PLCM 220807 final

Product Life Cycle Management Documents

Revision 01, May 2007

Copyright © 2007 Given Imaging Ltd. All rights reserved.

The Product Life Cycle Management Process

In order to win, we must always be one step ahead of our competitors.

Every product goes through a series of steps, from the moment it is first conceived, through becoming a manufactured product, until it is discontinued. The Product Life Cycle, developed and adopted as a master standard operating procedure, describes the succession of stages each Given Imaging product must go through.

In the Given product life cycle we have six stages:1 Product & Major Release Initiation2 Implementation3 Launch Readiness4 Marketing Support of Sales (Regional Launch)5 Ongoing Management6 End of Life

Among the PLC process stages we have PLC gates that establish timelines which define the transition from one stage to another in the product life cycle. Each gate marks the end point of one stage and leads to the next one: from after product & major release initiation until before end of life.

The PLC Gates allow us to:• Draw a road map of the product cycle• Simplify all SOPs to a clear PLC path• Create cross company language for common understanding for common

understanding of products status in its life cycle• Present clear deliverables in each stage of the PLC• Identify needs for decision points in the PLC

The goals of a formal product life cycle are to:• Align all of Given's processes towards the market and towards customer needs• Formalize processes and relevant internal communication in order to improve

efficiency and boost innovative ideas• Set out clear roles and responsibilities• Reduce cost and eliminate redundancy• Improve time to market

Homi Shamir, CEO

Product Life Cycle Management OverviewProduct Life Cycle Management Overview Flowchart

Stage 1: Major Release InitiationProduct & Major Release Initiation FlowchartDetailed Stage Description: Major Release Initiation

Gate P0:Product Initiation—Concept EvaluationBusiness Risk Analysis Preliminary Risk Analysis: PLCM-001-01Business Case Business Case: PLCM-003-01Technology Feasibility Technical Feasibility: PLCM-002-01Product Requirement Definition Product Requirements Definition: PLCM-004-01Road MapRegulatory Strategy

Stage 2: ImplementationImplementation FlowchartDetailed Stage Description: Implementation

Gate P1:Product Development—A Working ProductProduct Performance Versus Marketing Req. Product Requirements Definition: PLCM-004-01

Make-Buy-Partner Analysis and Decision: PLCM-005-01Product Specification: PLCM-006-01Design Review Document: PLCM-009-01Design History File (DHF): PLCM-010-01Design and Development Validation: PLCM-012-01Design and Development Verification: PLCM-036-01

Acceptance Criteria Testing Requirements: PLCM-008-01Business Case Business Case: PLCM-003-01Road Map & Detailed Work PlanRegistration Submissions Plan Regulatory Submissions: PLCM-016-01Preliminary ForecastPre-Production Plan Release to Engineering: PLCM-011-01Product Risk Analysis Risk Analysis for Development: PLCM-007-01Clinical Trials Plan Clinical Trials Approval Forms (CTAF): PLCM-013-01

CT Protocols: PLCM-014-01IRB Documents: PLCM-015-01

R&D Implementation FlowchartGate P2:Production Readiness—Transition of Product from R&D to Production

Product Production Files Release to Engineering: PLCM-011-01Production Capabilities

Manufacturing Implementation Flowchart

Stage 3: Launch ReadinessLaunch Readiness FlowchartDetailed Stage Description: Launch Readiness

Gate P3:Product Commercialization—Pre LaunchCommercialization Plan Comercialization Plan: PLCM-017-01

Competitive Profile: PLCM-018-01Global Pricing Plan: PLCM-019-01Global Training and Education: PLCM-023-01Global Launch Package: PLCM-025-01

Clinical Trials Final ReportRegistration StatusField Testing Report Field Testing: PLCM-021-01

External Evaluation Release: PLCM-022-01Customer Service Plan

Stage 4: Marketing Support of Sales (Regional Launching Process)Marketing Support Sales FlowchartDetailed Stage Description: Marketing Support of Sales

Gate P4:Product Launch—Regional Launch Plans Regional Launch Plan: PLCM-026-01

Product Release: PLCM-024-01Labeling Creation and Production: PLCM-020-01Project Requirement Specification (PRS): PLCM-028-01

Regional Training Global Training and Education: PLCM-023-01Regulatory Approvals

Marketing Support of Sales: PLCM-035-01

Stage 5: Ongoing Management and Roadmap SteeringDetailed Stage Description: Ongoing Management and Roadmap Steering

Gate P5:Product Progression and Customer Satisfaction—From Product Launch to On-going SalesDepartmental Feedback CAPA - Corrective and Preventive Action: PLCM-030-01

Field Modification: PLCM-031-01Installed Base Report Format: PLCM-033-01

Product Improvement

Gate P6:Product End of Life (EOL)—From a Commercial Product to DeclineTransition to Alternative ProductsEOL Plan End Of Life: PLCM-034-01

Detailed Stage Description: End of Life

PLCM Department Responsibilities

PLC Gate Deliverables

PLC Gate SOPs

PLC General Flowchart.fm

Product Life Cycle Management Overview Flowchart

IMPLEMENTATION PROCESS

PRODUCT & MAJOR RELEASE INITIATION

PROCESS

MARKETING SUPPORTS OF SALES

(REGIONAL LAUNCH) PROCESS

LAUNCH READINESS PROCESS

END OF LIFE

?

Gate P0 ?

Gate P1

?Gate P2

?Gate P3

?Gate P4

ONGOING MANAGEMENT PROCESS

?Gate P5

Gate P6

Product Initiation – Concept Evaluation

Product Development - A working Product

Production Readiness - Transition of product

from a R&D to production

Product Commercialization - Pre Launch

Product Launch

Product progression & Customer Satisfaction –

From product’s launch to on going sales

End of life

Stage 1: Major Release InitiationDetailed Stage Description: Major Release Initiation

Major Release Initiation Flowchart

Gate P0: Product Initiation Deliverables

Major Release Initiation Flowchart

Product & Major Release Initiation Flowchart

Gather need/idea & filter/assess

Product & Major Release Initiation

Define preliminary requirement

Perform a technical feasibility

RESPONSIBILITY PROCESS OUTPUT

NEED/IDEA ASSESSMENTLEADER

- Corp. Product Line Manager- Biz. Dev (in cases of outside of CE)

APPROVAL

- Corp. Product Line Director- Senior Management

TECHNICAL FEASIBILITYLEADER

- VP R&D

APPROVAL

- VP R&D - Corp. Product Line Director- Senior Management

BUSINESS CASELEADER

- Product Line Manager- Biz. Dev (in cases of outside of CE)

APPROVAL

- Geography Leaders- Global Marketing- Senior Management

GO/NO GO

The outputs from this stage are:1. Short (2-3) page overview of concept outlining product, customer need, market opportunity with preliminary business case.2. Go/No Go Decision to next phase.

Max. 3 months

PRELIMINARY REQUIREMENT DEFININGLEADER


APPROVAL

- Corp. Product Line Director- Senior Management

GO/NO GO

The outputs from this stage are:1. PRD2. Preliminary Risk Analysis3. Go/No Go Decision to Technical feasibility study phase

GO/NO GO

TECHNICAL FEASIBILITY

The outputs from this stage are:1. Feasibility Plan Document that clearly outlines time to market, risks (IP, Regulatory, Technical) and costs in achieving market entry. 2. Preliminary Risk (product- use and development) Analysis Document Updated to identify risks that need to be minimized or mitigated and possible mitigation modes3. Go/No Go decision on continuation of effortBUSINESS CASEThe outputs from this stage are:1. Business Case Document to include vol/pricing, regulatory path, serviceability, transition plan.2. Preliminary Risk Analysis Document Updated 3. Go/No Go Decision to continue effort

YES

YES

Conduct a business Case

GO/NO GO

Max. 2 months

Max. 3 months

The outputs from this stage are:1. Final PRD document with updated product Roadmap. 2. Go/No Go decision to Implementation stage

NO

NO

NO NO

REFINE PR & ROADMAPLEADER


APPROVAL

- Corp. Product Line Director- CEO/Global Marketing- - Geography Leaders

Define preliminary requirement

IMPLEMENTATION

Max. 2 months

Max. 2 months

?Gate P0

se

Refine PR & Roadmap

tion, r et.

hat N he ward from

ess t icing

ng.

and ent.

1. Refine PRD to ensure customer needs are met and aligned to maximize value to GIVN.

2. Determine effect on existing roadmap, portfolio strategy and required changes that may be required.

3. Finalize business case, cost and timeline including regulatory approval and market entry

ch d

st take

ing/ting,

1. Update existing documentation with new information.

2. Review with all stakeholders

Detailed Stage Description: Major ReleaInitiation

Need/Idea Gathering & Filtering/Assessment

Preliminary Requirement Definition

Technical Feasibility Business Case

Objective(s)

Identify and evaluate product and service opportunities that meet unmet customer need

Draft of Product Requirement Definition

1. Determine technical feasibility (including costs), risks (IP, technology and technological approach) and timeline for product market entry, including technical risk of product development process and production risks as well as IP and regulatory risk.

2. Develop a Preliminary Product Specification Document

1. Define value proposiproduct messaging fospecified target markDoes it fit into GIVNbusiness model and wgaps exist within GIVBusiness? What are timplications (IB, BackCompatibility etc…) bringing product to market?

2. Develop 5 year busincase (ROI) for producwith product cost, prand volume and competitive positioniInclude preliminary market segmentationcompetitive environm

Process(es) Employed

1. Formal Regional Feedback validated by additional customer evaluation (focus groups, surveys, field visits including sales force)

2. Incorporate Product Line Technology Review Session

3. Establish database on ideas and evaluations.

4. Cross functional participation particularly with R&D & Marketing/Sales

1. Take feedback from previous phase and develop PRD document

2. Preliminary Risk Analysis & IP Risk Analysis Review

1. Conduct appropriate analysis and bench work to determine technical feasibility and regulatory risk

2. Done in parallel with Business Case?

1. Pricing Market resear2. Discussions with broa

customer base not juKOLs to determine upof product.

3. Cross functional teaminvolvement (MarketSales, Clinical MarkeFinance, Ops, R&D)

Detailed Stage Description: Major Release Initiation (page 2 of 3)

D

e, ends ent

lude

1. PRD2. Updated business case 3. Technical feasibility data.4. Product and development

risk analysis5. Corporate and Platform

Strategy6. R&D resources and

capabilities

Product Line Leader Biz Dev (only in cases outside of CE)

nt

1. Geography Leaders 1. R&D1. Product Line Leaders in

other Products1. Global RACA1. Legal/IP

Operations

Refine PR & Roadmap

Required Inputs

1. Customer input on market needs and acceptability of idea. (MUST)

2. Understanding of current GIVN Corporate Strategy.(MUST)

3. GIVN Technical Capabilities/Outside Vendor Capabilities (MUST)

4. Market Trends5. Competitive environment

and response1. Market Research (NTH)

1. Output from previous phase including overview documents from previous stage.

2. Product Line Leader Feedback

3. Customer Feedback 4. Regional Feedback (Sales &

Customer Facing Organization)

5. Market Research 6. Corporate strategy/

constraints

1. Draft of Product Requirement Definition Document with best current definition of how product is to be used in marketplace

2. State of Art (do technologies exist to make this a reality)

3. IP issues4. Risk Analysis Document

1. Estimated COGs (R&and Ops),

2. Pricing and volume (regional marketing).

3. Competitive responsmarket behavior & tr

4. Risk Analysis Docum(product and developmental to incregulatory)

Leader

Product Line Leader Biz Dev (only in cases outside of CE)

Product Line Leader-Biz Dev (only in cases outside of CE)

VP R&D Product Line Leader Biz Dev (only in cases outside of CE)

Partner(s)Internal/External

1. Product and Platform Managers

2. Geography Product Manager

3. Global Clinical Marketing 4. R&D5. Finance

1. Product and Platform Managers

1. R&D Project Managers 1. Geography Product

Managers 1. Global Clinical Affairs

1. R&D 1. Global RACA1. Product Line Leader 1. Outside Vendors1. Chief Scientist1. Operations 1. IP

1. Finance1. Geography Leaders 1. Product and Platform

Managers 1. Clinical Marketing 1. Business Developme1. Operations 1. Legal/IP

Contributor(s)

Internal/External

1. Sales Force 2. GIVN Customer Facing

Functions 3. Customers 4. Regulatory 5. IP6. Chief Scientist7. Biz Dev8. Outside Vendors/

Consultants

1. Customers2. Sales Force3. GIVN Customer Facing

Functions4. Chief Scientist5. Biz Dev

All Given Functions 1. R&D 2. Global RACA3. Outside Consultants




Detailed Stage Description: Major Release Initiation (page 3 of 3)

2 months

Global Marketing

1. CEO/Global Marketing2. Functional Leaders 3. Geography Leaders

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1. Final PRD document with updated Product Roadmap.

2. Go/No Go decision to Implementation Stage

Refine PR & Roadmap

Estimated M

aximum

Time Fram

e

3 months 2 month TBD (3 months?) 2 months

BudgetResponsibility

Global Marketing Global Marketing R&D Global Marketing

RequiredA

pprovals

1. Product Line Leader 2. Sr. Management

1. Product Line Leader 2. Sr. Management specifically

Regional Leaders

1. VP R&D2. Product Line Leader 3. Sr. Management

1. Geography Leader2. Global Marketing3. Sr. Management

Expected Output

1. A short (2-3) page overview of concept outlining product, customer need, market opportunity with preliminary business case. (need to develop template for concept overviews)

2. Go/No Go Decision to next phase.

1. PRD2. Go/No Go Decision to

Technical Feasibility Study Phase

3. Preliminary Risk Analysis Document

1. Feasibility Plan Document that clearly outlines time to market, risks (IP, Regulatory, Technical) and costs in achieving market entry.

2. Preliminary Risk (product-use and development) Analysis Document Updated to identify risks that need to be minimized or mitigated and possible mitigation modes

3. Go/No Go decision on continuation of effort

1. Business Case Documto include vol/pricingregulatory path, serviceability, transitiplan.

2. Go/No Go Decision continue effort

3. Preliminary Risk AnaDocument Updated




Gate P0: Product InitiationConcept Evaluation

Main Deliverables SOP Document

Business Risk Analysis Preliminary Risk Analysis PLCM-001-01

Business Case Business Case PLCM-003-01

Technology Feasibility Technical Feasibility PLCM-002-01

Product Requirement Definition Product Requirements Definition

PLCM-004-01

Road Map

Regulatory Strategy

Preliminary Risk Analysis SOP

This document provides a framework to determine technical feasibility, and regulatory, IP and business risks as input to a Go/No go decision for the Leaders in a Product & Major Release Initiation and Implementation process. This document provides a framework to identify risks and their possible mitigation modes. This document provides an updated status of risks at every Go/No go decision point throughout a PLCM process.

Preliminary Risk Analysis

Document Title: Document No. Revision Page

Preliminary Risk Analysis PLCM-001-01 01 2 of 6

THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.

1. Purpose

1.1 This document provides a framework to determine technical feasibility, and regulatory, IP and business risks as input to a Go/No go decision for the Leaders in a Product & Major Release Initiation and Implementation process.

1.2 This document provides a framework to identify risks and their possible mitigation modes.

1.3 This document provides an updated status of risks at every Go/No go decision point throughout a PCLM process.

2. Scope

2.2 The Preliminary Risk Analysis Document should relate to technical feasibility risks, regulatory risks, IP risks and business risks.

2.3 Technical feasibility Risks:

2.3.1 technology and technological approach

2.3.2 technical risk of product development process

2.3.3 (if relevant) cost for mitigating risk

2.4 Regulatory risks

2.4.1 Approval path and possible risks of this approval path


2.5 IP risks

2.5.1 Initial 3rd party patent search


2.6 Business risks:

3. Responsibility

3.1. Input required from the following:

3.1.1. R&D

3.1.2. Regulatory

3.1.3. IP

3.1.4. Marketing (Business)

3.2. Each party listed in section 3.1 above must be presented all the other parties’ input.

3.3. These people need to sign off:

3.3.1. Product Line Leader

3.3.1.1. Product Line Leader is responsible to initiate the risk analysis, gather input and present each party’s input to all other parties.

3.3.2. COO, VP R&D, Legal Counsel, CMO




4. Reference Documents

4.1. PLCM document (#)

5. Definitions

5.1. Leaders – Product Line Leader and COO, VP R&D, Legal Counsel, CMO

5.2. Product & Major Release Initiation process - A process designed to achieve

an overview of concept outlining product, customer need, market opportunity

with a preliminary business case. The process must conclude with a Go/No

Go Decision to the next phase.

5.3. Implementation process – Make/Buy/Partner decisions for the whole product

and/or major building blocks.

6. The Body of the Preliminary Risk Analysis Document

6.1. The Preliminary Risk Analysis should include the name of the product and a

short description of the product. For the product there should be input

regarding risks in four major fields - Technology risks, Regulatory risks, IP

Risks and Business risks. In each of the four major fields there could be

identified more than one risk. Each risk must include the following:

6.1.1. the risk name and explanation of this risk;

6.1.2. the probability for this risk happening;

6.1.3. the severity of the risk if it happens;

6.1.4. possible mitigation of the risk;

6.1.5. expected cost of such mitigation; and

6.1.6. Status of the risk.

6.2. The Preliminary Risk Analysis should be a “live” document; to be updated at

the Go/No go decision time points as to the status of each risk at that time

point.

7. Appendix

7.1. Appendix A is an exemplary Excel sheet that can be used as a Preliminary

Risk Analysis Document.




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Business Case SOP

This document provides a framework for evaluating a project’s value to Given Imaging. This document applies to all products that are using the Given Imaging Product Life Cycle Management (PLCM) process. The document is initiated in the 4th substage of the Product Initiation and Major Release Phase of PLCM and is carried through the entire PLCM process with a final Business Case document being issued as a key input in the Global Launch Planning subphase of the Marketing Support of Sales PLCM phase.

Business Case


Business Case PLCM-003-01 01 2 of 3


1.0 Purpose

This document provides a framework for evaluating a project’s value to Given Imaging.

2.0 Scope

This document applies to all products that are using the Given Imaging Product

Life Cycle Management (PLCM) process. The document is initiated in the 4th

substage of the Product Initiation and Major Release Phase of PLCM and is

carried through the entire PLCM process with a final Business Case document

being issued as a key input in the Global Launch Planning subphase of the

Marketing Support of Sales PLCM phase.

3.0 Responsibility

Product Line Leader will be responsible for initiating and building the business

case as the product or service moves through the PLCM process. Input from

Partners (Finance, Geography Leaders, Product and Platform Managers, Clinical

Marketing, Business Development, Operations and Legal/IP) and Contributors

(R&D, Global RACA and outside consultants) are expected. Global Marketing

has the budget responsibility and final approvals come from Geography Leader,

Global Marketing and Senior Management representing Finance, Operations,

Regulatory, R&D & Marketing.

4.0 Reference documents

4.1. Given Imaging Product Life Cycle Management (PLCM) Document that

outlines this process.

4.2. Cost of Goods Estimation (from R&D. Operations and Finance)

4.3. Volume Fcst (from Regions)

4.4. Market Research (pricing/volume, effect on other products’ prices, competitive

positioning, market behavior and trends)

4.5. Operational assessment

4.6. Financial assessment

5.0 Definitions

5.1. Value Proposition: Specific value a particular product brings to the customer

5.2. Product Messaging: Key messaging or language used to communicate value

proposition to customer


Business Case PLCM-003-01 01 3 of 3


6.0 The Process

6.1. Executive Summary: concise summary of the key highlights of the business

case, including project’s purpose, goals, costs, revenue opportunity, risks and

criteria for success. The reader should be able to understand what the project

is about, its role in the business and a justification for the project.

6.2. Project Background: Brief description of the business problem or opportunity

or customer need that project is intended to meet.

6.3. Objectives: Clear definition of what the project will accomplish, its scope and

expected results (revenue, gross profit, increased marketshare) and who are

the key stakeholders. Include data for 1, 3 and 5 years.

6.4. Competitive Assessment: Describe current competitive offerings that will

compete with the project and anticipated competitive response to the new

offering including barriers to entry that may prevent effective launch of

product. Also address the customer’s ability to adopt the project and integrate

into their daily work habit.

6.5. Technological Assessment: Describe the current understanding of our

technological capability in developing this product or service. Define the

technological hurdles to be overcome.

6.6. Regulatory Assessment: Define the current understanding of the regulatory

path for the product and any potential issues to overcome

6.7. Operational Assessment: Define operational needs.

6.8. Financials: Include projected impact thru 5 years.

7.0 Appendix

Technical Feasibility SOP

The purpose of this procedure is to determine technical feasibility including costs, risks (technology and technological approach) and timeline for product market entry, including technical risk of product development process and production risks as well as regulatory risk.The purpose of this procedure is also to develop a Preliminary Product Specification Document

Technical Feasibility


Technical Feasibility PLCM- 002-01 01 2 of 3


1.0 Purpose

1.1. The purpose of this procedure is to determine technical feasibility including

costs, risks (technology and technological approach) and timeline for product

market entry, including technical risk of product development process and

production risks as well as regulatory risk.

1.2. Develop a Preliminary Product Specification Document.

2.0 Scope

2.1. This document applies to conduct appropriate analysis and bench work to

determine technical feasibility and regulatory risk

2.2. The technical feasibility can be done in parallel with Business Case.

3.0 Responsibility

3.1. Leader - V.P R&D is the leader and has the overall responsibility for all

development activities and for the implementation of this document.

3.2. Partners in the Technical Feasibility phase are:

Dept./Entity Name

3.2.1. R&D

3.2.2. Global CA

3.2.3. Product Line Leader

3.2.4. Operations

3.2.5. Chief Scientist

3.2.6. Outside Vendors

3.3. Contributors: all Given functions

4.0 Required Inputs

4.1. Draft of Product Requirement Definition Document with best current definition

of how product is to be used in marketplace.

4.2. State of Art (do technologies exist to make this a reality).

4.3. IP issues

4.4. Risk Analysis Document

5.0 Estimated Maximum Time Frame

TBD


Technical Feasibility PLCM- 002-01 01 3 of 3


6.0 Budget Responsibility

R&D

7.0 Required Approvals

7.1. VP R&D

7.2. Product Line Leader

7.3. Sr. Management

8.0 Expected Output

8.1. Feasibility Plan Document that clearly outlines time to market, risks (IP,

Regulatory, Technical) and costs in achieving market entry.

8.2. Preliminary Risk (product-use and development) Analysis Document Updated to

identify risks that need to be minimized or mitigated and possible mitigation

modes

8.3. Go/No-Go decision on continuation of effort

9.0 Definitions

Any initials, technical or professional terms should be defined in this section.

10.0 Feasibility Plan Document

10.1. Timeline for product market entry

10.2. Costs in achieving market entry

10.3. Preliminary Risks Analysis Document

10.3.1. Product use

10.3.2. Technical (development and production)

10.3.3. IP

10.3.4. Regulatory

10.4. Preliminary Product Specification Document

10.5. Go/No-Go decision on continuation of effort

11.0 Appendix

Product Requirements Definition SOP

The purpose of this procedure is to assure the systematic preparation of a clear Product Requirements Definition document for any GIVEN product or service offered for sale.

The Product Requirements Definition (PRD) document shall be:

1. The main output of the “Product & Major Release Initiation” phase

2. By its creation during the “Product & Major Release Initiation” phase it shall gain the endorsement of the main stakeholders of the product

It shall serve as the Design Input Document (DID) in the Design History File (DHF) of the product

Product Requirements Definition


SOP Product Requirements Definition PLCM-004-01 01 2 of 11

THIS DOCUMENT, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.

1.0 Purpose

The purpose of this procedure is to assure the systematic preparation of a clear

Product Requirements Definition document for any GIVEN product or service

offered for sale.

The Product Requirements Definition (PRD) document shall be:

1. The main output of the “Product & Major Release Initiation” phase

2. By its creation during the “Product & Major Release Initiation” phase it shall

gain the endorsement of the main stakeholders of the product

3. It shall serve as the Design Input Document (DID) in the Design History

File (DHF) of the product.

2.0 Scope

2.1 The Product Requirements Definition document is the first product definition

document (followed by the Product Specification document in the

Implementation phase of the PLCM process), which defines the features and

other aspects of the product, so that it will comply with the marketing plan and

positioning for the product.

2.2 The Product Requirements Definition document is a controlled document.

2.3 All relevant GIVEN functionaries listed in this SOP will participate in the Product

Requirements Definition document preparation process according to this SOP.

3.0 Definitions

3.1 GIVEN Product - any product software, hardware or paper ware or any service

offered for sale that is produced in whole or in part by GIVEN Imaging, for

customers or for routine use of GIVEN support staff.

3.2 Product Manager - responsible for the life cycle management of the product

from initiation by Management, through development of a business case,

evaluation of feasibility study results, obtaining management decision on

development, development of life-cycle schedule, product definition,

coordination of development and marketing effort and launch and post launch

monitoring of the product till End Of Line (EOL) of the product.

3.3 Project Manager – An R&D function responsible for the development of the

product from product definition until its launch, through developing a PRD-

based Product Specification (PS), project (=product development)

schedule/GANTT, design, development and preparation for clinical trials and

regulatory approval, until the product is ready for launch and shipping.




4.0 Responsibility

4.1. The Product Line Manager, who is responsible for the life cycle management of

the product, is responsible for the implementation of this SOP for the Product

Requirements Definition document through the execution of the first phase of

the Product Life Cycle management (PLCM) - Product & Major Release

Initiation.

4.2. The Project Manager from R&D, who is leading the development effort of the

product, is responsible for the step-by-step implementation and monitoring of

the development plan of the product.

5.0 Applicable document

5.1. Product & Major Release Initiation flowchart.doc

5.2. PLCM Final 271106.doc

6.0 Procedure

6.1. Product management, following senior management or other initiation, will

prepare the Product Requirements Definition document while executing the first

phase of the PLCM - Product & Major Release Initiation according to the

flowchart in Appendix A and the detailed description in Appendix B.

6.2. The issues and items defined in the Product Requirements Definition document

will be according to the template attached in appendix C.

6.3. Section 1 in the PRD is the material that in general is prepared as the output of

the “Need/Idea Gathering & Filtering/Assessment” – “A short 2-3 page overview

of concept outlining product, customer need, market opportunity with preliminary

business case”

6.4. The document will be based on senior management guidance and market

requirements, following market research and marketing input from the field, as

well as other relevant input from the GIVEN organization according to Appendix

A and B.

6.5. Different GIVEN functions, as detailed in Appendix A and B will contribute to the

preparation of the Product Requirement Definition document, will review and

approve the document to obtain endorsement of all main stakeholders in the

development of the product.

6.6. The Product Line Manager will drive the final GO decision based on material

accumulated during the preparation of the Product Requirement Definition and

accumulated/represented in it.

6.7. The Product Requirement Definition document will be maintained and updated

by Product Management according to requirements changes during the life

cycle of the product.




Appendix A - Product & Major Release Initiation

Do

cu

me

nt T

itle:

Do

cu

me

nt N

o.

R

evis

ion

P

ag

e

SOP

Pro

du

ct R

eq

uir

em

en

ts D

efi

nit

ion

PLCM

-00

4-0

1

01

5

of

11

Ap

pen

dix

B –

PLCM

- P

rod

uct &

Majo

r R

ele

ase I

nit

iati

on

N

ee

d/I

dea

Gath

eri

ng

&

Fil

teri

ng/A

ss

es

sm

en

t P

reli

min

ary

R

eq

uir

em

en

t D

efi

nit

ion

Te

ch

nic

al F

ea

sib

ility

B

usin

es

s C

ase

R

efi

ne

PR

&

Ro

ad

ma

p

Obje

cti

ve

Identify

and evaluate

product and service

opportunities that meet unmet customer

need

Draft

of

Product

Requirement

Definition

1.

Determine technical

feasibility

(including

costs

), risks

(technolog

y and

technological

approach) and

timeline

for product market

entr

y, including

technical risk of product

development process

and production

risks as

well as regulatory

risk.

2.

Develop a

Preliminary

Product

Specification

Document

1.

Define value proposition,

product messaging for

specified target market. Does

it fit into

GIV

N business model

and what gaps exist within

G

IVN

Business? What are

the implications (

IB,

Backward

Compatibility

etc

…) from

bringing product to

market?

2.

Develop 5

year

business case

(RO

I) for product with product

cost, pricing and volume and

competitive positioning.

Include preliminary

market

segmentation

and competitive

environment.

1. Refine P

RD

to ensure

customer needs are

met

and aligned to maximize

value to G

IVN

.

2. Determine effect on

existing roadmap,

portfolio

strateg

y and

required changes that

may

be required.

3. Finalize business case,

cost and timeline

including regulatory

approval and market

entr

y

Pro

cess

Em

ployed

1.

Formal Regional Feedback validated

by

additional customer evaluation (focus

groups, surve

ys, field

visits including sale

force)

2.

Incorporate

Product Line Technolog

y Review

Session

3.

Esta

blish data

base on ideas and

evaluations.

4.

Cross functional participation particularl

y with R

&D

&

Marketing/Sales

1. Take feedback

from

previous

phase and develop

P

RD

document

2. Preliminary

Risk

Analysis

& I

P

Review

1.

Conduct appropriate

analysis

and bench

work

to determine

technical feasibility

and

regulatory

risk

2.

Possibly

Done in

parallel with Business

Case

1.

Pricing Market research

2.

Discussions with broad

customer

base not just K

OLs

to determine uptake of

product.

3.

Cross functional team

involvement (Marketing/Sales,

Clinical Marketing, Finance,

Ops, R

&D

)

1. Update

existing

documentation

with new

information.

2. Review

with all

stakeholders

Do

cu

me

nt T

itle:

Do

cu

me

nt N

o.

R

evis

ion

P

ag

e

SOP

Pro

du

ct R

eq

uir

em

en

ts D

efi

nit

ion

PLCM

-00

4-0

1

01

6

of

11

THIS

DOCUMENT, AND/OR

THE

SUBJECT

MATTER

ARE

RESTRICTED

SOLELY

FOR

THE

USE

OF

GIVEN

IMAGING

LTD.

N

ee

d/I

dea

Gath

eri

ng

&

Fil

teri

ng/A

ss

es

sm

en

t P

reli

min

ary

R

eq

uir

em

en

t D

efi

nit

ionT

ec

hn

ical F

ea

sib

ility

B

us

ine

ss C

as

e

R

efi

ne

PR

&

Ro

ad

ma

p

Req

uir

ed

In

pu

ts

1.

Customer input on market

needs and accepta

bility

of

idea. (M

US

T)

2.

Understanding of current

GIV

N Corporate

Strateg

y.(M

US

T)

3.

GIV

N Technical

Capa

bilities/Outside Vendor

Capa

bilities (

MU

ST

) 4.

Market Trends

5.

Competitive environment

and response

6.

Market Research (

NT

H)

1. Output from

previous

phase including overview

documents

from

previous

stage.

2. Product

Line Leader

Feedback

3. Customer

Feedback

4. Regional Feedback

(Sales &

Customer

Facing

Organization)

5. Market Research

6. Corporate

strateg

y/constraints

1.

Draft

of

Product

Requirement Definition

Document with best

current definition of

how

product is

to be

used in marketplace

2.

State

of

Art

(do

technologies exist to

make this

a realit

y)

3.

IP issues

4.

Risk Analysis

Document

1.

Estimated C

OGs (

R&

D and

Ops),

2.

Pricing and volume (regional

marketing).

3.

Competitive response, market

behavior

& trends

4.

Risk Analysis

Document

(product and developmental

to include regulatory

)

1. P

RD

2. Updated business case

3. Technical feasibility

data

. 4. Product and

development risk

analysis

5. Corporate

and Platform

Strateg

y 6. R

&D

resources and

capabilities

Lead

er

Product

Line Leader or

Biz

Dev

(only

in cases outside

of

CE

) Product

Line Leader or

Biz

Dev (only

in cases outside

of

CE

)

VP

R&

D

Product

Line Leader

Biz

Dev (only

in cases outside of

CE

)

Product

Line Leader

Biz

Dev (only

in cases

outside of

CE

)

Part

ner(

s)

• In

tern

al

• E

xte

rnal

1.

Product and

Platform

Managers

2.

Geograph

y Product

Manager

3.

Glo

bal Clinical Marketing

4.

R&

D

5.

Finance

1. Product and

Platform

Managers

2. R

&D

Pro

ject Managers

3. Geograph

y Product

Managers

4. Glo

bal Clinical Affairs

5. I

P

1.

R&

D

2.

Glo

bal R

AC

A

3.

Product

Line Leader

4.

Outside Vendors

5.

Chief

Scientist

6.

Operations

1.

Finance

2.

Geograph

y Leaders

3.

Product and

Platform

Managers

4.

Clinical Marketing

5.

Business Development

6.

Operations

7.

Legal/I

P

1.

Geograph

y Leaders

2.

R&

D

3.

Product

Line Leaders

in

other

Products

4.

Glo

bal R

AC

A

5.

Legal/I

P

Co

ntr

ibu

tor(

s)

• In

tern

al

• E

xte

rnal

1.

Sales Force

2.

GIV

N Customer

Facing

Functions

3.

Customers

4.

Regulatory

5.

IP

6.

Chief

Scientist

7.

Biz

Dev

8.

Outside

Vendors

/Consultants

1. Customers

2. Sales Force

3. G

IVN

Customer

Facing

Functions

4. Chief

Scientist

5. Biz

Dev

All

Given

Functions

1.

R&

D

2.

Glo

bal R

AC

A

3.

Outside Consultants

Operations

Do

cu

me

nt T

itle:

Do

cu

me

nt N

o.

R

evis

ion

P

ag

e

SOP

Pro

du

ct R

eq

uir

em

en

ts D

efi

nit

ion

PLCM

-00

4-0

1

01

7

of

11

THIS

DOCUMENT, AND/OR

THE

SUBJECT

MATTER

ARE

RESTRICTED

SOLELY

FOR

THE

USE

OF

GIVEN

IMAGING

LTD.

N

ee

d/I

dea

Gath

eri

ng

&

Fil

teri

ng/A

ss

es

sm

en

t P

reli

min

ary

R

eq

uir

em

en

t D

efi

nit

ionT

ec

hn

ical F

ea

sib

ility

B

us

ine

ss C

as

e

R

efi

ne

PR

&

Ro

ad

ma

p

Esti

mate

d

Maxim

um

T

ime F

ram

e

3 months

2 month

TB

D (

3 months?)

2 months

2 months

Bu

dg

et

Resp

on

sib

ility

Glo

bal Marketing

Glo

bal Marketing

R&

D

Glo

bal Marketing

Glo

bal Marketing

Req

uir

ed

A

pp

rovals

1.

Product

Line Leader

2.

Sr.

Management

1.

Product

Line Leader

2.

Sr.

Management

specifically

Regional

Leaders

1.

VP

R&

D

2.

Product

Line Leader

3.

Sr.

Management

1.

Geograph

y Leader

2.

Glo

bal Marketing

3.

Sr.

Management

1.

CE

O/Glo

bal Marketing

2.

Functional Leaders

3.

Geograph

y Leaders

Exp

ecte

d

Ou

tpu

t

1.

A short

(2-3

) page

overview

of concept

outlining

product, customer

need, market opportunity

with preliminary

business

case. (need to develop

template

for concept

overviews)

2.

Go/No Go Decision to next

phase.

1.

PR

D

2.

Go/No Go Decision to

Technical Feasibility

Stud

y Phase

3.

Preliminary

Risk

Analysis

Document

1.

Feasibility

Plan

Document that clearl

y outlines time

to

market,

risks (

IP,

Regulatory,

Technical)

and

costs

in

achieving

market entr

y.

2.

Preliminary

Risk

(product-use

and

development)

Analysis

Document

Updated

to

identify

risks that need

to

be

minimized

or

mitigated

and

possible

mitigation

modes

3.

Go

/No

Go

decision

on

continuation of effort

1.

Business Case Document to

include vol/pricing, regulatory

path, serviceability, transition

plan.

2.

Go/No Go Decision to

continue effort

3.

Preliminary

Risk Analysis

Document Updated

1.

Final P

RD

document

with updated Product

Roadmap.

2.

Go/No Go decision to

Implementation

Stage



Appendix C – Product Requirements Definition - template

AUTHORIZATION

NAME TITLE SIGNATURE DATE

Issued by:

Approved by:

Approved by:

Approved by:

Approved by:

Approved by:

REVISION HISTORY

REVISION # CO # DESCRIPTION DATE

1 1 New Issue

DISTRIBUTION LIST

COPY NAME TITLE / DEPARTMENT

#1

#2

#3





1. General

Synopsis of market need and product concept and use. Refer to

the business case document PLCM-003-01

2. Purpose of “product” (formal definition)

3. Functional requirements

3.1. Function1

3.2. Function2

3.3. Function3

3.4. ….

4. Medical requirements

4.1. Efficacy requirements

4.2. Toxicity and biocompatibility requirements

4.3. Clinical testing requirements

4.4. Sterilization requirements

4.5. Safety requirements

5. Marketing requirements

5.1. Physical characteristics requirements

5.1.1. Dimensions requirements

5.1.2. Materials requirements

5.1.3. Strength requirements

5.1.4. Look and Feel requirements

5.2. Competitive/performance requirements

5.3. Human interface/ergonomic requirements

5.4. Packaging requirements

5.5. Labeling/documentation requirements

5.5.1. Documentation concept/component requirements




5.5.2. Language requirements

5.6. Environmental requirements

5.6.1. Environmental compatibility requirements

5.6.2. Environmental endurance/durability requirements

5.7. Cost requirements

5.8. Price targets

5.9. Service requirements

6. Regulatory requirements

Statutory/regulatory requirements (FDA, MDD, others)

7. Standards requirements

7.1. ISO, ANSI, ASTM, GIVEN company standards

7.2. General safety standards requirements (e.g. IEC 60601-1,

ISO 10983)

7.3. Other

8. QA requirements

8.1. Risk level requirements

8.2. Reliability/Failure requirements

9. Product Tree/Component requirements

10. Product Life Cycle milestones/Roadmap requirements

10.1. Availability requirements

10.2. EOL requirements

11. Special requirements

12. Related Documents

Stage 2: ImplementationDetailed Stage Description: Implementation

Implementation Flowchart

Gate P1: Product Development Deliverables

R&D Implementation Flowchart

Gate P2: Production Readiness Deliverables




Make/Buy/Partner Analysis

Implementation

Define product specification


MAKE/BUY/PARTNER ANALYSISLEADER

- VP R&D

APPROVAL

- VP R&D

MAKE/BUY/PARTNER

ANALYSIS –

Make/Buy/Partner decisions for the whole product and/or major building blocks. The expected outputs are decisions & contracts

PRODUCT SPECIFICATION -

Derive functional, technological, testing and clinical specifications to fit product requirements. The expected output is specification document

1 Quarter Depends on product complexity

Comply with national and international laws and regulations. The expected output is a market clearance

REGISTRATIONLEADER

- Director of Regulatory

APPROVAL

- COO

Development Planning, Execution & Release

LAUNCH

PRODUCT SPECIFICATION

LEADER

- VP R&D

APPROVAL

- Corp. Product Line Director

Depends on product comlexity

Develop product to fit Product Specifications, define product labeling & release to engineering. The expected outputs are:

Product available for production

IP product portfolio

Production file (including Product

detailed description)

DEVELOPMENT PLANNING, EXECUTION & RELEASELEADER

- VP R&D

APPROVAL

- COO - Corp. Product Line Director (Change of specs only)

Engineering, Production & Monitoring

Clinical Trials


Registration

ENGINEERING, PRODUCTION & MONITORINGLEADER

- VP Operations

APPROVAL

- COO Depends on product comlexity

Prepare manufacturing capabilities to fit manufacturing plan, production, monitoring production quality & yield. The expected output is product available for sales according to sales forecast

Prove safety of product, prove efficacy, provide clinical data to support regulatory, R&D, and marketing requirements. The expected outputs are:

Final report

Manuscripts/Abstracts and

presentations

CLINICAL TRIALSLEADER

- Global Clinical Affairs

APPROVAL

- Corp. Product Line Director- COO

- CMO


?

P1

?

P2

?

P3

als Registration

y of

acy nical data regulatory, marketing nts

• Comply with national and international laws and regulations

Detailed Stage Description: Implementation


Product Specification



Clinical Tri

Objectives

• Make/Buy/Partner decisions for the whole product and/or major building blocks

• Derive functional, technological, testing and clinical specifications to fit product requirements

• Develop product to fit Product Specifications

• Define product labeling

• Release to engineering

• Prepare manufacturing capabilities to fit manufacturing plan

• Production• Monitoring

production quality & yield

• Prove safetproduct

• Prove effic• Provide cli

to support R&D, and requireme

Detailed Stage Description: Implementation (page 2 of 5)

nical trials rmsnical trials

rmal sonudyal report of apers and ns

• Verify applicable regulations and requirements

• Develop regulatory strategy

• Submit applications• Obtain market

clearance

als Registration

Processes Employed

• Define system and major building blocks

• Identify technological gaps

• Identify Given in-house capabilities and capacity

• Identify potential partners/sub-contractors/off-the shelf modules

• Request proposals• Risk analysis• Make decision

parameters:• Quality• Cost• Time-to-Market• Given core

technological capabilities

• Check Capacity of R&D & Manufacturing

• Risks (including IP risk)

• Create IP portfolio

• Perform top level design

• Develop fast prototypes for high risk/ performance gaps

• Verify compliance with regulatory affairs

• Prepare:1. specification

document2. testing requirement

document3. Risk analysis

• Prepare detailed design documents

• Develop fast prototypes for high risk/ performance gaps (if needed)

• Development• Prepare acceptance

tests plan for external modules and perform the tests

• Progress tracking using project plans

• Design reviews• PDR• DR• CDR• Production DR

(see in Project Initiation Form)

• Prepare Quality assurance, V&V

• Verify compliance with regulatory affairs

• Pre-clinical R&D trials• BOM creation• Release to engineering

document (hand-shake)

• Validation master-plan document

• Purchasing• Create production

flow chart• Create

manufacturing line• Training &

certification for production team

• Pilot run• Production• Yield control• Sustaining

engineering

• Prepare cliapproval fo

• Prepare cliprotocol

• Prepare fodocument

• Site selecti• Monitor st• Prepare fin• Generation

scientific ppresentatio





Clinical Tri


nts and ns and

l study

• Product specification document

• Product detailed description

• Results of pre-clinical studies (safety, EMC, environmental, SW validation, etc.)

• Risk analysis• Results of clinical

studies• Draft labeling (UM,

package insert, labels, etc.)

al Affairs Director of Regulatory

As needed

rectorselal affairs regional

artners

Internal• R&D• Product director• QA• Global and regional

marketing

als Registration

Required Inputs

• Product requirements

• Given roadmap• Results of feasibility

studies• Business case• Core strategic Given

capabilities• IP risk analysis

• Product requirements

• Product roadmap• Results of feasibility

studies•

• Product specification• Manufacturing

forecast (sales, clinical trials, marketing needs)

• Release to engineering document (hand-shake)

• Manufacturing forecast (sales, clinical trials, marketing needs)

• Product requiremespecificatio(marketingregulatory)

• Pre-clinicaresults

Leader

VP R&D VP R&D or designee VP R&D VP Operations Global Clinic

Engagement

Frequency

As needed Daily As needed As needed As needed


Internal• R&D• Operations• Finance• Product director.• Legal counsel• IP

Internal• Product director.• Operations• Clinical Affairs• Regulatory Affairs• IPExternal• Business partners

Internal• Operations• Product director• QA• Clinical Affairs• Regulatory Affairs

Internal• R&D• QA

Internal• R&D• Product di• Legal coun• Local clinic• Global and

marketingExternal• Business p





Clinical Tri


visors

roduct depends on product complexity

al Affairs Director QA

torCOO

tts/nd ns

Market clearance

als Registration

Contributors

Internal/External

Internal• Business Develop.• CTO (TBH?)External• Advisors• Experts

Internal• CSExternal• Advisors• Experts

Internal• CS• IPExternal• Advisors• Experts

Internal• CS• IPExternal• Advisors• experts

Internal• CS• LogisticsExternal• Medical ad• KOLs

Estimated

Time Fram

e

One Quarter (may be longer in case of Partner decision)

depends on product complexity



depends on pcomplexity


VP R&D VP R&D COO COO Global Clinic

RequiredA

pprovals

VP R&D Product director COOProduct director -(Change of specs only)

COO Head CAProduct direcCMOCOO

ExpectedO

utput

Decisions + contracts Specification document • Product available for production

• IP product portfolio• Production file

(including Product detailed description)

• Product available for sales according to sales forecast

• Final repor• Manuscrip

Abstracts apresentatio





Clinical Tri


tion

ationdata

s

• Compliance with regulatory requirements

• Meeting timeframes• Getting desired

indications

als Registration

Metrics to

Measure Success

• Risk level• Predicted gross

margin

• Risk level (taking into account the results of the fast prototypes for high risk/ performance gaps)

• Compliance with product requirements


• Implementation duration

• Budget• Quality of

documentation• IP protection• Customer satisfaction• Dependency on single

suppliers


• Budget• Quality of

documentation• Production capacity

to fit sales forecast• Yield • Failure rate • Customer satisfaction• Dependency on

single suppliers• Production costs

• Study dura• Budget• Quality of

document• Quality of • Quality of

publication





Clinical Tri

Gate P1: Product DevelopmentA Working Product


Product Performance Versus Marketing Req.


PLCM-004-01

Make-Buy-Partner Analysis and Decision

PLCM-005-01

Product Specification PLCM-006-01

Design Review Document PLCM-009-01

Design History File (DHF) PLCM-010-01

Design and Development Validation

PLCM-012-01

Design and Development Verification

PLCM-036-01

Acceptance Criteria Testing Requirements PLCM-008-01

Business Case Business Case PLCM-003-01

Road Map & Detailed Work Plan

Registration Submissions Plan Regulatory Submissions PLCM-016-01

Preliminary Forecast

Pre-Production Plan Release to Engineering PLCM-011-01

Product Risk Analysis Risk Analysis for Development PLCM-007-01

Clinical Trials Plan Clinical Trials Approval Forms (CTAF)

PLCM-013-01

CT Protocols PLCM-014-01

IRB Documents PLCM-015-01




Implementation




- VP R&D

APPROVAL

- VP R&D

MAKE/BUY/PARTNER

ANALYSIS –






REGISTRATIONLEADER


APPROVAL

- COO


LAUNCH


LEADER

- VP R&D

APPROVAL









- VP R&D

APPROVAL




- VP Operations

APPROVAL




Final report


presentations



APPROVAL


- CMO


?

?


Clinical Trials

Registration

P1

P2

Make-Buy-Partner Analysis and Decision SOP

The purpose of this phase is to make a decision whether to make, buy, or to partner for the development and/or manufacturing of a whole product and/or major building blocks. The Make/Buy/Partner analysis and decision document applies to the development and manufacturing whole product and/or major building blocks.

Product Specification SOP

The purpose of this phase is to derive functional, technological, testing and clinical specifications to fit product requirements.



Product Specification PLCM-006-01 AA Page 2 of 4


1.0 Purpose

1.1. The purpose of this phase is to derive functional, technological, testing and

clinical specifications to fit product requirements.

2.0 Scope

This document applies to:

2.1. Perform top level design

2.2. Develop fast prototypes for high risk/ performance gaps

2.3. Verify compliance with regulatory affairs

2.4. Prepare:

2.4.1. specification document

2.4.2. testing requirement document

2.4.3. Risk analysis

3.0 Responsibility

3.1. Leader - V.P R&D is the leader and has the overall responsibility for all

development activities and for the implementation of this document.

3.2. Partners in the Product Specification feasibility phase are:

Dept./Entity Name

3.2.1. Product Director (R&D)

3.2.2. Global Clinical Affairs

3.2.3. Regulatory Affairs

3.2.4. Operations

3.2.5. IP

3.2.6. Business partners

3.3. Contributors: all Given functions

3.3.1. Customer Support

3.3.2. External advisers

3.3.3. External experts




4.0 Required Inputs

4.1. Product Requirement Definition Document with best current definition of how

the product is to be used in marketplace

4.2. Product roadmap

4.3. Result of feasibility studies

5.0 Estimated Maximum Time Frame

TBD

6.0 Budget Responsibility

6.1. VP R&D

7.0 Required Approvals

7.1. Product Director

8.0 Expected Output

8.1. Specifications document.

9.0 Definitions

Any initials, technical or professional terms (related to the specific product) should

be defined in this section.

10.0 The Process

(See appendix for capsule product specifications)




11.0 Appendix

Product Specification Table for Capsule

Features Comments

Mechanics

Dimensions: Diameter: [mm] Length: [mm]

Materials: Dome: Cover:

Optics & Illumination

Number of optical heads

FOV – Field of view F number DOV – Depth of view 0 to XX mm from Dome

apex

Resolution x.xx lpmm @ 0 mm Illumination x.xx lpmm @ XX mm x.xx lpmm @ YY mm Light collection: Total optical power:

Electronics Components

Imager ASIC LEDs Switch Antenna Batteries

General

Frame rate XX fps Active working time XX hr Imager mode Delay mode Shelf life time XX month

Design Review Document SOP

The purpose of this procedure is to define the method for conducting official and documented design reviews of design results at the end of each defined phase. Such reviews include representatives of all concern parties in order to identify and predict problematic areas and discrepancies and to initiate corrective actions so as to ensure that the final design fully complies with it predefined requirements.

Design Review Document


Design and Development Review PLCM-009-01 (QA-734-1

022 of 7


1.0 Purpose

The purpose of this procedure is to define the method for conducting official

and documented design reviews of design results at the end of each defined

phase. Such reviews include representatives of all concern parties in order to

identify and predict problematic areas and discrepancies and to initiate

corrective actions so as to ensure that the final design fully complies with it

predefined requirements.

2.0 Scope

2.1 Design Review is an element of design control, and it is applicable as

described in that procedure. Where design output is not applicable,

written rational is required.

2.2 Given Imaging applies the design review process as demonstrations of

proof that a design meets its requirements, identify problems, and

satisfies its intended use.

3.0 Definitions

3.1 Design Review: Initiated and recorded evaluation intended to

systematically evaluate the design outcomes and project progression, to

resolve development problems occurred during the development process

and to approve advancement to the next development phase.

3.2 Formal Design Review: A documented, comprehensive, systematic

examination to evaluate the adequacy of the design requirements, to

evaluate the capability of the design to meet these requirements and to

identify problems using cross-functional team participants.

3.3 Informal Design Review: A documented examination of a design or

process by the project design team to evaluate the adequacy of the

design and process developments, to identify problems and assign

tasks.

4.0 Applicable Documents

4.1 QA-730-1 Design and Development

4.2 QA-732-1 Design and Development Inputs

4.3 QA-733-1 Design and Development Outputs

4.4 QA-735-1 Design and Development Verification

4.5 QA-736-1 Design and Development Validation



023 of 7


4.6 F-734-1 Design and Development Review Form

4.7 RM-10-2 Risk Analysis

4.8 737-1 Design Change

5.0 Responsibility

5.1 V.P. R&D has the overall responsibility for all development activities and

for the implementation of this procedure.

5.2 Projects Managers are responsible to perform Design and Development

Reviews in their projects.

6.0 Procedure

6.1 Formal Design Reviews:

6.1.1 Are pre-planned and performed according to the project timeline

developed by the Project Manager during the Design Planning

process.

6.1.2 Meetings should include persons knowledgeable about the

technical characteristics of the design, as appropriate, such as:

R&D Engineering Production Quality Assurance and Regulatory Affairs Sales and Marketing Purchasing Regulatory Affairs Medical Affairs Individuals(s) who does not have direct responsibility for the design stage being reviewed.

6.1.3 The meetings may include as appropriate to the review phase:

6.1.3.1 Reviews of design validation,

6.1.3.2 Failure Mode and Effect Analysis (F.M.E.A.)

6.1.3.3 Verification/ validation activities

6.1.3.4 Bench/ clinical testing

6.1.3.5 Surveys

6.1.3.6 Focus group results



024 of 7


6.1.4 The meeting minutes must include the deliverable and expectations of the specific items reviewed and the resultant activities that brought to closure each item listed. It should include (but not limited to) information such as:

6.1.4.1 List of key attendees (mandatory)

6.1.4.2 Date (mandatory)

6.1.4.3 Plans and/or agenda (mandatory)

6.1.4.4 Minutes and reports (or references to) from prior meeting (mandatory)

6.1.4.5 Product Manager’s signature (mandatory)

6.1.4.6 Design phase/stage (mandatory) 6.1.4.7 Follow-up report(s) of solutions and/ or the next review

covers the solutions and remaining issues.

6.1.5 Four kinds of Formal Design Reviews are identified during the life

cycle product:

6.1.6 Primary Design Review:

6.1.6.1 General: This review is the first review during the project life. It is perform during the establishment of the general concept for the product, based on requirement specification, requirements document and project planning.

6.1.6.2 The main objectives of this review are:

6.1.6.2.1 Adjustment of the initial design to customer/market requirements.

6.1.6.2.2 Establishment of communication between the various parties involved in the design process.

6.1.6.2.3 Early detection of problems.

6.1.6.3 Recommended issues for review:

6.1.6.3.1 Development plan

6.1.6.3.2 Design Input Document (D.I.D.)

6.1.6.4 Review Output: Approval of the development plans and requirements document.

6.1.6.5 Mandatory signature: Management forum representative and Product Manager.



025 of 7


6.1.7 Critical Design Review (C.D.R.):


6.1.7.1.1 Comprehensive evaluation of the detailed design and its compliance with the performance requirements as presented in its specifications.

6.1.7.1.2 Review of progress and developments risks (F.M.E.A.).

6.1.7.1.3 Detailed review of project progress and estimated timetables.

6.1.7.1.4 Freezing of design basis and approval of detailed design of prototype.


6.1.7.2.1 Project progress update.

6.1.7.2.2 Software and hardware requirements.

6.1.7.2.3 Test plans review.

6.1.7.3 Review Output: Approval of applicable documents generated during the detailed design phase.

6.1.7.4 Mandatory signature: Management forum representative and Product Manager.

6.1.8 Production Design Review:

6.1.8.1 The main objective of this review is approval of the documentation of the implementing phase towards initiation of manufacturing of prototypes.


6.1.8.2.1 Drawings.

6.1.8.2.2 Components list.

6.1.8.2.3 Manufacturing and assembly instructions.

6.1.8.2.4 Labeling.

6.1.8.2.5 Product packaging.

6.1.8.3 Review Output: approval of implementation phase documentation and manufacturing methods.

6.1.8.4 Mandatory signatures:

6.1.8.4.1 Management forum representative.

6.1.8.4.2 Product Manager.

6.1.8.4.3 Production Manager.

6.1.8.4.4 QA Manager



026 of 7


6.1.9 Review of Organization for Full-Scale Manufacturing:


6.1.9.1.1 Resolution of problems identified during initial manufacturing and product testing.

6.1.9.1.2 Implementation of required adjustments.

6.1.9.1.3 Improvement of design, production and inspection techniques.

6.1.9.1.4 Correction and update of Device Master File.

6.1.9.1.5 Evaluation of the feasibility to initiate full-scale manufacturing.

6.1.9.2 Review Output:

6.1.9.2.1 Approval of final device configuration.

6.1.9.2.2 Device Master File approval.

6.1.9.2.3 Initiation of full-scale manufacturing.

6.1.9.3 Mandatory signatures:

6.1.9.3.1 Management forum representative.

6.1.9.3.2 Product Manager.

6.1.9.3.3 Production Manager.

6.1.9.3.4 QA Manager.

6.1.10 The Formal Design Review meeting results are incorporated to the Design History File (D.H.F.).

6.2 Informal Design Reviews - On-going Design Reviews:

6.2.1 General: This type of design reviews will be performed as required during the development phases according to the design progress and complexity, and scheduled by each Project Manager. These design reviews will be scheduled by the Product Manager.

6.2.2 The main objectives of this review are to:

6.2.2.1 Update all individuals involved in the project on the progression of development process.

6.2.2.2 Discuss and resolve problems.

6.2.2.3 Define interfaces and coordinate between the various project subsystems.

6.2.2.4 Assign tasks to work teams.

6.2.3 Personal: same as in Formal Design Review, see paragraph 6.1.2.



027 of 7


6.2.4 The meeting my include:

6.2.4.1 Review or determination of any additions or revisions to the Failure Mode and Effect Analysis (F.M.E.A.).

6.2.4.2 Verifications/ validations activities.

6.2.4.3 Bench/ clinical testing.

6.2.4.4 Surveys.

6.2.4.5 Focus group results.

6.2.4.6 Clinical trial results.

6.2.4.7 Technical problems.

6.2.5 Appropriate tasks will be assigned for formal F.M.E.A., testing, evaluations, updates per policies and procedures

6.2.6 The meeting minutes include:

6.2.6.1 List of key attendees (mandatory).

6.2.6.2 Date (mandatory).

6.2.6.3 Product Manager’s signature (mandatory).

6.2.6.4 Definition of the problem.

6.2.6.5 Action items.

6.2.6.6 Closure items.

6.2.7 The Informal Design Review meeting results are incorporated into Design History File (D.H.F.).

Design History File (DHF) SOP

The purpose of the DHF procedure is to define the method and the process for the creation and the maintenance of the design history file.

Each manufacturer has to establish and maintain a DHF for each type of device (device=product/project/version etc). The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of obligatory standards (FDA QSR, ISO).

Design and Development Validation SOP

The purpose of this procedure is to define the validation process of a design in order to ensure that the device conforms to defined user needs and intended use. Design Validation is an essential element of any design control. It is applicable for all Given products & production utilities (assembly and testing) as well

Design and Development Validation


Design and Development Validation PLCM-012-01 (QA-736-1)

2 2 of 5


1.0 Purpose

The purpose of this procedure is to define the validation process of a

design in order to ensure that the device conforms to defined user needs

and intended use.

2.0 Scope

Design Validation is an essential element of any design control. It is

applicable for all Given products & production utilities (assembly and

testing) as well. When design validation is not applicable, written rational

is required.

3.0 Responsibility

3.1 V.P. R&D has the overall responsibility for all development

activities, including design validation, and for the implementation of

this procedure.

3.2 The Director of Engineering and the Manager of Test Engineering

are responsible for the validation of testing utilities.

3.3 The Director of Engineering department is responsible for the

validation of production utilities

4.0 Definitions

4.1 Validation: Confirmation by examination and provision of objective

evidence that the particular requirements for a specific intended

use can be consistently fulfilled.

4.2 Design Validation: Establishing by objective evidence that device

specifications confirm to user needs and intended use(s)

4.3 Process Validation: Establishing by objective evidence that a

process consistently produces a result or product meeting its

predetermined specifications (note: this definition is included herein

to avoid confusion between process validation and design

validation. This procedure does not address process validation)



2 3 of 5


4.4 Production utilities: Utilities (devices and stations) in the production

assembly lines.

4.5 Testing utilities: Automatic functional and final testers in the

production line, including their software.


5.1 QA-730-1 Design and Development.

5.2 QA-732-1 Design and Development Inputs.

5.3 QA-733-1 Design and Development Outputs.


5.5 D.H.F. Design History File.

6.0 Procedure

6.1 The validation requirements are outline to each product and

production and test utilities. The validation plan should include:

6.1.1 Objectives and intended use.

6.1.2 Definition of the testing conditions (including environmental

conditions, safety requirements, etc.).

6.1.3 Definition of the functions to be tested including methods

and means.

6.1.4 Acceptable results.

6.1.5 The executing individual(s) and the authorities to approve

the results.

6.2 Examples for Design validation subjects:

6.2.1 Clinical trials

6.2.2 Focus group testing

6.2.3 Software validation

6.2.4 Risk analysis (including F.M.E.A.)

6.2.5 Literature searches

6.2.6 Review of labels and labeling

6.2.7 Packaging

6.2.8 510(k) and CE (M.D.D.) information



2 4 of 5


6.3 Any new design inputs which result from validation activities will be

incorporated into design process, per Design Input procedure

6.4 Any changes to design output which result from validation activities

will be incorporated into design process, per Design Output

procedure, and must be re-verified per Design Verification

procedure.

6.5 Design validation is to be performed on initial production units,

made by final production process. If initial production units are not

used, equivalent devices must be used and documentation of their

equivalence must be provided. If there are significant differences

between these devices and initial production devices, the

justification of the validity of the results, as they are applied to initial

production, must also be documented

6.6 Design validation must include testing under actual use and/ or

simulated use conditions.

6.7 The maximum number of initial production units will be defined in

the design and development validation work plan.

6.8 All results of design validation will be documented, and must

include:

6.8.1 Identification of the design that was validated.

6.8.2 Methods used in validation

6.8.3 Date of validation.

6.8.4 Individual(s) performing the validation.

6.9 The design validation will be reviewed by management forum

representative before release, that will sign and date the document

6.10 The results will be entered properly into the D.H.F..

6.11 Any change in the design, production or service processes requires

re-validation before its release.

6.12 Records of validation shall be kept..

6.13 Any changes to a design validation document (file) after it has been

completed require documented revision, including the signature(s)

of a department representative of the individual performing the

original validation.



2 5 of 5


6.14 The decision on how to handle the initial production units that have

been produced during the validation period should be determined

by a MRB committee (after opening a MRB report for these units)

*************

Design and Development Verification SOP

The purpose of this procedure is to describe the verification process of designed products to ensure that the design and development outputs have met the design and development input requirements.

Design and Development Verification


Design and Development VerificationPLCM-036-01 (QA-735-1)

02 2 of 4


1.0 Purpose

The purpose of this procedure is to describe the verification process of

designed products to ensure that the design and development outputs

have met the design and development input requirements.

2.0 Scope

Design and development verification shall be performed for all medical

devices designed and developed in Given Imaging.

3.0 Definitions

Verification: confirmation by examination and provision of objective

evidence that specified requirements has been fulfilled.


4.1 QA-730-1 Design and development

4.2 QA-732-1 Design and development Inputs

4.3 QA-733-1 Design and development Outputs

4.4 F-04-1-1 E.C.R./E.C.O./D.A.: Design Change Form.


5.0 Responsibility

5.1 V.P. R&D has the overall responsibility for all development

activities and for the implementation of this procedure.

5.2 Projects Managers are responsible to perform Design and

Development Verification to their projects.

6.0 Procedure

6.1 Design and development verification shall be performed in order to

ensure that all the design and development outputs have met the

design and development input requirements.



02 3 of 4


6.2 Design and development verification testing usually begins with

working prototypes or breadboards and may be repeated as design

changes are made.

6.3 Typical verification tests include, where applicable :

Comparative tests with a proven design.

Simulated use in the laboratory.

Animal model tests.

Biocompatibility tests.

Material/device compatibility tests.

Prototype tests.

Reliability tests.

Performance tests.

Tests of compatibility with other devices.

Environmental tests.

6.4 For software, typical verification activities include:

Code review

Schematic reviews

Unit and components tests.

Integration tests.

Alternate calculation demonstrations.

6.5 Verification plan shall include:

Definition of required tests.

Definitions of the functions to be tested.

The executing individual(s) and the authorities to approve the

results.

Test methods and means.

Acceptable results and documentation manners (or reference

to internal documents that define them).

6.6 Any inputs which are not satisfactorily met will be reviewed, to

determine whether they are applicable. Any new design and

development Inputs revisions must be performed per the Design

and Development Inputs procedure.



02 4 of 4


6.7 When all design and development inputs requirements have been

met, the Project Manager will document the followings:

6.7.1 Identification of the design.

6.7.2 Methods used (all).

6.7.3 Date.

6.7.4 The individual(s) performing the verification.

6.8 Changes in the design and development inputs, outputs, and/or

any other information in the final verification file after it has been

completed requires additional review and change as per Design

Changes procedure.

******************

Testing Requirements SOP

The testing requirements document is a document that describes the product’s testing approach and the testing needs. This document is derived in parallel to the specification document. This document can identify in advance the necessary testing procedures and testing tools needed in order to produce a safe and reliable product that fits the requirements.

Testing Requirements


Testing Requirements document PLCM-008-01 01 2 of 4


1.0 Purpose

The testing requirements document is a document that describes the product’s

testing approach and the testing needs. This document is derived in parallel to

the specification document. This document can identify in advance the necessary

testing procedures and testing tools needed in order to produce a safe and

reliable product that fits the requirements.

2.0 Scope

The document applies to all products developed in Given Imaging.

3.0 Responsibility

The project manager appointed by the V.P. R&D is in charge of preparing this

document. This document should be reviewed by representatives of the R&D

development team and representatives of the engineering, testing, QA and

production teams.

V.P. R&D, V.P. Operations & QA director should approve the content of this

document.


In this section there should be a reference to the specifications document and to

external standards that might be relevant to the specific testing.

5.0 Definitions

N.A.

6.0 Functional testing

6.1 Functions to be tested

This section will include high level list of all the functions or features that will

require testing.

6.2 Functions not to be tested

This section will include high level list of all the functions or features that will

not be tested and the justification for not testing. The reasons might be: lack

of suitable equipment, lack of knowledge, priorities, low risk for failure etc.

The reasons should be backed-up by risk assessment.




6.3 Functions testing pass/fail criteria

This section will provide criteria for the testing results.

7.0 Regulatory testing requirements

In this section we should identify all the potential regulatory, safety and

environmental issues and the type of testing required to assure that no hazards

or potential problems will exist in the product.

8.0 Reliability testing requirements

In this section we should identify all the testing required to assure a reliable

product. This section should include for every test: the testing conditions during

the test, the testing conditions before starting the test (if relevant), the duration of

the testing, the sample size and the pass/fail criteria.

9.0 Test data and the applicable tools for creating the test data

In this section we identify the type of test data required for executing the testing,

how is it going to be created, and any type of tools (if required) for creating the

data.

10.0 Testing environment

10.1. Tools

In this section we identify the tools required for doing the actual testing

10.2. Methodology

In this section we identify the methods that will be used for executing the

testing: special testing methods, order of execution, methods for

calculation, etc.

10.3. Hardware

In this section we identify hardware needs for performing the testing:

instrumentation, network, computers, special equipment, special

materials, etc.




10.4. Software

In this section we identify the software needs for testing: operating

system, automation testing, software environment, debuggers,

simulations, special installations, etc.

11.0 Resources & Schedule

The purpose of this section is to create the linkage between all the requested

testing and the resources needed.

This section identifies the manpower needed for performing the testing, the

special skills required, the amount of help needed from other groups and the

extent of the work.

This section also determines the time frame for performing the testing and basic

time table. It can also include constraints on the start and finish of the process.

12.0 Appendix

This section can include a more detailed traceability matrix that correlates

between every item in the specifications document and the section in the testing

document that covers this specification.

Regulatory Submissions SOP

Regulatory Submissions


Regulatory Submissions and Registration PLCM-016-01 01 2 of 3


1.0 Purpose

1.1 The purpose of this procedure is to define the responsibility for product

regulatory submissions, licensing and registration maintenance.

2.0 Scope

2.1 All Given Imaging products that requires license to be placed in market.

This includes hardware and software such as Capsules, Data recorder

and data reading/viewing tools.

3.0 Responsibility

3.1 QA&RC director is responsible for implementing this procedure.

3.2 R&D, Clinical Trials and QA&RC departments responsible to support

any registration submission in process.

4.0 Procedure

4.1 QA&RC director is responsible for Product registration and registration

maintenance

4.2 QA&RC director is not responsible for Product registration and Product

submission in US and Japan. The submissions and registrations in US

and Japan are with the local subsidiaries.

4.3 QA&RC director is responsible for European community products

license (CE Mark).

4.4 Global products registration will be coordination with the product

management, region marketing and region regulatory.

4.5 Submissions and registrations in Latin America, Non Euro-community,

Africa, Asia and Middle East will be done by contract distributors

AQ&RC department will support with required document per request.

4.6 Once a product is registered QA&RC director is responsible for

registration maintained.


Regulatory Submissions and Registration PLCM-016-01 01 3 of 3


4.7 Given Imaging KK Regulatory Director is responsible for Products

submission and registration in Japan. LTD QA&RC. R&D and CT

department will support Japan products registration with any

information/documentation.

4.8 Products submission and registration in US – TBD.

4.9 QA&RC will keep an original copy of the clearance document.

Release to Engineering SOP

The Release to Engineering template enables the beginning of the transition from an R&D prototype to a serial production.

Risk Analysis for Development SOP

Risk Analysis for Development


Commercialization Plan PLCM-017-01 01 2 of 4


1.0 Purpose

This procedure defines the process for creating a commercialization plan for a

new product or major software release.

2.0 Scope

This procedure applies to all global and regional activities related to all product

launches including major software version releases.

3.0 Responsibility

3.1. The Product-Line Director is responsible for the implementation of this

procedure.

3.2. The Global Product Manager is responsible for field testing activities

described in this procedure.


4.1. Global Launch Package Template

4.2. Global Pricing Plan SOP

4.3. Regional Launch Plan Template

4.4. Product Requirements Definition Template

5.0 Definitions

5.1. Global Launch Package - output from PLCM Launch Procedure that

includes global pricing strategy, clinical trial activity, regulatory plan,

competitive strategy, etc.

5.2. Global Pricing Plan - plan includes cost structure of product, financial

objectives of product, and guidelines for establishing regional pricing

policies for direct and indirect markets.

5.3. Regional Launch Plan – plan developed at the regional level which

includes all elements required for a successful product launch. This plan

includes the Product Description, Key Launch Milestones, Product Launch

Strategy, Product Pricing Strategy, Launch Risks, Competitive Landscape

and Positioning, and Launch Action Plan.

5.4. Product Requirements Definition – document that describes in detail the

market need, formal product definition, Product Life Cycle




milestones/Roadmap as well as all functional, medical, marketing,

regulatory, standards, QA requirements and any other special requirements

for the product.

5.5. Product Field Test – testing performed at customer sites designed to

validate the product marketing, customer, and technical specifications prior

to full launch of the product.

6.0 Procedure

6.1. The Product Line Director develops and delivers the initial

Commercialization Plan and uses this plan to guide the process of global

marketing planning and product field testing. The Commercialization Plan

includes:

Global Launch Package

Global Pricing Plan

Global Marketing Strategy, including marketing communication plan

Product development time-line

Global product launch time-line including action items and accountability

6.2. The Global Product Manager develops and executes the field testing plan to

validate that the product meets the marketing and performance objectives.

6.3. The Global Product Manager documents the results of the field testing and

submits them for review and approval to the Product Line Director, VP of

R&D, VP of Regulatory Affairs, and Regional Marketing Directors.

6.4. After reviewing the field test results, a final go-no go decision is made on

the product launch. The product launch must be approved by the Chief

Marketing Officer, Chief Financial Officer, Chief Operating Officer, VP of

R&D, VP of RA, and the Senior Executive for each region in which the

product will be launched.

6.5. If a “go for launch” decision is made, the Product Line Director develops and

delivers the final commercialization plan to the Regional Product Manager

approximate three months prior to scheduled launch. The Regional Product

Manager then completes the development of the Regional Launch Plan.

7.0 Appendix




Clinical Trials Approval Forms (CTAF) SOP

This document is an in-house evaluation form, required whenever a new idea for a clinical research/study is offered to Given Imaging, either by outside investigators, in house R&D or marketing requirements for clinical development of any of our products. The form includes the major details of the clinical protocol, its budget and the input of the relevant marketing officers.

Clinical Trials Approval Forms (CTAF)


Clinical Trials Approval Forms (CTAF) PLCM-013-01 01 2 of 9


Clinical Trials Approval Forms (CTAFs)

1.0 Purpose:

This document is an in-house evaluation form, required whenever a new

idea for a clinical research/study is offered to Given Imaging, either by

outside investigators, in house R&D or marketing requirements for clinical

development of any of our products. The form includes the major details of

the clinical protocol, its budget and the input of the relevant marketing

officers.

2.0 Scope:

The relevant product teams, to include a representative from each of R&D,

marketing and clinical affairs depts.

3.0 Responsibility:

Clinical affairs relevant (product-) clinical trials manager, CA director,

regional CA team, marketing representatives and financial approval

signatures.

4.0 Reference documents: none

5.0 Definitions

CA – Clinical Affairs (dept)

CTAF – clinical trial approval form

APPROVAL PROCESS FOR CLINICAL TRIAL # MA - - - -




(Complete name of study, as will appear in the formal protocol)

Clinical Trials Approval Form

AUTHORIZATION LINE – APPROVAL TO INITIATE NAME TITLE SIGNATURE DATE

Issued by: Clinical Trials Manager,

XXXXX product

Approved by: CA director

Approved by: Corp director XXXX product

Approved by: Data analysis manager

Approved by: Kevin Rubey Chief Operation Officer

Approved by: Mark Gilreath Chief Marketing Officer

Approved by Yuval Yanai/ Gilad Mamlok

VP finance/ CFO

Product line Committee Approval – prioritize and recommend

(Should be completed before handing over to SM approvals)

Name position Signature Comments

Corp Director

Yael Koren Global CA Director

Global CT manager

Local RACA

Local PM

Clinical Marketing

Biostatistics / DA

Ian Gralnek Disease Mgmt

Ari Bergwerk Medical Advisor




APPROVAL PROCESS FOR CLINICAL TRIAL # MA - - - -


1) Primary Scientific Objective

Study Hypothesis:

2) Proposed Investigators

Investigator Country Institution Type of Practice (volume, partners,

specialty)

PI

PI

Co-Investigator

Co-Investigator

Co-Investigator

3) Proposed Design

4) Inclusion Criteria

5) Exclusion Criteria

6) Study End Points

a) Primary end point:

b) Secondary end points:




7) Timeline & Goals

Start Date End Date Comments Finalize CTAF Finalize protocol IRB submission/ expected approval

Start enrollment expected Interim Results Investigators’ meeting (date)

Manuscript (drafting+submission)

Meeting Presentation Publication

8) Budget

A. Sample size calculations: (should always be done with the involvement of a biostatistician)

B. Number of patients: XXX (based on A) Number of sites: YY

Per Site Per Patient Total IRB + amendments Per patient payment(per completed e-CRF)

RAPID reading Monitoring & CRC + expenses Administrative costs Patient’s compensation Additional non-covered tests Materials / equipment Insurance - Migdal Insurance – local (if required) Investigators meetings Investigators honorarium Other (unpredicted) costs Overhead (5-10%) Total Cost




9) Expected Outcomes – marketing input

a) What is the study hypothesis?

b) Will this study expand our potential procedure volume? If positive, by how much?

c) Will this study support expanded reimbursement? If positive, how?

d) Will doctors accept the results and change their habits of usage?

e) How much will the study cost?

f) Can we effectively monitor and manage this study? Who will be the primary monitor? What resources are required from Global and Local RACA and what required support is required from R&D?

g) When will the full data be available

h) When will the results be presented publicly?

i) When and where will the results be published?




APPROVAL PROCESS FOR R&D CLINICAL TRIAL #RD - - - -


R&D Clinical Trials Approval Form

AUTHORIZATION LINE – APPROVAL TO INITIATE NAME TITLE SIGNATURE DATE

Issued by: R&D project manager, XXXX product

Issued by: Clinical Trials Manager,

XXXXX product

Approved by: CA director

Approved by: Ari Bergwerk Medical advisor

Approved by: Daniel Gat Director, R&D projects

Approved by: Daphna Levy VP R&D

Approved by: Kevin Rubey Chief Operation Officer

Approved by Yuval Yanai/ Gilad Mamlok

VP finance/ CFO




APPROVAL PROCESS FOR R&D CLINICAL TRIAL # MA - - - -


10)Primary Objective

Study hypothesis:

11)Proposed Investigators

Investigator Country Institution Type of Practice (volume, partners,

specialty)

PI

PI

Co-Investigator

Co-Investigator

Co-Investigator

12)Proposed Design

13)Inclusion Criteria

14)Exclusion Criteria

15)Study End Points

a) Primary end point:

b) Secondary end points:




16)Timeline & Goals

StartDate

End Date Comments

Finalize CTAF Finalize protocol IRB submission/ expected approval

Start enrollment expected Interim Results Complete enrollment expected

Investigators’ meeting (date)

17)Budget

C. Sample size calculations: (should always be done with the involvement of a biostatistician)

D. Number of patients: XXX (based on A) Number of sites: YY

Per Site Per Patient Total IRB + amendments Per patient payment(per completed e-CRF)

RAPID reading Monitoring expenses Administrative costs Patient’s compensation Additional non-covered tests Materials / equipment Insurance - Migdal Insurance – local (if required) Investigators meetings Investigators honorarium Other (unpredicted) costs Overhead (5-10%) Total Cost

CT Protocols SOP

CT Protocols


Clinical Trials Standard Protocols PLCM-014-01 01 2 of 13


Clinical Trials Standard Protocols

1.0 Purpose:

To standardize the protocols that accompany, define and manage all clinical

development activity in Given Imaging; the protocol template will have to

answer FDA requirement on the one hand and to back up products’ safety

and efficacy claims as required by marketing.

2.0 Scope:

Investigators, clinical trials managers, regional clinical personnel.

3.0 Responsibility:

CA director, Clinical affairs relevant clinical trials manager, regional CA

team, and financial approval signatures.


Protocol outline template (see attached) with appendices

5.0 Definitions

NA




Clinical Trial Protocol MA-XX:

Evaluation of Capsule Endoscopy in Patients with (disease definition)

Principal Investigators:

Co-Investigators:

Test product: Given® Diagnostic System and PillCam™ - - - Capsule

Sponsor's name and address:

Given Imaging Ltd. New Industrial Park, Yoqneam IsraelGiven Imaging, Inc. 5555 Oakbrook Parkway, Ste. 355 Norcross, GA 30093

Sponsor’s Telephone Number:

Israel: 93-04-909-7777 US: 800-662-0870

Study NumberVersion number and Date:

MA-XXVersion yy, dd/mm/yy

CONFIDENTIAL This material is the property of Given Imaging. The information is confidential and is to be used

only

in connection with matters authorized by Given Imaging and no part of it is to be without

prior written permission from Given Imaging.




TABLE OF CONTENTS

STUDY SUMMARY................................................................................................................... 51 INTRODUCTION............................................................................................................. 52 DEVICE DESCRIPTION ................................................................................................. 5

2.1 PillCam™ SB Capsule ....................................................................................... 52.2 Given

® DataRecorder......................................................................................... 5

2.3 RAPID® Workstation .......................................................................................... 5

3 OBJECTIVES.................................................................................................................. 63.1 Primary objectives ............................................................................................. 63.2 Secondary objectives ........................................................................................ 6

4 STUDY ENDPOINTS ...................................................................................................... 64.1 Primary endpoint ............................................................................................... 64.2 Secondary endpoints ........................................................................................ 6

5 STUDY DESIGN ............................................................................................................. 65.1 Overall design .................................................................................................... 65.2 Investigational product and Accountability .................................................... 7

6 SUBJECT ELIGIBILITY.................................................................................................. 76.1 Study population................................................................................................ 76.2 Inclusion criteria ................................................................................................ 76.3 Exclusion criteria ............................................................................................... 76.4 Withdrawal criteria............................................................................................. 7

7 STUDY PLAN.................................................................................................................. 77.1 Enrollment of participants ................................................................................ 77.2 Informed Consent Process (day 1) .................................................................. 77.3 Assessment of eligibility and Patient baseline condition (visit 1)................ 77.4 Capsule Endoscopy (visit 2) ............................................................................. 87.5 SBFT (visit 3) ...................................................................................................... 87.6 Ileo-Colonoscopy (visit 4) ................................................................................. 87.7 Follow Up of patients (visit 5)........................................................................... 8

8 ASSESSMENT OF EFFICACY....................................................................................... 89 ASSESSMENT OF SAFETY .......................................................................................... 8

9.1 Safety parameters.................................................. Error! Bookmark not defined.9.2 Methods and timing of assessing safety parameters ...... Error! Bookmark not defined.9.3 Adverse events .................................................................................................. 8

10 STATISTICS.................................................................................................................. 1010.1 Determination of sample size ......................................................................... 1010.2 Description of statistical methods ................................................................. 10

11 DATA COLLECTION AND QUALITY CONTROL ....................................................... 1011.1 Data collection ................................................................................................. 1011.2 Archiving .......................................................................................................... 11

12 ETHICAL AND LEGAL ASPECTS............................................................................... 1112.1 Independent Ethics Committee (IEC)............................................................. 1112.2 Ethical conduct of the study........................................................................... 1112.3 Patient Information and Consent ................................................................... 1112.4 Insurance .......................................................................................................... 1112.5 Confidentiality .................................................................................................. 12

13 USE OF DATA AND PUBLICATIONS ......................................................................... 12APPENDICES ......................................................................................................................... 13

Appendix A – Schedule of Assessment.................................................................... 13Appendix B – Patient’s condition questionnaires ......... Error! Bookmark not defined.Appendix C – CE, SBFT and ileo-colonoscopy case report formError! Bookmark not defined.




Study Summary

Purpose of studyStudy design: Number of subjects:Subjectpopulation

No of centers InterimAnalysis Duration of follow-up

Duration of studyPrimaryobjectivesSecondaryobjectives

Introduction

Device Description

The Given® Diagnostic System used in this study consists of three main subsystems: an ingestible PillCam™ SB Capsule, A Given® DataRecorder, and a RAPIDWorkstation.

PillCam™ - - - Capsule

The disposable, ingestible PillCam™ - - - Capsule acquires the video images during natural propulsion through the digestive system. The Capsule transmits the acquired images via digital radio frequency communication channel to the Given® Data Recorder unit located outside the body.

Given® DataRecorder

The DataRecorder is an external receiving/recording unit that receives the data transmitted by the ingestible Capsule. The portable Recorder consists of an antenna array carried in proximity to the body, a receiver, and memory for accumulation of the data during the examination. Upon completion of the examination, the physician transfers the accumulated data in the Recorder to the RAPID® Workstation for interpretation. The data transmission is performed via high capacity digital link.

RAPID® Workstation

The Workstation is a modified standard personal computer that is intended for interpretation, and analysis of the acquired data and for generating reports (for more details, please review the RAPID™ User manual.




OBJECTIVES

Primary objectives

Secondary objectives

STUDY ENDPOINTS

Primary endpoint

Secondary endpoints

.

STUDY DESIGN

Overall design

(Usually displayed as an algorithm)

Inclusion / Exclusion

Serology

CDAI; other scores

CE

Test I

Test II




Investigational product and Accountability

For each dispensed capsule, the following information should be recorded: The subject’s initials, the subject study number, the type of Investigational product used, the lot number of the investigational product, and the initial of the person dispensing the capsule. At the termination of the study, all unused study material must be returned with the corresponding documentation as directed by Given Imaging.

SUBJECT ELIGIBILITY

Study population

Inclusion criteria

Exclusion criteria

Withdrawal criteria

STUDY PLAN

Enrollment of participants

Eligibility to participate in the study will be performed by the investigator based on the inclusion and exclusion criteria.

Informed Consent Process (day 1)

Each patient will receive a full oral explanation on the study and will receive a copy of the patient Informed Consent Form. The patient (or legal guardian) will be requested by the investigator, or his designee, to sign the Informed Consent Form. The consent to participate in this study must be given in writing. The signed informed consent will remain in the file of the patient; a signed copy will be given to the patient. A patient log will be kept at the site with all patients who signed an informed consent for participating in the trial. The log will include the patient’s full name I.D. number, patient study code and date of enrolment.

Assessment of eligibility and Patient baseline condition (visit 1)

After obtaining the consent, patients will be assessed for eligibility to participate, based on inclusion and exclusion criteria, past medical history (life threatening, chronic diseases), physical examination and use of concomitant medications. Patient baseline condition will be assessed based on:

o Patient details as follows: date of birth, gender, height, weight, waistline, nutritional status, alcohol use, illicit substance use, prior abdominal surgery, pregnancy test performed and general information relates to female childbearing potential, reason for referral and clinical current condition.

o Documentation of previous GI investigations such as EGD, Intra-operative enteroscopy, colonoscopy / ileo-colonoscopy, SBFT, enteroclysis, SB




radiography and CT. For each procedure the following data will be capture: number of procedures performed, date and results from most recent procedure

o General medical history as follows: concomitant medication (name, date, dose, period and current status), and clinical condition categorized by category code specify in the e-CRF.

o Physical exam as follows: date, blood pressure, pulse, temperature and route, abdominal exam and lab test results if they were performed such as: WBC, Hgb, Hct, Plt, Ferritin, PT and/or INR.

o CDAI, Van Hees, Harvey-Bradshaw, IBDQ, SF36 (Appendix B presents detailed information).

Capsule Endoscopy (visit 2)

Test I (visit 3)

Test II (visit 4)

Follow Up of patients (visit 5)

ASSESSMENT OF Efficacy

ASSESSMENT OF Safety

Adverse events

An adverse event is any undesirable experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a patient that appears or worsens during a clinical study. An adverse event may or may not be related to the investigational device or drug therapy prescribed as part of the study protocol.

All adverse events will be graded as follows: Mild: Sign or symptom, usually transient, requiring no special treatment and generally not interfering with usual activities. Moderate: Sign or symptom, which may be ameliorated by simple therapeutic measures, may interfere with usual activity. Severe: Sign or symptom that are intense or debilitating and that interfere with usual activities. Recovery is usually aided by therapeutic measures and the discontinuation of the study device may be required. The relationship of the adverse event to the study is defined as follows: Probable: An adverse event has a strong temporal relationship to study device, and another etiology is unlikely or significantly less likely. Possible: An adverse event has a strong temporal relationship to the study device, and an alternative etiology is equally or less likely compared to the potential relationship to study device. Unlikely: An adverse event has little or no temporal relationship to the study device and/or a more likely alternative etiology exists. Not related: An adverse event has no temporal relationship to study device or has a much more likely alternative etiology.




Adverse device reactions

Adverse device reactions are adverse events caused wholly or partly by the use of the device. A causal relationship between an observed adverse event and the use of the trial device may exist with various degrees of probability, on the basis of statistical probability, or of plausible medical data and considerations.

Serious adverse events

A serious adverse event is any untoward medical occurrence that results in:

Death

Life-threatening drug experience

Patient hospitalization or prolongation of existing hospitalization

Persistent or significant disability/incapacity

Congenital anomaly/birth defect.

Some important medical events, although they may not result in death, be life-threatening, or require hospitalization may still be considered serious adverse events when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed above.Life threatening means that the patient was, in the view of the investigator, at immediate risk of death from the reaction as it occurred. This does not include an adverse event that, if more severe, might have caused death. Disability means a substantial disruption of a person’s ability to conduct normal life’s functions.

Serious Adverse Events have to be reported to Given Imaging in writing within 24 hours of the investigator’s awareness.

Unexpected Adverse Event

Any adverse event, the specificity or severity of which is not consistent with the current Investigator Brochure (or Package Insert for marketed products). Also, reports that add significant information on specificity or severity of a known, already documented adverse event constitute unexpected adverse events. For example, an event more specific or more severe than described in the Investigator Brochure would be considered “unexpected”.

Adverse events reactions associated with PILLCAM™- - - capsules

Rare cases of delayed excretion of the capsule in clinical studies have occurred in 0.7-3.6% of the high risk patients who suffer from GI diseases. In healthy volunteers no delayed excretions have been reported. These delays in excretion were resolved by either laxative ingestion or removal of the capsule during colonoscopy or surgery. Surgery was performed only in cases where confirmed strictures in the intestine have caused the delay in the capsule excretion.

In case of any symptoms consistent with this delayed excretion, the investigator should exclude the possibility of small bowel obstruction. This should be done by surgical evaluation of the subject immediately, and obtaining the appropriate tests on an emergency basis. A surgeon who is skilled with both the conventional and laparoscopic surgery should be acquainted with this study and protocol in case of the unexpected and rare need for removal of the capsule.




Recording and documentation of adverse events

Every adverse event should be recorded in the case report form. The following data must be documented:

Type of event

Patient number

Time of occurrence: date, time

Time of resolution: date time

Severity degree: mild / moderate / severe / unknown

Relationship to study device probable/possible/unlikely/not related

Outcome of event: unchanged / worsened / improved / resolved / unknown / death

STATISTICS

Determination of sample size

Description of statistical methods

Demographic and other baseline characteristics

Pathologies identified during procedures

Adverse eventsIndividual listings of adverse events including type of device, age, weight, height, gender, adverse events (reported term), start, duration, relationship to device and severity will be provided.

Interim AnalysisAn interim analysis will be performed after ZZZ patients are enrolled in the study in order to evaluate the enrolment criteria. The final sample size of each group will be estimated following those results.

DATA COLLECTION AND QUALITY CONTROL

Data collection

It is the responsibility of the clinical coordinator to ensure the completeness and accuracy of the case report forms (CRFs). One case report form must exist for each patient participating in the study. The case report forms may serve as source documents. Each clinical site will receive an electronic case report form software program that will be installed into the RAPID workstation.

Electronic case report form entries will be user-identifiable and will include an audit

trail. Once the CRFs have been collected by the clinical coordinator no changes should

be made to the CRFs. If corrections are required they will be performed on designated

electronic forms only.




Archiving

All source documents and case report forms will be kept for a period of no less than five years after the later of the following dates: the date of which the study is terminated or completed or; the date that the records are no longer required to support marketing applications.

ETHICAL AND LEGAL ASPECTS

Independent Ethics Committee (IEC)

Documented approval from appropriate Ethics Committee will be obtained for all participating centers prior to study initiation, according to ISO 14155, local laws, regulations and organization. When necessary, an extension, amendment or renewal of the Ethics Committee approval must be obtained. The Ethics Committees must supply to the sponsor, a list of the Ethics Committee members and a statement to confirm that the Ethics Committee is organized and operates according to GCP and applicable laws and regulations.

Ethical conduct of the study

The procedures set out in this study protocol, pertaining to the conduct, evaluation, and documentation of this study, are designed to ensure that the sponsor and investigator abide by Good Clinical Practice Guidelines (GCP in the appropriate current version). The study will also be carried out in keeping with applicable local law(s) and regulation(s). This may include an inspection by Given Imaging representatives and/or Regulatory Authority representatives at any time. The investigator must agree to the inspection of study-related records by the Regulatory Authority/Given Imaging representatives, and must allow direct access to source documents to the Regulatory Authority/ Given Imaging representatives. Regulatory Authority approvals/ authorizations/ notifications, where required, will also be in place and fully documented prior to study start.

Patient Information and Consent

A core information and consent form will be provided. Prior to the beginning of the trial, the investigator must have the Ethics Committee written approval/favorable opinion of the written informed consent form and any other written information to be provided to patients. The written approval of the Ethics Committee together with the approved patient information/informed consent forms must be filed in the study files. The process of obtaining informed consent must be in accordance with applicable regulatory requirement(s), and must adhere to GCP and to the ethical principles originating in the Declaration of Helsinki. Written informed consent must be obtained before any study specific procedure takes place. Participation in the trial and date of informed consent given by the patient should be documented appropriately in the patient files.

Insurance

All patients participating in the trial will have insurance coverage by the Sponsor, which is in line with applicable local laws




Confidentiality

All records identifying the patient will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. Patient names will be kept confidential. Only the patient number and patient initials will be recorded in the case report form, and if the patient name appears on any other document, it must be obliterated. Study findings stored on a computer will be stored in accordance with local data protection laws. The patients will be informed in writing that representatives of the sponsor, IEC or Regulatory Authorities may inspect their medical records to verify the information collected, and that all personal information made available for inspection will be handled in strictest confidence and in accordance with local data protection laws. If the results of the trial are published, the patient’s identity will remain confidential. The investigator will maintain a list to enable patients’ records to be identified.

USE OF DATA AND PUBLICATIONS

All data and results and all intellectual property rights in the data and results derived from the study will be the property of Given Imaging, who may utilize the data in various ways, such as for submission to government regulatory authorities or disclosure to other investigators, educational and marketing uses. The investigator, whilst free to utilize data derived from the study for scientific purposes, must discuss any publication with the sponsor prior to release and obtain written consent of the sponsor on the intended publication. The sponsor recognizes the right of the investigator to publish the results upon completion of the study. However, the investigator must send a draft manuscript of the publication or abstract to the sponsor thirty days in advance of submission in order to obtain approval prior to submission of the final version for publication. This will be reviewed promptly and approval will not be withheld unreasonably. In case of a difference of opinion between the sponsor and the investigator(s), the contents of the publication will be discussed in order to find a solution which satisfies both parties.




Appendices

Appendix A – Schedule of Assessment

Appendix B – …n

Questionnaires – CDAI, IBDQ, SF-36, Mow, Lewis Score…

Enrolment Evaluation I Evaluation II Final evaluation

Informed Consent X

Medical History and Concomitant medications

X

Vital Signs and Physical examination X

CE procedure (if no obstructive symptoms present using AGILE)

X

Test I X

Test II X

Follow-up CE (1 week) X

Follow-up patient condition (CDAI, IBDQ, SF36)

X

Adverse events monitoring X

IRB Documents SOP

IRB Documents


Binder of IRB documents PLCM-015-01 01 Page 2 of 2


Compilation of IRB documents

1.0 Purpose:

A compiled list of documents (and their relevant templates) required for

submission to Institutional Review Board (IRB, or otherwise known as

Helsinki/ethical committee) evaluation of clinical trials.

2.0 Scope:

CA teams, global and regional

3.0 Responsibility:

Relevant clinical trials’ manager and regional CA teams.

4.0 Reference documents: see list

5.0 Definitions

IRB – institutional review board, located in each USA site/hospital

EC – ethical committee, in EU sites

6.0 The Procedure

The requirements of the different IRBs or ECs differ for different locations/sites,

and are derived from the local regulatory system (FDA or CE or others).

The binder, to include the required documents is prepared by the local site,

usually by the site’s Clinical Research Coordinator (CRC); it is our utmost interest

to assist him/her in this task, to ensure accurate filing and quick submission.

The following is the list of documents required in general:

1. Protocol

2. Investigators’ brochure (or user manual in case of licensed product)

3. Informed consent form (ICF) (translated to local language, as required)

4. Package of submission documents, specific to the site (to include all details related to the study)

5. Financial disclosure form

6. Insurance approval document

7. Other documents, as required by specific countries/sites (warrants, check lists, commitment of sponsor etc.)

An example of IRB/EC submission files can be found in clinical affairs files under “shared”.

Gate P2: Production ReadinessTransition of Product from R&D to Production


Product Production Files Release to Engineering PLCM-011-01

Production Capabilities





- VP R&D

APPROVAL

- VP R&D

MAKE/BUY/PARTNER

ANALYSIS –






REGISTRATIONLEADER


APPROVAL

- COO

LAUNCH


LEADER

- VP R&D

APPROVAL









- VP R&D

APPROVAL




- VP Operations

APPROVAL




Final report


presentations



APPROVAL


- CMO


?

?


Clinical Trials

Registration

Implementation




P1

P2

Stage 3: Launch Readiness

Detailed Stage Description: Launch Readiness

Launch Readiness Flowchart

Gate P3: Product Commercialization Deliverables

Stages of Launch

Stage 1

Regulatory Clearance Product development and testing is completed, product has received regulatory approval but may not be available for shipment.

Stage 2

Announcement Announcement of a launch via press release or during a congress/clinical meeting. May occur prior to regulatory clearance.

Stage 3

Product Availability Product has regulatory clearance and is market ready for shipping from GIVEN Ltd to subsidiaries or distributors. Sales Force has not been trained and promotional materials are in process. Product may be field tested during this stage prior to launch.

Stage 4

Limited Launch Product has regulatory clearance but introduction into the market is limited. Sales force is trained and has basic information to introduce and educate a group of targeted customers.

Stage 5

Full Launch Product is available for every customer in a region. Sales force is trained with full access to promotional materials and GIVN as a company is promoting.



Launch Readiness


GLOBAL MARKETING PLANNINGLEADER


APPROVAL

- Global Marketing- Heads of regions- Business partners (if applicable)

Global marketing planning –Develop initial commercialization plan for new product.The expected output is:Initial commercialization plan including:- Forecasting (for delivery)- Pricing - Training- Branding - Competition- Key messages - Reimbursement- Servicing policies - Channels- Promotions - Positioning- Marketing collaterals- Product support materials- Field Implementation strategy

Global marketing planning

ONGOING MANAGEMENT & ROADMAP

STEERING

2 months

Validation of product meeting market needs and technical performance against specifications. The expected outputs are:

Field Tests Results Summary :

- Technical- Clinical- Marketing

Go/No Go decision for Launch

PERFORM FIELD TESTING

LEADER

- Corp. Product Line Manager

APPROVAL

- Global Marketing- Director CA (if applicable)- Heads of regions

Launch

GLOBAL LAUNCH PLANNINGLEADER


APPROVAL

- Senior Management- Global Marketing- Heads of regions- VP R&D

1 month

Perform field testing

2-3 months

MARKETING SUPPORT SALES

GO/NO GO

NO

Develop final commercialization plan for specific product or major release. The expected outputs are:

Final commercialization Plan

including:- Action items (what?)- Responsibilities (who?)- Schedule (when?)


Successful Global Product Launch

Execution

Marketing release (MR)

?

P3

?

Global launch planning

Gate P3

nch Planning

commercialization plan for specific jor release

ctives of launchmercial plan and launch Go/No Go

and commercialg Plan Development with profitability d targets

ility (see separate plan)lobal vs. regional considerationsmotion development

ation (regulatory, service manual)material developmenting and education material nt

mercialization plansults summaryapproval documents

Director

Detailed Stage Description: Launch Readiness

Global Marketing Planning Field Testing Global Lau

Objective(s)

Develop initial commercialization plan for new product

Validation of product meeting market needs and technical performance against specifications

Develop finalproduct or ma

Process(es) Employed

• Collect regional information and needs• Pricing Plan Development (needs a separate

process)• Discuss and planning for regulatory issues• Plan marketing-oriented clinical trials• Analyze competition/alternatives• Market positioning• Plan marketing introduction schedule

(publications, shows, etc.)• Writing commercialization plan

• Prior to FDA approval• IRB required• After FDA approval• IRB not required• Site Selection and Management• Prepare & Ship relevant material• Product• Questionnaires• Training material• Perform training• Follow-up on execution• Receive feedback• Questionnaires• Videos• Change requests• Analyze feedback & conclusions

• Define obje• Update com

– technical• Final Pricin

analysis an• Scheduling• Accountab• Evaluate G• Launch Pro• Document• Marketing • Global train

developme

RequiredInputs

Output from Product & Major Release Initiation including: • Business Case• Product Roadmap• Clinical trials and regulatory issues • Special labeling needs (e.g., IP, per country)

• Product Requirements and Specification documents

• Regulatory submission documentation

• Initial Com• Field test re• Regulatory

Leader

Product-Line Director Global Product Manager Product-Line

Detailed Stage Description: Launch Readiness (page 2 of 3)

oduct Managerand CA

erviced other Product-Line Managers

nical Trainingrtnersrketing

ting

agementketinggions

nch Planning


• Regional Product Manager• Clinical marketing• Finance• Global RA and CA • Platform and other Product-Line Managers• Business Partners

• Regional Product Manager• R&D• Global RA and CA • Customer Services• Platform and other Product-Line Managers• Business Partners

• Regional Pr• Global RA • MarCom• Operations• Customer S• Platform an• Sales & Cli• Business Pa• Clinical Ma

Contributor(s)

Internal/External

• R&D• Operations• IP/Legal• MarCom

• Clinical marketing• Operations • Field Sales & distributors (Sites Selection)

• R&D• Finance• Legal

Estimated

Time Fram

e

2 months 2-3 months 1 month


Global Marketing Global Marketing Global Marke

RequiredA

pprovals

• Global Marketing• Heads of regions • Business Partners (i.e. Inscope)

• Global Marketing• VP RACA (if applicable)• Heads of regions

• Senior Man• Global Mar• Heads of re• VP R&D


Detailed Stage Description: Launch Readiness (page 3 of 3)

ercialization Plan including:ems (what?)ibilities (who?) (when?)

aunch Packageul Global Product Launch Executiong release (MR)

lan on timeProduct Launch measured by sales upport organization preparednessProduct Launch measured by product and product profitability

agementketinggions

nch Planning

ExpectedO

utput

• Initial commercialization plan• Forecasting (for delivery)• Pricing• Branding• Key messages• Servicing policies• Product support materials• Channels• Promotions• Positioning• Training• Reimbursement• Competition• Marketing collaterals• Field Implementation strategy

• Field Tests Results Summary:• Technical• Clinical• Marketing

• Go/No Go decision for Launch

• Final comm• Action it• Respons• Schedule• Global L• Successf• Marketin

Metrics to

Measure Success

• Complete plan on time• Adherence to plan• Success of next two phases dependent on

quality of plan

• Effective communication with test sites as measured by test site activity and quality of feedback

• Receive complete feedback information on time• Analyzed feedback & conclusions on time

• Complete p• Successful

force and s• Successful

shipments

RequiredApprovals

• Global Marketing• Heads of regions • Business Partners (i.e. Inscope)

• Global Marketing• VP RACA (if applicable)• Heads of regions

• Senior Man• Global Mar• Heads of re• VP R&D


Gate P3: Product CommercializationPre Launch


Commercialization Plan Comercialization Plan PLCM-017-01

Competitive Profile PLCM-018-01

Global Pricing Plan PLCM-019-01

Global Training and Education PLCM-023-01

Global Launch Package PLCM-025-01

Clinical Trials Final Report

Registration Status

Field Testing Report Field Testing PLCM-021-01

External Evaluation Release PLCM-022-01

Customer Service Plan

Comercialization Plan SOP

This procedure defines the process for creating a commercialization plan for a new product or major software release. This procedure applies to all global and regional activities related to all product launches including major software version releases.

Comercialization Plan




1.0 Purpose

This procedure defines the process for creating a commercialization plan for a

new product or major software release.

2.0 Scope

This procedure applies to all global and regional activities related to all product

launches including major software version releases.

3.0 Responsibility

3.1. The Product-Line Director is responsible for the implementation of this

procedure.

3.2. The Global Product Manager is responsible for field testing activities

described in this procedure.



4.2. Global Pricing Plan SOP


4.4. Product Requirements Definition Template

5.0 Definitions




5.2. Global Pricing Plan - plan includes cost structure of product, financial

objectives of product, and guidelines for establishing regional pricing

policies for direct and indirect markets.

5.3. Regional Launch Plan – plan developed at the regional level which

includes all elements required for a successful product launch. This plan

includes the Product Description, Key Launch Milestones, Product Launch

Strategy, Product Pricing Strategy, Launch Risks, Competitive Landscape

and Positioning, and Launch Action Plan.

5.4. Product Requirements Definition – document that describes in detail the

market need, formal product definition, Product Life Cycle




milestones/Roadmap as well as all functional, medical, marketing,

regulatory, standards, QA requirements and any other special requirements

for the product.

5.5. Product Field Test – testing performed at customer sites designed to

validate the product marketing, customer, and technical specifications prior

to full launch of the product.

6.0 Procedure

6.1. The Product Line Director develops and delivers the initial

Commercialization Plan and uses this plan to guide the process of global

marketing planning and product field testing. The Commercialization Plan

includes:


Global Pricing Plan

Global Marketing Strategy, including marketing communication plan

Product development time-line

Global product launch time-line including action items and accountability

6.2. The Global Product Manager develops and executes the field testing plan to

validate that the product meets the marketing and performance objectives.

6.3. The Global Product Manager documents the results of the field testing and

submits them for review and approval to the Product Line Director, VP of

R&D, VP of Regulatory Affairs, and Regional Marketing Directors.

6.4. After reviewing the field test results, a final go-no go decision is made on

the product launch. The product launch must be approved by the Chief

Marketing Officer, Chief Financial Officer, Chief Operating Officer, VP of

R&D, VP of RA, and the Senior Executive for each region in which the

product will be launched.

6.5. If a “go for launch” decision is made, the Product Line Director develops and

delivers the final commercialization plan to the Regional Product Manager

approximate three months prior to scheduled launch. The Regional Product

Manager then completes the development of the Regional Launch Plan.

7.0 Appendix




Competitive Profile SOP

The purpose of the competitive profile is to consolidate information necessary to develop competitive benchmarks and field sales strategies. It is intended to be a living document to be continually updated with information gathered from the field. The competitive profile is intended to provide critical information needed to accomplish the above purpose.

Competitive Profile


Competitive Profile Document PLCM-018-01 01 2 of 8


1.0 Purpose

The purpose of the competitive profile is to consolidate information necessary to

develop competitive benchmarks and field sales strategies. It is intended to be a

living document to be continually updated with information gathered from the

field.

2.0 Scope

The competitive profile is intended to provide critical information needed to

accomplish the above purpose. It is not intended to provide every detail of

product capabilities or competitive field activities but needs to contain enough

information to identify trends.

3.0 Responsibility

A designated individual in the Corporate Marketing Department (currently the SB

Product Line Director) will maintain centralized reference files for use by the

company. Regional marketing departments are also encouraged to create

duplicate references on their own. It is the responsibility of the regional sales and

marketing leaders to ensure that pertinent competitive information is provided to

the Corporate Marketing Department in a timely fashion.


Competitive sales brochures

Internet sites

Current comparison charts and internal sales training presentations

5.0 Definitions

Competitive Profile Document: A Word file containing product descriptions,

technical comparisons, pricing and sales strategy information received from

regional field activities.

Centralized reference files:

a. A hardcopy notebook and/or pentaflex file containing the Competitive Profile

Document and all available brochures, sales information, quotations, etc.

gathered from the field and/or received from the regional offices.

b. Electronic files containing timely information via e-mail or other electronic

format maintained by the Corporate Marketing Dept. Administrator.


Competitive Profile Document PLCM-018-01 01 3 of 8


6.0 The Body of the Document

Please see the attached file “Competitive Profile.”

7.0 Appendix


Competitive Profile PLCM-018-01 01 4 of 8

Competitive Profile

Company: Date:

Product:

I. Executive Summary a. Describe competitive threat (1 paragraph) b. Provide forecast for potential loss of market share c. Recommended response

II. Product Description a. Marketing brochure b. Sales materials gathered from field

III. Technical Comparison

Feature [Company] Given Imaging Comments

General Description

CapsuleModel [Product Name] PillCam SB Dimensions Weight Field of View Camera Type Imager Resolution LEDs Frame Rate Image Enhancements Other Functions Battery Type Battery Life End User List Price SoftwareName/Version

Key Messages Unique Features Same Features Viewing Speed Real Time Viewer Download Time Reading Time Size of Archive File Storage Medium Clinical Experience





Availability Price

Workstation Processor Speed Internal Memory Hard Disk Capacity External Storage Monitor Printer Type Tower Dimensions Data Recorder Dimensions Weight Capacity Memory Type LED Displays Power Data Recorder Battery Battery Type Battery Operating Capacity

Battery Charge Cycle Operating Voltage Charge Level Display Charge Level Indicator Typical Charging Period Weight

Li-Ion Battery Charger Charge Level Display Charge Configuration Charge Level Indicator Discharge Cycle Weight Dimensions Input Power Range

Data Recorder Belt Type Sizes

Sensor Arrays Small Bowel Esophageal

Real Time Viewer Configuration Software Capabilities





Optional Accessories Workstation Cart Portable Memory Drives

20” TFT LCD Flat Screen Monitor

DVD R/W

Applications Training Workstation Installation

Warranty Term System Coverage Service Support Direct Markets Distributor Markets Reimbursement Support

Services Available

ProfessionalEducation

Courses Available

Industry Activity Joint Ventures Marketing Alliances Society Support

Regulatory Approvals and Standards

IV. System Pricing a. Manufacturer’s List Price b. Quotations gathered from field

V. Competitor’s Sales Strategy a. Case histories from field b. Accounts won c. Accounts lost

VI. Distribution Channels a. Estimated installed base b. Direct markets i. Number of sales reps ii. Other products sold (describe)

c. Indirect markets




i. Number of distributors ii. Size of distributors

VI. Company SWOTs a. Overview

[Company] Given Imaging

Strengths Strengths

Weaknesses Weaknesses

Opportunities Opportunities

Threats Threats

b. Given Imaging Competitive Response

[Company] Given Imaging

Strengths Response

Given Imaging Given Imaging

Weaknesses Response




Given Imaging Given Imaging

Global Pricing Plan SOP

The purpose of this procedure is:

1. To assure a systematic preparation of the Product Pricing for any Product developed by the Company, or any OEM product offered for sale by Given as service to its customers, while taking into account all relevant costs, competition and long term profit margin considerations as well as senior management policy guidance.

2. To ensure the long term profitability of the Company’s products while minimizing exposure to currency risks.

3. To gain the endorsement of the prospective sales and marketing leaders in the company.

Global Pricing Plan


Product Pricing SOP PLCM-019-01 01 2 of 8


1.0 Purpose

The purpose of this procedure is:

1. To assure a systematic preparation of the Product Pricing for any Product

developed by the Company, or any OEM product offered for sale by Given as

service to its customers, while taking into account all relevant costs,

competition and long term profit margin considerations as well as senior

management policy guidance.

2. To ensure the long term profitability of the Company’s products while

minimizing exposure to currency risks.

3. To gain the endorsement of the prospective sales and marketing leaders in

the company.

2.0 Scope

2.1. The Product Pricing document is a controlled document.

2.2. All relevant Given functionaries listed In this SOP will participate in the

Product Pricing preparation process according to this SOP.

3.0 Responsibility

3.1. Corporate Marketing and Corporate Finance are responsible for the

implementation of this SOP for all the Company’s product.


Product Pricing SOP Document PPRSOP-1, Rev. 3.0

5.0 Definitions

Given Product: Any product, software, hardware or paper ware that is

developed, produced and sold by Given Imaging for its customers or for routine

use of Given support staff.

OEM Product: Any off-the-shelf product, software, hardware, or paper ware that

is sold by Given Imaging to its customers.




6.0 Procedure

6.1. Pricing of Given Products

6.1.1. Corporate Finance will maintain the Product Pricing Document with

assistance from the Product Team Leaders as shown in Appendix A. For

new product pricing or the periodic updating of existing prices, each

Product Team Leader will recommend product pricing changes for

products managed within his/her respective product line at least 120 days,

when possible, prior to the effective date of the product availability or field

pricing change (to allow for 90 day advanced notice to distributors).

The recommended pricing will be based upon cost input from the R&D

and Production Departments, on competitive benchmarks within each

distribution region, and on the long term profitability targets of Given

Imaging, then submitted for approval to Corporate Finance with a brief

explanation according to the templates attached in Appendix B. The

competitive benchmarks must include inputs from different marketing

departments throughout the Company, including subsidiaries and

distributors that are relevant to the specific pricing that needs to be

defined. The pricing recommendation should be consistent with market

research and marketing input from the field, on senior management

guidance and on other relevant input.

In case of OEM Products, the pricing will be based on the prevailing

market prices available in the market plus a gross margin that will ensure

the coverage of the handling cost, any modifications costs, plus an

average distribution profit. Pricing for OEM products should be reviewed

at no less than 6-month intervals to maintain a competitive relationship

with prevailing market prices. Each Product Team Leader is responsible

for maintaining competitive pricing of the OEM Products managed within

his/her respective product line.

Approval of recommended end-user, distributor and subsidiary transfer

pricing will be determined jointly by Corporate Finance and Corporate

Marketing in consultation and agreement with the President of Given

Imaging, Inc., and/or Corporate VP General Manager Europe, and/or

Corporate VP General Manager Japan, and/or Corporate VP General

Manager Asia/RoW. In the case of OEM product pricing, agreement




between Corporate Finance and Corporate Marketing (including the

Product Team Leader) will be sufficient in accordance with policies set by

Senior Staff, and can be accomplished by telephone.

Upon pricing approval as above, Corporate Finance will update the

Product Pricing Document as shown in Appendix A and distribute same

as confidential to Senior Staff, the Product Team Leaders, and the

Director of Customer Service (for implementation into SAP). Upon receipt

of the Product Pricing Document from Corporate Finance, Corporate

Marketing will then remove the cost information from the form and forward

the Product Pricing Document (without costs) to the Regions.

6.2. Regional Promotional Pricing

6.2.1. Corporate Finance and Corporate Marketing will jointly set levels of

authority to discount from the company’s end-user prices to be used by

the subsidiary senior manager for short-term promotions and individual

sales situations in the region, the net effect to be consistent with the

regional operating budget profit expectations and target average selling

price of each individual product. Prior to field announcement of the

promotion, the subsidiary senior manager will ensure that Corporate

Finance, Corporate Marketing (including Product Team Leaders), and

Director of Customer Service are properly notified of promotions using the

signature page and attachment shown in Appendix C. The Regional

Marketing Department will be responsible for obtaining signatures prior to

field announcement, and maintaining records of the signed documents.

At the subsidiary leader’s discretion, further discount authority policies

may be set within the subsidiary to enable timely decision-making from

sales and marketing managers in order to accommodate the needs of the

competitive environment, new product introductions, and periodic sales

promotions; provided, however, that the sum total of discounts does not

exceed the discounting authority of the subsidiary senior manager. Prior

approval to exceed the level of discounting authority by a subordinate

manager in any situation must be obtained from the subsidiary senior

manager.




For cases in which the business may require net discounts that exceed

the level set for the subsidiary, the subsidiary senior manager or designee

must discuss each case with the Product Team Leader to obtain

agreement on pricing and strategy prior to making an offer, who if in

agreement, will gain approval from the VP Finance (verbal approval will

be sufficient). Upon e-mail notification of approval by the Product Team

Leader, the subsidiary senior manager or designee will communicate with

the internal organization using Appendix C prior to receipt of an order from

the customer whenever possible so that the order can be processed when

received, or accompanying the order to help contemporaneously

communicate the competitive environment to the internal organization.

6.3. The pricing data is sensitive data and so is the pricing document, the

confidentiality of which should be kept to only those who need to know.

Product cost data shall not be shared outside of the Corporate offices

(including Corporate Marketing in Atlanta), and also only on a need to

know basis.

6.4. The final document should be kept in the archive as all controlled

documents.

6.5. While auditing marketing and sales functionaries of Given for relevant

information during the process of creating the Pricing Document, care

should be taken to control the distribution of pricing related documents,

draft or final and the awareness to their sensitivities by appropriate

warnings on the documents, instructions to shred when appropriate, and

appropriate notice to restrict the information to only those who need to

know.

7.0 Appendix

7.1. See attached Appendix A, Appendix B, and Appendix C

TH

IS S

PE

CIF

ICA

TIO

N,

AN

D/O

R T

HE

SU

BJE

CT

MA

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AR

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ES

TR

ICT

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US

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G L

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Pri

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oc

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t T

em

pla

te--

Co

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CO

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NT

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Pri

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g -

En

d U

se

r, T

ran

sfe

r a

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Dis

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rs

Da

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at

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(U

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r P

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Dis

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US

A (U

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(E

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L

A

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du

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xx

x

Pro

du

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yyy

Product xxx components

Product xxx component 1

Product xxx component .

Product xxx component .

Product yyy components

Product yyy component 1

Product yyy component .

Product yyy component .

TH

IS S

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Actu

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Cost

(L

td

.)R

eg

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Lo

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or €

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or €

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Document Title: Document No. Revision

Product Pricing SOP PLCM-019-01 01


Appendix C

Notice of Regional Promotion

CONFIDENTIAL

Name of Promotion ________________ From (Date) to (Date)

AUTHORIZATION

NAME/TITLE SIGNATURE DATE

Issued by: Name of Region

Regional Marketing

Approved by: Name of Region

Regional Leader


Regional Finance


Regional Sales

Approved by: Corporate

Chief Marketing Officer


Corporate Finance


Corp. Customer Service


Product Team Leader


Product Team Leader


Product Team Leader


Product Team Leader

Attach description including target customers, promotion description, product, pricing and duration (same as field notification). If a single sale, briefly describe the competitive situation and specify the date of approval notification by the Product Team Leader.

Global Training and Education SOP

This document provides the framework for the development, approval, revision and storage of training and educational materials in support of new product and/or product enhancement introductions.

Global Training and Education


Global Education Training Material Development PLCM – 023-01 01 2 of 6


1.0 Purpose

This document provides the framework for the development, approval, revision

and storage of training and educational materials in support of new product

and/or product enhancement introductions.

2.0 Scope

This procedure applies to all training and education materials intended for

distribution to Given employees, customers or their staff as they relate to clinical

or product content in an eLearning delivery medium/format. eLearning does not

replace interim training development (i.e. materials for trials, Announcements,

Regulatory Clearance, Product Availability, Limited or Full Launch), but is an

adjunct for “training on demand” and the fulfillment of subsequent training needs.

As such, other development centers may have their own T&D budgets to satisfy

training material development.

3.0 Responsibility

3.1 The Global Education Manager is responsible for the implementation of this

procedure and the following:

Coordinating with Product Line Leaders and Global Product Managers

on the identification of training and educational outcomes/objectives as

they apply to the learning constituency.

Obtaining from designated Subject Matter Experts (SME’s) assets and

content related to the development of training and education materials

to support product training.

Coordinating with the Global Regions for specific training

needs/requirements.

Working with internal resources, outside consultants and/or sourcing

and selecting qualified vendors for training program/materials creation.

Issuing P.O. to approved suppliers

Developing and producing training and education materials.

Obtaining necessary approvals

Disseminating Training and Education Materials.

3.2 Approvals

Refer to PRS




4.0 Definitions

4.1 Training and Education materials are any materials (print, audio, video,

digital or web based communication vehicles) intended to facilitate the

understanding, comprehension, usage of the Given platform. The primary

focus is product and clinical training designed for employees and

customers.

4.2 Project Requirements Specifications (PRS): A form controlled and used

by Given Imaging Global Marketing to define, initiate and revise Global

Education training materials or programs.

5.0 Procedure

Initiation of training or education materials:

5.1 Product Line Leaders or Global Region Representatives initiate a request

for Clinical or Product Training or Education Materials by completing a

PRS Form and submitting it to the Global Education Manager.

a. Originator proposes new or revised Training or Education material(s)

need by submitting a Project Requirement Specification (PRS) form for

initiation. Appendix A

b. Global Education Manager communicates with key stakeholders to

determine approval for initiation or rejection of the project.

i. If approved, the production schedule, budget, SMEs and project team is established and defined through coordination with originator and Global Education Manager.

ii. If rejected, the Global Education Manager communicates justification to the originator.

c. When PRS is approved, outside resources are identified and secured

and if appropriate a PO is issued

d. Training program materials are designed, developed and produced.

e. Training materials are reviewed, modified and/or approved by the

originator and designated review team

f. Final approval goes to Review Board for regulatory review of Labeling

g. Approved materials are disseminated to the field.




6.0 Appendix

Appendix A – Project Requirement Specification (PRS) Appendix B – Process Flow

Appendix A

PROJECT REQUIREMENT SPECIFICATION (PRS) Training Materials

Project Definition: To be completed by originator

Project Title

Region(s) supported

Target audience

Objective

Description with Key Message

Intended use

Content owner

Deadline for delivery

Quantity (Inc., Int’l, KK)

Language requirements

PROJECT INITIATION APPROVAL (Print & Sign Name) DATEPRS Submitted by

PRS Accepted by (Global Education Manager)

REVIEWER APPROVALS (Print & Sign Name) DATEClinical Marketing

Marketing Communications

Finance

Regional Marketing Organizations Inc., International, KK (as needed)

Product Line Management SB, ESO, COLON, Platform (as

needed)

InScope (as needed)

Other Reviewers (as needed)

PRODUCTION SPECIFICATIONS Vendor

Size

Material

Graphics & Design Elements

Within Style Guide

Part Number (US & Global)




FINAL PRODUCTION APPROVALS (Print & Sign Name) DATEChief Marketing Officer

Regulatory Affairs

MARCOM INSPECTION Delivery Date & Location

Inspection Date

Approved By (Print & Sign Name)




Appendix B – Process Flow

Initiator sendsPRS to GEM

GEM reviews PRS with Stakeholders

Approval

ProjectScope,Team,

Budget, Timeline

Defined and Approved

YES

NO

Decision communicated

to initiatorOutside

Resources Identified Secured;

PO Issued

ProgramMaterials

Developed/Produced

MaterialsReviewed/ Modified/ Approved

MaterialsDisseminated

Regulatory Approval

Global Launch Package SOP

The purpose of this document is to describe the content of the Global Launch Package, which will be used by the regional and corporate marketing teams as a product reference and to help organize roll-out plans.



Global Launch Package PLCM-025-01 01 2 of 4


1.0 Purpose

The purpose of this document is to describe the content of the Global Launch

Package, which will be used by the regional and corporate marketing teams as a

product reference and to help organize roll-out plans.

2.0 Scope

The Global Launch Package is required by the regions as far in advance as

possible prior to product availability, but not less than 60 days prior to a regional

product release. Information that cannot be supplied in this timeframe due to

Regulatory uncertainties or other possible unsettled claims or product

positioning/performance issues should be supplied in periodic updates as soon

as the uncertainties are resolved. Distributor information such as product name,

description, part number, distributor cost, end-user price, expected availability

date, etc. should be provided to regions in indirect markets not less than 3

months in advance of product availability so that proper notification can be

provided to the distributors.

3.0 Responsibility

The responsibility to create the Global Launch Package is with the Corporate

Product Line Leaders in conjunction with the Regional Marketing Leaders.


1) Product Release Document from Corporate Product Management.

2) New Product Release Document from Corporate Customer Support.

5.0 Definitions

The Global Launch Package should be one comprehensive document that

contains the primary information needed to assist a region in preparing for the

product release. The components described below may be contained in a single

binder (hard copy) and/or electronic files.

6.0 Body of the Document




The Global Launch Package should consist of:

Product Description

o Product Description

o Functioning Principle

o Technical Specifications

Logistics

o Order Part Numbers

o Availability

o System Components, End User Packaging

Marketing

o Brand Name

o Unique Selling Proposition and Key Messages

o Market Positioning

o Target Market

o Market Profile (# accts, etc.)

o Launch event (e.g. DDW, ACG, UEGW, etc.)

Pricing:

o Standard End User Prices (supplied by Corp. Marketing)

o Distributor Transfer Prices (supplied by Corp. Marketing)

o Promo Packages (supplied by Regions in coordination with Corporate Finance)

Training Material

o Product and Sales Training Material

o Medical Application

o Clinical Support / References

o Demo Cases on CD/ DVD

o FAQ´s

Price

Performance




Service Support (supplied by Corporate Customer Support Dept.)

o Service Concept

o Service Training Materials

o Spare Parts (prices, part numbers, availability, handling with supplier for warranty, complaint process)

MarCom Materials

o Product Brochure

o Flyers

o Sales Collaterals, etc.

Communications Plan

o PR

o Advertising

o Website, etc.

Registration (CE mark, FDA, etc.)

Competition (Competitive Profile Documents)

o Description of main competitors and their products

o Strengths and weaknesses

o Comparison to our products

7.0 Appendix

Field Testing SOP

The purpose of this procedure is to establish clear and effective guidelines for the testing of new products prior to their market release. This procedure covers the logistics, technical support and data collection processes affiliated with the field testing of products.

External Evaluation Release SOP

This procedure defines the process and steps required for preparing and approving external evaluation of products designed and developed by Given Imaging. External evaluation of a product is an integral part of the design process, and as such its pre-requisites are defined in the Design and Development Outputs

External Evaluation Release


External Evaluation ReleasePLCM-022-01(PLCM-736-1)

1 2 of 5


1.0 Purpose

This procedure defines the process and steps required for preparing and

approving external evaluation of products designed and developed by Given

Imaging. External evaluation of a product is an integral part of the design

process, and as such its pre-requisites are defined in the Design and

Development Outputs (QA-733)

2.0 Scope

This procedure is applicable for all Given Imaging products except capsules

(PillCom). This procedure is not for clinical trials.

3.0 Responsibility

3.1 QA & RC Director is responsible for the implementation of this procedure.

3.2 V.P. R&D has the responsibility for all development activities and the

product readiness for External Evaluation.

3.3 Director Platform Products has the responsibility of planning, coordinating

and executing the External Evaluation.

3.4 Region Marketing Manager has the responsibility of communicating the

External Evaluation to the end customer.

4.0 Definitions

4.1 PID: Product In Development

4.2 External Evaluation Release: Release of a PID to an external site for

purposes of evaluation and end user feedback.

4.3 End (Customer) user: the end user of the PID to be evaluated. Clinic,

Hospital, Physician.

4.4 Beta Site: Evaluation site that agreed with Given Imaging to be the

product evaluator.

4.5 DHF – Device History File.



1 3 of 5



5.1 QA-730-1 Design and Development.

5.2 QA-732-1 Design and Development Inputs.

5.3 QA-733-1 Design and Development Outputs.



6.0 Procedure

6.1 Delivery of a PID to end user for External Evaluation will be done only

after approval of QA & RC Director, using a standard form F-736-1a

6.2 PID approval will be valid only for a particular units/software version

destined to particular end user/s as listed in PID for External Evaluation

Delivery to Beta Site using form F-736-1c.

6.3 The PID documentation and attached documents (forms F-736-1a,b,c,d)

will be the record that the PID was delivered under controlled condition

and will be filed in the DHF.

6.4 An External Evaluation Plan will be prepared before the release of PID for

external evaluation. The External Evaluation Plan requirements are

defined in form F-736-1b. The External Evaluation Plan will be prepared

by R&D Project Manager and approved by the Director Platform

Products.

6.5 The Director Platform Products will be responsible for preparation of

Evaluation Agreement with evaluation site, and obtaining the end

customer signature for this agreement before installation or delivery of

the product to the site. The Program Manager should use the help of the

Marketing Manager Representative at the evaluation site.

6.6 The Director Platform Products, will sign form F-736-1c taking

responsibility for getting the signature of the End User (Customer)

agreement form F-736-1d or for an equivalent evaluation agreement,

before the delivery/installation of the product for External Evaluation.



1 4 of 5


6.7 Delivery or installation of PID will be controlled by Customer Support via

PSR (Product Service Report) open in the SR (Service Request) in SAP.

6.8 The R&D Project Manager is responsible for supporting the External

Evaluation process and following-up on its results. An External Evaluation

Report will be prepared by the R&D Project Manager.

6.9 The Director Platform Products is responsible for updating (or removing)

the product at the evaluation site after the External Evaluation is

completed and a nominal product upgrade is available, but no later than 6

month after External Evaluation Plan was completed.

*************

Stage 4: Marketing Support of Sales (Regional Launching Process)

Detailed Stage Description: Marketing Support of Sales

Marketing Support of Sales Flowchart

Gate P4: Product Launch Deliverables

Marketing Support of Sales Flowchart

Marketing Support Sales Flowchart

Marketing support sales(Regional launch readiness)


LOCAL LAUNCH & OFFERING MANAGEMENTLEADER

- Regional Product Mgr- RACA (Global & Local)

APPROVAL

- Head of Geography- Product Line Director

Create and implement a successful product or major release launch plan at the regional level.The expected output are: Local launch plan and timeline

Local Launch & Offering Management

90 Days including at least 30 Days Post Launch

Develop marketing & sales support communications in conjunction with product

launch.

The expected outputs are: Effective sales and marketing communications

MARKETING SERVICESLEADER

- MarCom

APPROVAL

- Global Marketing- Regional Sales & Marketing Management- RACA

- Legal/IP (Internal or External as required)- MarCom

Local launch

PRODUCT SPECIFIC KOLSLEADER

- Regional Marketing Director

APPROVAL

- Global Marketing- Regional Geography Leader

Marketing Services

60 Days

To establish product pricing by region that meets both product placement & Global profitability objectives.The expected output is: Effective pricing plan.

Pricing Plan

15 Days

PRICING

LEADER

- Regional Marketing Director

APPROVAL

- Finance- Global Marketing- Regional Geography Leader

To identify and manage local product KOLs can represent Given products at training and trade show events as well as function as advisory panelThe expected output is: Active list of Product KOLs.

Product specific KOLs

OnGoing

?Gate P4


To identify and manage local product KOLs can represent Given products at training and trade show events as well as function as advisory panel

• Identify local product KOLs based fit of clinical expertise to product as well as name recognition and quality of company representation

• Training KOLs on product knowledge & presentation skills

• Manage KOL relationship and activities to keep relationship healthy and maximize benefit to Given Imaging

Recommendations from medical peers, sales representatives and other employees/partnersTraining materials and programs designed to improve impact of KOL

Detailed Stage Description: Marketing Support of Sales


Marketing Services Pricing

Objective(s)

Create and implement a successful product or major release launch plan at the regional level

Develop marketing & sales support communications in conjunction with product launch

To establish product pricing by region that meets both product placement & Global profitability objectives

Process(es)Em

ployed

• Meet local regulatory requirements• Development of Local Pricing and

Distribution Promotions• Develop local trade show product

introduction plan• Conduct sales training• Conduct training for local support

personnel

• Develop product brochures and sales flyers

• Develop trade show strategy and collateral

• Develop other sale tools as required

• Develop PR, Advertising, Media, website and communications plan

• Develop local/regional pricing policies

• Develop promotional pricing to support sales and placement objectives

RequiredInputs

Global Launch Package (Commercialization Plan)

Global Launch Package (Commercialization Plan)Local Launch PlanField Sales needs/desires for product and sales support materials

Global Launch Package (Commercialization Plan)Product Business CaseCorporate Strategy Financial Objectives for profitability and sales

Detailed Stage Description: Marketing Support of Sales (page 2 of 3)

Regional Marketing Director

Product Line DirectorBusiness Partners (JNJ & Distributors)Regional Product MgrRegional RACA

Clinical Marketing

At launch and then Ongoing


Leader (R/R, Frequency ofEngagem

ent, Deliverables)

Regional Product MgrRACA (Global & Local)

MarCom Regional Marketing Director


Product Line DirectorRACA (Global & Local)Clinical MarketingTraining Business Partners(JNJ & Distributors)Local Operations Team

Product Line DirectorRegional Marketing MgmtRegional Sales MgmtRACA (Global & Local)Clinical MarketingTraining Business Partners(JNJ & Distributors)

Product Line DirectorFinanceRegional Product MgrReg Sales Management

Contributor(s)

Internal/External

Field Sales – Direct & Distributors Reimbursement

Customer SupportOperationsPR Organization

Sales Admin (Ops)Reimbursement

Estimated

Time Fram

e

90 Days including at least 30 Days Post Launch

60 Days 15 Days



Detailed Stage Description: Marketing Support of Sales (page 3 of 3)

Regional Marketing & Sales

Global MarketingRegional Geography Leader

Active List of Product KOLs

• Good relationships with KOL’s• KOL engagement in representation

of company and products



Regional Marketing & Sales MarCom Regional Marketing & Sales

RequiredA

pprovals

Head of GeographyProduct Line Director

Global MarketingRegional Sales & Marketing ManagementRACALegal/IP (Internal or External as required)MarCom(per Review Board SOP)

FinanceGlobal MarketingRegional Geography Leader

ExpectedO

utput

Local Launch Plan and Timeline Effective Sales and Marketing Communications

Effective Pricing Plan

Metrics to

Measure Success

• Product Sales Volume and Revenue

• Market Share

• Sales/Regional feedback on communications effectiveness

• Budget adherence

• Product Sales Volume, Revenue, Global Profitability

• Market Share

Notes

• Inventory management note for metrics was general metric for all launch/implementation activities• Global Launch package includes final Commercialization Plan – clarify in Launch Template• Global Launch package includes Product Release document• Product Release document (PR) should include all product descriptions and pricing- No separate doc from CS



Gate P4: Product Launch


Regional Launch Plans Regional Launch Plan PLCM-026-01

Product Release PLCM-024-01

Labeling Creation and Production

PLCM-020-01

Project Requirement Specification (PRS)

PLCM-028-01

Regional Training Global Training and Education PLCM-023-01

Regulatory Approvals

Marketing Support of Sales PLCM-035-01

Regional Launch Plan SOP

The purpose of this document is to describe the content of the Rgional Launch Package, which will be used by the regional and corporate marketing teams as a product reference and to help organize roll-out plans.

Regional Launch Plan


Regional Product Launch Plan PLCM – 026-01 01 2 of 3

Given Imaging CONFIDENTIAL 4/11/2007

Regional Product Launch Plan

CONFIDENTIAL

Given Imaging


Regional Product Launch Plan PLCM – 026-01 01 3 of 3

Given Imaging CONFIDENTIAL 4/11/2007

TABLE OF CONTENTS Page

I. Executive Summary

II. Key Launch Milestones

III. Product Description A. Technical Description B. Clinical Support and Messaging C. Marketing Messaging and Strategy

IV. Product Launch Strategy, Goals and Objectives

V. Pricing Strategy A. Direct Markets B. Indirect (Distributor) Markets C. Promotional Strategy

VI. Launch Risks

VII. Competitive Landscape and Positioning

VIII. Launch Action Plan

A. Sales Support (Launch Binder Creation) i. Product Information ii. Clinical Support iii. MarCom Support iv. Competitive Information v. Etc……

B. Training i. Sales and Distributor Training ii. Support Staff Training iii. Customer Training

C. Customer Installation/Upgrade Plan D. Reimbursement and Economic Action Plan E. MarCom Support

i. Marketing Collateral ii. Trade Show Participation iii. Clinical Marketing Support iv. PR, Media, Web, etc. Action Plans

F. Operations Support i. Product Availability ii. Inventory Transition iii. Sales Quotation/Ordering

1. Pricing Details 2. Part numbers/BOMs

iv. Product Shipment

IX. Appendix A – Customer base details B – XXXXXXX C – YYYYYYYY

3

Product Release SOP

Product Release


Product Release Template PLCM-024-01 01 2 of 3

Note: Specifications are subject to change without prior notice and without any obligation on the part of the manufacturer.


© 2006 Given Imaging Ltd. 28-Jun-06

Product XX – Product Release

Product Description

Product Name and Branding

The names for the components of this system are:

Indications/Contraindications

IndicationsContraindications

Product Pricing

Product Specifications

Details on product and procedure

Product Documentation

Packaging Information

Product Marketing Information

Product Positioning

Marketing Message

Competitive Environment Description

Product Training Requirements

Employees Customers

Product Support Information

Warranty Repairable Parts Non-Repairable Parts Shipment Policies Packaging for Shipment Product Documentation Policy: Support Contact Information


Product Release Template PLCM-024-01 01 3 of 3

Note: Specifications are subject to change without prior notice and without any obligation on the part of the manufacturer.


© 2006 Given Imaging Ltd. 28-Jun-06

Availability

Launch Product shipping by

Product Ordering Information:

Description Ordering P/N Lead Times

Product A FGS-XXXX X-Y Weeks Product A Accessory FGS-XXXX X-Y Weeks

Labeling Creation and Production SOP

This SOP controls the creation, approval, revision, and controlled document storage of product labeling and marketing communication materials at Given Imaging USA for the US and Global marketing organization.

This procedure applies to the following:

1. All labeling and marketing materials that are intended for distribution to customers or non-Given employees.

2. All Marketing communication Materials intended for internal distribution.

Labeling Creation and Production


Labeling Creation and Production PLCM-020-01

(MK-07)01 2 of 7

1.0 Purpose and Scope

This SOP controls the creation, approval, revision, and controlled document storage of

product labeling and marketing communication materials at Given Imaging USA for the

US and Global marketing organization.

This procedure applies to the following; All labeling and marketing materials that are intended for distribution to customers

or non-Given employees.

All Marketing communication Materials intended for internal distribution.

This procedure does not apply to labeling included with the product. This is

controlled by Product Management.

2.0 Definitions

2.1 Labeling is any material that is intended to be included with or supplemental to

the finished, packaged, and labeled device. This includes product brochures

(printed or digital), and web sites/pages that describe the product performance

characteristics. Approved label materials shall conform to 21 CFR, part 801,

subpart H and meet the requirements of the current version of the Corporate Style

Guide (GMB-0023).

2.1.1 Marketing Materials (MarCom Materials): A MarCom Material is defined

as any Marketing communication that does not make a product claim and

is NOT to be included with or supplemental to the finished, packaged,

and labeled device. Examples of MarCom materials can include

brochures, fliers, conference invitations, e-mail invitations, etc.

2.2 Project Requirements Specification (PRS): A form controlled and used by the

MarCom Department of Given Imaging to define, initiate and revise a MarCom

material development or production project.

2.3 Corporate Style Guide: The Given Imaging, Ltd., marketing style guide outlines

guidelines relative to design and layout of Labeling and MarCom materials. The

current version of the Style Guide GMB-0023 is controlled by Corporate

Marketing. Exceptions to the Style Guide may be accepted on a per-project basis

after discussion.



(MK-07)01 3 of 7

3.0 Responsibilities

3.1 The Director of Marketing Communications, Given Imaging, Ltd. is responsible for

the implementation of this procedure and the following:

coordinating with global regions, when appropriate

obtaining necessary approvals

developing and producing Label and MarCom materials and specifications

responsible for developing the electronic file along with the documentation for

part numbers

responsible for receiving inspection of MarCom materials

3.2 Materials Management is responsible for P.O issuance to approved suppliers,

stocking, storing, and distributing Labeling and MarCom materials.

3.3 QA is responsible for Receiving Inspection of Labeling received in Atlanta.


Appendix A Project Requirements Specification

Appendix B Process flow

Form Number F-06-1 Request for New/Change Part Form

5.0 Procedure

Initiation of Labeling or MarCom materials:

5.1 Anyone in Given Imaging can initiate a Label or MarCom material request by

filling out a PRS Form and submitting it to the Corporate Marketing

Communications Department.

a. Originator proposes new or revised material to Corporate Marketing

Communications (MarCom) department by submitting a Project Requirement

Specification (PRS) form for initiation. (Appendix A)

b. MarCom department communicates with key stakeholders to determine

approval for initiation or rejection of the project.

i. If approved, the ownership, timeline, budget, content expert and

project team is established and defined by originator and MarCom

department.

ii. If rejected, MarCom is to communicate a justification to the originator.



(MK-07)01 4 of 7

c. When PRS form INITIATION is approved, a New/Change Part Number form is

generated and submitted by the MarCom Department.

d. MarCom provides the originator or other approving entity with a

quote/estimate from an approved vendor to determine if MarCom should

proceed with the production of a proof.

i. MarCom generates an expense PO for design cost.

e. MarCom proceeds with the design of a proof and approval for

printing/production.

i. Content is reviewed during development by MarCom and key

stakeholders.

ii. Part Number will be printed on the material.

iii. Proof will be generated within Style Guide and material specifications

outlined in the PRS form.

iv. MarCom will call a regular meeting for designated reviewers to discuss

and approve (with or without changes) or reject materials.

v. MarCom will send minutes from this meeting delineating approvals

and any required edits necessary for approval.

vi. After required edits are completed, MarCom will verify that all required

edits have been incorporated and sign the PRS VERIFICATION OF

EDITS.

vii. Proof will be circulated for review for FINAL PRODUCTION

APPROVAL as indicated on the PRS form.

viii. Once MarCom receives FINAL PRODUCTION APPROVAL, the local

purchasing process is followed.

ix. MarCom department will keep all records of PRS forms, Part Number

Requests, proofs and specification documents.

x. Final production files and hard copy sample will be maintained by

MarCom department in an archive file for document control.

f. Incoming Inspection of Labeling and Marketing Materials

i. Labeling materials are reviewed by local QA and Marketing

departments.

ii. MarCom materials are reviewed by local Marketing department.



(MK-07)01 5 of 7

6.0 Approvals Refer to PRS Form (Appendix A)



(MK-07)01 6 of 7


Project Title

Region(s) supported

Target audience

Objective


Intended use

Content owner




PROJECT INITIATION APPROVAL (Print & Sign Name) DATE PRS Submitted by

PRS Accepted by (MarCom)

REVIEWER APPROVALS (Print & Sign Name) DATE Clinical Marketing



Product Line Management SB, ESO, COLON, Platform (as needed)

InScope (as needed)



Size

Material


Within Style Guide


FINAL PRODUCTION APPROVALS (Print & Sign Name) DATE Chief Marketing Officer

Regulatory Affairs


Inspection Date


Appendix A



(MK-07)01 7 of 7

Appendix B

MarCom Department

reviews PRS with key stakeholders

Proceed?

Initiator sends PRS to MarCom

Department

Decision is communicated to

initiator

Project scope, budget and timeline are defined and approved

Marcom Department requests part

number

MarCom creates design and sends proof to reviewers for regular meeting

discussion and approvals

PRS is circulated for final production

approval

MarCom obtains edits and/or approvals

Local purchasing process is followed.

PRS form, design files and final

document specification are filed

QA & local Marketing verifies quality from specifications

and proof.

Yes

No

MarCom creates PR/PO for design

cost

MarCom makes edits and verifies

incorporation

Project Requirement Specification (PRS) SOP

Project Requirement Specification (PRS)

Q ( )Marketing/Training Materials PLCM-028-01

Page 1 of 1


Project Title

Region(s) supported

Target audience

Objective


Intended use

Content owner




PROJECT INITIATION APPROVAL (Print & Sign Name) DATEPRS Submitted by

PRS Accepted by (MarCom)

REVIEWER APPROVALS (Print & Sign Name) DATEClinical Marketing



Product Line Management SB, ESO, COLON, Platform (as needed)

InScope (as needed)



Size

Material


Within Style Guide


FINAL PRODUCTION APPROVALS (Print & Sign Name) DATEChief Marketing Officer

Regulatory Affairs


Inspection Date


Marketing Support of Sales SOP

This procedure defines the process for creating the documents, tools, and support materials necessary for a successful product or major software release launch at the regional level.

Marketing Support of Sales


Marketing Support of Sales PLCM-035-01 01 2 of 3


1.0 Purpose

This procedure defines the process for creating the documents, tools, and

support materials necessary for a successful product or major software release

launch at the regional level.

2.0 Scope

This procedure applies to regional activities related to all product launches

including major software version releases.

3.0 Responsibility

3.1. The Regional Marketing Director is responsible for the implementation of

this procedure.

3.2. The Regional Product Manager is responsible for all product and major

software release launch development and implementation activities.

3.3. Corporate Director of Marketing Communications is responsible for

development and production of marketing and sales support

communications and tools related to the launch activities.



4.2. Product Business Case Template


4.4. KOL Database Template

5.0 Definitions




5.2. Regional Launch Plan - launch plan at regional level including

regional pricing and promotion strategy, product introduction strategy,

product training activities, etc.

5.3. Product KOL - Physician Key Opinion Leader who can represent the

product in support of launch and educational activities.


Marketing Support of Sales PLCM-035-01 01 3 of 3


6.0 Procedure

6.1. The Product Line Director delivers the Global Launch Package to the

Regional Product Manager.

6.2. The Regional Product Manager develops complete product launch plan

utilizing the Regional Launch Plan Template.

6.3. The Corporate Director of Marketing Communications develops and delivers

the marketing and sales support communications as required per the

Regional Launch Plan.

6.4. The Regional Marketing Director develops a product pricing plan that

supports both the product placement and global profitability objectives, in

coordination with Corporate Finance.

6.5. The Regional Marketing Director identifies local Product KOLs and the

Regional Product Manager manages their activities.

6.6. The Regional Product Manager executes the Regional Product Launch Plan

through to completion, while providing feedback to the Corporate Product

Line Leader.

6.7. The Regional Product Manager monitors the success of the product launch

utilizing achievement of product placement and profitability objectives as

primary metrics of launch success. This information is reported back to the

Corporate Product Line Leader to modify ongoing work as necessary.

7.0 Appendix

Stage 5: Ongoing Management and Roadmap Steering

Detailed Stage Description: Ongoing Management and Roadmap Steering

Gate P5: Product Progression and Customer Satisfaction Deliverables

Gate P6: Product End of Life (EOL) Deliverables

Product End Of Life (Obsolescence)

1. Controlled phase-out of product from market

2. Sustain customer satisfaction during EOL process (CS, replacements, warranties)

3. Comply with regulation concerning EOL requirements

4. Ensure smooth business transition (inventories of material and FGS, production line resources

5. Ensure customer loyalty continuity

1. Plan End of Life (EOL) process 2. Forecast EOL 3. Plan production scale-down 4. Plan CS transition (FGS inventories

@ Ltd and regions, spares and options, tech-support)

5. Design EOL strategy & announcement

6. Plan EOL marketing package:• EOL “promos”• Replacement offerings• Messages

Detailed Stage Description: Ongoing Management and Roadmap Steering

Capture and Resolve Product Quality and Use Issues

Install Base Management Products Ongoing Incremental Improvements

Objective(s)

Market/user oriented1. Collect/track field/use quality issues2. Follow field/use quality issue trends 3. Analyze quality cause-effect (tech,

use)4. Define solutions/mitigationsProduction/product oriented5. Collect/track manufacturing quality

issues6. Follow manufacturing quality issue

trend7. Analyze manufacturing quality

cause-effect (design, process)8. Define solutions/mitigations

1. Product (version) deployment picture (customer/region) to support customer satisfaction management and efficiency

2. Installed base customer profile, use trend (application, quantities, demography) to provide input for business improvements

1. Improve customer satisfaction2. Improve profitability/productivity/

cost-effectiveness/utilization3. Respond to competition

Process(es)Em

ployed

1. Gather quality data• Hierarchical SR system (Call-

center, DB, templates)• Track incoming inspection

results (supplier quality) and supplier audit; production performance quality

2. conduct monthly FFF (Field-Failure-Forum)

3. Problem oriented dedicated task/activity

4. create Product line level solution plan and processes for execution and follow-up

1. Set-up and maintain customer data base for sales, installation and maintenance system (personnel, training, infrastructure)

2. Produce and analyze sales/trends/performance reports from SAP

3. Set-up and maintain customer data base for sales, installation and maintenance system (personnel, training, infrastructure)

4. Produce and analyze sales/trends/performance reports from SAP

1. Collect and track end-user suggestions/requests (ideabox)

2. Follow SR and production trends3. Collect and track sales/CS/

marketing suggestions/requests4. perform Customer (satisfaction/

trend) surveys5. Analysis of production costs6. Analysis of market/sales trends/

performance7. Product annual review (?)8. Improvement implementation

(plan, execution)9. Annual plan

Detailed Stage Description: Ongoing Management and Roadmap Steering (page 2 of 3)

1. Given Roadmap2. Supplier roadmaps3. IB data4. Inventory levels (materials, FGS)5. Competition data6. Marketing event data7. Finance report

PL-manger –(part of PLC plan)

• Global Marketing,• CS, • Operation• Finance• R&D, • Suppliers• Regions

QA

According to PLC plan (roadmap)


RequiredInputs

SRs, DB, FFF, Incoming-Inspection data, Production-Performance data, Supplier-Audit-data

1. Sales data (SAP)2. TS data (SAP)3. Customer master data

1. Ideas database2. Sales performance3. BOM cost4. Competition data5. FFF

Leader

QA CS – cont.CS + Finance – cont.

PL-manger - cont


• QA, • R&D, • CS, • PL manger, • production, • finance• Distributor, • subsidiaries, • supplier

• Finance, • PL• Subsidiaries,• Distributors

• Production• Clinical marketing• CS and production• Clinical marketing• Production• R&D

Contributor(s)

Internal/External

• R&D• Finance• Sales administration

Estimated

Time Fram

e

context Continuous Later than 6 months after product launch



Detailed Stage Description: Ongoing Management and Roadmap Steering (page 3 of 3)

Product line life-cycle budget dedicated to EOL activity

1. COO2. VP Global Marketing3. Regions

1. EOL process plan2. EOL forecasts3. Production scale-down plan4. CS transition plan (FGS inventories

@ Ltd and regions, spares and options, tech-support)

5. EOL strategy & announcement6. Marketing support:

• EOL “promos”• Replacement offerings

7. Messages

1. Low dead inventories2. Sustained customer satisfaction3. Sustained customer loyalty



1. Infrastructure (MPWR/”SAP”)2. Infrastructure (MPWR/”SAP”)3. Product line life-cycle budget

dedicated sustained engineering resources

4. Context specific ad-hoc resources

Infrastructure R&D if relevantManufacturing if relevant

RequiredA

pprovals

Context dependent:GLBL marketing, Finance, Region

1. COO2. VP Global Marketing

ExpectedO

utput

Quality issue solutions/mitigations 1. 1.Reliable IB configuration (HW/SW) Database

2. Usage/sales trends

Product improvement program

Metrics to

Measure Success

Customer satisfaction, Quality issue trends (FFF)Time-to-solution?

1. Average time to solutions2. CS cost-effectiveness3. PL-manager satisfaction

Meet annual improve. plan objectives (time, budget)



Gate P5: Product Progression and Customer SatisfactionFrom Product Launch to On-going Sales


Departmental Feedback(such as Customer Feedback Evaluation, Usage/Sales Trends)

CAPA - Corrective and Preventive Action

PLCM-030-01

Field Modification PLCM-031-01

Installed Base Report Format PLCM-033-01

Product Improvement

CAPA - Corrective and Preventive Action SOP

The purpose of this procedure is to provide the method for initiating and implementing corrective and preventive actions (CAPA) to maintain and improve the quality of Given Imaging operations.This procedure applies to all aspects of the quality systems at Given Imaging that are not specifically controlled by other systems (e.g. change order, product improvement ideas, etc.).

CAPA - Corrective and Preventive Action


Corrective and Preventive Action PLCM-030-01

(QA-852-2)

2 2 of 5


1.0 Purpose

The purpose of this procedure is to provide the method for initiating and

implementing corrective and preventive actions (CAPA) to maintain and improve

the quality of Given Imaging operations.

2.0 Scope

This procedure applies to all aspects of the quality systems at Given Imaging

that are not specifically controlled by other systems (e.g. change order, product

improvement ideas, etc.).

3.0 Responsibility

3.1. The QA Director is responsible for implementing this procedure, for managing

the CAPA process through completion, and ensuring employees are trained

on the CAPA system.

3.2. All company employees are responsible to initiate a corrective/preventive

action when deficiencies and/or problems are detected.


4.1. F-852-2-1 Corrective/ Preventive Action form

4.2. F-852-2-2 Corrective/ Preventive Action log form

4.3. QA-423-02 Document Change Control procedure

5.0 Definitions

5.1. Corrective action: Action been taken after non-conformity was detected in a

product or a process. Typically initiated as a result of field service problems,

customer complaints, internal/external audits, management reviews, product

manufacturing/inspection etc..

5.2. Preventive action: Action taken to eliminate the cause of a potential non-

conformity, defect, or other undesirable situation in order to prevent

occurrence

5.3. CAPA - Corrective and Preventative Action



(QA-852-2)

2 3 of 5


6.0 Procedure

6.1. The need for CAPA may rise from different sources, such as field service

problems, customer complaints, internal/external audits, management

reviews, product manufacturing/inspection etc..

6.2. Any employee may initiate a request for CAPA by completing the CAPA

Request Form, attaching any applicable documents, and forwarding the

completed and signed form to the QA Director.

6.3. The QA Director evaluates the request for completeness and rationale. If

accepted, the QA Director assigns the request a number per the CAPA Log.

6.4. If the rationale is questionable, the QA Director meets with the initiator or

other appropriate individuals to gather additional data before deciding whether

to accept or reject the request.

6.5. The QA Director forwards the accepted and numbered CAPA request to the

responsible department manager for analysis and action. As applicable, the

department manager may initiate a department-specific or management

meeting to discuss the request and identify corrective action(s) to be taken.

The meeting participants will be invited according to the nature of the request.

When deemed necessary, the initiator may be invited to the meeting to

discuss the request.

6.6. The department manager submits a working plan to the QA Director, including

a date for implementation and efficacy verification.

6.7. The department manager validates the corrective action to ensure it is

effective and does not adversely affect the finished product/process.

6.8. After validating, the department manager implements the corrective action;

ensuring information is disseminated to those directly responsible for the

quality of the product/process. Action(s) taken is documented on the CAPA

Request Form. When changes are required to a policy or procedure, a

document change request is submitted according to QA-423-02.

6.9. The department manager signs and dates the CAPA Request Form,

approving the corrective action, and submits the signed form to the QA

Director for verification.

6.10. The QA Director is responsible for efficacy verification of the corrective action,

recording the effectiveness of the action on the CAPA Request Form. If



(QA-852-2)

2 4 of 5


effective, the QA Director closes the CAPA by signing and dating the request

form and notifying the department manager, initiator and other appropriate

parties of the closure, and providing the department manager with a copy of

the completed CAPA Request Form.

6.11. If the CAPA is directly related to an SR, a copy of the completed CAPA form

is electronically linked to the SR when the SR is closed.

6.12. If the corrective action proves to be ineffective, the QA Director marks the

form accordingly and returns it to the department manager for further action.

6.13. If the CAPA was initiated due to a customer complaint and the customer

requested a desire to be updated regarding actions taken, it is the

responsibility of the QA Director to contact the customer.

***************

Field Modification SOP

The purpose of this procedure is to provide clear and effective guidelines for handling of Field Modifications to ensure customer satisfaction and compliance with all regulatory requirements.

Field Modification


Field Modification PLCM-031-01 01 2 of 4


1.0 Purpose

The purpose of this procedure is to provide clear and effective guidelines for

handling of Field Modifications to ensure customer satisfaction and compliance

with all regulatory requirements.

2.0 Scope

2.1. This procedure applies to all products supplied by Given Imaging and it covers

the activities and processes needed to implement Field Modifications.

2.2. Field Modifications can be the result of software updates, corrective actions,

etc.

3.0 Definitions

o FMI: Field Modification Instructions

o Corrective and Preventative Actions (CAPA): actions taken to eliminate known or potential causes of nonconformities.

o ECO: Engineering Changing Order

o Service Request (SR): Notification to record Customer Inquiries.

o SAP: Database

o PM: Corporate Product Management

o CS: Customer Support

4.0 Reference Documents


5.1 It is the responsibility of the Director of Customer Services to implement and

maintain this procedure and to manage the Field Modification process

through completion.

5.2 It is the responsibility of all Given Imaging Customer Support personnel to

read, understand, and comply with this procedure.




6.0 Field Modification Procedure

6.1. Once a Field Modification is necessary, a committee including but not

necessarily limited to Product Management. Marketing, QA, R&D, Operations

and CS will decide the appropriate method(s) to perform the modifications in

the field.

6.2. For the same Field Modification, the implementation may vary according to the

needs of the different Regions.

6.3. Product Management will define the kit

6.4. Based on the method/s adopted, the kit containing all the necessary materials

and instructions will be prepared by Given Operations in coordination with PM

and CS.

6.5. Whether the FM is mandatory or not, a list containing all the materials to be

modified in the field will be prepared by CS.

6.6. Corporate CS will train and instruct Regional CS & PM teams on the

modification process.

6.7. Field Modification:

- If the modification will take place at the Customer site by the Customer, the

kit will be sent to the customer account. The Regional Customer Support

team will be ready to provide online support in case it is needed.

- If the modification will take place at the Customer site by Given personnel or

a third party contracted by Given, a training session or written instructions

will be arranged prior to the implementation in the field.

- If the modification cannot be performed at the Customer site, materials will

be retrieved and modified at the Regional offices or at the Headquarters

depending on the complexity of the modification.

6.8. The implementer will communicate to CS and confirm that the modification

was satisfactorily performed.

6.9. CS will document the information in SAP for future system configuration follow

up and Field Modification tracking implementation.

7.0 Appendices

7.1 Appendix A: Field Modification Flowchart




FMIRequest

Mandatory

Technicianless

Prepare list of materials to be modified

Instruct Given personnel -Third party

In the field Retrieve materials

Perform modification

Document in SAP

Send modification kit

no

yes

no

yes

no

yes

Confirm Implementation

Regional Support

Successful yesno

Defineimplementation

method

Release FMI(ECO)

Train Regional CS teams

Prepare FMI kit-in-service

Create SRsIn SAP

Validate kit

Appendix A

Installed Base Report Format SOP

TBD

Gate P6: Product End of Life (EOL)From a Commercial Product to Decline


Transition to Alternative Products

EOL Plan End Of Life PLCM-034-01

Detailed Stage Description: End of Life Product End of Life (Obsolescence)

Objective(s)

1. Controlled phase-out of product from market2. Sustain customer satisfaction during EOL process (CS, replacements, warranties)3. Comply with regulation concerning EOL requirements4. Ensure smooth business transition (inventories of material and FGS, production line resources5. Ensure customer loyalty continuity

Process(es)Em

ployed

1. Plan End of Life (EOL) process 2. Forecast EOL 3. Plan production scale-down 4. Plan CS transition (FGS inventories @ Ltd and regions, spares and options, tech-support)5. Design EOL strategy & announcement

Process(es)Em

ployed

Plan EOL marketing package:• EOL "promos"• Replacement offerings• Messages

RequiredInputs

1. Given Roadmap2. Supplier roadmaps3. IB data4. Inventory levels (materials, FGS)5. Competition data6. Marketing event data7. Finance report

Leader

PL-manger -(part of PLC plan

Detailed Stage Description: End of Life (page 2 of 3)


• Global Marketing,• CS, • Operation• Finance• R&D, • Suppliers• Regions

"Contributor(s)

Internal/External

QA

Estimated

Time Fram

e

According to PLC plan (roadmap)


Product line life-cycle budget dedicated to EOL activity

RequiredA

pprovals

1. COO2. VP Global Marketing3. Regions

Product End of Life (Obsolescence)

Detailed Stage Description: End of Life (page 3 of 3)

ExpectedO

utput

1. EOL process plan2. EOL forecasts3. Production scale-down plan4. CS transition plan (FGS inventories @ Ltd and regions, spares and options, tech-support)5. EOL strategy & announcement6. Marketing support:

• EOL "promos"• Replacement offerings

7. Messages

Metrics to

Measure Success

1. Low dead inventories2. Sustained customer satisfaction3. Sustained customer loyalty

Product End of Life (Obsolescence)

End Of Life SOP

The purpose of this procedure is to provide clear and effective guidelines for handling of discontinued products.

End Of Life


Product End of Life PLCM-034-01 01 2 of 5


1.0 Purpose

The purpose of this procedure is to provide clear and effective guidelines for handling of discontinued products.

2.0 Scope

2.1 This procedure applies to all products supplied by Given Imaging. 2.2 This SOP covers all the aspects related to products discontinuity like provision of spare parts, field announcements and substitute products.

3.0 Definitions

o EOL: End of life.

o TSB: Technical Support Bulletin

o MR: Marketing Release

o SAP: Database

o CS: Customer Support

4.0 Reference Documents

FMI SOPTSB Template


5.1 It is the responsibility of the Product Line Manager to implement and maintain this procedure and to manage the End of Life process through completion.




6.0 End of Life Procedure

6.1 The Product Line Manager will define a plan containing initializationdate of a new product and suggested production and service end dates.

6.2 Once a third party product supplied by Given (printers, monitors, etc.)

is discontinued, CS will communicate the field through a TSB.

6.3 CS will recommend whether a small stock of materials End of Life

should be kept in stock for support purposes or not.

6.4 A decision regarding discontinuation of a product will be taken by Marketing, CS, Operations, and Finance.

6.5 The decision will take into consideration Marketing aspects, inventory status and accounting effects.

6.6 Once a decision is made, an approval form and Memo summarizing the reasons for the discontinuation will be filled by CS and signed by the relevant parties (See Appendix B)

6.7 Once a product is discontinued, Given Imaging will follow the steps below:- Check if the product is upgradeable or it can be replaced by a compatible unit

- If upgradeable, Given Imaging will follow Field Modification instructions

- If the product can be exchanged by a compatible unit, Marketing will prepare a plan to promote the exchange of the discontinued units.

- Marketing together with CS will decide whether the old units will be retrieved or not.

- Retrieved units will be tested, reconditioned and used for spare parts.

- CS will provide forecast for spare parts (based on the end date) and it will implement the necessary actions to support the product until the end date

- CS and Marketing will inform the Regional offices the end date of a product through the TSB and MR

- CS will recommend the Regional offices whether a stock of spare parts to support the End of Life product is necessary or not.

6.8 Given Imaging will keep all the documentation generated during product’s life time for tracking and regulatory purposes.

6.9 Given Imaging will keep the necessary inventory to support the product until the end date.




EOL

Alternative product

Forecast Spare parts

O ffer new product(Promo packages)

Communicate the field (TSB-MR)

Keep documentation

Keep inventory

yes

no

Exchange materials

Keep old materials for spare parts

Define Support period

G iven productCommunicate the field (TSB-MR)

Keep inventory for Support purposes

no

Upgradable

yes

no

Go to FMI SOP

yes

Customer accept new product

yes

no

7.0 Appendices

7.1 Appendix A: End of Life Flowchart

Appendix A


Product End Of Life PLCM-034-01 01 5 of 5


7.2 Appendix B: End of Life approval form

Notice of Product discontinuation

CONFIDENTIAL

AUTHORIZATION

NAME/TITLE SIGNATURE DATE

Issued by: CS

Approved by: Corporate Marketing

Approved by: VP Operations

Approved by: Corporate Finance

Approved by:

PLCM Department ResponsibilitiesClinical Trials

PLCM-013-01 (Clinical Trials Approval Forms (CTAF) —Gate P1PLCM-014-01 (CT Protocols) —Gate P1PLCM-015-01 (IRB Documents) —Gate P1

CSPLCM-031-01 (Field Modification) —Gate P5PLCM-033-01 (Installed Base Report Format) —Gate P5PLCM-034-01 (End of Life) —Gate P6

IPPLCM-001-01 (Preliminary Risk Analysis) —Gate P0

MarketingPLCM-003-01 (Business Case) —Gate P0, —Gate P1PLCM-004-01 (Product Requirements Definition —Gate P0PLCM-005-01 (Make/Buy/Partner Analysis and Decision) —Gate P1PLCM-017-01 (Comercialization Plan) —Gate P3PLCM-018-01 (Competitive Profile) —Gate P3PLCM-019-01 (Global Pricing Plan) —Gate P3PLCM-020-01 (Labeling Creation and Production) —Gate P4PLCM-023-01 (Global Training and Education) —Gate P3, —Gate P4PLCM-024-01 (Product Release) —Gate P4PLCM-025-01 (Global Launch Package) —Gate P3PLCM-026-01 (Regional Launch Plan) —Gate P4PLCM-028-01 (Project Requirement Specification) —Gate P4PLCM-035-01 (Marketing Support of Sales) —Gate P4

OperationsPLCM-011-01 (Release to Engineering) —Gate P1

QAPLCM-007-01 (Risk Analysis for Development) —Gate P1PLCM-009-01 (Design Review Document) —Gate P1PLCM-010-01 (DHF) —Gate P1PLCM-012-01 (Design and Development Validation) —Gate P1PLCM-016-01 (Regulatory Submissions) —Gate P1PLCM-022-01 (External Evaluation Release) —Gate P3PLCM-030-01 (CAPA - Corrective and Preventive Action —Gate P5PLCM-036-01 (Design and Development Verification) —Gate P1

R & DPLCM-002-01 (Technical Feasibility) —Gate P0PLCM-006-01 (Product Specification) —Gate P1PLCM-008-01 (Testing Requirements) —Gate P1

PLC Gate DeliverablesAcceptance Criteria .................................... Gate P1Business Case ............................................. Gate P0Business Case ............................................. Gate P1Business Risk Analysis.................................. Gate P0Clinical Trials Final Report........................... Gate P3Clinical Trials Plan....................................... Gate P1Commercialization Plan .............................. Gate P3Customer Service Plan ................................ Gate P3Departmental Feedback.............................. Gate P5EOL Plan .................................................... Gate P6Field Testing Report .................................... Gate P3Preliminary Forecast.................................... Gate P1Pre-Production Plan.................................... Gate P1Product Improvement ................................. Gate P5Product Performance Versus Marketing Req.Gate P1

Product Production Files............................. Gate P2Product Requirement Definition ................. Gate P0Product Risk Analysis .................................. Gate P1Production Capabilities............................... Gate P2Regional Launch Plans ................................ Gate P4Regional Training........................................ Gate P4Registration Status ...................................... Gate P3Registration Submissions Plan ..................... Gate P1Regulatory Approvals .................................. Gate P4Regulatory Strategy ..................................... Gate P0Road Map & Detailed Work Plan................ Gate P1Road Map .................................................. Gate P0Technology Feasibility................................. Gate P0Transition to Alternative Products ............... Gate P6

PLC Gate SOPsPLCM-001-01............................................. Gate P0PLCM-002-01............................................. Gate P0PLCM-003-01............................................. Gate P0PLCM-003-01............................................. Gate P1PLCM-004-01............................................. Gate P0PLCM-004-01............................................. Gate P1PLCM-005-01............................................. Gate P1PLCM-006-01............................................. Gate P1PLCM-007-01............................................. Gate P1PLCM-008-01............................................. Gate P1PLCM-009-01............................................. Gate P1PLCM-010-01............................................. Gate P1PLCM-011-01............................................. Gate P1PLCM-011-01............................................. Gate P2PLCM-012-01............................................. Gate P1PLCM-013-01............................................. Gate P1PLCM-014-01............................................. Gate P1PLCM-015-01............................................. Gate P1PLCM-016-01............................................. Gate P1

PLCM-017-01 ............................................ Gate P3PLCM-018-01 ............................................ Gate P3PLCM-019-01 ............................................ Gate P3PLCM-020-01 ............................................ Gate P4PLCM-021-01 ............................................ Gate P3PLCM-022-01 ............................................ Gate P3PLCM-023-01 ............................................ Gate P3PLCM-023-01 ............................................ Gate P4PLCM-024-01 ............................................ Gate P4PLCM-025-01 ............................................ Gate P3PLCM-026-01 ............................................ Gate P4PLCM-028-01 ............................................ Gate P4PLCM-030-01 ............................................ Gate P5PLCM-031-01 ............................................ Gate P5PLCM-033-01 ............................................ Gate P5PLCM-034-01 ............................................ Gate P6PLCM-035-01 ............................................ Gate P4PLCM-036-01 ............................................ Gate P1

PLCM 220807 final

Documents

product cycle

given product life cycle

imaging product

formal product life

product developmenta

product specification

manufactured product

business case business