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 Questions / Comments

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 Endo Wound 25% 30% 45%

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.

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

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

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

U.S. Distribution Model

Global Distribution Model

Start like this…

…end like this?

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

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

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

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

Distribution Channel Real World

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

EDR Test Plan - Warehouse

EDR Test Plan – Transit Shipment

EDR Test Plan – Sales Rep Cycle

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

Environmental Data Recorder (EDR) Drop Height

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

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?