||Opening and Welcome
||Keynote: Pete Martinez - The Five Big Ideas that Will Transform Healthcare: This session will focus on issues that face healthcare specifically related to technologies as the great catalyst for its transformation. The Five Big Ideas touch on Health Analytics (Big Data), Imaging, Telemedicine, Simulation (mannequins, animation, avatars), and Genomics. This will include a discussion around industry demographics, financial implications, technology examples, and business opportunities in these areas.
||Keynote: Dr. Irma Becerra-Fernandez
||Breakout Session 1 - Process Management with Stages and RTC OR
Breakout Session 2 - A Practitioner's Guide for Engineering Medical Device Software: This session is intended for medical device and software engineers, QA and compliance professionals, and business managers to better understand approaches to help bring medical devices to completion sooner, at higher quality, and in compliance with regulations. We will examine the activities for each phase of the development lifecycle and show why these activities are important and add value, how to undertake them, and what outputs need to be created to document the validation process for regulations like 21 CFR 820.70(i), meeting the IEC 61508 and the new IEC 62304 standard, and automating the generation of FDA documentation.
||Breakout Session 1 - Getting Requirements Right through Model Based Functional Analysis: Requirements definition is a critical part of the development lifecycle, but it is common for system-level requirements to be inconsistent and incomplete. The Rational Solution for Systems and Software Engineering provides process guidance and tooling for model-based System Functional Analysis. By visualizing requirements, engineers have a better understanding of intended behavior. The Rational solution does not replace traditional approaches, but instead applies modeling in a non-implementation way to refine and improve upon system requirements. The outcome is requirements that have been validated through model execution, and the avoidance of costly specification errors. OR
Breakout Session 2 - Audits: Organizational Steps to safe process & product quality: Medical device manufacturers are responsible for errors in their products and also errors introduced by their suppliers. The quality of work from suppliers is extremely important. A key step to ensuring process and product quality is through supplier auditing.
||Lunch Sponsored by CloudOne
||Breakout Session 1 - Finally, True Requirements Branching/Merging in DOORS: Best practices in engineering encourage the reuse of assets to meet demands of quality and timeliness. However, the ability to reuse requirements is often limited in opportunity based on the complexity of managing the reuse relationship in Rational DOORS. With the introduction of BranchManager for DOORS®, new patterns of usage can be applied quickly with high quality. Looking at patterns of reuse such as Product Lines and Product Derivatives we demonstrate the capabilities and opportunities of BranchManager to accelerate the efficiency of your Systems Engineers in delivering high quality requirements. OR
Breakout Session 2 - Challenges and opportunities for the medical device industry: Meeting the new IEC 62304 standard: The recent IEC 62304 standard for medical device software is causing companies worldwide to step back and examine their software development processes with considerable scrutiny. While software development and testing is still an integral part of overall system design and production, the IEC 62304 standard focuses on software as a separate life-cycle process with specific needs for risk management and safety assessment. With IEC 62304, the world has changed—country by country—for medical device manufacturers. This doesn’t mean, however, that complying with IEC 62304 must slow down your medical device software development. By applying best practices guidance and process automation, companies have a new opportunity to improve on their fundamental business goals, while getting through regulatory approvals faster, lowering costs and delivering safer devices.
This session will explore what IEC 62304 compliance means for manufacturers and also describe the larger context of systems and software engineering best practices at work in many of today’s most successful companies.
||Breakout Session 1 - The Power of Cloud Computing in Software and Systems Development, or How I Stopped Worrying and Learned to Love the Cloud OR
Breakout Session 2 - Being agile while still being compliant: A practical approach for medical device manufacturers: Although medical device regulations do not enforce a fixed lifecycle model, activities are presented in a sequential manner, thus hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from agile development methods. Several medical device manufacturers have adopted agile practices while keeping development in compliance with regulations, but conflicts arise and decisions have to be taken in favor of agility or formality. The Association for the Advancement of Medical Instrumentation (AAMI) has produced a new Technical Information Report, TIR45, that gives guidance on the use of agile practices in medical device development. This "Medical device software - Software life cycle processes" report adds new insights on the subject by mapping IEC 62304 activities into the agile development process.
||IBM Watson and Jeopardy!: Was it only a Game?: In February 2011, an IBM computer called Watson astonished audiences worldwide by soundly beating the two all-time greatest Jeopardy! champions – at their own game. A great parlor trick to be sure, but why did IBM invest in this grand challenge and then, after years of research and development, why was the entire IBM team on the edge of their seats for the final match? (Hint: Watson’s victory was far from a sure thing!)
In this session, we’ll explore Watson with a focus on the technology and the systems engineering approach that enabled it to not only answer questions, but meet the unusually demanding performance requirements needed to win the game. This session will include video of Watson in action and a live demonstration of Watson technology.
||Cocktail Reception Sponsored by Method Park