12th software design for medical devices

Understanding and Managing FDA Requirementto Ensure Compliance, Safety and Usability

April 27 - 29, 2009 | Philadelphia, PA

Register Today! Call Sam Eid at 416-597 4719 or e-mail: [email protected]

Honorably Present the:

U. S. Food and DrugAdministration

Abbott Laboratories

SoftwareCPR

Bayer HealthCare - O&I

Certified ComplianceSolutions

Minnetronix, Inc.

Software EngineeringInstitute

IEEE – CS

MEDTRONIC, INC. | CRDM

Massachusetts GeneralHospital

Electro Optical Sciences

SterlingTech Software,Inc.

LynuxWorks

Design Science

Ethicon Endo-Surgery

• Understand and manage regulatory requirement specifications forsoftware in medical devices

• Consider multi-site development and global regulatory discrepancies

• Improve agile software development and speed up time-to-market

• Implement risk management tools in software development

• Discuss software design modularization and integration

• Ensure safer development and reduce launch product defects

• Discuss Human Factors Engineering for software design usability

Sponsors:

Media Partners:

Don’t miss the keynote address from FDA on HumanFactors Guidance and related regulations!

SAVE up to $500 offthe standard

conference price

Conference highlights at a glance:

Learn from Designingand RegulatoryExperts such as:

Who Has AttendedIQPC’s Past SoftwareDesign Events:

About the Sponsors:

Sponsorship andExhibition Opportunities

LynuxWorks is a leader in the embedded software market providing open and reliable real-timeoperating systems (RTOS) and software tools to embedded developers. The LynxOS RTOS familyoffers open standards with the highest level of safety and security, enabling many mission-criticalsystems in medical, defense, avionics and other industries requiring adherence to regulatory

standards such as those set forth by the FAA and FDA. LynuxWorks' BlueCat Linux provides the open source technologyof embedded Linux with the features and support for embedded applications. The Eclipse-based Luminosity IDE gives apowerful and consistent development system across all LynuxWorks operating systems

Klocwork is an enterprise software company providing automated source code analysis softwareproducts that automate security vulnerability and quality risk assessment, remediation andmeasurement for C, C++ and Java software. More than 300 organizations have integrated

Klocwork's automated source code analysis tools into their software development process in order to ensure their code isfree of mission-critical flaws while freeing their developers to focus on what they do best – innovate.

Sponsorships and Exhibits are excellentopportunities for your company to showcaseits products and services to high-level,targeted decision makers attending SoftwareDesign for Medical Devices. IQPC andHealthcare IQ help companies like yoursachieve sales, marketing and brandingobjectives by setting aside a limited number ofevent sponsorships and exhibit spaces – all ofwhich are custom tailored to help yourcompany create a platform to maximize itsexposure at the event. Visit us atwww.iqpc.com to see what other exciting andinformationpacked conferences are beingoffered by the International Quality &Productivity Center. For more information,contact SSam Eid at 416-597 4719

38% Software Engineer

13% Director

9% Mgr

4% Business Process Mgr

4% Unknown

2% IT Project Mgr

2% Product Support Mgr

2% Business Mgr

2% Software Specialist

2% Software Designer

2% Test Engineer

2% Software Quality Engineer

2% Quality Director

34% Medical Device

17% Pharma

13% Computer Production /Development

9% Healthcare Technology

6% Diagnostics

6% Researcher

4% Medical Technology

4% Software Engineer

2% Medical Imaging

2% Human Bionics

2% Water Technology



2 Register Today! Call Sam Eid at 416-597 4719 or e-mail: [email protected]

Dear Colleagues,

We can’t place enough importance on the topic of Software Design for MedicalDevices. As devices themselves become smaller and their software becomes larger, thedesign, testing and FDA approval process becomes more expensive and complex. Withthe recent number of recalled software products, manufacturers can no longer affordto fall behind on the latest advancements in the field.IQPC’s 12th Software Design for Medical Devices conference will delivergroundbreaking practices and thought-provoking perspectives on understanding andmanaging requirements in a time and cost effective way.Don’t miss the opportunity to: • Meet both regulatory leaders and industry best practitioners who will provideunique perspectives of software design and compliance for medical device• Join our interactive workshops and presentations to explore the collaborativesoftware design process

• Learn the ground-breaking techniques to accelerate design and approval • Get access to the most up-to-date standards

We look forward to meeting you in Philadelphia!

Cathy GuConference Director, [email protected]

Pre-Conference Workshops Monday, April 27, 2009

Establishing a Collaborative Environment to the Software Design Process 8:00 am – 10:30am

Medical device design is pressed by complicated safety requirements andtight deadlines. Introducing and creating a collaborative environment isan effective way to improve efficiency and reduce the cost.

What will be covered: • Breaking down the design process to analyze cost & procedures• Exploring the opportunities beyond the design team• Understanding the regulations and interpreting them into your

design process

How you will benefit: • Gain the insights of design process and compliance requirements• Have access to real life collaboration case studies• Learn cost-effective methods to improve safety and reduce launch

product defaults

Workshop Leader: Renay A. Ebelle, Electro Optical Sciences

Use of Software Virtualization Techniques for Medical DevicesAdvances in both software and hardware technologies mean it is nowfeasible to run multiple operating systems and applications simultaneouslyon the same piece of hardware. Running guest operating systems likeLinux, Windows or an RTOS on top of an embedded hypervisor allows foreasy software application migration to the next generation of hardware,and allows for information assurance by offering secure separationbetween them. This workshop will look under the hood at an embeddedhypervisor and how it can help with the consolidation of both hardwareand software for multiple modalities on a single system.

What will be covered: • Software architecture of an embedded hypervisor • The differences between software virtualization techniques • New hardware techniques for efficient software virtualization • Application migration using Linux, POSIX and Windows • Performance demonstration of an embedded hypervisor

• Development of a complete virtualized platform with ahypervisor/separation kernel and virtualization enabled hardware

• Safety and security considerations using software separation techniques

How will you Benefit: • Understanding of both software and hardware requirements for a

virtualized device • Knowledge of how safety and security standards can be handled • See first-hand the performance of a virtualized system • Software design using open standards for effective re-use • How implementing a virtualized platform today increases productivity

and provides cost reductions now and for the long-term

Workshop Leader: Stuart Fisher, Sr. Product Marketing Manager, LynuxWorks

Enhancing the Usability of Devices through Improving Interface EaseHuman Factors Engineering (HFE) and Ergonomics are concerned withways to design tools, machines, operations, environment or worksystems so they are compatible with human capabilities and limitations.Drawing on case studies, this workshop will discuss close collaborationbetween human factors and industrial design as a means to achievebreakthroughs in the design of safe and effective medical devices.

What will be covered:• Gathering principles of graphic user interface design• Understanding pitfalls associated with the design of medical interfaces

and how to avoid them• Acknowledging the pros and cons of different approaches to

rapid prototyping• Usability testing

• Meeting FDA QSR/design control requirements• Learning alarm design

How You Will Benefit:• Obtaining an understanding of what graphic user interface

design entails• Learning specific methods for developing a usable interface, including

alarm design• Understanding how to identify and eliminate usability problems

Workshop Leaders:Stephen B. Wilcox, Ph.D., FIDSA, Founder and President, DesignSciencePatrick Swindon, Senior Industrial Designer, Ethicon Endo-Surgery

The Economics and Application of the Software Design ProcessEngineers often wish to apply “best practices” in their softwaredevelopment projects but are often driven to “just write code”. This isoften due to a fundamental misunderstanding that code equals progressand lack of code means nothing is getting done. This workshop willstart by exploring the motivation for applying “best practices” and theeconomic advantages they produce. This will help put the practicesengineers want to apply in terms that managers and business leadersunderstand and relate to… the company’s bottom line and ultimatesurvival. The economic discussion will be followed by a training sessionin the application of Use Case Driven software development techniques.

What will be covered:• How does the application of “best practices” impact your company’s

bottom line• Why the survival of your company ultimately depends on the use of a

good software process

• A Use Case Driven Design and Development Methodology will be presented• Attendees will work through a design exercise using several UML diagrams• A brief introduction to UML will be presented; just enough to work

the exercise

How will you benefit:• You will be able to make an effective argument to management for

implementing a good software process in your organization• You will be introduced to a particular process that incorporates the

tenants of Medical Device software guidance while remaining asstreamlined and efficient as possible

• You will come away with knowledge of UML and Use Cases which willserve as a start for further exploration of modern software designtechniques. You will also have a list of resources to help you in your quest

Workshop Leader:Dan Sterling, President, SterlingTech Software, Inc.

A

10:45 am – 1:45 pmB

2:00 pm – 4:30 pmC

4:45 pm – 7:15 pm D


Main Conference Day One Tuesday, April 28, 2009

8:30 Coffee and Registration

8:45 Chairperson Opening Remarks

9:00 Updating FDA Requirements and Standards• Discussing critical requirements regarding medical devices• Detailing the specifications and management issues in

seeking FDA approval• Addressing issues of standards obsolescence

and complianceRenay A, EbellePrincipal EngineerElectro Optical Sciences

9:45 Developments within European Medical Device Directives• Giving an overview of the European standards• Understanding the harmonization of IEC 62304 • Examining the classifications and strategies of how to

implement new standardsSherman EaglesPartnerSoftwareCPR

10:30 Networking Break

11:00 Supporting Software Design with Software &System Engineering Life Cycle Process StandardsRecent IEEE / ISO / IEC harmonization has resulted in welldefined Software Life Cycle Process descriptions supported byindividual standards. This session will explore the variousstandards and how do they support the software design. • Examining how advanced software engineering governance

& methods will achieve: quality, productivity, customersatisfaction, and conformance

• Understanding global medical device industry needs ONEStandard, ONE Test, ONE Approval

• Exploring consensus developed International Standards • Zooming in Software engineering (SE) methods include both

life cycle model and the life cycle process descriptions• Managing quality processes - IEEE/ISO/IEC have recently

defined the global standards for software & systemengineering life cycle process descriptions

• How to design Artifacts from IEEE SE StandardsJohn WalzVP StandardsIEEE - CS

11:45 Auditing a Medical Device Using Global StandardsAuditing is a critical procedure in medical device design and inthis session, a close study on the global auditing standards willbe presented and practical suggestions will be given to help youachieve total compliance. • Understanding why audit medical device • Examining global auditing standards• Aiming for continuous improvement of device development • Studying the regulatory aspect and what to do• Getting CE marking • Achieving total complianceBhanu P. SharmaGlobal Manager, IT Quality, Validation & Documentation,Bayer HealthCare - O&I

12:30 Networking Luncheon

1:30 Understanding the Validation of Software forRegulated Processes• Taking a comprehensive look at TIR36 – The significance of

the new report• Understanding How much V&V is necessary for compliance• Implementing Critical thinking vs. Checklist mentalityThomas BentoSr. Software Quality EngineerCertified Compliance Solutions

2:15 Panel Discussion: Exploring Global Collaborationand Standardization InitiativesThis panel will discuss developments with the Global HarmonizationTask Force (GHTF) and how multinational device companies areaddressing new FDA regulations, European directives, and changes tosoftware standards and risk management.Sherman EaglesPartnerSoftwareCPR

Please contact [email protected] to join this panel discussion


3:30 Leveraging Industrial Collaboration to ImprovingTime to Market• Addressing compliance issues and lean manufacturing• Using agile and adaptive methods to expediting processes• Improving software agile software development Mike PhillipsSenior Technical LeadSoftware Engineering Institute

4:15 Closing Remarks and End of Day One

REGULATION & COMPLIANCE

COLLABORATIVE DESIGN


Here’s what people are saying about IQPC conferences:

“Very good approach and level of detail. Great use of actual examples and case studies”

“Informative, great opportunity to expand your knowledge and seek guidance from your business partners”

8:30 Coffee and Registration

8:45 Chairperson Opening Remarks

9:00 Detailing Risk Assessments to ManageRequirements Effectively• Writing requirements that address all factors of testing,

code, and tracing errors• Factoring risk analysis into requirements and relating the

data to implementation• Determining the goals of test cases• Debating the scope of technical implementation in

requirements versus design documents• Addressing the challenges of requirements writing and

requirement analysisLynn IhlenfeldtVP Product DevelopmentMinnetronix, Inc.

9:45 Design with the End in Mind: Evolving System,Device, and User Interfaces throughout theMedical Device Product Lifecycle• Understanding requirements and validation from a point-of-

care perspective• Assuring medical device and medical device system quality

and safety at the bedside• Addressing challenges arising from technology

heterogeneity and advancement throughout productlifecycle, particularly for software-based devices and systems

• Understanding software maintenance from a provider perspective

• Optimizing device and system maintenance and support toensure patient safety

Rick SchrenkerSystems Engineering ManagerMassachusetts General Hospital Department ofBiomedical Engineering Boston


11:00 Case Study: Going Beyond the Code – Optimizing the Validation Process to AchieveAgile Development • Exploring the integration challenges for risk management

of software• Analyzing the complexity of source code• Exploring IEC 62304’s significance • Detecting issues in unit tests, integration tests, and verificationPlease contact [email protected] for speakingopportunities

11:45 Keynote Address: Understanding Perspectives from FDA on Human Factors andRelated Regulations• Introducing human factors guidance • Quality system/design control regulation for medical devices • Understanding FDA recognized standards • Specifying FDA medical device labeling information • Most importantly – safety! Ron Kaye Team Leader, Human Factors Engineering Team, Centerfor Devices and Radiological HealthU. S. Food and Drug Administration

12:30 Networking Luncheon

1:30 Designing Software Considering Human Factorsto Enhance Usability • Determining the usability of product interfaces• How do human factors apply to mission critical related issues?• Identifying how human factors engineering is affecting R&D Edmond IsraelskiHuman Factors Program ManagerAbbott Laboratories

2:15 Application of ISO 14971 to Medical DeviceSoftware - Risk Analysis and Writing EffectiveSoftware Requirements• Overview of draft IEC TR 800002-1 medical device software

– Guidance on the application of ISO 14971 to medicaldevice software

• Factoring the risk analysis process into development ofsoftware requirements

• Managing requirements changes effectively to mitigate risks Patty KrantzR&D Quality ManagerMEDTRONIC, INC. | CRDM


3:30 Driving Design Through DFSS Methods and Tools• Building statistical models for reliability• Integrating software into system reliability models• Measuring and predicting the quality attributes of the

software product Dr. Julian GoldmanDirector of InteroperabilityMassachusetts General Hospital

4:15 Closing Remarks and End of Conference

Please note that multiple discounts cannot be combined.

A $99 processing charge will be assessed to allregistrations not accompanied by credit cardpayment at the time of registration.

MAKE CHECKS PAYABLE IN U.S. DOLLARS TO:IQPC* CT residents or people employed in the state

of CT must add 6% sales tax.

TEAM DISCOUNTSFor information on team discounts, pleasecontactSam Eid at 416-597 4719 or [email protected]

Special Discounts Available: A limited numberof discounts are available for the non-profitsector, government organizations and academia.For more information, please contact Sam Eid at 416-597 4719

Details for making payment via EFT or wire transfer: JPMorgan ChasePenton Learning Systems LLC dba IQPC: 957-097239ABA/Routing #: 021000021Reference: Please include the name of the attendee(s) andthe event number: 10364.006

Payment Policy: Payment is due in full at the time ofregistration and includes lunches, refreshment and detailedconference materials. Your registration will not beconfirmed until payment is received and may be subject tocancellation. For IQPC’s Cancellation, Postponement andSubstitution Policy, please visitwww.iqpc.com/cancellation

Special Dietary Needs: If you have a dietary restriction,please contact Customer Service at 1-800-882-8684 todiscuss your specific needs.

©2009 IQPC. All Rights Reserved. The format, design,content and arrangement of this brochure constitute atrademark of IQPC. Unauthorized reproduction will beactionable under the Lanham Act and common lawprinciples.

END USERS Register and Register and Register and Register and Pay by 2/13/09 Pay by 2/27/09 Pay by 3/27/09 After 3/27/09

Conference Only $1,299 $1,399 $1,599 $1,799Conference +1 Workshop $1,848 $1,948 $2,148 $2,348Conference +2 Workshops $2,397 $2,497 $2,697 $2,897Conference +3 Workshops $2,846 $2,946 $3,146 $3,346Conference +4 Workshops $3,295 $3,395 $3,595 $3,795Workshop Only $549 $549 $549 $549

SOLUTION PROVIDERS Register and Register and Register and Pay by 2/27/09 Pay by 3/27/09 After 3/27/09

Conference Only $1,999 $2,399 $2,799Conference + 1 Workshop $2,548 $2,948 $3,348Conference +2 Workshops $3,097 $3,497 $3,897Conference + 3 Workshops $3,546 $3,946 $4,346Conference + 4 Workshops $3,995 $4,395 $4,795Workshop Only $549 $549 $549

Registration Information

Main Conference Day Two Wednesday, April 29, 2009

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