HOLOGIC AGILE STORYORACLE VCS

Feb 5, 2014

DAVE RUDZINSKYSVP & CIOHOLOGIC, INC.

Improving Lives and Making a Difference:

Enterprise PLM as an Enabler at Hologic

AgendaAn 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

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

Diverse, Innovative Products Focused on Early Detection and Intervention

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!

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

IS Budget DriversWhy We Spend on IS/Technology?

Compliance (Required)

Strategic Initiatives (Required)

Revenue Growth Driver

Customer Programs

Productivity / Operational Efficiency

Agile as an Enterprise PlatformNot 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

Asia PacificAustraliaBeijingHong KongTokyo

North AmericaMassachusettsConnecticutDelawareIndianaWisconsinCaliforniaCanada

Central & South AmericaCosta Rica

EuropeBelgiumFranceGermanyItalySpainSwitzerlandUK

Our Global Rollout of …………………. …Is Almost Complete!

One Single Global Enterprise System… for One Company!

China 2014

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 EvolutionEngineering Collaboration• C

AD Integration

P

r

o

d

u

c

t

Q

u

a

lit

y

M

a

n

a

g

e

m

e

n

t

N

C

M

R

,

C

o

m

p

l

a

i

n

t

s

,

C

A

P

A

,

S

C

A

R

,

A

u

d

it

s

Oracle Product Lifecycle Analytics

Future projects include… UDI (in process), OPLA and eDHR

Business Challenge – Silos

QACorrective Actions

AuditDoc Control

Parts

ManufacturingNCMR’s

Preventative Actions

Doc ControlParts

Customer Service

ComplaintsDoc Control

Parts

DesignFailure

AnalysisDesign Defects

Doc ControlParts

FieldField

IncidentsDoc Control

Parts

SupplierSupplier

Corrective Actions (SCAR)

Doc ControlParts

Manual or Periodic interaction between

Silos

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 DefectsAudit Findings

Resolve problems through Changes to Parts and Documents

ECO Deviations

Stop Ships MCO

Parts, BOMs, AML

Documents

CustomerFieldMfgDesign QA Supplier

Benefits

11x Faster •Average ECO cycle time days improved from 45 to 13 to 4

50% •Labor efficiency improved in Engineering and Doc Control

80% •Labor efficiency improvement for Product Quality Metrics*

100% •Regulatory Compliance for 21CFR Part 11

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

BenefitsQuotes 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”

Loosely Coupled IntegrationWhat My Enterprise Architect Preaches

Integration HubUniversal

Data Model

System 3 Data

Model

System 4 Data

Model

System 2 Data

Model

System 1 Data

Model1

2

34

4 4

1

2

3

44

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

Agile Integration

Integration HubService Request

Event UDM

System X Data

Model

Agile PLM Data

Model

System Y Data

Model

eBS Service Request

Data Model1

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

44

4

Agile PLM

System X - Potential

System Y - Potential