Characterizing Distribution Channels to Provide Analysis for Package Validations Russell Darley /...
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Transcript of Characterizing Distribution Channels to Provide Analysis for Package Validations Russell Darley /...
Characterizing Distribution Channels to Provide Analysis for Package Validations
Russell Darley / Randall TroutmanMay 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’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
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 3x901.08 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 DistributionLab 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)
Distribution ChannelReal World
Package /Product Damage
Truck
Plane
Sales Rep Handling
Conveyor HandlingLoad / Unload
Handling
Auto
EnvironmentalConditions
Warehouse Conditions
Distribution Channel
• EDR Test Plan – 3 Segments
– 1. Warehouse
– 2. Transit Shipment
– 3. Sales Rep Cycle
EDR Test Plan - Warehouse
Mfg Floor
Handling
Truck
Sterilizer Warehouse
Handling
Truck
Handling
Conveyor
EDR Test Plan – Transit Shipment
Handling
Truck
FEDEX Hub(Memphis)
Conveyor
Handling
Truck
Air
Truck
DO(Domestic)
Hospital
DO(Intl.)
EDR Test Plan – Sales Rep Cycle
Store on Office ShelfStore On Shelf
(until use)
District Office(Domestic)
District Office(International)
Hospital(Directly)
Carry to Hospital(For Surgery)
Do Not Use inSurgery
Use in Surgery(END)
Use in Surgery(END)
Auto Vehicle
Handling
Environmental Data Recorder (EDR)Drop Height
Height = 31.38 in
Time = 1:34pm Apr, 15
Impact Orientation = Edge-Back Left
Drop Type = Tossed Up
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?