Global New Product Commercialization
Product Lifecycle Management
Implementing Successful Transformational Change
David G. Sherburne
Director
Global R&D Effectiveness
And Engineering IT Director
(and PLM simple license model
advocate)
David G. Sherburne
Carestream Health Inc.
Page 1
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
David G. Sherburne
Carestream Health Inc.
Page 2
Carestream Health – Who We Are
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
David G. Sherburne
Carestream Health Inc.
Page 3
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.
David G. Sherburne
Carestream Health Inc.
Page 4
Who We Are
A global company with Manufacturing and R&D locations around
the world
Rochester,
New York
London,
United Kingdom
Woodbridge,
Connecticut
Oakdale,
Minnesota
Berlin, Germany
White City,
Oregon
Yokneam, Israel
Shanghai, China
Baltimore,
Maryland
Windsor,
Colorado
Atlanta,
Georgia
Xiamen,
China
Ra’anana, Israel
Guadalajara,
Mexico
Paris, France
Toulouse, France
Manufacturing
R&D
Both Manufacturing and R&D
David G. Sherburne
Carestream Health Inc.
Page 5
The Business Challenge
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• Legacy systems were outdated and not easily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
David G. Sherburne
Carestream Health Inc.
Page 6
Non- Standard Commercialization Process
Innovative
people innovate
many local
processes.
Site C
Site B
Site A
Project Information –
Processes and Tools
Works alright if
sites are
focused on
product families
and are colocated.
4/13/2015
General flow of product information
FDA - DHF
Product Design Information –
Processes and Tools
FDA - DMR
If work flows
between sites
then the gaps
between blocks
represent
inefficient
manual sharing
of information.
Product Manufacturing Information –
Processes and Tools
FDA - DHR
Product Service Information –
Processes and Tools
FDA - QS
David G. Sherburne
Carestream Health Inc.
Page 7
Point Solutions lacked proper architecture to enable global
productivity
Authoring
Enterprise
PDM
MCAD Tools
No
Integration
Part
Data
Teamcenter
Excel
NX
Pro/E
Intralinks
EQDS
AutoCAD
Mentor DX
Cadence
OrCAD
Altium
Electrical Part
Data, RoHS
File Shares
EE File
Shares,
library
cache
CAD Files PDFs
No
Integration
Software
Authoring
Sys 9K
SOP
DA
MMR
Team
Room
RoHS,
DoC,
MSDS
(no
home)
Lotus Domino
External
Systems
DocManager
Standalone
Systems
CQuest
No
Integration
Subversion
Defects
ClearQuest
Enhancement
Requests
StarTeam
Quality Center
CAPA
CAPA
CAPA
No Integration
Clearcase
PVCS
MS
Project
Lotus Notes DB
CIDx
No
Integration
Version Control Tools
Desktop Tools
(Browser,
MSOffice, etc)
BOM
No Integration
ECAD Tools
SAP
No
Integration
CAD Files PDF’s
SolidWorks
Confluence
MQDS
DOORS Requirements
Management Tools
David G. Sherburne
Carestream Health Inc.
Problem was
caused by an
“IT Cost Center”
mentality and
noncoordinated
local efforts
Information
Flow
Manual
Integration
Automated
Integration
Page 8
Demands on Workers are Ever Increasing
• 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
David G. Sherburne
Carestream Health Inc.
Page 9
Global Standard Commercialization Process (future)
PLM Initiative
processes cut
across many
functional
areas & sites
Site C
Site B
FDA - DHF
Eliminates barriers
to internal sharing of
resources
General flow of product information
Site A
Project Information –
Processes and Tools
Improves
enterprise
collaboration
effectiveness
FDA - DMR
Product Design Information –
Processes and Tools
Enables Metrics and
Reporting
FDA - DHR
Product Manufacturing Information –
Processes and Tools
Reduces
organizational
complexity
Product Service Information –
Processes and Tools
FDA - QS
Sets up foundation for
continuous improvements
4/13/2015
Knowledge workers can
focus on innovation
David G. Sherburne
Carestream Health Inc.
Page 10
Holistic PLM Approach- Its not just a simple arrow anymore
1990s PLM was
technology driven,
supporting local
needs
Today PLM
must improve
organizational
performance
People
Change
Management
Communications
Global Leadership
Process
Vision
Closed Loop
Standard
Technology
Inclusive
Global
Applications
End to end
integrated
Architecture
Strategy
Awareness
Leading multiCultural Change
Infrastructure
Master Data
People were Colocated and
Focused
Global and
Distributed
Environment
David G. Sherburne
Carestream Health Inc.
Page 11
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
David G. Sherburne
Carestream Health Inc.
Page 12
Leadership Governance
CIO Office
CTO Office
Alignment with IT
Alignment with R&D
and Manufacturing
Director R&D
Effectiveness
• Allowed focus on
business knowledge and
needs
• Focused time to support
initiative
• Home for continuous
improvement
•
•
•
•
David Sherburne
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
David G. Sherburne
Carestream Health Inc.
Page 13
Approach to 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 – 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
David G. Sherburne
Carestream Health Inc.
Page 14
Partner Selection Model – Give Yourself Time
Business Objectives
ID Capabilities
Missing
Write Key Use Cases
ROI of New
Capabilities
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
Business
Requirements
Strategies to Obtain
Capabilities
Final Selection of
Partners
Request for
Information
Request for Quote
Time ~ 9 months 1½ FTEs
David G. Sherburne
Carestream Health Inc.
Page 15
License Models Proposed
Many License Models
Models Proposed
• Named User
• Discourage access to data…
• Module Based
• Are costly to pilot functionality
• Business User or Engineering User
• Front load cost and risk
• Geographic Location Based
• Complex and difficult to predict
total capital costs
• Enterprise – Based on Revenue
• Open Source
• Place crazy price tags on
document management and
simple workflow
• No Concurrent User Models Offered
• Tanked the ROI
• Subscription – Based on Total Users 
• Cause crazy behaviors
Right People
Right Information
Right System
Right Time
David G. Sherburne
• Are the gifts that keep on
giving…
Carestream Health Inc.
Page 16
Partner Selection Process – Give Yourself Time
2009
APR
MAY
Made short list
High-Level Requirements
Development
RFP Issued and Refined
RFP Review
• Current
Relationship
JUN
JUL
2010
AUG
SEP
OCT
NOV
DEC
JAN
FEB
MAR
Request for Proposal (RFP) issued to five (5)
application suppliers and three (3) independent
implementers
Application suppliers reduced to three (3)
• Uniqueness
in Industry
Independent implementers reduced to two (2)
• Quadrant
• PDM History
First-Cut Decision
Paid leading independent
implementer to aid ROI
and application
evaluations
• Current
Assets
ROI Analysis
Application Supplier
Capability Analysis
Application suppliers reduced to two (2)
Second-Cut Decision &
RFQ Issued
Independent implementer reduced to one (1)
Request for Quote (RFQ) issued
Application supplier
selected
Implementer
selected
RFQ Analysis
Supplier Selection
Project Start
David G. Sherburne
Carestream Health Inc.
Page 17
Partner Selection Process Benefits
Allowed 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
David G. Sherburne
Carestream Health Inc.
Page 18
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
David G. Sherburne
Carestream Health Inc.
Page 19
Complete View – Understanding the Building Blocks
Portfolio – Dashboards, Metrics, Web Channels
ideas
Hardware
Design
Authoring –
CAD-ME,EE
Software
Design –
Authoring IDE
Integration of Applications and
Master Data Strategy
David G. Sherburne
Carestream Health Inc.
Manufacture and Sustain
ALM – Data
Management
for Software
Quality Data Management
Core
Project Management - PCP
ideas
Product Planning Definition
ideas
Portfolio Management
ideas
PDM – Data
Management
for Hardware
Service Delivery, Pubs,Training
ideas
SUPPORTABLE PRODUCTS
PLM – Product Life Cycle Management Platform
BOLD = Industry Term
Page 20
Appreciated the Complexity in Each “Architectural Block”
Social, Dashboards, Business Intelligence
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 Maturity
Data Layer –
System of Record for Master Data, Attributes, Field Mapping to Metrics, Clean-Up
Increasing Architectural Maturity
Business Process Maturity
Presentation Layer – Web Channels internal and external;
IT Infrastructure Layer – Networks, Servers, Databases,
Storage, Back-Up, Archive
Increase Organizational Maturity + Architectural Awareness = Success
David G. Sherburne
Carestream Health Inc.
Page 21
Business Process Focus – Low-Level Architecture  Swim Lanes
Key Points
Drives deeper “usecase” 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
David G. Sherburne
Carestream Health Inc.
Page 22
Understand Process Balance & Increase Productivity
Manage for fast idea
cycles
Manage for
repeatability and
consistency
Research and
Development
Manufacturing and
Regulatory
Carefully Architected
Business Process
David G. Sherburne
Carestream Health Inc.
Page 23
Architectural Orientation and Strategic Planning Ability
Desktop
Office,
Project
MCAD Tools
Supplier 1
PDM
HW
PDM Upgrade
Authoring Systems
Supplier 2
Supplier 3
New
Modeling
RQMTS
New
Platform
ECAD Tools
ECAD 1
Testing
ECAD 2
ECAD 3
Enterprise Systems
PLM Aras Innovator
Closed Loop Engineering Change
Management (HW/SW)
Event Tracking and Defect Mgmt
CAPA Management
Audit Management
Supplier Access/ DFM Input
Supplier Quote
ECAD, MCAD PDM Integrations
 EBOM, MBOM Management
Costing
Commercial Parts Library
RoHAS
Requirements Change Control
ISDE Integration for SW events
Quality
Platform
(HPQC)
Knowledge Sharing, Social Nets,
and Webchannel
Webchannel/
Social
Development
Dashboards –
Metrics
LN DBs
KM
Platform
Manufacturing Transfer
Raw Material Master
Purchase
Portals –
ECoutlook
Smart source-Ebid
SW Authoring
MS Visual Studio
XCODE, Other
Key IDEs
SW CM –
SVN
Integrated As Built
Master Data
Established
Standard
Integrated SW Development Environment- SW Environment)
ISDE
Core
SAP
SW Project Management,
Dashboards
Some
(Rally)
Integration
Build Tools and Services
Test Scripting
Build Configuration
Management
Emerging
Standard
2012
Proposal
No
Standard
End of
Life
David G. Sherburne
Carestream Health Inc.
Page 24
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
David G. Sherburne
Carestream Health Inc.
Page 25
Complete Teams = Successful PLM Results
Business Process
and
Metrics Development
Coding and
Configuration
Skills for
implementation
David G. Sherburne
Technology
Partners
&
Application
Architecture
IT Architecture,
Master Data
Cleaning and
Migration
Carestream Health Inc.
All skills are
critical and
equal for
success
Page 26
Carestream Case Study
• Final Selection of Partners
• Open Source and Aras Innovator Platform
• Scope and Scale of Phase One
• Benchmark with Industry Expert
• Findings Summary
David G. Sherburne
Carestream Health Inc.
Page 27
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
David G. Sherburne
Carestream Health Inc.
Page 28
“A”ras Innovator = “A”ttitude & “A”dvantages
• 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”
David G. Sherburne
Carestream Health Inc.
Page 29
Case Study Goal, Phase 1 – Implement a Global PLM that delivers:
Global Standard Business Processes
Defect Management
Overall Engineering Change-Mgmt-Closed Loop
Engineering Change Request (ECR)
Engineering Change Notice (ECN)
Deviation Authorization
Engineering Change Implementation (ECI, MBOM)
Design Parts Release
MBOM/EBOM Mgmt
Package Parts Mgmt.
Commercial Parts Mgmt.
CAPA Mgmt.
Audit Mgmt
Supplier Collaboration
Product/Team Mgmt.
Feature Function Request Mgmt.
Dropped from Phase 1
Across 4 Major Sites
Uniting Many Point Solutions
Rochester (DCS, HCIS)
Closed loop Engineering Change (One Example)
Oakdale (DO)
Defects – ClearQuest (1300 users)
Woodbridge (CMI)
ECR – Spreadsheet, Manual
Shanghai (DCS, DO, CMI, Rayco)
ECN – EQDS Retired (450 users)
+ 11 additional Global Sites for CAPA ECI – Spreadsheet Manual, SAP Integrated
& AMS
Requiring Involvement of ~75 Subject Matter Experts
PLI Provides the Foundation
for Carestream
Future
Process
Standardization
David G. Sherburne
Health
Inc.
Page
30
Baseline Comparisons
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
Schedule (Implement & Deploy)
Implementation Cost
Maintenance Cost
Functionality for a Phase 1
Industry Expert (Typical PLM)
Carestream PLI- ARAS
18-24 months
19 months deliver features
24 months stabilized deploy
$4000/user
$3300/user
$360/user
$300>$165>*$75
Engineering Change
Configuration/Revision Control
BOM Management
Supplier Collaboration
Product/Portfolio Management
Closed-Loop Engineering Change
Configuration/Revision Control
BOM Management
Deviation Authorization
Product Defect Management
Audit Management
SAP Integration
3
4 Development Sites
5.5 FTE
5.5 FTE
60
75
# of Sites for Deployment
Internal Resources to coordinate (in addition to
implementation)
Subject Matter Involvement
*When suppliers access the system >$75/user
David G. Sherburne
Carestream Health Inc.
Page 31
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
David G. Sherburne
Carestream Health Inc.
Page 32
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
David G. Sherburne
Carestream Health Inc.
Page 33
Willing to talk more about PLM…?
PLM is a complex journey
that requires discussion
• Strategic Approach
• Architectures
• Benchmarking
• Implementation
• Process
David G. Sherburne
Carestream Health Inc.
Page 34
Contact Information
David G. Sherburne – Director of Global R&D Effectiveness
Linked in:
http://www.linkedin.com/in/davidsherburne
Email
me@davidgsherburne.com
david.g.sherburne@carestream.com
Twitter
@dgsherburne
David G. Sherburne
Carestream Health Inc.
Page 35