1. Reducing the New
Product Development
Timeline
Kenneth D. Delcol, PEng, PMP
Director, Product Development
MDS SCIEX

2. Agenda
• Introduction
• Changes in Development Philosophy
– Principles
– Governances
– Organizational Behaviour
– Individual Behaviour
• NPI Characteristics
– Speed In Development
– Development Strategy
– Development Approach
• Conclusions

3. Introduction – MDS SCIEX
• Division of MDS Inc
– Largest health & life sciences company in Canada
– 75 countries around the world
• World leadership position in ultra-trace analytical systems
– Impact the quality of life
• New pharmaceuticals
• Disease testing and diagnostics
• Environmental safety
– Biological, chemical pesticides, water and soil contamination
• www.sciex.com

4. Milestones
70’s 80’s 90’s 2000’- 2002 2003+
•TAGA 6000 •Canada •QSTARPulsar •PhotoSpray 2000
•SCIEX
Award for •Analyst QS v1.0 •4000 QTRAP
formed •MDS Business
acquires Excellence •QSTAR Pulsar i •nDCI 4000
•TAGA SCIEX •API III+ •API 4000 •proTOF
000
•ELAN 250 •ELAN 6000 •BioAnalyst v1.0 •API 5000
•TAGA •Canada •API 100 •Elan DRC+ •Analyst 1.4.1
3000 Award for •API 300 •Elan 9000 •Analyst QS v1.1
Business
Excellence •TurboMass •Elan DRC II
•Joint Venture •API 365 •Prep LC II
with Perkin- •API 150 1996 •PhotoSpray 3000
Elmer •Prep LC •QTRAP
•Ontario •API 2000 •QSTAR XL
Technology •DuoSpray
Fund Award - •API 3000
$17M •QSTAR •Elan DRCe
•ELAN 5000 •Analyst v1.0
•API III •ELAN DRC
•ELAN 6100

5. Changes in Development Philosophy
• Development approach was based heavily on
documentation
– End result
• In consistency in delivery results
– Root cause
• Difficult to train new staff
– Documents were too large
– Hard to keep up to date with changing business needs
• Each group had its own interpretation of the development process, all of which were:
– Wrong
– Narrowly focused
– Mixed development process with work instructions
• Lack of understanding of what information was required to run the business
• Mixing project execution needs with business requirements

6. Old Product Introduction
Guiding
Principles
Governance
Business Needs
Gates – Deliverables – Activities
Organizational
Behaviour
Individual
Behaviour

7. New Product Introduction
Guiding
Principles
What? Governance
Business Needs
Gates – Deliverables - Activities
Organizational
How? Behaviour
Individual
Behaviour

8. NPI Guiding Principles
• Foundation: MDS Core Values
– Mutual trust
– Genuine concern and respect for others
– Integrity
– Commitment to excellence
• NPI Guiding Principles
– Disciplined thought and action
– Information driven
– Iterative design & development
– Collaborative team-based

9. NPI Guiding Principles - Detail
• Disciplined thought and action
– Strict adherence to the Governance process and deliverables.
– Clear definition of responsibility for producing the deliverables.
• Information driven
– Manage risk proactively. Risk is reduced through information,
and the iterative planning to generate that information.
– Working quality products are the best measure of progress.
• Iterative design & development
– Design at a system level; think “top-down”.
– Disciplined iterative approach to reduce risk.
• Collaborative team-based
– Collaborative practices are the foundation of effective project team
activities.
– External partners are treated as an extension of the Sciex team.
– Build an environment that is conducive to open, frank discussion.

10. Governance
MDS SCIEX NEW PRODUCT INTRODUCTION PROCESS
VISION:
PRE-CONCEPT OUTPUT/INPUT
“The corner stone of our product development process is the ability to be flexible, adaptive and
ACTIVITIES agile thus allowing a project team to be able to configure the process to meet the needs of the
business unit i.e. sponsor of the project while meeting the needs of the development process.”
NO GO K. Delcol
CONCEPT OUTPUT/INPUT
GATE CONCEPT PHASE
GO
PLANNING OUTPUT/INPUT
GATE PLANNING PHASE
P GO
r
o
NO GO
j
e PROJECT
c SHUT- DESIGN OUTPUT/INPUT
t DOWN NO GO
GATE DESIGN PHASE
S GO
t
a
r
t PROJECT
SHUT-
NO GO PROTO PROTOTYPE OUTPUT/INPUT
DOW N
GATE PHASE
GO
Clear deliverables from each phase -> Gate Requirements PROJECT
SHUT- PILOT OUTPUT/INPUT
DOWN NO GO PILOT PHASE
LEGEND:
Clear champion for each deliverable GATE
GO
Identify “high-level” activities within each phase
Drill-Down Feature
(Double-click)
PROJECT
SHUT- LAUNCH
Primary Process DOWN NO GO
GATE LAUNCH PHASE
Responsibility GO
PROJECT
SHUT-
Return to NPI DOW N OUTPUT
REVISION: 2004 March 26
Process

11. Governance
Concept Phase:
Risk associated with Science, Engineering and Project (vendors, market, customer etc.) must be addressed during this phase.
Critical performance requirements are solidified and recorded. Necessary studies to generate this performance are made;
tolerances and optimizations are studied as well as day-to-day and device-to-device behaviour.
For areas with high risk, engineers conduct studies and demonstrate the feasibility of technological solutions and/or new
developments.
Systems Engineers, Software Architects and Design Engineers concentrate on the creation of system level specifications, system
architectures, physical architectures, sub system specifications and overall system tests.
Project Managers are tracking the progress of concept phase activities and updating the following communications tools: Balanced
Score Card (BSC), resource loading, project schedule, weekly reporting and financial reporting.
2. CONCEPT PHASE
COLLABORATIVE PRACTICES USED
2.1
PHASE STARTUP
ACTIVITIES COMPLETED
2.2
SCOPE DEFINED
2.3
RISK PLAN ISSUED
2.4
SIGNIFICANT RISKS MITIGATED
2.5
PLANNING GATE PREPARATION
COMPLETE
PROJECT SCHEDULE, BUDGET, RISKS AND ISSUES MONITORING, SPECULATION, EXPLORATION AND ADAPTATION. EXISTING DOCUMENTS
UPDATED

12. Governance
CONCEPT PHASE ACTIVITIES QP-7.3 MDS SCIEX "NEW PRODUCT INTRODUCTION" PROCESS REVISION: C
2.1 Phase Startup 2.4 Significant 2.5 Planning Gate
Activities Completed
2.2 Scope Defined 2.3 Risk Plan Issued
Risks Mitigated Preparation Complete
DRAFT OF
SCIENCE PLAN
FUNCTIONAL
REVIEWED AND SCEINCE FEASIBILITY STUDY CONDUCTED
ARCHITECTURE
FINALIZED
PDSA
PREPARED
DRAFT OF PRODUCT
SPECIFICATION
TECHNICAL PLAN DOCUMENT (PSD) DRAFT OF PHYSICAL
REVIEWED AND PREPARED SYSTEM
UPDATED ARCHITECTURE
PREPARED
PRODUCT CONCEPT
DOCUMENT (PCD)
PDM
REVIEWED AND
UPDATED
NO
PROJECT PRODUCT CONCEPT
START-UP DOCUMENT (PCD) PROJECT INTEGRATED
ACTIVITIES REVIEWED AND STRATEGY PROJECT GATE PACKAGE
RISK TABLE AND IP OWNERSHIP UPDATED
PRM
PERFORMED UPDATED CUSTOMER CUSTOMER REVIEWED AND SCHEDULE PREPARED
INVOLVEMENT YES INVOLVEMENT UPDATED PREPARED
PROJECT VISION REQUIRED? CAP PREPARED
COLLABORATIVE DOCUMENT DESIGN PARTNER
PROJECT ISSUES LIST GENERATED POST MORTEM
PRACTICES REVIEWED AND RELATIONSHIPS
CONDUCTED
UPDATED INITIATED
PROJECT TEAM
PROJECT VISION DRAFT OF PRODUCT DRAFT OF PHYSICAL
CUSTOMER PERSONAS SYSTEM ARCHITECTURE PROJECT ISSUES LIST GENERATED
DOCUMENT SPECIFICATION PLANNING PHASE DEVELOPMENT TASKS
REVIEWED AND INVOLVEMENT DEVELOPED PREPARED
DOCUMENT (PSD) CAPS DEVELOPED PERFORMED TO
UPDATED CAP PREPARED
PREPARED FACILITATE PRODUCT
CARS, SCRS, PPS RISK TABLE AND IP OWNERSHIP UPDATED INTRODUCTION AS
PRELIMINARY DESIGN REQUESTS&NCRS REVIEWED& DEFINED IN SCIENCE
CONCEPT DEVELOPED CUSTOMER INSIGHT INCORPORATED WHEN AND PROJECT
TECHNICAL FEASIBILITY STUDY CONDUCTED STRATEGY
PLAN UPDATED APPLICABLE
INTEGRATED
VERIFICATION STRATEGY VALIDATION STRATEGY VALIDATION PLAN
INTEGRATED TEST
TEST
DEVELOPED DEVELOPED DEVELOPED VALIDATION CONDUCTED
STRATEGY DEVELOPED
SW FEASIBILITY
HIGH LEVEL SW
SWD
CRITICAL SW FEASIBILITY REQUIREMENTS AND
ARCHITECTURE
STUDY PERFORMED TECHNOLOGY
CREATED
REVIEWED
DRAFT DOCUMENT
IDV
STRATEGY DEVELOPED
(TWR)
RETURN TO
CONCEPT PHASE
Return to NPI Process

13. Governance
QP-7.3 MDS SCIEX "NEW PRODUCT INTRODUCTION" PROCESS REVISION: C
CONCEPT PHASE OUTPUTS/PLANNING PHASE INPUTS
OUTPUT/INPUT DESCRIPTION CHAMPION CONTRIBUTORS
1 PRODUCT CONCEPT DOCUMENT (PCD) PRM PDM, QA, RES, PDSA, ARG,
MARKETING, ICS/CUS/GSS, MFG, PDV,
Project Team
2 SCIENCE PLAN PDSA RES
3 RISK TABLE PRM Project Team
4 IP OWNERSHIP PRM Legal, RES, ARG, PDSA, Project Team
5 PROJECT VISION DOCUMENT PRM Project Team
6 PROJECT STRATEGY PRM Project Team
7 TECHNICAL PLAN PDSA Project Team
8 COLLABORATIVE PRACTICES CHECKLIST PRM Project Team
9 PROJECT ISSUES LIST PRM Project Team
10 CUSTOMER INSIGHT PLAN CUE Project Team
11 PRELIMINARY DESIGN CONCEPT CAP Owner Project Team
12 PRODUCT SPECIFICATION DOCUMENT (PSD) PDSA (SWD for SW only project) Project Team
13 PHYSICAL SYSTEM ARCHITECTURE PDSA (SWD for SW only project) Project Team
14 FUNCTIONAL ARCHITECTURE PDSA (SWD for SW only project) Project Team
15 SCIENCE &TECHNICAL FEASIBILITY STUDY REPORTS PDSA (SWD for SW only project ) Project Team
16 INTEGRATED PROJECT SCHEDULE PRM Project Team
17 CUSTOMER INVOLVEMENT CAP PRM Project Team
18 PLANNING PHASE CAPS CAP Owner Project Team
19 DOCUMENTATION STRATEGY IDV Project Team
20 PERSONAS CUE PAL, PDM, TWR, PTE, SWD, PDSA
21 INTEGRATED TEST STRATEGY Integrated Test PTE, PAL, RES, SQA, HQA, PDM, PDSA,
Project Team
22 VALIDATION STRATEGY Integrated Test PTE, PAL, RES, SQA, HQA, PDM, PDSA,
Project Team
23 VERIFICATION STRATEGY Integrated Test PAL, RES, SQA, HQA, PDM, PDSA, Project
Team
24 VALIDATION PLAN Integrated Test PTE, PAL, RES, SQA, HQA, PDM, PDSA,
Project Team, Business Unit Product
Marketing
25 CONCEPT VALIDATION REPORT Integrated Test PTE, PAL, RES, SQA, HQA, PDM, PDSA,
Project Team
26 GATE PACKAGE ISSUED PRM Project Team
27 CONCEPT POST MORTEM REPORT PRM Project Team RETURN TO
CONCEPT PHASE
Note: SW project will produce equivalent to outputs listed under #13&14, but can combine and/or name them differently)
Return to NPI Process

14. Governance - Key Characteristics
• Value added activities
– Clearly identify the champion of each activity and output
• Controlled introduction into manufacturing through the Pilot
Phase
• Heavy emphasis on the Planning Phase
– Reduce risk and understand how to deliver the product before
committing to large development expenditures
• Beta process well defined
• Explicitly define pre-concept activities
– Helps in project start up
• Team “Collaborative Practice” activities at every phase
• Stage gate process frames the overall NPI process

15. Organizational Behaviour
• Deliverables are defined by the
Governance process Collaborative Practices
•Collaborative practices form the Project Management Practices
foundation of effective project teams: Technical Practices
•Chartering workshops PDSA
ESD
•Project Vision/Mission RES
MEN
•Working agreements
•Project environment PDM
SWD
•Technical practices are supported by MFG MPE
ITE
disciplined PRM practices.
•Technical practices to produce the
Governance deliverables are …
•Functionally driven
•Tailored to meet specific needs of project
and product

16. Collaborative Practice
• Create a clear vision of the product
• Develop project scope, boundaries, & initial iterative
plan
• Provide information for concept gate presentation
• Building our Project Community (cohesion, roles,
responsibilities,energize,)
• Create required project documentation
• Introduce the use of collaborative & agile practices

17. Collaborative Practice Objectives
Build Project
Community
Create Shared
Understanding
Deliver Project
Content (PM &
Technical)

18. Individual Behaviour
Knowing the tools is n o longer enough…
We need people who …
collaborate lead solve problems
effectively and proactively communicate
achieve results
…in a way that shows…
innovation flexibility
professionalism
integrity
…and who do these things because…
they see the big picture they have a broad
perspective
they are motivated
they want to learn and grow
Success at MDS Sciex will require these aptitudes and the knowledge
and background necessary for the position.
We will not compromise on these qualities when looking for new
employees.
We will gladly train the right people in our tools, technology, and
processes.

19. NPI Characteristics
• Speed in development
• Development strategy
• Development approach
– Partnerships
– People
– Innovation
– Advance Development Tools

20. Speed In
Development
• Focused cross functional project teams
• Active bridging functions between
– Research to Product Development
– Product Development to Manufacturing
– Integrated Product Test Group
– Portfolio Management
• Professional Project Management

21. Speed In Development
• Emphasis on core engineering practices
– Top down design, specifications, standards -
internal/external, systems engineering
– Up front planning, design working first on paper
– DFMA, tolerance stack up, reliability calculations, QFD,
post mortems, personas, OOA, OOD, eXtreme
Programming
– Managing areas of risk through
• Early testing, analysis, bread-boarding, parallel development, collaboration and
use of field experts
– Meeting most demanding standards for product design
• ISO 9001, ISO 9000-3 Tickit
• CSA, IEC 1010
• CFR21 Part 11

22. Development Strategy
• Multiple delivery approaches
– Evolving products
• Extending platforms by only modifying what is truly required [what
adds value to the customer] vs big bang development
• Ensure the science is understood to avoid feasibility issues during
design
• Respond to the market quicker and obtain feedback in a timely
manner
– Delivering on discontinuities in technology and
science
• Discipline management of development
– Product Stage Gating
– Product Strategy Maps
– Project Dashboards

23. Development Strategy
EVOLVING
PRODUCTS
SCOPE /
RISK
THE
BIG
BANG
TIME IN YEARS

24. High End Triple Quadrupole
API 5000
SCOPE /
RISK
API 4000
API 3000, NT
API 3000, Mac
API 365
API 300
TIME

25. Development Approach
• Partnerships
– World Wide
– Suppliers/Vendors
– Contractors
– Joint Ventures
• Emphasis on people
– Ownership and Responsibility
– Collaboration
– Development
• Training
• Two tiered career paths
• Giving opportunities to develop new and expand existing capabilities

26. Development Approach
• Emphasis on innovation
– Tools and training
– Seminars
– Application of principles to our work
– External partnerships
• Advanced Development Tools
– MS Project
– CATIA V5
– View Logic
– MS Development Tools
– FrameMaker
– Matrix One
– Collaboration tools – WebEx, CipherShare, Project Web sites
– Software Metrics Tools

27. Conclusion
• NPI consists of four major elements
– Philosophy
– Governance
– Organizational Behaviour
– Individual Behaviour
• Most organizations fail to distinguish between the four major
elements of NPI process
– Leads to confusing documentation and inconsistency in performance
• NPI Process that is built for speed needs
– Bridging groups to help in product transfers
– Discipline engineering practices
– Strategy to development products
– People
– Partnerships
– Advance tools