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Presentation as to why Medical Device Companies May Want To Outsource Their Manufacturing
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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OEMs manufacturing equipment may be outdated for the production of highly complex products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 [email protected]
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