Monday, Feb. 11, 2013

Plenary Session: Opening Keynote Speech

Is there room for innovation in today's medical device industry?

Stanton Rowe
Corporate Vice President, Advanced Technology and Chief Scientific Officer
Edwards Lifesciences >More

Chair's Opening Remarks

Georgette Belair, VP R&D and co-author of “Implementing Design for Six Sigma – A Leader’s Guide”, Össur America Inc.

Assumption Storming: Disruptive innovations in medical devices
This is a two-part workshop to introduce a powerful innovation tool, applied at Medtronic and taught at the Stanford Design School, to truly think outside of the box and create novel medical device concepts in disruptive ways. You will experience firsthand the techniques and benefits of this tool, a more robust and directed form of brainstorming. The workshop allows you to work in small groups to directly apply the knowledge gleaned from the session.

We live and work making assumptions, creating biases, and they're important for our sanity as well as productivity. We need our world ordered. But our assumed order also creates problems and stifles creative solutions when creative solutions are needed. In order to solve problems in disruptive ways we need to temporarily escape the confines of our assumed order, break out of our mental boxes, and explore those assumptions that created our problem in the first place. “You can’t solve problems at the same level of thinking that created them,” was Einstein’s insight. Listing and then leapfrogging assumptions turns out to be the fastest way to create breakthrough solutions to simple, as well as your most demanding, challenges.

Part 1: Experiencing the Design Problem

• Learn how bad designers fail (short exercises)
• Witness how creative designers think

Craig Lauchner, Innovation Program Manager, Medtronic

Part 2: Learning to be disruptive

• Practice with a simple problem
• Understand the scope of Assumption Storming
• Practice with a current problem of your own

Craig Lauchner, Innovation Program Manager, Medtronic

Creativity workshop ─ Using Design Thinking methodology to discover creative solutions to your device development challenges

How you ask a question is as important as the question you ask.  Too often, the result of a design exploration is hamstrung by the context in which it is considered. This workshop walks you through IDEO’s techniques to help you think unconventionally about your design challenges. You’ll discover methods for getting inspired by ideas outside of your domain, and how to apply that tangibly to your own development program.

Stacey Chang, Associate Partner and Director of Health & Wellness practice, IDEO
Brian Mason, Lead of Medical Products Group, IDEO
Jesse Fourt, Senior Program Lead, IDEO

Design for Six Sigma—Steps to execute design concepts

• An overview of Six Sigma principles for medical device design
• Discussing the benefits of Design for Six Sigma
• Understanding the Voice of the Customer, and incorporating into new device design
• A case study on DFSS

Georgette Belair, VP R&D and co-author of “Implementing Design for Six Sigma – A Leader’s Guide”, Össur America Inc.

How to capitalize on the consumerization of medical devices?

• Adopting a consumer-centric approach to design
• Understanding advances in consumer electronics to enable novel functionalities for medical devices
• Discussing the future of the consumerized medical device
• Device design for global health—Understanding global needs for globalized devices

Sonny Vu, CEO and Founder, Misfit Wearables

Plenary Session: Keynote Speech

Innovation with ears: Designing a consumer-friendly medical device

Kim Blickenstaff
President and Chief Executive Officer
Tandem Diabetes Care >More

Chair's Opening Remarks

Brian Buntz, Editor-at-large, MPMN

Prototyping workshop – Building to Think

The traditional role of a prototype is to validate a design or an idea. This workshop will help you understand how prototyping can be employed as a tool for creative discovery, in addition to validation.  In this workshop, learn how to answer critical development questions through a rapid prototype – you’ll develop your own prototype, and learn from it, in less than an hour.

Stacey Chang, Associate Partner and Director of Health & Wellness practice, IDEO
Brian Mason, Lead of Medical Products Group, IDEO
Jesse Fourt, Senior Program Lead, IDEO

Utilizing advances in computational modeling and simulation platforms to accelerate design

• Updating on the latest technologies and best practices in simulation models
• Predicting the performance of medical devices in different patient groups
• An update on FDA guidance on computational modeling and implications for patient safety
• Will medical devices be approved based on computer models?

Alison Marsden, Assistant Professor of Mechanical and Aerospace Engineering, University of California San Diego

General Lunch Break & Networking

RSVP Required: Lunch & Learn Session – Polymer Technology for Implantables: Devices and Excipients presented by Lubrizol

Software Design for Six Sigma: Best practices and Agile development

• An overview of Six Sigma principles for software design and software reliability testing
• Reviewing the principles of Agile methods as applied to the software development life-cycle model
• Using Agile methods to achieve FDA standards and requirement s for testing and validation
• Best practices in cost control and quality improvement in developing medical software

Vivek Vasudeva, Co-Founder, SWReliability.com (Former  Director of Engineering, Medtronic)

Optimizing the use of COMSOL Multiphysics in design projects

• Updating on the COMSOL systems and use cases through case studies
• Understanding applications for design, system analysis and applied research
• Optimizing Finite Element Analysis (FEA) to reveal weak spots and understand device interaction with the human body
• Discovering applications in product development and safety improvement

John F. Kalafut, Director of Research and Strategy, MEDRAD Innovations/Bayer Healthcare

Motion capture for the heart: A close look at the CyberHeart design project at Medtronic

• Using biomedical visualization technology to study pathologic states for device design and perform virtual implants
• Applying 3-dimensional analyses of real-time motion-capture data to understand the mechanical differences of mitral valve function in pathologic states
• Transforming the 3D ovine numeric analyses into an animated, deformable human model of the mitral apparatus
• Understanding the applications in simulation and design concept verification to accelerate the design process

Aaron Oliker, Co-Founder, BioDigital Systems

Plenary Session: Keynote Speech

The science (and art) of miniaturizing medical devices: A closer look at the CD technology in molecular diagnostics

Marc Madou
Chancellor's Professor and BioMEMS Lab Director
UC Irvine >More

Chair's Opening Remarks

Brian Buntz, Editor-at-large, MPMN

Optimizing Medical Device Development via Systems Engineering

• Optimization parameters for medical device development
• Identifying foundational elements of systems engineering
• Maximizing the utility of systems engineering elements during development
• Achieving optimization via integration of systems engineering elements

Martin Coe, Systems Engineer CSEP, Covidien

Human Factors Pre-Market Review: Incorporating HF engineering into risk management

• Understanding the increased consideration of HF/Usability at the FDA and device reviews in new submissions
• Update of IEC 62366:2007: Usability engineering and AAMI/ANSI
• Application of HE75:2009: Human factors engineering-Design of medical devices, for safety and effectiveness
• Updating on the latest FDA guidance on HF engineering and the relationship with the GHTF framework for design controls
• Analyzing use-related risk, validation study data, and usability information

Ron Kaye, Team Leader; Human Factors Pre-Market Evaluation Team, Office of Device Evaluation Center for Devices and Radiological Health, FDA

General Lunch Break & Networking

RSVP Required: Lunch & Learn Session – Portable Power Considerations for Medical Devices presented by Electrochem Medical

Featured Keynote Speech - EXPO FLOOR

The Future of Health and Medicine: Where Can Technology Take Us?

From the perspective of a leading physician, scientist, and innovator, this talk examines rapidly emerging, game-changing, and convergent technology trends and how they are and will be leveraged to change the face of healthcare, the medical device industry, and the practice of medicine in the next decade.

The talk will be a deep dive into how emergent fields such as low-cost personal genomics, the digitization of health information, crowd-sourced data, molecular imaging, wearable devices and mobile health, systems medicine, robotics, artificial intelligence, nanotechnology, 3D printing and regenerative medicine are transforming healthcare. The talk also will explain how these developments have the potential to enable clinicians, empower patients, and deliver better care and outcomes at lower cost.

Daniel Kraft, MD
Executive Director
FutureMed >More

Meeting the FDA-recognized IEC 62304:2006 standard: Medical software processes

• Reviewing the standard and how it impacts software development in medical devices
• Understanding how IEC 62304 fits with other standards such as 14971 in terms of requirements analysis, design, and testing
• Exploring the relationship between agile software development methodologies and 62304 in terms of flexibility and structure
• Choosing suitable software tools for IEC 62304 compliance
• Conforming to the new MEDDEV 2.1/6 guidelines for standalone medical software

Dan Olivier, President, Certified Compliance Solutions

Innovating with quality in mind – A new theme in medical device development

• Highlighting common pitfalls in de novo R&D projects as well as alarming trends in design quality
• A primer on how to leverage legacy product information to make your development program more robust
• Understanding the benefits of early implementation of design controls, efficient organization of risk management and creating innovative test plans
• A series of practical case studies demonstrating instances when ignoring quality issues led to program failures as well as highlight successes driven by implementation of creative quality initiatives

David Amor, Design Quality Engineer, St. Jude Medical and Sr. Innovation Fellow, University of Minnesota
Madhavi Ayyalasomayajula, Sr. Design Assurance Engineer, St. Jude Medical

Integrating Pharmaceutical Technology Transfer Practices into a Design Control System for Combination/Convergent Medical Products

• Providing an overview of how Technology Transfer (TT) pharmaceutical development (PD) deliverables and best practices can be integrated into a Design Control (DC) System and the New Product Development (NPD) Process for Combination/Convergent Medical Products
• Developing strategies for Pharmaceutical Technology Transfer into Design Control System
• Integration & Translation of Pharmaceutical Technology Transfer Deliverables into Design Control
• Outlining key concepts of Pharmaceutical Technology Transfer Guidelines
• Examples of Roadmap and Internal guides for New Product Development of Combination/Convergent Medical Products

Roy R. Fennimore, Jr., Research Fellow, Product & Process Scientific Solutions (P²S²) – Johnson & Johnson

Bridging the gap between ideas and the marketplace for MedTech

David Gollaher
President and Chief Executive Officer
CHI-California Healthcare Institute >More

Chair's Opening Remarks

Glenn White, Associate Director of Device Tehnology, Novartis Pharmaceuticals

Developing and implementing an effective and robust materials selection process for medical devices

• Reviewing the regulatory and safety considerations (design controls requirements) for the material selection process
• Understanding the inputs to the selection process and how device requirements are translated into material selection criteria
• Determining the output of the material selection process and producing a material selection worksheet to support the Design History File (DHF)
• Case study: The impact of a material selection strategy on the development and launch the Simoon dry-powder inhaler device

Glenn White, Associate Director of Device Technology, Novartis Pharmaceuticals

Selecting materials for implantable electronic devices

• Reviewing the latest advances in implantable devices to understand the specific requirements for materials
• Understanding the role of material biocompatibility in the device implant strategy
• Reliability testing method for materials: HALT Testing

Mike Colvin, Senior Research Fellow, Boston Scientific

Panel Discussion: Selecting and working with material suppliers to ensure quality and streamline CAPA systems

• Best practices in supplier selection—Understanding the OEM’s guidebook
• Developing a framework for purchasing controls and integrate the supplier’s CAPA with internal risk management system
• Understanding the OEM’s supplier control approach in the planning and selection stage of materials
• Leveraging partnership with material suppliers to optimize risk management and gain innovation

MODERATOR: Michael Checketts, Division Director of QA/RA and Technology, Ametek Engineered Medical Components

Olen Chiddix, Director of Materials, Pathway Medical Technologies

Yong Cho, Sr. Technical Manager, Genentech

Materials selection based on the new RoHS requirements: Selecting alternative lead-free alloys for circuit boards assembly

• Reviewing the history of RoHS (Restriction of Hazardous Substances) regulation and its recent application to medical device manufacturing
• Updating on scientific work done in collaboration with universities on alternative RoHS alloys selection
• Selecting alternative alloys for cost-effectiveness, lower processing temperature and improved product quality
• Understanding the benefits in reducing and eliminating potential failures such as laminates "Pad cratering" defect, solder joints " head on pillow - HoP" defect, Sn whiskers
• Design and use of test vehicle boards to test solder joints formed using the new alloys
• Discussing results obtained so far for thermo-mechanical "Accelerated Thermal Cycling" properties of solder joints formed using these alloys in both normal and harsh environments (0-100 ºC) and (-55 to +125 ºC)
• Discussing results obtained so far for Mechanical properties of solder joints formed using these alloys: "drop test"

Simin Bagheri, M.A.Sc., P.Eng. Customer Engagement Lead, Celestica Inc.

Selecting materials for medical devices

• Outlining general selection criteria and qualification testing used to select a metal for use in a medical device
• Case studies on specific tests, machines and devices

Paul Schmidt, Sr. Dist. Engineer, Edwards Lifesciences