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Agile Product Lifecycle Management Demo Series

Agile PLM solution overview for the Medical Device Industry
Warren Basch
Principle Presales Consultant, PLM

Safe Harbor Statement

The following is intended to outline our general
product direction. It is intended for information
purposes only, and may not be incorporated into
any contract. It is not a commitment to deliver any
material, code, or functionality, and should not be
relied upon in making purchasing decision. The
development, release, and timing of any features
or functionality described for Oracles products
remains at the sole discretion of Oracle.

2008 Oracle Corporation Proprietary and Confidential

What is PLM?
PLM enables companies to accelerate
product innovation and maximize product
profitability
through the management of the
information, processes and decisions
about their products
throughout the product lifecycle and
across the global product network

2008 Oracle Corporation Proprietary and Confidential

PLM Mission: Maximize Profitability at each

Phase of the Product Lifecycle

2008 Oracle Corporation Proprietary and Confidential

The Problem

No Single View of the Product and Program Information

Testing
Testing
Facilities
Facilities

Suppliers
Suppliers
ERP

ERP

Excel

? ?
?

Concept
Briefs

Project
Project
Manager
Manager

Pack
Pack
Manager
Manager
Costs

FIN

HCM

Product
Product
Developers
Developers
Formula
tion

2008 Oracle Corporation Proprietary and Confidential

Specs HACCP

Regulatory
Regulatory
Bodies
Bodies

Ideas

MES

Value
Chain

Project

Marketing
Marketing

SCM

? ?

Enterprise

Outsourced
Outsourced
Partners
Partners

Adobe

Quark

LIMS

Customers
Customers

Logos

Artwork
Artwork
Houses
Houses

Sample

Analyst
Analyst
CRM

Quality
Quality

Sourcing
Sourcing
Manager
Manager
Site
Recipe

ERP

Complaints

Test
Data

LIMS
Compliance
Documents

MES

Life Science Enterprise Product Record = PLM

DHF Program Data

Quality Management

- Customer
Complaints/CAPA
- NCMR/Deviations
- Audit Management
- Voice of Customer

Design Data

Manufacturing Data

(DMR-ERP/MES Sync)
- Bills of Materials
- Mfg. Instructions
- Revision data

Supplier Data
-

Approved Vendors
Quality Management
Pricing
Availability

Schedules
Resources
Constraints
Risk

Design Spec History

Verification/Validation
Lab/Clinical Results
E-Submittals (510K/PMA)

Process Data (DHF/DMR)

-

ECOs/MCOs/Deviations
Change History
Documentation

The product record includes all the information required by the

extended enterprise to conceptualize, design, source, build, sell, service
and dispose of products
2008 Oracle Corporation Proprietary and Confidential

The Solution
A Central Repository with One Version of the Truth

Testing
Testing
Facilities
Facilities
Suppliers
Suppliers
ERP

Artwork
Artwork
Houses
Houses
Quark

LIMS

Outsourced
Outsourced
Partners
Partners

Adobe

ERP

Excel

SCM

MES

Regulatory
Regulatory
Bodies
Bodies

Customers
Customers

Product
Mgmt
Supplier
Management
Quality
24/7Management

Enterprise

Value
Chain

Collaboration

Program
Management

Marketing
Marketing
Logos

Concept
Briefs

Ideas

CRM

Pack
Pack
Manager
Manager
Costs

Analyst
Analyst

FIN

HCM

Formulas

2008 Oracle Corporation

7
Proprietary and Confidential

Product
Product
Developers
Developers
Specs HACCP

Sample

Sourcing
Sourcing
Managers
Managers
Site
AML

ERP

Complaints

Quality
Quality
Test
Data

Compliance
Documents

LIMS

MES

Agile PLM
Executives & Program Office
Compliance
Office

Agile Product Portfolio Management

Agile Product
Governance &
Compliance

Integrated product, program,

resource & portfolio management

Agile Engineering
Collaboration
Engineering desktop
integration & collaboration

Product & program

compliance against
standards & regulatory
requirements

Cross-Enterprise

Agile Enterprise
Visualization
Native document
collaborative visualization
across the global enterprise

Quality
Professionals

Agile Quality
Management
Closed-loop product
quality management
across the extended
enterprise

Development
& Engineering

Engineering,
Operations &
Supply Chain

Procurement Professionals

Agile Product Cost Management

Product sourcing and lifecycle cost
& risk management

2008 Oracle Corporation Proprietary and Confidential

Agile Product
Collaboration
Enterprise product record
visibility, management &
collaboration

Demonstration Scenario
A live DHF/DMR system used to react quickly to issues with full
CAPA management in a single system
S00466
S00466

Stop
Stop Shipment
Shipment
C00570
C00570
Training
Training

CAPA00121
Improve System Flow Rate

CC00010
CC00010
Customer
Customer Complaint
Complaint

DMR5000

DMR4500

PR00121
PR00121
Failure
Failure Report
Report

C00570
C00570
Enlarge
Enlarge Case
Case
C00567
C00567
Increase
Increase Tubing
Tubing Strength
Strength

R00141
R00141
Increase
Increase Pump
Pump Output
Output

2008 Oracle Corporation Proprietary and Confidential

Demo

When the demo concludes:

1. Close the demo window
2. Click the play button below to continue

1,300+ Enterprise PLM Customers

GSK

Cisco

Apple
Coca Cola

Philip
Morris
International

2008 Oracle Corporation Proprietary and Confidential

Tyson
Foods

11

Agile Life Sciences Customers

Agile is the enterprise PLM market leader in medical device
with 170+ customers

2008 Oracle Corporation Proprietary and Confidential

12

Agile Medical Device Customer Results

Business Needs

Results with Agile

16 global sites, 48 document &

change management systems
Change cycle times of 2 weeks to up
to 24 weeks
Not compliant with FDA Parts 820
and 11

Reduced change cycle time by 52%

& administrative cost by 25%
Reduced scrap and rework by $2MM
per line
Passed regulatory audits with
minimal costs

NPD&I costs were 25% higher than

competition
Time to market was 20% slower
Michael Gallagher (CEO/CJO to VP
QA): Keep the feds out of my
office!

$2.7M labor efficiency

improvement
15% packaging development cost
savings
Low-cost compliance with FDA
regulations

Quickly incorporate acquisitions

Reduce lengthy product change
cycle times
Achieve compliance with FDA QSR
and Part 11

Reduced change cycle time by 90%

Achieved compliance with FDA
QSR /Part 11
Primary tool used in acquisitions
to leverage new IP

Bring innovative robotic surgery

technology to market first
Maintain compliance with regulatory
requirements

Brought first product to market 7

months ahead of competition
($18M in sales & market share)
Achieved compliance with FDA
QSR and Part 11 requirements

2008 Oracle Corporation Proprietary and Confidential

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Enabling Compliance with 21 CFR Part 11

Agile Capabilities
Security

All users must log into the system with an individual UserID and Password
Ability to access / modify/ change / approve product records are based on
roles and privileges
Change executions require double authentication which constitute the
electronic signature
Agile employs encryption technology from Verisign
Agile allows for configurable password management (e.g. password aging)

Audit Trail
Validation

2008 Oracle Corporation Proprietary and Confidential

All prior revisions of product records are maintained in Agile

History of all actions, including electronic signoff, can be displayed at the
application level and printed
Signoff information includes: Username, date/time stamp (local and/or
server time), action performed, and comments
Agile provides the Agile Validation Protocol Pak to assist Agile users in
validating their implementation of Agile software. This supports the
validation of Agile as a system that enables compliance with 21 CFR Part
11.

14

Requirements for Life Sciences PLM

Single, Secure Vault for all Product Record Components
Electronic NPI and Change Control Workflows
Inclusion of Trading/Development Partners
21 CFR Part 11 Compliance
Complete Audit Records and Accountability
Integrated Program Management
Closed Loop CAPA Management System
System Configurability
High User Acceptance Levels
Integration Platform
Quick System Validation
Vendor QSR for Product Development and Support

2008 Oracle Corporation Proprietary and Confidential

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Who
Benefits?
The challenge to accelerate more new products to market, while following all
necessary FDA compliant practices

Increase
Revenue

Rapidly introduce new

products

VP, Product Management

VP, Operations

Successfully leverage
acquisitions

VP, Product Management

VP, Operations
VP, IT

Increase patent
protection time
Increase
Shareholder
Value

Reduce Pack. Mgmt.

Costs
Decrease
Operating
Costs

CEO
or
Division
President

Reduce Direct
Material Costs
Seek cost efficiencies
via Outsourcing

VP, Operations or Manufacturing

VP, Engineering
VP, Sourcing or Supply Chain
VP, Supply Chain Management

Increase re-use of IP
Ensure Product
Safety
Protect
customer,
company
and self

Ensure
Regulatory
Compliance
Ensure ability to
react to Adverse
Event

2008 Oracle Corporation Proprietary and Confidential

Maintain control
of documentation
Maintain compliance
of processes

VP, Quality Assurance

VP, Regulatory Affairs

Maintain compliance
of systems

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Why Agile PLM

1

Business Ready Applications

Out-of-the-Box, Configurable Applications
Fastest Time-To-Implement & Lowest Overall TCO

Broadest Enterprise PLM Solution Footprint

Broadest footprint, strongest adoption outside mechanical engineering
Supply chain, electronics, cost, quality, compliance, portfolio, decision support

Industry Domain Expertise & Best Practices

3

4
5
6

PLM market leader with focus & presence across key Industries
(Electronics & High Tech, Medical Device, Consumer Packaged Goods, Industrial Products )
Deep domain expertise & best practices developed working with 1300+ customers

Customer Success
Best track record for customer success & referenceability in PLM
Fastest TTV, Lowest TCO, Lowest Risk

CAD & ERP Agnostic; 100% Enterprise PLM Focused

MCAD, ECAD, SW Integration Breadth; CAD & ERP agnostic approach

Product Network Built & Proven

Built for collaboration across enterprise & product network since inception
Mature, out-of-the-box network capabilities; 100s of live product network customers

2008 Oracle Corporation Proprietary and Confidential

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Q&
A
QUESTIONS
ANSWERS

2008 Oracle Corporation Proprietary and Confidential

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