Page 1David 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)
Page 2David G. Sherburne Carestream Health Inc.
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
Page 3David G. Sherburne Carestream Health Inc.
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
Page 4David G. Sherburne Carestream Health Inc.
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.
Page 5David G. Sherburne Carestream Health Inc.
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
Page 6David G. Sherburne Carestream Health Inc.
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Hurdles to effective globalization• Legacy systems were outdated and not easily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
Page 7David 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.
Page 8David G. Sherburne Carestream Health Inc.
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
Page 9David G. Sherburne Carestream Health Inc.
• 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
Page 10David 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
Page 11David G. Sherburne Carestream Health Inc.
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
Page 12David G. Sherburne Carestream Health Inc.
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
Page 13David G. Sherburne Carestream Health Inc.
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
Page 14David G. Sherburne Carestream Health Inc.
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
Page 15David G. Sherburne Carestream Health Inc.
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
Page 16David G. Sherburne Carestream Health Inc.
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
Page 17David G. Sherburne Carestream Health Inc.
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
Page 18David G. Sherburne Carestream Health Inc.
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
Page 19David G. Sherburne Carestream Health Inc.
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
Page 20David G. Sherburne Carestream Health Inc.
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
Page 21David G. Sherburne Carestream Health Inc.
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”
Page 22David G. Sherburne Carestream Health Inc.
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
Page 23David G. Sherburne Carestream Health Inc.
Carefully ArchitectedBusiness Process
Research and Development
Manufacturing and Regulatory
Manage for fast idea cycles
Manage for repeatability and consistency
Understand Process Balance & Increase Productivity
Page 24David G. Sherburne Carestream Health Inc.
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
Page 25David G. Sherburne Carestream Health Inc.
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
Page 26David G. Sherburne Carestream Health Inc.
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
Page 27David G. Sherburne Carestream Health Inc.
• 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
Page 28David G. Sherburne Carestream Health Inc.
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
Page 29David G. Sherburne Carestream Health Inc.
• 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
Page 30David G. Sherburne Carestream Health Inc.
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:
Page 31David G. Sherburne Carestream Health Inc.
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
Page 32David G. Sherburne Carestream Health Inc.
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
Page 33David G. Sherburne Carestream Health Inc.
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
Page 34David G. Sherburne Carestream Health Inc.
PLM is a complex journey that requires discussion
• Strategic Approach
• Architectures
• Benchmarking
• Implementation
• Process
Willing to talk more about PLM…?
Page 35David G. Sherburne Carestream Health Inc.
Contact InformationDavid G. Sherburne – Director of Global R&D Effectiveness
Linked in:
http://www.linkedin.com/in/davidsherburne
@dgsherburne
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