plm rev5 innovation 2012

David G. Sherburne Carestream Health Inc.

Global New Product Commercialization

Product Lifecycle Management Implementing Successful Transformational Change

David G. SherburneDirector

Global R&D Effectiveness

And Engineering IT

(and PLM simple license model advocate)


Topic Outline- The PLM Journey

• Snapshot of Carestream• Globalization –The forcing

function• Insights for setting up a

successful transformation• Carestream Case Study

Take- A – Ways

•When to consider an upgrade to a PLM system

•Forming a PLM project and choosing partners

•Benchmark data for estimation purposes

•Another PLM friend for your network


An independent company with a proven track record and $2.5 billion in revenue

A world leader in:• Medical imaging … digital and film

• Healthcare information solutions

• Dental imaging and dental practice management software

• Molecular imaging

• Non-destructive testing

Carestream Health – Who We Are


Manufacturing

R&D

Both Manufacturing and R&D

Oakdale, Minnesota

Shanghai, China

Windsor, Colorado

White City, Oregon

Rochester, New York

Yokneam, Israel

Ra’anana, Israel

Baltimore, Maryland

Atlanta, Georgia

Woodbridge, Connecticut

Toulouse, France

Paris, France

Xiamen,China

London, United Kingdom

Berlin, Germany

Guadalajara, Mexico

A global company with Manufacturing and R&D locations around the world

Global R&D and Manufacturing


Globalization was required to meet the business needs of our company

• Desired access to global talent

• Needed a balanced cost structure

• Presence in emerging markets

Impact of Globalization

• Collaboration became more time consuming via e-mail, uncontrolled data sharing with partners

• Complexity in the organization increased as projects globalized

• Knowledge-workers’ time was drained, impacting innovation

• Productivity of NPD remained roughly flat

The Business Challenges

David G. Sherburne Carestream Health Inc.04/10/23

Non- Standard Commercialization Process

Product Service Information – Processes and Tools

Product Manufacturing Information – Processes and Tools

Product Design Information – Processes and Tools

Project Information – Processes and Tools

Site A

Site B

Site C

FDA - DHF

FDA - DMR

FDA - DHR

FDA - QS

Gen

eral

flow

of p

rodu

ct in

form

atio

nGaps between blocks represent inefficient manual sharing of information.

Innovative people innovate many local processes.

Local resources focus onproduct families

Complexity increased as work required flow between sites.


EnterpriseEnterprisePDMPDMAuthoringAuthoring

Point Solutions worked but lacked proper architecture to enable global productivity

MCAD Tools

NXNX

Pro/EPro/E

SolidWorksSolidWorks

AutoCADAutoCAD

ECAD Tools

Mentor DXMentor DX

CadenceCadence

OrCADOrCAD

AltiumAltium

Software AuthoringDesktop

Tools(Browser, MSOffice,

etc)

Desktop Tools

(Browser, MSOffice,

etc)

EE File Shares,library cache

MQDS

SAP

Lotus Notes DB

CAPACAPA

SOPSOP

DADAMMRMMR

Lotus Domino

DocManager

DocManager

Version Control Tools

DOORS Requirements Management Tools

DOORS Requirements Management Tools

ClearcaseClearcase

Subversion

SubversionPVCSPVCS

StarTeamStarTeam

ClearQuestClearQuestDefectsDefects

Enhancement RequestsEnhancement Requests

BOM

Electrical Part Data,

RoHS

Part

DataCAD Files

PDF’s

Quality Center

External Systems

Standalone

Systems

Manual Integration

Automated Integration

Information Flow

No Integration

No Integration

No Integratio

n

No Integratio

n

No Integrat

ion

No Integrat

ion

No IntegrationNo Integration

MS Project

Team Room

CAPACAPACAPACAPA

Confluence

Excel

Sys 9KSys 9KRoHS, DoC,

MSDS (no

home)

RoHS, DoC,

MSDS (no

home)

CAD Files PDFs

CIDxCIDx

IntralinksIntralinks

Teamcenter

Teamcenter

File Shares

File Shares

EQDSEQDS

CQuest

No Integratio

n

No Integratio

n

No Integratio

n

No Integratio

n

No Integrati

on

No Integrati

on

Problem was caused by an “IT Cost Center” mentality and non- coordinated local efforts


• Quality and Compliance must be maintained in our business

• Project teams are split across several locations

• Platform development adds complexity

• Iterative methods required faster information transfer

• Faster prototyping cycles are needed for hardware

• Design for manufacturability and supplier IP capture are critical as ties to the supplier base weaken

• Access to historical data is needed to improve planning, compare reliability, and drive improvements to the development cycles

• Engineers are required to do deeper analysis to ensure product quality

• Requests for metrics are ever increasing and are difficult to produce

• Disjointed IT and Non-Standard process environment kills collaboration

Demands on Workers are Ever Increasing


Holistic PLM Approach- Its not just a simple arrow anymore

People were Co-located and Focused

Global Leadership

Focused Organization

Vision

Strategy

Awareness

Leading multi-Cultural Change

Technology

Solid Partners

Global Applications

Architecture

Solid Infrastructure

Master Data

People

Change Management

Communications

Complete Team

Process

Balanced

Closed Loop

Standard

Inclusive

End to end integrated

1990s PLM was technology driven, supporting local needs

Global andDistributed Environment

Today PLM must improve organizational performance


CTO Office CIO Office

Director R&D Effectiveness

David Sherburne

Alignment with IT• Ensured scalability• Architectural focus and alignment• Improved on-going services• Leveraged strengths of both groups

Vertical Business Structure • Stakeholders• Subject Matter Experts• Middle Managers• Finance

Alignment with R&D and Manufacturing •Allowed focus on business knowledge and needs•Focused time to support initiative•Home for continuous improvement

Leadership Governance


Technology Partner Selection

Examined our business objectives and the capabilities we were lacking

Examined market options for both the application platform and implementation services

Started evaluation process early to learn partners’ depth and long-term approach

Emphasized building relationships

Contracted the implementation partner to help make the final application selection

Used a rigorous evaluation process against the high-level functional AND businesses requirements


Partner Selection Model – Give Yourself Time

Business Objectives

ID Capabilities Missing

ROI of New Capabilities

Strategies to Obtain Capabilities

Business Requirements

Write Key Use Cases

Final Selection of Partners

Request for Information Request for Quote

Time ~ 9 months 1½ FTEs

Look for a strategic relationship Share in risk Offer flexible terms in line with

business ROI Remain a partner during

implementation Keep costs in line with benefits


License Models Proposed During Process

Models Proposed

• Named User

• Module Based

• Business User or Engineering User

• Geographic Location Based

• Enterprise – Based on Revenue

• Subscription – Based on Total Users

• Open Source

• No Concurrent User Models Offered

Many License Models

•Discourage access to data…

•Are costly to pilot functionality

•Front load cost and risk

•Complex and difficult to predict total capital costs

•Place crazy price tags on document management and simple workflow

•Tanked the ROI

•Cause crazy behaviors

•Are the gifts that keep on giving…Right PeopleRight InformationRight System Right Time


Partner Selection Process Benefits

Allowed us to refine the requested information and expectations over a period of three cycles with suppliers

Drove internal understanding, maturity of estimates, and costs through the first two cycles giving credibility to the project with senior managers

Eliminated suppliers fairly and in stages and maximized the understanding, along the way, of the finalists

Candidates left in the last cycle deeply understood our functional requirements, business drivers, and expectations

Process obtained the best balance of functionality, risk, and cost to our company


Technology Architectural Elements

• Complete view of New Product Development “building blocks”

• Appreciation of the complexity in the “Layers”

• Business Process Focus and Balance

• Application Architectural orientation and familiarity with industry technology


Product P

lanning Definition

PLM – Product Life Cycle Management Platform

PDM – Data Management for Hardware

ALM – Data Management for Software

Hardware Design Authoring – CAD-ME,EE

Software Design – Authoring IDE

Project M

anagement - P

CP

Quality D

ata Managem

ent

Portfolio – Dashboards, Metrics, Web Channels

Portfolio

Managem

ent

Manufacture and S

ustain

Service D

elivery, Pubs,T

raining

ideas

ideas

ideas

ideas

ideas

SU

PP

OR

TA

BL

E

SU

PP

OR

TA

BL

E

PR

OD

UC

TS

PR

OD

UC

TS

BOLD = Industry Term

Integration of Applications and Master Data StrategyCore

Complete View – Understanding the Building Blocks


Business Process Layer – Standard Workflow and Responsibilities(Engineering Change Control, Production Release Process,

Supplier Quote Process, Defect Management Process)

Application Layer –

Aras Innovator, Teamcenter, Doors, Clearquest, and Clearcase

IT Infrastructure Layer – Networks, Servers, Databases, Storage, Back-Up, Archive

Presentation Layer – Web Channels internal and external;Social, Dashboards, Business Intelligence Increasing A

rchitectural Maturity

Business P

rocess Maturity IT

Maturity

Increase Organizational Maturity + Architectural Awareness = Success

Data Layer –

System of Record for Master Data, Attributes, Field Mapping to Metrics, Clean-Up

Appreciated the Complexity in Each “Architectural Block”


MCAD Tools

Knowledge Sharing, Social Nets, and Webchannel

Desktop Enterprise SystemsEnterprise Systems

Supplier 1Supplier 1

Supplier 3Supplier 3

ECAD Tools

ECAD 1

ECAD 2

ECAD 3

Integrated As Built Master

Data

Raw Material Master

SW Project Management, Dashboards

(Rally)

SW Project Management, Dashboards

(Rally)

KM Platform

KM Platform

PLM Aras InnovatorClosed Loop Engineering Change Management (HW/SW)Event Tracking and Defect MgmtCAPA ManagementAudit ManagementSupplier Access/ DFM InputSupplier Quote ECAD, MCAD PDM Integrations EBOM, MBOM ManagementCosting Commercial Parts LibraryRoHASRequirements Change ControlISDE Integration for SW events

PLM Aras InnovatorClosed Loop Engineering Change Management (HW/SW)Event Tracking and Defect MgmtCAPA ManagementAudit ManagementSupplier Access/ DFM InputSupplier Quote ECAD, MCAD PDM Integrations EBOM, MBOM ManagementCosting Commercial Parts LibraryRoHASRequirements Change ControlISDE Integration for SW events

SW CM – SVN

SW CM – SVN

Build Tools and Services

Test ScriptingBuild Configuration

Management

RQMTS

PDM Upgrade

End of Life

Established

Standard

Established

Standard

LN DBs

MS Visual Studio

MS Visual Studio

XCODE, Other Key

IDEs

XCODE, Other Key

IDEs

SW Authoring

Office, ProjectOffice, Project

Au

thori

ng

Syste

ms

New Platform

No Standar

d

PDM

SAPSAP

Some Integratio

n

Quality Platform(HPQC)

Quality Platform(HPQC)

Dashboards – Metrics

Manufacturing TransferManufacturing Transfer

Testing

HW

Emerging

Standard2012

Proposal

Purchase Portals –

ECoutlookSmart source-

Ebid

Purchase Portals –

ECoutlookSmart source-

Ebid

ISDE Core

New Modeling

Integrated SW Development Environment- SW Environment)

Supplier 2

Webchannel/ Social

Development

Architectural Orientation and Strategic Planning Ability


Key Points

Drives deeper “use-case” discussions

Refines functional requirement understanding

Concentrates people on future state and consistency vs. current state, holding on to today

Swim Lanes are organization independent

Focuses training development on process not button clicks

Focuses test plans for validation on key workflow performance

Business Process Focus – Low-Level Architecture Swim Lanes

David G. Sherburne Carestream Health Inc.04/10/23

Global Standard Commercialization Process (future)

Eliminates barriers to internal sharing of resourcesFDA - DHF

FDA - DMR

FDA - DHR

FDA - QS

Product Service Information – Processes and Tools

Product Manufacturing Information – Processes and Tools

Product Design Information – Processes and Tools

Project Information – Processes and Tools

Site A

Site B

Site C

Gen

eral

flow

of p

rodu

ct in

form

atio

n

Improves enterprise collaboration effectiveness

PLM Initiative processes cut across many

functional areas & sites

Enables Metrics and Reporting

Reduces organizational complexitySets up foundation for

continuous improvements

Knowledge workers focus on innovation not communication


Carefully ArchitectedBusiness Process

Research and Development

Manufacturing and Regulatory

Manage for fast idea cycles

Manage for repeatability and consistency

Understand Process Balance to Increase Productivity


Process-Based Training

• Technology and process are complex; skimping on training leads to inefficiency and slow adoption

• Training helps change the culture

• Train in the context of standard business process – not technology “button clicks”

• Carefully identify the roles that require training and target information

• Evaluate self-paced training,it’s the hardest to deliver, but it’s most flexible for users


Complete Teams = Successful PLM Results

Business Processand

Metrics Development

Technology Partners

&Application Architecture

IT Architecture,Master Data

Cleaning and Migration

Coding and Configuration

Skills for implementation All skills are

critical and equal for success


• Open Source and Aras Innovator Platform

• Scope and Scale of Phase One

• Benchmark with Industry Expert

• Findings Summary

Carestream Case Study


• Cost model allowed global scale that’s not tied to modules, geographic locations, or named users – key to ubiquitous internal and external access

• Flexible architecture enabled rapid development – 50% easier than other platforms to configure

• Upgrades… Guaranteed…

• Open access to ALL data elements

• Good Technical Partnership – Anti-virus performance, e-Signature Help, Visualization strategy

• Some risk (early adopter) but balanced with higher value

• Community development concept, which we are beginning to leverage

• Single company provides the Aras Core – it’s not traditional “Open Source”

“A”ras Innovator = “A”ttitude & “A”dvantages


Global Standard Business ProcessesDefect ManagementOverall Engineering Change-Mgmt-Closed Loop

Engineering Change Request (ECR)Engineering Change Notice (ECN) Deviation AuthorizationEngineering Change Implementation (ECI, MBOM)

Design Parts ReleaseMBOM/EBOM Mgmt

Across 4 Major SitesRochester (DCS, HCIS)Oakdale (DO)Woodbridge (CMI)Shanghai (DCS, DO, CMI, Rayco)+ 11 additional Global Sites for CAPA & AMS

Requiring Involvement of ~75 Subject Matter Experts

Uniting Many Point SolutionsClosed loop Engineering Change (One Example)

Defects – ClearQuest (1300 users)ECR – Spreadsheet, ManualECN – EQDS Retired (450 users)ECI – Spreadsheet Manual, SAP Integrated

Package Parts Mgmt.Commercial Parts Mgmt.CAPA Mgmt.Audit MgmtSupplier CollaborationProduct/Team Mgmt.Feature Function Request Mgmt.

PLI Provides the Foundation for Future Process Standardization

Dropped from Phase 1

Case Study Goal, Phase 1 – Implement a Global PLM that delivers:


Baseline Comparisons

Industry Expert (Typical PLM) Carestream PLI- ARAS

Schedule (Implement & Deploy) 18-24 months 19 months deliver features 24 months stabilized deploy

Implementation Cost $4000/user $3300/user

Maintenance Cost $360/user $300>$165>*$75Functionality for a Phase 1 Engineering Change

Configuration/Revision ControlBOM Management

Supplier CollaborationProduct/Portfolio Management

Closed-Loop Engineering ChangeConfiguration/Revision Control

BOM ManagementDeviation Authorization

Product Defect ManagementAudit Management

SAP Integration

# of Sites for Deployment 3 4 Development Sites

Internal Resources to coordinate (in addition to implementation)

5.5 FTE 5.5 FTE

Subject Matter Involvement 60 75

Key Points• User = Core engineering process worker that contributes to Part Creations, BOM management, Engineering Change• Solutions for medical device companies take longer that average to implement, as more effort is required to meet

regulatory requirements for Part 11 – verification and validation.• Most PLM solutions typically require configuration/customization, as the OOB solutions do not fully meet the business

needs• Aras architecture is impressive, flexible and modular, which is more cost effective and scalable, but will take more

effort to implement

*When suppliers access the system >$75/user


Strategic Take Away

Globalization without standardization will lead to reduced innovation time and flat productivity

PLM Implementations require a holistic approach that includes;

•Global Leadership – Leadership Organization•People and Change Management•Standard Processes Development •Standard Technology and Applications

Cost center IT mentality delivers local proliferation of point solutions and little enterprise architecture


Practical Take Away• Carefully craft a balanced team

• Set project governance, know key decisions and set decision rights formally

• Know your critical mass (how much work your team can handle) and match that with implementation partner’s speed and capacity

• Ensure business-process work leads and functional requirements follow

• Take work in small chunks (AGILE development methods work well here)

• Turn user interface prototypes early, fast, and review the implementation approach

• Work process in parallel with master data modeling and data migration

• Train in context of the business process not in the context of the tool

• Get involvement of SMEs early and often. Cover all disciplines and phases of the lifecycle

• Balance “cowboy process” in support of early innovation with regulatory and manufacturing structure required later

• Prioritize architecture and code reviews to avoid a poor code base due to rapid cycles and possible turn over of developers

• Verify and validate functionality using business-process diagrams as the basis


PLM is a complex journey that requires discussion

• Strategic Approach

• Architecture

• Benchmarking

• Implementation

• Process and Data Knowledge

Willing to talk more about PLM…?


Contact Information

David G. Sherburne – Director of Global R&D Effectiveness

Linked in:

http://www.linkedin.com/in/davidsherburne

Email

[email protected]

[email protected]

Twitter

@dgsherburne