Wind River For Medical

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  • Wind River is a global company building on a heritage of success. Founded in `81 as an embedded systems consulting firm, we went public in ’93 and now operate as a wholly-owned subsidiary of Intel Corporation since 2009. Best known for just our operating systems, our software is actually under the hood in equipment that impacts your lives daily. You’ll notice a theme of safety and security in the markets we serve, and we’ve developed a broad portfolio of products and services around that, with the most extensive partner ecosystem in the industry.
  • Lastly back to our “4-step program” to overcome interoperability barriers, it’s important for medical device manufacturers to ensure they work with qualified, reliable vendors, particularly those experienced with stringent quality and regulatory requirements. It’s also important that your vendors don’t stand alone in their field, as cross-functional partnerships are critical to success in building complex embedded systems.
  • Thank you so much for your time and interest. Any questions or comments or feedback?
  • More than 1 billion products worldwide across every industry segment rely on Wind River technology. And that number is growing exponentially.
  • Wind River For Medical

    1. 1.  VxWorks, Linux, Android  Simulation, Test Management  Hypervisor (Virtualization)  CMMI-certified Development and Professional ServicesAerospace and Defense Automotive Industrial Controls Mobile and Consumer Network and Telecom Medical Devices 1 | © 2012 Wind River. All Rights Reserved.
    2. 2. Wind River in Medical Equipment An Abbreviated List…2 | © 2012 Wind River. All Rights Reserved.
    3. 3. Medical Market Trends ∑ Cost Pressures + Interoperability + Safety/Security ═ Disruptive Opportunities  Operation and buying cost  Diagnostics, therapy, a  Few devices get  Complexity is managed of high-end devices are nd imaging are approval. Assessment is through consolidation under intense pressure. connected in the uncertain; too many Hospital Information devices fail after market.  Focus drives growth  Diagnostics and economy System (HIS). drive the need for  Compliance is not an  Local products for local scalability and high  Connectivity drives option anymore. Liability market needs throughput (lower average down operating costs are high.  Consumer and medical diagnostic time). expense, but devices technologies merge at are not ready to be  Security impacts safety. mHealth exposed.3 | © 2012 Wind River. All Rights Reserved.
    4. 4. Wind River in the Medical Value Chain Embedded System Contract Hospital Silicon Design Manufacturing CIO Software Medical Device OEM4 | © 2012 Wind River. All Rights Reserved.
    5. 5. Project / Process Excellence Mapping to IEC62304 CMMI Level 3+ Rated TRACE  Project Management Process Requirements Design Process Implementation Test Functional Requirements Design Documents Coding/Schematics Engineering Tests Market Requirements Modeling Systems Integration Compliance Tests Specifications Project Planning Defect Management Test Runs Test Coverage Requirements Bugs Actions Risks Test Plans Design Reviews Test Runs IssuesTRACE integrates all phasesof a development project 5 | © 2012 Wind River. All Rights Reserved.
    6. 6. 6 | © 2012 Wind River. All Rights Reserved.
    7. 7. 7 | © 2012 Wind River. All Rights Reserved.
    8. 8. 8 | © 2012 Wind River. All Rights Reserved.
    9. 9. Wind River in Medical Wind River partners with leading medical companies to develop innovative products. Our platform for medical devices is targeted to companies in the imaging, therapy and m-Health segments, it is THE platform for healthcare innovation. This safe, secure and interoperable platform complies with FDA and IEC regulations for a commercial off the shelf software vendor. In addition, WR services and lifecycle management tools enable you to accelerate product development and improve quality and reliability. Our world class support organization supports you through the life cycle of your products.9 | © 2012 Wind River. All Rights Reserved.
    10. 10. Wind River Products and Services Designed to address both technology and process VxWorks, Linux, Android Operating Systems – Industry-leading Safety and Security Certifications – Google partnership, first Android commercialization Wind River Hypervisor Wind River Test Management – Coverage-based testing fits well with FDA validation guidance Wind River Simics – Complex system simulation with powerful debug capabilities Product Realization Services – Consulting, Architecture, Team augmentation, Turnkey Design, debug10 services | © 2012 Wind River. All Rights Reserved.
    11. 11. WR Professional Services Architectural Consulting & Planning Services • Architectural Studies & Technology Migration Planning VxWorks 5 / 6 Platform Services (DO-178B, IEC 61508) • Application and Middleware development VxWorks 653 • Porting, Integration and Migration Services (DO-178B) • Kernel, OS, Hypervisor Customization, Acceleration & Optimization VxWorks MILS • BSP, Drivers, Bootloaders (Common Criteria) • UI/UX Customization Wind River Linux Turn-key Product Development Services (HW & SW) (Common Criteria) • Turnkey Product Design and Manufacturing insertion WR Android Platform FAST IP Management Services • Long term Customized Platform Management Certification Services • Systems Safety & Security Consulting (IEC61508, DO178, MILS) Tooling Services Work Bench • Workbench Customization and Integration Simics • Simics Modeling, Integration and Consulting Services • TM Methodology Consulting and Integration Services Test Management11 | © 2012 Wind River. All Rights Reserved.
    12. 12. Core Values and World Wide Presence Wind River Solutions and Services has 550+ engineers worldwide with deep knowledge in Embedded software solutions on Linux, VxWorks and Android across the following verticals:  Mobile  Automotive  Medical  Industrial  A&D  Networking Additionally, WR Services provides expert knowledge in Simics, Product Enabling (BSP’s for VxWorks and Linux) as well as advanced Project Management capabilities.12 | © 2012 Wind River. All Rights Reserved.
    13. 13. Professional Services Engagement Process Establish Vision-Match Set Objectives Project Execution Financial Agreement Your needs Phase 1 Engagement Master Services Our Capabilities Project Scope, Agreement Schedule Staffing, Planning Explore Synergies Statement of Work Program Management Budget Estimate (ROM) Proposal Ratings & Performance13 | © 2012 Wind River. All Rights Reserved.
    14. 14. Services Global Presence  550+ Engineers Worldwide  Undisputed Worldwide Leader for RTOS and Embedded Linux: > 35%14 | © 2012 Wind River. All Rights Reserved.
    15. 15. Medical Equipment Market Trends  Becoming Agile  Multi Core/Multi OS Multicore Virtualization Linear APP APP APP OS OS OS Iterative Hypervisor Core 1 Core 2 ContinuousFeedback15 | © 2012 Wind River. All Rights Reserved.
    16. 16. Trends to Leverage  Embedded Virtualization – Enables scalability, configurability (device sharing/isolation) – Hypervisor speeds legacy migration to multicore – Improves development isolation  Shrinkage – Parallel interfaces serialize – Form Factors getting smaller – Compute density increases16 – IO moves into CPU | © 2012 Wind River. All Rights Reserved.
    17. 17. Benefits of Hardware Consolidation  Lower CAPEX – Reduce boards, power supplies, fans, cabling – Drive sharing may reduce storage costs – Switches become virtual switches – Configure firewall into OS?  Lower OPEX – Power savings may be radical – Aggregate and lengthen MTBF – Faster problem resolution17 | © 2012 Wind River. All Rights Reserved.
    18. 18. Financial Analysis Original Item Description Qty Each $ Ext $ Notes PASY, MTBD, P45MX, P4-3.4 GHZ 1 $827.80 $827.80 Acq. Server Motherboard (Linux) PASY,PC,EPIC-500MHZ,128MB-CFGD 1 $397.44 $397.44 Gantry PC Motherboard (VxWorks) PASY,PC/104,CAN 2-CHANNEL COMM 1 $106.36 $106.36 CANcard PCBA,PWR,I/O,CAN INTERFACE 1 $99.75 $99.75 ? VxWorks PL 1 $100.00 $100.00 lot of 150 licenses $1,431.34 Replacement Item Description Qty Each $ Ext $ Notes PASY, MTBD, CP330-NRM, ITOX 1 $335.00 $335.00 Acq. Server Motherboard (Linux) CPU, Intel Core I5 520M 2.40 GHz 1 $225.00 $225.00 4G DDR3 memory 1 $60.00 $60.00 PASY,USB to CAN, USB2-F-7001, EasySYNC 1 $110.00 $110.00 USB to CAN adapter PASY,USB to Serial, USBG-4X-RS232, CableMax 1 $69.98 $69.98 USB to serial adapter VxWorks PL 1 $150.00 $150.00 muticore license fees Hypervisor PL 1 $100.00 $100.00 Hypervisor fee for <=250 units $799.98 Cost Reduction: $1,431.34 $799.98 $631.36 44.11% Virtualization literally cuts compute costs in half.18 | © 2012 Wind River. All Rights Reserved.
    19. 19. Software Development Benefits  True software separation  Decoupled dependencies  Independent development App App App App OS 1 OS 2 Middleware Middleware Hypervisor OS 1 OS 2 Core 1 Core 2 Target 1 Target 219 | © 2012 Wind River. All Rights Reserved.
    20. 20. Medical Equipment Market Trends  Becoming Agile  Multi Core/Multi OS Multicore Virtualization Linear APP APP APP OS OS OS Iterative Hypervisor Core 1 Core 2 ContinuousFeedback20 | © 2012 Wind River. All Rights Reserved.
    21. 21. What is Test Management?  Enables coverage-driven verification and testing – Proprietary technology allows coverage on production code  Optimizes test suite generation – Measure functional differences between software builds – Maps changes to test cases to optimize test execution  Provides a platform for Development to interact with Test – Allows LIVE changes to code on running production code  Deploys common execution and test framework – Consistency in testing methodology – Test case management and assignment21 | © 2012 Wind River. All Rights Reserved.
    22. 22. Olympus Surgical Technologies IEC 62304 Class B use case  Features: – Support to meet “Off-the Shelf Software Use In Medical…” – IEC 62304 Class B, material relevant to and used for FDA  Key Advantages using Test Management – Time To Quality accelerated by 30-40% – Time To Approval accelerated by 30-40% – Improved “sharpness” of test cases  White box tests during integration and system test  Error injection & boundary condition tests  Full test coverage during black box testing  Faster Time To Market with lower cost22 | © 2012 Wind River. All Rights Reserved.

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