medplast china presentation · medplast overview 2 headquartered in tempe, arizona, usa 15...

Bringing Compliance, Partnership

and Solutions Together.

MedPlast Confidential 1

Overview



MedPlast Confidential

MedPlast Overview

2

Headquartered in Tempe, Arizona, USA

15 wholly-owned facilities worldwide

(US, Mexico, Europe and Asia)

850,000 sq. ft. assembly and

manufacturing capacity

Over 400 thermoset & thermoplastic

processing presses (3 - 1,000 tons)

1700+ employees worldwide

MedPlast is one of the leading US based manufacturers of precision

engineered plastic products and value-added services with global operations

and comprehensive service offerings across a diverse product base




MedPlast Tijuana, Mexico

MedPlast Fremont, CA

MedPlast Chicopee, MA UPG-

Wales, UK UPG-Suzhou

MedPlast China

Worldwide Locations

MedPlast HQ: Tempe, AZ

MedPlast Monticello, IA

MedPlast Elkhorn, WI

MedPlast West Berlin, NJ UPG-

Houston, TX

MedPlast Westfield, PA

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MedPlast – focused on Healthcare Markets Orthoplastics, a MedPlast company - focused on Implantable Orthopedic Market UPG, a MedPlast company – focused on Select Industrial Markets

Orthoplastics Bacup, UK




MedPlast Company Strategy

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• Invest in long term customer relationships

– Become an integral part of our customers’ design & manufacturing processes

• Leverage unique material capabilities and processing

expertise – Industry Experts in Thermoplastics, Silicone, Rubber Processing,

Assembly, Automation & Secondary Processing

• Build Quality systems based on customer’s requirements – All facilities ISO13485 certified – Other certifications obtained dependent upon customers’ business

requirements




MedPlast Value Pyramid

5




MedPlast Healthcare Facilities & Services

All MedPlast Medical facilities are ISO 13485 certified and registered with the

FDA

MedPlast medical services include…

– Full Contract Manufacturing

– Lab Services (Bioburden, LAL, & EM Monitoring)

– Class 100,000 clean room assembly/molding

– Packaging

– Contract Sterilization

– Electronics systems assembly and testing

– Supply chain and logistic management

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•Syringes, plungers, fluid separation

•Stents, seals, ablation catheters, IV sets

Cardiovascular

•Surgical implants, oral care devices

•Orthodontic cases, dental trays

•Surgical dental instruments Dentistry

•Lab testing components, diabetes testing kits

•Blood collection systems, vials for assays

•Stellant barrels (diagnostic imaging) Diagnostics

•Metering devices, diagnostic testing systems

•Contrast media delivery systems

•Dialysis components Oncology

•Diagnostic systems, Implantables

•Contact lens cases, eye care applicators

Ophthalmology

•Disposable syringes, IV sets & components

•Surgical ablation devices, trocars, ligatures

•Silicone extruded tubing, harmonic scalpels Surgical

•Tracheostomy components, valves, seals

• Inhalation device components

•Remote monitoring devices Respiratory

• Instruments for hip/knee replacement

•Orthopedic implants

•Orthopedic supplies Orthopedics

•Pessary devices, drug delivery pumps

•Catheter systems, dialysis systems

•Pumps Urology

•Skin treatment systems, Hydration systems

•Disinfectant systems, ambulatory devices

Pharmaceutical dispensers, receptacles

Targeted Healthcare Markets

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Experienced Leadership

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Harold Faig

CEO

Chris Sigmon

Sr. VP NA Operations

Jim Doerr

CFO

Mike Farrel EVP Sales

Matt Langton EVP Sales

Tim Joiner

Dir Compliance

Alexi Ergang

Regulatory

Tom Fuller

CAPA

Pilar xx

Doc Control




China Operations

Overview

Experience

9




MedPlast China Medical Strategy

Build A World Class Manufacturing Organization To Provide The International and Domestic

Medical Device Companies with Highly Capable, Low Cost Total Solutions that meet and exceed all Customer Requirements and Industry Standards.

Utilizing the Best People, Equipment and Technologies

Available.

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China Facility Details

UPG Suzhou I (Domestic & Export)

MedPlast Suzhou EPZ I (Domestic/Export)

MedPlast Tooling Group (“MTG”)

Date Opened 2002 2006 2004

Plant Space 23,000 sq. ft. 115,000 sq. ft. 23,000 sq. ft.

Highlights / Capabilities

Injection molding, assembly, full service contract manufacturing and testing

TS 16949 and ISO 9001

Class 100,000 aseptic clean room molding, assembly, contract manufacturing, bio-lab, testing, tooling and sterilization

ISO 13485, ISO 9001 and FDA registration

Tooling design / development and process development

Utilizes RJG process development techniques

Tooling built to international standards

Molding Equipment

18 machines (35-530 tons) Currently 20 machines (3-610 tons)

Total capacity up to 60 machines

Pro E, Solid Works design and mold flow analysis

Special Equipment and Process

White room assembly, hot stamping, heat stacking, pad printing, sonic welding, insert molding, electrical / mechanical testing

White room and Class 100,000 clean room molding and assembly, insert molding, pad printing, sonic welding and all electric machines / star servo robotics

CNC, EDM, wire, high speed machine centers, quality assurance lab and CMM

End Markets Datacenter, Electronics,

Industrial, Automotive Healthcare Mould

# Employees 104 282 39

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Finance

Human Resource

Sean Yang

Operation Manager

Jose Luis Gomez

Technical Support Director

Beth Fang

Material Director

Accountant Supervisor

Elian Yi

HR Specialist

Kate Bi

Training Specialist

Titi Zhu

Admin Assistant

Audrey Lu

Molding Supervisor

Bill Rong

Facility Supervisor

Jim Mao

Senior Tooling Engineer

Zhang Jinli

Logistics Specialist

Yan Hong

Planner

Jia Hailin

Buyer

Leo Li/Fiona Yu

Assembly Supervisor

Bobby Zhang

QC Supervisor

Zhang JIangang

Quality Engineer

Jenny Jin/Jacky Wang/Jane

Wang

Sissi Yu

QA Manager

Customer Service

Karen Zheng/Lisa Mao

Accountant

Grace Jin

Cashier

Vivian Sun

IT Assistant

Edward Wang

Program Manager

Calvin Rui

Microbiologist Engineer

Cathy Feng

Analyst

Xu Chunping

Assistant Egnineer

Chen Lina

Planning Supervisor

Jiang Xuehai

Bruce Song

General Manager

Wang Chunyuan

Engineering Director

Engineering Assistant

Manager

Miller Yao

Tooling Program Assis.

Supervisor

Gary Tang

Acting Toolmaker

Supervisor

Jiang Guohua

Machining Supervisor

Wang Jian

Purchase

Lemmon Shen

Senior Process Engineer

Dennis Chen

Process Engineer

Simon Wu

Manufacturing Engineer

Polly Liu/Edward Qin

David Brooks

President MedPlast International

Program Manager

Joan Liu

Logistics Supervisor




MedPlast China Medical Focus

• Class 1 & 2 Medical Device Manufacturing

• Class 100,000 Aseptic Clean Room

(Molding and Assembly)

• White Room Molding & Assembly

• Microbiology Lab

• Contract Sterilization (Gamma/ETO/E-Beam)

• All Electric Machine Molding

• FDA Registration/GMP/ ISO 13485

• Full Lot Control and Tractability

• Sonic welding, Chemical bonding, Heat Staking,

Pad Print, Hot Stamp, Painting, Plating, Coating

• Medical Packaging (FFS, Pouch, Tray)

• Medical Validation Process (IQ/OQ/PQ

• Product Testing

• Supply Chain and Logistic Solutions

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MedPlast China/Global Full Service Capabilities

Tool/ Product Design

Engineering

Application Development

Engineering

Prototyping/

Tooling

Precision Molding

Supply Chain/Logistics

Management Contract Manufacturing

& Decorative Services

Worldwide Program

Management

Global Footprint

Bio Lab Services

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Phase 1 Milestones: • Review Drawings &

Specifications

• Capacity review

• Technical Review

• Packaging Define

• Sterilization(ETO,

Gamma)

• Phase 1

Management Sign-

Off

Phase 2 Milestones: • PM & Team Members

assigned

• Program Plan

developed

• Validation Master Plan

(VMP) & Protocols

• Product Design review

• Tool & Process

Technical Review

• Establish Supply

Chain

• DFMEA/PFMEA

Phase 3 Milestones: • Tooling Verification

Runs, TVR, IQ/OQ

• Secondary Equipment

Verification ; IQ/OQ,

CPK

• Purchase component

validation, OQ

• Finalize Quality &

Manufacturing

Documentation

Phase 4 Milestones: • Sterilization Validation

• Submit Final VMP

report

• Submit product to

Customer, PQ

• Final Customer

Approval

Phase 5 Milestones: • Monitor 1st production

shipment (3 lots)

• Quoted vs. Actual

analysis

• Phase 5 Management

Sign-Off

New Product Introduction Process

Phase 1 Business Planning

& Quotation

Phase 4Process

Qualification(PQ)

Phase 5Production

Release

Phase 3Tool & Equipment

& Operation Validation

IQ / OQ

Phase 2Tool, Equipment

& Process Development

Business Award:(Customer &

MP Sales)

Program ManagementCustomer Launch Team

& MP Launch Team

Program Management

Customer & MP Operations

RFQ: Pre-Award

MP

OPERATIONS

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Quality Equipment & Capabilities

Lab

Equipment

Quality

Management Tools

Certifications

Co-ordinate Measuring Machine (CMM)

Profile Projector Spectrometer Color Booth; Vacuum Oven; Melt Flow Indexer Moisture Analyzer Thickness Tester Pull Tester

First Article Inspection (FAI)

Statistical Process Control (SPC) Advanced Product Quality Planning (APQP) Validation Master Plan (VMP) Production Part Approval Process (IQ/OQ/PQ) Failure Mode and Effects Analysis (FMEA) Design of Experiment (DOE) Six Sigma Methodology Measurement System Analysis (MSA)

• FDA/UL/CCC Registration

• ISO 9001:2000

• TS 16949: 2003

• ISO 13485

Pencil Hardness Abrasion Tester Gloss Tester High Gauge Depth Gauge Pin Gauge Block Gauge OGP

OGP Vision System

Brown & Sharp CMM’s

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MedPlast China Microbiology Lab

Full Capability Lab

• Bioburden Testing

• LAL Testing

• Environmental Monitoring

• Outsource Services

• Degreed Microbiologist with 8 years experience &

Analyst

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MedPlast China Technology

Engineering,&

Construction

Primary

Process

Full Assembly,

Testing and

Decorating

Molding

Assembly

• Toshiba Electric /JSW

• Micro Injection

Molding

• Blow Molding

• Insert Molding

• Two shot molding

• LSR molding

• Extrusion Material & Product Testing

Tool Design & Construction

MedPlast Tooling Group

Mold Flow Analysis

• Full Assembly Clean

Room

• Pad Printing, Heat

Staking, hot stamping,

hot sealing，sonic

welding

• Electrical/Mechanical

/Pressure Testing

• Tool Design (Pro E)

• CAD/CAM (Pro

E/Master Cam)

• 2D & 3D Design

• Mold Flow Analysis

• FAI & Process

Development

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MedPlast China Products

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China Obstacles and MedPlast Advantages

By utilizing MedPlast's global footprint and systems (program management, quality,

engineering), customers feel comfortable with MedPlast’s services anywhere in the world

Common China Obstacles MedPlast China Advantages

Lack of knowledge and/or experience with international medical standards

Medical focused quality systems with experience around validation requirements

Employees trained in medical device manufacturing and international medical standards

Language barrier, communication challenges and cultural differences

Managers and staff are fluent in English

Unstable quality, service and workforce FDA registered and comprehensive ISO/TS certifications

UPG China is a wholly-owned, U.S.-based company

Logistics integration Full supply chain and logistics solutions

Copyright and IP infringement Understands and protects IP rights

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Program Success

Our Values Best People

Highest Quality

Competitive Cost

Worldwide Growth

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ThankS!

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medplast china presentation · medplast overview 2 headquartered in tempe, arizona, usa 15...

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