Hologic's Presentation from the Oracle Value Chain Summit

1. HOLOGIC AGILE STORY
ORACLE VCS
Feb 5, 2014

2. DAVE RUDZINSKY
SVP & CIO
HOLOGIC, INC.
Improving Lives and Making a Difference:
Enterprise PLM as an Enabler at Hologic

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. 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

6. Diverse, Innovative Products Focused
on Early Detection and Intervention

7. 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!

8. 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

9. IS Budget Drivers
Why We Spend on IS/Technology?
Compliance (Required)
Strategic Initiatives (Required)
Revenue Growth Driver
Customer Programs
Productivity / Operational Efficiency

10. 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

11. 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!

12. 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

13. 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

14. 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

15. 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

16. 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%

17. 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

18. 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”

19. 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

20. 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