SHORT RUN PRODUCTION

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SHORT RUN PRODUCTION

• PLASTICS
• _______________
• MEDICAL
• COMPONENTS
• AND
• DEVICES

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PLASTICS

• Fused Deposition Modeling (FDM)
• Casting
• Thermoforming
• Machining
• Injection Molding

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FUSED DEPOSITION MODELING (FDM)

• Limited (but growing) material options
• Unit cost high
• Tolerance (- .005)
• Not all designs can be built
• Structural weakness

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CASTING

• Limited material options urethane, nylon
• Low cost (epoxy) mold - 300
• Difficult to hold dimensions
• Often requires futher machining of features

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Thermoforming Process
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Thermoforming

• Heat a thermoplastic sheet until it softens
• Force the hot and pliable material against the
  contours of a mold by using either mechanical,
  air or vacuum pressure
• Hold against mold and allow to cool
• Plastics retains shape of mold on one side

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FORMING PROCESS

• The material is clamped into a frame
• Material is heated, begin to sag
• Vacuum is applied to the back of the mold

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Thermoforming Advantages

• Large parts easily formed
• Lower temperature requirements (material is not
  melted)
• Fast mold cycles
• Lower pressures
• Low mold cost (constructed from soft material,
  such as wood)

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Thermoforming Disadvantages

• Limited part shapes
• High scrap rate
• Only one side of part defined by mold
• Internal stresses
• Inherent wall thickness variation
• Inability to hold tolerances

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MACHINING

• Flexibility
• Material options
• Fast turnaround
• No tooling
• High precision

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Machined vs. Molded
Core Out Heavy Sections
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INJECTION MOLDING

• Low unit cost
• Material options
• Part strength
• Design flexibility
• Surface appearance

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MANUFACTURING ENGINEERING

• Preparing for the transition
• from the production of
• one or few
• to the production of
• many

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LONG TERM COST ANALYSIS - 2001

• Machining
• Tooling cost low
• Part price high
• Eg. Part cost 30
• Life of product is 5,000
• Total 150,000

• Molding
• Tooling cost high
• Part price low
• Part cost 1
• Tool cost 25,000
• Total 30,000

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LONG TERM COST ANALYSIS - 2008

• Machining
• Tooling cost low
• Part price high
• Eg. Part cost 20
• Life of product is 5,000
• Total 100,000

• Molding
• Tooling cost high
• Part price low
• Part cost 1
• Tool cost 8,000
• Total 13,000

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BREAKEVEN DROPPING

• 2001
• 1,000 units

• 2008
• 650 units

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INJECTION MOLDING - PROTOTYPE PROCESS

• Surface appearance confirmed
• Plan for gate location, draft, etc.
• Tests performed on production parts
• Improve reliability by insert molding
• Eliminate assembly steps

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MEDICAL COMPONENTS AND DEVICES

• Special Considerations

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DEVELOPMENT CONSIDERATIONS

• Regulatory approval of manufactured product
• Design and process FMEA
• Sterility and packaging protocols

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QUALITY

• Test failure can delay product launch
• Process validation required
• Supply chain may need to be ISO 13485

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OFFSHORE

• What
• When
• Where
• Why
• Why Not?

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OFFSHORE NPI SUPPORT

• Limited collaborative engineering
• Same mold cost
• No mold transportation
• Provide raw material
• Transportation of product

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SHORT RUN PRODUCTION- OFFSHORE

• Minimum orders are climbing
• Transportation cost
• Delays
• Troubleshooting
• Travel expenses

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