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Injection Molding & Manufacturing

1985 Plastic Engineering and Development, Inc. (“PEDI”) is formed in Carlsbad, California
1989 R. Witchey purchases the assets of PEDI via Witco (C-Corp). 1996 Company relocates operations to current building – design
built specifically for plastics manufacturing 1996 PEDI achieves ISO 9001 certification 2001 J. Sparacio hired as President and CEO 2003 Facility registers as Medical Device Establishment with the
U.S. Food and Drug Administration 2004 PEDI achieves ISO 13485 certification 2009 Acquires Emergent production assets and signs proprietary
manufacturing, distribution and servicing agreement with Bound Tree Medical, LLC
2010 Providien, LLC, funded by Endeavor Capital, acquires PEDI
PEDI Timeline

A Phoenix, AZ based holding company focused on acquiring small companies that provide contract manufacturing of medical devices. External funding by Endeavor Capital a Portland, OR based
company and has committed $75 million to Providien Acquired to date
Specialty Manufacturing, Inc. a pressure former of plastics based in San Diego, CA
PEDI a plastic molder contract manufacturing based in Carlsbad, CA. Providien is managed by Jeffrey Goble and Charles Stroupe.
C. Stroupe was CEO and J. Goble, President of Medegen, LLC an Ontario, CA based company of disposable intravenous therapy products
Medgen was acquired by Carefusion Corp., a San Diego, CA based company for $225 million in April, 2010.
PROVIDIEN

Jack W. Sparacio – President – Business Development - 25 years experience in healthcare. Formerly with J & J, American Hospital, served as General Manager of V. Mueller, Executive V.P. of Advanced Technology Labs, President & CEO of IMED Corporation and Lang Manufacturing.
James Bennett – Vice President Operations - 30 years of various and progressive operational experiences in Plastics and Medical Manufacturing firms. Experience includes management in Administration, Manufacturing, Regulatory Affairs/Quality Assurance, Equipment-Facilities Maintenance, and Tooling. Directive responsibilities also include Engineering, Warehousing, Distribution, Assembly, and Human Resources.
Dick Manson - Sales Manager - 25 years experience in plastic and metal injection molding sales and marketing. VP of Sales & Marketing for Guest Supply Inc., Director of Marketing, Cairns Brothers, Inc. and VP of Sales with Injectamax Injection in Escondido, Ca.
Management Team

James O’Connor - Engineering Manager - 20 years experience in engineering, quality, engineering design and product development for Cubic Defense, Easton Sports and Sanyo Energy.
Rob Gilman - Plant Manager - 25 years of tooling, manufacturing, and injection molding experience. BSE Degree, Cal State Poly and AA degree in machine tool technology. Certified Toolmaker. Formerly, Engineering and Operations Manager for Trademark Plastics.
Bob DePew – Senior Account Manager - Over 25 years of manufacturing and injection molding experience, featuring PCB Contract Assembly, Sheet Metal Fabrication, CNC Machining, Fiberglass & Composite Molding, Prototyping and Pre-Production Services as well as Operations experience.
Management Team

Fully Collaborative Manufacturing Partner From Concept to Distribution Highly Competent Engineering Capability – consult on
product design, FDA qualification, tooling design and cost reduction strategies for customers
Tooling design and outsourcing of tooling fabrication both foreign and domestic
Ability to Solve Tough Product Issues: examples are work with exotic resins (PEEK), tight tolerances (Aurora) and Emergent with roughly 150 components in final product that must be tested before shipment
General Capabilities

Full logistics capability – warehousing of product, maintaining SKU’s and direct shipments e.g. Emergent, Kirby, Ivera Medical
Collaborative relationship with Integra Bio in Tijuana, MX for outsourcing of high labor content assembly
PEDI is the virtual manufacturing and warehouse company for medical start-ups such as Ivera, Auroa, Venetec, and Access Scientific
Aftermarket services - testing and warranty work for Emergent CPAP devices
General Capabilities (cont.)

Operations Supported by Quality Certification and Registrations
ISO 13485:2003 (medical devices)FDA and State of California registered production
facilityClass 8 (100K) Cleanroom and White Room
Product EnvironmentsAncillary Operations to Complement the
Manufacture of Plastic Components – automation and robotics
Systems and Infrastructure

Medical Biotech Life Sciences Recreation Connectors Pro Audio Aerospace Industrial Electronic Irrigation
Industries Served

Our Facility 50,000 sq.ft. custom designed injection- molding
facility (ample room for expansion) 5,000 sq.ft. Class 8 clean room Clean room assembly and packaging area Custom Customer Cells White Room Assembly and Manufacturing 28 Toyo, Sumitomo & Toshiba injection-molding
presses, 18 ton to 500 ton, 10 in clean room Vacuum-fed material handling system Video CMM

19 Molding machines with mobile enclosures for added cleanliness
Commercial molding floor

Our modular assembly facility can be configured to meet customer manufacturing requirements
White room assembly facility with testing

Clean Room Molding with assembly automation

5,000 square foot Class 8 Clean RoomAutomation reduces operator interface
Clean Room Production

Operators check the parts against the quality requirements
Clean Room Molding Cell

Product Design Assistance
3-D Solid ModelingMold DesignMold Flow AnalysisMold Construction and
Project CoordinationElectronic File Transfer
Material SelectionProduct & Process
Validation
Full CAD Engineering

Mold Types
SPE/SPI
Class 101, 102
Hot Runner
Runnerless
Sub-Gates
Automatic
Prototype & Low Volume
Single & Multi Cavity

CNC Machining CentersCNC Turning CentersSurface GrindersRam EDMsVertical MillsHorizontal MillsLathes
In House Tooling Capability

Process Control PlansValidation - IQ/OQ/PQRisk Assessment - Failure
Modes and Effects Analysis (FMEA)
Statistical Process Control (SPC)
Automated InspectionPreventive Maintenance
Program
QC Operations

ISO 13485:2003 CertifiedCA Device Manufacturing LicenseFDA Registered – Class 2 listingsUL RecognizedcGMP (Good Manufacturing Practices)Accredited membership in SPE, SPI, and
ASQCMembers of Biocom and Octane
Certifications

Inserts
Rigids, Connectors, Filters, Flexibles, and Floating Elastomeric Molding Implantable Two Shot Molding Optical lens Unscrewing connectors Reeled overmolding In Mold Decorating Micromolding
Molding Specialties

Production Examples
From the very very small parts

Production Examples
Urological Assembly Valve Assembly

Medical Production Examples

Medical Production Examples

Medical Production ExamplesTyvek Bag Packaging

Production Examples
From the very small To the very large

PolypropyleneHDPELDPE/LLDPETPO/TPEPETPBTAcrylicPVC
AcetalNylonPolycarbonatePolystyreneABS SANLCPPEEK
Materials

Molding small and large parts Insert and over molding Clean room molding Complex assembly Automation assembly Assembly done at the machine Packaging at the machine Experienced with engineered plastics Contract assembly medical devices Experienced with automation in assembly
Production Summary

KanbanVendor Managed Inventory (VMI)Year-Over-Year Cost Reduction ProgramJust In Time (JIT) InventoryElectronic Data Interchange (EDI)Product Bar Coding (Shipping/Packaging Labels)Packaging, order and shipping fulfillmentMold consolidation and materials purchasing
advantages
Customer Services

Secondary ServicesProduction
Hot stamping Ultrasonic welding Machining/tapping/
drilling/inserting Assembly Access to Mexico
assembly facility
Finishing PAD printing Painting/silk screening Coating EMI shielding Bar coding

Heat sealing Bar Code labelingCustomized packagingLocated near airport and
international borderCompany-owned
delivery trucks
Packaging and Fulfillment