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Table of ContentsTable of Contents

About HVOAbout HVO HVO HistoryHVO History HVO Expanded ServicesHVO Expanded Services Customized Surgical DrapesCustomized Surgical Drapes HVO Product Design & DevelopmentHVO Product Design & Development Regional Outsource DevelopmentRegional Outsource Development Quality & Continuous ImprovementQuality & Continuous Improvement HVO Business Continuity PlanningHVO Business Continuity Planning

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About HVO About HVO HVO is a private not-for-profit HVO is a private not-for-profit

corporationcorporation HVO employs & trains more than 475 HVO employs & trains more than 475

individuals each dayindividuals each day HVO is one of the largest leading HVO is one of the largest leading

employers in Haywood Countyemployers in Haywood County HVO is a HVO is a social enterprisesocial enterprise & utilizes a & utilizes a

blended workforce of disabled & non-blended workforce of disabled & non-disabled employees to maintain high disabled employees to maintain high levels of production efficiencieslevels of production efficiencies

HVO is currently the largest HVO is currently the largest manufacturer of custom medical drapes manufacturer of custom medical drapes in the USin the US

HVO provides over 260,000 square feet HVO provides over 260,000 square feet manufacturing space across 3 facilities.manufacturing space across 3 facilities.

Over 35 Years Experience of Medical Over 35 Years Experience of Medical Device ManufacturingDevice Manufacturing

ISO 9001 and 13485ISO 9001 and 13485 HVO is Regulated and Audited by FDAHVO is Regulated and Audited by FDA Has the ability to accommodate medical Has the ability to accommodate medical

projects ranging in size from individual projects ranging in size from individual samples to full production runs.samples to full production runs.

ISO Class 7 & ISO Class 8 controlled ISO Class 7 & ISO Class 8 controlled environments.environments.

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HVO WNC FacilitiesHVO WNC FacilitiesWaynesville, NCWaynesville, NC

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HVO HistoryHVO History HVO is a HVO is a

private not-private not-for-profit for-profit corporation corporation that has been that has been in business in business since 1972since 1972

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HVO Expanded ServicesHVO Expanded ServicesHVO Offers:HVO Offers: OEM ServicesOEM Services Regulatory AssistanceRegulatory Assistance Customized Surgical DrapesCustomized Surgical Drapes Disposable Health Care ProductsDisposable Health Care Products Product Design and DevelopmentProduct Design and Development Warehouse and DistributionWarehouse and Distribution Customer SupportCustomer Support Technical SupportTechnical Support Contract Packaging & AssemblyContract Packaging & Assembly Private LabelingPrivate Labeling Start to Finish PartnershipStart to Finish Partnership Custom Medical Sterile and Non-Custom Medical Sterile and Non-

Sterile KitsSterile Kits Customized Equipment & Customized Equipment &

ProcessesProcesses Medical Sterilization Medical Sterilization

CoordinationCoordination

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Custom Surgical Drape Custom Surgical Drape Product OfferingsProduct Offerings

AngiographyAngiography ArthroscopyArthroscopy CardiovascularCardiovascular C-SectionC-Section CystocopyCystocopy ExtremityExtremity Head & NeckHead & Neck LaparoscopyLaparoscopy Minor ExtremityMinor Extremity OphthalmicOphthalmic

NeurosurgeryNeurosurgery Orthopedic Plastic & Orthopedic Plastic &

ReconstructiveReconstructive Picc Insertion DrapesPicc Insertion Drapes ShoulderShoulder UrologyUrology Back Table CoversBack Table Covers Instrument CoversInstrument Covers Sterile PackagingSterile Packaging AssemblyAssembly Additional offerings Additional offerings

available upon requestavailable upon request

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HVO Product Design & HVO Product Design & DevelopmentDevelopment

Computer-aided software Computer-aided software design capabilitiesdesign capabilities

Confidential & Confidential & professional serviceprofessional service

Technical expertise & Technical expertise & adviceadvice

Projects followed through Projects followed through from start to finishfrom start to finish

Works one-on-one with Works one-on-one with customers to ensure customers to ensure common goal alignmentcommon goal alignment

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Regional Outsource Regional Outsource DevelopmentDevelopment

HVO partners with other organizations in the WNC region to further HVO partners with other organizations in the WNC region to further enhance its own medical manufacturing capabilities enhance its own medical manufacturing capabilities

This networked structure provides versatility in HVO products & This networked structure provides versatility in HVO products & services by offering additional manufacturing space & core services by offering additional manufacturing space & core competenciescompetencies

These facilities are monitored & maintain all necessary regulatory These facilities are monitored & maintain all necessary regulatory compliances in accordance with HVOcompliances in accordance with HVO

Additional capabilities, including commercial sewing & thermoform Additional capabilities, including commercial sewing & thermoform moldingmolding

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HVO Quality Certifications & HVO Quality Certifications & RegistrationsRegistrations

ISO 9001 Registered ISO 9001 Registered Manufacturer & DesignerManufacturer & Designer

ISO 13485 RegisteredISO 13485 Registered Regulated & Audited by Regulated & Audited by

the FDAthe FDA CARF AccreditedCARF Accredited Continuous Improvement Continuous Improvement

& Lean Manufacturing & Lean Manufacturing Initiatives Initiatives

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Business Continuity PlanningBusiness Continuity Planning

HVO is committed to HVO is committed to providing its customers with providing its customers with the additional necessary the additional necessary production and technical production and technical support needed to lessen the support needed to lessen the supply chain impact in the supply chain impact in the event of an unplanned plant event of an unplanned plant shut-down at any facility.shut-down at any facility.

Through regional outsource Through regional outsource partnerships, HVO has the partnerships, HVO has the ability to shift current ability to shift current production demands to sister production demands to sister production facilities for production facilities for contingency planning contingency planning purposes. purposes.

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Empowering People…Empowering People…

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Delivering World Class Delivering World Class Medical SolutionsMedical Solutions