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Considerations when implementing an enterprise business transformation like Product Lifecycle Management software. Comment if you like it!
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Page 1David G. Sherburne Carestream Health Inc.
Global New Product Commercialization Improvement
Topic : Product Lifecycle Management- Implementing Successful Transformational Change
David G. SherburneDirector Global R&D Effectiveness and Engineering IT
I am a PLM simple license model advocate
Page 2David G. Sherburne Carestream Health Inc.
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
•This presentation
•When to consider a PLM system
•How to form a PLM project and choose partners
•Some benchmark data for estimation purposes
•Opportunity to add some PLM friends to 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
• Non-destructive testing
Carestream Health – Who We Are
Page 4David 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
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
Page 5David G. Sherburne Carestream Health Inc.
Globalization was required to meet our business needs
• Desired access to talent
• Needed a balanced cost structure
• Desired a presence in emerging markets
Impact of globalization = more decentralized teams, more complex environment
• Collaboration became more time consuming
• Complexity in the organization increased
• Knowledge-workers’ time was drained by managing complexity, impacting time spent on innovation
• Productivity of new product development remained flat
The Business Challenges
Page 6David G. Sherburne Carestream Health Inc.
• Project teams are less collocated
• Platform development and globalization add to complexity
• Iterative methods required faster information transfer
• More stringent IP capture from suppliers is required to be flexible and to improve design for manufacturability
• Access to historical data is needed to improve planning, compare reliability trends, and drive improvements to the development cycle
• Engineers are required to do deeper analysis and model more
• Requests for metrics are more frequent and are difficult to manually produce
• Disjointed IT and non-standard process environments reduce effectiveness and increase demands on time
Increasing Demands on Knowledge Workers
Key Point -quality and compliance must be maintained so people manage the complexity with manual processes and spreadsheets impacting productivity
Page 7David G. Sherburne Carestream Health Inc.04/08/23
Evolution of Non- Standard Commercialization Process
Product Service InformationProcesses and Tools
Product Manufacturing InformationProcesses and Tools
Product Design InformationProcesses and Tools
Project Information Processes and Tools
Site A
Site B
Site C
DHF- Design History File
DMR- Device Master Record
DHR- Device History Record
Service Baseline
Ge
nera
l flo
w o
f pr
oduc
t inf
orm
atio
n du
ring
lifec
ycle
Gaps between blocks represent inefficient manual sharing of information
Innovative people innovate many local processes to assemble and baseline information
Local resources focus on working local product families
Complexity increases as work begins to flow between sites due to globalization
Page 8David G. Sherburne Carestream Health Inc.
PLM - EnterprisePLM - EnterprisePDMPDMAuthoringAuthoring
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
Point solutions are caused by an “IT Cost Center” mentality and non- coordinated local efforts
Page 9David G. Sherburne Carestream Health Inc.
Holistic PLM Approach- Its not just a simple arrow anymore
People were co-located and focused
Leadership
Focus the organization
Develop, inspire vision
Communicate strategy
Build awareness
Lead multi-cultural change
Technology
Provided by solid partners
Globally scalable
Architectural orientation
Solid IT infrastructure
Master data foundation
People
Skilled in ;
Leading change management
Communication/training
Project managementProcess
Balanced - Structure vs Innovation
Standard across sites
End to end integration across functions
Real time metrics
Continuous improvement mindset
1990s PLM was technology driven, supporting local needs
PLM must scale to service a global anddistributed environment
Today PLM must improve operational performance across an enterprise
Page 10David G. Sherburne Carestream Health Inc.
CTO Office CIO Office
Director R&D Effectiveness
David Sherburne
Alignment with IT• Ensure solution scalability• Enable architectural alignment• Improve on-going services• Ensure leverage strengths of both IT and business
Vertical Business Structure • Major stakeholders• Home for subject matter experts• Key middle managers• Finance the work and reap the benefits
Alignment with R&D and Manufacturing •Central group to manage the effort that’s close to the business •Ensured focus on the business•Gave focused time to process development and SME involvement•Provided a home for continuous improvement
Leadership/ Governance the tip of the arrow
What are the key decisions?Who has the decision rights?
Page 11David G. Sherburne Carestream Health Inc.
Technology and Partner Selection Process
Examined our business objectives and the capabilities we were lacking
Examined market options for both the application platform and implementation services
Started the evaluation process early to learn partners’ depth and long-term partnership approach
Emphasized building long term relationships
Contracted the implementation partner to help make the final technology partner selection
Used a rigorous evaluation process against high-level functional AND businesses requirements that enabled a strong ROI for the Carestream business scenario
Page 12David G. Sherburne Carestream Health Inc.
Partner Selection Model – Give Yourself Time
Business Objectives
ID Capabilities Missing
ROI of New Capabilities
Strategies to Obtain Capabilities
Develop Business Requirements
Write Key Use Cases
Final Selection of Partners
Request for InformationRequest for Quote
Time ~ 9 months 1½ FTEs
Look for a strategic long term relationship (5 years minimum)
Willingness to share in risk Flexible license/implementation
terms in line with business ROI Partnership during entire
implementation lifecycle Structure to keep on-going costs
in line with benefits
Page 13David G. Sherburne Carestream Health Inc.
Benefits of the Partner Selection Process
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, maximizing the understanding along the way of the finalists
Candidates remaining in the last cycle deeply understood our functional requirements, business drivers, and expectations and provided the best offers possible
Process obtained the best balance of functionality, risk, and cost to our company, maximizing ROI and reducing risk
Page 14David G. Sherburne Carestream Health Inc.
License Models Limited PLMs Business Value
Models Proposed
• Named User
• Module Based
• Creator/Consumer
• Geographic Location Based
• Enterprise – Based on Revenue
• Subscription – Based on Total Users
• Open Source – Free without support
• No Concurrent User Models Offered
Many License Models
•Discouraged access to data
•Were costly to pilot and test
•Front loaded our cost and risk
•Were complex and difficult to predict the total cost
•Limited platform scalability
•Placed crazy price tags on document management and simple workflow management
•Tanked the ROI
•Caused crazy behaviors to work around license models
•Became a gift that would provide a rapidly growing revenue stream out of the company
Right PeopleRight InformationRight System Right Time
License Models
Page 15David G. Sherburne Carestream Health Inc.
Technology Architecture- Understand the Layers
Understand the complete view of New Product Development “building blocks” and how to communicate them clearly
Appreciate the complexity and interaction in the “Architectural Layers”
Keep business process focus and balance between structure and flexibility
Maintain good architectural orientation and familiarity with industry technology
Mature the architectural maturity and understanding between the multiple functional organizations involved with PLM
Page 16David G. Sherburne Carestream Health Inc.
Product P
lanning Definition
PLM – Product Life Cycle Management Platform
PDM – Data Management for Hardware Development WIP
ALM – Data Management for Software Development WIP
Authoring Hardware Design CAD-ME,EE
Authoring Software Design –IDE
Project M
anagement - G
ates
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
High Level Process Architecture- Describe the blocks
Page 17David G. Sherburne Carestream Health Inc.
Business Process Layer – Optimized Workflow and Roles and Responsibilities(Engineering Change Control, Production Release Process,
Supplier Quote Process, Defect Management Process)
Application Layer –
Aras Innovator, Teamcenter, Doors, Rally, Subversion
IT Infrastructure Layer – Global Networks, Servers, Databases, Storage, Back-Up, Archive
Presentation/Data Access Layer – Web Channel/Portals for internal and external Consumption; Dashboards, Business Intelligence Analysis, Supplier Portals Increasing A
rchitectural Maturity
Business P
rocess Maturity IT
Maturity
Increase Organizational Maturity + Architectural Awareness = Success
Data Layer –
Master Data (System of Record/clean-up) , Attributes, Field Mapping to Metrics
Appreciate the Complexity in Each “Architectural Block”
Need to drive understanding deep & across the functional groups to mature the enterprise understanding
Page 18David G. Sherburne Carestream Health Inc.
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
Application Architecture Representation
Page 19David G. Sherburne Carestream Health Inc.
Process diagrams ;
must be organization independent
provide visual scope
drive deeper “use-case” discussions
provide context to user story– for the “Role”, that desires to “do something in a process” the PLM system will “do something”
refine functional requirement understanding
concentrates people on future state and consistency vs. current state & holding on to it
can be analyzed to reduce waste
help focus training development on process and not button clicks
help testing for validation on key workflows and performance
Business Process Architecture Swim Lanes
Page 20David G. Sherburne Carestream Health Inc.
Key: Carefully architect business processes with balanced SME input (MFG,RD,Quality, Regulatory) with consideration as to what point in the lifecycle data will be start to be entered into the PLM system
Research and Development
Manufacturing and Regulatory
Manage for fast idea cycles
Manage for repeatability and consistency
Understand Process Balance & Increase Productivity
Page 21David 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 application “button clicks”
Carefully identify the roles that require training and target information to the roles
Evaluate self-paced training,it’s the hardest to deliver, but it’s most flexible for users
Page 22David G. Sherburne Carestream Health Inc.
Properly Skilled Teams = Successful PLM Results
Business Processand
Metrics Development
Technology Partners
&Application Architecture
IT Architecture,Master Data
Migration
Coding and Configuration
Skills for implementation
Page 23David G. Sherburne Carestream Health Inc.
• Open Source and Aras Innovator Platform
• Scope and Scale of Phase One
• Benchmark with Industry Expert
• Findings Summary
Carestream Case Study
Page 24David 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 and enabling proper ROI
• Flexible architecture supports rapid development – 50% easier than other platforms to configure
• Upgrades… Guaranteed… when you subscribe
• Open access to ALL data elements
• Technical partnership – anti-virus performance, e-signature Help, visualization strategy, search functionality
• Some risk (early adopter) but balanced with higher value
• Community solution concept, which we are beginning to leverage
• Single company provides the PLM Core – it’s not traditional “Open Source”
“A”ras Innovator = “A”ttitude & “A”dvantages
Page 25David 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)
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 currently working now
Case Study, Phase 1 – Implement a Global PLM that delivers:
Page 26David G. Sherburne Carestream Health Inc.
Baseline Comparison with industry expert
User = Core engineering process worker that contributes to Part Creations, BOM management, Engineering Change
Industry Expert (Typical PLM) Carestream PLI- ARAS
Schedule (Implement & Deploy) 18-24 months 19 months deliver features 24 months stabilize and deploy most modules
Initial Implementation Cost (Core engineering users- measured in hundreds)
$4000/user $3300/user
License Maintenance/Subscription 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• Solutions for medical device companies take longer that average to implement, as more effort is required to meet
regulatory requirements for 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, more cost effective and scalable, but may take more effort to
implement than industry solutions but once implemented on going costs are minimal.
*When suppliers access the system >$75/user
Page 27David G. Sherburne Carestream Health Inc.
Results to date for Carestream PLMDeployment was slower than anticipated - why up front license cost needs to be questioned!
•Users of the system = 500 ramping up to 1000+ when defects fully deployed•Slow deployment of defect module due to software engineering metrics requirements•CAPA/Supplier portal/Requirements have been delayed
Total Engineering Changes Processed, over 1000 in first yearCompared to prior solution baseline;
•Number of changes has dropped 20%•Average cycle time for a change has dropped 30%•Rejections for content mistakes has increased 40%
Current Support Staff – Year one of operation•Investments (choice) – New modules and enhancement functionality – 6.25 FTEs
(Project Management, Development, Business Process, Testing)•Supplier Portal Development•Enhancements to current modules •CAPA (being re-evaluated)
•Services (keep it running) – Support of users and defects fixes – 1 support FTE/100 Engineering Users
(Project Management, Development, Testing)•Defects and bug fixes •User support, help tickets •Upgrade testing and release
Page 28David G. Sherburne Carestream Health Inc.
Strategic Take Away
Globalization without process standardization will lead to reduced innovation time and flat productivity
PLM Implementations require a holistic approach that includes;
•Global Leadership = A Leadership Organization/Governance•People with change management/leadership skills•Processes mapping, standardization and development •Progressive and flexible technology partners
Cost center IT mentality delivers proliferation of local point solutions and little enterprise architecture or process efficiency
PLM license models should be evaluated closely to reduce risk, allow ubiquitous access and enable the business ROI
Page 29David G. Sherburne Carestream Health Inc.04/08/23
Global Standard Commercialization Process (future)
Eliminated 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
Improved enterprise collaboration effectiveness
PLM Initiative cut across 14
processes many functional areas & 4 sites
Enabled improved Metrics and Reporting
Reduced organizational complexity
Standard process set up a foundation for continuous improvements
PLM when successfully implemented will provide more time to knowledge workers to focus on innovative tasks that are
truly valued by customers
Page 30David G. Sherburne Carestream Health Inc.
Practical Take Away• Craft a balanced cross functional team
• Prioritize project governance, know key decisions and set decision rights formally
• Know your teams critical mass (how much work your team can handle) and match that with implementation partner’s speed and development capacity
• Ensure business process work leads and use cases-requirements follow
• Take work in small chunks (AGILE development methods works well)
• Turn user interface prototypes early, fast, and review the implementation approach
• Train in context of the business process not in the context of the tools button clicks
• Get involvement of SMEs early and often. Cover all disciplines and phases of the lifecycle to ensure a balance between process structure and flexibility
• Prioritize architecture and code reviews to ensure standards and avoid a poor code base due to rapid cycles/ turn over of developers
• Verify and validate functionality using business-process diagrams as the basis
• PLM will always take longer to deploy than estimated because of organizational change management
• When automating manual integrations between point solutions multiply time estimates by 2 and spend the time to understand the business process
Page 31David G. Sherburne Carestream Health Inc.
PLM is a complex journey that requires discussion and;
Leadership
Strategic technology approach
Solid architecture at all levels
Process focus and knowledge
Highly skilled team
Lots -O- Benchmarking
Willing to talk more about PLM…?
Page 32David G. Sherburne Carestream Health Inc.
Contact InformationDavid G. Sherburne – Director of Global R&D Effectiveness and Engineering IT, Carestream Health Inc.
Linked in:
http://www.linkedin.com/in/davidsherburne
Personal email: me@davidgsherburne.com
Work email: david.g.sherburne@carestream.com
Slide Share : http://www.slideshare.net/dgsherburne
Twitter: @dgsherburne
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