12th Software design for medical devices


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Understand and manage regulatory requirement specifications for
software 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

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12th Software design for medical devices

  1. 1. SAVE up to Honorably Present the: $500 off the standard conference price Understanding and Managing FDA Requirement to Ensure Compliance, Safety and Usability Learn from Designing April 27 - 29, 2009 | Philadelphia, PA and Regulatory Experts such as: Conference highlights at a glance: U. S. Food and Drug Administration Understand and manage regulatory requirement specifications for • Abbott Laboratories software in medical devices SoftwareCPR Consider multi-site development and global regulatory discrepancies • Bayer HealthCare - O&I Improve agile software development and speed up time-to-market • Certified Compliance Implement risk management tools in software development • Solutions Discuss software design modularization and integration • Minnetronix, Inc. Ensure safer development and reduce launch product defects • Software Engineering Discuss Human Factors Engineering for software design usability • Institute IEEE – CS Don’t miss the keynote address from FDA on Human MEDTRONIC, INC. | CRDM Factors Guidance and related regulations! Massachusetts General Hospital Electro Optical Sciences Sponsors: SterlingTech Software, Inc. LynuxWorks Media Partners: Design Science Ethicon Endo-Surgery Register Today! Call Sam Eid at 416-597 4719 or e-mail: sam.eid@iqpc.com
  2. 2. Who Has Attended IQPC’s Past Software Design Events: Understanding and Managing FDA Requirement 38% Software Engineer to Ensure Compliance, Safety and Usability 13% Director 9% Mgr 4% Business Process Mgr April 27 - 29, 2009 | Philadelphia, PA 4% Unknown 2% IT Project Mgr 2% Product Support Mgr 2% Business Mgr Dear Colleagues, 2% Software Specialist 2% Software Designer We can’t place enough importance on the topic of Software Design for Medical Devices. As devices themselves beco 2% Test Engineer me smaller and their software beco mes larger, the design, testing and FDA approval 2% Software Quality Engineer process becomes more expensive and complex. With the recent number of recalled soft 2% Quality Director ware products, manufacturers can no longer afford to fall behind on the latest advancem ents in the field. IQPC’s 12th Software Design for Med ical Devices conference will deliver groundbreaking practices and thou ght-provoking perspectives on und erstanding and managing requirements in a time and cost effective way. Don’t miss the opportunity to: Meet both regulatory leaders and • industry best practitioners who will provide unique perspectives of software desi gn and compliance for medical devi ce Join our interactive workshops and • presentations to explore the coll aborative software design process 34% Medical Device Learn the ground-breaking tech • 17% Pharma niques to accelerate design and app roval Get access to the most up-to-da • te standards 13% Computer Production / Development We look forward to meeting you in Philadelphia! 9% Healthcare Technology 6% Diagnostics 6% Researcher 4% Medical Technology 4% Software Engineer 2% Medical Imaging 2% Human Bionics Cathy Gu Conference Director, IQPC 2% Water Technology Cathy.gu@iqpc.com Sponsorship and Exhibition Opportunities About the Sponsors: Sponsorships and Exhibits are excellent opportunities for your company to showcase its products and services to high-level, LynuxWorks is a leader in the embedded software market providing open and reliable real-time targeted decision makers attending Software operating systems (RTOS) and software tools to embedded developers. The LynxOS RTOS family Design for Medical Devices. IQPC and offers open standards with the highest level of safety and security, enabling many mission-critical Healthcare IQ help companies like yours systems in medical, defense, avionics and other industries requiring adherence to regulatory achieve sales, marketing and branding standards such as those set forth by the FAA and FDA. LynuxWorks' BlueCat Linux provides the open source technology objectives by setting aside a limited number of of embedded Linux with the features and support for embedded applications. The Eclipse-based Luminosity IDE gives a event sponsorships and exhibit spaces – all of powerful and consistent development system across all LynuxWorks operating systems which are custom tailored to help your company create a platform to maximize its Klocwork is an enterprise software company providing automated source code analysis software exposure at the event. Visit us at products that automate security vulnerability and quality risk assessment, remediation and www.iqpc.com to see what other exciting and measurement for C, C++ and Java software. More than 300 organizations have integrated informationpacked conferences are being Klocwork's automated source code analysis tools into their software development process in order to ensure their code is offered by the International Quality & free of mission-critical flaws while freeing their developers to focus on what they do best – innovate. Productivity Center. For more information, contact SSam Eid at 416-597 4719 Register Today! Call Sam Eid at 416-597 4719 or e-mail: sam.eid@iqpc.com 2
  3. 3. Pre-Conference Workshops Monday, April 27, 2009 8:00 am – 10:30am A Establishing a Collaborative Environment to the Software Design Process Medical device design is pressed by complicated safety requirements and How you will benefit: tight deadlines. Introducing and creating a collaborative environment is • Gain the insights of design process and compliance requirements an effective way to improve efficiency and reduce the cost. • Have access to real life collaboration case studies • Learn cost-effective methods to improve safety and reduce launch What will be covered: product defaults Breaking down the design process to analyze cost & procedures • • Exploring the opportunities beyond the design team Workshop Leader: • Understanding the regulations and interpreting them into your Renay A. Ebelle, Electro Optical Sciences design process 10:45 am – 1:45 pm B Use of Software Virtualization Techniques for Medical Devices Advances in both software and hardware technologies mean it is now Development of a complete virtualized platform with a • feasible to run multiple operating systems and applications simultaneously hypervisor/separation kernel and virtualization enabled hardware on the same piece of hardware. Running guest operating systems like Safety and security considerations using software separation techniques • Linux, Windows or an RTOS on top of an embedded hypervisor allows for How will you Benefit: easy software application migration to the next generation of hardware, Understanding of both software and hardware requirements for a • and allows for information assurance by offering secure separation virtualized device between them. This workshop will look under the hood at an embedded • Knowledge of how safety and security standards can be handled hypervisor and how it can help with the consolidation of both hardware • See first-hand the performance of a virtualized system and software for multiple modalities on a single system. • Software design using open standards for effective re-use What will be covered: • How implementing a virtualized platform today increases productivity • Software architecture of an embedded hypervisor and provides cost reductions now and for the long-term • The differences between software virtualization techniques Workshop Leader: • New hardware techniques for efficient software virtualization Stuart Fisher, Sr. Product Marketing Manager, LynuxWorks • Application migration using Linux, POSIX and Windows • Performance demonstration of an embedded hypervisor 2:00 pm – 4:30 pm C Enhancing the Usability of Devices through Improving Interface Ease Human Factors Engineering (HFE) and Ergonomics are concerned with Meeting FDA QSR/design control requirements • ways to design tools, machines, operations, environment or work Learning alarm design • systems so they are compatible with human capabilities and limitations. How You Will Benefit: Drawing on case studies, this workshop will discuss close collaboration Obtaining an understanding of what graphic user interface • between human factors and industrial design as a means to achieve design entails breakthroughs in the design of safe and effective medical devices. • Learning specific methods for developing a usable interface, including What will be covered: alarm design • Gathering principles of graphic user interface design • Understanding how to identify and eliminate usability problems • Understanding pitfalls associated with the design of medical interfaces Workshop Leaders: and how to avoid them Stephen B. Wilcox, Ph.D., FIDSA, Founder and President, Design • Acknowledging the pros and cons of different approaches to Science rapid prototyping Patrick Swindon, Senior Industrial Designer, Ethicon Endo-Surgery • Usability testing 4:45 pm – 7:15 pm D The Economics and Application of the Software Design Process Engineers often wish to apply “best practices” in their software A Use Case Driven Design and Development Methodology will be presented • development projects but are often driven to “just write code”. This is Attendees will work through a design exercise using several UML diagrams • often due to a fundamental misunderstanding that code equals progress A brief introduction to UML will be presented; just enough to work • and lack of code means nothing is getting done. This workshop will the exercise start by exploring the motivation for applying “best practices” and the How will you benefit: economic advantages they produce. This will help put the practices You will be able to make an effective argument to management for • engineers want to apply in terms that managers and business leaders implementing a good software process in your organization understand and relate to… the company’s bottom line and ultimate • You will be introduced to a particular process that incorporates the survival. The economic discussion will be followed by a training session tenants of Medical Device software guidance while remaining as in the application of Use Case Driven software development techniques. streamlined and efficient as possible What will be covered: • You will come away with knowledge of UML and Use Cases which will • How does the application of “best practices” impact your company’s serve as a start for further exploration of modern software design bottom line techniques. You will also have a list of resources to help you in your quest • Why the survival of your company ultimately depends on the use of a Workshop Leader: good software process Dan Sterling, President, SterlingTech Software, Inc. Register Today! Call Sam Eid at 416-597 4719 or e-mail: sam.eid@iqpc.com 3
  4. 4. Main Conference Day One Tuesday, April 28, 2009 Coffee and Registration Auditing a Medical Device Using Global Standards 8:30 11:45 Auditing is a critical procedure in medical device design and in Chairperson Opening Remarks 8:45 this session, a close study on the global auditing standards will be presented and practical suggestions will be given to help you REGULATION & COMPLIANCE achieve total compliance. • Understanding why audit medical device Updating FDA Requirements and Standards 9:00 • Examining global auditing standards Discussing critical requirements regarding medical devices • Aiming for continuous improvement of device development • Detailing the specifications and management issues in • Studying the regulatory aspect and what to do • seeking FDA approval • Getting CE marking • Addressing issues of standards obsolescence • Achieving total compliance and compliance Bhanu P. Sharma Renay A, Ebelle Global Manager, IT Quality, Validation & Documentation, Principal Engineer Bayer HealthCare - O&I Electro Optical Sciences Networking Luncheon 12:30 Developments within European Medical 9:45 Device Directives Understanding the Validation of Software for 1:30 Regulated Processes Giving an overview of the European standards • • Understanding the harmonization of IEC 62304 Taking a comprehensive look at TIR36 – The significance of • • Examining the classifications and strategies of how to the new report implement new standards • Understanding How much V&V is necessary for compliance Sherman Eagles • Implementing Critical thinking vs. Checklist mentality Partner Thomas Bento SoftwareCPR Sr. Software Quality Engineer Certified Compliance Solutions Networking Break 10:30 COLLABORATIVE DESIGN Supporting Software Design with Software & 11:00 System Engineering Life Cycle Process Standards Panel Discussion: Exploring Global Collaboration 2:15 and Standardization Initiatives Recent IEEE / ISO / IEC harmonization has resulted in well defined Software Life Cycle Process descriptions supported by This panel will discuss developments with the Global Harmonization individual standards. This session will explore the various Task Force (GHTF) and how multinational device companies are standards and how do they support the software design. addressing new FDA regulations, European directives, and changes to • Examining how advanced software engineering governance software standards and risk management. & methods will achieve: quality, productivity, customer Sherman Eagles satisfaction, and conformance Partner • Understanding global medical device industry needs ONE SoftwareCPR Standard, ONE Test, ONE Approval Please contact cathy.gu@iqpc.com to join this • Exploring consensus developed International Standards panel discussion • Zooming in Software engineering (SE) methods include both life cycle model and the life cycle process descriptions Networking Break 3:00 • Managing quality processes - IEEE/ISO/IEC have recently defined the global standards for software & system Leveraging Industrial Collaboration to Improving 3:30 engineering life cycle process descriptions Time to Market • How to design Artifacts from IEEE SE Standards Addressing compliance issues and lean manufacturing • John Walz Using agile and adaptive methods to expediting processes • VP Standards • Improving software agile software development IEEE - CS Mike Phillips Senior Technical Lead Software Engineering Institute Closing Remarks and End of Day One 4:15 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” Register Today! Call Sam Eid at 416-597 4719 or e-mail: sam.eid@iqpc.com 4
  5. 5. Main Conference Day Two Wednesday, April 29, 2009 Coffee and Registration Keynote Address: Understanding 8:30 11:45 Perspectives from FDA on Human Factors and Chairperson Opening Remarks Related Regulations 8:45 Introducing human factors guidance • REQUIREMENTS AND CHANGE MANAGEMENT Quality system/design control regulation for medical devices • • Understanding FDA recognized standards Detailing Risk Assessments to Manage 9:00 • Specifying FDA medical device labeling information Requirements Effectively • Most importantly – safety! Writing requirements that address all factors of testing, Ron Kaye • code, and tracing errors Team Leader, Human Factors Engineering Team, Center • Factoring risk analysis into requirements and relating the for Devices and Radiological Health data to implementation U. S. Food and Drug Administration • Determining the goals of test cases Networking Luncheon • Debating the scope of technical implementation in 12:30 requirements versus design documents RISK & QUALITY • Addressing the challenges of requirements writing and requirement analysis Designing Software Considering Human Factors Lynn Ihlenfeldt 1:30 to Enhance Usability VP Product Development Minnetronix, Inc. Determining the usability of product interfaces • How do human factors apply to mission critical related issues? • Design with the End in Mind: Evolving System, 9:45 • Identifying how human factors engineering is affecting R&D Device, and User Interfaces throughout the Edmond Israelski Medical Device Product Lifecycle Human Factors Program Manager Understanding requirements and validation from a point-of- Abbott Laboratories • care perspective Application of ISO 14971 to Medical Device • Assuring medical device and medical device system quality 2:15 Software - Risk Analysis and Writing Effective and safety at the bedside Software Requirements • Addressing challenges arising from technology heterogeneity and advancement throughout product Overview of draft IEC TR 800002-1 medical device software • lifecycle, particularly for software-based devices and systems – Guidance on the application of ISO 14971 to medical • Understanding software maintenance from a device software provider perspective • Factoring the risk analysis process into development of • Optimizing device and system maintenance and support to software requirements ensure patient safety • Managing requirements changes effectively to mitigate risks Rick Schrenker Patty Krantz Systems Engineering Manager R&D Quality Manager Massachusetts General Hospital Department of MEDTRONIC, INC. | CRDM Biomedical Engineering Boston Networking Break 3:00 Networking Break 10:30 Driving Design Through DFSS Methods 3:30 Case Study: Going Beyond the Code – and Tools 11:00 Optimizing the Validation Process to Achieve Building statistical models for reliability • Agile Development Integrating software into system reliability models • Exploring the integration challenges for risk management • Measuring and predicting the quality attributes of the • of software software product • Analyzing the complexity of source code Dr. Julian Goldman • Exploring IEC 62304’s significance Director of Interoperability • Detecting issues in unit tests, integration tests, and verification Massachusetts General Hospital Please contact cathy.gu@iqpc.com for speaking Closing Remarks and End of Conference opportunities 4:15 Registration Information Please note that multiple discounts cannot Details for making payment via EFT or wire transfer: Register and Register and Register and Register and END USERS be combined. JPMorgan Chase Pay by 2/13/09 Pay by 2/27/09 Pay by 3/27/09 After 3/27/09 Penton Learning Systems LLC dba IQPC: 957-097239 A $99 processing charge will be assessed to all ABA/Routing #: 021000021 Conference Only $1,299 $1,399 $1,599 $1,799 registrations not accompanied by credit card Reference: Please include the name of the attendee(s) and Conference + payment at the time of registration. the event number: 10364.006 1 Workshop $1,848 $1,948 $2,148 $2,348 Conference + MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: Payment Policy: Payment is due in full at the time of 2 Workshops $2,397 $2,497 $2,697 $2,897 IQPC registration and includes lunches, refreshment and detailed Conference + * CT residents or people employed in the state conference materials. Your registration will not be 3 Workshops $2,846 $2,946 $3,146 $3,346 of CT must add 6% sales tax. confirmed until payment is received and may be subject to Conference + cancellation. For IQPC’s Cancellation, Postponement and 4 Workshops $3,295 $3,395 $3,595 $3,795 TEAM DISCOUNTS Substitution Policy, please visit For information on team discounts, please www.iqpc.com/cancellation Workshop Only $549 $549 $549 $549 contact SOLUTION PROVIDERS Register and Register and Register and Special Dietary Needs: If you have a dietary restriction, Sam Eid at 416-597 4719 or e-mail Pay by 2/27/09 Pay by 3/27/09 After 3/27/09 please contact Customer Service at 1-800-882-8684 to sam.eid@iqpc.com discuss your specific needs. Conference Only $1,999 $2,399 $2,799 Special Discounts Available: A limited number Conference + 1 Workshop $2,548 $2,948 $3,348 of discounts are available for the non-profit ©2009 IQPC. All Rights Reserved. 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  6. 6. International Quality & Productivity Center REGISTRATION CARD 535 5th Avenue, 8th Floor New York, NY 10017 YES! Please register me for ❑ Conference Only ❑ Conference + 3 Workshops ❑ Conference + 1 Workshop ❑ Conference + 4 Workshops ❑ Conference + 2 Workshops ❑ Workshop Only See Page 5 for pricing details. Your customer registration code is: TLS/SE When registering, please provide the code above. Name__________________________________ Job Title ________________________ Organization____________________________________________________________ Approving Manager______________________________________________________ Address_______________________________________________________________ City__________________________________State______________Zip___________ Phone________________________________Fax_______________________________ 3 EASY WAYS TO REGISTER: E-mail__________________________________________________________________ ❑ Please keep me informed via email about this and other related events. ❑ Check enclosed for $_________ (Payable to IQPC) 1 Call: 1-416-597 4719 ❑ Charge my __Amex __Visa __Mastercard __Diners Club Email: sam.eid@iqpc.com 2 Card #____________________________________Exp. Date___/___ Fax: 1-416 598 7934 3 Details for making payment via EFT or wire transfer can be found on preceding page. ❑ I cannot attend, but please keep me informed of all future events. 10364.006/D/KA Register by 3/27/09 and Honorably Present the: SAVE up to $400 off the standard conference price Understanding and Managing FDA Requirement to Ensure Compliance, Safety and Usability April 27 - 29, 2009 | Philadelphia, PA Sponsors: Media Partners: