® IBM Software Group © 2009 IBM Corporation Best practices to deliver smart medical devices Name Title

®

IBM Software Group

© 2009 IBM Corporation

Best practices to deliver smart medical devices

NameTitle

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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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.”


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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


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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


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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

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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.


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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

Documents

® IBM Software Group © 2009 IBM Corporation Best practices to deliver smart medical devices Name Title