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Characterizing Distribution Channels to Provide Analysis for Package Validations

This presentation by Russell Darley and Randall Troutman delves into the distribution model of Smith & Nephew Orthopedics, a global leader in medical technology. It explores the nuances of their distribution channels for orthopedic, endoscopy, and wound management products. The analysis emphasizes the significance of environmental data recorders (EDR) in validating packaging through real-world comparisons vs. simulations and ASTM/ISTA testing methods. The key insights aim to enhance understanding of product flow, necessary testing procedures, and ensuring the safety and efficacy of medical products during distribution.

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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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