How PLM can improve NPI, reg compl and … Microsoft PowerPoint - How PLM can improve NPI, reg compl...

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

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



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


Solution Strategy for the Medical Industry:Holistic, Completely Integrated, End–to–End



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



PLM Strategy: Holistic, Integrated, End-to-EndVisibility, Traceability & Change Mgmt

CAPA

NCR

Complaints

AdverseEvents



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



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



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...



NX Digital Product Development Solutions

Styling Design Documentation

Simulation Tooling Machining



Tecnomatix Digital Manufacturing Solutions

Part Assembly Resource

Human Quality Production

Plant



Teamcenter Digital Lifecycle Management Solutions



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


UGS PLM SoftwareAuthor 14UGS Confidential

Globally Scalable Deployment

Satellite Site

Lead Site

Supplier Site

Web ServerWeb Server

Business LogicBusiness LogicServerServer

DatabaseDatabaseServerServer

File ServerFile Server









LocalLocalClientsClients

Remote ClientsRemote Clients

Controlled LocalControlled LocalFile ServerFile Server


Controlled DMZControlled DMZFile ServerFile Server

Server / Server connectionServer / Server connection

Client / Server connectionClient / Server connection

Intra-Company Inter-Company




Leverage Medical Device Best Practice Across Industries

powerAero / Defense

Machinery / Heavy Equp

Automotive

Hi Tech / Consumer

Health-care



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


Q & A

What do you think?

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