PLM Implementing Successful Transformational Change

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


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


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


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


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


• 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


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


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


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?


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


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


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


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


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


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


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


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


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


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


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


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


• 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 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


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:


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


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


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


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


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…?


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: [email protected]

Work email: [email protected]

Slide Share : http://www.slideshare.net/dgsherburne

Twitter: @dgsherburne

Documents

PLM Implementing Successful Transformational Change