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Transcript of ® IBM Software Group © 2009 IBM Corporation Best practices to deliver smart medical devices Name...
®
IBM Software Group
© 2009 IBM Corporation
Best practices to deliver smart medical devices
NameTitle
IBM Software Group | Rational software
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IBM Software Group | Rational software
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What we will cover on today’s webcast
Current status and future trends of the Medical Device industry
Smart medical device – a definition
Challenges and best practices in Medical Device development
Success stories based on IBM solutions
Question & Answer session
IBM Software Group | Rational software
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IBM Software Group | Rational software
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Five forces affecting the industry today
Legal issues Patient lawsuits Patents Product recalls Liability Data retention
Technology Systems integration New technologies Compliance
Markets and financial issues Consolidation Overseas marketplace
expansion Slowing marketplaces Profitability and cost
Regulations FDA New forms of regulation Patient privacy, HIPAA SOX
New product development Speed to market Strategic agreements Significant R & D spend
Healthcare is shifting to a patient-centric model
IBM Software Group | Rational software
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IBM Software Group | Rational software
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As healthcare becomes more patient-centric, the impacts are starting to be felt in the industry
Impact of the patient-centric model
Marketing and sales requirements will become more complex as they begin to involve multiple stakeholders
Medical device manufacturers need to address ever-changing requirements
New product development
Firms will leverage technology solutions to protect patient information and provide protection against lawsuits
Patient lawsuits
Patient privacy
Legal issues
Doctor and patient adoption/acceptance of new products will become more critical as patients take more responsibility for their health
Firms will need to expand their services and explore new business models to market solutions directly to patients
As the product lifecycle shortens, adoption of new products is critical
Markets and financial issues
The industry has to balance patient privacy rights with the need to make patient information readily available
HIPAA (Health Insurance Portability and Accountability Act)
Regulations
Firms will need to make accurate and accessible product information available over the Internet
Firms will need to collaborate with hospitals, doctors and other stakeholders to streamline communications and information-sharing
The patient-centric model is technology driven, with the Internet being the primary method of disseminating information
Technology
Short-term outlookToday’s landscapeIndustry forces
IBM Software Group | Rational software
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IBM Software Group | Rational software
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Five predictions
Smart Medical Devices will drive the evolution of the healthcareSmart Medical Devices will drive the evolution of the healthcare
Prediction 1: Popular consumer electronics will have more health-related functionality
Prediction 2: New health-oriented devices will be cool and easy-to-use
Prediction 3: New medical software will adopt familiar consumer electronic interfaces
Prediction 4: Device adoption will depend on the ability to build a unique eco-system
Prediction 5: A mastery of the data is what will create value for patients and providers
IBM Software Group | Rational software
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IBM Software Group | Rational software
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What we will cover on today’s webcast
Current status and future trends of the Medical Device industry
Smart medical device – a definition
Challenges and best practices in Medical Device development
Success stories based on IBM solutions
Question & Answer session
IBM Rational software
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What makes a product smarter? How do they deliver value?
Hint: think software
INSTRUMENTED
They have the ability to measure, sense and see the exact condition of everything
INTERCONNECTED
They enable people, systems and other productsto communicate and interact with each other in entirely new ways
INTELLIGENT
They can respond to changes quicklyand accurately, and get better resultsby predicting and optimizing for future events
Smart products transcend “one-size-fits-all” products enabling customers to get exactly what they want – tailored to their unique needs
IBM Rational software
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Examples of IBM Rational and smart medical devices
Endless possibilities with the growing trend of embedded software
Implantable Defibrillators Implantable Defibrillators Delivers a life-saving shock to restore the
heart to a more normal rateDelivers a life-saving shock to restore the
heart to a more normal rate
Operating Room Navigation SystemsOperating Room Navigation SystemsTrack spatial location of surgical instruments during procedureTrack spatial location of surgical instruments during procedure
Medtronics LandmarX ElementEndoscopic Image Guidance System
Medtronics LandmarX ElementEndoscopic Image Guidance System
Infusion PumpsInfusion PumpsHelps prevent errors in delivering medicine dosageHelps prevent errors in delivering medicine dosage
Cardinal HealthAlaris System
Cardinal HealthAlaris System
Next Generation CT Scanners Next Generation CT Scanners An "early health" model of care focused on earlier
diagnosis, disease detection and prevention.An "early health" model of care focused on earlier
diagnosis, disease detection and prevention.
GE HealthcareCT Scanner
GE HealthcareCT Scanner
IBM Software Group | Rational software
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IBM Software Group | Rational software
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What we will cover on today’s webcast
Current status and future trends of the Medical Device industry
Smart medical device – a definition
Challenges and best practices in Medical Device development
Success stories based on IBM solutions
Question & Answer session
IBM Rational software
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Numerous challenges abound within the medical device product development lifecycle
Managing new project/product complexity and increasing amount of software with
existing process
Economic/competitive climate demands reduction in product development costs
Quality problems result in product recalls, audits,
delayed product launches, and brand erosion
Challenging to deliver innovative products quickly
and within guidelines
Inability to collaborate and integrate many disciplines increases time to market
Difficult and time consuming to prove compliance with government regulations
IBM Rational software
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Satisfying regulations from international agencies adds complexity to global development plans
European Commission Medical Devices Directives
U.S. Food and Drug Administration
National Institute of Health Sciences (Japan)
Pharmaceuticals and Medical Devices Agency (Japan)
Korea Food and Drug Administration
Medicines and Healthcare products Regulatory Agency (UK)
Therapeutic Goods Administration (Australia)
State Food and Drug Administration (China)
Ministry of Health (China)
Partial ListingPartial Listing
IBM Rational software
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Best Practices for Successful Medical Device Development
1. Evolve Product Portfolios effectivelyBuild the right product, at the right time, for the right market
2. Manage Requirements across the Product Lifecycle Capture, define, analyze, and manage requirements
3. Develop Systems and Software in a Model-Driven wayVisually develop complex systems using a structured approach
4. Control Change for Good Manufacturing Practice (GMP) Establish an integrated change process across the lifecycle
5. Automate Document Generation and ReportingGenerate the right document at the right time
6. Improve Quality from the Beginning through the EndMake quality management a continuous lifecycle activity
7. Increase Profitability through Product Line Growth A More Efficient Means of Software-Based Product Line Production
8. Achieve Agility at Scale Agile development success regardless of a companies size and complexities
IBM Rational software
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Manage Product Portfolios effectivelyBuild the right product, at the right time, for the right market
Connect directly with customers and partners
and engage them in setting direction and priorities
Product
Management
Idea
Management
Portfolio
Management
Market
Management
Program
ManagementManage product plans, roadmaps, offerings, editions, and scope
Manage initiatives and programs that span multiple
products and product lines
Analyze and strategically balance capital and resource allocations across
the enterprise portfolio
Manage ideas – big or small - from inception to market execution
IBM Rational software
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Manage Requirements across the Product LifecycleCapture, define, analyze, and manage requirements
Improves visibility of and collaboration on requirements for all product stakeholders
Comprehensive support for recording, structuring, managing, and analyzing requirements and their traceability
Supports FDA CFR21 Part 11 compliant electronic signatures for signing off requirements baselines
Integrates with portfolio management, modeling, change management and quality management solutions for a full lifecycle solution
IBM Rational software
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Develop Systems and Software in a Model-Driven wayVisually develop complex systems using a structured approach
Traceability from requirements through implementation and test
Validate, simulate and verify design and implementation during entire product lifecycle
Customizable documentation generation automates FDA documentation submission
Visual modeling manages complexity and improves communication
Generate production quality code for embedded targets
Reduce testing time and improve results with model-driven testing
Leverage and visualize existing code for documentation
IBM Rational software
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Manage Change for Good Manufacturing Practice (GMP)Establish an integrated change process across the lifecycle
Testing Eco-system
Manage Portfolio &
Product Priorities
Develop Model-Driven
System -> Software
Collaboration,Process, Workflow
ExecuteTests
Capture & manage
requirements
Integrated Change
Management
Configuration Management
Integrate Suppliers
Capture customer requests & market
driven enhancements
Mechanical
Collaborate across Development Disciplines
Electrical
Software
IBM Rational software
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Automate Document GenerationGenerate the right document at the right time
Increase productivity by allowing engineers to focus on engineering, NOT formatting concerns
Maintain accuracy through quick one-click document generation that captures last minute changes to data held in disparate source applications
Enhance documentation quality and consistency by sharing and reusing templates
IBM Rational software
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Manage Quality from the Beginning through the EndMake quality management a continuous lifecycle activity
Unify the entire team with a shared view of quality assets
Comprehensive dynamic planning and updates
Intelligent automation to improve accuracy and efficiency
Automated reporting to enhance project decision-making
QA Manager
Security Officer
Project Manager
Tester
Business Stakeholder
Test Cases
Skill Availability
Project Logs
Use Cases
Requirements
Security Mandates
Defect Logs
Business Objectives
Quality Asset Infrastructure
Central hub captures
everything that matters
for quality releases
QA Manager
Security OfficerSecurity Officer
Project ManagerProject Manager
TesterTester
Business StakeholderBusiness Stakeholder
Test Cases
Skill Availability
Project Logs
Use Cases
Requirements
Security Mandates
Defect Logs
Business Objectives
Test Cases
Skill Availability
Project Logs
Use Cases
Requirements
Security Mandates
Defect Logs
Business Objectives
Quality Asset Infrastructure
Central hub captures
everything that matters
for quality releases
IBM Rational software
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Increase Profitability through Product Line Growth A More Efficient Means of Software-Based Product Line Production
The IBM Rational 2nd generation approach enables organizations to engineer a feature-based product line portfolio as a single system rather than a multitude of productsConsolidate … Efficient means of production to optimize growth, productivity and cost
Simplify … Product line focused development maximizes reuse and product quality
Leverage … Feature-based portfolio evolution optimizes time-to-market and customer satisfaction
IBM-BigLever Product Line Lifecycle FrameworkIBM-BigLever Product Line Lifecycle Framework
Software Product VariationProduct Portfolio of Similar Systems
DiscoveryPET CT 690Discovery
PET CT 690
DiscoveryPET CT 600Discovery
PET CT 600
DiscoverySTE
DiscoverySTE
IBM Rational software
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Team size
Under 10developers
100’s ofdevelopers
Enterprise discipline
Projectfocus
Enterprisefocus
Compliance requirement
Low risk Critical,Audited
Co-located
Geographical distribution
Global
Organization and culture
Open Entrenched
Application complexity
Simple, single platform
Complex, multi-platform
Organization distribution(outsourcing, partnerships)
In-house Third party
Disciplined Agile
Development
Achieve Agility at Scale Agile development success regardless of a company’s size and complexity
IBM Rational software
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IBM Rational Software Platform for Systems Full coverage of the systems engineering lifecycle
Spans the entire systems and software lifecycle
Integrates complex systems, embedded software and IT to create innovative products
Achieves end-to-end traceability
Provides proof of compliance
RequirementsCapture & Analysis
SystemsAnalysis & Design
SystemAcceptance
(Sub-)System Integration & Test
ModuleIntegration & TestSW Design
Implementation& Unit Test
Customer Needs
Develop Concept
Product / SystemBuild
Product Definition
Product / SystemDeliver
Run / Support / Maintain
Reporting, Version &
Change Mgmt
BestPractices
IBM Software Group | Rational software
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IBM Software Group | Rational software
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What we will cover on today’s webcast
Current status and future trends of the Medical Device industry
Smart medical device – a definition
Challenges and best practices in Medical Device development
Success stories based on IBM solutions
Question & Answer session
IBM Rational software
23
Merge HealthcareMobile access to medical images
What’s smart? Provides medical professionals access to
complex medical images on mobile devices Helps facilitate prompt access to medical
imaging data – anytime or anywhere*
Smarter business outcomes Reduced hospital operations costs Reliable, secure, scalable delivery
of medical images and reports
How Rational enables smarter products Collaboration across globally distributed
development teams Change management across the end-to-end
software lifecycle
**Product not yet released
“We rely on Synergy and Changeto 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.”
IBM Rational software
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Waters CorporationTesting equipment for medical, pharmaceutical and food products
“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 allof his audit questions.”
What’s smart? Efficient systems for verifying the purity of drugs,
food products and water resources Highly accurate blood tests with greater precision
for healthcare diagnosis
Smarter business outcomes Innovation to enable significant advancements in
healthcare delivery, environmental management, food safety, and water quality
Increased quality and throughput of the assays performed with cost effective technology
How Rational enables smarter products Full traceability with an integrated requirements,
change, and configuration management solution Performance improvement through global
collaboration and component-based development
IBM Software Group | Rational software
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IBM Software Group | Rational software
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All Top 10 Medical Device firms are using Rational software
9 out of 10 use Rational ClearCase and Rational ClearQuest for Software Configuration and Change Management
8 out of 10 use Rational DOORS for Requirements Engineering
6 out of 10 use Rational Rhapsody for Model-Driven System Development
Based on FY2007 revenue and IBM licensing data as of 8/18/09
IBM Rational software
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IBM Rational Solution for Medical Devices
Deliver medical devices that address market needs through portfolio management
Provide clear audit trail across the development lifecycle with requirements management
Validate designs early with model driven development
Integrate change processes to coordinate development
Automate document generation for compliance
Drive quality throughout the product lifecycle
Execute best practices and collaborate through an integrated product lifecycle solution
Execute best practices and collaborate through an integrated product lifecycle solution
Powered by
IBM Software Group | Rational software
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IBM Software Group | Rational software
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IBM Software Group | Rational software
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IBM Software Group | Rational software
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© 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.
IBM Rational software
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Compliance to FDA and international guidelines drives adoption of quality processes
Cost of non-compliance -- Risk vs Cost Audit costs (if audited) – Efficiency in performing the audit, business impact; fines Product failure / lawsuit risk – May incur substantial penalties if found non-compliant. More risks: Product recalls; Delayed market entry; Reputation risk, …
Detect issues earlier “The vast majority of software problems are traceable to errors made during the design and
development process” *
Perform analysis dynamically “Dynamic analysis is concerned with demonstrating the software’s run time behavior in response to
selected inputs and conditions” *
Iteratively validate as changes are made “Proper software validation is not a one time event. Software validation should begin when design
planning and design input begin.“*
Document, Document, Document Maintain extensive documentation in a design history file
Traceability, Accountability FDA governance defines how audit trails and electronic signatures must be applied to electronic
record-keeping systems used during the development of drugs and medical devices. Customers implement documented Change processes and eSignatures – with ‘requirements to code’
traceability
* Source – “General Principles of Software Validation; Final Guidance for Industry and FDA Staff” Center for Devices and Radiological Health* Source – “General Principles of Software Validation; Final Guidance for Industry and FDA Staff” Center for Devices and Radiological Health