VxWorks, Linux, Android Simulation, Test Management Hypervisor (Virtualization)
CMMI-certified Developmentand Professional Services
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Aerospace and Defense Automotive Industrial Controls Mobile and Consumer Network and Telecom Medical Devices
Medical Market Trends
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Cost PressuresCost Pressures InteroperabilityInteroperability Safety/SecuritySafety/Security
Operation and buying cost of high-end devices are under intense pressure.
Diagnostics and economy drive the need for scalability and high throughput (lower average diagnostic time).
Diagnostics, therapy, and imaging are connected in the Hospital Information System (HIS).
Connectivity drives down operating expense, but devices are not ready to be exposed.
Few devices get approval. Assessment is uncertain; too many devices fail after market.
Compliance is not an option anymore. Liability costs are high.
Security impacts safety.
∑﴾∑﴾ ++ ++ ﴿﴿ DisruptiveOpportunitiesDisruptiveOpportunities
Complexity is managed through consolidation
Focus drives growth
Local products for local market needs
Consumer and medical technologies merge at mHealth
══
Wind River in the Medical Value Chain
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EmbeddedSilicon
SystemDesign
Contract Manufacturing
HospitalCIO
Software MedicalDevice OEM
TRACE
Project / Process Excellence Mapping to IEC62304
Project Management Process
Engineering TestsCompliance TestsTest RunsTest Coverage
TestDesign DocumentsModelingProject Planning
Design ProcessCoding/SchematicsSystems IntegrationDefect Management
Implementation
Issues
RisksTest Runs
ActionsTest Plans
Design ReviewsTRACE integrates all phases of a development project
Bugs
Functional RequirementsMarket RequirementsSpecifications
Requirements
Requirements
CMMI Level 3+ Rated
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1 billion products worldwiderely on Wind River technology.
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.
Wind River in Medical
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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, debug
services| © 2012 Wind River. All Rights Reserved.
WR Professional ServicesArchitectural Consulting & Planning Services
• Architectural Studies & Technology Migration Planning
Platform Services• Application and Middleware development• Porting, Integration and Migration Services• Kernel, OS, Hypervisor Customization, Acceleration & Optimization• BSP, Drivers, Bootloaders• UI/UX Customization
Turn-key Product Development Services (HW & SW)• Turnkey Product Design and Manufacturing insertion
IP Management Services• Long term Customized Platform Management
Certification Services• Systems Safety & Security Consulting (IEC61508, DO178, MILS)
VxWorks MILS (Common Criteria)
VxWorks 5 / 6(DO-178B, IEC 61508)
VxWorks 653(DO-178B)
Wind River Linux(Common Criteria)
WR Android PlatformFAST
Tooling Services• Workbench Customization and Integration• Simics Modeling, Integration and Consulting Services• TM Methodology Consulting and Integration Services
Work Bench
Simics
Test Management
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Core Values and World Wide PresenceWind 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.
| © 2012 Wind River. All Rights Reserved.12
Professional Services Engagement Process
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Project Execution
Master Services Agreement
Financial Agreement
Staffing, Planning
Program Management
Ratings & Performance
Your needs
Our Capabilities
Explore Synergies
Budget Estimate (ROM)
Establish Vision-Match Set Objectives
Project Scope, Schedule
Statement of Work
Proposal
Phase 1 Engagement
Services Global Presence
| © 2012 Wind River. All Rights Reserved.14
550+ Engineers Worldwide Undisputed Worldwide Leader for RTOS and Embedded Linux:
> 35%
15 | © 2012 Wind River. All Rights Reserved.
Medical Equipment Market TrendsL
inea
rIt
erat
ive
ContinuousFeedback
Becoming Agile
OS OS
Hypervisor
Core 2Core 1
Multicore Virtualization
OS
APP APPAPP
Multi Core/Multi OS
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Trends to Leverage Embedded Virtualization
– Enables scalability,configurability (device sharing/isolation)
– Hypervisor speedslegacy migration to multicore
– Improves development isolation
Shrinkage– Parallel interfaces serialize– Form Factors getting smaller– Compute density increases– IO moves into CPU
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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 resolution
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Financial Analysis
| © 2012 Wind River. All Rights Reserved.
Virtualization literally cuts compute costs in half.
Original Item Description Qty Each $ Ext $ NotesPASY, 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 CANcardPCBA,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 $ NotesPASY, MTBD, CP330-NRM, ITOX 1 $335.00 $335.00 Acq. Server Motherboard (Linux)CPU, Intel Core I5 520M 2.40 GHz 1 $225.00 $225.004G DDR3 memory 1 $60.00 $60.00PASY,USB to CAN, USB2-F-7001, EasySYNC 1 $110.00 $110.00 USB to CAN adapterPASY,USB to Serial, USBG-4X-RS232, CableMax 1 $69.98 $69.98 USB to serial adapterVxWorks PL 1 $150.00 $150.00 muticore license feesHypervisor PL 1 $100.00 $100.00 Hypervisor fee for <=250 units
$799.98
Cost Reduction: $1,431.34 $799.98 $631.36 44.11%
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Software Development Benefits True software separation Decoupled dependencies Independent development
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OS 1
Core 2Core 1
OS 2
HypervisorOS 1
Target 1
Middleware
App App
OS 2
Target 2
Middleware
App App
= +
20 | © 2012 Wind River. All Rights Reserved.
Medical Equipment Market TrendsL
inea
rIt
erat
ive
ContinuousFeedback
Becoming Agile
OS OS
Hypervisor
Core 2Core 1
Multicore Virtualization
OS
APP APPAPP
Multi Core/Multi OS
21 | © 2012 Wind River. All Rights Reserved.
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 assignment
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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 cost
Olympus Surgical Technologies