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 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

• 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

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?