Why Outsource Manufacturing Of Medical Devices and Disposables

Outsourcing Manufacturing Of Your Medical Devices and Disposables ?Presentation indicates why companies decide to outsource The decision to outsource is usually made to improve short and long range profitability and cash flow & to improve speed to market for the OEM

Contracting with only ISO 13485 Certified and FDA Registered CMsOEMs Can focus on generating a faster rate of internal design innovation to meet worldwide competitions accelerating speed to market

CMs represented are very experienced building and testing medical devices, they are FDA registered and ISO 13485 certified

OEMs & CMs can be great strategic partners from a design and design for manufacturing (DFM) perspectives

OEMs high development and clinical costs prohibit the assets required to engage in high quality, high productivity manufacturing

Why Should You Use Contract Manufacturing

Contracting with only ISO 13485 Certified and FDA Registered CMsCMs have access to world wide high volume supply chains not accessible for most stand alone OEMs

CMs have access to the finest state-of-the-art manufacturing and testing equipment

CMs highly capable process assembly and manufacturing test engineers. Dedicated customer cell teams for lean manufacturing and personal customer focus.

OEMs can/will reduce overhead including facility costs

OEMs will reduce labor costs

Why You Should Contract Manufacturing

Contracting with only ISO 13485 Certified and FDA Registered CMs

Why You Should Use Contract ManufacturingOEM Manufacturing may not be a core competencies

OEMs Logistics may not be optimized for procuring and handling materials required in your products

OEMs ROI on capital equipment for manufacturing is volume related and is usually very low

OEMs manufacturing equipment may be outdated for the production of highly complex products

OEMs cash may be tied up in manufacturing inventory and equipment

OEMs overhead structure maybe too high

Contracting with only ISO 13485 Certified and FDA Registered CMsCMs have the ability to support diverse services such as direct order fulfillment

CMs can perform and handle all service repairs for a total product life cycle support.

CMs can help develop quality packaging and material handling systems for your productWhy You Should Use Contract Manufacturing

Contracting with only ISO 13485 Certified and FDA Registered CMs

How To Select A Contract ManufacturerManufacturing Competencies

Quality Certifications (FDA Registered, ISO 134845, RoHs)

Supply Chain Strength

Test Capabilities

Size of OEMs business as related to other customer

CMs level of unused capacity level

CMs level of focus On Medical Devices

CM has similar Customers with similar product complexity

Contracting with only ISO 13485 Certified and FDA Registered CMs

How To Choose The Right CMCM will be a financially Stable Partner

CM has positive customer References current & past

CM is price Competiveness

CM has a focus on Manufacturing Engineering Services

CM currently provides warranty repair & support

CM has a Management Commitment to develop long term medical device customer relationships

CM has a cellular team approach

Contracting with only ISO 13485 Certified and FDA Registered CMs

The Manufacturing Agreement (recipe for success)Clear Statement of WorkManufacturing PlanTesting PlanAcceptance Criteria

Mutual ResponsibilitiesGoal SettingBusiness ReviewsCommunicationsProblem Resolution

Shared Risks & ReturnsInventory ExcessReschedule WindowsLong Lead Items

Payment TermsProduct End Of LifePurchase OrderPurchase Price Variance

Legal IssuesWarrantyIndemnityTerminationsIntellectual PropertyConfidentialityContracting with only ISO 13485 Certified and FDA Registered CMs

Obstacles To Successful RelationshipPoor fit between the OEM and the CM

Outsourcing of designs not ready for manufacturing, effecting yields

High levels of debug, repair, support, on-time delivery, poor quality

Poor Forecasting and lead-time problems

Poor communications, poor goal setting, no business reviews

Lack of investment of people & time to manage outsourcing

Lack of partnering creating transfer problems

Lack of Buy-In from OEMs cross functional organization

Contracting with only ISO 13485 Certified and FDA Registered CMs

How To Get Started (perfect world)NDA Signed by both parties

Tour of facility meeting management teams

Request For QuoteOEM supplies CM with a complete set of drawings, files and approved suppliers

Quality Audit by OEM of CM

CM provides OEM with a quote of services, labor, material, overhead, profit

Contract signed by both parties to proceed forward

Purchase Order let by OEM to begin the procurement of materials process

Contracting with only ISO 13485 Certified and FDA Registered CMsDocumentation and or material suppliers not complete or accurate

OEM has inventory needing transfer to CM

OEM has capital equipment needing transfer

OEM has human capital needing transfer

WE WORK WITH YOU ON ALL OF THE ABOVE AS PARTNERS IN THE PROCESSImperfect World Start

Contracting with only ISO 13485 Certified and FDA Registered CMsI only represent the best and most capable medical device & disposable CMs in the business

My CMs have facilities in all areas of the United States, Pacific Rim and Central America

I can personally engage with you and the CM on a daily basis to insure successIf for some reason, the CMs I am engaged with cannot meet your needs, I am fully capable of helping you find the right CM for your business model & productsHow Can I HelpContracting with only ISO 13485 Certified and FDA Registered CMsBachelors of Electrical Engineering Degree

General Electric MMP Graduate

Twenty-Five (25) years of senior level medical device manufacturing experience

Siemens Ultrasound, VP OperationsCriticare Systems, VP Operations and GMSpacelabs Medical, Sr. Director OperationsCorometrics Medical Systems, VP Operations

My CredentialsContracting with only ISO 13485 Certified and FDA Registered CMsSuccessfully managed projects and improved processes for some of the leading medical device companies in the world

Supply-chain management

Operations Management

Design engineering management

Sustaining engineering management

Quality systems compliance management

Expert in outsourcing box build medical devicesPacific Rim Expertise

My Skills Used To Insure Your SuccessContracting with only ISO 13485 Certified and FDA Registered CMsJoe LesterPresident Medical Manufacturing LLC414-745-6202Medical.mfg@hotmail.com

I only represent the most capable medical device and medical disposable CMs I can help you find the right partner

I can and will work with you and the CM to make certain the project is successfulPlease Call Or E-Mail

Contracting with only ISO 13485 Certified and FDA Registered CMs