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Characterizing Distribution Channels to Provide Analysis for Package Validations

Characterizing Distribution Channels to Provide Analysis for Package Validations. Russell Darley / Randall Troutman May 11, 2005. Presentation Overview . Smith and Nephew Orthopedics Company & Products S&N’s Distribution Model U.S. & Global Real World vs. Simulation EDR & Lab Testing

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Characterizing Distribution Channels to Provide Analysis for Package Validations

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  1. Characterizing Distribution Channels to Provide Analysis for Package Validations Russell Darley / Randall Troutman May 11, 2005

  2. Presentation Overview • Smith and Nephew Orthopedics • Company & Products • S&N’s Distribution Model • U.S. & Global • Real World vs. Simulation • EDR & Lab Testing • Questions / Comments

  3. About Smith & Nephew • A global medical technology company with a focus on repairing and healing the human body in three high-growth sectors: • Orthopedics (Memphis, TN) • Endoscopy (Andover, MA) • Advanced Wound Management (Largo, FL) • HQ in London, England • Three Business Units • 8,000 plus employees in 32 countries Ortho Wound 25% 45% 30% Endo

  4. S&N Products • Orthopedics (Memphis, TN) • Reconstructive, Trauma, & Clinical Therapies • Hips, Knees, Shoulders, Nails, Screws, Frames, Supartz, & Exogen • Endoscopy • Cameras, Blades, Tissue Repair Devices • Allows for minimal access and pain to affected areas. • Wound Management • Specializing in medical solutions for: Leg ulcers, diabetic foot ulcers, burns, and scars.

  5. S&N Products Over 1,000 innovative and cost effective products to meet pressing health care needs.

  6. S&N’s Distribution Model • Importance? • Product – costly and highly technical • Customer – Doctor / Patient, end use in OR

  7. S&N’s Distribution Model • Where are our products needed? • How does it get there? • U.S. Distribution • Global Distribution

  8. U.S. Distribution Model

  9. Global Distribution Model

  10. Start like this…

  11. …end like this?

  12. …end like this?

  13. Real World vs. Simulation • ASTM / ISTA test method for package validation • Define “Real World” distribution • Determine gaps

  14. Environmental Data Recorder (EDR) Measures: • Shock • Vibration • Drop Height • Impact Orientation • Temperature • % RH • Time • GPS Saver 3x90 1.08 lbs 3.75” x 3.0” x 1.75”

  15. Environmental Data Recorder (EDR) • Suppliers • Lansmont • Instrumented Sensor Technology • Services • Purchase • Rent • Test Request (consulting)

  16. Lab Testing vs. Real World Distribution Lab Testing • ISTA 1G – Small Parcel Shipment, under 150# • Vibration Simulation (random) • 30 min • 10 min • 10 min • Drop Simulation • Drop Height (weight) • 10 drops (orientation)

  17. Distribution Channel Real World

  18. Distribution Channel • EDR Test Plan – 3 Segments • 1. Warehouse • 2. Transit Shipment • 3. Sales Rep Cycle

  19. EDR Test Plan - Warehouse

  20. EDR Test Plan – Transit Shipment

  21. EDR Test Plan – Sales Rep Cycle

  22. Environmental Data Recorder (EDR) Drop Height Height = 31.38 in Time = 1:34pm Apr, 15 Impact Orientation = Edge-Back Left Drop Type = Tossed Up

  23. Environmental Data Recorder (EDR) Drop Height

  24. Package Validation • ISTA 1G test method sufficient? • EDR study still in progress • Continue to use ISTA 1G • ISTA 4AB – User Defined • Project Complete – Q4, 2005

  25. Summary • KNOW • Your products • Where your products go • How they get there • Current test method accurate / adequate? • Instrumentation (EDR) can be used to verify • Questions / Comments?

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