Wind River For Medical

VxWorks, Linux, Android Simulation, Test Management Hypervisor (Virtualization)

CMMI-certified Developmentand Professional Services

| © 2012 Wind River. All Rights Reserved.1

Aerospace and Defense Automotive Industrial Controls Mobile and Consumer Network and Telecom Medical Devices

Wind River in Medical EquipmentAn Abbreviated List…


Medical Market Trends


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


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



Questions?



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


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, 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


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.


Professional Services Engagement Process


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


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

16

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

| © 2012 Wind River. All Rights Reserved.

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 resolution


18

Financial Analysis


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%

19

Software Development Benefits True software separation Decoupled dependencies Independent development


OS 1

Core 2Core 1

OS 2

HypervisorOS 1

Target 1

Middleware

App App

OS 2

Target 2

Middleware

App App

= +


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


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


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