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Injection Molding & Manufacturing

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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

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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.


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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

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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

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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

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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.)

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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

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

Industries Served

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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

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19 Molding machines with mobile enclosures for added cleanliness

Commercial molding floor

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Our modular assembly facility can be configured to meet customer manufacturing requirements

White room assembly facility with testing

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Clean Room Molding with assembly automation

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

Clean Room Production

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Operators check the parts against the quality requirements

Clean Room Molding Cell

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Product Design Assistance

3-D Solid ModelingMold DesignMold Flow AnalysisMold Construction and

Project CoordinationElectronic File Transfer

Material SelectionProduct & Process


Full CAD Engineering

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Mold Types


Class 101, 102

Hot Runner




Prototype & Low Volume

Single & Multi Cavity

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CNC Machining CentersCNC Turning CentersSurface GrindersRam EDMsVertical MillsHorizontal MillsLathes

In House Tooling Capability

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Process Control PlansValidation - IQ/OQ/PQRisk Assessment - Failure

Modes and Effects Analysis (FMEA)

Statistical Process Control (SPC)

Automated InspectionPreventive Maintenance


QC Operations

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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


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

Molding Specialties

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Production Examples

From the very very small parts

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Production Examples

Urological Assembly Valve Assembly

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Medical Production Examples

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Medical Production Examples

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Medical Production ExamplesTyvek Bag Packaging

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Production Examples

From the very small To the very large

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AcetalNylonPolycarbonatePolystyreneABS SANLCPPEEK


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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

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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


Customer Services

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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

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Heat sealing Bar Code labelingCustomized packagingLocated near airport and

international borderCompany-owned

delivery trucks

Packaging and Fulfillment