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
BD Application: Autoguard
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
BD Application: Autoguard
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
BD Application: Autoguard
Click picture for video of assembly process
BD Application: Autoguard
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 4Inspect Presence 1
1 5Flare Tube / Wedge 1
1 6Measure Flare 1
1 7Load Adapter 1
1 8Inspect Presence 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
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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 26’ x 26’
BD Application: AutoguardFloor Space 100’ x 24’ per System
BD Application: Autoguard
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
BD Application: Autoguard
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
Operators and Techs /shift
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
Operators and Techs /shift
DedicatedAutomationAlternative
Operators and Techs /shift
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
DedicatedAutomationAlternative
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)
DedicatedAutomationAlternative
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