Transcript Smith & Nephew PowerPoint Template [Simple]

Characterizing Distribution Channels to
Provide Analysis for Package Validations
Russell Darley / Randall Troutman
May 11, 2005
Presentation Overview
•
Smith and Nephew Orthopedics
–
•
S&N’s Distribution Model
–
•
U.S. & Global
Real World vs. Simulation
–
•
Company & Products
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
Ortho
Wound
25%
45%
Three Business Units
8,000 plus employees in 32 countries
30%
Endo
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?
…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
Saver 3x90
• GPS
1.08 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 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)
Distribution Channel
Real World
Truck
Plane
Auto
Conveyor Handling
Package /
Product Damage
Load / Unload
Handling
Sales Rep Handling
Warehouse Conditions
Environmental
Conditions
Distribution Channel
• EDR Test Plan – 3 Segments
– 1. Warehouse
– 2. Transit Shipment
– 3. Sales Rep Cycle
EDR Test Plan - Warehouse
Handling
Mfg Floor
Handling
Sterilizer
Truck
Handling
Warehouse
Truck
Conveyor
EDR Test Plan – Transit Shipment
DO
(Domestic)
Conveyor
Truck
Handling
FEDEX Hub
(Memphis)
Air
DO
(Intl.)
Truck
Truck
Handling
Hospital
EDR Test Plan – Sales Rep Cycle
District Office
(International)
District Office
(Domestic)
Store On Shelf
(until use)
Store on Office Shelf
Auto Vehicle
Handling
Carry to Hospital
(For Surgery)
Do Not Use in
Surgery
Hospital
(Directly)
Use in Surgery
(END)
Use in Surgery
(END)
Environmental Data Recorder (EDR)
Drop Height
Height = 31.38 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?