Reducing the New Product Development

Timeline

Kenneth D. Delcol, PEng, PMP

Director, Product Development

MDS SCIEX 

AgendaAgenda

• Introduction• Changes in Development Philosophy

– Principles– Governances– Organizational Behaviour– Individual Behaviour

• NPI Characteristics– Speed In Development– Development Strategy– Development Approach

• Conclusions

Introduction – MDS Introduction – MDS SCIEXSCIEX

• 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

MilestonesMilestones70’s

•SCIEX formed

•TAGA 000

•TAGA 3000

80’s

•TAGA 6000

•MDS acquires SCIEX

•ELAN 250

•Canada Award for Business Excellence

•Joint Venture with Perkin-Elmer

•Ontario Technology Fund Award - $17M

•ELAN 5000

•API III

2000’- 2002•QSTARPulsar

•Analyst QS v1.0

•QSTAR Pulsar i

•API 4000

•BioAnalyst v1.0

•Elan DRC+

•Elan 9000

•Elan DRC II

•Prep LC II

•PhotoSpray 3000

•QTRAP

•QSTAR XL

•DuoSpray

•Elan DRCe

90’s•Canada Award for Business Excellence•API III+•ELAN 6000•API 100•API 300•TurboMass•API 365•API 150•Prep LC •API 2000•API 3000•QSTAR•Analyst v1.0•ELAN DRC•ELAN 6100

1996

2003+•PhotoSpray 2000

•4000 QTRAP

•nDCI 4000

•proTOF

•API 5000

•Analyst 1.4.1

•Analyst QS v1.1

Changes in Development Changes in Development PhilosophyPhilosophy

• 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

Old Product IntroductionOld Product Introduction

GovernanceBusiness Needs

Gates – Deliverables – Activities

OrganizationalBehaviour

GuidingPrinciples

IndividualBehaviour

OrganizationalBehaviourHow?

New Product IntroductionNew Product Introduction

GuidingPrinciples

IndividualBehaviour

GovernanceBusiness Needs

Gates – Deliverables - Activities

What?

NPI Guiding PrinciplesNPI 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

NPI Guiding Principles - DetailNPI 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.

GovernanceGovernance MDS SCIEX NEW PRODUCT INTRODUCTION PROCESS

PRE-CONCEPTACTIVITIES

CONCEPTGATE CONCEPT PHASE

PLANNINGGATE PLANNING PHASE

DESIGNGATE DESIGN PHASE

PROTOGATE

PROTOTYPEPHASE

PILOTGATE PILOT PHASE

LAUNCHGATE LAUNCH PHASE

OUTPUT/INPUT

OUTPUT/INPUT

OUTPUT/INPUT

OUTPUT/INPUT

OUTPUT/INPUT

OUTPUT/INPUT

OUTPUT

NO GO

NO GO

NO GO

NO GO

NO GO

NO GO

PROJECTSHUT-DOWN

PROJECTSHUT-DOWN

PROJECTSHUT-DOWN

PROJECTSHUT-DOWN

GO

GO

LEGEND:Drill-Down Feature

(Double-click)

VISION:

“The corner stone of our product development process is the ability to be flexible, adaptive and 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.”

K. Delcol

Primary ProcessResponsibility

GO

GO

GO

GO

REVISION: 2004 March 26

PROJECTSHUT-DOWN

Project

Start

Return to NPIProcess

Clear deliverables from each phase -> Gate Requirements

Clear champion for each deliverable

Identify “high-level” activities within each phase

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 newdevelopments.

Systems Engineers, Software Architects and Design Engineers concentrate on the creation of system level specifications, systemarchitectures, 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: BalancedScore Card (BSC), resource loading, project schedule, weekly reporting and financial reporting.

2. CONCEPT PHASE

2.1PHASE STARTUP

ACTIVITIES COMPLETED

2.2SCOPE DEFINED

2.3RISK PLAN ISSUED

2.4SIGNIFICANT RISKS MITIGATED

2.5PLANNING GATE PREPARATION

COMPLETE

COLLABORATIVE PRACTICES USED

PROJECT SCHEDULE, BUDGET, RISKS AND ISSUES MONITORING, SPECULATION, EXPLORATION AND ADAPTATION. EXISTING DOCUMENTSUPDATED

GovernanceGovernance

CONCEPT PHASE ACTIVITIES QP-7.3 MDS SCIEX "NEW PRODUCT INTRODUCTION" PROCESS REVISION: C

2.1 Phase StartupActivities Completed

2.5 Planning GatePreparation Complete

2.3 Risk Plan Issued2.2 Scope Defined2.4 Significant

Risks Mitigated

IDV

SW

DIN

TE

GR

AT

ED

TE

ST

PR

OJE

CT

TE

AM

PR

MP

DM

PD

SA

YES

NO

PROJECT VISIONDOCUMENT

REVIEWED ANDUPDATED

RISK TABLE AND IP OWNERSHIP UPDATED

PERSONASDEVELOPED

CUSTOMERINVOLVEMENT

REQUIRED?

DEVELOPMENT TASKSPERFORMED TO

FACILITATE PRODUCTINTRODUCTION AS

DEFINED IN SCIENCEAND PROJECT

STRATEGY

PROJECT ISSUES LIST GENERATED

CARS, SCRS, PPSREQUESTS&NCRS REVIEWED&

INCORPORATED WHENAPPLICABLE

TECHNICAL PLANREVIEWED AND

UPDATED

PROJECT ISSUES LIST GENERATED

SCEINCE FEASIBILITY STUDY CONDUCTED

CUSTOMERINVOLVEMENT

CAP PREPARED

GATE PACKAGEPREPARED

DRAFT OF PHYSICALSYSTEM ARCHITECTURE

PREPARED

INTEGRATED TESTSTRATEGY DEVELOPED

VALIDATION STRATEGYDEVELOPED

DESIGN PARTNERRELATIONSHIPS

INITIATED

POST MORTEMCONDUCTED

DRAFT DOCUMENTSTRATEGY DEVELOPED

(TWR)

VERIFICATION STRATEGYDEVELOPED

DRAFT OF PHYSICALSYSTEM

ARCHITECTUREPREPARED

SW FEASIBILITYREQUIREMENTS AND

TECHNOLOGYREVIEWED

HIGH LEVEL SWARCHITECTURE

CREATED

PRODUCT CONCEPTDOCUMENT (PCD)REVIEWED AND

UPDATED

CUSTOMER INSIGHTPLAN UPDATED

CUSTOMERINVOLVEMENT

CAP PREPARED

CRITICAL SW FEASIBILITYSTUDY PERFORMED

DRAFT OFFUNCTIONAL

ARCHITECTUREPREPARED

PRODUCT CONCEPTDOCUMENT (PCD)REVIEWED AND

UPDATED

RISK TABLE AND IP OWNERSHIP UPDATED

DRAFT OF PRODUCTSPECIFICATION

DOCUMENT (PSD)PREPARED

PROJECTSTRATEGY

REVIEWED ANDUPDATED

PRELIMINARY DESIGNCONCEPT DEVELOPED

PROJECT VISIONDOCUMENT

REVIEWED ANDUPDATED

INTEGRATEDPROJECT

SCHEDULEPREPARED

PROJECTSTART-UPACTIVITIES

PERFORMED

SCIENCE PLANREVIEWED AND

FINALIZED

DRAFT OF PRODUCTSPECIFICATION

DOCUMENT (PSD)PREPARED

Return to NPI Process

COLLABORATIVEPRACTICES

RETURN TOCONCEPT PHASE

VALIDATION PLANDEVELOPED VALIDATION CONDUCTED

TECHNICAL FEASIBILITY STUDY CONDUCTED

PLANNING PHASECAPS DEVELOPED

GovernanceGovernance

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 Note: SW project will produce equivalent to outputs listed under #13&14, but can combine and/or name them differently)

Return to NPI Process

QP-7.3 MDS SCIEX "NEW PRODUCT INTRODUCTION" PROCESS REVISION: C

RETURN TOCONCEPT PHASE

GovernanceGovernance

Governance - Key Governance - Key CharacteristicsCharacteristics • 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

Organizational BehaviourOrganizational Behaviour

Collaborative Practices

Project Management Practices

PDM

MPEITE

SWD

MEN

ESDPDSA

RES

MFG

Technical Practices

• Deliverables are defined by the Governance process

•Collaborative practices form the foundation of effective project teams:

•Chartering workshops•Project Vision/Mission•Working agreements•Project environment

•Technical practices are supported by disciplined PRM practices.

•Technical practices to produce the Governance deliverables are …

•Functionally driven•Tailored to meet specific needs of project and product

Collaborative PracticeCollaborative 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

Collaborative PracticeCollaborative Practice

ObjectivesObjectives

Build Project Community

Deliver Project Content (PM &

Technical)

Create Shared Understanding

Individual BehaviourIndividual BehaviourKnowing the tools is no 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.

NPI CharacteristicsNPI Characteristics

• Speed in development• Development strategy• Development approach

– Partnerships– People– Innovation– Advance Development Tools

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• Introduction of Systems Engineer

Speed In DevelopmentSpeed 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

Development StrategyDevelopment 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

Development StrategyDevelopment Strategy

THEBIGBANG

TIME IN YEARS

SCOPE /RISK

EVOLVINGPRODUCTS

API 5000

High End Triple High End Triple QuadrupoleQuadrupole

TIME

SCOPE /RISK

API 365

API 3000, Mac

API 3000, NT

API 4000

API 300

Development ApproachDevelopment 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

Development ApproachDevelopment 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

ConclusionConclusion

• 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