Mack -- Plastic Molding, Metal & Manufacturing

Corporate Overview
- Mack Confidential & Proprietary-

WHO WE ARE
 Full-service contract manufacturer
 Specializing in…
 Custom injection molding
 Painting
 Metal fabrication
 Machining
 Assembly
 Offering product development resources…
 Product design
 Prototyping
 Engineering services

WHO WE ARE
 Founded in 1920 – privately owned & operated
 Headquartered in Arlington, Vermont
 Three operating divisions, 10 locations
 ~1800 employees
 Annual sales: $260 million
 No long-term debt, 5A1 D&B rating
 Certifications
 ISO 9001
 ISO 13485 (Mack North, Mack Prototype, Mack Technologies)
 ISO 14001 (Mack South)
 AS9100 (Mack Technologies)
 ISO/TS 16949 (Mack South)
 FDA Registered (Mack North)

Mack Molding - North
 Mack Molding/MackMedical
 Product Development
 Plastic Molding
 Metal Fabrication
 Paint and Assembly
 Contract Manufacturing
 Mack Prototype
Mack Molding - South
 Plastic Molding
 Class A paint
 Assembly
Mack Technologies
 Electronics Contract
Manufacturing
 SMT, Turn-key System
Integration, PCB/System
Level Test Development
MACK
Group SLA Rapid Prototyping
 Fused Deposition Modeling
 CNC Machining
 LIM Cast Urethane
 Low-volume Injection
Molding & Manufacturing
CORPORATE STRUCTURE

Mack Technologies
Westford, Massachusetts
Melbourne, Florida
Juarez, Mexico
Mack North
Arlington, Vermont (2)
Cavendish, Vermont
Pownal, Vermont
Mack South
Statesville, North Carolina
Inman, South Carolina
Mack Prototype
Gardner, Massachusetts
LOCATIONS

WHAT WE DO
 Contract manufacturing
 Product design & development
 Rapid prototyping & low volume
manufacturing
 Custom injection molding
 Cleanroom molding
 Finishing & assembly
 Sheet metal fabrication
 Full-service machining
 Medical Class II/Class III
contract manufacturing

DESIGN & DEVELOPMENT
 Application
Development Center
 Engineering analysis
 Supply base selection
and management
 Material and process
selection
 Tool design and
management

DESIGN & DEVELOPMENT
 Interactive feedback with
designers
 Mechanical design
 Design for manufacturing
 Moldflow
 Finite element analysis
 Process selection

METAL-TO-PLASTIC CONVERSION
Orthopedic Ankle Clamp

INDUSTRIAL & MECHANICAL DESIGN

PROTOTYPING/LOW VOLUME MFG
 SLA rapid prototyping
 Fused deposition modeling
(FDM)
 CNC machining
 LIM cast urethane
 Low-volume injection molding
(10-230 ton)
 Extensive finishing capabilities

CUSTOM INJECTION MOLDING
 92 years of expertise
 Six facilities
 Vermont (3)
 Massachusetts
 North Carolina
 South Carolina
 120 injection molding
machines
 28-4000 tons
 .6-800 ozs

MOLDING PROCESSES
 Injection
 Structural foam
 Gas counter pressure
 Gas-assist (internal &
external)
 Two-shot molding
 In-mold decorating
 Overmolding
 Insert molding
 High temp molding

INJECTION MOLDING
 Molten plastic injected into a
mold under high pressure
 Fast cycles
 3-5 ton/sq in clamp required
 Lowest part weight
 Good surface finish
 Low molded-in stress

STRUCTURAL FOAM MOLDING
 Molten plastic injected with a
chemical blowing agent
 Short shot process
 Thicker part wall required
 Low stress
 Slow cycles
 ¼ - 1 ton/sq in clamp required
 Reduces sink issues
 Rib-to-wall ratio can be greater
 Poor surface finish; lots of swirl
 Heavier part weight

GAS COUNTERPRESSURE
 Structural foam shot into a
pressurized cavity
 Improved surface finish over
structural foam
 Cavity pressure holds out-
gassing in check
 Slightly heavier part than
structural foam
 Slightly slower cycle
 Higher tool cost & maintenance

INTERNAL GAS-ASSIST
 Gas confined within the part
 Reduces sink
 Reduces stress
 Reduces press tonnage
required
 Longer flow lengths can
eliminate need for manifolds
 Licensed for any application

EXTERNAL GAS-ASSIST
 Gas is pressurized between the
core steel and the part
 Reduces sink
 Reduces stress
 Must be confined by using core
side part design

FINISHING & ASSEMBLY
Automated
Cleanroom
Heat staking
Testing
Ultrasonic
Laser welding
Inserting
Work cell
RFID tagging
Assembly Decorating
Heat sealing
Heat transferring
Hot stamping
Laser marking
Pad printing
Silk screening
Painting
Decorative
Conductive
Robots
Automated
Overhead lines
Walk-in booths
Class A
CNC machining
Swiss lathes
Integrex turning &
machining ctr
14” optical
comparator
CAD/CAM
Ultrasonic parts
washing
Vibratory tumble
Machining

PREMIUM CLASS ‘A’ PAINT SYSTEM
 11,000-sq-ft enclosed HEPA
filter environment
 1200’ of conveyor supported
from underside of parts using
175 paint racks
 Ultra high filtration 5-station
wash & rinse system
 Color changes <5 minutes
 3 Fanuc model 250i paint
robots
 Electrostatic or HVLP
 Infrared/convection curing
ovens

PREMIUM CLASS ‘A’ PAINT SYSTEM
 HEPA filtered air
 Dust & dirt free environment
 Underside part support
 Reduces scrap generated by
standard overhead systems
 5-station wash system
 Insures clean surfaces
 Electrostatic paint system
 Ransburg rotary atomizer
improves transfer efficiency and
final finish quality
 Infrared curing ovens
 Reduce air movement
 Improve first pass yield

SHEET METAL FABRICATION
 State-of-the-art soft-tooled
fabrication
 Complete laser, punching &
forming for NPI & production
requirements
 Product development focus
featuring rapid prototype
development

SECONDARY PROCESSING
 Vibration deburr
 E-series press brake
 Haeger insertion equipment
 Auto-assist silk screening
 Wash line
 Automated bead blasting
 Wet time-savings equipment

SECONDARY PROCESSING
 Welding
 Metal finishing
 Fastening

SHEET METAL CASE STUDY
Commercial High-tech Blender
86 unique metal parts
Stainless steel construction
Multiple gauge materials
Riveted assembly
Laser cutting/punching
Metal forming
Hardware insertion

SHEET METAL CASE STUDY
Commercial Mail Sorting System
34 unique metal parts
CRS, pre-plated, stainless steel
Thicknesses range from 18-10 gauge
Part size: 2”x2” to 48”x96”
Laser cutting/punching/forming
Tapping
Hardware insertion
Welding: Spot, MIG
Metal finishing

MACHINING
 Milling & turning
 Small parts
 Parts with long length-to-
diameter ratios
 Complex parts

DONE-IN-ONE MILLING
 Mazak Integrex Mark IV
 Turning & machining in a
single setup
 40-tool capacity
 Touch probe tool setter
 KM63 dual contact tool
connection
 2” thru-capacity
 LNS Servo 65 bar feeder

CITIZEN SWISS LATHES
 Two Citizen A20VII lathes
 Seven-axes, 20mm
machines
 21 tools
 C-320 bar feeders
 3-20 mm barstock capacity
 +0.0000”/-0.0005” precision
ground stock
 Minimized cycle times via
simultaneous main & sub-
spindle processes, 32
m/min rapid feed rates

AUXILIARY EQUIPMENT/SOFTWARE
 Ultrasonic parts washing
 Vibratory tumble
deburring
 14” optical comparator
 Surface finish analyzer
 Fully integrated
CAD/CAM
 Part-Maker -- From solid
model to complete 3D
simulation to machine G-
code (Swiss & Integrex)
 MatrixCam – Offline
conversation programming
(Integrex)

CONTRACT MANUFACTURING
 Program management
 Global supply management
 DFM/DFT
 FMEA
 Electronic integration & test
 Order fulfillment &
distribution

PROJECT TEAM
Program
Manager
Supplier Selection /
Management
Tooling
Prototyping
Design
Order Fulfillment
Manufacturing
Services
Plastic Molded
Products
Soft Tool Metal
Product Assembly
Quality & Regulatory
Compliance

Mack Technologies
Westford, MA
Melbourne, FL
Juarez, Mexico
Mack North
Arlington, VT (2)
Cavendish, VT
Pownal, VT
Mack South
Statesville, NC
Inman, SC
Mack Prototype
Gardner, MA
MARKETS WE SERVE
 Medical
 Devices
 Disposables
 Instrumentation
 Transportation
 Heavy truck parts
 Recreation/utility vehicles
 Computer &
business equipment
 Consumer
 Defense/aerospace
 Energy
 Batteries
 Solar-powered products
 Fuel cell technology
 Industrial
 Structural HVAC
 Furniture & seating
 Industrial & building
supplies
 Lawn & garden

41 Mack: Company Confidential
MEDICAL ACCOUNT SAMPLES

CLEANROOM MOLDING
 Class 100,000 molding
cleanroom
 Installation complete, 12/11
 Dedicated to reusable &
disposable medical
applications
 46’ x 44’ modular design
 Removable panels to allow for
future expansion
 Dual air-lock doors, 8’ wide
 Rapid roll-up doors
 Ease of product flow, tool changes

CLEANROOM PRESSES
 Six Toshiba 110-ton electric
presses
 60% less energy consumption
than hydraulic
 High-precision machines
 Outfitted with high pressure
water controllers
 More versatility in resin selection

ENVIRONMENTAL MONITORING
 Gowns/personal protective
equipment required
 Particulate airborne
monitoring according to
ISO 14644-1 standard
 Particulate control plan
includes:
 Alert level
 Action level
 Ensure compliance with
GMPs

WHITEROOM PRESSES
 Currently operational
 Adjacent to new Class
100,000 molding
cleanroom
 Engel hydraulic presses
 Low-volume, multi-color
products requiring quick
resin/tool changes
 24-hour operation for
orthopedic trials, medical
disposables

CLEANROOM ASSEMBLY
 Class 100,000 cleanroom
assembly
 30’ x 70’
 Non-sterile packaging for
medical disposables
 Light sonic weld assembly
 Temperature & humidity-
controlled functional
testing

CONTRACT MANUFACTURING
 Project management
 Supply management
 Regulatory compliance
 DHF/DMR/DHR management
 Design verification
 Process validation
 Training
 DFM/DFT
 Order fulfillment/distribution

QUALITY ASSURANCE CONTROL
 Quality system
 21 CFR 11 & 820 compliant
 Electronic DMR & DHR retention
 Advanced product quality
planning
 Process flow diagrams
 Risk assessment/pFMEA
 Control plans
 Dynamic control plans

QUALITY ASSURANCE CONTROL
 Component & process
qualification/validation
 PPAP
 IQ/OQ/PQ
 Reqs traceability/supplier change
controls
 Config controls/validated software
 Measurement systems
 CMMs (3)
 Optical systems (4)
 NIST-traceable calibration
 Gage R&R
 Minitab & DataMite
 Post-prod risk assessment

DEVICES
 Class II/Class III PMA products
 FDA registered
 Clean room molding & assembly
 White room molding
 Complaint investigation
 Obsolescence management
 FRU/kitting

CASE & TRAY SYSTEMS
 Custom designs based on OEM
requirements
 Validated manufacturing process
 Plastic, stainless steel, titanium &
aluminum
 Laser welding
 Hermetically sealed weld bead
 Free of gas, air, contaminants
 JIT stocking arrangements with full
lot code
 Complete kitting and ship-to
distribution services

INSTRUMENTATION
 Soft-touch ergonomic handles
 Disposable & reusable
 Material analysis
 Lipid resistant resins
 Gamma stable resins
 Anti-microbial resins
 Autoclaveable ergonomic resins
 Overmolding
 Insert molding
 Final assembly

CASE STUDY
Therapeutic Device, Photopheresis
Class III PMA device
1,921 total components
616 unique components/80 suppliers
49 subassemblies
Dedicated work cell
Dedicated product support team
8 functional tests

CASE STUDY
Therapeutic Device, Photopheresis
Class III PMA device
1,400 total components
358 custom parts/65 suppliers
18 subassemblies
Component qualification
Dedicated work cell
Dedicated product support team
10 functional tests

Mack -- Plastic Molding, Metal & Manufacturing

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