plcm 220807 final
DESCRIPTION
Revision 01, May 2007 Copyright © 2007 Given Imaging Ltd. All rights reserved. The Product Life Cycle Management Process Homi Shamir, CEOTRANSCRIPT
Product Life Cycle Management Documents
Revision 01, May 2007
Copyright © 2007 Given Imaging Ltd. All rights reserved.
The Product Life Cycle Management Process
In order to win, we must always be one step ahead of our competitors.
Every product goes through a series of steps, from the moment it is first conceived, through becoming a manufactured product, until it is discontinued. The Product Life Cycle, developed and adopted as a master standard operating procedure, describes the succession of stages each Given Imaging product must go through.
In the Given product life cycle we have six stages:1 Product & Major Release Initiation2 Implementation3 Launch Readiness4 Marketing Support of Sales (Regional Launch)5 Ongoing Management6 End of Life
Among the PLC process stages we have PLC gates that establish timelines which define the transition from one stage to another in the product life cycle. Each gate marks the end point of one stage and leads to the next one: from after product & major release initiation until before end of life.
The PLC Gates allow us to:• Draw a road map of the product cycle• Simplify all SOPs to a clear PLC path• Create cross company language for common understanding for common
understanding of products status in its life cycle• Present clear deliverables in each stage of the PLC• Identify needs for decision points in the PLC
The goals of a formal product life cycle are to:• Align all of Given's processes towards the market and towards customer needs• Formalize processes and relevant internal communication in order to improve
efficiency and boost innovative ideas• Set out clear roles and responsibilities• Reduce cost and eliminate redundancy• Improve time to market
Homi Shamir, CEO
Product Life Cycle Management OverviewProduct Life Cycle Management Overview Flowchart
Stage 1: Major Release InitiationProduct & Major Release Initiation FlowchartDetailed Stage Description: Major Release Initiation
Gate P0:Product Initiation—Concept EvaluationBusiness Risk Analysis Preliminary Risk Analysis: PLCM-001-01Business Case Business Case: PLCM-003-01Technology Feasibility Technical Feasibility: PLCM-002-01Product Requirement Definition Product Requirements Definition: PLCM-004-01Road MapRegulatory Strategy
Stage 2: ImplementationImplementation FlowchartDetailed Stage Description: Implementation
Gate P1:Product Development—A Working ProductProduct Performance Versus Marketing Req. Product Requirements Definition: PLCM-004-01
Make-Buy-Partner Analysis and Decision: PLCM-005-01Product Specification: PLCM-006-01Design Review Document: PLCM-009-01Design History File (DHF): PLCM-010-01Design and Development Validation: PLCM-012-01Design and Development Verification: PLCM-036-01
Acceptance Criteria Testing Requirements: PLCM-008-01Business Case Business Case: PLCM-003-01Road Map & Detailed Work PlanRegistration Submissions Plan Regulatory Submissions: PLCM-016-01Preliminary ForecastPre-Production Plan Release to Engineering: PLCM-011-01Product Risk Analysis Risk Analysis for Development: PLCM-007-01Clinical Trials Plan Clinical Trials Approval Forms (CTAF): PLCM-013-01
CT Protocols: PLCM-014-01IRB Documents: PLCM-015-01
R&D Implementation FlowchartGate P2:Production Readiness—Transition of Product from R&D to Production
Product Production Files Release to Engineering: PLCM-011-01Production Capabilities
Manufacturing Implementation Flowchart
Stage 3: Launch ReadinessLaunch Readiness FlowchartDetailed Stage Description: Launch Readiness
Gate P3:Product Commercialization—Pre LaunchCommercialization Plan Comercialization Plan: PLCM-017-01
Competitive Profile: PLCM-018-01Global Pricing Plan: PLCM-019-01Global Training and Education: PLCM-023-01Global Launch Package: PLCM-025-01
Clinical Trials Final ReportRegistration StatusField Testing Report Field Testing: PLCM-021-01
External Evaluation Release: PLCM-022-01Customer Service Plan
Stage 4: Marketing Support of Sales (Regional Launching Process)Marketing Support Sales FlowchartDetailed Stage Description: Marketing Support of Sales
Gate P4:Product Launch—Regional Launch Plans Regional Launch Plan: PLCM-026-01
Product Release: PLCM-024-01Labeling Creation and Production: PLCM-020-01Project Requirement Specification (PRS): PLCM-028-01
Regional Training Global Training and Education: PLCM-023-01Regulatory Approvals
Marketing Support of Sales: PLCM-035-01
Stage 5: Ongoing Management and Roadmap SteeringDetailed Stage Description: Ongoing Management and Roadmap Steering
Gate P5:Product Progression and Customer Satisfaction—From Product Launch to On-going SalesDepartmental Feedback CAPA - Corrective and Preventive Action: PLCM-030-01
Field Modification: PLCM-031-01Installed Base Report Format: PLCM-033-01
Product Improvement
Gate P6:Product End of Life (EOL)—From a Commercial Product to DeclineTransition to Alternative ProductsEOL Plan End Of Life: PLCM-034-01
Detailed Stage Description: End of Life
PLCM Department Responsibilities
PLC Gate Deliverables
PLC Gate SOPs
PLC General Flowchart.fm
Product Life Cycle Management Overview Flowchart
IMPLEMENTATION PROCESS
PRODUCT & MAJOR RELEASE INITIATION
PROCESS
MARKETING SUPPORTS OF SALES
(REGIONAL LAUNCH) PROCESS
LAUNCH READINESS PROCESS
END OF LIFE
?
Gate P0 ?
Gate P1
?Gate P2
?Gate P3
?Gate P4
ONGOING MANAGEMENT PROCESS
?Gate P5
Gate P6
Product Initiation – Concept Evaluation
Product Development - A working Product
Production Readiness - Transition of product
from a R&D to production
Product Commercialization - Pre Launch
Product Launch
Product progression & Customer Satisfaction –
From product’s launch to on going sales
End of life
Stage 1: Major Release InitiationDetailed Stage Description: Major Release Initiation
Major Release Initiation Flowchart
Gate P0: Product Initiation Deliverables
Major Release Initiation Flowchart
Product & Major Release Initiation Flowchart
Gather need/idea & filter/assess
Product & Major Release Initiation
Define preliminary requirement
Perform a technical feasibility
RESPONSIBILITY PROCESS OUTPUT
NEED/IDEA ASSESSMENTLEADER
- Corp. Product Line Manager- Biz. Dev (in cases of outside of CE)
APPROVAL
- Corp. Product Line Director- Senior Management
TECHNICAL FEASIBILITYLEADER
- VP R&D
APPROVAL
- VP R&D - Corp. Product Line Director- Senior Management
BUSINESS CASELEADER
- Product Line Manager- Biz. Dev (in cases of outside of CE)
APPROVAL
- Geography Leaders- Global Marketing- Senior Management
GO/NO GO
The outputs from this stage are:1. Short (2-3) page overview of concept outlining product, customer need, market opportunity with preliminary business case.2. Go/No Go Decision to next phase.
Max. 3 months
PRELIMINARY REQUIREMENT DEFININGLEADER
- Corp. Product Line Manager- Biz. Dev (in cases of outside of CE)
APPROVAL
- Corp. Product Line Director- Senior Management
GO/NO GO
The outputs from this stage are:1. PRD2. Preliminary Risk Analysis3. Go/No Go Decision to Technical feasibility study phase
GO/NO GO
TECHNICAL FEASIBILITY
The outputs from this stage are:1. Feasibility Plan Document that clearly outlines time to market, risks (IP, Regulatory, Technical) and costs in achieving market entry. 2. Preliminary Risk (product- use and development) Analysis Document Updated to identify risks that need to be minimized or mitigated and possible mitigation modes3. Go/No Go decision on continuation of effortBUSINESS CASEThe outputs from this stage are:1. Business Case Document to include vol/pricing, regulatory path, serviceability, transition plan.2. Preliminary Risk Analysis Document Updated 3. Go/No Go Decision to continue effort
YES
YES
Conduct a business Case
GO/NO GO
Max. 2 months
Max. 3 months
The outputs from this stage are:1. Final PRD document with updated product Roadmap. 2. Go/No Go decision to Implementation stage
NO
NO
NO NO
REFINE PR & ROADMAPLEADER
- Corp. Product Line Manager- Biz. Dev (in cases of outside of CE)
APPROVAL
- Corp. Product Line Director- CEO/Global Marketing- - Geography Leaders
Define preliminary requirement
IMPLEMENTATION
Max. 2 months
Max. 2 months
?Gate P0
se
Refine PR & Roadmap
tion, r et.
hat N he ward from
ess t icing
ng.
and ent.
1. Refine PRD to ensure customer needs are met and aligned to maximize value to GIVN.
2. Determine effect on existing roadmap, portfolio strategy and required changes that may be required.
3. Finalize business case, cost and timeline including regulatory approval and market entry
ch d
st take
ing/ting,
1. Update existing documentation with new information.
2. Review with all stakeholders
Detailed Stage Description: Major ReleaInitiation
Need/Idea Gathering & Filtering/Assessment
Preliminary Requirement Definition
Technical Feasibility Business Case
Objective(s)
Identify and evaluate product and service opportunities that meet unmet customer need
Draft of Product Requirement Definition
1. Determine technical feasibility (including costs), risks (IP, technology and technological approach) and timeline for product market entry, including technical risk of product development process and production risks as well as IP and regulatory risk.
2. Develop a Preliminary Product Specification Document
1. Define value proposiproduct messaging fospecified target markDoes it fit into GIVNbusiness model and wgaps exist within GIVBusiness? What are timplications (IB, BackCompatibility etc…) bringing product to market?
2. Develop 5 year busincase (ROI) for producwith product cost, prand volume and competitive positioniInclude preliminary market segmentationcompetitive environm
Process(es) Employed
1. Formal Regional Feedback validated by additional customer evaluation (focus groups, surveys, field visits including sales force)
2. Incorporate Product Line Technology Review Session
3. Establish database on ideas and evaluations.
4. Cross functional participation particularly with R&D & Marketing/Sales
1. Take feedback from previous phase and develop PRD document
2. Preliminary Risk Analysis & IP Risk Analysis Review
1. Conduct appropriate analysis and bench work to determine technical feasibility and regulatory risk
2. Done in parallel with Business Case?
1. Pricing Market resear2. Discussions with broa
customer base not juKOLs to determine upof product.
3. Cross functional teaminvolvement (MarketSales, Clinical MarkeFinance, Ops, R&D)
Detailed Stage Description: Major Release Initiation (page 2 of 3)
D
e, ends ent
lude
1. PRD2. Updated business case 3. Technical feasibility data.4. Product and development
risk analysis5. Corporate and Platform
Strategy6. R&D resources and
capabilities
Product Line Leader Biz Dev (only in cases outside of CE)
nt
1. Geography Leaders 1. R&D1. Product Line Leaders in
other Products1. Global RACA1. Legal/IP
Operations
Refine PR & Roadmap
Required Inputs
1. Customer input on market needs and acceptability of idea. (MUST)
2. Understanding of current GIVN Corporate Strategy.(MUST)
3. GIVN Technical Capabilities/Outside Vendor Capabilities (MUST)
4. Market Trends5. Competitive environment
and response1. Market Research (NTH)
1. Output from previous phase including overview documents from previous stage.
2. Product Line Leader Feedback
3. Customer Feedback 4. Regional Feedback (Sales &
Customer Facing Organization)
5. Market Research 6. Corporate strategy/
constraints
1. Draft of Product Requirement Definition Document with best current definition of how product is to be used in marketplace
2. State of Art (do technologies exist to make this a reality)
3. IP issues4. Risk Analysis Document
1. Estimated COGs (R&and Ops),
2. Pricing and volume (regional marketing).
3. Competitive responsmarket behavior & tr
4. Risk Analysis Docum(product and developmental to incregulatory)
Leader
Product Line Leader Biz Dev (only in cases outside of CE)
Product Line Leader-Biz Dev (only in cases outside of CE)
VP R&D Product Line Leader Biz Dev (only in cases outside of CE)
Partner(s)Internal/External
1. Product and Platform Managers
2. Geography Product Manager
3. Global Clinical Marketing 4. R&D5. Finance
1. Product and Platform Managers
1. R&D Project Managers 1. Geography Product
Managers 1. Global Clinical Affairs
1. R&D 1. Global RACA1. Product Line Leader 1. Outside Vendors1. Chief Scientist1. Operations 1. IP
1. Finance1. Geography Leaders 1. Product and Platform
Managers 1. Clinical Marketing 1. Business Developme1. Operations 1. Legal/IP
Contributor(s)
Internal/External
1. Sales Force 2. GIVN Customer Facing
Functions 3. Customers 4. Regulatory 5. IP6. Chief Scientist7. Biz Dev8. Outside Vendors/
Consultants
1. Customers2. Sales Force3. GIVN Customer Facing
Functions4. Chief Scientist5. Biz Dev
All Given Functions 1. R&D 2. Global RACA3. Outside Consultants
Need/Idea Gathering & Filtering/Assessment
Preliminary Requirement Definition
Technical Feasibility Business Case
Detailed Stage Description: Major Release Initiation (page 3 of 3)
2 months
Global Marketing
1. CEO/Global Marketing2. Functional Leaders 3. Geography Leaders
ent ,
on
to
lysis
1. Final PRD document with updated Product Roadmap.
2. Go/No Go decision to Implementation Stage
Refine PR & Roadmap
Estimated M
aximum
Time Fram
e
3 months 2 month TBD (3 months?) 2 months
BudgetResponsibility
Global Marketing Global Marketing R&D Global Marketing
RequiredA
pprovals
1. Product Line Leader 2. Sr. Management
1. Product Line Leader 2. Sr. Management specifically
Regional Leaders
1. VP R&D2. Product Line Leader 3. Sr. Management
1. Geography Leader2. Global Marketing3. Sr. Management
Expected Output
1. A short (2-3) page overview of concept outlining product, customer need, market opportunity with preliminary business case. (need to develop template for concept overviews)
2. Go/No Go Decision to next phase.
1. PRD2. Go/No Go Decision to
Technical Feasibility Study Phase
3. Preliminary Risk Analysis Document
1. Feasibility Plan Document that clearly outlines time to market, risks (IP, Regulatory, Technical) and costs in achieving market entry.
2. Preliminary Risk (product-use and development) Analysis Document Updated to identify risks that need to be minimized or mitigated and possible mitigation modes
3. Go/No Go decision on continuation of effort
1. Business Case Documto include vol/pricingregulatory path, serviceability, transitiplan.
2. Go/No Go Decision continue effort
3. Preliminary Risk AnaDocument Updated
Need/Idea Gathering & Filtering/Assessment
Preliminary Requirement Definition
Technical Feasibility Business Case
Gate P0: Product InitiationConcept Evaluation
Main Deliverables SOP Document
Business Risk Analysis Preliminary Risk Analysis PLCM-001-01
Business Case Business Case PLCM-003-01
Technology Feasibility Technical Feasibility PLCM-002-01
Product Requirement Definition Product Requirements Definition
PLCM-004-01
Road Map
Regulatory Strategy
Preliminary Risk Analysis SOP
This document provides a framework to determine technical feasibility, and regulatory, IP and business risks as input to a Go/No go decision for the Leaders in a Product & Major Release Initiation and Implementation process. This document provides a framework to identify risks and their possible mitigation modes. This document provides an updated status of risks at every Go/No go decision point throughout a PLCM process.
Preliminary Risk Analysis
Document Title: Document No. Revision Page
Preliminary Risk Analysis PLCM-001-01 01 2 of 6
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
1. Purpose
1.1 This document provides a framework to determine technical feasibility, and regulatory, IP and business risks as input to a Go/No go decision for the Leaders in a Product & Major Release Initiation and Implementation process.
1.2 This document provides a framework to identify risks and their possible mitigation modes.
1.3 This document provides an updated status of risks at every Go/No go decision point throughout a PCLM process.
2. Scope
2.2 The Preliminary Risk Analysis Document should relate to technical feasibility risks, regulatory risks, IP risks and business risks.
2.3 Technical feasibility Risks:
2.3.1 technology and technological approach
2.3.2 technical risk of product development process
2.3.3 (if relevant) cost for mitigating risk
2.4 Regulatory risks
2.4.1 Approval path and possible risks of this approval path
2.4.2 (if relevant) cost for mitigating risk
2.5 IP risks
2.5.1 Initial 3rd party patent search
2.5.2 (if relevant) cost for mitigating risk
2.6 Business risks:
3. Responsibility
3.1. Input required from the following:
3.1.1. R&D
3.1.2. Regulatory
3.1.3. IP
3.1.4. Marketing (Business)
3.2. Each party listed in section 3.1 above must be presented all the other parties’ input.
3.3. These people need to sign off:
3.3.1. Product Line Leader
3.3.1.1. Product Line Leader is responsible to initiate the risk analysis, gather input and present each party’s input to all other parties.
3.3.2. COO, VP R&D, Legal Counsel, CMO
Document Title: Document No. Revision Page
Preliminary Risk Analysis PLCM-001-01 01 3 of 6
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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.
Document Title: Document No. Revision Page
Preliminary Risk Analysis PLCM-001-01 01 4 of 6
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
Do
cu
men
t T
itle
Do
cu
me
nt
No
.
Re
vis
ion
P
ag
e
Pre
lim
ina
ry R
isk
An
aly
sis
PL
CM
-00
1-0
1
01
5 o
f 6
TH
IS S
PE
CIF
ICA
TIO
N,
AN
D/O
R T
HE
SU
BJE
CT
MA
TT
ER
AR
E R
ES
TR
ICT
ED
SO
LE
LY
FO
R T
HE
US
E O
F G
IVE
N I
MA
GIN
G L
TD.
Ap
pen
dix
A
EX
AM
PL
E
ES
O 2
- dou
ble
headed
capsule
that will
have
more
PC
B space (
ME
Ms and
battery
contacts
and
change
antenna
location
) and better illumination
(LE
D ring
)
STA
TU
S
Ris
ke
xp
lan
ati
on
p
rob
ab
ilit
y
severi
ty
mit
igati
on
co
st
of
mit
igati
on
d
ate
sta
tus
date
sta
tus
ME
Ms
new
component,
no
in-house
knowledge
low
high
no
xxxx
severity
low
due
to
hiring
new
ME
MS
expert
yyyy
mitigated
LE
D ring
new
component,
vendors
not
known
medium
medium
re-design
XX
XX
$
zzzz
severity
medium
pppp
mitigated
antenna
location
antenna
near
metal parts
medium
medium
re-design,
em
bedded
antenna
XX
XX
$
Tech
no
log
y
Battery
contacts
new
component
low
medium
re-design
XX
XX
$
Re
gu
lato
ry
special 510K
X
XX
X
high
low
traditional
510K
3 more
months to
schedule
TH
IS S
PE
CIF
ICA
TIO
N,
AN
D/O
R T
HE
SU
BJE
CT
MA
TT
ER
AR
E R
ES
TR
ICT
ED
SO
LE
LY
FO
R T
HE
US
E O
F G
IVE
N I
MA
GIN
G L
TD.
existing
registered
patent
belonging
to
X
XX
patent covers
M
EMs switch in
Ph
capsule
medium
high
1. design
around
patent,
2. O
btain
rights
in patent
(liscence etc
.),
3. invalidate
patent
1. xxxx$, 2. xxxx$ 3
. xxxx$
www
mitigated
due
to
design
around
at Given
IP
Existing
patent
application
belonging
to
X
XX
patent
application
potentially
covering
antenna
location
low
high
1. design
around
and
pu
blish
new
design
so
that
our design
cannot be
patented
by
third part
y 2
. O
btain
rights
in
patent
(liscence etc
.)
1. xxx$, 2. xxx$
Bu
sin
es
s
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. Revision Page
Business Case PLCM-003-01 01 2 of 3
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
1.0 Purpose
This document provides a framework for evaluating a project’s value to Given Imaging.
2.0 Scope
This document applies to all products that are using the Given Imaging Product
Life Cycle Management (PLCM) process. The document is initiated in the 4th
substage of the Product Initiation and Major Release Phase of PLCM and is
carried through the entire PLCM process with a final Business Case document
being issued as a key input in the Global Launch Planning subphase of the
Marketing Support of Sales PLCM phase.
3.0 Responsibility
Product Line Leader will be responsible for initiating and building the business
case as the product or service moves through the PLCM process. Input from
Partners (Finance, Geography Leaders, Product and Platform Managers, Clinical
Marketing, Business Development, Operations and Legal/IP) and Contributors
(R&D, Global RACA and outside consultants) are expected. Global Marketing
has the budget responsibility and final approvals come from Geography Leader,
Global Marketing and Senior Management representing Finance, Operations,
Regulatory, R&D & Marketing.
4.0 Reference documents
4.1. Given Imaging Product Life Cycle Management (PLCM) Document that
outlines this process.
4.2. Cost of Goods Estimation (from R&D. Operations and Finance)
4.3. Volume Fcst (from Regions)
4.4. Market Research (pricing/volume, effect on other products’ prices, competitive
positioning, market behavior and trends)
4.5. Operational assessment
4.6. Financial assessment
5.0 Definitions
5.1. Value Proposition: Specific value a particular product brings to the customer
5.2. Product Messaging: Key messaging or language used to communicate value
proposition to customer
Document Title: Document No. Revision Page
Business Case PLCM-003-01 01 3 of 3
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.0 The Process
6.1. Executive Summary: concise summary of the key highlights of the business
case, including project’s purpose, goals, costs, revenue opportunity, risks and
criteria for success. The reader should be able to understand what the project
is about, its role in the business and a justification for the project.
6.2. Project Background: Brief description of the business problem or opportunity
or customer need that project is intended to meet.
6.3. Objectives: Clear definition of what the project will accomplish, its scope and
expected results (revenue, gross profit, increased marketshare) and who are
the key stakeholders. Include data for 1, 3 and 5 years.
6.4. Competitive Assessment: Describe current competitive offerings that will
compete with the project and anticipated competitive response to the new
offering including barriers to entry that may prevent effective launch of
product. Also address the customer’s ability to adopt the project and integrate
into their daily work habit.
6.5. Technological Assessment: Describe the current understanding of our
technological capability in developing this product or service. Define the
technological hurdles to be overcome.
6.6. Regulatory Assessment: Define the current understanding of the regulatory
path for the product and any potential issues to overcome
6.7. Operational Assessment: Define operational needs.
6.8. Financials: Include projected impact thru 5 years.
7.0 Appendix
Technical Feasibility SOP
The purpose of this procedure is to determine technical feasibility including costs, risks (technology and technological approach) and timeline for product market entry, including technical risk of product development process and production risks as well as regulatory risk.The purpose of this procedure is also to develop a Preliminary Product Specification Document
Technical Feasibility
Document Title: Document No. Revision Page
Technical Feasibility PLCM- 002-01 01 2 of 3
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
1.0 Purpose
1.1. The purpose of this procedure is to determine technical feasibility including
costs, risks (technology and technological approach) and timeline for product
market entry, including technical risk of product development process and
production risks as well as regulatory risk.
1.2. Develop a Preliminary Product Specification Document.
2.0 Scope
2.1. This document applies to conduct appropriate analysis and bench work to
determine technical feasibility and regulatory risk
2.2. The technical feasibility can be done in parallel with Business Case.
3.0 Responsibility
3.1. Leader - V.P R&D is the leader and has the overall responsibility for all
development activities and for the implementation of this document.
3.2. Partners in the Technical Feasibility phase are:
Dept./Entity Name
3.2.1. R&D
3.2.2. Global CA
3.2.3. Product Line Leader
3.2.4. Operations
3.2.5. Chief Scientist
3.2.6. Outside Vendors
3.3. Contributors: all Given functions
4.0 Required Inputs
4.1. Draft of Product Requirement Definition Document with best current definition
of how product is to be used in marketplace.
4.2. State of Art (do technologies exist to make this a reality).
4.3. IP issues
4.4. Risk Analysis Document
5.0 Estimated Maximum Time Frame
TBD
Document Title: Document No. Revision Page
Technical Feasibility PLCM- 002-01 01 3 of 3
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.0 Budget Responsibility
R&D
7.0 Required Approvals
7.1. VP R&D
7.2. Product Line Leader
7.3. Sr. Management
8.0 Expected Output
8.1. Feasibility Plan Document that clearly outlines time to market, risks (IP,
Regulatory, Technical) and costs in achieving market entry.
8.2. Preliminary Risk (product-use and development) Analysis Document Updated to
identify risks that need to be minimized or mitigated and possible mitigation
modes
8.3. Go/No-Go decision on continuation of effort
9.0 Definitions
Any initials, technical or professional terms should be defined in this section.
10.0 Feasibility Plan Document
10.1. Timeline for product market entry
10.2. Costs in achieving market entry
10.3. Preliminary Risks Analysis Document
10.3.1. Product use
10.3.2. Technical (development and production)
10.3.3. IP
10.3.4. Regulatory
10.4. Preliminary Product Specification Document
10.5. Go/No-Go decision on continuation of effort
11.0 Appendix
Product Requirements Definition SOP
The purpose of this procedure is to assure the systematic preparation of a clear Product Requirements Definition document for any GIVEN product or service offered for sale.
The Product Requirements Definition (PRD) document shall be:
1. The main output of the “Product & Major Release Initiation” phase
2. By its creation during the “Product & Major Release Initiation” phase it shall gain the endorsement of the main stakeholders of the product
It shall serve as the Design Input Document (DID) in the Design History File (DHF) of the product
Product Requirements Definition
Document Title: Document No. Revision Page
SOP Product Requirements Definition PLCM-004-01 01 2 of 11
THIS DOCUMENT, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
1.0 Purpose
The purpose of this procedure is to assure the systematic preparation of a clear
Product Requirements Definition document for any GIVEN product or service
offered for sale.
The Product Requirements Definition (PRD) document shall be:
1. The main output of the “Product & Major Release Initiation” phase
2. By its creation during the “Product & Major Release Initiation” phase it shall
gain the endorsement of the main stakeholders of the product
3. It shall serve as the Design Input Document (DID) in the Design History
File (DHF) of the product.
2.0 Scope
2.1 The Product Requirements Definition document is the first product definition
document (followed by the Product Specification document in the
Implementation phase of the PLCM process), which defines the features and
other aspects of the product, so that it will comply with the marketing plan and
positioning for the product.
2.2 The Product Requirements Definition document is a controlled document.
2.3 All relevant GIVEN functionaries listed in this SOP will participate in the Product
Requirements Definition document preparation process according to this SOP.
3.0 Definitions
3.1 GIVEN Product - any product software, hardware or paper ware or any service
offered for sale that is produced in whole or in part by GIVEN Imaging, for
customers or for routine use of GIVEN support staff.
3.2 Product Manager - responsible for the life cycle management of the product
from initiation by Management, through development of a business case,
evaluation of feasibility study results, obtaining management decision on
development, development of life-cycle schedule, product definition,
coordination of development and marketing effort and launch and post launch
monitoring of the product till End Of Line (EOL) of the product.
3.3 Project Manager – An R&D function responsible for the development of the
product from product definition until its launch, through developing a PRD-
based Product Specification (PS), project (=product development)
schedule/GANTT, design, development and preparation for clinical trials and
regulatory approval, until the product is ready for launch and shipping.
Document Title: Document No. Revision Page
SOP Product Requirements Definition PLCM-004-01 01 3 of 11
THIS DOCUMENT, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
4.0 Responsibility
4.1. The Product Line Manager, who is responsible for the life cycle management of
the product, is responsible for the implementation of this SOP for the Product
Requirements Definition document through the execution of the first phase of
the Product Life Cycle management (PLCM) - Product & Major Release
Initiation.
4.2. The Project Manager from R&D, who is leading the development effort of the
product, is responsible for the step-by-step implementation and monitoring of
the development plan of the product.
5.0 Applicable document
5.1. Product & Major Release Initiation flowchart.doc
5.2. PLCM Final 271106.doc
6.0 Procedure
6.1. Product management, following senior management or other initiation, will
prepare the Product Requirements Definition document while executing the first
phase of the PLCM - Product & Major Release Initiation according to the
flowchart in Appendix A and the detailed description in Appendix B.
6.2. The issues and items defined in the Product Requirements Definition document
will be according to the template attached in appendix C.
6.3. Section 1 in the PRD is the material that in general is prepared as the output of
the “Need/Idea Gathering & Filtering/Assessment” – “A short 2-3 page overview
of concept outlining product, customer need, market opportunity with preliminary
business case”
6.4. The document will be based on senior management guidance and market
requirements, following market research and marketing input from the field, as
well as other relevant input from the GIVEN organization according to Appendix
A and B.
6.5. Different GIVEN functions, as detailed in Appendix A and B will contribute to the
preparation of the Product Requirement Definition document, will review and
approve the document to obtain endorsement of all main stakeholders in the
development of the product.
6.6. The Product Line Manager will drive the final GO decision based on material
accumulated during the preparation of the Product Requirement Definition and
accumulated/represented in it.
6.7. The Product Requirement Definition document will be maintained and updated
by Product Management according to requirements changes during the life
cycle of the product.
Document Title: Document No. Revision Page
SOP Product Requirements Definition PLCM-004-01 01 4 of 11
THIS DOCUMENT, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
Appendix A - Product & Major Release Initiation
Do
cu
me
nt T
itle:
Do
cu
me
nt N
o.
R
evis
ion
P
ag
e
SOP
Pro
du
ct R
eq
uir
em
en
ts D
efi
nit
ion
PLCM
-00
4-0
1
01
5
of
11
Ap
pen
dix
B –
PLCM
- P
rod
uct &
Majo
r R
ele
ase I
nit
iati
on
N
ee
d/I
dea
Gath
eri
ng
&
Fil
teri
ng/A
ss
es
sm
en
t P
reli
min
ary
R
eq
uir
em
en
t D
efi
nit
ion
Te
ch
nic
al F
ea
sib
ility
B
usin
es
s C
ase
R
efi
ne
PR
&
Ro
ad
ma
p
Obje
cti
ve
Identify
and evaluate
product and service
opportunities that meet unmet customer
need
Draft
of
Product
Requirement
Definition
1.
Determine technical
feasibility
(including
costs
), risks
(technolog
y and
technological
approach) and
timeline
for product market
entr
y, including
technical risk of product
development process
and production
risks as
well as regulatory
risk.
2.
Develop a
Preliminary
Product
Specification
Document
1.
Define value proposition,
product messaging for
specified target market. Does
it fit into
GIV
N business model
and what gaps exist within
G
IVN
Business? What are
the implications (
IB,
Backward
Compatibility
etc
…) from
bringing product to
market?
2.
Develop 5
year
business case
(RO
I) for product with product
cost, pricing and volume and
competitive positioning.
Include preliminary
market
segmentation
and competitive
environment.
1. Refine P
RD
to ensure
customer needs are
met
and aligned to maximize
value to G
IVN
.
2. Determine effect on
existing roadmap,
portfolio
strateg
y and
required changes that
may
be required.
3. Finalize business case,
cost and timeline
including regulatory
approval and market
entr
y
Pro
cess
Em
ployed
1.
Formal Regional Feedback validated
by
additional customer evaluation (focus
groups, surve
ys, field
visits including sale
force)
2.
Incorporate
Product Line Technolog
y Review
Session
3.
Esta
blish data
base on ideas and
evaluations.
4.
Cross functional participation particularl
y with R
&D
&
Marketing/Sales
1. Take feedback
from
previous
phase and develop
P
RD
document
2. Preliminary
Risk
Analysis
& I
P
Review
1.
Conduct appropriate
analysis
and bench
work
to determine
technical feasibility
and
regulatory
risk
2.
Possibly
Done in
parallel with Business
Case
1.
Pricing Market research
2.
Discussions with broad
customer
base not just K
OLs
to determine uptake of
product.
3.
Cross functional team
involvement (Marketing/Sales,
Clinical Marketing, Finance,
Ops, R
&D
)
1. Update
existing
documentation
with new
information.
2. Review
with all
stakeholders
Do
cu
me
nt T
itle:
Do
cu
me
nt N
o.
R
evis
ion
P
ag
e
SOP
Pro
du
ct R
eq
uir
em
en
ts D
efi
nit
ion
PLCM
-00
4-0
1
01
6
of
11
THIS
DOCUMENT, AND/OR
THE
SUBJECT
MATTER
ARE
RESTRICTED
SOLELY
FOR
THE
USE
OF
GIVEN
IMAGING
LTD.
N
ee
d/I
dea
Gath
eri
ng
&
Fil
teri
ng/A
ss
es
sm
en
t P
reli
min
ary
R
eq
uir
em
en
t D
efi
nit
ionT
ec
hn
ical F
ea
sib
ility
B
us
ine
ss C
as
e
R
efi
ne
PR
&
Ro
ad
ma
p
Req
uir
ed
In
pu
ts
1.
Customer input on market
needs and accepta
bility
of
idea. (M
US
T)
2.
Understanding of current
GIV
N Corporate
Strateg
y.(M
US
T)
3.
GIV
N Technical
Capa
bilities/Outside Vendor
Capa
bilities (
MU
ST
) 4.
Market Trends
5.
Competitive environment
and response
6.
Market Research (
NT
H)
1. Output from
previous
phase including overview
documents
from
previous
stage.
2. Product
Line Leader
Feedback
3. Customer
Feedback
4. Regional Feedback
(Sales &
Customer
Facing
Organization)
5. Market Research
6. Corporate
strateg
y/constraints
1.
Draft
of
Product
Requirement Definition
Document with best
current definition of
how
product is
to be
used in marketplace
2.
State
of
Art
(do
technologies exist to
make this
a realit
y)
3.
IP issues
4.
Risk Analysis
Document
1.
Estimated C
OGs (
R&
D and
Ops),
2.
Pricing and volume (regional
marketing).
3.
Competitive response, market
behavior
& trends
4.
Risk Analysis
Document
(product and developmental
to include regulatory
)
1. P
RD
2. Updated business case
3. Technical feasibility
data
. 4. Product and
development risk
analysis
5. Corporate
and Platform
Strateg
y 6. R
&D
resources and
capabilities
Lead
er
Product
Line Leader or
Biz
Dev
(only
in cases outside
of
CE
) Product
Line Leader or
Biz
Dev (only
in cases outside
of
CE
)
VP
R&
D
Product
Line Leader
Biz
Dev (only
in cases outside of
CE
)
Product
Line Leader
Biz
Dev (only
in cases
outside of
CE
)
Part
ner(
s)
• In
tern
al
• E
xte
rnal
1.
Product and
Platform
Managers
2.
Geograph
y Product
Manager
3.
Glo
bal Clinical Marketing
4.
R&
D
5.
Finance
1. Product and
Platform
Managers
2. R
&D
Pro
ject Managers
3. Geograph
y Product
Managers
4. Glo
bal Clinical Affairs
5. I
P
1.
R&
D
2.
Glo
bal R
AC
A
3.
Product
Line Leader
4.
Outside Vendors
5.
Chief
Scientist
6.
Operations
1.
Finance
2.
Geograph
y Leaders
3.
Product and
Platform
Managers
4.
Clinical Marketing
5.
Business Development
6.
Operations
7.
Legal/I
P
1.
Geograph
y Leaders
2.
R&
D
3.
Product
Line Leaders
in
other
Products
4.
Glo
bal R
AC
A
5.
Legal/I
P
Co
ntr
ibu
tor(
s)
• In
tern
al
• E
xte
rnal
1.
Sales Force
2.
GIV
N Customer
Facing
Functions
3.
Customers
4.
Regulatory
5.
IP
6.
Chief
Scientist
7.
Biz
Dev
8.
Outside
Vendors
/Consultants
1. Customers
2. Sales Force
3. G
IVN
Customer
Facing
Functions
4. Chief
Scientist
5. Biz
Dev
All
Given
Functions
1.
R&
D
2.
Glo
bal R
AC
A
3.
Outside Consultants
Operations
Do
cu
me
nt T
itle:
Do
cu
me
nt N
o.
R
evis
ion
P
ag
e
SOP
Pro
du
ct R
eq
uir
em
en
ts D
efi
nit
ion
PLCM
-00
4-0
1
01
7
of
11
THIS
DOCUMENT, AND/OR
THE
SUBJECT
MATTER
ARE
RESTRICTED
SOLELY
FOR
THE
USE
OF
GIVEN
IMAGING
LTD.
N
ee
d/I
dea
Gath
eri
ng
&
Fil
teri
ng/A
ss
es
sm
en
t P
reli
min
ary
R
eq
uir
em
en
t D
efi
nit
ionT
ec
hn
ical F
ea
sib
ility
B
us
ine
ss C
as
e
R
efi
ne
PR
&
Ro
ad
ma
p
Esti
mate
d
Maxim
um
T
ime F
ram
e
3 months
2 month
TB
D (
3 months?)
2 months
2 months
Bu
dg
et
Resp
on
sib
ility
Glo
bal Marketing
Glo
bal Marketing
R&
D
Glo
bal Marketing
Glo
bal Marketing
Req
uir
ed
A
pp
rovals
1.
Product
Line Leader
2.
Sr.
Management
1.
Product
Line Leader
2.
Sr.
Management
specifically
Regional
Leaders
1.
VP
R&
D
2.
Product
Line Leader
3.
Sr.
Management
1.
Geograph
y Leader
2.
Glo
bal Marketing
3.
Sr.
Management
1.
CE
O/Glo
bal Marketing
2.
Functional Leaders
3.
Geograph
y Leaders
Exp
ecte
d
Ou
tpu
t
1.
A short
(2-3
) page
overview
of concept
outlining
product, customer
need, market opportunity
with preliminary
business
case. (need to develop
template
for concept
overviews)
2.
Go/No Go Decision to next
phase.
1.
PR
D
2.
Go/No Go Decision to
Technical Feasibility
Stud
y Phase
3.
Preliminary
Risk
Analysis
Document
1.
Feasibility
Plan
Document that clearl
y outlines time
to
market,
risks (
IP,
Regulatory,
Technical)
and
costs
in
achieving
market entr
y.
2.
Preliminary
Risk
(product-use
and
development)
Analysis
Document
Updated
to
identify
risks that need
to
be
minimized
or
mitigated
and
possible
mitigation
modes
3.
Go
/No
Go
decision
on
continuation of effort
1.
Business Case Document to
include vol/pricing, regulatory
path, serviceability, transition
plan.
2.
Go/No Go Decision to
continue effort
3.
Preliminary
Risk Analysis
Document Updated
1.
Final P
RD
document
with updated Product
Roadmap.
2.
Go/No Go decision to
Implementation
Stage
Document Title: Document No. Revision Page
SOP Product Requirements Definition PLCM-004-01 01 8 of 11
Appendix C – Product Requirements Definition - template
AUTHORIZATION
NAME TITLE SIGNATURE DATE
Issued by:
Approved by:
Approved by:
Approved by:
Approved by:
Approved by:
REVISION HISTORY
REVISION # CO # DESCRIPTION DATE
1 1 New Issue
DISTRIBUTION LIST
COPY NAME TITLE / DEPARTMENT
#1
#2
#3
Document Title: Document No. Revision Page
SOP Product Requirements Definition PLCM-004-01 01 9 of 11
THIS DOCUMENT, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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
Document Title: Document No. Revision Page
SOP Product Requirements Definition PLCM-004-01 01 10 of 11
THIS DOCUMENT, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
5.5.2. Language requirements
5.6. Environmental requirements
5.6.1. Environmental compatibility requirements
5.6.2. Environmental endurance/durability requirements
5.7. Cost requirements
5.8. Price targets
5.9. Service requirements
6. Regulatory requirements
Statutory/regulatory requirements (FDA, MDD, others)
7. Standards requirements
7.1. ISO, ANSI, ASTM, GIVEN company standards
7.2. General safety standards requirements (e.g. IEC 60601-1,
ISO 10983)
7.3. Other
8. QA requirements
8.1. Risk level requirements
8.2. Reliability/Failure requirements
9. Product Tree/Component requirements
10. Product Life Cycle milestones/Roadmap requirements
10.1. Availability requirements
10.2. EOL requirements
11. Special requirements
12. Related Documents
Stage 2: ImplementationDetailed Stage Description: Implementation
Implementation Flowchart
Gate P1: Product Development Deliverables
R&D Implementation Flowchart
Gate P2: Production Readiness Deliverables
Manufacturing Implementation Flowchart
Implementation Flowchart
Implementation Flowchart
Make/Buy/Partner Analysis
Implementation
Define product specification
RESPONSIBILITY PROCESS OUTPUT
MAKE/BUY/PARTNER ANALYSISLEADER
- VP R&D
APPROVAL
- VP R&D
MAKE/BUY/PARTNER
ANALYSIS –
Make/Buy/Partner decisions for the whole product and/or major building blocks. The expected outputs are decisions & contracts
PRODUCT SPECIFICATION -
Derive functional, technological, testing and clinical specifications to fit product requirements. The expected output is specification document
1 Quarter Depends on product complexity
Comply with national and international laws and regulations. The expected output is a market clearance
REGISTRATIONLEADER
- Director of Regulatory
APPROVAL
- COO
Development Planning, Execution & Release
LAUNCH
PRODUCT SPECIFICATION
LEADER
- VP R&D
APPROVAL
- Corp. Product Line Director
Depends on product comlexity
Develop product to fit Product Specifications, define product labeling & release to engineering. The expected outputs are:
Product available for production
IP product portfolio
Production file (including Product
detailed description)
DEVELOPMENT PLANNING, EXECUTION & RELEASELEADER
- VP R&D
APPROVAL
- COO - Corp. Product Line Director (Change of specs only)
Engineering, Production & Monitoring
Clinical Trials
Depends on product comlexity
Registration
ENGINEERING, PRODUCTION & MONITORINGLEADER
- VP Operations
APPROVAL
- COO Depends on product comlexity
Prepare manufacturing capabilities to fit manufacturing plan, production, monitoring production quality & yield. The expected output is product available for sales according to sales forecast
Prove safety of product, prove efficacy, provide clinical data to support regulatory, R&D, and marketing requirements. The expected outputs are:
Final report
Manuscripts/Abstracts and
presentations
CLINICAL TRIALSLEADER
- Global Clinical Affairs
APPROVAL
- Corp. Product Line Director- COO
- CMO
Depends on product comlexity
?
P1
?
P2
?
P3
als Registration
y of
acy nical data regulatory, marketing nts
• Comply with national and international laws and regulations
Detailed Stage Description: Implementation
Make/Buy/Partner Analysis
Product Specification
Development Planning, Execution & Release
Engineering, Production & Monitoring
Clinical Tri
Objectives
• Make/Buy/Partner decisions for the whole product and/or major building blocks
• Derive functional, technological, testing and clinical specifications to fit product requirements
• Develop product to fit Product Specifications
• Define product labeling
• Release to engineering
• Prepare manufacturing capabilities to fit manufacturing plan
• Production• Monitoring
production quality & yield
• Prove safetproduct
• Prove effic• Provide cli
to support R&D, and requireme
Detailed Stage Description: Implementation (page 2 of 5)
nical trials rmsnical trials
rmal sonudyal report of apers and ns
• Verify applicable regulations and requirements
• Develop regulatory strategy
• Submit applications• Obtain market
clearance
als Registration
Processes Employed
• Define system and major building blocks
• Identify technological gaps
• Identify Given in-house capabilities and capacity
• Identify potential partners/sub-contractors/off-the shelf modules
• Request proposals• Risk analysis• Make decision
parameters:• Quality• Cost• Time-to-Market• Given core
technological capabilities
• Check Capacity of R&D & Manufacturing
• Risks (including IP risk)
• Create IP portfolio
• Perform top level design
• Develop fast prototypes for high risk/ performance gaps
• Verify compliance with regulatory affairs
• Prepare:1. specification
document2. testing requirement
document3. Risk analysis
• Prepare detailed design documents
• Develop fast prototypes for high risk/ performance gaps (if needed)
• Development• Prepare acceptance
tests plan for external modules and perform the tests
• Progress tracking using project plans
• Design reviews• PDR• DR• CDR• Production DR
(see in Project Initiation Form)
• Prepare Quality assurance, V&V
• Verify compliance with regulatory affairs
• Pre-clinical R&D trials• BOM creation• Release to engineering
document (hand-shake)
• Validation master-plan document
• Purchasing• Create production
flow chart• Create
manufacturing line• Training &
certification for production team
• Pilot run• Production• Yield control• Sustaining
engineering
• Prepare cliapproval fo
• Prepare cliprotocol
• Prepare fodocument
• Site selecti• Monitor st• Prepare fin• Generation
scientific ppresentatio
Make/Buy/Partner Analysis
Product Specification
Development Planning, Execution & Release
Engineering, Production & Monitoring
Clinical Tri
Detailed Stage Description: Implementation (page 3 of 5)
nts and ns and
l study
• Product specification document
• Product detailed description
• Results of pre-clinical studies (safety, EMC, environmental, SW validation, etc.)
• Risk analysis• Results of clinical
studies• Draft labeling (UM,
package insert, labels, etc.)
al Affairs Director of Regulatory
As needed
rectorselal affairs regional
artners
Internal• R&D• Product director• QA• Global and regional
marketing
als Registration
Required Inputs
• Product requirements
• Given roadmap• Results of feasibility
studies• Business case• Core strategic Given
capabilities• IP risk analysis
• Product requirements
• Product roadmap• Results of feasibility
studies•
• Product specification• Manufacturing
forecast (sales, clinical trials, marketing needs)
• Release to engineering document (hand-shake)
• Manufacturing forecast (sales, clinical trials, marketing needs)
• Product requiremespecificatio(marketingregulatory)
• Pre-clinicaresults
Leader
VP R&D VP R&D or designee VP R&D VP Operations Global Clinic
Engagement
Frequency
As needed Daily As needed As needed As needed
Partner(s)Internal/External
Internal• R&D• Operations• Finance• Product director.• Legal counsel• IP
Internal• Product director.• Operations• Clinical Affairs• Regulatory Affairs• IPExternal• Business partners
Internal• Operations• Product director• QA• Clinical Affairs• Regulatory Affairs
Internal• R&D• QA
Internal• R&D• Product di• Legal coun• Local clinic• Global and
marketingExternal• Business p
Make/Buy/Partner Analysis
Product Specification
Development Planning, Execution & Release
Engineering, Production & Monitoring
Clinical Tri
Detailed Stage Description: Implementation (page 4 of 5)
visors
roduct depends on product complexity
al Affairs Director QA
torCOO
tts/nd ns
Market clearance
als Registration
Contributors
Internal/External
Internal• Business Develop.• CTO (TBH?)External• Advisors• Experts
Internal• CSExternal• Advisors• Experts
Internal• CS• IPExternal• Advisors• Experts
Internal• CS• IPExternal• Advisors• experts
Internal• CS• LogisticsExternal• Medical ad• KOLs
Estimated
Time Fram
e
One Quarter (may be longer in case of Partner decision)
depends on product complexity
depends on product complexity
depends on product complexity
depends on pcomplexity
BudgetResponsibility
VP R&D VP R&D COO COO Global Clinic
RequiredA
pprovals
VP R&D Product director COOProduct director -(Change of specs only)
COO Head CAProduct direcCMOCOO
ExpectedO
utput
Decisions + contracts Specification document • Product available for production
• IP product portfolio• Production file
(including Product detailed description)
• Product available for sales according to sales forecast
• Final repor• Manuscrip
Abstracts apresentatio
Make/Buy/Partner Analysis
Product Specification
Development Planning, Execution & Release
Engineering, Production & Monitoring
Clinical Tri
Detailed Stage Description: Implementation (page 5 of 5)
tion
ationdata
s
• Compliance with regulatory requirements
• Meeting timeframes• Getting desired
indications
als Registration
Metrics to
Measure Success
• Risk level• Predicted gross
margin
• Risk level (taking into account the results of the fast prototypes for high risk/ performance gaps)
• Compliance with product requirements
• 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 dura• Budget• Quality of
document• Quality of • Quality of
publication
Make/Buy/Partner Analysis
Product Specification
Development Planning, Execution & Release
Engineering, Production & Monitoring
Clinical Tri
Gate P1: Product DevelopmentA 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
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
R&D Implementation Flowchart
Make/Buy/Partner Analysis
Implementation
Define product specification
RESPONSIBILITY PROCESS OUTPUT
MAKE/BUY/PARTNER ANALYSISLEADER
- VP R&D
APPROVAL
- VP R&D
MAKE/BUY/PARTNER
ANALYSIS –
Make/Buy/Partner decisions for the whole product and/or major building blocks. The expected outputs are decisions & contracts
PRODUCT SPECIFICATION -
Derive functional, technological, testing and clinical specifications to fit product requirements. The expected output is specification document
1 Quarter Depends on product complexity
Comply with national and international laws and regulations. The expected output is a market clearance
REGISTRATIONLEADER
- Director of Regulatory
APPROVAL
- COO
Development Planning, Execution & Release
LAUNCH
PRODUCT SPECIFICATION
LEADER
- VP R&D
APPROVAL
- Corp. Product Line Director
Depends on product comlexity
Develop product to fit Product Specifications, define product labeling & release to engineering. The expected outputs are:
Product available for production
IP product portfolio
Production file (including Product
detailed description)
DEVELOPMENT PLANNING, EXECUTION & RELEASELEADER
- VP R&D
APPROVAL
- COO - Corp. Product Line Director (Change of specs only)
Depends on product comlexity
ENGINEERING, PRODUCTION & MONITORINGLEADER
- VP Operations
APPROVAL
- COO Depends on product comlexity
Prepare manufacturing capabilities to fit manufacturing plan, production, monitoring production quality & yield. The expected output is product available for sales according to sales forecast
Prove safety of product, prove efficacy, provide clinical data to support regulatory, R&D, and marketing requirements. The expected outputs are:
Final report
Manuscripts/Abstracts and
presentations
CLINICAL TRIALSLEADER
- Global Clinical Affairs
APPROVAL
- Corp. Product Line Director- COO
- CMO
Depends on product comlexity
?
?
Engineering, Production & Monitoring
Clinical Trials
Registration
P1
P2
Make-Buy-Partner Analysis and Decision SOP
The purpose of this phase is to make a decision whether to make, buy, or to partner for the development and/or manufacturing of a whole product and/or major building blocks. The Make/Buy/Partner analysis and decision document applies to the development and manufacturing whole product and/or major building blocks.
Product Specification SOP
The purpose of this phase is to derive functional, technological, testing and clinical specifications to fit product requirements.
Product Specification
Document Title: Document No. Revision Page
Product Specification PLCM-006-01 AA Page 2 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
1.0 Purpose
1.1. The purpose of this phase is to derive functional, technological, testing and
clinical specifications to fit product requirements.
2.0 Scope
This document applies to:
2.1. Perform top level design
2.2. Develop fast prototypes for high risk/ performance gaps
2.3. Verify compliance with regulatory affairs
2.4. Prepare:
2.4.1. specification document
2.4.2. testing requirement document
2.4.3. Risk analysis
3.0 Responsibility
3.1. Leader - V.P R&D is the leader and has the overall responsibility for all
development activities and for the implementation of this document.
3.2. Partners in the Product Specification feasibility phase are:
Dept./Entity Name
3.2.1. Product Director (R&D)
3.2.2. Global Clinical Affairs
3.2.3. Regulatory Affairs
3.2.4. Operations
3.2.5. IP
3.2.6. Business partners
3.3. Contributors: all Given functions
3.3.1. Customer Support
3.3.2. External advisers
3.3.3. External experts
Document Title: Document No. Revision Page
Product Specification PLCM-006-01 AA Page 3 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
4.0 Required Inputs
4.1. Product Requirement Definition Document with best current definition of how
the product is to be used in marketplace
4.2. Product roadmap
4.3. Result of feasibility studies
5.0 Estimated Maximum Time Frame
TBD
6.0 Budget Responsibility
6.1. VP R&D
7.0 Required Approvals
7.1. Product Director
8.0 Expected Output
8.1. Specifications document.
9.0 Definitions
Any initials, technical or professional terms (related to the specific product) should
be defined in this section.
10.0 The Process
(See appendix for capsule product specifications)
Document Title: Document No. Revision Page
Product Specification PLCM-006-01 AA Page 4 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
11.0 Appendix
Product Specification Table for Capsule
Features Comments
Mechanics
Dimensions: Diameter: [mm] Length: [mm]
Materials: Dome: Cover:
Optics & Illumination
Number of optical heads
FOV – Field of view F number DOV – Depth of view 0 to XX mm from Dome
apex
Resolution x.xx lpmm @ 0 mm Illumination x.xx lpmm @ XX mm x.xx lpmm @ YY mm Light collection: Total optical power:
Electronics Components
Imager ASIC LEDs Switch Antenna Batteries
General
Frame rate XX fps Active working time XX hr Imager mode Delay mode Shelf life time XX month
Design Review Document SOP
The purpose of this procedure is to define the method for conducting official and documented design reviews of design results at the end of each defined phase. Such reviews include representatives of all concern parties in order to identify and predict problematic areas and discrepancies and to initiate corrective actions so as to ensure that the final design fully complies with it predefined requirements.
Design Review Document
Document Title: Document No. Revision Page
Design and Development Review PLCM-009-01 (QA-734-1
022 of 7
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
1.0 Purpose
The purpose of this procedure is to 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
Document Title: Document No. Revision Page
Design and Development Review PLCM-009-01 (QA-734-1
023 of 7
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
4.6 F-734-1 Design and Development Review Form
4.7 RM-10-2 Risk Analysis
4.8 737-1 Design Change
5.0 Responsibility
5.1 V.P. R&D has the overall responsibility for all development activities and
for the implementation of this procedure.
5.2 Projects Managers are responsible to perform Design and Development
Reviews in their projects.
6.0 Procedure
6.1 Formal Design Reviews:
6.1.1 Are pre-planned and performed according to the project timeline
developed by the Project Manager during the Design Planning
process.
6.1.2 Meetings should include persons knowledgeable about the
technical characteristics of the design, as appropriate, such as:
R&D Engineering Production Quality Assurance and Regulatory Affairs Sales and Marketing Purchasing Regulatory Affairs Medical Affairs Individuals(s) who does not have direct responsibility for the design stage being reviewed.
6.1.3 The meetings may include as appropriate to the review phase:
6.1.3.1 Reviews of design validation,
6.1.3.2 Failure Mode and Effect Analysis (F.M.E.A.)
6.1.3.3 Verification/ validation activities
6.1.3.4 Bench/ clinical testing
6.1.3.5 Surveys
6.1.3.6 Focus group results
Document Title: Document No. Revision Page
Design and Development Review PLCM-009-01 (QA-734-1
024 of 7
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.1.4 The meeting minutes must include the deliverable and expectations of the specific items reviewed and the resultant activities that brought to closure each item listed. It should include (but not limited to) information such as:
6.1.4.1 List of key attendees (mandatory)
6.1.4.2 Date (mandatory)
6.1.4.3 Plans and/or agenda (mandatory)
6.1.4.4 Minutes and reports (or references to) from prior meeting (mandatory)
6.1.4.5 Product Manager’s signature (mandatory)
6.1.4.6 Design phase/stage (mandatory) 6.1.4.7 Follow-up report(s) of solutions and/ or the next review
covers the solutions and remaining issues.
6.1.5 Four kinds of Formal Design Reviews are identified during the life
cycle product:
6.1.6 Primary Design Review:
6.1.6.1 General: This review is the first review during the project life. It is perform during the establishment of the general concept for the product, based on requirement specification, requirements document and project planning.
6.1.6.2 The main objectives of this review are:
6.1.6.2.1 Adjustment of the initial design to customer/market requirements.
6.1.6.2.2 Establishment of communication between the various parties involved in the design process.
6.1.6.2.3 Early detection of problems.
6.1.6.3 Recommended issues for review:
6.1.6.3.1 Development plan
6.1.6.3.2 Design Input Document (D.I.D.)
6.1.6.4 Review Output: Approval of the development plans and requirements document.
6.1.6.5 Mandatory signature: Management forum representative and Product Manager.
Document Title: Document No. Revision Page
Design and Development Review PLCM-009-01 (QA-734-1
025 of 7
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.1.7 Critical Design Review (C.D.R.):
6.1.7.1 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.
6.1.7.2 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.
6.1.8 Production Design Review:
6.1.8.1 The main objective of this review is approval of the documentation of the implementing phase towards initiation of manufacturing of prototypes.
6.1.8.2 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
Document Title: Document No. Revision Page
Design and Development Review PLCM-009-01 (QA-734-1
026 of 7
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.1.9 Review of Organization for Full-Scale Manufacturing:
6.1.9.1 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 full-scale manufacturing.
6.1.9.2 Review Output:
6.1.9.2.1 Approval of final device configuration.
6.1.9.2.2 Device Master File approval.
6.1.9.2.3 Initiation of full-scale manufacturing.
6.1.9.3 Mandatory signatures:
6.1.9.3.1 Management forum representative.
6.1.9.3.2 Product Manager.
6.1.9.3.3 Production Manager.
6.1.9.3.4 QA Manager.
6.1.10 The Formal Design Review meeting results are incorporated to the Design History File (D.H.F.).
6.2 Informal Design Reviews - On-going Design Reviews:
6.2.1 General: This type of design reviews will be performed as required during the development phases according to the design progress and complexity, and scheduled by each Project Manager. These design reviews will be scheduled by the Product Manager.
6.2.2 The main objectives of this review are to:
6.2.2.1 Update all individuals involved in the project on the progression of development process.
6.2.2.2 Discuss and resolve problems.
6.2.2.3 Define interfaces and coordinate between the various project subsystems.
6.2.2.4 Assign tasks to work teams.
6.2.3 Personal: same as in Formal Design Review, see paragraph 6.1.2.
Document Title: Document No. Revision Page
Design and Development Review PLCM-009-01 (QA-734-1
027 of 7
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.2.4 The meeting my include:
6.2.4.1 Review or determination of any additions or revisions to the Failure Mode and Effect Analysis (F.M.E.A.).
6.2.4.2 Verifications/ validations activities.
6.2.4.3 Bench/ clinical testing.
6.2.4.4 Surveys.
6.2.4.5 Focus group results.
6.2.4.6 Clinical trial results.
6.2.4.7 Technical problems.
6.2.5 Appropriate tasks will be assigned for formal F.M.E.A., testing, evaluations, updates per policies and procedures
6.2.6 The meeting minutes include:
6.2.6.1 List of key attendees (mandatory).
6.2.6.2 Date (mandatory).
6.2.6.3 Product Manager’s signature (mandatory).
6.2.6.4 Definition of the problem.
6.2.6.5 Action items.
6.2.6.6 Closure items.
6.2.7 The Informal Design Review meeting results are incorporated into Design History File (D.H.F.).
Design History File (DHF) SOP
The purpose of the DHF procedure is to define the method and the process for the creation and the maintenance of the design history file.
Each manufacturer has to establish and maintain a DHF for each type of device (device=product/project/version etc). The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of obligatory standards (FDA QSR, ISO).
Design and Development Validation SOP
The purpose of this procedure is to define the validation process of a design in order to ensure that the device conforms to defined user needs and intended use. Design Validation is an essential element of any design control. It is applicable for all Given products & production utilities (assembly and testing) as well
Design and Development Validation
Document Title: Document No. Revision Page
Design and Development Validation PLCM-012-01 (QA-736-1)
2 2 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
1.0 Purpose
The purpose of this procedure is to 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)
Document Title: Document No. Revision Page
Design and Development Validation PLCM-012-01 (QA-736-1)
2 3 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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
Document Title: Document No. Revision Page
Design and Development Validation PLCM-012-01 (QA-736-1)
2 4 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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.
Document Title: Document No. Revision Page
Design and Development Validation PLCM-012-01 (QA-736-1)
2 5 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.14 The decision on how to handle the initial production units that have
been produced during the validation period should be determined
by a MRB committee (after opening a MRB report for these units)
*************
Design and Development Verification SOP
The purpose of this procedure is to describe the verification process of designed products to ensure that the design and development outputs have met the design and development input requirements.
Design and Development Verification
Document Title: Document No. Revision Page
Design and Development VerificationPLCM-036-01 (QA-735-1)
02 2 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
1.0 Purpose
The purpose of this procedure is to 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.
Document Title: Document No. Revision Page
Design and Development VerificationPLCM-036-01 (QA-735-1)
02 3 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.2 Design and development verification testing usually begins with
working prototypes or breadboards and may be repeated as design
changes are made.
6.3 Typical verification tests include, where applicable :
Comparative tests with a proven design.
Simulated use in the laboratory.
Animal model tests.
Biocompatibility tests.
Material/device compatibility tests.
Prototype tests.
Reliability tests.
Performance tests.
Tests of compatibility with other devices.
Environmental tests.
6.4 For software, typical verification activities include:
Code review
Schematic reviews
Unit and components tests.
Integration tests.
Alternate calculation demonstrations.
6.5 Verification plan shall include:
Definition of required tests.
Definitions of the functions to be tested.
The executing individual(s) and the authorities to approve the
results.
Test methods and means.
Acceptable results and documentation manners (or reference
to internal documents that define them).
6.6 Any inputs which are not satisfactorily met will be reviewed, to
determine whether they are applicable. Any new design and
development Inputs revisions must be performed per the Design
and Development Inputs procedure.
Document Title: Document No. Revision Page
Design and Development VerificationPLCM-036-01 (QA-735-1)
02 4 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.7 When all design and development inputs requirements have been
met, the Project Manager will document the followings:
6.7.1 Identification of the design.
6.7.2 Methods used (all).
6.7.3 Date.
6.7.4 The individual(s) performing the verification.
6.8 Changes in the design and development inputs, outputs, and/or
any other information in the final verification file after it has been
completed requires additional review and change as per Design
Changes procedure.
******************
Testing Requirements SOP
The testing requirements document is a document that describes the product’s testing approach and the testing needs. This document is derived in parallel to the specification document. This document can identify in advance the necessary testing procedures and testing tools needed in order to produce a safe and reliable product that fits the requirements.
Testing Requirements
Document Title: Document No. Revision Page
Testing Requirements document PLCM-008-01 01 2 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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.
Document Title: Document No. Revision Page
Testing Requirements document PLCM-008-01 01 3 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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.
Document Title: Document No. Revision Page
Testing Requirements document PLCM-008-01 01 4 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
10.4. Software
In this section we identify the software needs for testing: operating
system, automation testing, software environment, debuggers,
simulations, special installations, etc.
11.0 Resources & Schedule
The purpose of this section is to create the linkage between all the requested
testing and the resources needed.
This section identifies the manpower needed for performing the testing, the
special skills required, the amount of help needed from other groups and the
extent of the work.
This section also determines the time frame for performing the testing and basic
time table. It can also include constraints on the start and finish of the process.
12.0 Appendix
This section can include a more detailed traceability matrix that correlates
between every item in the specifications document and the section in the testing
document that covers this specification.
Regulatory Submissions SOP
Regulatory Submissions
Document Title: Document No. Revision Page
Regulatory Submissions and Registration PLCM-016-01 01 2 of 3
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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.
Document Title: Document No. Revision Page
Regulatory Submissions and Registration PLCM-016-01 01 3 of 3
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
4.7 Given Imaging KK Regulatory Director is responsible for Products
submission and registration in Japan. LTD QA&RC. R&D and CT
department will support Japan products registration with any
information/documentation.
4.8 Products submission and registration in US – TBD.
4.9 QA&RC will keep an original copy of the clearance document.
Release to Engineering SOP
The Release to Engineering template enables the beginning of the transition from an R&D prototype to a serial production.
Risk Analysis for Development SOP
Risk Analysis for Development
Document Title: Document No. Revision Page
Commercialization Plan PLCM-017-01 01 2 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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
Document Title: Document No. Revision Page
Commercialization Plan PLCM-017-01 01 3 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
milestones/Roadmap as well as all functional, medical, marketing,
regulatory, standards, QA requirements and any other special requirements
for the product.
5.5. Product Field Test – testing performed at customer sites designed to
validate the product marketing, customer, and technical specifications prior
to full launch of the product.
6.0 Procedure
6.1. The Product Line Director develops and delivers the initial
Commercialization Plan and uses this plan to guide the process of global
marketing planning and product field testing. The Commercialization Plan
includes:
Global Launch Package
Global Pricing Plan
Global Marketing Strategy, including marketing communication plan
Product development time-line
Global product launch time-line including action items and accountability
6.2. The Global Product Manager develops and executes the field testing plan to
validate that the product meets the marketing and performance objectives.
6.3. The Global Product Manager documents the results of the field testing and
submits them for review and approval to the Product Line Director, VP of
R&D, VP of Regulatory Affairs, and Regional Marketing Directors.
6.4. After reviewing the field test results, a final go-no go decision is made on
the product launch. The product launch must be approved by the Chief
Marketing Officer, Chief Financial Officer, Chief Operating Officer, VP of
R&D, VP of RA, and the Senior Executive for each region in which the
product will be launched.
6.5. If a “go for launch” decision is made, the Product Line Director develops and
delivers the final commercialization plan to the Regional Product Manager
approximate three months prior to scheduled launch. The Regional Product
Manager then completes the development of the Regional Launch Plan.
7.0 Appendix
Document Title: Document No. Revision Page
Commercialization Plan PLCM-017-01 01 4 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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)
Document Title: Document No. Revision Page
Clinical Trials Approval Forms (CTAF) PLCM-013-01 01 2 of 9
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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 - - - -
Document Title: Document No. Revision Page
Clinical Trials Approval Forms (CTAF) PLCM-013-01 01 3 of 9
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
(Complete name of study, as will appear in the formal protocol)
Clinical Trials Approval Form
AUTHORIZATION LINE – APPROVAL TO INITIATE NAME TITLE SIGNATURE DATE
Issued by: Clinical Trials Manager,
XXXXX product
Approved by: CA director
Approved by: Corp director XXXX product
Approved by: Data analysis manager
Approved by: Kevin Rubey Chief Operation Officer
Approved by: Mark Gilreath Chief Marketing Officer
Approved by Yuval Yanai/ Gilad Mamlok
VP finance/ CFO
Product line Committee Approval – prioritize and recommend
(Should be completed before handing over to SM approvals)
Name position Signature Comments
Corp Director
Yael Koren Global CA Director
Global CT manager
Local RACA
Local PM
Clinical Marketing
Biostatistics / DA
Ian Gralnek Disease Mgmt
Ari Bergwerk Medical Advisor
Document Title: Document No. Revision Page
Clinical Trials Approval Forms (CTAF) PLCM-013-01 01 4 of 9
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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:
Document Title: Document No. Revision Page
Clinical Trials Approval Forms (CTAF) PLCM-013-01 01 5 of 9
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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
Document Title: Document No. Revision Page
Clinical Trials Approval Forms (CTAF) PLCM-013-01 01 6 of 9
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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?
Document Title: Document No. Revision Page
Clinical Trials Approval Forms (CTAF) PLCM-013-01 01 7 of 9
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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
Issued by: R&D project manager, XXXX product
Issued by: Clinical Trials Manager,
XXXXX product
Approved by: CA director
Approved by: Ari Bergwerk Medical advisor
Approved by: Daniel Gat Director, R&D projects
Approved by: Daphna Levy VP R&D
Approved by: Kevin Rubey Chief Operation Officer
Approved by Yuval Yanai/ Gilad Mamlok
VP finance/ CFO
Document Title: Document No. Revision Page
Clinical Trials Approval Forms (CTAF) PLCM-013-01 01 8 of 9
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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:
Document Title: Document No. Revision Page
Clinical Trials Approval Forms (CTAF) PLCM-013-01 01 9 of 9
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
16)Timeline & Goals
StartDate
End Date Comments
Finalize CTAF Finalize protocol IRB submission/ expected approval
Start enrollment expected Interim Results Complete enrollment expected
Investigators’ meeting (date)
17)Budget
C. Sample size calculations: (should always be done with the involvement of a biostatistician)
D. Number of patients: XXX (based on A) Number of sites: YY
Per Site Per Patient Total IRB + amendments Per patient payment(per completed e-CRF)
RAPID reading Monitoring expenses Administrative costs Patient’s compensation Additional non-covered tests Materials / equipment Insurance - Migdal Insurance – local (if required) Investigators meetings Investigators honorarium Other (unpredicted) costs Overhead (5-10%) Total Cost
CT Protocols SOP
CT Protocols
Document Title: Document No. Revision Page
Clinical Trials Standard Protocols PLCM-014-01 01 2 of 13
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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
Document Title: Document No. Revision Page
Clinical Trials Standard Protocols PLCM-014-01 01 3 of 13
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
Clinical Trial Protocol MA-XX:
Evaluation of Capsule Endoscopy in Patients with (disease definition)
Principal Investigators:
Co-Investigators:
Test product: Given® Diagnostic System and PillCam™ - - - Capsule
Sponsor's name and address:
Given Imaging Ltd. New Industrial Park, Yoqneam IsraelGiven Imaging, Inc. 5555 Oakbrook Parkway, Ste. 355 Norcross, GA 30093
Sponsor’s Telephone Number:
Israel: 93-04-909-7777 US: 800-662-0870
Study NumberVersion number and Date:
MA-XXVersion yy, dd/mm/yy
CONFIDENTIAL This material is the property of Given Imaging. The information is confidential and is to be used
only
in connection with matters authorized by Given Imaging and no part of it is to be without
prior written permission from Given Imaging.
Document Title: Document No. Revision Page
Clinical Trials Standard Protocols PLCM-014-01 01 4 of 13
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
TABLE OF CONTENTS
STUDY SUMMARY................................................................................................................... 51 INTRODUCTION............................................................................................................. 52 DEVICE DESCRIPTION ................................................................................................. 5
2.1 PillCam™ SB Capsule ....................................................................................... 52.2 Given
® DataRecorder......................................................................................... 5
2.3 RAPID® Workstation .......................................................................................... 5
3 OBJECTIVES.................................................................................................................. 63.1 Primary objectives ............................................................................................. 63.2 Secondary objectives ........................................................................................ 6
4 STUDY ENDPOINTS ...................................................................................................... 64.1 Primary endpoint ............................................................................................... 64.2 Secondary endpoints ........................................................................................ 6
5 STUDY DESIGN ............................................................................................................. 65.1 Overall design .................................................................................................... 65.2 Investigational product and Accountability .................................................... 7
6 SUBJECT ELIGIBILITY.................................................................................................. 76.1 Study population................................................................................................ 76.2 Inclusion criteria ................................................................................................ 76.3 Exclusion criteria ............................................................................................... 76.4 Withdrawal criteria............................................................................................. 7
7 STUDY PLAN.................................................................................................................. 77.1 Enrollment of participants ................................................................................ 77.2 Informed Consent Process (day 1) .................................................................. 77.3 Assessment of eligibility and Patient baseline condition (visit 1)................ 77.4 Capsule Endoscopy (visit 2) ............................................................................. 87.5 SBFT (visit 3) ...................................................................................................... 87.6 Ileo-Colonoscopy (visit 4) ................................................................................. 87.7 Follow Up of patients (visit 5)........................................................................... 8
8 ASSESSMENT OF EFFICACY....................................................................................... 89 ASSESSMENT OF SAFETY .......................................................................................... 8
9.1 Safety parameters.................................................. Error! Bookmark not defined.9.2 Methods and timing of assessing safety parameters ...... Error! Bookmark not defined.9.3 Adverse events .................................................................................................. 8
10 STATISTICS.................................................................................................................. 1010.1 Determination of sample size ......................................................................... 1010.2 Description of statistical methods ................................................................. 10
11 DATA COLLECTION AND QUALITY CONTROL ....................................................... 1011.1 Data collection ................................................................................................. 1011.2 Archiving .......................................................................................................... 11
12 ETHICAL AND LEGAL ASPECTS............................................................................... 1112.1 Independent Ethics Committee (IEC)............................................................. 1112.2 Ethical conduct of the study........................................................................... 1112.3 Patient Information and Consent ................................................................... 1112.4 Insurance .......................................................................................................... 1112.5 Confidentiality .................................................................................................. 12
13 USE OF DATA AND PUBLICATIONS ......................................................................... 12APPENDICES ......................................................................................................................... 13
Appendix A – Schedule of Assessment.................................................................... 13Appendix B – Patient’s condition questionnaires ......... Error! Bookmark not defined.Appendix C – CE, SBFT and ileo-colonoscopy case report formError! Bookmark not defined.
Document Title: Document No. Revision Page
Clinical Trials Standard Protocols PLCM-014-01 01 5 of 13
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
Study Summary
Purpose of studyStudy design: Number of subjects:Subjectpopulation
No of centers InterimAnalysis Duration of follow-up
Duration of studyPrimaryobjectivesSecondaryobjectives
Introduction
Device Description
The Given® Diagnostic System used in this study consists of three main subsystems: an ingestible PillCam™ SB Capsule, A Given® DataRecorder, and a RAPIDWorkstation.
PillCam™ - - - Capsule
The disposable, ingestible PillCam™ - - - Capsule acquires the video images during natural propulsion through the digestive system. The Capsule transmits the acquired images via digital radio frequency communication channel to the Given® Data Recorder unit located outside the body.
Given® DataRecorder
The DataRecorder is an external receiving/recording unit that receives the data transmitted by the ingestible Capsule. The portable Recorder consists of an antenna array carried in proximity to the body, a receiver, and memory for accumulation of the data during the examination. Upon completion of the examination, the physician transfers the accumulated data in the Recorder to the RAPID® Workstation for interpretation. The data transmission is performed via high capacity digital link.
RAPID® Workstation
The Workstation is a modified standard personal computer that is intended for interpretation, and analysis of the acquired data and for generating reports (for more details, please review the RAPID™ User manual.
Document Title: Document No. Revision Page
Clinical Trials Standard Protocols PLCM-014-01 01 6 of 13
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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
Document Title: Document No. Revision Page
Clinical Trials Standard Protocols PLCM-014-01 01 7 of 13
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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
Document Title: Document No. Revision Page
Clinical Trials Standard Protocols PLCM-014-01 01 8 of 13
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
radiography and CT. For each procedure the following data will be capture: number of procedures performed, date and results from most recent procedure
o General medical history as follows: concomitant medication (name, date, dose, period and current status), and clinical condition categorized by category code specify in the e-CRF.
o Physical exam as follows: date, blood pressure, pulse, temperature and route, abdominal exam and lab test results if they were performed such as: WBC, Hgb, Hct, Plt, Ferritin, PT and/or INR.
o CDAI, Van Hees, Harvey-Bradshaw, IBDQ, SF36 (Appendix B presents detailed information).
Capsule Endoscopy (visit 2)
Test I (visit 3)
Test II (visit 4)
Follow Up of patients (visit 5)
ASSESSMENT OF Efficacy
ASSESSMENT OF Safety
Adverse events
An adverse event is any undesirable experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a patient that appears or worsens during a clinical study. An adverse event may or may not be related to the investigational device or drug therapy prescribed as part of the study protocol.
All adverse events will be graded as follows: Mild: Sign or symptom, usually transient, requiring no special treatment and generally not interfering with usual activities. Moderate: Sign or symptom, which may be ameliorated by simple therapeutic measures, may interfere with usual activity. Severe: Sign or symptom that are intense or debilitating and that interfere with usual activities. Recovery is usually aided by therapeutic measures and the discontinuation of the study device may be required. The relationship of the adverse event to the study is defined as follows: Probable: An adverse event has a strong temporal relationship to study device, and another etiology is unlikely or significantly less likely. Possible: An adverse event has a strong temporal relationship to the study device, and an alternative etiology is equally or less likely compared to the potential relationship to study device. Unlikely: An adverse event has little or no temporal relationship to the study device and/or a more likely alternative etiology exists. Not related: An adverse event has no temporal relationship to study device or has a much more likely alternative etiology.
Document Title: Document No. Revision Page
Clinical Trials Standard Protocols PLCM-014-01 01 9 of 13
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
Adverse device reactions
Adverse device reactions are adverse events caused wholly or partly by the use of the device. A causal relationship between an observed adverse event and the use of the trial device may exist with various degrees of probability, on the basis of statistical probability, or of plausible medical data and considerations.
Serious adverse events
A serious adverse event is any untoward medical occurrence that results in:
Death
Life-threatening drug experience
Patient hospitalization or prolongation of existing hospitalization
Persistent or significant disability/incapacity
Congenital anomaly/birth defect.
Some important medical events, although they may not result in death, be life-threatening, or require hospitalization may still be considered serious adverse events when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed above.Life threatening means that the patient was, in the view of the investigator, at immediate risk of death from the reaction as it occurred. This does not include an adverse event that, if more severe, might have caused death. Disability means a substantial disruption of a person’s ability to conduct normal life’s functions.
Serious Adverse Events have to be reported to Given Imaging in writing within 24 hours of the investigator’s awareness.
Unexpected Adverse Event
Any adverse event, the specificity or severity of which is not consistent with the current Investigator Brochure (or Package Insert for marketed products). Also, reports that add significant information on specificity or severity of a known, already documented adverse event constitute unexpected adverse events. For example, an event more specific or more severe than described in the Investigator Brochure would be considered “unexpected”.
Adverse events reactions associated with PILLCAM™- - - capsules
Rare cases of delayed excretion of the capsule in clinical studies have occurred in 0.7-3.6% of the high risk patients who suffer from GI diseases. In healthy volunteers no delayed excretions have been reported. These delays in excretion were resolved by either laxative ingestion or removal of the capsule during colonoscopy or surgery. Surgery was performed only in cases where confirmed strictures in the intestine have caused the delay in the capsule excretion.
In case of any symptoms consistent with this delayed excretion, the investigator should exclude the possibility of small bowel obstruction. This should be done by surgical evaluation of the subject immediately, and obtaining the appropriate tests on an emergency basis. A surgeon who is skilled with both the conventional and laparoscopic surgery should be acquainted with this study and protocol in case of the unexpected and rare need for removal of the capsule.
Document Title: Document No. Revision Page
Clinical Trials Standard Protocols PLCM-014-01 01 10 of 13
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
Recording and documentation of adverse events
Every adverse event should be recorded in the case report form. The following data must be documented:
Type of event
Patient number
Time of occurrence: date, time
Time of resolution: date time
Severity degree: mild / moderate / severe / unknown
Relationship to study device probable/possible/unlikely/not related
Outcome of event: unchanged / worsened / improved / resolved / unknown / death
STATISTICS
Determination of sample size
Description of statistical methods
Demographic and other baseline characteristics
Pathologies identified during procedures
Adverse eventsIndividual listings of adverse events including type of device, age, weight, height, gender, adverse events (reported term), start, duration, relationship to device and severity will be provided.
Interim AnalysisAn interim analysis will be performed after ZZZ patients are enrolled in the study in order to evaluate the enrolment criteria. The final sample size of each group will be estimated following those results.
DATA COLLECTION AND QUALITY CONTROL
Data collection
It is the responsibility of the clinical coordinator to ensure the completeness and accuracy of the case report forms (CRFs). One case report form must exist for each patient participating in the study. The case report forms may serve as source documents. Each clinical site will receive an electronic case report form software program that will be installed into the RAPID workstation.
Electronic case report form entries will be user-identifiable and will include an audit
trail. Once the CRFs have been collected by the clinical coordinator no changes should
be made to the CRFs. If corrections are required they will be performed on designated
electronic forms only.
Document Title: Document No. Revision Page
Clinical Trials Standard Protocols PLCM-014-01 01 11 of 13
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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
Document Title: Document No. Revision Page
Clinical Trials Standard Protocols PLCM-014-01 01 12 of 13
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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.
Document Title: Document No. Revision Page
Clinical Trials Standard Protocols PLCM-014-01 01 13 of 13
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
Appendices
Appendix A – Schedule of Assessment
Appendix B – …n
Questionnaires – CDAI, IBDQ, SF-36, Mow, Lewis Score…
Enrolment Evaluation I Evaluation II Final evaluation
Informed Consent X
Medical History and Concomitant medications
X
Vital Signs and Physical examination X
CE procedure (if no obstructive symptoms present using AGILE)
X
Test I X
Test II X
Follow-up CE (1 week) X
Follow-up patient condition (CDAI, IBDQ, SF36)
X
Adverse events monitoring X
IRB Documents SOP
IRB Documents
Document Title: Document No. Revision Page
Binder of IRB documents PLCM-015-01 01 Page 2 of 2
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
Compilation of IRB documents
1.0 Purpose:
A compiled list of documents (and their relevant templates) required for
submission to Institutional Review Board (IRB, or otherwise known as
Helsinki/ethical committee) evaluation of clinical trials.
2.0 Scope:
CA teams, global and regional
3.0 Responsibility:
Relevant clinical trials’ manager and regional CA teams.
4.0 Reference documents: see list
5.0 Definitions
IRB – institutional review board, located in each USA site/hospital
EC – ethical committee, in EU sites
6.0 The Procedure
The requirements of the different IRBs or ECs differ for different locations/sites,
and are derived from the local regulatory system (FDA or CE or others).
The binder, to include the required documents is prepared by the local site,
usually by the site’s Clinical Research Coordinator (CRC); it is our utmost interest
to assist him/her in this task, to ensure accurate filing and quick submission.
The following is the list of documents required in general:
1. Protocol
2. Investigators’ brochure (or user manual in case of licensed product)
3. Informed consent form (ICF) (translated to local language, as required)
4. Package of submission documents, specific to the site (to include all details related to the study)
5. Financial disclosure form
6. Insurance approval document
7. Other documents, as required by specific countries/sites (warrants, check lists, commitment of sponsor etc.)
An example of IRB/EC submission files can be found in clinical affairs files under “shared”.
Gate P2: Production ReadinessTransition of Product from R&D to Production
Main Deliverables SOP Document
Product Production Files Release to Engineering PLCM-011-01
Production Capabilities
Manufacturing Implementation Flowchart
Manufacturing Implementation Flowchart
RESPONSIBILITY PROCESS OUTPUT
MAKE/BUY/PARTNER ANALYSISLEADER
- VP R&D
APPROVAL
- VP R&D
MAKE/BUY/PARTNER
ANALYSIS –
Make/Buy/Partner decisions for the whole product and/or major building blocks. The expected outputs are decisions & contracts
PRODUCT SPECIFICATION -
Derive functional, technological, testing and clinical specifications to fit product requirements. The expected output is specification document
1 Quarter Depends on product complexity
Comply with national and international laws and regulations. The expected output is a market clearance
REGISTRATIONLEADER
- Director of Regulatory
APPROVAL
- COO
LAUNCH
PRODUCT SPECIFICATION
LEADER
- VP R&D
APPROVAL
- Corp. Product Line Director
Depends on product comlexity
Develop product to fit Product Specifications, define product labeling & release to engineering. The expected outputs are:
Product available for production
IP product portfolio
Production file (including Product
detailed description)
DEVELOPMENT PLANNING, EXECUTION & RELEASELEADER
- VP R&D
APPROVAL
- COO - Corp. Product Line Director (Change of specs only)
Depends on product comlexity
ENGINEERING, PRODUCTION & MONITORINGLEADER
- VP Operations
APPROVAL
- COO Depends on product comlexity
Prepare manufacturing capabilities to fit manufacturing plan, production, monitoring production quality & yield. The expected output is product available for sales according to sales forecast
Prove safety of product, prove efficacy, provide clinical data to support regulatory, R&D, and marketing requirements. The expected outputs are:
Final report
Manuscripts/Abstracts and
presentations
CLINICAL TRIALSLEADER
- Global Clinical Affairs
APPROVAL
- Corp. Product Line Director- COO
- CMO
Depends on product comlexity
?
?
Engineering, Production & Monitoring
Clinical Trials
Registration
Implementation
Make/Buy/Partner Analysis
Define product specification
Development Planning, Execution & Release
P1
P2
Stage 3: Launch Readiness
Detailed Stage Description: Launch Readiness
Launch Readiness Flowchart
Gate P3: Product Commercialization Deliverables
Stages of Launch
Stage 1
Regulatory Clearance Product development and testing is completed, product has received regulatory approval but may not be available for shipment.
Stage 2
Announcement Announcement of a launch via press release or during a congress/clinical meeting. May occur prior to regulatory clearance.
Stage 3
Product Availability Product has regulatory clearance and is market ready for shipping from GIVEN Ltd to subsidiaries or distributors. Sales Force has not been trained and promotional materials are in process. Product may be field tested during this stage prior to launch.
Stage 4
Limited Launch Product has regulatory clearance but introduction into the market is limited. Sales force is trained and has basic information to introduce and educate a group of targeted customers.
Stage 5
Full Launch Product is available for every customer in a region. Sales force is trained with full access to promotional materials and GIVN as a company is promoting.
Launch Readiness Flowchart
Launch Readiness Flowchart
Launch Readiness
RESPONSIBILITY PROCESS OUTPUT
GLOBAL MARKETING PLANNINGLEADER
- Corp. Product Line Director
APPROVAL
- Global Marketing- Heads of regions- Business partners (if applicable)
Global marketing planning –Develop initial commercialization plan for new product.The expected output is:Initial commercialization plan including:- Forecasting (for delivery)- Pricing - Training- Branding - Competition- Key messages - Reimbursement- Servicing policies - Channels- Promotions - Positioning- Marketing collaterals- Product support materials- Field Implementation strategy
Global marketing planning
ONGOING MANAGEMENT & ROADMAP
STEERING
2 months
Validation of product meeting market needs and technical performance against specifications. The expected outputs are:
Field Tests Results Summary :
- Technical- Clinical- Marketing
Go/No Go decision for Launch
PERFORM FIELD TESTING
LEADER
- Corp. Product Line Manager
APPROVAL
- Global Marketing- Director CA (if applicable)- Heads of regions
Launch
GLOBAL LAUNCH PLANNINGLEADER
- Corp. Product Line Director
APPROVAL
- Senior Management- Global Marketing- Heads of regions- VP R&D
1 month
Perform field testing
2-3 months
MARKETING SUPPORT SALES
GO/NO GO
NO
Develop final commercialization plan for specific product or major release. The expected outputs are:
Final commercialization Plan
including:- Action items (what?)- Responsibilities (who?)- Schedule (when?)
Global Launch Package
Successful Global Product Launch
Execution
Marketing release (MR)
?
P3
?
Global launch planning
Gate P3
nch Planning
commercialization plan for specific jor release
ctives of launchmercial plan and launch Go/No Go
and commercialg Plan Development with profitability d targets
ility (see separate plan)lobal vs. regional considerationsmotion development
ation (regulatory, service manual)material developmenting and education material nt
mercialization plansults summaryapproval documents
Director
Detailed Stage Description: Launch Readiness
Global Marketing Planning Field Testing Global Lau
Objective(s)
Develop initial commercialization plan for new product
Validation of product meeting market needs and technical performance against specifications
Develop finalproduct or ma
Process(es) Employed
• Collect regional information and needs• Pricing Plan Development (needs a separate
process)• Discuss and planning for regulatory issues• Plan marketing-oriented clinical trials• Analyze competition/alternatives• Market positioning• Plan marketing introduction schedule
(publications, shows, etc.)• Writing commercialization plan
• Prior to FDA approval• IRB required• After FDA approval• IRB not required• Site Selection and Management• Prepare & Ship relevant material• Product• Questionnaires• Training material• Perform training• Follow-up on execution• Receive feedback• Questionnaires• Videos• Change requests• Analyze feedback & conclusions
• Define obje• Update com
– technical• Final Pricin
analysis an• Scheduling• Accountab• Evaluate G• Launch Pro• Document• Marketing • Global train
developme
RequiredInputs
Output from Product & Major Release Initiation including: • Business Case• Product Roadmap• Clinical trials and regulatory issues • Special labeling needs (e.g., IP, per country)
• Product Requirements and Specification documents
• Regulatory submission documentation
• Initial Com• Field test re• Regulatory
Leader
Product-Line Director Global Product Manager Product-Line
Detailed Stage Description: Launch Readiness (page 2 of 3)
oduct Managerand CA
erviced other Product-Line Managers
nical Trainingrtnersrketing
ting
agementketinggions
nch Planning
Partner(s)Internal/External
• Regional Product Manager• Clinical marketing• Finance• Global RA and CA • Platform and other Product-Line Managers• Business Partners
• Regional Product Manager• R&D• Global RA and CA • Customer Services• Platform and other Product-Line Managers• Business Partners
• Regional Pr• Global RA • MarCom• Operations• Customer S• Platform an• Sales & Cli• Business Pa• Clinical Ma
Contributor(s)
Internal/External
• R&D• Operations• IP/Legal• MarCom
• Clinical marketing• Operations • Field Sales & distributors (Sites Selection)
• R&D• Finance• Legal
Estimated
Time Fram
e
2 months 2-3 months 1 month
BudgetResponsibility
Global Marketing Global Marketing Global Marke
RequiredA
pprovals
• Global Marketing• Heads of regions • Business Partners (i.e. Inscope)
• Global Marketing• VP RACA (if applicable)• Heads of regions
• Senior Man• Global Mar• Heads of re• VP R&D
Global Marketing Planning Field Testing Global Lau
Detailed Stage Description: Launch Readiness (page 3 of 3)
ercialization Plan including:ems (what?)ibilities (who?) (when?)
aunch Packageul Global Product Launch Executiong release (MR)
lan on timeProduct Launch measured by sales upport organization preparednessProduct Launch measured by product and product profitability
agementketinggions
nch Planning
ExpectedO
utput
• Initial commercialization plan• Forecasting (for delivery)• Pricing• Branding• Key messages• Servicing policies• Product support materials• Channels• Promotions• Positioning• Training• Reimbursement• Competition• Marketing collaterals• Field Implementation strategy
• Field Tests Results Summary:• Technical• Clinical• Marketing
• Go/No Go decision for Launch
• Final comm• Action it• Respons• Schedule• Global L• Successf• Marketin
Metrics to
Measure Success
• Complete plan on time• Adherence to plan• Success of next two phases dependent on
quality of plan
• Effective communication with test sites as measured by test site activity and quality of feedback
• Receive complete feedback information on time• Analyzed feedback & conclusions on time
• Complete p• Successful
force and s• Successful
shipments
RequiredApprovals
• Global Marketing• Heads of regions • Business Partners (i.e. Inscope)
• Global Marketing• VP RACA (if applicable)• Heads of regions
• Senior Man• Global Mar• Heads of re• VP R&D
Global Marketing Planning Field Testing Global Lau
Gate P3: Product CommercializationPre 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
Clinical Trials Final Report
Registration Status
Field Testing Report Field Testing PLCM-021-01
External Evaluation Release PLCM-022-01
Customer Service Plan
Comercialization Plan SOP
This procedure defines the process for creating a commercialization plan for a new product or major software release. This procedure applies to all global and regional activities related to all product launches including major software version releases.
Comercialization Plan
Document Title: Document No. Revision Page
Commercialization Plan PLCM-017-01 01 2 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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
Document Title: Document No. Revision Page
Commercialization Plan PLCM-017-01 01 3 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
milestones/Roadmap as well as all functional, medical, marketing,
regulatory, standards, QA requirements and any other special requirements
for the product.
5.5. Product Field Test – testing performed at customer sites designed to
validate the product marketing, customer, and technical specifications prior
to full launch of the product.
6.0 Procedure
6.1. The Product Line Director develops and delivers the initial
Commercialization Plan and uses this plan to guide the process of global
marketing planning and product field testing. The Commercialization Plan
includes:
Global Launch Package
Global Pricing Plan
Global Marketing Strategy, including marketing communication plan
Product development time-line
Global product launch time-line including action items and accountability
6.2. The Global Product Manager develops and executes the field testing plan to
validate that the product meets the marketing and performance objectives.
6.3. The Global Product Manager documents the results of the field testing and
submits them for review and approval to the Product Line Director, VP of
R&D, VP of Regulatory Affairs, and Regional Marketing Directors.
6.4. After reviewing the field test results, a final go-no go decision is made on
the product launch. The product launch must be approved by the Chief
Marketing Officer, Chief Financial Officer, Chief Operating Officer, VP of
R&D, VP of RA, and the Senior Executive for each region in which the
product will be launched.
6.5. If a “go for launch” decision is made, the Product Line Director develops and
delivers the final commercialization plan to the Regional Product Manager
approximate three months prior to scheduled launch. The Regional Product
Manager then completes the development of the Regional Launch Plan.
7.0 Appendix
Document Title: Document No. Revision Page
Commercialization Plan PLCM-017-01 01 4 of 4
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
Document Title: Document No. Revision Page
Competitive Profile Document PLCM-018-01 01 2 of 8
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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 Reference documents
Competitive sales brochures
Internet sites
Current comparison charts and internal sales training presentations
5.0 Definitions
Competitive Profile Document: A Word file containing product descriptions,
technical comparisons, pricing and sales strategy information received from
regional field activities.
Centralized reference files:
a. A hardcopy notebook and/or pentaflex file containing the Competitive Profile
Document and all available brochures, sales information, quotations, etc.
gathered from the field and/or received from the regional offices.
b. Electronic files containing timely information via e-mail or other electronic
format maintained by the Corporate Marketing Dept. Administrator.
Document Title: Document No. Revision Page
Competitive Profile Document PLCM-018-01 01 3 of 8
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.0 The Body of the Document
Please see the attached file “Competitive Profile.”
7.0 Appendix
Document Title: Document No. Revision Page
Competitive Profile PLCM-018-01 01 4 of 8
Competitive Profile
Company: Date:
Product:
I. Executive Summary a. Describe competitive threat (1 paragraph) b. Provide forecast for potential loss of market share c. Recommended response
II. Product Description a. Marketing brochure b. Sales materials gathered from field
III. Technical Comparison
Feature [Company] Given Imaging Comments
General Description
CapsuleModel [Product Name] PillCam SB Dimensions Weight Field of View Camera Type Imager Resolution LEDs Frame Rate Image Enhancements Other Functions Battery Type Battery Life End User List Price SoftwareName/Version
Key Messages Unique Features Same Features Viewing Speed Real Time Viewer Download Time Reading Time Size of Archive File Storage Medium Clinical Experience
Document Title: Document No. Revision Page
Competitive Profile PLCM-018-01 01 5 of 8
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
Feature [Company] Given Imaging Comments
Availability Price
Workstation Processor Speed Internal Memory Hard Disk Capacity External Storage Monitor Printer Type Tower Dimensions Data Recorder Dimensions Weight Capacity Memory Type LED Displays Power Data Recorder Battery Battery Type Battery Operating Capacity
Battery Charge Cycle Operating Voltage Charge Level Display Charge Level Indicator Typical Charging Period Weight
Li-Ion Battery Charger Charge Level Display Charge Configuration Charge Level Indicator Discharge Cycle Weight Dimensions Input Power Range
Data Recorder Belt Type Sizes
Sensor Arrays Small Bowel Esophageal
Real Time Viewer Configuration Software Capabilities
Document Title: Document No. Revision Page
Competitive Profile PLCM-018-01 01 6 of 8
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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
ProfessionalEducation
Courses Available
Industry Activity Joint Ventures Marketing Alliances Society Support
Regulatory Approvals and Standards
IV. System Pricing a. Manufacturer’s List Price b. Quotations gathered from field
V. Competitor’s Sales Strategy a. Case histories from field b. Accounts won c. Accounts lost
VI. Distribution Channels a. Estimated installed base b. Direct markets i. Number of sales reps ii. Other products sold (describe)
c. Indirect markets
Document Title: Document No. Revision Page
Competitive Profile PLCM-018-01 01 7 of 8
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
i. Number of distributors ii. Size of distributors
VI. Company SWOTs a. Overview
[Company] Given Imaging
Strengths Strengths
Weaknesses Weaknesses
Opportunities Opportunities
Threats Threats
b. Given Imaging Competitive Response
[Company] Given Imaging
Strengths Response
Given Imaging Given Imaging
Weaknesses Response
Document Title: Document No. Revision Page
Competitive Profile PLCM-018-01 01 8 of 8
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
Given Imaging Given Imaging
Global Pricing Plan SOP
The purpose of this procedure is:
1. To assure a systematic preparation of the Product Pricing for any Product developed by the Company, or any OEM product offered for sale by Given as service to its customers, while taking into account all relevant costs, competition and long term profit margin considerations as well as senior management policy guidance.
2. To ensure the long term profitability of the Company’s products while minimizing exposure to currency risks.
3. To gain the endorsement of the prospective sales and marketing leaders in the company.
Global Pricing Plan
Document Title: Document No. Revision Page
Product Pricing SOP PLCM-019-01 01 2 of 8
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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.
Document Title: Document No. Revision Page
Product Pricing SOP PLCM-019-01 01 3 of 8
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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
Document Title: Document No. Revision Page
Product Pricing SOP PLCM-019-01 01 4 of 8
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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.
Document Title: Document No. Revision Page
Product Pricing SOP PLCM-019-01 01 5 of 8
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
For cases in which the business may require net discounts that exceed
the level set for the subsidiary, the subsidiary senior manager or designee
must discuss each case with the Product Team Leader to obtain
agreement on pricing and strategy prior to making an offer, who if in
agreement, will gain approval from the VP Finance (verbal approval will
be sufficient). Upon e-mail notification of approval by the Product Team
Leader, the subsidiary senior manager or designee will communicate with
the internal organization using Appendix C prior to receipt of an order from
the customer whenever possible so that the order can be processed when
received, or accompanying the order to help contemporaneously
communicate the competitive environment to the internal organization.
6.3. The pricing data is sensitive data and so is the pricing document, the
confidentiality of which should be kept to only those who need to know.
Product cost data shall not be shared outside of the Corporate offices
(including Corporate Marketing in Atlanta), and also only on a need to
know basis.
6.4. The final document should be kept in the archive as all controlled
documents.
6.5. While auditing marketing and sales functionaries of Given for relevant
information during the process of creating the Pricing Document, care
should be taken to control the distribution of pricing related documents,
draft or final and the awareness to their sensitivities by appropriate
warnings on the documents, instructions to shred when appropriate, and
appropriate notice to restrict the information to only those who need to
know.
7.0 Appendix
7.1. See attached Appendix A, Appendix B, and Appendix C
TH
IS S
PE
CIF
ICA
TIO
N,
AN
D/O
R T
HE
SU
BJE
CT
MA
TT
ER
AR
E R
ES
TR
ICT
ED
SO
LE
LY
FO
R T
HE
US
E O
F G
IVE
N I
MA
GIN
G L
TD.
Ap
pen
dix
A
Pro
du
ct
Pri
cin
g D
oc
um
en
t T
em
pla
te--
Co
rpo
rate
CO
NF
IDE
NT
IAL
Pri
cin
g -
En
d U
se
r, T
ran
sfe
r a
nd
Dis
trib
uto
rs
Da
te
Pro
du
ct
Co
st
at
Ltd
(U
SD
)E
ND
U
SE
R
Tra
nsfe
r P
rice
Dis
trib
uto
rs
US
A (U
S$
) E
uro
pe
(E
UR
) U
SA
E
uro
pe
E
uro
pe
L
A
As
ia
Pro
du
ct
xx
x
Pro
du
ct
yyy
Product xxx components
Product xxx component 1
Product xxx component .
Product xxx component .
Product yyy components
Product yyy component 1
Product yyy component .
Product yyy component .
TH
IS S
PE
CIF
ICA
TIO
N,
AN
D/O
R T
HE
SU
BJE
CT
MA
TT
ER
AR
E R
ES
TR
ICT
ED
SO
LE
LY
FO
R T
HE
US
E O
F G
IVE
N I
MA
GIN
G L
TD.
Ap
pen
dix
B
Pri
cin
g B
en
ch
ma
rk W
ork
sh
ee
t--C
orp
ora
te
CO
NF
IDE
NT
IAL
PR
OD
UC
T L
IN
E:
DA
TE
:
RE
PO
RT
ED
BY
:
GIV
EN
IM
AG
IN
G
CO
MP
ET
IT
IV
E B
EN
CH
MA
RK
R
EC
OM
ME
ND
ED
GIV
EN
PR
IC
IN
G
En
d-U
ser P
ric
e
Dis
trib
uto
rP
ro
du
ct
Actu
al
Cost
(L
td
.)R
eg
ion
Lo
w
Hig
hU
SD
or €
U
SD
or €
Brie
f D
escrip
tio
n:
M
ark
et e
nv
iro
nm
ent
and
pri
cin
g s
trat
egy
, in
clu
din
g e
nd
-use
r re
imb
urs
emen
t st
atu
s.
Document Title: Document No. Revision
Product Pricing SOP PLCM-019-01 01
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
Appendix C
Notice of Regional Promotion
CONFIDENTIAL
Name of Promotion ________________ From (Date) to (Date)
AUTHORIZATION
NAME/TITLE SIGNATURE DATE
Issued by: Name of Region
Regional Marketing
Approved by: Name of Region
Regional Leader
Approved by: Name of Region
Regional Finance
Approved by: Name of Region
Regional Sales
Approved by: Corporate
Chief Marketing Officer
Approved by: Corporate
Corporate Finance
Approved by: Corporate
Corp. Customer Service
Approved by: Corporate
Product Team Leader
Approved by: Corporate
Product Team Leader
Approved by: Corporate
Product Team Leader
Approved by: Corporate
Product Team Leader
Attach description including target customers, promotion description, product, pricing and duration (same as field notification). If a single sale, briefly describe the competitive situation and specify the date of approval notification by the Product Team Leader.
Global Training and Education SOP
This document provides the framework for the development, approval, revision and storage of training and educational materials in support of new product and/or product enhancement introductions.
Global Training and Education
Document Title: Document No. Revision Page
Global Education Training Material Development PLCM – 023-01 01 2 of 6
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
1.0 Purpose
This document provides the framework for the development, approval, revision
and storage of training and educational materials in support of new product
and/or product enhancement introductions.
2.0 Scope
This procedure applies to all training and education materials intended for
distribution to Given employees, customers or their staff as they relate to clinical
or product content in an eLearning delivery medium/format. eLearning does not
replace interim training development (i.e. materials for trials, Announcements,
Regulatory Clearance, Product Availability, Limited or Full Launch), but is an
adjunct for “training on demand” and the fulfillment of subsequent training needs.
As such, other development centers may have their own T&D budgets to satisfy
training material development.
3.0 Responsibility
3.1 The Global Education Manager is responsible for the implementation of this
procedure and the following:
Coordinating with Product Line Leaders and Global Product Managers
on the identification of training and educational outcomes/objectives as
they apply to the learning constituency.
Obtaining from designated Subject Matter Experts (SME’s) assets and
content related to the development of training and education materials
to support product training.
Coordinating with the Global Regions for specific training
needs/requirements.
Working with internal resources, outside consultants and/or sourcing
and selecting qualified vendors for training program/materials creation.
Issuing P.O. to approved suppliers
Developing and producing training and education materials.
Obtaining necessary approvals
Disseminating Training and Education Materials.
3.2 Approvals
Refer to PRS
Document Title: Document No. Revision Page
Global Education Training Material Development PLCM – 023-01 01 3 of 6
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
4.0 Definitions
4.1 Training and Education materials are any materials (print, audio, video,
digital or web based communication vehicles) intended to facilitate the
understanding, comprehension, usage of the Given platform. The primary
focus is product and clinical training designed for employees and
customers.
4.2 Project Requirements Specifications (PRS): A form controlled and used
by Given Imaging Global Marketing to define, initiate and revise Global
Education training materials or programs.
5.0 Procedure
Initiation of training or education materials:
5.1 Product Line Leaders or Global Region Representatives initiate a request
for Clinical or Product Training or Education Materials by completing a
PRS Form and submitting it to the Global Education Manager.
a. Originator proposes new or revised Training or Education material(s)
need by submitting a Project Requirement Specification (PRS) form for
initiation. Appendix A
b. Global Education Manager communicates with key stakeholders to
determine approval for initiation or rejection of the project.
i. If approved, the production schedule, budget, SMEs and project team is established and defined through coordination with originator and Global Education Manager.
ii. If rejected, the Global Education Manager communicates justification to the originator.
c. When PRS is approved, outside resources are identified and secured
and if appropriate a PO is issued
d. Training program materials are designed, developed and produced.
e. Training materials are reviewed, modified and/or approved by the
originator and designated review team
f. Final approval goes to Review Board for regulatory review of Labeling
g. Approved materials are disseminated to the field.
Document Title: Document No. Revision Page
Global Education Training Material Development PLCM – 023-01 01 4 of 6
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.0 Appendix
Appendix A – Project Requirement Specification (PRS) Appendix B – Process Flow
Appendix A
PROJECT REQUIREMENT SPECIFICATION (PRS) Training Materials
Project Definition: To be completed by originator
Project Title
Region(s) supported
Target audience
Objective
Description with Key Message
Intended use
Content owner
Deadline for delivery
Quantity (Inc., Int’l, KK)
Language requirements
PROJECT INITIATION APPROVAL (Print & Sign Name) DATEPRS Submitted by
PRS Accepted by (Global Education Manager)
REVIEWER APPROVALS (Print & Sign Name) DATEClinical Marketing
Marketing Communications
Finance
Regional Marketing Organizations Inc., International, KK (as needed)
Product Line Management SB, ESO, COLON, Platform (as
needed)
InScope (as needed)
Other Reviewers (as needed)
PRODUCTION SPECIFICATIONS Vendor
Size
Material
Graphics & Design Elements
Within Style Guide
Part Number (US & Global)
Document Title: Document No. Revision Page
Global Education Training Material Development PLCM – 023-01 01 5 of 6
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
FINAL PRODUCTION APPROVALS (Print & Sign Name) DATEChief Marketing Officer
Regulatory Affairs
MARCOM INSPECTION Delivery Date & Location
Inspection Date
Approved By (Print & Sign Name)
Document Title: Document No. Revision Page
Global Education Training Material Development PLCM – 023-01 01 6 of 6
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
Appendix B – Process Flow
Initiator sendsPRS to GEM
GEM reviews PRS with Stakeholders
Approval
ProjectScope,Team,
Budget, Timeline
Defined and Approved
YES
NO
Decision communicated
to initiatorOutside
Resources Identified Secured;
PO Issued
ProgramMaterials
Developed/Produced
MaterialsReviewed/ Modified/ Approved
MaterialsDisseminated
Regulatory Approval
Global Launch Package SOP
The purpose of this document is to describe the content of the Global Launch Package, which will be used by the regional and corporate marketing teams as a product reference and to help organize roll-out plans.
Global Launch Package
Document Title: Document No. Revision Page
Global Launch Package PLCM-025-01 01 2 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
1.0 Purpose
The purpose of this document is to describe the content of the Global Launch
Package, which will be used by the regional and corporate marketing teams as a
product reference and to help organize roll-out plans.
2.0 Scope
The Global Launch Package is required by the regions as far in advance as
possible prior to product availability, but not less than 60 days prior to a regional
product release. Information that cannot be supplied in this timeframe due to
Regulatory uncertainties or other possible unsettled claims or product
positioning/performance issues should be supplied in periodic updates as soon
as the uncertainties are resolved. Distributor information such as product name,
description, part number, distributor cost, end-user price, expected availability
date, etc. should be provided to regions in indirect markets not less than 3
months in advance of product availability so that proper notification can be
provided to the distributors.
3.0 Responsibility
The responsibility to create the Global Launch Package is with the Corporate
Product Line Leaders in conjunction with the Regional Marketing Leaders.
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
Document Title: Document No. Revision Page
Global Launch Package PLCM-025-01 01 3 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
The Global Launch Package should consist of:
Product Description
o Product Description
o Functioning Principle
o Technical Specifications
Logistics
o Order Part Numbers
o Availability
o System Components, End User Packaging
Marketing
o Brand Name
o Unique Selling Proposition and Key Messages
o Market Positioning
o Target Market
o Market Profile (# accts, etc.)
o Launch event (e.g. DDW, ACG, UEGW, etc.)
Pricing:
o Standard End User Prices (supplied by Corp. Marketing)
o Distributor Transfer Prices (supplied by Corp. Marketing)
o Promo Packages (supplied by Regions in coordination with Corporate Finance)
Training Material
o Product and Sales Training Material
o Medical Application
o Clinical Support / References
o Demo Cases on CD/ DVD
o FAQ´s
Price
Performance
Document Title: Document No. Revision Page
Global Launch Package PLCM-025-01 01 4 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
Service Support (supplied by Corporate Customer Support Dept.)
o Service Concept
o Service Training Materials
o Spare Parts (prices, part numbers, availability, handling with supplier for warranty, complaint process)
MarCom Materials
o Product Brochure
o Flyers
o Sales Collaterals, etc.
Communications Plan
o PR
o Advertising
o Website, etc.
Registration (CE mark, FDA, etc.)
Competition (Competitive Profile Documents)
o Description of main competitors and their products
o Strengths and weaknesses
o Comparison to our products
7.0 Appendix
Field Testing SOP
The purpose of this procedure is to establish clear and effective guidelines for the testing of new products prior to their market release. This procedure covers the logistics, technical support and data collection processes affiliated with the field testing of products.
External Evaluation Release SOP
This procedure defines the process and steps required for preparing and approving external evaluation of products designed and developed by Given Imaging. External evaluation of a product is an integral part of the design process, and as such its pre-requisites are defined in the Design and Development Outputs
External Evaluation Release
Document Title: Document No. Revision Page
External Evaluation ReleasePLCM-022-01(PLCM-736-1)
1 2 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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.
Document Title: Document No. Revision Page
External Evaluation ReleasePLCM-022-01(PLCM-736-1)
1 3 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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.
Document Title: Document No. Revision Page
External Evaluation ReleasePLCM-022-01(PLCM-736-1)
1 4 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.7 Delivery or installation of PID will be controlled by Customer Support via
PSR (Product Service Report) open in the SR (Service Request) in SAP.
6.8 The R&D Project Manager is responsible for supporting the External
Evaluation process and following-up on its results. An External Evaluation
Report will be prepared by the R&D Project Manager.
6.9 The Director Platform Products is responsible for updating (or removing)
the product at the evaluation site after the External Evaluation is
completed and a nominal product upgrade is available, but no later than 6
month after External Evaluation Plan was completed.
*************
Stage 4: Marketing Support of Sales (Regional Launching Process)
Detailed Stage Description: Marketing Support of Sales
Marketing Support of Sales Flowchart
Gate P4: Product Launch Deliverables
Marketing Support of Sales Flowchart
Marketing Support Sales Flowchart
Marketing support sales(Regional launch readiness)
RESPONSIBILITY PROCESS OUTPUT
LOCAL LAUNCH & OFFERING MANAGEMENTLEADER
- Regional Product Mgr- RACA (Global & Local)
APPROVAL
- Head of Geography- Product Line Director
Create and implement a successful product or major release launch plan at the regional level.The expected output are: Local launch plan and timeline
Local Launch & Offering Management
90 Days including at least 30 Days Post Launch
Develop marketing & sales support communications in conjunction with product
launch.
The expected outputs are: Effective sales and marketing communications
MARKETING SERVICESLEADER
- MarCom
APPROVAL
- Global Marketing- Regional Sales & Marketing Management- RACA
- Legal/IP (Internal or External as required)- MarCom
Local launch
PRODUCT SPECIFIC KOLSLEADER
- Regional Marketing Director
APPROVAL
- Global Marketing- Regional Geography Leader
Marketing Services
60 Days
To establish product pricing by region that meets both product placement & Global profitability objectives.The expected output is: Effective pricing plan.
Pricing Plan
15 Days
PRICING
LEADER
- Regional Marketing Director
APPROVAL
- Finance- Global Marketing- Regional Geography Leader
To identify and manage local product KOLs can represent Given products at training and trade show events as well as function as advisory panelThe expected output is: Active list of Product KOLs.
Product specific KOLs
OnGoing
?Gate P4
Product specific KOLs
To identify and manage local product KOLs can represent Given products at training and trade show events as well as function as advisory panel
• Identify local product KOLs based fit of clinical expertise to product as well as name recognition and quality of company representation
• Training KOLs on product knowledge & presentation skills
• Manage KOL relationship and activities to keep relationship healthy and maximize benefit to Given Imaging
Recommendations from medical peers, sales representatives and other employees/partnersTraining materials and programs designed to improve impact of KOL
Detailed Stage Description: Marketing Support of Sales
Local Launch & Offering Management
Marketing Services Pricing
Objective(s)
Create and implement a successful product or major release launch plan at the regional level
Develop marketing & sales support communications in conjunction with product launch
To establish product pricing by region that meets both product placement & Global profitability objectives
Process(es)Em
ployed
• Meet local regulatory requirements• Development of Local Pricing and
Distribution Promotions• Develop local trade show product
introduction plan• Conduct sales training• Conduct training for local support
personnel
• Develop product brochures and sales flyers
• Develop trade show strategy and collateral
• Develop other sale tools as required
• Develop PR, Advertising, Media, website and communications plan
• Develop local/regional pricing policies
• Develop promotional pricing to support sales and placement objectives
RequiredInputs
Global Launch Package (Commercialization Plan)
Global Launch Package (Commercialization Plan)Local Launch PlanField Sales needs/desires for product and sales support materials
Global Launch Package (Commercialization Plan)Product Business CaseCorporate Strategy Financial Objectives for profitability and sales
Detailed Stage Description: Marketing Support of Sales (page 2 of 3)
Regional Marketing Director
Product Line DirectorBusiness Partners (JNJ & Distributors)Regional Product MgrRegional RACA
Clinical Marketing
At launch and then Ongoing
Product specific KOLs
Leader (R/R, Frequency ofEngagem
ent, Deliverables)
Regional Product MgrRACA (Global & Local)
MarCom Regional Marketing Director
Partner(s)Internal/External
Product Line DirectorRACA (Global & Local)Clinical MarketingTraining Business Partners(JNJ & Distributors)Local Operations Team
Product Line DirectorRegional Marketing MgmtRegional Sales MgmtRACA (Global & Local)Clinical MarketingTraining Business Partners(JNJ & Distributors)
Product Line DirectorFinanceRegional Product MgrReg Sales Management
Contributor(s)
Internal/External
Field Sales – Direct & Distributors Reimbursement
Customer SupportOperationsPR Organization
Sales Admin (Ops)Reimbursement
Estimated
Time Fram
e
90 Days including at least 30 Days Post Launch
60 Days 15 Days
Local Launch & Offering Management
Marketing Services Pricing
Detailed Stage Description: Marketing Support of Sales (page 3 of 3)
Regional Marketing & Sales
Global MarketingRegional Geography Leader
Active List of Product KOLs
• Good relationships with KOL’s• KOL engagement in representation
of company and products
Product specific KOLs
BudgetResponsibility
Regional Marketing & Sales MarCom Regional Marketing & Sales
RequiredA
pprovals
Head of GeographyProduct Line Director
Global MarketingRegional Sales & Marketing ManagementRACALegal/IP (Internal or External as required)MarCom(per Review Board SOP)
FinanceGlobal MarketingRegional Geography Leader
ExpectedO
utput
Local Launch Plan and Timeline Effective Sales and Marketing Communications
Effective Pricing Plan
Metrics to
Measure Success
• Product Sales Volume and Revenue
• Market Share
• Sales/Regional feedback on communications effectiveness
• Budget adherence
• Product Sales Volume, Revenue, Global Profitability
• Market Share
Notes
• Inventory management note for metrics was general metric for all launch/implementation activities• Global Launch package includes final Commercialization Plan – clarify in Launch Template• Global Launch package includes Product Release document• Product Release document (PR) should include all product descriptions and pricing- No separate doc from CS
Local Launch & Offering Management
Marketing Services Pricing
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
Regional Training Global Training and Education PLCM-023-01
Regulatory Approvals
Marketing Support of Sales PLCM-035-01
Regional Launch Plan SOP
The purpose of this document is to describe the content of the Rgional Launch Package, which will be used by the regional and corporate marketing teams as a product reference and to help organize roll-out plans.
Regional Launch Plan
Document Title: Document No. Revision Page
Regional Product Launch Plan PLCM – 026-01 01 2 of 3
Given Imaging CONFIDENTIAL 4/11/2007
Regional Product Launch Plan
CONFIDENTIAL
Given Imaging
Document Title: Document No. Revision Page
Regional Product Launch Plan PLCM – 026-01 01 3 of 3
Given Imaging CONFIDENTIAL 4/11/2007
TABLE OF CONTENTS Page
I. Executive Summary
II. Key Launch Milestones
III. Product Description A. Technical Description B. Clinical Support and Messaging C. Marketing Messaging and Strategy
IV. Product Launch Strategy, Goals and Objectives
V. Pricing Strategy A. Direct Markets B. Indirect (Distributor) Markets C. Promotional Strategy
VI. Launch Risks
VII. Competitive Landscape and Positioning
VIII. Launch Action Plan
A. Sales Support (Launch Binder Creation) i. Product Information ii. Clinical Support iii. MarCom Support iv. Competitive Information v. Etc……
B. Training i. Sales and Distributor Training ii. Support Staff Training iii. Customer Training
C. Customer Installation/Upgrade Plan D. Reimbursement and Economic Action Plan E. MarCom Support
i. Marketing Collateral ii. Trade Show Participation iii. Clinical Marketing Support iv. PR, Media, Web, etc. Action Plans
F. Operations Support i. Product Availability ii. Inventory Transition iii. Sales Quotation/Ordering
1. Pricing Details 2. Part numbers/BOMs
iv. Product Shipment
IX. Appendix A – Customer base details B – XXXXXXX C – YYYYYYYY
3
Product Release SOP
Product Release
Document Title: Document No. Revision Page
Product Release Template PLCM-024-01 01 2 of 3
Note: Specifications are subject to change without prior notice and without any obligation on the part of the manufacturer.
THIS DOCUMENT, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
© 2006 Given Imaging Ltd. 28-Jun-06
Product XX – Product Release
Product Description
Product Name and Branding
The names for the components of this system are:
Indications/Contraindications
IndicationsContraindications
Product Pricing
Product Specifications
Details on product and procedure
Product Documentation
Packaging Information
Product Marketing Information
Product Positioning
Marketing Message
Competitive Environment Description
Product Training Requirements
Employees Customers
Product Support Information
Warranty Repairable Parts Non-Repairable Parts Shipment Policies Packaging for Shipment Product Documentation Policy: Support Contact Information
Document Title: Document No. Revision Page
Product Release Template PLCM-024-01 01 3 of 3
Note: Specifications are subject to change without prior notice and without any obligation on the part of the manufacturer.
THIS DOCUMENT, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
© 2006 Given Imaging Ltd. 28-Jun-06
Availability
Launch Product shipping by
Product Ordering Information:
Description Ordering P/N Lead Times
Product A FGS-XXXX X-Y Weeks Product A Accessory FGS-XXXX X-Y Weeks
Labeling Creation and Production SOP
This SOP controls the creation, approval, revision, and controlled document storage of product labeling and marketing communication materials at Given Imaging USA for the US and Global marketing organization.
This procedure applies to the following:
1. All labeling and marketing materials that are intended for distribution to customers or non-Given employees.
2. All Marketing communication Materials intended for internal distribution.
Labeling Creation and Production
Document Title: Document No. Revision Page
Labeling Creation and Production PLCM-020-01
(MK-07)01 2 of 7
1.0 Purpose and Scope
This SOP controls the creation, approval, revision, and controlled document storage of
product labeling and marketing communication materials at Given Imaging USA for the
US and Global marketing organization.
This procedure applies to the following; All labeling and marketing materials that are intended for distribution to customers
or non-Given employees.
All Marketing communication Materials intended for internal distribution.
This procedure does not apply to labeling included with the product. This is
controlled by Product Management.
2.0 Definitions
2.1 Labeling is any material that is intended to be included with or supplemental to
the finished, packaged, and labeled device. This includes product brochures
(printed or digital), and web sites/pages that describe the product performance
characteristics. Approved label materials shall conform to 21 CFR, part 801,
subpart H and meet the requirements of the current version of the Corporate Style
Guide (GMB-0023).
2.1.1 Marketing Materials (MarCom Materials): A MarCom Material is defined
as any Marketing communication that does not make a product claim and
is NOT to be included with or supplemental to the finished, packaged,
and labeled device. Examples of MarCom materials can include
brochures, fliers, conference invitations, e-mail invitations, etc.
2.2 Project Requirements Specification (PRS): A form controlled and used by the
MarCom Department of Given Imaging to define, initiate and revise a MarCom
material development or production project.
2.3 Corporate Style Guide: The Given Imaging, Ltd., marketing style guide outlines
guidelines relative to design and layout of Labeling and MarCom materials. The
current version of the Style Guide GMB-0023 is controlled by Corporate
Marketing. Exceptions to the Style Guide may be accepted on a per-project basis
after discussion.
Document Title: Document No. Revision Page
Labeling Creation and Production 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:
coordinating with global regions, when appropriate
obtaining necessary approvals
developing and producing Label and MarCom materials and specifications
responsible for developing the electronic file along with the documentation for
part numbers
responsible for receiving inspection of MarCom materials
3.2 Materials Management is responsible for P.O issuance to approved suppliers,
stocking, storing, and distributing Labeling and MarCom materials.
3.3 QA is responsible for Receiving Inspection of Labeling received in Atlanta.
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: Document No. Revision Page
Labeling Creation and Production 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: Document No. Revision Page
Labeling Creation and Production PLCM-020-01
(MK-07)01 5 of 7
6.0 Approvals Refer to PRS Form (Appendix A)
Document Title: Document No. Revision Page
Labeling Creation and Production PLCM-020-01
(MK-07)01 6 of 7
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)
Appendix A
Document Title: Document No. Revision Page
Labeling Creation and Production PLCM-020-01
(MK-07)01 7 of 7
Appendix B
MarCom Department
reviews PRS with key stakeholders
Proceed?
Initiator sends PRS to MarCom
Department
Decision is communicated to
initiator
Project scope, budget and timeline are defined and approved
Marcom Department requests part
number
MarCom creates design and sends proof to reviewers for regular meeting
discussion and approvals
PRS is circulated for final production
approval
MarCom obtains edits and/or approvals
Local purchasing process is followed.
PRS form, design files and final
document specification are filed
QA & local Marketing verifies quality from specifications
and proof.
Yes
No
MarCom creates PR/PO for design
cost
MarCom makes edits and verifies
incorporation
Project Requirement Specification (PRS) SOP
Project Requirement Specification (PRS)
Q ( )Marketing/Training Materials PLCM-028-01
Page 1 of 1
Project Definition: To be completed by originator
Project Title
Region(s) supported
Target audience
Objective
Description with Key Message
Intended use
Content owner
Deadline for delivery
Quantity (Inc., Int’l, KK)
Language requirements
PROJECT INITIATION APPROVAL (Print & Sign Name) DATEPRS Submitted by
PRS Accepted by (MarCom)
REVIEWER APPROVALS (Print & Sign Name) DATEClinical 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) DATEChief Marketing Officer
Regulatory Affairs
MARCOM INSPECTION Delivery Date & Location
Inspection Date
Approved By (Print & Sign Name)
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
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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.
Document Title: Document No. Revision Page
Marketing Support of Sales PLCM-035-01 01 3 of 3
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.0 Procedure
6.1. The Product Line Director delivers the Global Launch Package to the
Regional Product Manager.
6.2. The Regional Product Manager develops complete product launch plan
utilizing the Regional Launch Plan Template.
6.3. The Corporate Director of Marketing Communications develops and delivers
the marketing and sales support communications as required per the
Regional Launch Plan.
6.4. The Regional Marketing Director develops a product pricing plan that
supports both the product placement and global profitability objectives, in
coordination with Corporate Finance.
6.5. The Regional Marketing Director identifies local Product KOLs and the
Regional Product Manager manages their activities.
6.6. The Regional Product Manager executes the Regional Product Launch Plan
through to completion, while providing feedback to the Corporate Product
Line Leader.
6.7. The Regional Product Manager monitors the success of the product launch
utilizing achievement of product placement and profitability objectives as
primary metrics of launch success. This information is reported back to the
Corporate Product Line Leader to modify ongoing work as necessary.
7.0 Appendix
Stage 5: Ongoing Management and Roadmap Steering
Detailed Stage Description: Ongoing Management and Roadmap Steering
Gate P5: Product Progression and Customer Satisfaction Deliverables
Gate P6: Product End of Life (EOL) Deliverables
Product End Of Life (Obsolescence)
1. Controlled phase-out of product from market
2. Sustain customer satisfaction during EOL process (CS, replacements, warranties)
3. Comply with regulation concerning EOL requirements
4. Ensure smooth business transition (inventories of material and FGS, production line resources
5. Ensure customer loyalty continuity
1. Plan End of Life (EOL) process 2. Forecast EOL 3. Plan production scale-down 4. Plan CS transition (FGS inventories
@ Ltd and regions, spares and options, tech-support)
5. Design EOL strategy & announcement
6. Plan EOL marketing package:• EOL “promos”• Replacement offerings• Messages
Detailed Stage Description: Ongoing Management and Roadmap Steering
Capture and Resolve Product Quality and Use Issues
Install Base Management Products Ongoing Incremental Improvements
Objective(s)
Market/user oriented1. Collect/track field/use quality issues2. Follow field/use quality issue trends 3. Analyze quality cause-effect (tech,
use)4. Define solutions/mitigationsProduction/product oriented5. Collect/track manufacturing quality
issues6. Follow manufacturing quality issue
trend7. Analyze manufacturing quality
cause-effect (design, process)8. Define solutions/mitigations
1. Product (version) deployment picture (customer/region) to support customer satisfaction management and efficiency
2. Installed base customer profile, use trend (application, quantities, demography) to provide input for business improvements
1. Improve customer satisfaction2. Improve profitability/productivity/
cost-effectiveness/utilization3. Respond to competition
Process(es)Em
ployed
1. Gather quality data• Hierarchical SR system (Call-
center, DB, templates)• Track incoming inspection
results (supplier quality) and supplier audit; production performance quality
2. conduct monthly FFF (Field-Failure-Forum)
3. Problem oriented dedicated task/activity
4. create Product line level solution plan and processes for execution and follow-up
1. Set-up and maintain customer data base for sales, installation and maintenance system (personnel, training, infrastructure)
2. Produce and analyze sales/trends/performance reports from SAP
3. Set-up and maintain customer data base for sales, installation and maintenance system (personnel, training, infrastructure)
4. Produce and analyze sales/trends/performance reports from SAP
1. Collect and track end-user suggestions/requests (ideabox)
2. Follow SR and production trends3. Collect and track sales/CS/
marketing suggestions/requests4. perform Customer (satisfaction/
trend) surveys5. Analysis of production costs6. Analysis of market/sales trends/
performance7. Product annual review (?)8. Improvement implementation
(plan, execution)9. Annual plan
Detailed Stage Description: Ongoing Management and Roadmap Steering (page 2 of 3)
1. Given Roadmap2. Supplier roadmaps3. IB data4. Inventory levels (materials, FGS)5. Competition data6. Marketing event data7. Finance report
PL-manger –(part of PLC plan)
• Global Marketing,• CS, • Operation• Finance• R&D, • Suppliers• Regions
QA
According to PLC plan (roadmap)
Product End Of Life (Obsolescence)
RequiredInputs
SRs, DB, FFF, Incoming-Inspection data, Production-Performance data, Supplier-Audit-data
1. Sales data (SAP)2. TS data (SAP)3. Customer master data
1. Ideas database2. Sales performance3. BOM cost4. Competition data5. FFF
Leader
QA CS – cont.CS + Finance – cont.
PL-manger - cont
Partner(s)Internal/External
• QA, • R&D, • CS, • PL manger, • production, • finance• Distributor, • subsidiaries, • supplier
• Finance, • PL• Subsidiaries,• Distributors
• Production• Clinical marketing• CS and production• Clinical marketing• Production• R&D
Contributor(s)
Internal/External
• R&D• Finance• Sales administration
Estimated
Time Fram
e
context Continuous Later than 6 months after product launch
Capture and Resolve Product Quality and Use Issues
Install Base Management Products Ongoing Incremental Improvements
Detailed Stage Description: Ongoing Management and Roadmap Steering (page 3 of 3)
Product line life-cycle budget dedicated to EOL activity
1. COO2. VP Global Marketing3. Regions
1. EOL process plan2. EOL forecasts3. Production scale-down plan4. CS transition plan (FGS inventories
@ Ltd and regions, spares and options, tech-support)
5. EOL strategy & announcement6. Marketing support:
• EOL “promos”• Replacement offerings
7. Messages
1. Low dead inventories2. Sustained customer satisfaction3. Sustained customer loyalty
Product End Of Life (Obsolescence)
BudgetResponsibility
1. Infrastructure (MPWR/”SAP”)2. Infrastructure (MPWR/”SAP”)3. Product line life-cycle budget
dedicated sustained engineering resources
4. Context specific ad-hoc resources
Infrastructure R&D if relevantManufacturing if relevant
RequiredA
pprovals
Context dependent:GLBL marketing, Finance, Region
1. COO2. VP Global Marketing
ExpectedO
utput
Quality issue solutions/mitigations 1. 1.Reliable IB configuration (HW/SW) Database
2. Usage/sales trends
Product improvement program
Metrics to
Measure Success
Customer satisfaction, Quality issue trends (FFF)Time-to-solution?
1. Average time to solutions2. CS cost-effectiveness3. PL-manager satisfaction
Meet annual improve. plan objectives (time, budget)
Capture and Resolve Product Quality and Use Issues
Install Base Management Products Ongoing Incremental Improvements
Gate P5: Product Progression and Customer SatisfactionFrom 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: Document No. Revision Page
Corrective and Preventive Action PLCM-030-01
(QA-852-2)
2 2 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
1.0 Purpose
The purpose of this procedure is to 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 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
5.0 Definitions
5.1. Corrective action: Action been taken after non-conformity was detected in a
product or a process. Typically initiated as a result of field service problems,
customer complaints, internal/external audits, management reviews, product
manufacturing/inspection etc..
5.2. Preventive action: Action taken to eliminate the cause of a potential non-
conformity, defect, or other undesirable situation in order to prevent
occurrence
5.3. CAPA - Corrective and Preventative Action
Document Title: Document No. Revision Page
Corrective and Preventive Action PLCM-030-01
(QA-852-2)
2 3 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
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
Document Title: Document No. Revision Page
Corrective and Preventive Action PLCM-030-01
(QA-852-2)
2 4 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
effective, the QA Director closes the CAPA by signing and dating the request
form and notifying the department manager, initiator and other appropriate
parties of the closure, and providing the department manager with a copy of
the completed CAPA Request Form.
6.11. If the CAPA is directly related to an SR, a copy of the completed CAPA form
is electronically linked to the SR when the SR is closed.
6.12. If the corrective action proves to be ineffective, the QA Director marks the
form accordingly and returns it to the department manager for further action.
6.13. If the CAPA was initiated due to a customer complaint and the customer
requested a desire to be updated regarding actions taken, it is the
responsibility of the QA Director to contact the customer.
***************
Field Modification SOP
The purpose of this procedure is to provide clear and effective guidelines for handling of Field Modifications to ensure customer satisfaction and compliance with all regulatory requirements.
Field Modification
Document Title: Document No. Revision Page
Field Modification PLCM-031-01 01 2 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
1.0 Purpose
The purpose of this procedure is to 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.
Document Title: Document No. Revision Page
Field Modification PLCM-031-01 01 3 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.0 Field Modification Procedure
6.1. Once a Field Modification is necessary, a committee including but not
necessarily limited to Product Management. Marketing, QA, R&D, Operations
and CS will decide the appropriate method(s) to perform the modifications in
the field.
6.2. For the same Field Modification, the implementation may vary according to the
needs of the different Regions.
6.3. Product Management will define the kit
6.4. Based on the method/s adopted, the kit containing all the necessary materials
and instructions will be prepared by Given Operations in coordination with PM
and CS.
6.5. Whether the FM is mandatory or not, a list containing all the materials to be
modified in the field will be prepared by CS.
6.6. Corporate CS will train and instruct Regional CS & PM teams on the
modification process.
6.7. Field Modification:
- If the modification will take place at the Customer site by the Customer, the
kit will be sent to the customer account. The Regional Customer Support
team will be ready to provide online support in case it is needed.
- If the modification will take place at the Customer site by Given personnel or
a third party contracted by Given, a training session or written instructions
will be arranged prior to the implementation in the field.
- If the modification cannot be performed at the Customer site, materials will
be retrieved and modified at the Regional offices or at the Headquarters
depending on the complexity of the modification.
6.8. The implementer will communicate to CS and confirm that the modification
was satisfactorily performed.
6.9. CS will document the information in SAP for future system configuration follow
up and Field Modification tracking implementation.
7.0 Appendices
7.1 Appendix A: Field Modification Flowchart
Document Title: Document No. Revision Page
Field Modification PLCM-031-01 01 4 of 4
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
FMIRequest
Mandatory
Technicianless
Prepare list of materials to be modified
Instruct Given personnel -Third party
In the field Retrieve materials
Perform modification
Document in SAP
Send modification kit
no
yes
no
yes
no
yes
Confirm Implementation
Regional Support
Successful yesno
Defineimplementation
method
Release FMI(ECO)
Train Regional CS teams
Prepare FMI kit-in-service
Create SRsIn SAP
Validate kit
Appendix A
Installed Base Report Format SOP
TBD
Gate P6: Product End of Life (EOL)From a Commercial Product to Decline
Main Deliverables SOP Document
Transition to Alternative Products
EOL Plan End Of Life PLCM-034-01
Detailed Stage Description: End of Life Product End of Life (Obsolescence)
Objective(s)
1. Controlled phase-out of product from market2. Sustain customer satisfaction during EOL process (CS, replacements, warranties)3. Comply with regulation concerning EOL requirements4. Ensure smooth business transition (inventories of material and FGS, production line resources5. Ensure customer loyalty continuity
Process(es)Em
ployed
1. Plan End of Life (EOL) process 2. Forecast EOL 3. Plan production scale-down 4. Plan CS transition (FGS inventories @ Ltd and regions, spares and options, tech-support)5. Design EOL strategy & announcement
Process(es)Em
ployed
Plan EOL marketing package:• EOL "promos"• Replacement offerings• Messages
RequiredInputs
1. Given Roadmap2. Supplier roadmaps3. IB data4. Inventory levels (materials, FGS)5. Competition data6. Marketing event data7. Finance report
Leader
PL-manger -(part of PLC plan
Detailed Stage Description: End of Life (page 2 of 3)
Partner(s)Internal/External
• Global Marketing,• CS, • Operation• Finance• R&D, • Suppliers• Regions
"Contributor(s)
Internal/External
QA
Estimated
Time Fram
e
According to PLC plan (roadmap)
BudgetResponsibility
Product line life-cycle budget dedicated to EOL activity
RequiredA
pprovals
1. COO2. VP Global Marketing3. Regions
Product End of Life (Obsolescence)
Detailed Stage Description: End of Life (page 3 of 3)
ExpectedO
utput
1. EOL process plan2. EOL forecasts3. Production scale-down plan4. CS transition plan (FGS inventories @ Ltd and regions, spares and options, tech-support)5. EOL strategy & announcement6. Marketing support:
• EOL "promos"• Replacement offerings
7. Messages
Metrics to
Measure Success
1. Low dead inventories2. Sustained customer satisfaction3. Sustained customer loyalty
Product End of Life (Obsolescence)
End Of Life SOP
The purpose of this procedure is to provide clear and effective guidelines for handling of discontinued products.
End Of Life
Document Title: Document No. Revision Page
Product End of Life PLCM-034-01 01 2 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
1.0 Purpose
The purpose of this procedure is to provide clear and effective guidelines for handling of discontinued products.
2.0 Scope
2.1 This procedure applies to all products supplied by Given Imaging. 2.2 This SOP covers all the aspects related to products discontinuity like provision of spare parts, field announcements and substitute products.
3.0 Definitions
o EOL: End of life.
o TSB: Technical Support Bulletin
o MR: Marketing Release
o SAP: Database
o CS: Customer Support
4.0 Reference Documents
FMI SOPTSB Template
5.0 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.
Document Title: Document No. Revision Page
Product End of Life PLCM-034-01 01 3 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
6.0 End of Life Procedure
6.1 The Product Line Manager will define a plan containing initializationdate of a new product and suggested production and service end dates.
6.2 Once a third party product supplied by Given (printers, monitors, etc.)
is discontinued, CS will communicate the field through a TSB.
6.3 CS will recommend whether a small stock of materials End of Life
should be kept in stock for support purposes or not.
6.4 A decision regarding discontinuation of a product will be taken by Marketing, CS, Operations, and Finance.
6.5 The decision will take into consideration Marketing aspects, inventory status and accounting effects.
6.6 Once a decision is made, an approval form and Memo summarizing the reasons for the discontinuation will be filled by CS and signed by the relevant parties (See Appendix B)
6.7 Once a product is discontinued, Given Imaging will follow the steps below:- Check if the product is upgradeable or it can be replaced by a compatible unit
- If upgradeable, Given Imaging will follow Field Modification instructions
- If the product can be exchanged by a compatible unit, Marketing will prepare a plan to promote the exchange of the discontinued units.
- Marketing together with CS will decide whether the old units will be retrieved or not.
- Retrieved units will be tested, reconditioned and used for spare parts.
- CS will provide forecast for spare parts (based on the end date) and it will implement the necessary actions to support the product until the end date
- CS and Marketing will inform the Regional offices the end date of a product through the TSB and MR
- CS will recommend the Regional offices whether a stock of spare parts to support the End of Life product is necessary or not.
6.8 Given Imaging will keep all the documentation generated during product’s life time for tracking and regulatory purposes.
6.9 Given Imaging will keep the necessary inventory to support the product until the end date.
Document Title: Document No. Revision Page
Product End of Life PLCM-034-01 01 4 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
EOL
Alternative product
Forecast Spare parts
O ffer new product(Promo packages)
Communicate the field (TSB-MR)
Keep documentation
Keep inventory
yes
no
Exchange materials
Keep old materials for spare parts
Define Support period
G iven productCommunicate the field (TSB-MR)
Keep inventory for Support purposes
no
Upgradable
yes
no
Go to FMI SOP
yes
Customer accept new product
yes
no
7.0 Appendices
7.1 Appendix A: End of Life Flowchart
Appendix A
Document Title: Document No. Revision Page
Product End Of Life PLCM-034-01 01 5 of 5
THIS SPECIFICATION, AND/OR THE SUBJECT MATTER ARE RESTRICTED SOLELY FOR THE USE OF GIVEN IMAGING LTD.
7.2 Appendix B: End of Life approval form
Notice of Product discontinuation
CONFIDENTIAL
AUTHORIZATION
NAME/TITLE SIGNATURE DATE
Issued by: CS
Approved by: Corporate Marketing
Approved by: VP Operations
Approved by: Corporate Finance
Approved by:
PLCM Department ResponsibilitiesClinical Trials
PLCM-013-01 (Clinical Trials Approval Forms (CTAF) —Gate P1PLCM-014-01 (CT Protocols) —Gate P1PLCM-015-01 (IRB Documents) —Gate P1
CSPLCM-031-01 (Field Modification) —Gate P5PLCM-033-01 (Installed Base Report Format) —Gate P5PLCM-034-01 (End of Life) —Gate P6
IPPLCM-001-01 (Preliminary Risk Analysis) —Gate P0
MarketingPLCM-003-01 (Business Case) —Gate P0, —Gate P1PLCM-004-01 (Product Requirements Definition —Gate P0PLCM-005-01 (Make/Buy/Partner Analysis and Decision) —Gate P1PLCM-017-01 (Comercialization Plan) —Gate P3PLCM-018-01 (Competitive Profile) —Gate P3PLCM-019-01 (Global Pricing Plan) —Gate P3PLCM-020-01 (Labeling Creation and Production) —Gate P4PLCM-023-01 (Global Training and Education) —Gate P3, —Gate P4PLCM-024-01 (Product Release) —Gate P4PLCM-025-01 (Global Launch Package) —Gate P3PLCM-026-01 (Regional Launch Plan) —Gate P4PLCM-028-01 (Project Requirement Specification) —Gate P4PLCM-035-01 (Marketing Support of Sales) —Gate P4
OperationsPLCM-011-01 (Release to Engineering) —Gate P1
QAPLCM-007-01 (Risk Analysis for Development) —Gate P1PLCM-009-01 (Design Review Document) —Gate P1PLCM-010-01 (DHF) —Gate P1PLCM-012-01 (Design and Development Validation) —Gate P1PLCM-016-01 (Regulatory Submissions) —Gate P1PLCM-022-01 (External Evaluation Release) —Gate P3PLCM-030-01 (CAPA - Corrective and Preventive Action —Gate P5PLCM-036-01 (Design and Development Verification) —Gate P1
R & DPLCM-002-01 (Technical Feasibility) —Gate P0PLCM-006-01 (Product Specification) —Gate P1PLCM-008-01 (Testing Requirements) —Gate P1
PLC Gate DeliverablesAcceptance Criteria .................................... Gate P1Business Case ............................................. Gate P0Business Case ............................................. Gate P1Business Risk Analysis.................................. Gate P0Clinical Trials Final Report........................... Gate P3Clinical Trials Plan....................................... Gate P1Commercialization Plan .............................. Gate P3Customer Service Plan ................................ Gate P3Departmental Feedback.............................. Gate P5EOL Plan .................................................... Gate P6Field Testing Report .................................... Gate P3Preliminary Forecast.................................... Gate P1Pre-Production Plan.................................... Gate P1Product Improvement ................................. Gate P5Product Performance Versus Marketing Req.Gate P1
Product Production Files............................. Gate P2Product Requirement Definition ................. Gate P0Product Risk Analysis .................................. Gate P1Production Capabilities............................... Gate P2Regional Launch Plans ................................ Gate P4Regional Training........................................ Gate P4Registration Status ...................................... Gate P3Registration Submissions Plan ..................... Gate P1Regulatory Approvals .................................. Gate P4Regulatory Strategy ..................................... Gate P0Road Map & Detailed Work Plan................ Gate P1Road Map .................................................. Gate P0Technology Feasibility................................. Gate P0Transition to Alternative Products ............... Gate P6
PLC Gate SOPsPLCM-001-01............................................. Gate P0PLCM-002-01............................................. Gate P0PLCM-003-01............................................. Gate P0PLCM-003-01............................................. Gate P1PLCM-004-01............................................. Gate P0PLCM-004-01............................................. Gate P1PLCM-005-01............................................. Gate P1PLCM-006-01............................................. Gate P1PLCM-007-01............................................. Gate P1PLCM-008-01............................................. Gate P1PLCM-009-01............................................. Gate P1PLCM-010-01............................................. Gate P1PLCM-011-01............................................. Gate P1PLCM-011-01............................................. Gate P2PLCM-012-01............................................. Gate P1PLCM-013-01............................................. Gate P1PLCM-014-01............................................. Gate P1PLCM-015-01............................................. Gate P1PLCM-016-01............................................. Gate P1
PLCM-017-01 ............................................ Gate P3PLCM-018-01 ............................................ Gate P3PLCM-019-01 ............................................ Gate P3PLCM-020-01 ............................................ Gate P4PLCM-021-01 ............................................ Gate P3PLCM-022-01 ............................................ Gate P3PLCM-023-01 ............................................ Gate P3PLCM-023-01 ............................................ Gate P4PLCM-024-01 ............................................ Gate P4PLCM-025-01 ............................................ Gate P3PLCM-026-01 ............................................ Gate P4PLCM-028-01 ............................................ Gate P4PLCM-030-01 ............................................ Gate P5PLCM-031-01 ............................................ Gate P5PLCM-033-01 ............................................ Gate P5PLCM-034-01 ............................................ Gate P6PLCM-035-01 ............................................ Gate P4PLCM-036-01 ............................................ Gate P1