“Outsourcing Manufacturing” Of Your Medical Devices and Disposables ?

1. Contracting with “only” ISO 13485 Certified and FDA Registered CM’s “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

2. Why Should You Use Contract Manufacturing • OEM’s Can focus on generating a faster rate of internal design innovation to meet worldwide competitions accelerating speed to market • CM’s represented are very experienced building and testing medical devices, they are FDA registered and ISO 13485 certified • OEM’s & CM’s can be great strategic partners from a design and design for manufacturing (DFM) perspectives • OEM’s high development and clinical costs prohibit the assets required to engage in high quality, high productivity manufacturing Contracting with only ISO 13485 Certified and FDA Registered CM’s

3. Why You Should Contract Manufacturing • CM’s have access to world wide high volume supply chains not accessible for most stand alone OEM’s • CM’s have access to the finest state-of-the-art manufacturing and testing equipment • CM’s highly capable process assembly and manufacturing test engineers • OEM’s can/will reduce overhead including facility costs • OEM’s will reduce labor costs Contracting with only ISO 13485 Certified and FDA Registered CM’s

4. Why You Should Use Contract Manufacturing • OEM Manufacturing may not be a core competencies • OEM’s Logistics may not be “optimized” for procuring and handling materials required in your products • OEM’s ROI on capital equipment for manufacturing is volume related and is usually very low • OEM’s manufacturing equipment may be outdated for the production off highly complex products • OEM’s cash may be tied up in manufacturing inventory and equipment • OEM’s overhead structure maybe too high Contracting with only ISO 13485 Certified and FDA Registered CM’s

5. Why You Should Use Contract Manufacturing • CM’s can drop ship your product to your final customer • CM’s can perform and handle all service repairs • CM’s can help develop quality packaging and material handling systems for your product Contracting with only ISO 13485 Certified and FDA Registered CM’s

6. How To Select A Contract Manufacturer • Manufacturing Competencies • Quality Certifications (FDA Registered, ISO 134845, RoHs) • Supply Chain Strength • Test Capabilities • Size of OEM’s business as related to other customer • CM’s level of unused capacity level • CM’s level of focus On Medical Devices • CM has similar Customers with similar product complexity Contracting with only ISO 13485 Certified and FDA Registered CM’s

7. How To Choose The Right CM • CM 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 CM’s

8. The Manufacturing Agreement (recipe for success) Payment Terms Product End Of Life Purchase Order Purchase Price Variance Legal Issues Warranty Indemnity Terminations Intellectual Property Confidentiality Clear Statement of Work Manufacturing Plan Testing Plan Acceptance Criteria Mutual Responsibilities Goal Setting Business Reviews Communications Problem Resolution Shared Risks & Returns Inventory Excess Reschedule Windows Long Lead Items Contracting with only ISO 13485 Certified and FDA Registered CM’s

9. Obstacles To Successful Relationship • Poor “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 OEM’s cross functional organization Contracting with only ISO 13485 Certified and FDA Registered CM’s

10. How To Get Started (perfect world) • NDA Signed by both parties • Tour of facility meeting management teams • Request For Quote • OEM 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 CM’s

11. Imperfect World Start • Documentation 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 PROCESS Contracting with only ISO 13485 Certified and FDA Registered CM’s

12. How Can I Help • I only represent the “best and most capable” medical device & disposable CM’s in the business • My CM’s 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 success • If for some reason, the CM’s I am engaged with cannot meet your needs, I am fully capable of helping you find the “right” CM for your business model & products Contracting with only ISO 13485 Certified and FDA Registered CM’s

13. My Credentials • Bachelors of Electrical Engineering Degree • General Electric MMP Graduate • Twenty-Five (25) years of senior level medical device manufacturing experience • Siemens Ultrasound, VP Operations • Criticare Systems, VP Operations and GM • Spacelabs Medical, Sr. Director Operations • Corometrics Medical Systems, VP Operations Contracting with only ISO 13485 Certified and FDA Registered CM’s

14. My Skills Used To Insure Your Success • Successfully 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 devices • Pacific Rim Expertise Contracting with only ISO 13485 Certified and FDA Registered CM’s

15. Please Call Or E-Mail • Joe Lester • President Medical Manufacturing LLC • 414-745-6202 • Medical.mfg@hotmail.com • I only represent the “most capable” medical device and medical disposable CM’s • I can help you find the right partner • I can and will work with you and the CM to make certain the project is successful Contracting with only ISO 13485 Certified and FDA Registered CM’s