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Introduction to GPS
                                              Design, Manufacture, Logistics




GPS China Ltd. Design-Manufacture-Logistics                      CONFIDENTIAL
Who we are

GPS is a provider of Design, Manufacture, and Logistics Services out of Asia.
GPS is Irish owned and managed.


Founded in 2004 we have experience serving the following markets:
    Medical Devices
    Pharmaceutical Devices & Packaging
    Industrial Products


GPS have locations in:
    Ireland – Galway
    China – Cixi, Ningbo, Shanghai




GPS China Ltd. Design-Manufacture-Logistics                                     CONFIDENTIAL
Capabilities and Services




GPS China Ltd. Design-Manufacture-Logistics   CONFIDENTIAL
GPS offers integrated capabilities from product design to delivery.


GPS China Ltd. Design-Manufacture-Logistics                              CONFIDENTIAL
GPS Services




1. At GPS we work with       2. Our design team now       3. Once the design           4. GPS offers a full        5. We can cater for your
your in house resources      set to work on the design    direction is approved we     prototyping service         Design Verification
to plan your development     phase using advanced         then develop the product     enabling concept            Protocol needs, ensuring
program and define your      techniques to develop        further, optimising it and   evaluation up to product    the product is verified
product.                     design concepts.             designing for manufacture    testing.                    and production ready.
                                                          and assembly.




6. Once a design is ready    7. Our QA/RA personnel       8. GPS has built up          9. We ensure your           10. Often overlooked,
for production, we offer     ensure that client           extensive production         packaging and labelling     GPS offers extensive
full tool design, analysis   validation requirements      capabilities through a       requirements are met        logistical capabilities to
and manufacture              are satisfied. We can also   combination of own           and can provide all types   ensure your product is
services.                    assist with your             manufacturing facility       of sterilisation.           delivered on time to your
                             regulatory needs.            and approved channel                                     demand schedule.
                                                          partners.

GPS China Ltd. Design-Manufacture-Logistics                                                                               CONFIDENTIAL
GPS services


                                              Here we bring ideas/IP through a rigorous research and
                                              innovation program. This is followed by extensive idea and
                                              concept generation to ensure the best design solution.


 Definition:
 Systematic innovation
 Human factors engineering
 User studies
 Competitor analysis
 Project management
 Product design specification

 Design:
 Idea generation
 Concept development
 Visualisations
 2d / 3d CAD modelling
 User centred design

GPS China Ltd. Design-Manufacture-Logistics                                                        CONFIDENTIAL
GPS services

                                                         During this phase we develop the design concept,
                                                         provide prototypes and work with the client to
                                                         ensure the product is fully verified and prepared
                                                         for production.


  Capabilities:
  Design optimisation
  Design for manufacture and assembly
  Technical design:
  • Motion analysis
  • FEA
  Full prototyping service:
  • Soft models, SLA, Vac casting, CNC machining, etc.
  FMEA
  Risk analysis
  Design verification protocol testing




GPS China Ltd. Design-Manufacture-Logistics                                                   CONFIDENTIAL
GPS services

                                              Providing a seamless link with our Design Services, or interfacing
                                              directly with your in-house design, we can translate your design
                                              into production.




 Tool Design & Manufacture:                                     Validation & Regulatory
 Tool design                                                    Quality Management Systems
 Mold flow analysis                                             ISO 13485 approved
 Complete tool making service                                   FDA registered facility
 Tool validation                                                cGMP compliant
                                                                Approved vendor auditing
                                                                Regulatory documentation:
                                                                • Design verification testing
                                                                • Process Validation
                                                                • Bio Testing
                                                                Statistical Process Control
                                                                Lean & Six Sigma



GPS China Ltd. Design-Manufacture-Logistics                                                        CONFIDENTIAL
GPS services


                                 From components to finished products, we channel client
                                 needs through our Supply Chain capabilities, enabling
                                 complete manufacturing solutions.


 Capabilities:
 Material selection and procurement services                     Metal processing:
 Clean-room manufacturing                                        • Casting
 Plastics processing:                                            • Forging
 • Injection molding                                             • Machining
 • Insert and over-molding                                       Surface printing capabilities:
 • Blow molding                                                  • Pad, Silk screen
 • Specialty Extrusion – Tube, Strip, etc.                       • Laser etching
 • Post Extrusion Processes – Tipping, drilling, forming, etc.   Electronics / PCB’s
 • Bonding, RF & Ultrasonic Welding.
 Silicone Spray Dispensing




GPS China Ltd. Design-Manufacture-Logistics                                                       CONFIDENTIAL
GPS services


                                              GPS provides custom packaging solutions using validated
                                              sterilisation methods if required. We can provide tailored logistical
                                              solutions to meet client demand.


  Packaging & Sterilisation:                            Logistics:
  Custom packaging solutions                            Inventory management
  Packaging and labelling design                        Consignment product
  Class 100k clean-room                                 Order desk management
  On site Bio-Lab                                       Warehousing and fulfilment
  Validated sterilisation processes:                    Import/Export Duties
  • Internal EtO sterilisation unit                     Customs clearance
  • External Gamma sterilisation                        Shipping and Air Freight
                                                        Global presence
                                                        In-Region completion




GPS China Ltd. Design-Manufacture-Logistics                                                              CONFIDENTIAL
In-Region completion options

                                                                     Entire Product Manufacture and Completion in China
                                                                       Product Warehousing and Fulfillment on each Geo

           Product      Sub          Component       Materials         Materials       Life Cycle       Product                     Warehousing
           Design    Components     Manufacturing   Management        Management      Management       Completion                   & Fulfilment




                                                                                            Base Unit Manufacturing in China
                                                                                      Product Completion “In Region” Globally
          Product        Sub      Component            QA &                         Materials        Life Cycle      Product        Warehousing
          Design      Components Manufacturing      Sterilisation                  Management       Management      Completion      & Fulfilment




                                                                                            Component source ex China
                                                                          Product Manufacture and Completion in Region
           Product      Sub          Component                       Materials      Life Cycle       Product           QA &         Warehousing
           Design    Components     Manufacturing                   Management     Management       Completion      Sterilisation   & Fulfilment




                                                                    Design, Source, Product Manufacture and Completion
                                                                                                              In Region
                                     Sub        Component            Materials      Life Cycle       Product           QA &         Warehousing
                                  Components   Manufacturing        Management     Management       Completion      Sterilisation   & Fulfilment



GPS China Ltd. Design-Manufacture-Logistics                                                                                                  CONFIDENTIAL
Supply Chain Capabilities




GPS China Ltd. Design-Manufacture-Logistics   CONFIDENTIAL
Supply Chain Capabilities
GPS enables our clients to realise their objectives in China.

We provide:
- Local presence with a global footprint
- Project management
- Clear communication
- Seamless process




       Our team in China includes:
       - R&D
       - Engineering
       - Quality Assurance
       - Logistics



GPS China Ltd. Design-Manufacture-Logistics                     CONFIDENTIAL
Supply Chain Capabilities

Medical categories serviced:                  Processes used:
• Infusion therapy                            • Plastics
• Transfusion & Dialysis therapy              • Molding & Extrusion
• Angiography / cardiology                    • Blow Molding
• Endovascular                                • Assembly
• Neonatal                                    • Packaging
• Gastroenterology                            • Sterilisation
• Anaesthesia / Respiratory                   • Electronics
• Endoscopy / Laparoscopy                     • Metal Fabrication
• Urology                                           • Casting
• Orthopaedic surgery                               • Machining
• Wound management                                  • Forging
• Syringes & Diagnostics                      • Printing
                                                    • Pad, Silk screen
                                                    • Laser Etch
Pharmaceutical categories serviced:
                                              • Packaging
• Dispensing containers
                                              • Labelling
• Moulded packaging
                                              • Sterilisation
• Extruded packaging
                                              • Logistics


GPS China Ltd. Design-Manufacture-Logistics                              CONFIDENTIAL
Ningbo facility

24,000m2 facility:
• Building size – 12,000m2
• Clean room (100k) - 3,000m2
• Warehouse - 5,250m2
• Bio Lab - 250m2
• Other - 3,500m2

Western style management and systems:
• ISO 13485 certified
• FDA Registered
• cGMP compliant
• Lean initiatives
• Six sigma processes

Currently approx 300 employees.




                                              Top: One of our clean room assembly areas.
                                              Above: Location of our facilities.
                                              Left: Examples of blow moulded pharmaceutical packaging.


GPS China Ltd. Design-Manufacture-Logistics                                             CONFIDENTIAL
Ningbo facility

• Vertical & Horizontal Injection Moulding                              Injection moulding
                                                                           machines at our
      •12 x injection machines: 80 – 150T                                     Ningbo plant.
      • Planned addition of 200T+

• Extrusion - 9 x extrusion lines

• Injection blow moulding – IBM
                                                                          Blow moulding
                                                                      production in clean
•Extrusion blow moulding - EBM                                             environment.


•ETO sterilisation internally
     • 6m3 (2 pallets)
     • 15m3 (5 pallets)
     • 20m3 (7 pallets)
                                                                     Clean Room assembly
• Assembly, Packaging & Labelling                                    at our Ningbo facility.


• Logistics

Plastic Materials – HDPE, MDPE, LDPE, PVC, PU, PP,PS,PC,ABS
All our materials are sourced both domestically and internationally to meet our customers requirements

GPS China Ltd. Design-Manufacture-Logistics                                                         CONFIDENTIAL
Additional capabilities

We regularly audit a selection of approved vendors for additional capabilities in the areas of:

• Electronics
• Specialised extrusion
• Packaging
• Metals processing
• Casting
• Forging
• etc




GPS China Ltd. Design-Manufacture-Logistics                                                 CONFIDENTIAL
What can we do for you?




GPS China Ltd. Design-Manufacture-Logistics   CONFIDENTIAL

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Gps China Company Presentation

  • 1. Introduction to GPS Design, Manufacture, Logistics GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 2. Who we are GPS is a provider of Design, Manufacture, and Logistics Services out of Asia. GPS is Irish owned and managed. Founded in 2004 we have experience serving the following markets: Medical Devices Pharmaceutical Devices & Packaging Industrial Products GPS have locations in: Ireland – Galway China – Cixi, Ningbo, Shanghai GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 3. Capabilities and Services GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 4. GPS offers integrated capabilities from product design to delivery. GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 5. GPS Services 1. At GPS we work with 2. Our design team now 3. Once the design 4. GPS offers a full 5. We can cater for your your in house resources set to work on the design direction is approved we prototyping service Design Verification to plan your development phase using advanced then develop the product enabling concept Protocol needs, ensuring program and define your techniques to develop further, optimising it and evaluation up to product the product is verified product. design concepts. designing for manufacture testing. and production ready. and assembly. 6. Once a design is ready 7. Our QA/RA personnel 8. GPS has built up 9. We ensure your 10. Often overlooked, for production, we offer ensure that client extensive production packaging and labelling GPS offers extensive full tool design, analysis validation requirements capabilities through a requirements are met logistical capabilities to and manufacture are satisfied. We can also combination of own and can provide all types ensure your product is services. assist with your manufacturing facility of sterilisation. delivered on time to your regulatory needs. and approved channel demand schedule. partners. GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 6. GPS services Here we bring ideas/IP through a rigorous research and innovation program. This is followed by extensive idea and concept generation to ensure the best design solution. Definition: Systematic innovation Human factors engineering User studies Competitor analysis Project management Product design specification Design: Idea generation Concept development Visualisations 2d / 3d CAD modelling User centred design GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 7. GPS services During this phase we develop the design concept, provide prototypes and work with the client to ensure the product is fully verified and prepared for production. Capabilities: Design optimisation Design for manufacture and assembly Technical design: • Motion analysis • FEA Full prototyping service: • Soft models, SLA, Vac casting, CNC machining, etc. FMEA Risk analysis Design verification protocol testing GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 8. GPS services Providing a seamless link with our Design Services, or interfacing directly with your in-house design, we can translate your design into production. Tool Design & Manufacture: Validation & Regulatory Tool design Quality Management Systems Mold flow analysis ISO 13485 approved Complete tool making service FDA registered facility Tool validation cGMP compliant Approved vendor auditing Regulatory documentation: • Design verification testing • Process Validation • Bio Testing Statistical Process Control Lean & Six Sigma GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 9. GPS services From components to finished products, we channel client needs through our Supply Chain capabilities, enabling complete manufacturing solutions. Capabilities: Material selection and procurement services Metal processing: Clean-room manufacturing • Casting Plastics processing: • Forging • Injection molding • Machining • Insert and over-molding Surface printing capabilities: • Blow molding • Pad, Silk screen • Specialty Extrusion – Tube, Strip, etc. • Laser etching • Post Extrusion Processes – Tipping, drilling, forming, etc. Electronics / PCB’s • Bonding, RF & Ultrasonic Welding. Silicone Spray Dispensing GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 10. GPS services GPS provides custom packaging solutions using validated sterilisation methods if required. We can provide tailored logistical solutions to meet client demand. Packaging & Sterilisation: Logistics: Custom packaging solutions Inventory management Packaging and labelling design Consignment product Class 100k clean-room Order desk management On site Bio-Lab Warehousing and fulfilment Validated sterilisation processes: Import/Export Duties • Internal EtO sterilisation unit Customs clearance • External Gamma sterilisation Shipping and Air Freight Global presence In-Region completion GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 11. In-Region completion options Entire Product Manufacture and Completion in China Product Warehousing and Fulfillment on each Geo Product Sub Component Materials Materials Life Cycle Product Warehousing Design Components Manufacturing Management Management Management Completion & Fulfilment Base Unit Manufacturing in China Product Completion “In Region” Globally Product Sub Component QA & Materials Life Cycle Product Warehousing Design Components Manufacturing Sterilisation Management Management Completion & Fulfilment Component source ex China Product Manufacture and Completion in Region Product Sub Component Materials Life Cycle Product QA & Warehousing Design Components Manufacturing Management Management Completion Sterilisation & Fulfilment Design, Source, Product Manufacture and Completion In Region Sub Component Materials Life Cycle Product QA & Warehousing Components Manufacturing Management Management Completion Sterilisation & Fulfilment GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 12. Supply Chain Capabilities GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 13. Supply Chain Capabilities GPS enables our clients to realise their objectives in China. We provide: - Local presence with a global footprint - Project management - Clear communication - Seamless process Our team in China includes: - R&D - Engineering - Quality Assurance - Logistics GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 14. Supply Chain Capabilities Medical categories serviced: Processes used: • Infusion therapy • Plastics • Transfusion & Dialysis therapy • Molding & Extrusion • Angiography / cardiology • Blow Molding • Endovascular • Assembly • Neonatal • Packaging • Gastroenterology • Sterilisation • Anaesthesia / Respiratory • Electronics • Endoscopy / Laparoscopy • Metal Fabrication • Urology • Casting • Orthopaedic surgery • Machining • Wound management • Forging • Syringes & Diagnostics • Printing • Pad, Silk screen • Laser Etch Pharmaceutical categories serviced: • Packaging • Dispensing containers • Labelling • Moulded packaging • Sterilisation • Extruded packaging • Logistics GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 15. Ningbo facility 24,000m2 facility: • Building size – 12,000m2 • Clean room (100k) - 3,000m2 • Warehouse - 5,250m2 • Bio Lab - 250m2 • Other - 3,500m2 Western style management and systems: • ISO 13485 certified • FDA Registered • cGMP compliant • Lean initiatives • Six sigma processes Currently approx 300 employees. Top: One of our clean room assembly areas. Above: Location of our facilities. Left: Examples of blow moulded pharmaceutical packaging. GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 16. Ningbo facility • Vertical & Horizontal Injection Moulding Injection moulding machines at our •12 x injection machines: 80 – 150T Ningbo plant. • Planned addition of 200T+ • Extrusion - 9 x extrusion lines • Injection blow moulding – IBM Blow moulding production in clean •Extrusion blow moulding - EBM environment. •ETO sterilisation internally • 6m3 (2 pallets) • 15m3 (5 pallets) • 20m3 (7 pallets) Clean Room assembly • Assembly, Packaging & Labelling at our Ningbo facility. • Logistics Plastic Materials – HDPE, MDPE, LDPE, PVC, PU, PP,PS,PC,ABS All our materials are sourced both domestically and internationally to meet our customers requirements GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 17. Additional capabilities We regularly audit a selection of approved vendors for additional capabilities in the areas of: • Electronics • Specialised extrusion • Packaging • Metals processing • Casting • Forging • etc GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL
  • 18. What can we do for you? GPS China Ltd. Design-Manufacture-Logistics CONFIDENTIAL