x-cell presentation for bd 2015-02-16

X-Cell Modular PlatformChanging the launch model to enable more control

over time to market and capital investments

Table of Contents

•X-Cell Purpose•Sample BD Application – Autoguard Catheter•Sample Launch Progression•Cost Structure•Comparison to Actual BD Project•X-Cell Module Background•Calvary Introduction

X-Cell Strategy Purpose

X-Cell Modular Platform: Common production tools and code from lab to medium volumeDevelop processes with production-intent toolingMore incremental throughput steps compared to automated systemMore reusable content after full production launch

Benefits to BD: Less lead-time, validation time, risk on throughput increasesMore agile manufacturing reaction to development and market demandsLess investment risk with smaller incremental capacity investmentsMore reuse of investments to reduce cost of future developments

BD Application: Autoguard

Sample application shows how the X-Cell modules can be implemented in a BD launch

Configurations show evolution from lab/prototypes into medium volume manufacturing

Autoguard Safety IV Catheter chosen due to process complexity and variety of technologies used


Zone 3Grip &Spring Assembly

Zone 4Cannula Assembly

Zone 1Catheter & Adapter

Assembly

Zone 2Catheter Tipping

Zone 6Final Assembly

Autoguard BC Full Automation Process Flow Chart

Potential Configuration

Zone 2.5 Septum & Actuator

Assembly

Zone 4.5Cannula Lubrication

Zone 5Set Together

Zone 5.5Vision Inspect & Catheter Lube

Zone 7Packaging

11 steps

Not incl. in this study

11 steps

8 steps

4 steps

1 step

2 steps

8 steps

7 steps

Not incl. in this study

NOTE: This flowchart shows existing platform configuration, complete with zones that are not included in this exercise as defined by BD. This information is for reference only


Lab / Prototype level production completed in 6 modules

First module includes all 11 steps included in zone 1

Video shows simulation of process and tooling for illustration, focused on zone 1 (catheter/adapter subassembly)

Following illustrations and chart show ramp-up of throughput

Catheter/Adapter Subassembly


Click picture for video of assembly process


Each module includes multiple stepsTooling and software created in modular

fashion. As throughput increases, tooling and code is distributed among new modules, reducing cycle time

Process, tools and software remain constant as throughput increases

Part feeding is separated from processing to support modular approach

Operators kit parts in pallet at low volumes. Feeders replace kitting operation at higher volumes. Process is independent of feeding

Click picture for video of volume progression

BD Application: AutoguardDescription of Chart Structure:Zone #: Per BD Spec, grouping of stations by

subassembliesProcess #: Per BD spec, sequential within a

zoneLab Column (mfg. phase): Indicates which

module is used for the particular manufacturing stepZone 1 steps all take place in Module 1Manual steps take place outside the module, kitting parts upstream on the conveyor

Steps at the top in Magenta show the kitting process; separated from the process steps for modularity of task

Lab

Throughput (sec/part) 30

Zone # Process # Description Module

1 1,3Feed Wedge, Catheter Manual

1 7Feed Adapter Manual

2.5 1Feed Septum Manual

3 1,2Feed Grip, Button Manual

3 7,8Feed Hub, Spring Manual

4, 6 1,1Feed Needle, Cover Manual

6 3,5Feed Plug, Barrel Manual

1 1Load Wedge 1

1 2Inspect Presence 1

1 3Load Catheter Tube 1


1 5Flare Tube / Wedge 1

1 6Measure Flare 1

1 7Load Adapter 1


1 9Swage Adapter/Wedge 1

1 10Measure Swage 1

1 13Offload 1

2 1Not Included in Simulation X

2.5 1Load Septum Manual

2.5 2Slit Septum Manual

2.5 3Unload Septum Manual

2.5 4Unload Septum Inspection Manual

2.5 5Load Septum to Adapter 2

2.5 6Seat Septum in Adapter 2

2.5 7Probe Septum 2

2.5 8Feed Actuator 2

2.5 9Lubricate Actuator 2

2.5 10Load Actuator 2

2.5 11Reject Adapter Sub-Assy 2

1

1

3

2

2

3

4

4

BD Application: AutoguardDescription of Chart Structure:Zone # alternates in color to visualize grouping

betterModule # alternates in color to visualize

boundaries betterThroughput increases by transferring processes

to additional modules:Zone 1 steps 7-13 are removed from module 1, reducing cycle timeZ1 steps 7-13 are loaded into a new module added to the systemZone 2.5 module 2 becomes module 3 in the Samples phase

The feeding steps can stay manual, or be automated by the new modules A ~ D

Lab Samples Throughput (sec/part) 30 17

Zone # Process # Description Module Module1 1,3Feed Wedge, Catheter Manual A or manual1 7Feed Adapter Manual A or manual

2.5 1Feed Septum Manual B or manual3 1,2Feed Grip, Button Manual C or manual3 7,8Feed Hub, Spring Manual C or manual

4, 6 1,1Feed Needle, Cover Manual D or manual

6 3,5Feed Plug, Barrel Manual D or manual1 1Load Wedge 1 11 2Inspect Presence 1 11 3Load Catheter Tube 1 11 4Inspect Presence 1 11 5Flare Tube / Wedge 1 11 6Measure Flare 1 11 7Load Adapter 1 21 8Inspect Presence 1 21 9Swage Adapter/Wedge 1 21 10Measure Swage 1 21 13Offload 1 22 1Not Included in Simulation X X

2.5 1Load Septum Manual B

2.5 2Slit Septum Manual B

2.5 3Unload Septum Manual B

2.5 4Unload Septum Inspection Manual B2.5 5Load Septum to Adapter 2 32.5 6Seat Septum in Adapter 2 32.5 7Probe Septum 2 32.5 8Feed Actuator 2 32.5 9Lubricate Actuator 2 32.5 10Load Actuator 2 32.5 11Reject Adapter Sub-Assy 2 3

3 1Load Grip 3 43 2Load Button 3 4

1

3

2

4

4

3

2

1

Lab Samples Startup Full ScaleThroughput (sec/part) 30 17 6 3

Zone # Process # Description Module Module ModuleDouble-ToolModule

1 1,3 Feed Wedge, Catheter Manual A or manual A A1 7 Feed Adapter Manual A or manual B B

2.5 1 Feed Septum Manual B or manual B B3 1,2 Feed Grip, Button Manual C or manual C C3 7,8 Feed Hub, Spring Manual C or manual D D

4, 6 1,1 Feed Needle, Cover Manual D or manual E E6 3,5 Feed Plug, Barrel Manual D or manual F F1 1 Load Wedge 1 1 1 11 2 Inspect Presence 1 1 1 11 3 Load Catheter Tube 1 1 2 21 4 Inspect Presence 1 1 2 21 5 Flare Tube / Wedge 1 1 3 31 6 Measure Flare 1 1 3 31 7 Load Adapter 1 2 4 41 8 Inspect Presence 1 2 4 41 9 Swage Adapter/Wedge 1 2 5 51 10 Measure Swage 1 2 5 51 13 Offload 1 2 6 6

6 1 Feed and Load Cover 6 8 24 246 2 Verify Presence 6 8 24 246 3 Feed and Load Vent Plug 6 9 25 256 4 Vision Verify Presence 6 9 25 256 5 Feed and Press Barrel 6 9 26 266 6 Verify Presence 6 9 26 266 8 Load to Buffer Tray 6 9 27 27

Total With Feeder Modules 6 9 / 13 33 33

Phases

BD Application: AutoguardDescription of Chart Structure:Total at bottom shows final module count for

each phase, including feeding modules with letter designations

Modules can be reused in throughput increases, so to move from the Lab to the Samples phase with auto feeding, 6 out of the 13 modules will be reused, and only 7 new modules are required

Note that the Full Scale phase requires double tooling to increase the throughput with the same number of modules as the maximum expected practical throughput for these modules

Additional throughput can be added duplicating the Full Scale system Click chart for ramp-up

and process breakdown

1

3

2

1

3

2

BD Application: AutoguardFloor Space 23’ x 3’

BD Application: AutoguardFloor Space 26’ x 26’

BD Application: AutoguardFloor Space 100’ x 24’ per System


Volume, Cycle Time and Manpower requirements of X-Cell implementation through different phases of product launch

Note the gradual ramp-up available with X-Cell Modules

BD Autoguard Assembly ProcessConfiguration Ramp-Up from Development to Production Base assumption:1-Shift available sec/yr 5,443,200 sec/yr @ 7hrs/shift, 240 days/yr, 90% efficiency

Cycle time sec/cycle

Target Volume Phase 1-up 2-up 1-shift 2-shift 3-shift

Direct Operators /shift

Technicians /shift

# of Modules Delivery

N/A Lab 30 181,440 362,880 544,320 1 0 6 18 wksN/A Samples Man 17 320,188 640,376 960,565 4 1 9 12 wksN/A Samples Auto 17 320,188 640,376 960,565 0 1 13 14 wks1M Startup 6 907,200 1,814,400 2,721,600 0 4 33 16 wks5M Full scale 3 6 1,814,400 3,628,800 5,443,200 0 4 33 20 wks9M Full scale x 2 1.5 6 3,628,800 7,257,600 10,886,400 0 8 66 20 wksNote 1: Module cycle time shown highlighted in greenNote 2: Volume calculated dividing available sec/yr by effective sec/part cycle (1-up column value)

X-Cell Data


Cost breakdown of X-Cell implementation through different phases of product launch

Note the reach of implementing the same production platform from very low volumes into medium volume production with high reusable content and available smaller production increments

BD Autoguard Assembly ProcessRamp-Up Cost from Development to Production

Target Volume Phase

Modules (Reusable)

Tooling (Dedicated) NRE Total 1-shift 2-shift 3-shift

Direct Operators /shift

Technicians /shift

N/A Lab 336$ 760$ 75$ 1,171$ 181,440 362,880 544,320 1 0N/A Samples Man 168$ 165$ 15$ 348$ 320,188 640,376 960,565 4 1N/A Samples Auto 224$ 390$ 40$ 654$ 320,188 640,376 960,565 0 11M Startup 1,120$ 290$ 30$ 1,440$ 907,200 1,814,400 2,721,600 0 45M Full scale -$ 995$ 80$ 1,075$ 1,814,400 3,628,800 5,443,200 0 49M Full scale x 2 1,848$ 2,200$ 4,048$ 3,628,800 7,257,600 10,886,400 0 8Note 1: Prices above are shown as incremental amounts assuming completion of all previous phases

Cost (000s) Operation Parameters

ComparisonX-Cell Modular Platform vs. Dedicated Automation, New and Reused Modules

Note the delayed investment and saving scenarios

Cost Savings

Target Volume Phase

Modules (Reusable)

Tooling (Dedicated) NRE Total Delivery

Operators and Techs /shift

DedicatedAutomationAlternative


All New Modules

Reduced Validation,Time to Market and Lost Production

500K Lab 336$ 760$ 75$ 1,171$ 18 wks 1 (1,171)$ 1M Samples Man 168$ 165$ 15$ 348$ 12 wks 5 (1,519)$ 1M Samples Auto 224$ 390$ 40$ 654$ 14 wks 1 (2,173)$ 2.5M Startup 1,120$ 290$ 30$ 1,440$ 16 wks 4 (3,613)$ 5M Full scale -$ 995$ 80$ 1,075$ 20 wks 4 (4,688)$ 9M Full scale x 2 1,848$ 2,200$ -$ 4,048$ 20 wks 8 (8,736)$

Cost Savings

Target Volume Phase

Modules (Reusable)

Tooling (Dedicated) NRE Total Delivery




Reusing X-Cell Modules

Reduced Validation,Time to Market and Lost Production

500K Lab Re-used 760$ 75$ 835$ 18 wks 1 (835)$ 1M Samples Man Re-used 165$ 15$ 180$ 12 wks 5 (180)$ 1M Samples Auto Re-used 390$ 40$ 430$ 14 wks 1 (430)$ 2.5M Startup Re-used 290$ 30$ 320$ 16 wks 4 (320)$ 5M Full scale Re-used 995$ 80$ 1,075$ 20 wks 4 (1,075)$ 9M Full scale x 2 Re-used 2,200$ -$ 2,200$ 20 wks 8 (2,200)$ Note 1: Prices and Deliveries above are shown as incremental amounts assuming completion of all previous phasesNote 2: Dedicated Automation Alternative based on BD experience


Ramp-Up Cost from Development to Production ($ 000s)X-Cell Modules (First System)

X-Cell Savings (capital equipment only)

Ramp-Up Cost from Development to Production ($ 000s)X-Cell Modules (Reusing Existing Modules)


X-Cell Savings (capital equipment only)

Modular, self contained platform Redeployable Flexible – Multiple Operations Low Cost – High Performance Simple Intuitive Controls Low Risk Quick Lead Times Scaleable Imbedded support Scalable to full automation Collaborative Robotics Combination High Repeatability – Robot Under 0.0200mm Pallet Repeatability – Under .125mm

X-Cell Advantages

SCARA robot Quick Change Tooling Package Vision Inspection, Correction Interlocked Guard Door Large Viewing Area Quick Change Part Handling Cassette Powered Adjustable Height Rear Access Door Control panel Floor locking casters

Basic Cell Layout Overview

Drawer

Conveyor

Dial

Part Presentation Cassettes

Part Feeders Labeling Tray Handlers Testing and Inspection Welding or Bonding Printing (Pad, Laser…) Dosing, Lubrication, Dipping Curing Pressing, Punching

Auxiliary Integration

Collaborative Robot Integration Machine Tending Part Loading Unload & Packaging Simple Intuitive Programming Fully Safe

Modular tooling and code to enable multiple operations

Remove operations to reuse module or reduce cycle time

Transfer removed operations to new modules

One Product – Multiple Solutions

Product Development / Product Launch

Standard module shortcuts custom design cost/time/risk Focus on process development vs. material handling and automation Low impact to module with product/process changes Develop with production-intent controls,

tooling and software to reducevalidation efforts at launch

Redeployable on product variants ornext product

Intuitive user-interface for faster production readiness

Small, lab friendly, self-contained footprint

BD Strategic Advantages

Production Ramp-Up and Scaleability Integrate with high-volume automated systems PLC-communications to main line and supervisory

systems Modular load/transfer interface links to multiple

material handling solutions Mounting interface for accurate and

repeatable handling Modular guarding/safety circuit scheme

for robust safety on overall system Faster deployment through duplication of

development tools/processes Faster time to market leveraging original

documentation and training Faster validation of throughput increases with

modular code/tooling

BD Strategic Advantages

Design and Build of Turnkey Automation SystemsSystem IntegrationInnovative Application of TechnologyEquipment Replication – Contract ManufacturingTooling and Fabricated ComponentsDevelopment and Commercialization of Products or Systems

Calvary Core Competencies

260 People

Highly Skilled, Motivated Workforce

Experienced Skill Set

Manufacturing the U.S. and Asia

Global Reach Scale

Over 20 Years in Automation

We are knowledgeable

Time-to-Market Total Cost of Ownership

Vertically Integrated

Multiple disciplines all in-house

Corporate Stability

Continuous growth for over 20 years

Financial Strength Long Term Sustainability

Calvary Overview

One Source/One Responsibility

I. Augment Engineering Resource for Business Flexibility and Subject Matter Experts

II. Utilizing Contractors and ConsultantsIII. Make Versus Buy Decisions based on Market Research FirstIV. Engineering Focus – Where should we Apply our Engineering ResourceV. Key Supplier and Technology Partnerships

Engineering ApproachGAMP V - Model

Closed loop Process for Engineering Design / Measurement and Validation

Research & Development

• Vision Inspection and Guidance• Industrial Robots • Collaborative Robots• Programmable Conveyance• 3D Vision• 3D Printing• Intuitive Controls• Direct R&D Investment – Indirect on every design build program• 6-7 Programs underway with Enabling Technologies

Feasibility Risk Reduction Development

x-cell presentation for bd 2015-02-16

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