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Product Life Cycle Management Documents Revision 01, May 2007 Copyright Š 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 Initiation 2 Implementation 3 Launch Readiness 4 Marketing Support of Sales (Regional Launch) 5 Ongoing Management 6 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 Overview Product Life Cycle Management Overview Flowchart

Stage 1: Major Release Initiation Product & Major Release Initiation Flowchart Detailed Stage Description: Major Release Initiation Gate P0:Product Initiation—Concept Evaluation Business Risk Analysis Business Case Technology Feasibility Product Requirement Definition Road Map Regulatory Strategy

Preliminary Risk Analysis: PLCM-001-01 Business Case: PLCM-003-01 Technical Feasibility: PLCM-002-01 Product Requirements Definition: PLCM-004-01

Stage 2: Implementation Implementation Flowchart Detailed Stage Description: Implementation Gate P1:Product Development—A Working Product

Product Performance Versus Marketing Req. Product Requirements Definition: 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

R&D Implementation Flowchart

Gate P2:Production Readiness—Transition of Product from R&D to Production Product Production Files Production Capabilities

Release to Engineering: PLCM-011-01

Manufacturing Implementation Flowchart


Stage 3: Launch Readiness Launch Readiness Flowchart Detailed Stage Description: Launch Readiness Gate P3:Product Commercialization—Pre Launch Commercialization Plan

Clinical Trials Final Report Registration Status Field Testing Report Customer Service 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 Field Testing: PLCM-021-01 External Evaluation Release: PLCM-022-01

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

Gate P4:Product Launch— Regional Launch Plans

Regional Training Regulatory Approvals

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 Global Training and Education: PLCM-023-01 Marketing Support of Sales: PLCM-035-01

Stage 5: Ongoing Management and Roadmap Steering Detailed Stage Description: Ongoing Management and Roadmap Steering Gate P5:Product Progression and Customer Satisfaction—From Product Launch to On-going Sales Departmental Feedback Product Improvement

CAPA - Corrective and Preventive Action: PLCM-030-01 Field Modification: PLCM-031-01 Installed Base Report Format: PLCM-033-01

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 PLCM Department Responsibilities PLC Gate Deliverables PLC Gate SOPs


PLC General Flowchart.fm

Product Life Cycle Management Overview Flowchart

PRODUCT & MAJOR RELEASE INITIATION PROCESS

Gate P0

?

Product Initiation – Concept Evaluation

IMPLEMENTATION PROCESS Gate P1

?

Gate P2

?

Product Development - A working Product Production Readiness - Transition of product from a R&D to production

LAUNCH READINESS PROCESS

Gate P3

?

Product Commercialization - Pre Launch

MARKETING SUPPORTS OF SALES (REGIONAL LAUNCH) PROCESS

Gate P4

?

Product Launch

ONGOING MANAGEMENT PROCESS

Gate P5

?

Product progression & Customer Satisfaction – From product’s launch to on going sales

END OF LIFE End of life

Gate P6


Stage 1: Major Release Initiation Detailed Stage Description: Major Release Initiation Major Release Initiation Flowchart Gate P0: Product Initiation Deliverables


Major Release Initiation Flowchart

Product & Major Release Initiation Flowchart RESPONSIBILITY

PROCESS

OUTPUT

Product & Major Release Initiation

NEED/IDEA ASSESSMENT LEADER

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

Gather need/idea & filter/ assess Max. 3 months

APPROVAL

- Corp. Product Line Director - Senior Management

NO

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.

GO/NO GO

YES PRELIMINARY REQUIREMENT DEFINING LEADER

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

The outputs from this stage are: 1. PRD 2. Preliminary Risk Analysis 3. Go/No Go Decision to Technical feasibility study phase

Define preliminary requirement Max. 2 months

APPROVAL

YES

- Corp. Product Line Director - Senior Management

NO

GO/NO GO

TECHNICAL FEASIBILITY LEADER

- VP R&D

Conduct a business Case

APPROVAL

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

CASE

Perform a technical feasibility

Max. 2 months

Max. 3 months

NO

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

GO/NO GO

GO/NO GO

APPROVAL

- Geography Leaders - Global Marketing - Senior Management

REFINE PR & ROADMAP LEADER - Corp. Product Line Manager - Biz. Dev (in cases of outside of CE) APPROVAL

Define preliminary requirement Max. 2 months

Gate P0

?

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

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 (productuse 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 NO continuation of effort BUSINESS CASE The 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

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


Detailed Stage Description: Major Release Initiation Need/Idea Gathering & Filtering/Assessment

Preliminary Requirement Definition

Technical Feasibility

Business Case

Refine PR & Roadmap

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 proposition, product messaging for specified target market. Does it fit into GIVN business model and what gaps exist within GIVN Business? What are the implications (IB, Backward Compatibility etc‌) from bringing product to market? 2. Develop 5 year business case (ROI) for product with product cost, pricing and volume and competitive positioning. Include preliminary market segmentation and competitive environment.

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

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 research 2. Discussions with broad customer base not just KOLs 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


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

Technical Feasibility

Business Case

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 Trends 5. Competitive environment and response 1. 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 issues 4. Risk Analysis Document

1. Estimated COGs (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. PRD 2. Updated business case 3. Technical feasibility data. 4. Product and development risk analysis 5. Corporate and Platform Strategy 6. R&D resources and capabilities

Leader

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

Product Line LeaderBiz 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)

1. Product and Platform Managers 2. Geography Product Manager 3. Global Clinical Marketing 4. R&D 5. Finance

1. Product and Platform Managers 1. R&D Project Managers 1. Geography Product Managers 1. Global Clinical Affairs

1. R&D 1. Global RACA 1. Product Line Leader 1. Outside Vendors 1. Chief Scientist 1. Operations 1. IP

1. Finance 1. Geography Leaders 1. Product and Platform Managers 1. Clinical Marketing 1. Business Development 1. Operations 1. Legal/IP

1. Geography Leaders 1. R&D 1. Product Line Leaders in other Products 1. Global RACA 1. Legal/IP

1. Sales Force 2. GIVN 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. GIVN Customer Facing Functions 4. Chief Scientist 5. Biz Dev

All Given Functions

1. R&D 2. Global RACA 3. Outside Consultants

Operations

Partner(s) Contributor(s) Internal/External Internal/External

Need/Idea Gathering & Filtering/Assessment


Detailed Stage Description: Major Release Initiation (page 3 of 3) Estimated Maximum Budget Required Expected Output Time Frame Responsibility Approvals

Need/Idea Gathering & Filtering/Assessment

Preliminary Requirement Definition

Technical Feasibility

Business Case

Refine PR & Roadmap

3 months

2 month

TBD (3 months?)

2 months

2 months

Global Marketing

Global Marketing

R&D

Global Marketing

Global Marketing

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. Geography Leader 2. Global Marketing 3. Sr. Management

1. CEO/Global Marketing 2. Functional Leaders 3. Geography Leaders

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. PRD 2. 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 (productuse 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 PRD document with updated Product Roadmap. 2. Go/No Go decision to Implementation Stage


Gate P0: Product Initiation Concept 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

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2 of 6

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:

2.4

2.5

2.6

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

Regulatory risks 2.4.1

Approval path and possible risks of this approval path

2.4.2

(if relevant) cost for mitigating risk

IP risks 2.5.1

Initial 3rd party patent search

2.5.2

(if relevant) cost for mitigating risk

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

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


Document Title:

Document No.

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Preliminary Risk Analysis

PLCM-001-01

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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.

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


Document Title:

Document No.

Revision

Page

Preliminary Risk Analysis

PLCM-001-01

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


Regulatory

Technology

special 510K

antenna location Battery contacts

LED ring

MEMs

low

medium

medium

medium

high

traditional 510K

re-design

re-design re-design, embedded antenna

no

3 more months to schedule

XXXX$

XXXX$

XXXX$

zzzz

xxxx

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

high

low

new component

XXXX

medium

medium

low

antenna near metal parts

new component, vendors not known

new component, no in-house knowledge

ESO 2 - double headed capsule that will have more PCB space (MEMs and battery contacts and change antenna location) and better illumination (LED ring) explanation Risk probability severity mitigation cost of mitigation

date

Preliminary Risk Analysis

EXAMPLE

01

Appendix A

Revision

Document No.

PLCM-001-01

Document Title

Page

severity medium

severity low due to hiring new MEMS expert

pppp

yyyy

STATUS status date

5 of 6

mitigated

mitigated

status


Business

IP

Existing patent application belonging to XXX

existing registered patent belonging to XXX

low

medium

high

high

1. xxx$, 2. xxx$

1. xxxx$, 2. xxxx$ 3. xxxx$ www

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

patent application potentially covering antenna location

patent covers MEMs switch in Ph capsule

1. design around patent, 2. Obtain rights in patent (liscence etc.), 3. invalidate patent 1. design around and publish new design so that our design cannot be patented by third party 2. Obtain rights in patent (liscence etc.) mitigated due to design around at Given


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

Document Title:

Document No.

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Business Case

PLCM-003-01

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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)

5.0

4.5.

Operational assessment

4.6.

Financial assessment

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

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


Document Title:

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Business Case

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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

7.0

6.7.

Operational Assessment: Define operational needs.

6.8.

Financials: Include projected impact thru 5 years.

Appendix

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


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

Document Title:

Technical Feasibility

1.0

Document No.

Revision

Page

PLCM- 002-01

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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 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

Name

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

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


Document Title:

Technical Feasibility

6.0

Document No.

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Page

PLCM- 002-01

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Budget Responsibility R&D

7.0

8.0

Required Approvals 7.1.

VP R&D

7.2.

Product Line Leader

7.3.

Sr. Management

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

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


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 Document Title:

SOP Product Requirements Definition

1.0

Document No.

Revision

PLCM-004-01

01

Page

2 of 11

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 PRDbased 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.

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Document Title:

SOP Product Requirements Definition

4.0

Document No.

PLCM-004-01

Revision

01

Page

3 of 11

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.

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


Document Title:

SOP Product Requirements Definition

Document No.

PLCM-004-01

Revision

01

Appendix A - Product & Major Release Initiation

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

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

1. Formal Regional Feedback validated by 1. Take feedback from previous additional customer evaluation (focus groups, surveys, field visits including sale phase and develop force) PRD document 2. Incorporate Product Line Technology 2. Preliminary Risk Review Session Analysis & IP 3. Establish database on ideas and Review evaluations. 4. Cross functional participation particularly with R&D & Marketing/Sales

Process Employed

Draft of Product Requirement Definition

Preliminary Requirement Definition

Objective

Need/Idea Gathering & Filtering/Assessment

Document No.

1. Conduct appropriate analysis and bench work to determine technical feasibility and regulatory risk 2. Possibly Done in parallel with Business Case

1. 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. 2. Develop a Preliminary Product Specification Document

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1. Refine PRD to ensure 1. Define value proposition, customer needs are met product messaging for and aligned to maximize specified target market. Does value to GIVN. it fit into GIVN business model 2. Determine effect on and what gaps exist within existing roadmap, GIVN Business? What are portfolio strategy and the implications (IB, Backward required changes that Compatibility etc‌) from bringing product to market? may be required. 2. Develop 5 year business case 3. Finalize business case, (ROI) for product with product cost and timeline cost, pricing and volume and including regulatory competitive positioning. approval and market Include preliminary market entry segmentation and competitive environment. 1. Pricing Market research 1. Update existing 2. Discussions with broad documentation with new customer base not just KOLs information. to determine uptake of 2. Review with all stakeholders product. 3. Cross functional team involvement (Marketing/Sales, Clinical Marketing, Finance, Ops, R&D)

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Business Case

PLCM-004-01

Technical Feasibility

Appendix B – PLCM - Product & Major Release Initiation

SOP Product Requirements Definition

Document Title:


1. Sales Force 2. GIVN Customer Facing Functions 3. Customers 4. Regulatory 5. IP 6. Chief Scientist 7. Biz Dev 8. Outside Vendors/Consultants

Contributor(s) • Internal • External

Page

All Given Functions

R&D Global RACA Product Line Leader Outside Vendors Chief Scientist Operations

Product Line Leader Biz Dev (only in cases outside of CE) 1. Finance 2. Geography Leaders 3. Product and Platform Managers 4. Clinical Marketing 5. Business Development 6. Operations 7. Legal/IP 1. R&D 2. Global RACA 3. Outside Consultants

VP R&D

1. 2. 3. 4. 5. 6.

1. Estimated COGs (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)

Refine PR & Roadmap

Operations

Product Line Leader Biz Dev (only in cases outside of CE) 1. Geography Leaders 2. R&D 3. Product Line Leaders in other Products 4. Global RACA 5. Legal/IP

1. PRD 2. Updated business case 3. Technical feasibility data. 4. Product and development risk analysis 5. Corporate and Platform Strategy 6. R&D resources and capabilities

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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 issues 4. Risk Analysis Document

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

1. Customers 2. Sales Force 3. GIVN Customer Facing Functions 4. Chief Scientist 5. Biz Dev

1. Product and Platform Managers 2. Geography Product Manager 3. Global Clinical Marketing 4. R&D 5. Finance

Partner(s) • Internal • External

Leader

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 Product Line Leader or Biz Dev (only in cases outside of CE) 1. Product and Platform Managers 2. R&D Project Managers 3. Geography Product Managers 4. Global Clinical Affairs 5. IP

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 Trends 5. Competitive environment and response 6. Market Research (NTH) Product Line Leader or Biz Dev (only in cases outside of CE)

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Preliminary Technical Feasibility Requirement Definition

Required Inputs

Need/Idea Gathering & Filtering/Assessment

SOP Product Requirements Definition

Document Title:


Expected Output

Estimated Maximum Time Frame Budget Responsibility Required Approvals

1. Business Case Document to 1. Final PRD document with updated Product include vol/pricing, regulatory Roadmap. path, serviceability, transition 2. Go/No Go decision to plan. Implementation Stage 2. Go/No Go Decision to continue effort 3. Preliminary Risk Analysis Document Updated

1.

1. PRD 2. Go/No Go Decision to Technical Feasibility Study Phase 3. Preliminary Risk Analysis Document

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.

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

3.

2.

Feasibility Plan Document that clearly outlines time to market, risks (IP, Regulatory, Technical) and costs in achieving market entry. Preliminary Risk (product-use and development) Analysis Document Updated to identify risks that need to be minimized or mitigated and possible mitigation modes Go/No Go decision on continuation of effort

1. Geography Leader 2. Global Marketing 3. Sr. Management

1. VP R&D 2. Product Line Leader 3. Sr. Management

1. CEO/Global Marketing 2. Functional Leaders 3. Geography Leaders

Global Marketing

1. Product Line Leader 2. Sr. Management specifically Regional Leaders

Global Marketing

1. Product Line Leader 2. Sr. Management

R&D

2 months

Refine PR & Roadmap

Global Marketing

2 months

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Global Marketing

TBD (3 months?)

Business Case

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2 month

Preliminary Technical Feasibility Requirement Definition

PLCM-004-01

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3 months

Need/Idea Gathering & Filtering/Assessment

SOP Product Requirements Definition

Document Title:


Document Title:

SOP Product Requirements Definition

Document No.

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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

1

1

New Issue

DATE

DISTRIBUTION LIST COPY

#1 #2 #3

NAME

TITLE / DEPARTMENT


Document Title:

SOP Product Requirements Definition

Document No.

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


Document Title:

SOP Product Requirements Definition

Document No.

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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

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


Stage 2: Implementation Detailed Stage Description: Implementation Implementation Flowchart Gate P1: Product Development Deliverables R&D Implementation Flowchart Gate P2: Production Readiness Deliverables Manufacturing Implementation Flowchart


Implementation Flowchart

Implementation Flowchart RESPONSIBILITY

PROCESS

OUTPUT

Implementation MAKE/BUY/PARTNER ANALYSIS LEADER

- VP R&D APPROVAL

- VP R&D PRODUCT SPECIFICATION LEADER

- VP R&D

Make/Buy/Partner Analysis

Define product specification

1 Quarter

Depends on product complexity

APPROVAL

- Corp. Product Line Director

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

DEVELOPMENT PLANNING, EXECUTION & RELEASE LEADER

Development Planning, Execution & Release

- VP R&D APPROVAL

Depends on product comlexity

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

?

P1

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)

ENGINEERING, PRODUCTION & MONITORING LEADER

- VP Operations APPROVAL

Engineering, Production & Monitoring Depends on product comlexity

- COO ?

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

P2

CLINICAL LEADER

TRIALS

- Global Clinical Affairs

Clinical Trials APPROVAL

- Corp. Product Line Director - COO - CMO

Depends on product comlexity

REGISTRATION LEADER - Director of Regulatory

Registration Depends on product comlexity

APPROVAL

- COO ?

P3

LAUNCH

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


Detailed Stage Description: Implementation Objectives

Make/Buy/Partner Analysis

Product Specification

Development Planning, Execution & Release

Engineering, Production & Monitoring

Clinical Trials

Registration

• 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 safety of product • Prove efficacy • Provide clinical data to support regulatory, R&D, and marketing requirements

• Comply with national and international laws and regulations


Detailed Stage Description: Implementation (page 2 of 5)

Processes Employed

Make/Buy/Partner Analysis

Product Specification

Development Planning, Execution & Release

Engineering, Production & Monitoring

Clinical Trials

Registration

• Define system and major building blocks • Identify technological gaps • Identify Given inhouse capabilities and capacity • Identify potential partners/subcontractors/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 document 2. testing requirement document 3. 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 (handshake)

• Validation masterplan document • Purchasing • Create production flow chart • Create manufacturing line • Training & certification for production team • Pilot run • Production • Yield control • Sustaining engineering

• Prepare clinical trials approval forms • Prepare clinical trials protocol • Prepare formal documents • Site selection • Monitor study • Prepare final report • Generation of scientific papers and presentations

• Verify applicable regulations and requirements • Develop regulatory strategy • Submit applications • Obtain market clearance


Detailed Stage Description: Implementation (page 3 of 5)

Required Inputs Leader Engagement Partner(s) Frequency Internal/External

Make/Buy/Partner Analysis

Product Specification

Development Planning, Execution & Release

Engineering, Production & Monitoring

Clinical Trials

Registration

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

• Product requirements and specifications (marketing and regulatory) • Pre-clinical study results

• 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.)

VP R&D

VP R&D or designee

VP R&D

VP Operations

Global Clinical Affairs

Director of Regulatory

As needed

Daily

As needed

As needed

As needed

As needed

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

Internal • Product director. • Operations • Clinical Affairs • Regulatory Affairs • IP External • Business partners

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

Internal • R&D • QA

Internal • R&D • Product director • Legal counsel • Local clinical affairs • Global and regional marketing External • Business partners

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


Detailed Stage Description: Implementation (page 4 of 5)

Contributors Estimated Budget Required Expected Internal/External Time Frame Responsibility Approvals Output

Make/Buy/Partner Analysis

Product Specification

Development Planning, Execution & Release

Engineering, Production & Monitoring

Clinical Trials

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

Internal • CS External • Advisors • Experts

Internal • CS • IP External • Advisors • Experts

Internal • CS • IP External • Advisors • experts

Internal • CS • Logistics External • Medical advisors • KOLs

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

depends on product complexity

depends on product complexity

depends on product complexity

depends on product complexity

depends on product complexity

VP R&D

VP R&D

COO

COO

Global Clinical Affairs

Director QA

VP R&D

Product director

COO Product director (Change of specs only)

COO

Head CA Product director CMO COO

COO

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 report • Manuscripts/ Abstracts and presentations

Market clearance

Registration


Detailed Stage Description: Implementation (page 5 of 5)

Metrics to Measure Success

Make/Buy/Partner Analysis

Product Specification

Development Planning, Execution & Release

Engineering, Production & Monitoring

Clinical Trials

Registration

• 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

• Compliance with product requirements • Implementation duration • Budget • Quality of documentation • IP protection • Customer satisfaction • Dependency on single suppliers

• Compliance with product requirements • Budget • Quality of documentation • Production capacity to fit sales forecast • Yield • Failure rate • Customer satisfaction • Dependency on single suppliers • Production costs

• Study duration • Budget • Quality of documentation • Quality of data • Quality of publications

• Compliance with regulatory requirements • Meeting timeframes • Getting desired indications


Gate P1: Product Development A Working Product Main Deliverables

SOP

Document

Product Performance Versus Marketing Req.

Product Requirements Definition

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

Regulatory Submissions

PLCM-016-01

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

Road Map & Detailed Work Plan Registration Submissions Plan Preliminary Forecast


R&D Implementation Flowchart

R&D Implementation Flowchart RESPONSIBILITY

PROCESS

OUTPUT

Implementation MAKE/BUY/PARTNER LEADER

ANALYSIS

- VP R&D APPROVAL

- VP R&D PRODUCT SPECIFICATION LEADER

- VP R&D

Make/Buy/Partner Analysis

Define product specification

1 Quarter

Depends on product complexity

APPROVAL

- Corp. Product Line Director

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

DEVELOPMENT PLANNING, EXECUTION & RELEASE LEADER

Development Planning, Execution & Release

- VP R&D APPROVAL

Depends on product comlexity

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

?

P1

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)

ENGINEERING, PRODUCTION & MONITORING LEADER

- VP Operations APPROVAL

Engineering, Production & Monitoring Depends on product comlexity

- COO

P2

CLINICAL LEADER

?

TRIALS

- Global Clinical Affairs APPROVAL

- Corp. Product Line Director - COO - CMO

Clinical Trials Depends on product comlexity

REGISTRATION LEADER - Director of Regulatory

Registration Depends on product comlexity

APPROVAL

- COO

LAUNCH

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


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

Document Title:

Document No.

Revision

Page

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

3.3.

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

Name

Contributors: all Given functions 3.3.1.

Customer Support

3.3.2.

External advisers

3.3.3.

External experts

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


Document Title:

Document No.

Revision

Page

Product Specification

PLCM-006-01

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Page 3 of 4

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.

7.0

Required Approvals 7.1.

8.0

VP R&D

Product Director

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)

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


Document Title:

Document No.

Revision

Page

Product Specification

PLCM-006-01

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11.0

Appendix Product Specification Table for Capsule Features Mechanics Dimensions: Materials:

Optics & Illumination Number of optical heads FOV – Field of view F number DOV – Depth of view Resolution Illumination

Comments

Diameter: [mm] Length: [mm] Dome: Cover:

0 to XX mm from Dome apex x.xx lpmm @ 0 mm 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 Active working time Imager mode Delay mode Shelf life time

XX fps XX hr

XX month

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


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

Document Title:

Document No.

Design and Development Review

PLCM-009-01 (QA-734-1

Revision

02

Page

2 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

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


Document Title:

Document No.

Design and Development Review

Revision

PLCM-009-01 (QA-734-1

4.6

F-734-1

Design and Development Review Form

4.7

RM-10-2

Risk Analysis

4.8

737-1

Design Change

02

Page

3 of 7

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: x x x x x x x x x

6.1.3

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.

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

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


Document Title:

Document No.

Design and Development Review

6.1.4

6.1.5

PLCM-009-01 (QA-734-1

Revision

02

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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 6.1.4.7

Design phase/stage (mandatory) Follow-up report(s) of solutions and/ or the next review covers the solutions and remaining issues.

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:

6.1.6.3

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.

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.

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


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Critical Design Review (C.D.R.): 6.1.7.1

6.1.7.2

6.1.8

PLCM-009-01 (QA-734-1

The main objectives of this review are: 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.

Recommended issues for review: 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.

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

Recommended issues for review: 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

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Document Title:

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Review of Organization for Full-Scale Manufacturing: 6.1.9.1

6.1.9.2

6.1.9.3

The main objectives of this review are: 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 fullscale manufacturing.

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.

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:

6.2.3

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.

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

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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:

6.2.7

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.

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

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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

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Design and Development Validation

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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)

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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.

5.0 Applicable Documents 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.

5.4 QA-735-1

Design and Development Verification

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

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


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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) *************

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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

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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.

4.0 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 F-04-1-1

E.C.R./E.C.O./D.A.: Design Change Form.

4.5 D.H.F.

Design History File.

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.

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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 : x

Comparative tests with a proven design.

x

Simulated use in the laboratory.

x

Animal model tests.

x

Biocompatibility tests.

x

Material/device compatibility tests.

x

Prototype tests.

x

Reliability tests.

x

Performance tests.

x

Tests of compatibility with other devices.

x

Environmental tests.

6.4 For software, typical verification activities include: x

Code review

x

Schematic reviews

x

Unit and components tests.

x

Integration tests.

x

Alternate calculation demonstrations.

6.5 Verification plan shall include: x

Definition of required tests.

x

Definitions of the functions to be tested.

x

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

x

Test methods and means.

x

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


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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.

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

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


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

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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.

4.0

Reference documents 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.

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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.

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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.

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Regulatory Submissions SOP


Regulatory Submissions

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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.

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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.

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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

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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.

4.0

Reference documents 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

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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: x

Global Launch Package

x

Global Pricing Plan

x

Global Marketing Strategy, including marketing communication plan

x

Product development time-line

x

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

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Document Title:

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Commercialization Plan

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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)

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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 - - - -

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

Clinical Trials Approval Form AUTHORIZATION LINE – APPROVAL TO INITIATE NAME TITLE SIGNATURE

DATE

Clinical Trials Manager,

Issued by:

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

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APPROVAL PROCESS FOR CLINICAL TRIAL # MA - - - (Complete name of study, as will appear in the formal protocol)

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:

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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

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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?

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Clinical Trials Approval Forms (CTAF)

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APPROVAL PROCESS FOR R&D CLINICAL TRIAL #RD - - - (Complete name of study, as will appear in the formal protocol)

R&D Clinical Trials Approval Form AUTHORIZATION LINE – APPROVAL TO INITIATE NAME TITLE SIGNATURE

DATE

R&D project manager, XXXX product

Issued by:

Clinical Trials Manager,

Issued by:

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

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APPROVAL PROCESS FOR R&D CLINICAL TRIAL # MA - - - (Complete name of study, as will appear in the formal protocol)

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:

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16) Timeline & Goals Start Date

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

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CT Protocols SOP


CT Protocols

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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.

4.0

Reference documents Protocol outline template (see attached) with appendices

5.0

Definitions NA

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Clinical Trial Protocol MA-XX:

Evaluation of Capsule Endoscopy in Patients with (disease definition) Principal Investigators: Co-Investigators: Given® Diagnostic System and PillCam™ - - Capsule Given Imaging Ltd. New Industrial Park, Yoqneam Israel Given Imaging, Inc. 5555 Oakbrook Parkway, Ste. 355 Norcross, GA 30093

Test product: Sponsor's name and address:

Sponsor’s Telephone Number: Study Number Version number and Date:

Israel: 93-04-909-7777 US: 800-662-0870 MA-XX Version 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.

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TABLE OF CONTENTS STUDY SUMMARY ................................................................................................................... 5 1 INTRODUCTION ............................................................................................................. 5 2 DEVICE DESCRIPTION ................................................................................................. 5 2.1 PillCam™ SB Capsule ....................................................................................... 5 2.2 Given® DataRecorder......................................................................................... 5 2.3 RAPID® Workstation .......................................................................................... 5 3 OBJECTIVES.................................................................................................................. 6 3.1 Primary objectives ............................................................................................. 6 3.2 Secondary objectives ........................................................................................ 6 4 STUDY ENDPOINTS ...................................................................................................... 6 4.1 Primary endpoint ............................................................................................... 6 4.2 Secondary endpoints ........................................................................................ 6 5 STUDY DESIGN ............................................................................................................. 6 5.1 Overall design .................................................................................................... 6 5.2 Investigational product and Accountability .................................................... 7 6 SUBJECT ELIGIBILITY.................................................................................................. 7 6.1 Study population................................................................................................ 7 6.2 Inclusion criteria ................................................................................................ 7 6.3 Exclusion criteria ............................................................................................... 7 6.4 Withdrawal criteria............................................................................................. 7 7 STUDY PLAN.................................................................................................................. 7 7.1 Enrollment of participants ................................................................................ 7 7.2 Informed Consent Process (day 1) .................................................................. 7 7.3 Assessment of eligibility and Patient baseline condition (visit 1)................ 7 7.4 Capsule Endoscopy (visit 2) ............................................................................. 8 7.5 SBFT (visit 3) ...................................................................................................... 8 7.6 Ileo-Colonoscopy (visit 4) ................................................................................. 8 7.7 Follow Up of patients (visit 5)........................................................................... 8 8 ASSESSMENT OF EFFICACY....................................................................................... 8 9 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.................................................................................................................. 10 10.1 Determination of sample size ......................................................................... 10 10.2 Description of statistical methods ................................................................. 10 11 DATA COLLECTION AND QUALITY CONTROL ....................................................... 10 11.1 Data collection ................................................................................................. 10 11.2 Archiving .......................................................................................................... 11 12 ETHICAL AND LEGAL ASPECTS............................................................................... 11 12.1 Independent Ethics Committee (IEC)............................................................. 11 12.2 Ethical conduct of the study........................................................................... 11 12.3 Patient Information and Consent ................................................................... 11 12.4 Insurance .......................................................................................................... 11 12.5 Confidentiality .................................................................................................. 12 13 USE OF DATA AND PUBLICATIONS ......................................................................... 12 APPENDICES ......................................................................................................................... 13 Appendix A – Schedule of Assessment.................................................................... 13 Appendix B – Patient’s condition questionnaires ......... Error! Bookmark not defined. Appendix C – CE, SBFT and ileo-colonoscopy case report formError! Bookmark not defined.

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Study Summary Purpose of study Study design: Number of subjects: Subject population No of centers Interim Analysis Duration of follow-up Duration of study Primary objectives Secondary objectives

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 RAPID¥ Workstation.

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.

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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

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


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o o o

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

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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: x Death x Life-threatening drug experience x Patient hospitalization or prolongation of existing hospitalization x Persistent or significant disability/incapacity x Congenital anomaly/birth defect. Some important medical events, although they may not result in death, be lifethreatening, 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 0.73.6% 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.

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Recording and documentation of adverse events x Every adverse event should be recorded in the case report form. The following data must be documented: x Type of event x Patient number x Time of occurrence: date, time x Time of resolution: date time x Severity degree: mild / moderate / severe / unknown x Relationship to study device probable/possible/unlikely/not related x 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 events Individual 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 Analysis An 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.

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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

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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.

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Evaluation II

Final evaluation

Appendices Appendix A – Schedule of Assessment

Enrolment

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

Evaluation I

X X

Test II Follow-up CE (1 week)

X

Follow-up patient condition (CDAI, IBDQ, SF36) Adverse events monitoring

X X

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

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IRB Documents SOP


IRB Documents

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Binder of IRB documents

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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”.

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Gate P2: Production Readiness Transition of Product from R&D to Production Main Deliverables

SOP

Document

Product Production Files

Release to Engineering

PLCM-011-01

Production Capabilities


Manufacturing Implementation Flowchart

Manufacturing Implementation Flowchart RESPONSIBILITY

PROCESS

OUTPUT

Implementation MAKE/BUY/PARTNER LEADER

ANALYSIS

- VP R&D APPROVAL

- VP R&D PRODUCT SPECIFICATION LEADER

- VP R&D

Make/Buy/Partner Analysis

Define product specification

1 Quarter

Depends on product complexity

APPROVAL

- Corp. Product Line Director

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

DEVELOPMENT PLANNING, EXECUTION & RELEASE LEADER

- VP R&D APPROVAL

Development Planning, Execution & Release Depends on product comlexity

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

?

P1

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)

ENGINEERING, PRODUCTION & MONITORING LEADER

- VP Operations APPROVAL

Engineering, Production & Monitoring Depends on product comlexity

- COO ?

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

P2 CLINICAL LEADER

TRIALS

- Global Clinical Affairs APPROVAL

- Corp. Product Line Director - COO - CMO

Clinical Trials Depends on product comlexity

REGISTRATION LEADER - Director of Regulatory

Registration Depends on product comlexity

APPROVAL

- COO

LAUNCH

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


Stage 3: Launch Readiness Stages of Launch Stage 1 Stage 2 Stage 3 Stage 4 Stage 5

Regulatory Clearance

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

Announcement

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

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.

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.

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.

Detailed Stage Description: Launch Readiness Launch Readiness Flowchart Gate P3: Product Commercialization Deliverables


Launch Readiness Flowchart

Launch Readiness Flowchart RESPONSIBILITY

PROCESS

OUTPUT

Launch Readiness

GLOBAL MARKETING PLANNING Global marketing planning

LEADER

- Corp. Product Line Director

2 months

APPROVAL

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

Perform field testing PERFORM FIELD TESTING LEADER

2-3 months

- Corp. Product Line Manager APPROVAL

- Global Marketing - Director CA (if applicable) - Heads of regions GO/NO GO

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 Validation of product meeting market needs and technical performance against specifications. The expected outputs are: Field Tests Results Summary : NO - Technical - Clinical - Marketing Go/No Go decision for Launch

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

GLOBAL LAUNCH PLANNING LEADER

- Corp. Product Line Director

? Global launch planning

P3

APPROVAL

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

Final commercialization Plan including: - Action items (what?) - Responsibilities (who?) - Schedule (when?) Global Launch Package

Gate P3

?

Successful Global Product Launch Execution Marketing release (MR)

Launch 1 month

ONGOING MANAGEMENT & ROADMAP STEERING

MARKETING SUPPORT SALES


Detailed Stage Description: Launch Readiness Objective(s) Process(es) Employed Required Inputs Leader

Global Marketing Planning

Field Testing

Global Launch Planning

Develop initial commercialization plan for new product

Validation of product meeting market needs and technical performance against specifications

Develop final commercialization plan for specific product or major release

• 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

• • • • • • • • • • • • • • • •

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 Commercialization plan • Field test results summary • Regulatory approval documents

Product-Line Director

Global Product Manager

Product-Line Director

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 objectives of launch • Update commercial plan and launch Go/No Go – technical and commercial • Final Pricing Plan Development with profitability analysis and targets • Scheduling • Accountability (see separate plan) • Evaluate Global vs. regional considerations • Launch Promotion development • Documentation (regulatory, service manual) • Marketing material development • Global training and education material development


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

Field Testing

• • • • • •

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

• • • • • •

Contributor(s) Estimated Budget Required Internal/External Time Frame Responsibility Approvals

Regional Product Manager Global RA and CA MarCom Operations Customer Service Platform and other Product-Line Managers Sales & Clinical Training Business Partners Clinical Marketing

Partner(s) Internal/External

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

Global Launch Planning

• • • •

R&D Operations IP/Legal MarCom

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

• R&D • Finance • Legal

2 months

2-3 months

1 month

Global Marketing

Global Marketing

Global Marketing

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

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

• • • •

• • • • • • • • •

Senior Management Global Marketing Heads of regions VP R&D


Detailed Stage Description: Launch Readiness (page 3 of 3) Global Marketing Planning

Field Testing

Global Launch Planning

Expected Output

• 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 commercialization Plan including: • Action items (what?) • Responsibilities (who?) • Schedule (when?) • Global Launch Package • Successful Global Product Launch Execution • Marketing release (MR)

Metrics to Required Measure Success Approvals

• 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 plan on time • Successful Product Launch measured by sales force and support organization preparedness • Successful Product Launch measured by product shipments and product profitability

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

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

• • • •

Senior Management Global Marketing Heads of regions VP R&D


Gate P3: Product Commercialization Pre Launch Main Deliverables

SOP

Document

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

Field Testing

PLCM-021-01

External Evaluation Release

PLCM-022-01

Clinical Trials Final Report Registration Status Field Testing Report 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

Document Title:

Document No.

Revision

Page

Commercialization Plan

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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.

4.0

Reference documents 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

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


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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: x

Global Launch Package

x

Global Pricing Plan

x

Global Marketing Strategy, including marketing communication plan

x

Product development time-line

x

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

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


Document Title:

Document No.

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Page

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


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

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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.

4.0

5.0

Reference documents ƒ

Competitive sales brochures

ƒ

Internet sites

ƒ

Current comparison charts and internal sales training presentations

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.

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


Document Title:

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Page

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6.0

The Body of the Document Please see the attached file “Competitive Profile.”

7.0

Appendix

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Document Title:

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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 General Description

Capsule Model Dimensions Weight Field of View Camera Type Imager Resolution LEDs Frame Rate Image Enhancements Other Functions Battery Type Battery Life End User List Price Software Name/Version Key Messages Unique Features Same Features Viewing Speed Real Time Viewer Download Time Reading Time Size of Archive File Storage Medium Clinical Experience

[Company]

Given Imaging

[Product Name]

PillCam SB

Comments


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Page

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Feature Availability Price

[Company]

Given Imaging

Comments

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


Document Title:

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Feature

[Company]

Given Imaging

Comments

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


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i. Number of distributors ii. Size of distributors

VI. Company SWOTs a. Overview

[Company] Strengths

Given Imaging Strengths

Weaknesses

Weaknesses

Opportunities

Opportunities

Threats

Threats

b. Given Imaging Competitive Response [Company] Strengths

Given Imaging Response

Given Imaging Weaknesses

Given Imaging Response

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Document Title:

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Given Imaging

Given Imaging

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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

Document Title:

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Page

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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.

4.0

Reference documents 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.

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


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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

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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.

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


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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

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


Cost at Ltd (USD) USA (US$)

Europe (EUR)

END USER USA

Europe

Transfer Price

LA

Distributors

Date

Europe

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

Product yyy component .

Product yyy component .

Product yyy component 1

Product yyy components

Product xxx component .

Product xxx component .

Product xxx component 1

Product xxx components

Product yyy

Product xxx

Product

Pricing - End User, Transfer and Distributors

CONFIDENTIAL

Product Pricing Document Template--Corporate

Appendix A

Asia




Actual Cost (Ltd.) Region

Low

High

COMPETITIVE BENCHMARK

CONFIDENTIAL

End-User Price USD or €

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

Distributor USD or €

RECOMMENDED GIVEN PRICING

Brief Description: Market environment and pricing strategy, including end-user reimbursement status.

Product

GIVEN IMAGING

PRODUCT LINE: DATE: REPORTED BY:

Pricing Benchmark Worksheet--Corporate

Appendix B


Document Title:

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Appendix C Notice of Regional Promotion CONFIDENTIAL Name of Promotion ________________

From

(Date)

to

(Date)

AUTHORIZATION NAME/TITLE

Issued by: Name of Region

Regional Marketing

Approved by: Name of Region

Regional Leader

Approved by: Name of Region

Regional Finance

Approved by: Name of Region

Regional Sales

Approved by: Corporate

Chief Marketing Officer

Approved by: Corporate Approved by: Corporate

Corporate Finance

Approved by: Corporate

Product Team Leader

Approved by: Corporate

Product Team Leader

Approved by: Corporate

Product Team Leader

Approved by: Corporate

Product Team Leader

SIGNATURE

DATE

Corp. Customer Service

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.

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


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

Document Title:

Global Education Training Material Development

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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: x

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.

x

Obtaining from designated Subject Matter Experts (SME’s) assets and content related to the development of training and education materials to support product training.

x

Coordinating

with

the

Global

Regions

for

specific

training

needs/requirements. x

Working with internal resources, outside consultants and/or sourcing and selecting qualified vendors for training program/materials creation. Issuing P.O. to approved suppliers

x

Developing and producing training and education materials.

x

Obtaining necessary approvals

x

Disseminating Training and Education Materials.

3.2 Approvals x

Refer to PRS

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


Document Title:

Global Education Training Material Development

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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 justification to the originator.

Manager

communicates

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.

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


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Global Education Training Material Development

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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)

DATE

PRS Submitted by PRS Accepted by (Global Education Manager)

REVIEWER APPROVALS (Print & Sign Name)

DATE

Clinical 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)

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FINAL PRODUCTION APPROVALS (Print & Sign Name)

DATE

Chief Marketing Officer Regulatory Affairs

MARCOM INSPECTION Delivery Date & Location Inspection Date Approved By (Print & Sign Name)

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Appendix B – Process Flow

Initiator sends PRS to GEM

GEM reviews PRS with Stakeholders

Approval

YES

Project Scope, Team, Budget, Timeline Defined and Approved

N O

Decision communicated to initiator

Materials Reviewed/ Modified/ Approved

Outside Resources Identified Secured; PO Issued

Program Materials Developed/ Produced

Regulatory Approval

Materials Disseminated

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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

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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.

4.0

Reference documents 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

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The Global Launch Package should consist of: x

x

x

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 Price

Performance

x

x

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

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x

x

x

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.

x

Registration (CE mark, FDA, etc.)

x

Competition (Competitive Profile Documents) o

Description of main competitors and their products

o

Strengths and weaknesses

o

Comparison to our products

7.0 Appendix

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


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

Document Title:

External Evaluation Release

Document No.

Revision

Page

PLCM-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.

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


Document Title:

External Evaluation Release

Document No.

Revision

Page

PLCM-022-01 (PLCM-736-1)

1

3 of 5

5.0 Applicable Documents 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.

5.4

QA-735-1 Design and Development Verification

5.5

D.H.F.

Design History File.

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.

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


Document Title:

External Evaluation Release 6.7

Document No.

Revision

Page

PLCM-022-01 (PLCM-736-1)

1

4 of 5

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.

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

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


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 RESPONSIBILITY

PROCESS

OUTPUT

Marketing support sales (Regional launch readiness)

LOCAL LAUNCH & OFFERING MANAGEMENT LEADER - Regional Product Mgr - RACA (Global & Local) APPROVAL - Head of Geography - Product Line Director

MARKETING SERVICES LEADER - MarCom APPROVAL - Global Marketing - Regional Sales & Marketing Management - RACA - Legal/IP (Internal or External as required) - MarCom

Local Launch & Offering Management 90 Days including at least 30 Days Post Launch

Marketing Services 60 Days

Pricing Plan

PRICING

LEADER - Regional Marketing Director

15 Days

APPROVAL - Finance - Global Marketing - Regional Geography Leader

Product specific KOLs PRODUCT SPECIFIC KOLS LEADER

OnGoing

- Regional Marketing Director APPROVAL

- Global Marketing - Regional Geography Leader

Gate P4

?

Local launch

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

Develop marketing & sales support communications in conjunction with product launch. The expected outputs are: Effective sales and marketing communications

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

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


Detailed Stage Description: Marketing Support of Sales Local Launch & Offering Management

Marketing Services

Pricing

Product specific KOLs

Objective(s) Process(es) Employed

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

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

• 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

• 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

Required Inputs

Global Launch Package (Commercialization Plan)

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

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

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


Detailed Stage Description: Marketing Support of Sales (page 2 of 3) Leader (R/R, Frequency of Partner(s) Contributor(s) Estimated Engagement, Deliverables) Internal/External Internal/External Time Frame

Local Launch & Offering Management

Marketing Services

Pricing

Product specific KOLs

Regional Product Mgr RACA (Global & Local)

MarCom

Regional Marketing Director

Regional Marketing Director

Product Line Director RACA (Global & Local) Clinical Marketing Training Business Partners(JNJ & Distributors) Local Operations Team

Product Line Director Regional Marketing Mgmt Regional Sales Mgmt RACA (Global & Local) Clinical Marketing Training Business Partners(JNJ & Distributors)

Product Line Director Finance Regional Product Mgr Reg Sales Management

Product Line Director Business Partners (JNJ & Distributors) Regional Product Mgr Regional RACA

Field Sales – Direct & Distributors Reimbursement

Customer Support Operations PR Organization

Sales Admin (Ops) Reimbursement

Clinical Marketing

90 Days including at least 30 Days Post Launch

60 Days

15 Days

At launch and then Ongoing


Detailed Stage Description: Marketing Support of Sales (page 3 of 3) Local Launch & Offering Management

Marketing Services

Pricing

Product specific KOLs

Budget Required Responsibility Approvals

Regional Marketing & Sales

MarCom

Regional Marketing & Sales

Regional Marketing & Sales

Head of Geography Product Line Director

Global Marketing Regional Sales & Marketing Management RACA Legal/IP (Internal or External as required) MarCom (per Review Board SOP)

Finance Global Marketing Regional Geography Leader

Global Marketing Regional Geography Leader

Expected Metrics to Notes Output Measure Success

Local Launch Plan and Timeline

Effective Sales and Marketing Communications

Effective Pricing Plan

Active List of Product KOLs

• Product Sales Volume and Revenue • Market Share

• Sales/Regional feedback on communications effectiveness • Budget adherence

• Product Sales Volume, Revenue, Global Profitability • Market Share

• Good relationships with KOL’s • KOL engagement in representation of company and products

• • • •

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

Main Deliverables

SOP

Document

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

Global Training and Education

PLCM-023-01

Marketing Support of Sales

PLCM-035-01

Regional Training Regulatory Approvals


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

Document Title:

Regional Product Launch Plan

Document No.

Revision

Page

PLCM – 026-01

01

2 of 3

Regional Product Launch Plan

CONFIDENTIAL

Given Imaging

Given Imaging

CONFIDENTIAL

4/11/2007


Document Title:

Regional Product Launch Plan

Document No.

Revision

Page

PLCM – 026-01

01

3 of 3

TABLE OF CONTENTS Page 3

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

Given Imaging

CONFIDENTIAL

4/11/2007


Product Release SOP


Product Release Document Title:

Document No.

Product Release Template

PLCM-024-01

Revision

01

Page

2 of 3

Product XX – Product Release Product Description Product Name and Branding The names for the components of this system are: Indications/Contraindications Indications Contraindications Product Pricing Product Specifications Details on product and procedure

Product Documentation Packaging Information Product Marketing Information x

Product Positioning

x

Marketing Message

x

Competitive Environment Description

Product Training Requirements x x

Employees Customers

Product Support Information x x x x x x x

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

Note: Specifications are subject to change without prior notice and without any obligation on the part of the manufacturer. THIS DOCUMENT, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.

© 2006 Given Imaging Ltd.

28-Jun-06


Document Title:

Product Release Template

Document No.

PLCM-024-01

Revision

Page

3 of 3

01

Availability x x

Launch Product shipping by

Product Ordering Information: Description Product A Product A Accessory

Ordering P/N FGS-XXXX FGS-XXXX

Lead Times X-Y Weeks X-Y Weeks

Note: Specifications are subject to change without prior notice and without any obligation on the part of the manufacturer. THIS DOCUMENT, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.

Š 2006 Given Imaging Ltd.

28-Jun-06


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

Document Title:

Labeling Creation and Production

Document No.

Revision

Page

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

All Marketing communication Materials intended for internal distribution.

x

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.


Document Title:

Labeling Creation and Production

Document No.

Revision

Page

PLCM-020-01 (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: x

coordinating with global regions, when appropriate

x

obtaining necessary approvals

x

developing and producing Label and MarCom materials and specifications

x

responsible for developing the electronic file along with the documentation for part numbers

x 3.2

responsible for receiving inspection of MarCom materials

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.

4.0 Applicable Documents 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.


Document Title:

Labeling Creation and Production

Document No.

Revision

Page

PLCM-020-01 (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.


Document Title:

Labeling Creation and Production

6.0 Approvals Refer to PRS Form (Appendix A)

Document No.

Revision

Page

PLCM-020-01 (MK-07)

01

5 of 7


Document Title:

Labeling Creation and Production

Document No.

Revision

Page

PLCM-020-01 (MK-07)

01

6 of 7

Appendix A

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)

DATE

PRS Submitted by PRS Accepted by (MarCom)

REVIEWER APPROVALS (Print & Sign Name)

DATE

Clinical Marketing Marketing Communications 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) Chief Marketing Officer Regulatory Affairs

MARCOM INSPECTION Delivery Date & Location Inspection Date Approved By (Print & Sign Name)

DATE


Document Title:

Labeling Creation and Production

Document No.

Revision

Page

PLCM-020-01 (MK-07)

01

7 of 7

Appendix B Initiator sends PRS to MarCom Department

MarCom Department reviews PRS with key stakeholders

No

Decision is communicated to initiator

QA & local Marketing verifies quality from specifications and proof.

Yes

Proceed?

Project scope, budget and timeline are defined and approved

Local purchasing process is followed.

MarCom creates PR/PO for design cost

PRS form, design files and final document specification are filed

Marcom Department requests part number

MarCom creates design and sends proof to reviewers for regular meeting discussion and approvals

MarCom obtains edits and/or approvals

MarCom makes edits and verifies incorporation

PRS is circulated for final production approval


Project Requirement Specification (PRS) SOP


Project Requirement Specification (PRS)

Q

(

)

Marketing/Training Materials PLCM-028-01

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)

DATE

PRS Submitted by PRS Accepted by (MarCom)

REVIEWER APPROVALS (Print & Sign Name)

DATE

Clinical Marketing Marketing Communications 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)

DATE

Chief Marketing Officer Regulatory Affairs

MARCOM INSPECTION Delivery Date & Location Inspection Date Approved By (Print & Sign Name)

Page 1 of 1


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

Document Title:

Document No.

Revision

Page

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.

4.0

Reference documents 4.1. Global Launch Package Template 4.2. Product Business Case Template 4.3. Regional Launch Plan Template

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


Document Title:

Document No.

Revision

Page

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

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


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


Detailed Stage Description: Ongoing Management and Roadmap Steering Objective(s) Process(es) Employed

Capture and Resolve Product Quality and Use Issues

Install Base Management

Products Ongoing Incremental Improvements

Product End Of Life (Obsolescence)

Market/user oriented 1. Collect/track field/use quality issues 2. Follow field/use quality issue trends 3. Analyze quality cause-effect (tech, use) 4. Define solutions/mitigations Production/product oriented 5. Collect/track manufacturing quality issues 6. Follow manufacturing quality issue trend 7. 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 satisfaction 2. Improve profitability/productivity/ cost-effectiveness/utilization 3. Respond to competition

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. Gather quality data • Hierarchical SR system (Callcenter, DB, templates) • Track incoming inspection results (supplier quality) and supplier audit; production performance quality 2. conduct monthly FFF (FieldFailure-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 trends 3. Collect and track sales/CS/ marketing suggestions/requests 4. perform Customer (satisfaction/ trend) surveys 5. Analysis of production costs 6. Analysis of market/sales trends/ performance 7. Product annual review (?) 8. Improvement implementation (plan, execution) 9. Annual plan

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 (page 2 of 3) Install Base Management

Products Ongoing Incremental Improvements

Product End Of Life (Obsolescence)

Required Inputs

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 database 2. Sales performance 3. BOM cost 4. Competition data 5. FFF

1. Given Roadmap 2. Supplier roadmaps 3. IB data 4. Inventory levels (materials, FGS) 5. Competition data 6. Marketing event data 7. Finance report

Leader Partner(s) Internal/External

QA

CS – cont. CS + Finance – cont.

PL-manger - cont

PL-manger – (part of PLC plan)

• • • • • • • • •

• • • •

• Production • Clinical marketing • CS and production • Clinical marketing • Production • R&D

• • • • • • •

• R&D • Finance • Sales administration

QA

Later than 6 months after product launch

According to PLC plan (roadmap)

Contributor(s) Estimated Internal/External Time Frame

Capture and Resolve Product Quality and Use Issues

QA, R&D, CS, PL manger, production, finance Distributor, subsidiaries, supplier

context

Finance, PL Subsidiaries, Distributors

Continuous

Global Marketing, CS, Operation Finance R&D, Suppliers Regions


Detailed Stage Description: Ongoing Management and Roadmap Steering (page 3 of 3) Products Ongoing Incremental Improvements

Product End Of Life (Obsolescence)

Infrastructure

R&D if relevant Manufacturing if relevant

Product line life-cycle budget dedicated to EOL activity

1. COO 2. VP Global Marketing

1. COO 2. VP Global Marketing 3. Regions

1. Infrastructure (MPWR/”SAP”) 2. Infrastructure (MPWR/”SAP”) 3. Product line life-cycle budget dedicated sustained engineering resources 4. Context specific ad-hoc resources

Quality issue solutions/mitigations

1. 1.Reliable IB configuration (HW/ SW) Database 2. Usage/sales trends

Product improvement program

1. EOL process plan 2. EOL forecasts 3. Production scale-down plan 4. CS transition plan (FGS inventories @ Ltd and regions, spares and options, tech-support) 5. EOL strategy & announcement 6. Marketing support: • EOL “promos” • Replacement offerings 7. Messages

Metrics to Measure Success

Install Base Management

Budget Required Expected Responsibility Approvals Output

Capture and Resolve Product Quality and Use Issues

Customer satisfaction, Quality issue trends (FFF) Time-to-solution?

1. Average time to solutions 2. CS cost-effectiveness 3. PL-manager satisfaction

Meet annual improve. plan objectives (time, budget)

1. Low dead inventories 2. Sustained customer satisfaction 3. Sustained customer loyalty

Context dependent: GLBL marketing, Finance, Region


Gate P5: Product Progression and Customer Satisfaction From Product Launch to On-going Sales Main Deliverables

SOP

Document

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 Document Title:

Corrective and Preventive Action

Document No.

Revision

Page

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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.

4.0

5.0

Reference documents

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

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 nonconformity, defect, or other undesirable situation in order to prevent occurrence

5.3.

CAPA - Corrective and Preventative Action

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


Document Title:

Corrective and Preventive Action

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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

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


Document Title:

Corrective and Preventive Action

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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.

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

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


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

Document Title:

Field Modification

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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

5.0

Responsibilities 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.

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


Document Title:

Field Modification 6.0

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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

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


Document Title:

Field Modification

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Appendix A FMI Request

Define implementation method

Release FMI (ECO)

Prepare FMI kitin-service

yes

Mandatory

Validate kit

no

Create SRs In SAP

Prepare list of materials to be modified

In the field

Train Regional CS teams

no

Retrieve materials

no

Instruct Given personnel Third party

yes

Technicianless

yes

Send modification kit

Regional Support

Perform modification

Confirm Document in SAP Implementation THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD. no

Successful

yes


Installed Base Report Format SOP TBD


Gate P6: Product End of Life (EOL) From a Commercial Product to Decline Main Deliverables

SOP

Document

End Of Life

PLCM-034-01

Transition to Alternative Products EOL Plan


Detailed Stage Description: End of Life Product End of Life (Obsolescence)

Objective(s) Process(es) Process(es) Required Employed Employed Inputs

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 Plan EOL marketing package: • EOL "promos" • Replacement offerings • Messages

1. Given Roadmap 2. Supplier roadmaps 3. IB data 4. Inventory levels (materials, FGS) 5. Competition data 6. Marketing event data 7. Finance report

Leader

PL-manger -(part of PLC plan


Detailed Stage Description: End of Life (page 2 of 3) Product End of Life (Obsolescence)

Partner(s) "Contributor(s) Estimated Budget Required Internal/External Internal/External Time Frame Responsibility Approvals

• • • • • • •

Global Marketing, CS, Operation Finance R&D, Suppliers Regions

QA

According to PLC plan (roadmap)

Product line life-cycle budget dedicated to EOL activity

1. COO 2. VP Global Marketing 3. Regions


Detailed Stage Description: End of Life (page 3 of 3) Product End of Life (Obsolescence)

Expected Output

1. EOL process plan 2. EOL forecasts 3. Production scale-down plan 4. CS transition plan (FGS inventories @ Ltd and regions, spares and options, tech-support) 5. EOL strategy & announcement 6. Marketing support: • EOL "promos" • Replacement offerings 7. Messages

Metrics to Measure Success

1. Low dead inventories 2. Sustained customer satisfaction 3. Sustained customer loyalty


End Of Life SOP The purpose of this procedure is to provide clear and effective guidelines for handling of discontinued products.


End Of Life

Document Title:

Product End of Life

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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 SOP TSB Template

5.0

Responsibilities 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.

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


Document Title:

Product End of Life 6.0

Document No.

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End of Life Procedure

6.1 The Product Line Manager will define a plan containing initialization date 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.

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


Document Title:

Product End of Life 7.0

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Appendices 7.1 Appendix A: End of Life Flowchart

Appendix A EOL

Given product

no

Communicate the field (TSB-MR)

yes

Offer new product (Promo packages)

Alternative product

yes

no

Upgradable

yes Customer accept new product

no

Go to FMI SOP

yes no Exchange materials

Keep old materials for spare parts

Define Support period

Forecast Spare parts

Communicate the field (TSB-MR)

Keep documentation

Keep inventory

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

Keep inventory for Support purposes


Document Title:

Product End Of Life

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7.2 Appendix B: End of Life approval form

Notice of Product discontinuation CONFIDENTIAL

AUTHORIZATION NAME/TITLE

Issued by:

CS

Approved by:

Corporate Marketing

Approved by:

VP Operations

Approved by:

Corporate Finance

SIGNATURE

DATE

Approved by:

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


PLCM Department Responsibilities Clinical Trials PLCM-013-01 (Clinical Trials Approval Forms (CTAF) —Gate P1 PLCM-014-01 (CT Protocols) —Gate P1 PLCM-015-01 (IRB Documents) —Gate P1

CS PLCM-031-01 (Field Modification) —Gate P5 PLCM-033-01 (Installed Base Report Format) —Gate P5 PLCM-034-01 (End of Life) —Gate P6

IP PLCM-001-01 (Preliminary Risk Analysis) —Gate P0

Marketing PLCM-003-01 (Business Case) —Gate P0, —Gate P1 PLCM-004-01 (Product Requirements Definition —Gate P0 PLCM-005-01 (Make/Buy/Partner Analysis and Decision) —Gate P1 PLCM-017-01 (Comercialization Plan) —Gate P3 PLCM-018-01 (Competitive Profile) —Gate P3 PLCM-019-01 (Global Pricing Plan) —Gate P3 PLCM-020-01 (Labeling Creation and Production) —Gate P4 PLCM-023-01 (Global Training and Education) —Gate P3, —Gate P4 PLCM-024-01 (Product Release) —Gate P4 PLCM-025-01 (Global Launch Package) —Gate P3 PLCM-026-01 (Regional Launch Plan) —Gate P4 PLCM-028-01 (Project Requirement Specification) —Gate P4 PLCM-035-01 (Marketing Support of Sales) —Gate P4

Operations PLCM-011-01 (Release to Engineering) —Gate P1

QA PLCM-007-01 (Risk Analysis for Development) —Gate P1 PLCM-009-01 (Design Review Document) —Gate P1 PLCM-010-01 (DHF) —Gate P1 PLCM-012-01 (Design and Development Validation) —Gate P1 PLCM-016-01 (Regulatory Submissions) —Gate P1 PLCM-022-01 (External Evaluation Release) —Gate P3 PLCM-030-01 (CAPA - Corrective and Preventive Action —Gate P5 PLCM-036-01 (Design and Development Verification) —Gate P1

R&D PLCM-002-01 (Technical Feasibility) —Gate P0 PLCM-006-01 (Product Specification) —Gate P1 PLCM-008-01 (Testing Requirements) —Gate P1


PLC Gate Deliverables Acceptance Criteria .................................... Gate P1 Business Case ............................................. Gate P0 Business Case ............................................. Gate P1 Business Risk Analysis.................................. Gate P0 Clinical Trials Final Report........................... Gate P3 Clinical Trials Plan....................................... Gate P1 Commercialization Plan .............................. Gate P3 Customer Service Plan ................................ Gate P3 Departmental Feedback.............................. Gate P5 EOL Plan .................................................... Gate P6 Field Testing Report .................................... Gate P3 Preliminary Forecast.................................... Gate P1 Pre-Production Plan.................................... Gate P1 Product Improvement ................................. Gate P5 Product Performance Versus Marketing Req.Gate P1

Product Production Files............................. Gate P2 Product Requirement Definition ................. Gate P0 Product Risk Analysis .................................. Gate P1 Production Capabilities............................... Gate P2 Regional Launch Plans ................................ Gate P4 Regional Training........................................ Gate P4 Registration Status ...................................... Gate P3 Registration Submissions Plan ..................... Gate P1 Regulatory Approvals .................................. Gate P4 Regulatory Strategy ..................................... Gate P0 Road Map & Detailed Work Plan................ Gate P1 Road Map .................................................. Gate P0 Technology Feasibility................................. Gate P0 Transition to Alternative Products ............... Gate P6


PLC Gate SOPs PLCM-001-01............................................. Gate P0 PLCM-002-01............................................. Gate P0 PLCM-003-01............................................. Gate P0 PLCM-003-01............................................. Gate P1 PLCM-004-01............................................. Gate P0 PLCM-004-01............................................. Gate P1 PLCM-005-01............................................. Gate P1 PLCM-006-01............................................. Gate P1 PLCM-007-01............................................. Gate P1 PLCM-008-01............................................. Gate P1 PLCM-009-01............................................. Gate P1 PLCM-010-01............................................. Gate P1 PLCM-011-01............................................. Gate P1 PLCM-011-01............................................. Gate P2 PLCM-012-01............................................. Gate P1 PLCM-013-01............................................. Gate P1 PLCM-014-01............................................. Gate P1 PLCM-015-01............................................. Gate P1 PLCM-016-01............................................. Gate P1

PLCM-017-01 ............................................ Gate P3 PLCM-018-01 ............................................ Gate P3 PLCM-019-01 ............................................ Gate P3 PLCM-020-01 ............................................ Gate P4 PLCM-021-01 ............................................ Gate P3 PLCM-022-01 ............................................ Gate P3 PLCM-023-01 ............................................ Gate P3 PLCM-023-01 ............................................ Gate P4 PLCM-024-01 ............................................ Gate P4 PLCM-025-01 ............................................ Gate P3 PLCM-026-01 ............................................ Gate P4 PLCM-028-01 ............................................ Gate P4 PLCM-030-01 ............................................ Gate P5 PLCM-031-01 ............................................ Gate P5 PLCM-033-01 ............................................ Gate P5 PLCM-034-01 ............................................ Gate P6 PLCM-035-01 ............................................ Gate P4 PLCM-036-01 ............................................ Gate P1

PLCM 220807 final  
PLCM 220807 final  

Revision 01, May 2007 Copyright © 2007 Given Imaging Ltd. All rights reserved. The Product Life Cycle Management Process Homi Shamir, CEO

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