutures• Bondek® Plus

PGA Suture• Monodek®

PDO Suture

Yarns• PGA• PLLA • PGLA

Resins• PGA• PLLA• PGLA• Custom blends

32

P I CEPIC Medtec® Centers

Limerick, Ireland and Maple Grove, MinnesotaCatheters and Access DevicesMansfield, MassachusettsSutures and Performance Fibers

Remote Services Available

33

Engineering Prototyping CollaborationInnovation• Access to our

engineering resources

• Data-driven decision making

• Develop intelligent designs

• Provide real DFM feedback into your design

• Create demonstrative prototypes within hours

• Tactile demonstration of our capabilities

• Understand the effects of each variable

• Dedicated space that promotes creativity and innovation

• State-of-the-art technology facilitates discussions

• In-house laboratory and 3D modeling

• Laser focus on customer needs

• Share ideas and refine concepts

• Stepped process builds in your requirements early

• Refine your design for optimal performance

E P I C

As a trusted co-development partner, we support industry leaders in the design and development of medical devices with the unparalleled expertise that improves speed, flexibility, and value.

34

P I CIDEA Medtec® Process

Incorporates your requirements early in the concept stage

35

Innovation Development AcceleratorEngineering

I D E AStructured, multi-stage, collaborative process enables quick-turn concept development and builds in your requirements early in the concept stage

Quick-turn concept development, idea sharing, brainstorm solutions• Access to our engineers and supplementary staff• Development of concepts by sharing ideas

and brainstorming solutions• Design for manufacturability • Material selection expertise• Demonstrative prototypes as aids to clarify best

concepts• Database of performance test data to guide

decision making

36

1.Project

initiation and overview

2. User needs definition

3. First stage

demonstrative prototypes

4.Review user

needs, priority and

criticality after prototyping

5. Select

capabilities relevant to customer’s

needs

6. Agree to draft concepts and second stage demonstrative

prototypes

7.Apply DFM knowledge

to prototype

8. Review second

stage demonstrative prototypes and

confirm concepts

9. Final

closeout meeting and agree to next

steps

IDEA Medtec®

Process

37

Get Your Device To Market Fast

• Reduce technical risk• Develop a market-ready device• Manage costs

Virtual, Medical Device Development Services• We adapted our IDEA Medtec® Process for online, collaboration tools, including

video conferencing• No travel required. You can work securely and remotely with our expert teams

based at the EPIC Medtec ® Centers• No complicated technology; services are delivered via a safe and secure platform

38

Let’s Get To Work On Your Projectwww.teleflexmedicaloem.com

©2020 Teleflex Incorporated. All rights reserved. Teleflex, EPIC Medtec, IDEA Medtec, Bondek, Cottony II, Deklene, Deklene Maxx, Force Fiber, Monodek, OrthoTape, Force Fiber Fusion, Polydek, Tevdek, and “Work with the Experts” are trademarks or registered trademarks of Teleflex Incorporated in the U.S. and other countries. Additional trademarks and registered trademarks are property of their respective owners. This presentation should not be reproduced, in part or whole, unless permission is granted by Teleflex Medical OEM.

teleflex incorporated - medica

Documents