David G. Sherburne Director Global R&D Effectiveness And Engineering IT Director

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 Director

(and PLM simple license model advocate)


Topic Outline- The PLM Journey• Snapshot of Carestream Health Inc.• Globalization –The forcing function• Insights for setting up a successful

transformation• Case Study

Take- A – Ways•When to consider an upgrade to a PLM system

•Considerations when 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


Who We Are

Approximately 7,300 employees serve customers in more than 150 countries worldwide.

We hold more than 1,000 patents for technology and intellectual property.

Our products are at work in 90 percent of hospitals worldwide.


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

Who We Are


Globalization was required to meet the business needs of our company• Needed a balanced cost structure

• Desired access to global talent pools

• Required deeper understanding of emerging markets

Hurdles to effective globalization• Legacy systems were outdated and not easily

scalable

• Lack of adequate IT investment resulted in proliferation of non-integrated point solutions

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

• IT Infrastructure and networks were performing poorly in some parts of the world

• Complexity in the organization increased as projects globalized

• Knowledge-workers’ time was being drained, impacting innovation

• Productivity of NPD remained roughly flat

The Business Challenge

David G. Sherburne Carestream Health Inc.04/22/23

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

nIf work flows between sites then the gaps between blocks represent inefficient manual sharing of information.

Innovative people innovate many local processes.

Works alright if sites are focused on product families and are co-located.


EnterprisePDMAuthoring

Point Solutions lacked proper architecture to enable global productivity

MCAD Tools

NX

Pro/E

SolidWorks

AutoCAD

ECAD ToolsMentor DXCadenceOrCADAltium

Software AuthoringDesktop

Tools(Browser, MSOffice,

etc)

EE File Shares,library cache

MQDS

SAP

Lotus Notes DB

CAPASOP

DA MMR

Lotus Domino

DocManager

Version Control Tools

DOORS Requirements Management Tools

ClearcaseSubversi

onPVCSStarTeam

ClearQuestDefects

Enhancement Requests

BOM

Electrical Part Data,

RoHS

Part

DataCAD Files

PDF’s

Quality Center

External Systems

Standalone

Systems

Manual IntegrationAutomated Integration

Information Flow

No Integration

No Integratio

n

No Integrat

ion

No Integration

MS Project

Team Room

CAPACAPA

Confluence

Excel

Sys 9K RoHS, DoC,

MSDS (no

home)

CAD Files PDFs

CIDx

Intralinks

Teamcenter

File Shares

EQDS

CQuest

No Integratio

n

No Integratio

n

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 being split across several locations

• Platform development added complexity in software and hardware

• Iterative methods required faster information transfer

• Daily/Weekly software build cycles are an expectation

• Faster cycles are required for prototyping hardware

• Design for manufacturability and IP capture is key as ties to supplier base become weaker

• Teams must leverage historical data to improve planning, compare reliability, and drive improvements to the development cycles

• Engineers are required to do deeper analysis to ensure product quality while coordinating many sources of information

• 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

David G. Sherburne Carestream Health Inc.04/22/23

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 complexity

Sets up foundation for continuous improvements

Knowledge workers can focus on innovation


Holistic PLM Approach- Its not just a simple arrow anymore

People were Co-located and Focused

Global Leadership Vision

Strategy

Awareness

Leading multi-Cultural Change

TechnologyGlobal Applications

Architecture

Infrastructure

Master Data

PeopleChange Management

Communications

ProcessClosed Loop

Standard

Inclusive

End to end integrated

1990s PLM was technology driven, supporting local needs

Global andDistributed Environment

Today PLM must improve organizational performance


What Our future Success Required• A Leadership Organization stepping up to create

awareness, develop strategy, provide governance, and drive change

• Solid partner selection process and deep understanding of the business needs that would provide a ROI

• Architectural awareness and maturity- Process, Data, and Tools

• Structure to set the stage for communicating the transformation


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


Approach to Partner SelectionExamined 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 – fully disclosing our approach and stages of elimination

Contracted the leading 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 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


APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR

High-Level Requirements Development

RFP Issued and Refined

RFP Review

First-Cut Decision

ROI Analysis

Application Supplier Capability Analysis

Second-Cut Decision & RFQ Issued

RFQ Analysis

Supplier Selection

Project Start

Request for Proposal (RFP) issued to five (5) application suppliers and three (3) independent implementers

Application suppliers reduced to three (3)

Independent implementers reduced to two (2)

Application suppliers reduced to two (2)

Independent implementer reduced to one (1)

Request for Quote (RFQ) issued

Application supplier selected

2009 2010

Paid leading independent implementer to aid ROI and application evaluations

Implementerselected

Made short list

• Current Relationship

• Uniqueness in Industry

• Quadrant

• PDM History

• Current Assets

Partner Selection Process – Give Yourself Time


Partner Selection Process BenefitsAllowed us to refine the requested information and expectations

over a period of three cycles with suppliers

Drove 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

Determined that third-party implementers offered a broader view of options available and were our best consultants

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


Key Elements of an Enterprise Transformation Initiative

• Complete view of New Product Development “building blocks”

• Appreciation of the complexity in the “Architecture Layers”

• Business Process Focus and Balance

• Application Architectural orientation and familiarity with industry technology

• Training developed in the context of standard process

• Complete teams designed and supported for success


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,Training

ideas

ideas

ideas

ideas

ideas

SUPPO

RTA

BLE

SUPPO

RTA

BLE

PRO

DU

CTS

PRO

DU

CTS

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 M

aturity

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”


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


Carefully ArchitectedBusiness Process

Research and Development

Manufacturing and Regulatory

Manage for fast idea cycles

Manage for repeatability and consistency

Understand Process Balance & Increase Productivity


MCAD Tools

Knowledge Sharing, Social Nets, and Webchannel

Desktop Enterprise Systems

Supplier 1

Supplier 3

ECAD ToolsECAD 1

ECAD 2

ECAD 3

Integrated As Built Master

Data

Raw Material Master

SW Project Management, Dashboards

(Rally)

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

SW CM – SVN

Build Tools and Services

Test ScriptingBuild Configuration

Management

RQMTS

PDM Upgrade

End of Life

Established

Standard

LN DBs

MS Visual StudioXCODE,

Other Key IDEs

SW Authoring

Office, Project

Aut

hori

ng S

yste

ms

New Platform

No Standar

d

PDM

SAP

Some Integratio

n

Quality Platform(HPQC)

Dashboards – Metrics

Manufacturing Transfer

Testing

HW

Emerging

Standard2012

Proposal

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


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


• Final Selection of Partners

• Open Source and Aras Innovator Platform

• Scope and Scale of Phase One

• Benchmark with Industry Expert

• Findings Summary

Carestream Case Study


Final Partner Selection and Solution Aras Innovator™– Determined to be our best choice for the

application. • Tight partnership; right sized for Carestream• Scalable subscription-based business model that did not

penalize ubiquitous access• Provided cost predictability by eliminating complex license

schemes that depend on deployment sequence of modules and location of the user base

• Unique application that provided the flexibility and scalability needed for our business

• Ability to trade ideas with the “Aras Community”

Wipro Technologies – Determined to be our best implementer choice.

• Tight partnership while working through technology options and implementation models

• Deep knowledge of many tools used across our business and how to integrate them

• Good “neutral” consultant for evaluation and discussion • “Agile” approach to development, allowing us to have flexibility

as we deploy


• 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- ARASSchedule (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 of work without Standardization of applications and processes will lead to reduced innovation time and productivity in New Product Development

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

PLM Implementations require a holistic approach that includes;

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


Practical Take Away• Carefully craft a balanced team, technical development skills, leadership

awareness, project management, process development, and communications skills

• 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 carefully 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 innovation with regulatory and manufacturing structure

• Prioritize architecture and code reviews

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


PLM is a complex journey that requires discussion

• Strategic Approach

• Architectures

• Benchmarking

• Implementation

• Process

Willing to talk more about PLM…?


Contact InformationDavid G. Sherburne – Director of Global R&D Effectiveness

Linked in:

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

Email

[email protected]

[email protected]

Twitter

@dgsherburne

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

David G. Sherburne Director Global R&D Effectiveness And Engineering IT Director

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