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HOLOGIC AGILE STORY
ORACLE VCS
Feb 5, 2014
DAVE RUDZINSKY
SVP & CIO
HOLOGIC, INC.
Improving Lives and Making a Difference:
Enterprise PLM as an Enabler at Hologic
Agenda
An Outline of Our Agile PLM Story
• The Good Life… Hologic’s Mission
• Our Ongoing Business Transformation
• Agile ...
We are a $2.5B global medical device
company that cares deeply about the
products we deliver and the customers
we serve.
O...
Diverse, Innovative Products Focused
on Early Detection and Intervention
What is our Opportunity
• Improved Customer Experience
• Increased Revenue and
Increased Market Share
• Greater Operationa...
The Hologic IS Evolution
$1.8B
$2.5B
$3+B?
How Do We Scale?
As Hologic grows we must
continuously evaluate who we
are and ...
IS Budget Drivers
Why We Spend on IS/Technology?
Compliance (Required)
Strategic Initiatives (Required)
Revenue Growth Dri...
Agile as an Enterprise Platform
Not just a Solution!
Innovative Systems
Collaborative
Systems
Foundational
Systems
ERP, Ma...
Asia Pacific
Australia
Beijing
Hong Kong
Tokyo
North America
Massachusetts
Connecticut
Delaware
Indiana
Wisconsin
Californ...
The Beginning… 1999
Why PDM
• Introduce products faster and more efficiently
• Reduce ECO Cycle Time
• Paper based ECO sys...
Agile Platform Evolution
Product Collaboration
• Foundation for Product Development, NPI, Change Control
• DHF, DMR, QSM, ...
Business Challenge – Silos
QA
Corrective Actions
Audit
Doc Control
Parts
Manufacturing
NCMR’s
Preventative
Actions
Doc Con...
Integrated into the Product Record
Active Management of Quality Processes
Centralized Product Quality Information
Manage p...
Benefits
• Average ECO cycle time days
improved from 45 to 13 to 411x Faster
• Labor efficiency improved in
Engineering an...
Benefits
Manage our critical product data across entire organization
• Inter-company suppliers, External suppliers, Engine...
Benefits
Quotes From Hologic Associates
“Agile has provided Hologic with a consistent
documentation control process. It im...
Loosely Coupled Integration
What My Enterprise Architect Preaches
Integration Hub
Universal
Data
Model
System 3
Data
Model...
Agile Integration
Integration Hub
Service
Request
Event UDM
System X
Data
Model
Agile PLM
Data
Model
System Y
Data
Model
e...
Oracle value chain summit 14
Oracle value chain summit 14
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Oracle value chain summit 14

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Oracle value chain summit 14

  1. 1. HOLOGIC AGILE STORY ORACLE VCS Feb 5, 2014
  2. 2. DAVE RUDZINSKY SVP & CIO HOLOGIC, INC. Improving Lives and Making a Difference: Enterprise PLM as an Enabler at Hologic
  3. 3. Agenda An Outline of Our Agile PLM Story • The Good Life… Hologic’s Mission • Our Ongoing Business Transformation • Agile as a Platform not just a Solution – The Beginning… PDM and Why Agile – Agile Evolution… Leveraging the Platform – Business Challenges and Benefits – Architecture and Integration
  4. 4. We are a $2.5B global medical device company that cares deeply about the products we deliver and the customers we serve. OUR VISION To Make a Difference in the Lives of People Everywhere
  5. 5. Diverse, Innovative Products Focused on Early Detection and Intervention
  6. 6. What is our Opportunity • Improved Customer Experience • Increased Revenue and Increased Market Share • Greater Operational Efficiency • Cutting Cost and Waste from all areas of the Business by eliminating Complexity • Build on the passion for the difference we can make in people’s lives How we can Achieve • Business Transformation is achieved by realigning the way staff work, how the organization is structured and how technology is used • Faster product development, improved quality with regulatory compliance • This is a major corporate initiative with many benefits Transforming Hologic as we return to Growth By Driving Internal Innovation… And By Facing Reality!
  7. 7. The Hologic IS Evolution $1.8B $2.5B $3+B? How Do We Scale? As Hologic grows we must continuously evaluate who we are and how we keep up! Hologic FY13 Revenue
  8. 8. IS Budget Drivers Why We Spend on IS/Technology? Compliance (Required) Strategic Initiatives (Required) Revenue Growth Driver Customer Programs Productivity / Operational Efficiency
  9. 9. Agile as an Enterprise Platform Not just a Solution! Innovative Systems Collaborative Systems Foundational Systems ERP, Master Data and other Systems of Record BI, Mobility, Social, Fusion CRM, HCM, PLM, EPM
  10. 10. Asia Pacific Australia Beijing Hong Kong Tokyo North America Massachusetts Connecticut Delaware Indiana Wisconsin California Canada Central & South America Costa Rica Europe Belgium France Germany Italy Spain Switzerland UK Our Global Rollout of ………………….…Is Almost Complete! One Single Global Enterprise System… for One Company!
  11. 11. The Beginning… 1999 Why PDM • Introduce products faster and more efficiently • Reduce ECO Cycle Time • Paper based ECO system had high overhead • Sudden awareness of FDA regulatory issues • Legacy Systems not Part 11 compliant • QSM and DHF were paper-based • Overall productivity - Quality, Engineering & MFG • Greater visibility of the Product Record and Collaboration across all Hologic Why Agile • Medical Device, High Tech and PDM Focus • Ease of Implementation • Validation Protocol Pack • Flexible - Easy to configure and use • Integration with ERP already existed
  12. 12. Agile Platform Evolution Product Collaboration • Foundation for Product Development, NPI, Change Control • DHF, DMR, QSM, MKT, OLM, UDI Engineering Collaboration • CAD Integration Product Quality Management • NCMR, Complaints, CAPA, SCAR, Audits Product Governance & Compliance • Reach, RoHS and Conflict Minerals Oracle Product Lifecycle Analytics 13 Future projects include… UDI (in process), OPLA and eDHR
  13. 13. Business Challenge – Silos QA Corrective Actions Audit Doc Control Parts Manufacturing NCMR’s Preventative Actions Doc Control Parts Customer Service Complaints Doc Control Parts Design Failure Analysis Design Defects Doc Control Parts Field Field Incidents Doc Control Parts Supplier Supplier Corrective Actions (SCAR) Doc Control Parts Manual or Periodic interaction between Silos
  14. 14. Integrated into the Product Record Active Management of Quality Processes Centralized Product Quality Information Manage problems through processes Corrective Actions Supplier Corrective Actions (SCAR) Failure Analysis Preventative Actions Audits Collect enterprise set of problems Defects NCR Customer Complaints Field Incidents Design Defects Audit Findings Resolve problems through Changes to Parts and Documents ECO Deviations Stop Ships MCO Parts, BOMs, AML Documents CustomerFieldMfgDesign QA Supplier
  15. 15. Benefits • Average ECO cycle time days improved from 45 to 13 to 411x Faster • Labor efficiency improved in Engineering and Doc Control50% • Labor efficiency improvement for Product Quality Metrics*80% • Regulatory Compliance for 21CFR Part 11100%
  16. 16. Benefits Manage our critical product data across entire organization • Inter-company suppliers, External suppliers, Engineering CAD integration Improved quality • Device Master Record, Design History Files, Quality System Manual • Marketing Collateral, Training Introduce new products faster • While increasing our product portfolio and entering new markets Enables Engineering Collaboration across all divisions Rapid implementation to all divisions and new acquisitions
  17. 17. Benefits Quotes From Hologic Associates “Agile has provided Hologic with a consistent documentation control process. It imposes a strict process, yet is flexible enough to enable us to make the changes necessary to meet our business demands” “Agile has been great for integrating new companies quickly!” “Workflows across the entire Agile platform are easy to use”
  18. 18. Loosely Coupled Integration What My Enterprise Architect Preaches Integration Hub Universal Data Model System 3 Data Model System 4 Data Model System 2 Data Model System 1 Data Model 1 2 34 4 4 1 2 3 4 4 4 Advantages: • Reuse & leverage: publish once, subscribe many times • Plug-in / unplug systems as needed • Works very well for (near) real time integration Event publication (lightweight) Asynchronous data gathering Data mapping to UDM Filtered subscription (payload dependent) & data mapping to a local data model Service Bus
  19. 19. Agile Integration Integration Hub Service Request Event UDM System X Data Model Agile PLM Data Model System Y Data Model eBS Service Request Data Model 1 2 34 4 4 20 Service Bus eBS 1 2 3 Event publication (lightweight) Asynchronous data gathering Data mapping to UDM Filtered subscription (payload dependent) & data mapping to a local data model ‒ Service Request created/updated ‒ Incident_id published to Event Queue table ‒ SR data gathered from eBS ‒ Data combined into an SOA XML payload ‒ XML payload mapped to an SR Event UDM ‒ SR Event routed to Agile based on data driven Business Rule ‒ SR Event mapped to Agile local data model ‒ Agile subscribers called ‒ Returned status updated in Event Queue table and e-mailed 4 4 4 Agile PLM System X - Potential System Y - Potential

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