How PLM can improve NPI, reg compl and … Microsoft PowerPoint - How PLM can improve NPI, reg compl...
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For internal use only / Copyright © 2007 UGS Corp. All rights reserved.
Siemens PLM Software
Copyright © Siemens AG 2008. All rights reserved.
James B. Thompson, Ph.D.Americas Sales & ServicesDirector, Healthcare Industry Solutions
How PLM can Improve NPI, Regulatory Compliance & Quality Control
2008 Medical Industry Forum 30th April 2008
Page 2 Mar-07For internal use only / Copyright © 2007 UGS Corp. All rights reserved. All rights reserved
UGS PLM SoftwareAuthor
Agenda
1. Medical Device Industry - Value Drivers & Impediments
2. PLM Solution Strategy
3. Overview of Siemens PLM Technology & Solutions
4. Global MDI Customers – Leveraging Solutions across Industries
5. Summary Siemens PLM Answers
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UGS PLM SoftwareAuthor
Medical Device IndustryValue Drivers & Impediments
Value
Increase Revenue
Decrease Risks
Value Creation
IncreaseInnovation
Improve Quality /Regulatory Compliance
ManageProduct Liability
DecreaseTime to Market
Business Value Drivers
ContainCosts
GlobalizeNPD & Manufacturing
Typical Impediments
• Lack of control and visibility to R&D activities throughout the extended enterprise.
• Multiple inconsistent business processes, and silos of product and mfg process data.
• Missing links that accurately trace from customer requirement thru design inputs to product & mfg process specs.
• Lack of formalization & capture of intellectual property and specialized technical knowledge.
• Product & mfg process performance problems discovered late in the development cycle.
• Non-scalable inefficient systems for Knowledge Mgmt, Change Control, and Quality Management
For internal use only / Copyright © 2007 UGS Corp. All rights reserved.
Solution Strategy for the Medical Industry:Holistic, Completely Integrated, End–to–End
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Typical Present Day Medical Device Company Scenario: Document-centric with Multiple IT Systems
Component Drawings
Component Drawings
Product Requirements
Product Requirements
Design Specifications
Design Specifications
ToolingTooling
Production Records
Production Records
Process Plans
Process Plans
ProductProduct
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PLM Strategy: Holistic, Integrated, End-to-EndVisibility, Traceability & Change Mgmt
CAPA
NCR
Complaints
AdverseEvents
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Vision of the Future – Available Today“Single Source of the Truth”
PartsAsm’s
Device Rev DMR/DHFSchedule
Change Request
Complaints
Mfg Process Plan
CAPA
Requirements
DeviceMaster
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Agenda
1. Medical Device Industry - Value Drivers & Impediments
2. PLM Solution Strategy
3. Overview of Siemens PLM Technology & Solutions
4. Global MDI Customers – Leveraging Solutions across Industries
5. Summary Siemens PLM Answers
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Siemens PLM Software Product Portfolio
DIGITAL PRODUCT DEVELOPMENTDesign & engineer better products faster...
DIGITAL MANUFACTURINGBuild & support products more efficiently...
DIGITAL LIFECYCLE MANAGEMENTCollaborate & innovate more intelligently...
PLM FOR MID-SIZED COMPANIESGet on the fast track to a PLM strategy...
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NX Digital Product Development Solutions
Styling Design Documentation
Simulation Tooling Machining
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Tecnomatix Digital Manufacturing Solutions
Part Assembly Resource
Human Quality Production
Plant
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Teamcenter Digital Lifecycle Management Solutions
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Modularity of Siemens PLM Solutions“Add on functionality as you want it”
CAD, Drawing, and BOM ManagementCAD, Drawing, and BOM Management
Regulatory Regulatory DocMgmtDocMgmt + FMEA DHF DMR CAPA Processes+ FMEA DHF DMR CAPA Processes
Mfg: BOM, CNC, Routings, Work Mfg: BOM, CNC, Routings, Work InstrInstr..
Implementation Plan
Val
ue
Time
NonNon--Conformance ReportingConformance ReportingPortfolio & Project MgmtPortfolio & Project Mgmt
VOC Requirements MgmtVOC Requirements Mgmt
Engineering Change MgmtEngineering Change Mgmt
Global Collaboration with 2D & 3D VisualizationGlobal Collaboration with 2D & 3D Visualization
Initi
al D
eplo
ymen
tFu
ture
Pro
ject
sFu
ture
+ 1
Build to orderBuild to order
MES MES & & eDHReDHR
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UGS PLM SoftwareAuthor 14UGS Confidential
Globally Scalable Deployment
Satellite Site
Lead Site
Supplier Site
Web ServerWeb Server
Business LogicBusiness LogicServerServer
DatabaseDatabaseServerServer
File ServerFile Server
Web ServerWeb Server
Business LogicBusiness LogicServerServer
DatabaseDatabaseServerServer
File ServerFile Server
Web ServerWeb Server
Business LogicBusiness LogicServerServer
DatabaseDatabaseServerServer
File ServerFile Server
LocalLocalClientsClients
Remote ClientsRemote Clients
Controlled LocalControlled LocalFile ServerFile Server
Controlled LocalControlled LocalFile ServerFile Server
Controlled DMZControlled DMZFile ServerFile Server
Server / Server connectionServer / Server connection
Client / Server connectionClient / Server connection
Intra-Company Inter-Company
Controlled LocalControlled LocalFile ServerFile Server
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Leverage Medical Device Best Practice Across Industries
powerAero / Defense
Machinery / Heavy Equp
Automotive
Hi Tech / Consumer
Health-care
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Medical Device IndustryValue Drivers & Impediments Siemens Answers
IncreaseInnovation
Improve Quality /Regulatory Compliance
ManageProduct Liability
DecreaseTime to Market
Business Value Drivers
ContainCosts
GlobalizeNPD & Manufacturing
Typical Impediments
• Lack of control and visibility to R&D activities throughout the extended enterprise.
• Multiple inconsistent business processes, and silos of product and mfg process data.
• Missing links that accurately trace from customer requirement thru design inputs to product & mfg process specs.
• Lack of formalization & capture of intellectual property and specialized technical knowledge.
• Product & mfg process performance problems discovered late in the development cycle.
• Non-scalable inefficient systems for Knowledge Mgmt, Change Control, and Quality Management
Single Integrated System
End-to-End Visibility
End-to-End Traceability
End-to-End Change Mgmt
Product –focused &Mfg Process- focused Applications
Globally Scalable Deployment