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Moving From R&D To Manufacturing Under SBIR/STTR

July 1, 2009. Moving From R&D To Manufacturing Under SBIR/STTR. Manufacturing Questions. Deciding if manufacturing is right for you & your company? When do you think about manufacturing & how relative to R&D activities Concepts in developing manufacturing processes

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Moving From R&D To Manufacturing Under SBIR/STTR

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  1. July 1, 2009 Moving From R&D To Manufacturing Under SBIR/STTR NIST MEP

  2. Manufacturing Questions • Deciding if manufacturing is right for you & your company? • When do you think about manufacturing & how relative to R&D activities • Concepts in developing manufacturing processes • Concepts in control of manufacturing processes NIST MEP

  3. What’s an “MEP” NIST MEP

  4. Do You Want To Manufacture? NIST MEP

  5. Exercise #1 • 1-2 Reasons why you might want to manufacture? – in 5 mins • Work with partner to right, end of rows with those behind you NIST MEP

  6. Developing Manufacturing Processes • Design for manufacturability • Concepts of “Vertical Integration” • Lean Manufacturing – “batch” versus “flow” • Value Stream Mapping (VSM) NIST MEP

  7. NPD Perspective Phase I Phase II NIST MEP

  8. Manufacturing StrategiesRequired Investment, potential risk & skill levels NIST MEP

  9. Manufacturing Levels 1-3 Concepts Established 4 Demonstration in laboratory 5 Overall plan Initiated 6 Demo in relevant environment 7 Pilot line established 8 Low-rate production runs 9 3 Sigma or better in production 10 Full-scale production NIST MEP

  10. Exercise #2 • Who will help you with developing your manufacturing processes? – 5 mins? • Work with person to your left, at end of row talk to person behind you NIST MEP

  11. Ambion, Inc., TexasBill Rafferty – TMAC Staff • Bulk & custom manufacturing of kits, enzymes & reagents • Prototyping of racks in reagent kits, rapid prototyping, initial production, Lean 101 training to reduce cycle times & inventory NIST MEP

  12. Control of Manufacturing Processes • “Open Market” Quality Control Standards • Systems versus Registration • Medical Market Quality Control Standards • 510 K • Good Manufacturing Practices (GMP) NIST MEP

  13. Wavefront Sciences, New MexicoRon Burke – NMEP Staff • Wavefront sensing metrology (such as detailed measurements for LASIK survery) • Tech Transfer from Sandia National Labs • Public seminars on Lean Principles, plant layout assistance as they expanded, ISO and GMP auditing assistance NIST MEP

  14. NIST MEP

  15. Contact Information http://www.mep.nist.gov/ Tab Wilkins Account Manager & Senior Technology Advisor (301) 646-4069 twilkins@nist.gov NIST MEP

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