Risk management in development of life critical systems


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  • Therac-25 – radiation therapy machine in which patients were given massive overdoses of radiation that led to several patient deaths because of software not detecting a potential unsafe state.
  • Here are just a few examples of smart medical devices. Operating Room Navigation Systems such as Medtronics LandmarX Element pictured here track the location of surgical instruments in space during the procedure and display the images on the screen. Benefits include im proved procedure precision, reduced trauma to the surrounding healthy anatomy, and decreased healing time. Background: The LandmarX Element endoscopic image guidance system is designed for use in functional endoscopic sinus surgery. The system provides an automated software flow and navigation instruments with rotating arrays. http://www.devicelink.com/expo/awards/awards/index.php?catId=-1&year=-1 2. Implantable defibrillators constantly monitor the rate and rhythm of the heart and deliver an electric shock to restore the heart to a normal condition. Background: http://en.wikipedia.org/wiki/Implantable_cardioverter-defibrillator Smart infusion pumps deliver the precise dosages of medicine and help prevent medical errors. This picture shows the Cardinal Health Alaris System which can store libraries containing information for medication concentration and infusion rate for several hundred medications. The device can also monitor the respiratory system and read bar codes. Background: http://jerryfahrni.com/2009/06/cool-technology-for-pharmacy-6/ “ The Alaris® System by Cardinal Health is designed for infusions and patient monitoring. It helps protect the patient and clinician from consequences of medical errors and helps positively affect patient outcomes through continuous improvements in clinical practice. The point-of-care platform standardizes every type of infusion on a common user interface and adds respiratory monitoring and bar coding as needed. Also a state-of-the-art computer, it bridges the gap between IV and IT to help prevent harm and optimize care.”
  • The keys to building the right products for the right markets at the right time are -Automating the capture of ideas and collecting them in a central repository – this includes enhancement requests, technology needs, market inputs, competitive intelligence, market information, and other details like personas, customers, and win/loss reports. -Making selections of product features, requirements, capabilities based on value that it provides to the customer and to your organization – you should be maximizing both in order to achieve success -Take advantage of best practices from leading companies and leading product management methods and use a tool that supports them while giving you the flexibility to adapt them to fit your organization’s culture
  • Establish or improve discipline and governance in SW delivery: Emphasize practices, not processes; platforms, not tools. Architecture by design, not accident Automate software development and testing Enable and increase reuse Establish discipline and governance for requirements engineering across whole product and lifecycle: Provide requirements visibility across all engineering disciplines, across the whole product, not just in silos Manage complexity and change: Use models to drive systems engineering practice—incorporate visual modeling, model execution, joint realization, and systems modeling languages; model, understand and automate dependencies, traceability and impact analysis Manage, assess, and respond to change with control & governance across the entire product lifecycle
  • Manage cross-domain changes through a centralized requirements change management process Reduce the time to propagate changes throughout the entire design team Reduce discovering ‘missed’ changes late in the project Improve management of multiple engineering disciplines Increase visibility and communication Obtain a more complete impact analysis of changes – with cross-domain visibility Better manage schedules, time to market, costs and ROI Leverage existing investments in Software and Systems development platforms
  • Complexity of systems is forcing a shift from document based to model based systems, which are more capable of managing complexity via abstraction. The models then become the source – meaning specifications, interface requirements are generated from the models, test plans can be derived from models, analysis and design can be based on models From execute, break, fix; to manage, adapt, co-align From an analysis paradigm to a synthesis paradigm Managing risk aggressively is the essence of IBM Model Driven Systems Development.
  • Business today is very different than it was only ten years ago, and is continuing to change rapidly. A variety of forces are fundamentally changing the way business works. For example: All businesses are being changed by the Internet. Everyone and every business is connected in ways never before imagined. Businesses must transform to stay competitiveness, but the ability to manage that transformation can be very difficult. Business flexibility is easy to talk about but hard to accomplish. Globalization is changing who we buy from, who we sell to, what we make, and how we make it. It is changing the fundamental economics of every industry. Products must be increasingly differentiated to meet personal and local needs and tastes. Customers have gotten more demanding, as companies are able to deliver increasingly customized experiences. Regulatory compliance is increasing difficult, as companies sell to customers around the world and as new laws and regulations put the burden on companies to prove regulatory compliance or suffer harsh penalties.
  • Combined Portfolio for technical systems development
  • “ After about 15 minutes of spending with the auditor, he was just blown away on how effective the Rational tools were in terms of addressing all of his audit questions.” Donald Cunningham, Business Analyst at Waters Corporation. See: www.waters.com
  • “ We rely on Synergy and Change to manage the complexity of the software and to ensure that our global development teams operate as one, for the best result to our customers. This software from IBM is part of our livelihood; it's our DNA.” Toni Wells, President OEM Division, Merge Healthcare OEM Division President What is their business, their product? Merge Healthcare works with IBM Rational Software to create medical imaging solutions. Merge Healthcare's solutions solve mission-critical issues for radiology practices, outpatient imaging centers, hospitals, pharmaceutical companies and device manufacturers worldwide. This solution helps doctors improve efficiency and have more options when delivering patient care. The technology developed by Merge delivers digital medical images – such as x-rays, CT scans and MRIs – to Web-enabled devices, including laptops, smart phones and PDAs. The images are rendered on a server so that they are viewed through a Web browser – without requiring high bandwidths or any local storage. It therefore enables lower cost viewing platforms, does not drive up client-side storage costs, and alleviates HIPAA patient data privacy concerns when doctors review images remotely. Viewing digital images typically requires film, specialized systems, or computers with the capability of handling large downloads. These systems can be expensive to buy and maintain – limiting their distribution in a healthcare setting. Key challenges: Managing change – with support for their custom change process Compliance with FDA requirements Responsive OEM support Ability to build new products quickly by reusing software assets Use of IBM Rational Synergy and Change At Merge Healthcare, the Synergy and Change tools let Merge developers simplify the process of managing changes throughout the life of the application. Tracking and Managing Change; Meeting FDA compliance regulations: Toni and Peter Bascom, Vice President of Engineering at Merge Healthcare recently highlighted these points for a reporter (May, 2009) Synergy and Change specifically improve the traceability and quality of their processes. The integration between Rational products simplifies and streamlines their product development. With IBM Rational software Merge is able to track all defects and change requests that come in, while easily mapping between code and defect, which is critical in ensuring compliance with FDA requirements. Related Quotes from a previous eweek.com article: “ The task-based nature of the [Synergy] product is what was attractive to us,” Bascom said. The product made it easy for developers to see whether a change to the software had been made, and whether that change broke anything that needed to be fixed, he said Customizable Change Process Support: In addition, the tool was easily customizable for what Merge wanted to do. “ We didn’t have to change our process for it to work for us,” he said. “We could change the tool to fit what we wanted to do.” Time to market & Regulatory Compliance: Merge Healthcare provides OEM and End User solutions The tools, according to Bascom, enabled Merge to assure customers that the Cedara WebAccess technology not only meets their needs for getting products to end users in a fast and efficient fashion, but that the product also complies with the demands of the various federal regulations governing privacy and security. Software Reuse Merge is able to develop additional solutions quickly by reusing its existing software assets. Software reuse and component based development are additional capabilities supported well in IBM Rational Synergy and Change. IBM Account Contact: Martin Victorin/Denver/IBM IBM / Merge Press Releases and articles: 1) “IBM and Merge Healthcare Join Forces for Better Development of Advanced Medical Imaging Technology” - Dec 2008 http://www-03.ibm.com/press/us/en/pressrelease/26233.wss 2) IBM Smarter Products May 7 Press Release – Merge is included http://www-03.ibm.com/press/us/en/pressrelease/27449.wss ) 3) “Merge Uses IBM Rational Tools to Build Medical Imaging Software” Dec 9, 2008 http://www.eweek.com/c/a/Application-Development/Merge-Uses-IBM-Rational-Tools-to-Build-Medical-Imaging-Software/ . For additional information, visit www.merge.com.
  • It was at this point that the Electronics Industry client decided to invest in a new software development approach built around the best practices of IBM’s ALM solution. They installed new processes, tools and automation, which has enabled them to fundamentally transform their software development cost structure and improve business agility. The net result was a reduction in costs by ~ twenty one million dollars over 3 years and enhanced team collaboration, automation and reporting.
  • Thank you!
  • Risk management in development of life critical systems

    1. 1. Kimberly Roberts-Cobb Industry Solution Executive IBM Software Group, Rational Tiger Team [email_address] Risk Management in Developing Life Critical Systems
    2. 2. Agenda <ul><li>Smarter Life Critical Systems and Products – a definition </li></ul><ul><li>What is Safety? Risk and Hazard Analysis </li></ul><ul><li>Product Development Best Practices </li></ul><ul><li>Rational Platform for Smarter Medical Device Development </li></ul><ul><li>Success stories based on IBM solutions </li></ul><ul><li>Questions and Next Steps </li></ul>
    3. 3. Life critical systems and devices are becoming instrumented, interconnected and intelligent, resulting in smarter devices Software, including artificial intelligence, monitors medical device data intake (e.g., physiological data) and sends alerts to caregivers. Chemical and biologic sensors monitor changes in patients’ vital signs and physiology. Micro-manipulation robotics and endoscopic imagery enable minimal invasive surgery. INSTRUMENTED INTERCONNECTED . INTELLIGENT And technological advances are enabling medical systems and devices to become smarter Wireless technologies such as Zigbee (low-power personal area network standard), Bluetooth, WiFi, cell phones, and RFID enable medical devices to communicate with caregivers, electronic medical records, and other devices. Wireless technologies support physiological telemetry systems that monitor patients in real-time Miniaturization in electro-mechanical components and electronics, including nanotechnology, enables devices to become portable, wearable and implantable. Passive, active, electromechanical and semi conductive sensors respond to patients’ physical changes (e.g., pressure, motion, thermal energy). Smart products transcend “one-size-fits-all” products enabling customers to get exactly what they want – tailored to their unique needs
    4. 4. Software drives innovation in smarter life critical systems and devices <ul><li>Software is key component in differentiating medical systems and products </li></ul><ul><li>Increasing amount functionality is now provided by software </li></ul><ul><li>Software increases risk: Device safety often now depends on proper software operation </li></ul><ul><li>FDA is increasing scrutiny of software controls for device manufacturers </li></ul><ul><ul><li>Drug and Device Accountability Act of 2009 proposes stiff financial penalties and even jail time for inaccuracies in certification </li></ul></ul><ul><li>Effective risk vs. reward in software delivery is a business critical imperative </li></ul><ul><li>Globalization and interconnected systems make compliance even more complex </li></ul>
    5. 5. Examples of IBM Rational and smarter life critical systems and devices <ul><li>Endless possibilities with the growing trend of embedded software </li></ul>Implantable Defibrillators Delivers a life-saving shock to restore the heart to a more normal rate Operating Room Navigation Systems Track spatial location of surgical instruments during procedure Medtronics LandmarX Element Endoscopic Image Guidance System Infusion Pumps Helps prevent errors in delivering medicine dosage Cardinal Health Alaris System Next Generation CT Scanners An &quot;early health&quot; model of care focused on earlier diagnosis, disease detection and prevention. GE Healthcare CT Scanner
    6. 6. Agenda <ul><li>Smarter Life Critical Systems and Products – a definition </li></ul><ul><li>What is Safety? Risk and Hazard Analysis </li></ul><ul><li>Product Development Best Practices </li></ul><ul><li>Rational Platform for Smarter Medical Device Development Success stories based on IBM solutions </li></ul><ul><li>Questions and Next Steps </li></ul>
    7. 7. What is Safety? <ul><li>Safety is freedom from accidents or losses. </li></ul><ul><li>Safety is not reliability! </li></ul><ul><ul><li>Reliability is the probability that a system will perform its intended function satisfactorily. </li></ul></ul><ul><li>Safety is not security! </li></ul><ul><ul><li>Security is protection or defense against attack, interference, or espionage. </li></ul></ul>
    8. 8. Safety-Related Concepts <ul><li>Accident is a loss of some kind, such as injury, death, or equipment damage </li></ul><ul><li>Risk is a combination of the likelihood of an accident and its severity: risk = p(a) * s(a) </li></ul><ul><li>Hazard is a set of conditions and/or events that leads to an accident. </li></ul><ul><li>Failure is the nonperformance of a system or component, not a random fault </li></ul><ul><ul><li>A random failure is one that can be estimated </li></ul></ul><ul><ul><li>Failures are events </li></ul></ul><ul><ul><li>e.g., a component failure </li></ul></ul><ul><li>Error is a systematic fault </li></ul><ul><ul><li>A systematic fault is a design error </li></ul></ul><ul><ul><li>Errors are states or conditions </li></ul></ul><ul><ul><li>e.g., a software bug </li></ul></ul><ul><li>A fault is either a failure or an error </li></ul>
    9. 9. Safety Measures <ul><li>Safety measures do one of the following: </li></ul><ul><ul><li>Remove the hazard </li></ul></ul><ul><ul><li>Reduce the risk, either by </li></ul></ul><ul><ul><ul><li>Reducing the likelihood of the accident </li></ul></ul></ul><ul><ul><ul><li>Reducing the severity of the accident </li></ul></ul></ul><ul><ul><li>Identify the hazard to supervisory personnel so that they can handle it within the fault tolerance time </li></ul></ul><ul><li>The purpose of the safety measure is to avoid accident or loss </li></ul><ul><li>The FDA and similar governing bodies are primarily concerned with health/safety – i.e. patient harm </li></ul><ul><ul><li>risks related to active lack of safety and risks related to ineffective performance of intended functions, on which patients and care providers might reasonably rely to avoid patient harm, are to be analyzed. If harm can occur through the function or dysfunction of the device, there's a hazard or risk to be analyzed and mitigated. </li></ul></ul><ul><li>The business is concerned with both health/safety and functionality </li></ul><ul><ul><li>A failure mode whose impact on health is a 0 but impact on functionality is a 10. E.g., if this happens, the device will absolutely not work, but there is absolutely no impact to health or safety. This type of device failure could still be a critical business issue despite lack of harm </li></ul></ul>
    10. 10. The Basic Risk Management Process <ul><li>Risk Analysis </li></ul><ul><ul><li>Intended use </li></ul></ul><ul><ul><li>Hazard Identification </li></ul></ul><ul><ul><li>Risk estimation (likelihood/severity) </li></ul></ul><ul><li>Risk Evaluation </li></ul><ul><ul><li>Acceptability decisions </li></ul></ul><ul><li>Risk Control </li></ul><ul><ul><li>Options </li></ul></ul><ul><ul><li>Implementation </li></ul></ul><ul><ul><li>Residual risk evaluation and overall risk acceptance </li></ul></ul><ul><li>Post Production </li></ul><ul><ul><li>Post production actual experience </li></ul></ul><ul><ul><li>Review of risk management experience </li></ul></ul>Risk Assessment Risk Management
    11. 11. Risk Assessment Methods <ul><li>Common Risk Assessment Methods </li></ul><ul><li>Risk matrix </li></ul><ul><li>Preliminary Hazard Analysis (PHA) </li></ul><ul><li>Fault Tree Analysis (FTA) </li></ul><ul><li>Failure Mode Effects (Criticality) Analysis (FMEA/FMECA) </li></ul><ul><li>Hazard Operability Analysis (HAZOP) </li></ul><ul><li>Hazard Analysis and Critical Control Point (HACCP) </li></ul><ul><li>The FDA &quot;Pre-production Quality Assurance Planning Recommendations For Medical Device Manufacturers&quot; identifies three methods for risk analysis: </li></ul><ul><ul><li>Failure mode effects analysis (FMEA) </li></ul></ul><ul><ul><li>Fault tree analysis (FTA) </li></ul></ul><ul><ul><li>Failure mode effects criticality analysis (FMECA) </li></ul></ul>
    12. 12. Product Development and Risk Management <ul><li>Basic Product Development Phases </li></ul><ul><ul><li>Phase 1 – Researching new opportunities Phase 2 – Proving feasibility Phase 3 – Scheduled development (prototypes) Phase 4 – Validation (clinical trials) Phase 5 – Delivery (launch) and Maintenance </li></ul></ul><ul><li>The Timing of Risk Mitigation </li></ul><ul><ul><li>The purpose of risk mitigation (FMEA/Hazard Analysis) is to affect the design. The time to begin this process is when competing designs are being considered (phases 1 and 2). </li></ul></ul><ul><ul><li>The FDA requires a risk assessment (hazard analysis) as a deliverable, but if done late in the product lifecycle this is primarily a documentation exercise rather than a true control measure used to identify and mitigate design choices that should not have been chosen or which introduce higher risk or more costly development. </li></ul></ul>Risk Reviews Risk Management Report Detailed risk analysis (FMEA, FTA) Preliminary Hazard Analysis and Risk Management Plan Risk Assessment Design Control Change Control Verification and Validation Build & Release Specification, Modeling, Simulation Product Portfolio Planning & Requirements Produce Test Develop Design Concept & Feasibility
    13. 13. Agenda <ul><li>Smart medical device – a definition </li></ul><ul><li>What is Safety? Risk and Hazard Analysis </li></ul><ul><li>Product Development Best Practices </li></ul><ul><li>Rational Platform for Smarter Medical Device Development </li></ul><ul><li>Success stories based on IBM solutions </li></ul><ul><li>Questions and Next Steps </li></ul>
    14. 14. Best Practices for Smarter and Safer Product Development <ul><li>Evolve Product Portfolios effectively Balance potential product reward with risk to choose the right product design, at the right time, for the right market: Risk Estimation/Balancing </li></ul><ul><li>Begin Hazard Analysis at the Requirements stage Capture, define, analyze potential hazards up front while developing and managing the requirements: Preliminary Hazard Analysis and Risk Management Plan </li></ul><ul><li>Develop Systems and Software in a Model-Driven way Visually develop complex systems using a structured approach and introduce control measures to balance risk vs reward in design choices: Detailed risk analysis (FTA) </li></ul><ul><li>Control Change for Good Manufacturing Practice (GMP) Establish an integrated change process across the lifecycle: Manage Safety Impact of Changes </li></ul><ul><li>Metrics, Measurement, Reporting and Automated Document Generation Generate the right document at the right time across the development disciplines to adhere to standards and demonstrate compliance: Dynamically Monitor Risk Factors and Generate Risk Management Reports </li></ul><ul><li>Improve Quality from the Beginning through the End Make quality management a continuous lifecycle activity: Verification and Validation </li></ul>
    15. 15. Product Portfolio Management - Evolve Product Portfolios Effectively <ul><li>Determine risk elements up front and balance risk with reward – perform decision analysis inclusive of increased or decreased risk of harm and/or higher/lower profit and reliability </li></ul><ul><li>Compare and rank features and functions against possible hazard s and impact on sales/profitability </li></ul><ul><li>Utilize visualization, prioritization, and unique road mapping and planning capabilities </li></ul><ul><li>Centralize information for key decision-making and status reporting </li></ul><ul><li>Ensure most valuable capabilities are not unintentionally minimized or eliminated </li></ul><ul><li>Use objective information to overcome the influence of the loudest voice </li></ul>Best Practice 1: Product Line Portfolio Management (generated from Rational FocalPoint)
    16. 16. Requirements Management across the Product Lifecycle Capture, define, analyze, and manage requirements <ul><li>Create Preliminary Hazard Analysis and Risk Management Plans </li></ul><ul><li>Improves visibility of and collaboration on requirements for all product stakeholders </li></ul><ul><li>Comprehensive support for recording, structuring, managing, and analyzing requirements, hazards and their traceability across development </li></ul><ul><li>Supports FDA CFR21 Part 11 compliant electronic signatures for sign off of specification baselines </li></ul><ul><li>Integrates with portfolio management, modeling, change management and quality management solutions for a full lifecycle solution </li></ul>Best Practice 2: Requirements Engineering and Management (generated from Rational DOORS)
    17. 17. Develop Systems and Software in a Model-Driven way Visually develop complex systems using a structured approach <ul><li>Design and analyze the system and to identify the conditions and events that can lead to hazards </li></ul><ul><li>Traceability from requirements through implementation and test </li></ul><ul><li>Validate, simulate and verify design and implementation during entire product lifecycle </li></ul><ul><li>Customizable documentation generation automates FDA documentation submission </li></ul><ul><li>Visual modeling manages complexity and improves communication </li></ul><ul><li>Generate production quality code for embedded targets </li></ul><ul><li>Reduce testing time and improve results with model-driven testing </li></ul><ul><li>Leverage and visualize existing code for documentation </li></ul>Best Practice 3: Model Driven Systems Engineering (generated from Rational Rhapsody)
    18. 18. Design for Safety <ul><li>The key to safe systems is to analyze the system and to identify the conditions and events that can lead to hazards </li></ul><ul><li>Fault Tree Analysis (FTA) determines what logical combination of events and conditions lead to faults </li></ul><ul><li>By adding “ANDing-redundancy”, architectural redundancy can be added </li></ul>Fault Tree Analysis determines what combinations of conditions or events are necessary for a hazard condition to occur Best Practice 3: Model Driven Systems Engineering
    19. 19. Model system use cases to understand and identify potential hazards and risks (generated from Rational Rhapsody) Best Practice 3: Model Driven Systems Engineering
    20. 20. Link requirements to use cases to ensure all uses are fully understood so hazards can be identified earlier (generated from Rational Rhapsody) Best Practice 3: Model Driven Systems Engineering
    21. 21. Produce Hazard and fault tables as part of your development and ongoing risk management process not “after the fact” (generated from Rational Rhapsody) Best Practice 3: Model Driven Systems Engineering
    22. 22. Link potential faults to requirements for clarity on requirements with hazard mitigations (generated from Rational Rhapsody) Best Practice 3: Model Driven Systems Engineering
    23. 23. Control Change for Quality Systems Good Manufacturing Practice Establish an integrated change process across the lifecycle Manage Portfolio & Product Priorities Develop Model-Driven System -> Software Collaboration, Process, Workflow Execute Tests Capture & manage requirements Configuration Management Integrate Suppliers Capture customer requests & market driven enhancements Mechanical Collaborate across Development Disciplines Electrical Software Best Practice 4: Integrated Change and Configuration Management Testing Eco-system Integrated Change Management
    24. 24. Use Metrics and Dynamic Reporting to Reduce Risk <ul><li>Make more informed, faster, and more aligned decisions to reduce risk & costs </li></ul><ul><li>Full range of BI capabilities for all software delivery communities to receive relevant information with connection to live ALM data – in a single integrated offering </li></ul><ul><li>Open enterprise-class platform to cost-effectively scale to meet user demands </li></ul>Why? Reporting & Analysis How are we doing? Scorecards & Dashboards Best Practice 5: Metrics, Measurement and Report Generation (generated from Rational Insight)
    25. 25. Automate Document Generation Generate the right report and the right document at the right time <ul><li>Increase productivity by allowing engineers to focus on engineering, NOT formatting concerns </li></ul><ul><li>Maintain accuracy through quick one-click document generation that captures last minute changes to data held in disparate source applications </li></ul><ul><li>Enhance documentation quality and consistency by sharing and reusing templates </li></ul><ul><li>Deploy a consistent set of reports, measurements, and dashboards with tight integrations to tools across the Rational and Telelogic ALM product lines, and other common/3rd data sources </li></ul><ul><li>Measure, monitor and analyze data to improve efficiency and process maturity, as well as early identification and mitigation of risks. </li></ul>Best Practice 5: Metrics, Measurement and Report Generation (generated from Rational Publishing Engine from data sources of Rational RTC and RQM)
    26. 26. Improve Quality from the Beginning through the End Make quality management a continuous lifecycle activity <ul><li>Unify the entire team with a shared view of quality assets </li></ul><ul><li>Comprehensive dynamic planning and updates </li></ul><ul><li>Intelligent automation to improve accuracy and efficiency </li></ul><ul><li>Automated reporting to enhance project decision-making </li></ul>Best Practice 6: Continuous Quality Management RM PPM RM PPM QM
    27. 27. Agenda <ul><li>Smart medical device – a definition </li></ul><ul><li>What is Safety? Risk and Hazard Analysis </li></ul><ul><li>Product Development Best Practices </li></ul><ul><li>Rational Platform for Smarter Medical Device Development </li></ul><ul><li>Success stories based on IBM solutions </li></ul><ul><li>Questions and Next Steps </li></ul>
    28. 28. Modern Approaches for Describing Systems Are Evolving To Better Manage Complexity and Reduce Time-to-market <ul><li>Specifications </li></ul><ul><li>Interface requirements </li></ul><ul><li>System design </li></ul><ul><li>Risk Analysis & trade-off </li></ul><ul><li>Test plans </li></ul>Lagging Moving from manual methods to an automated approach Leading Organizations are looking for a productivity breakthrough. Not just incremental improvement. How can we significantly increase the value from our product delivery platform?
    29. 29. The design and delivery of smart products is enabled by a collaborative solution that facilitates innovation while fostering visibility and integration to quantify hazards and risks Rational Workbench for Systems and Software Engineering Collaborate Improve Automate Collaborate across diverse engineering disciplines and development teams Achieve “quality by design” with an integrated, automated testing process Manage all system requirements with full traceability across the lifecycle Use modeling to validate requirements, architecture and design throughout the development process Rational Quality Manager Rational RRC/DOORS Rational Team Concert Rational Rhapsody
    30. 30. Rational Combined Portfolio in Action Industry’s most comprehensive offering System and Software Lifecycle Process Management Requirements Definition & Management Analysis & Design Quality Management Release Management Team Management Configuration & Change Mgmt Production / Operations Enterprise Architecture/ Architectural Frameworks Measurement & Reporting Product, Project & Portfolio Management
    31. 31. Agenda <ul><li>Smart medical device – a definition </li></ul><ul><li>What is Safety? Risk and Hazard Analysis </li></ul><ul><li>Product Development Best Practices </li></ul><ul><li>Rational Platform for Smarter Medical Device Development </li></ul><ul><li>Success stories based on IBM solutions </li></ul><ul><li>Questions and Next Steps </li></ul>
    32. 32. Aberdeen Study on Best in Class Product Development <ul><li>Performance measures of Best in Class </li></ul><ul><li>Achieve quality targets 95% on average, 12% above Industry average, 1.8 times as often as laggards </li></ul><ul><li>Achieve product launch dates 92% on average, 21% above Industry average, 2.9 times as often as laggards </li></ul><ul><li>Achieve revenue targets 96% on average, 25% above Industry average, nearly twice as often as laggards </li></ul><ul><li>Common characteristics of Best in Class </li></ul><ul><li>Manage Requirements : Twice as likely as the Industry average and 3 times as likely as laggards to address entire lifecycle of requirements </li></ul><ul><li>Leaders in Systems Modeling and Simulation . 5 times as likely as the Industry average and 7 times as likely as laggards to digitally validate system behavior with the simulation of integrated mechanical, electrical and software components </li></ul><ul><li>Manage Change : 51% more likely than Industry average and 3 times more likely than laggards to notify other disciplines of changes. </li></ul>Aberdeen System Design: New Product Development for Mechatronics Inclusion of embedded software components in product development 66% 34%
    33. 33. Customer Success: Safe Ventilation – at rest and on the move Hamilton Medical AG and IBM partner EVOCEAN GmbH <ul><li>What’s smart? </li></ul><ul><li>Intelligent ventilation for intensive care </li></ul><ul><li>Innovative cockpit display, ease of use </li></ul><ul><li>Frees medical staff, improves patient outcome, reduces cost </li></ul><ul><li>Smarter business outcomes: </li></ul><ul><li>Earlier error recognition, using modeling approach with code generation </li></ul><ul><li>Consistent documentation with direct association between design and code </li></ul><ul><li>Improved collaboration </li></ul><ul><li>How Rational Rhapsody helps: </li></ul><ul><li>Proven embedded and real-time track record </li></ul><ul><li>Code generation </li></ul><ul><li>Re-usable Software Platform </li></ul>&quot;Thanks to graphical representation of processes and states and being able to execute them, we now have a significantly improved basis for discussion. It's also easier for new employees to get going - provided they have some basic understanding of UML and Rhapsody ® , “ Andreas Anderegg – Software Engineer
    34. 34. Customer Success: Innovation, streamlined audits, increased quality Waters Corporation “ After about 15 minutes of spending with the auditor, he was just blown away on how effective the Rational tools were in terms of addressing all of his audit questions.” <ul><li>What’s smart? </li></ul><ul><ul><li>Efficient systems for verifying the purity of drugs, food products and water resources. </li></ul></ul><ul><ul><li>Highly accurate blood tests with greater precision for healthcare diagnosis </li></ul></ul><ul><li>Smarter business outcomes </li></ul><ul><ul><li>Innovation to enable significant advancements in healthcare delivery, environmental management, food safety, and water quality worldwide </li></ul></ul><ul><ul><li>Increased quality and throughput of the assays performed with cost effective technology </li></ul></ul><ul><li>How Rational enables smarter products </li></ul><ul><ul><li>Full traceability with an integrated requirements, change, and configuration management solution </li></ul></ul><ul><ul><li>Performance improvement through global collaboration and component based development </li></ul></ul>
    35. 35. Customer Success: Mobile access to medical images Merge Healthcare <ul><li>What’s smart? </li></ul><ul><li>Provides medical professionals access to complex medical images on mobile devices </li></ul><ul><li>Helps facilitate prompt access to medical imaging data – anytime or anywhere* </li></ul><ul><li>Smarter business outcomes </li></ul><ul><li>Reduced hospital operations costs </li></ul><ul><li>Reliable, secure, scalable delivery of medical images and reports </li></ul><ul><li>How Rational enables smarter products </li></ul><ul><li>Collaboration across globally distributed development teams </li></ul><ul><li>Change management across the end-to-end software lifecycle </li></ul>* *Product not yet released “ We rely on (Rational Change and Configuration Management Solutions) to manage the complexity of the software and to ensure that our global development teams operate as one, for the best result to our customers. This software from IBM is part of our livelihood; it's our DNA.”
    36. 36. Customer Success: Going Agile with Global Collaboration Reducing Cost in a Global Context – Medical Device Company Environment Issues Improved Outcomes <ul><li>Desire to use Agile techniques thwarted by internal process overhead </li></ul><ul><li>No global access to assets </li></ul><ul><li>Poor change management support for parallel development </li></ul><ul><li>Multiple points of failure </li></ul><ul><li>No continuous integration </li></ul><ul><li>Lack of compliance support </li></ul><ul><li>1000+ users worldwide </li></ul><ul><li>3 development sites (US, Europe, India) </li></ul><ul><li>Continuous unit testing required with strong auditing </li></ul><ul><li>Heterogeneous development infrastructure </li></ul><ul><li>Global Agile development process supported by repeatable deployment model </li></ul><ul><li>Iterations accelerated 3X, build times reduced by 65% </li></ul><ul><li>Improved compliance </li></ul><ul><li>Secure developer self-service established </li></ul><ul><li>$6M+ savings per year over 3 years </li></ul>“ We were interested to adopt Agile Development, but were limited by an inflexible, non-standard process. Each team did their own thing, and there were multiple points of failure on each project.”
    37. 37. Summary: IBM Rational Solution for Developing Life Critical Systems <ul><li>Deliver life critical systems and medical devices that address market needs through portfolio management </li></ul><ul><li>Provide clear audit trail across the development lifecycle with requirements management </li></ul><ul><li>Validate designs and associated risks early with model driven development and model and manage safety risks and hazards FTAs </li></ul><ul><li>Integrate change management processes to coordinate development in a collaborative platform </li></ul><ul><li>Automate document generation for compliance </li></ul><ul><li>Drive quality throughout the product lifecycle </li></ul>Execute best practices and collaborate through an integrated product lifecycle solution Powered by
    38. 38. © Copyright IBM Corporation 2008. All rights reserved. The information contained in these materials is provided for informational purposes only, and is provided AS IS without warranty of any kind, express or implied. IBM shall not be responsible for any damages arising out of the use of, or otherwise related to, these materials. Nothing contained in these materials is intended to, nor shall have the effect of, creating any warranties or representations from IBM or its suppliers or licensors, or altering the terms and conditions of the applicable license agreement governing the use of IBM software. References in these materials to IBM products, programs, or services do not imply that they will be available in all countries in which IBM operates. Product release dates and/or capabilities referenced in these materials may change at any time at IBM’s sole discretion based on market opportunities or other factors, and are not intended to be a commitment to future product or feature availability in any way. IBM, the IBM logo, the on-demand business logo, Rational, the Rational logo, and other IBM products and services are trademarks of the International Business Machines Corporation, in the United States, other countries or both. Other company, product, or service names may be trademarks or service marks of others.