Optimize New Product Development. Presenter s Name Presenter s Title

Transcription

1 Optimize New Product Development Presenter s Name Presenter s Title

2 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 Oracle s products remains at the sole discretion of Oracle. 2

3 Agenda Leadership in the Medical Device Industry Innovation in Medical Device Solutions Results Achieved by Oracle Customers 3

4 Oracle in Life Sciences Did You Know? 10 of the top 10 medical device companies run Oracle Applications 10 of the top 10 medical device companies run Oracle Technology 7 of the top 10 in vitro diagnostic companies run Oracle Applications 10 of the top 10 contract research organizations (CRO) run Oracle Applications 4

5 The Challenges We re Hearing Product Innovation How can I keep pace with new medical technologies, competitive offerings, and medical market demands to maximize revenue and profits? Rising to meet the demands for innovation R&D expenditures, have risen from 5.4% to over 12% Navigant Consulting Mar 05 Compliant & Cost Efficient Manufacturing How can my organization meet the increasing regulatory compliance demands while improving product quality and improving product profitability? Corrective and preventive action, complaint handling, and quality processes are among the most common sources of deficiencies cited in FDA inspections of device companies Centers for Devices and Radiological Health Feb 06 Customer Centricity How can I increase the efficiency of my sales, marketing and service organizations to provide greater value to our customers and maximize revenue growth? As high-technology medical supplies reach 40% of a hospital s overall supply budget, medical device companies must develop the sales and marketing tools needed to overcome customer concerns and skepticism Healthcare Financial Management Association Oct 06 5

6 The Challenges We re Hearing Product Innovation How can I keep pace with new medical technologies, competitive offerings, and medical market demands to maximize revenue and profits? Rising to meet the demands for innovation. R&D expenditures, have risen from 5.4% to over 12% Number of new product submissions have generally been declining FDA New Product Submissions PMA 510K IDE HDE Source: Center for Devices and Radiological Health, Food and Drug Administration 6

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8 Agenda Leadership in the Medical Device Industry Innovation in Medical Device Solutions Results Achieved by Oracle Customers 8

9 Optimize New Product Development Requirement Oracle Capability The Oracle Difference Optimize scarce resources across development project portfolios Enterprise Level Project and Portfolio Resource Management Single project repository that supports global projects with integrated project management and collaboration within the enterprise Provides an integrated portfolio, project, resource, and financial management solution Advanced Product Catalog and Collaborative Design Only solution that consolidates product, design, mfg, service and labeling information in a single compliant hub Manage numerous trials simultaneously in a regulatory compliant manner Clinical Trial and Data Management Market leader in clinical data and clinical trial management 9

10 Optimize New Product Development Requirement Oracle Capability The Oracle Difference Optimize scarce resources across development project portfolios Enterprise Level Project and Portfolio Resource Management Single project repository that supports global projects with integrated project management and collaboration within the enterprise Provides an integrated portfolio, project, resource, and financial management solution Advanced Product Catalog and Collaborative Design Only solution that consolidates product, design, mfg, service and labeling information in a single compliant hub Manage numerous trials simultaneously in a regulatory compliant manner Clinical Trial and Data Management Market leader in clinical data and clinical trial management 10

11 Enterprise Level Project and Portfolio Resource Management Manage Full Lifecycle with Integrated Project Information Delivers on time and within budget by providing timely and aggregated project information Continuously improves project quality by leveraging standard processes Reduces financial and project risk through more accurate and efficient forecasting Improves margins by increasing visibility into change impact Increases customer satisfaction through timely communication Project Manager Team Members Executives Role-Based Access Integrated Intelligence Establish plan Assign resources Automatically create budget & forecast Financial Systems Plan View progress Manage changes Forecast at completion HR System Control Complete deliverables Share documents Raise issues Update progress Execute Manage performance & exceptions Communicate status Scheduling / Estimating Tools 11

12 Resource Management Leverage Resources Across the Global Enterprise Optimizes utilization by efficiently matching available resources to open requirements Project Demand Utilization & Availability Tracking, Workforce Development Increases responsiveness by quickly identifying and deploying employees and contingent workers to global projects Lowers administrative effort by streamlining deployment process Resource Supply Self-Service Entry Define Demand Utilization / Forecasting Search Resources Workflow Automation Secure Access Single Repository Nominate Candidates Collaborative Staffing Deploy Global Projects Execute Lowers costs by leveraging and consolidating procured materials, equipment and contractors across global projects Project Manager Staffing Manager Resource Manager Team Membe r Partner 12

13 Collaboration Access Personalized, Secure, and Current Information Shortens delivery time by providing a single, secure and structured workspace for global teams Reduces costly errors by ensuring globally dispersed team members are working with latest project information Increases responsiveness by quickly raising and addressing issues Lowers project costs by reducing need for expensive face-to-face meetings, rush deliveries and travel Project Managers Employees Subcontractors and Partners Customers Structured Project Workspace Coordinate work Complete deliverables Share documents Resolve issues with deliverables 13

14 Oracle Project Collaboration Tools Internal Web-Based Access Collaboration Services Mfg Engineering External All Other Depts Project Data CAD Designs Specifications Docs / Files s Voice Messages Document Management Issue / Change Management Suppliers Customers Partners Web-Based Access New Product Introduction Role-Based Security Scheduling, Web Conferencing, CAD Review Share the right information, with the right people, at the right time by automating & optimizing collaborative business processes. 14

15 Portfolio Analysis Align Organizational Goals and Resources Better evaluate capital requests by aggregating business planning assumptions Proactively eliminate resource bottlenecks by balancing resources, timing and funds Plan for contingencies through What If scenarios Create recommendations for implementation of approved portfolio Monitor Portfolio Plan Portfolio Execute Portfolio Portfolio Management Define Standard Objectives Determine Project Costs and Requirements Score and Rank All Projects Balance Portfolio Approve & Launch Portfolio 15

16 Optimize New Product Development Requirement Oracle Capability The Oracle Difference Optimize scarce resources across development project portfolios Enterprise Level Project and Portfolio Resource Management Single project repository that supports global projects with integrated project management and collaboration within the enterprise Provides an integrated portfolio, project, resource, and financial management solution Advanced Product Catalog and Collaborative Design Only solution that consolidates product, design, mfg, service and labeling information in a single compliant hub Manage numerous trials simultaneously in a regulatory compliant manner Clinical Trial and Data Management Market leader in clinical data and clinical trial management 16

17 Accelerate New Product Introduction Shorten Time to Market for New Product Launches New Product Definition & Approval Process Gather New Product Ideas and Requests Capture ideas / issues from multiple sources Enforce corporate best practices for repeatable processes and highest quality Provide audit trail to meet regulatory requirements Evaluate Product Ideas to Assess Viability and Feasibility Define Product with Input from Experts in Cross-Functional Groups Execute Product Development Project Prepare for Product Manufacturing and Launch Route for analysis Capture evaluation details Automatically route concurrent requests for definition & approval Manage tasks and deliverables Coordinate progress and status reporting Capture all product information in single repository Share information with value chain 17

18 Oracle s Product Lifecycle Mgmt Solution Internal Portfolio Management Product Intelligence Engineering Manufacturing Sales & Mktg Purchasing Service Finance External Customers Specifications Drawings Schedules Issues Ideas Changes C o l l a b o r a t i o n Maintenance Retire Volume Production Ramp-up Concept Product Data Repository Design Release Prototype & Test N e w P r o d u c t I n t r o Phase-Gate Control Design for SC & Compliance BOM Mgmt & Release Component Sourcing Sales Configuration Issue/Change Management (Point-to-point or via PIM Data Hub) Suppliers Contract Mfgrs Engineering / MES ERP CRM Commerce Customers / Suppliers 18

19 Enterprise Product Data Management Manage and Leverage All Types of Information Related to a Device External Data Sources Product Data Structured Processes Security & Collaboration Data Users Requirement Mgmt System Attributes Policies Catalogs Search Online / Print Catalogs Configurations Relationships CAD Application Word docs Spreadsheets Lifecycle Management Customers & Suppliers MES PDFs (data sheets) Unstructured Images, CAD dwgs Change/ Configuration Management Internal Systems Manages structured and unstructured data Integrates to external product data sources* Provides data management processes Delivers data to internal & external users 19

20 Structured and Unstructured Data Support All Types of Information Related to Device Structured Data Captures operational information and specifications Manages product configurations Attributes Policies Catalogs Defines policies for product change and approval Configurations Relationships Manages an item s relationship with trading partners & locations Word docs Spreadsheets PDFs (data sheets) Images, CAD dwgs Unstructured Data Attaches documents to an item, BOM, or change order Check-in / out documents with version history Searches documents based on content or its attributes 20

21 Medical Device Master Catalog Classify All Products and Components to Enable Genealogy Tracking H ie r a r c h y Category Electronic Components Part # Manufacturer Price Attribute N Category Category Attributes User-defined category hierarchy User-defined attributes for each category Category Resistors Category Capacitors Attribute inheritance for easy maintenance Part # Manufacturer Price Attribute N Ohms Part # Manufacturer Price Attribute N Microfarads Inherited Attributes Unique Attributes Assign products and components to categories 21

22 Design Data Integration Enrich Product Data to Create Single, Complete Medical Device Record Design Apps MCAD ECAD Design Data Managers Integration Product Data Repository Item Specs ebom Published Models Sourcing Info Mfg Process Plng Quality / Testing Sales Configuration mbom Non-CAD Docs S/ware Authoring Integrates directly with design data managers for parts, specs, and structure data Publishes items and structure / BOM from viewable MCAD models Cleanses, match and blend incoming part specification and design data Retains existing design data sources for Work In Progress CAD file management Pro/INTRALINK Teamcenter Co-Create Visual Source Safe ProCAD Etc. 22

23 Document Tracking, Sharing, Approvals Improve Efficiency, Reduce Review Time and Maintain Document History Record Electronic Routing Person A Person B Person C Person D Establishes shared document repository for project team Use PLM Document Mgmt w/ Oracle Content DB Integrate with legacy enterprise document repositories Organizes via foldering and versioning Controls documents with secured check-in and check-out Route documents for review and approval Collaboratively reviews CAD data in real-time via CADView-3D streaming 23

24 Mfg Readiness -- BOM Management Effectively Author and Change eboms / mboms CAD Application Prototype Manufacturing Mfg Process Planning ebom mbom Quality Control Design System Integrated BOM Repository Sales Configuration Speeds BOM creation with drag and drop tools Accesses key product information directly from single UI Increases visibility to pending changes via red-lines for incorporating in mfg & design Enforces ebom and mbom change control based on item change policies by phase Imports product and structure information from CAD and design systems 24

25 Accelerated New Product Introduction Transition Smoothly from Design to Production Manufacturing Process Planning Define routing based on mbom Model linear, network, and flow routings Define / roll-up lead-times for supply chain and assembly operations Prototype Manufacturing Track prototype and first article builds as project work orders Collect parametric data for process improvements Capture issues and ideas for design and mfg improvements Quality Control Collect, distribute & analyze quality data in your supply chain Determine root cause with statistical analysis 25

26 Optimize New Product Development Requirement Oracle Capability The Oracle Difference Optimize scarce resources across development project portfolios Enterprise Level Project and Portfolio Resource Management Single project repository that supports global projects with integrated project management and collaboration within the enterprise Provides an integrated portfolio, project, resource, and financial management solution Advanced Product Catalog and Collaborative Design Only solution that consolidates product, design, mfg, service and labeling information in a single compliant hub Manage numerous trials simultaneously in a regulatory compliant manner Clinical Trial and Data Management Only combined clinical data management & electronic data capture solution 26

27 Siebel Clinical A Closed Loop Process Site Coordinator Reviews the Clinical site portal Enters subject information Views payment details Creates a Medical Information Request Reviews Med Ed Events Clinical Research Associate Discovers, assess Investigators Reviews site activities and protocol execution Enrolls subjects Site monitoring and trip report creation Generates payments Targeted Recruitment Global Trial Support Project and Logistics Management Streamlined Visit Reporting Compliance Clinical Director Reviews Clinical Programs Manages Global Projects Monitors Protocol execution Monitors/maintains team associated with Protocol Views subject screening & enrollment info Tracks payment information across all programs, protocols, and sites Study Manager Reviews and updates the Protocol details Sets up Site visit (protocol) templates for Site Initiation, Trip Report templates, CRA activity templates Monitors Subject recruitment 27

28 Project and Logistics Management Approach Outcome Maps a project plan with timelines and milestones based on past experience and industry benchmark Collects data as trial progresses Compares actual against planned, making adjustment as necessary (re-project) Leverages MS Project when desired Able to monitor project timelines & milestones in real time and against project plan; able to adjust quickly when slippage occurs Optimize resource allocation based on skills, availability and anticipated workloads 28

29 Fully Integrated Clinical Data Management and Electronic Data Capture Clinician Oracle Remote Data Capture Data Collection Study Design and Management Study Data Definition Study Conduct and Validation Data Access and Reporting Review Data Manager Monitor Review/Verify Data Discrepancies Oracle Clinical Approve Review/Verify Monitor Investigator 29

30 Accelerate CRF* Data Capture and Improve Accuracy Oracle Remote Data Capture *CRF = Case Report Form Enables direct, online entry of data instead of re-typing from handwritten notes or forms Easy access, completely web based. Displays electronic CRFs format with the same look and feel of paper version Flags incomplete or incorrect entries in real-time for immediate correction Provides easy-to-use UI designed with medical users in mind to manage electronic CRF creation and submission Maintains audit trail for all changes made to entries to support compliance with 21 CFR Part 11 30

31 Oracle Medical Device Solutions Summary Enterprise Level Project and Portfolio Resource Management Advanced Product Catalog and Collaborative Design Single project repository that supports global projects with integrated project management and collaboration within the enterprise Only solution that consolidates product, design, mfg, service and labeling information in a single compliant hub Clinical Trial and Data Management Only combined clinical data management & electronic data capture solution 31

32 The Only Complete Life Sciences Solution Platform Processes Customer Results People Partners 32

33 33 Medical Device Process Footprint

34 Market-Leading Middleware Platform Best-Selling 32,000+ Customers Deployed 70% of World s s 50 Largest Firms $1B+ Business Highest Rated Only vendor in Gartner and Forrester leader quadrants for all Middleware components. Most Comprehensive Source: Forrester Research ranking of Application Platform Servers, April 2005 SOA Vendor of Choice 34

35 Oracle s People Advantage 220,000 database customers 1700 application ISVs 30,000 applications customers 275,000 customers benefiting from shared innovation 30,000 middleware customers 29,000 developers, support engineers and consultants 1300 participants in early customer adoption programs 5000 middleware ISVs 950 customers participating in Customer Advisory Boards 9000 database ISVs 35 Fusion strategy council members 425 user groups 500 Industry & Product strategy council members 35

36 Agenda Leadership in the Medical Device Industry Innovation in Medical Device Solutions Results Achieved by Oracle Customers 36

37 What Customers are Achieving implemented electronic quality processes supporting edhr, encr and eres with Oracle e-business Suite implemented product data hub for maintaining enterprise wide product and label attributes 37

38 The Oracle Difference Only Oracle Single project repository that supports global projects with integrated project management and collaboration within the enterprise Only solution that consolidates product, design, mfg, service and labeling information in a single compliant hub Only combined clinical data management & electronic data capture solution 38