Wednesday, Sept. 28
8:00 am - 9:15 am

DM-300 Introduction to Personal Medical Devices
SPEAKER: Eduardo Bartolome, Engineer, Texas Instruments
TRACK: DesignMED    Medical Electronics Design   

This presentation describes the principles behind few personal medical devices like digital thermometers, blood pressure monitors, glucose meters and pulse oximeters. An overview of the physics and biology driving the several architectures for each of these systems will be explained, deriving the key specifications for the signal chain and followed by a description of the integrated circuits addressing each of these solutions.

Wednesday, Sept. 28
10:30 am - 11:45 am

DM-302 Determining the Right System Software for Your Medical Application
SPEAKER: Stephen Olsen, Software Architect, Embedded Systems Division, Mentor Graphics
TRACK: DesignMED    Medical Electronics Design

Finding the right system software in medical applications is critical as there is little room for error. And while some systems are becoming bulkier - using a more general purpose operating system (GPOS) - other systems need to trim down in order to boot faster, use less power, and become more reliable. Developers have many choices from rolling your own or using a small micro kernel, to employing a real time operating system (RTOS) or a GPOS such as Linux or Android. There is no optimal solution, but understanding the parameters of the application and the interaction between the target hardware will help developers select the operating system that's best for them. This session explores many of the issues developers face when selecting the right system hardware for today's medical embedded devices, including the next generation of SoCs which will undoubtedly have multiple cores. System software that runs across several cores and various approaches on how to divide the application between several different types of OSes will be discussed. This session also addresses certification by the FDA and other standards bodies and how this might impact the selection of system software.

Wednesday, Sept. 28
2:00 pm - 3:15 pm

DM-304 Advanced Thermal Management in Medical Devices
SPEAKERS: Peter Ritt, Advanced Cooling Technologies, Inc.
Richard Bonner, Lead R&D Engineer, Advanced Cooling Technologies
TRACK: DesignMED    Medical Electronics Design 

In many medical device applications, thermal management limits the overall performance and reliability of the system.  This presentation will briefly cover the proper application of basic thermal management strategies such as liquid cold plates, air cooled heat sinks and thermal interfaces material selection.  The main focus is the application of advanced technologies such as heat pipes and phase change materials to several different medical devices.  The application of heat pipes and phase change materials in several medical applications such as cryogenic surgery pens, laparoscopes, MRI equipment, PCR machines and neurosurgery equipment will be described in detail.  The down selection criteria for the applied thermal technologies in each of these applications will be thoroughly described, including electrical power usage, weight, cost, reliability, etc.

Wednesday, Sept. 28
3:30 pm - 4:45 pm

DM-306 ZigBee Health and Wellness Wireless Monitoring and Sensing Solutions for Telehealth
SPEAKERS: Mark Diperri, Field Applications Engineer, Freescale
Jon Adams, Business Development, Wireless Connectivity Operation, Freescale
TRACK: DesignMED    Medical Electronics Design 

Based on the aging of global populations, telehealth device design opportunities and installations continue to grow at rapid rates.  Incorporating ZigBee wireless connectivity into medical device design may provide an opportunity to grow significant revenue dollars for your business.   This presentation reviews the telehealth market potential, offers a basic foundation for wireless sensing, includes a list of potential applications, explains why the ZigBee standard-based wireless protocol is best-suited for these applications, and provides information on preferred system functionality.  ZigBee continues to shine as the wireless solution optimized for sensing and monitoring applications when the requirements include low data rate, ranges up to 100m line of sight, and low power.  As a confirmation of ZigBee capabilities, the Continua Health Alliance has selected ZigBee as a wireless solution of choice.

Wednesday, Sept. 28
8:00 am - 9:15 am

DM-301 Preparing Successful 510(k)s in a Changing Regulatory Landscape
SPEAKER: Barry Sall, Principal Consultant, PAREXEL Consulting
TRACK: DesignMED    Medical Electronics Regulatory Issues

Attendees will learn some of the newer informal expectations and formal requirements for data included in a 510(k) Premarket Notification.  Trends and likely changes to the 510(k) program will also be discussed.  Strategies to stay current and prepare 510(k)s that minimize post submission reviewer questions will be described.

Wednesday, Sept. 28
10:30 am - 11:45 am

DM-303 Building a Mobile Health App? Complying with FDA Medical Device Regulations         
SPEAKER: Elisa Maldonado-Holmertz, VP of Business Development, Emergo Group Inc.
TRACK: DesignMED    Medical Electronics Regulatory Issues

Elisa Maldonado-Holmertz, VP of Business Development for Austin-based medical device consultancy Emergo Group, will guide you through evolving FDA regulation of mobile health applications. If you are presently developing a mobile health application - as a standalone product or an accessory to an existing medical device or diagnostic - get the latest information on who needs to comply, how to comply, and how long it takes to do so. Learn about the different classifications of medical devices (Class 1, 2 and 3) and the cost of registering your product with the FDA, if needed.

Wednesday, Sept. 28
2:00 pm - 3:15 pm

DM-305 Leveraging Software Separation for Safe Medical Devices
SPEAKER: Joe Fabbre, Director, Platform Solutions, Green Hills Software
TRACK: DesignMED     Medical Electronics Regulatory

Medical device manufactures are faced with a daunting challenge.  They must balance customer demand for new features like advanced graphics, wireless communications, and secure management of patient information; while at the same time ensuring device reliability and safety, attaining device approval, and getting their products to market in a timely fashion.  In this session we'll examine a software architecture that leverages software separation to safely manage the increasing complexity of software in today's medical devices.

Wednesday, Sept. 28
3:30 pm - 4:45 pm

DM-307 The Changing Face of the Medical Field Courtesy of Wireless Technologies 
SPEAKER: Leo Estevez, Chief Technologist, Connectivity Software, Wireless Business Unit, Texas Instruments
TRACK: DesignMED     Medical Electronics Regulatory

This presentation will examine the vital role that wireless technologies play in advancing new capabilities in the telehealth and telemedicine markets. As life expectancies continue to increase and diseases continue to spread, the need for more accessible, accurate, cost-efficient and connected medical monitoring devices is more evident than ever. Semiconductor companies like TI provide the technologies that make equipment smaller, smarter and more affordable, creating "hospitals without walls" and opening new doors for health care in the U.S. and abroad. What is the industry's call to action in this process, and what part do connectivity chip designs play in the bigger picture? These questions and more will be addressed in this discussion.

Tuesday, Sept. 27
4:00 pm - 4:45 pm

A Closer Look Inside Nonin Onyx II Model 9560 Fingertip Pulse Oximeter: Teardown & Giveaway in the DesignDays Theater on the Expo Floor
SPEAKER: David Carey, Vice President, Technical Intelligence, TechInsights

With the ever-changing landscape of the semiconductor and medical industry came the introduction of electronics into the field of medicine. Over time, medical electronics and the semiconductors that powered them have evolved to the point where electronic innovation is now being first seen in the medical field. In this special presentation from UBM TechInsights, David Carey provides a detailed teardown analysis of one of these types of medical innovations with the Nonin Onyx II Model 9560 Fingertip Pulse Oximeter. This presentation will take a closer look at the technology within the Model 9560 including: The use of Bluetooth to allow clinicians to remotely monitor patients with chronic diseases such as congestive heart failure; The wireless oximetry which gives patients a new level of freedom and control over their monitoring. Attendees of the Live Teardown, performed in the ESC Theater, will have the opportunity to win one of these innovative devices

Tuesday, Sept. 27
9:30 am - 10:30 am

Embedded Design in a Black Hat World
Attacks on Embedded Systems are Spreading—Know Your Options

Keynote by Joerg Borchert, Vice President, Chip Card & Security ICs, Infineon Technologies North America

Joerg will be discussing security strategies to manage risk in embedded design, covering such pressing issues as:

• The security ecosystem in the embedded world
• New attack classes in hardware and software
• Upgrades and connectivity
• The evolution of security for connected devices
• Evolving counterstrategies
• The realities of embedded design that hinder or help address security issues
• Lessons learned from the PC ecosystem and more

Keynote Bio: Joerg Borchert has a broad perspective on the state of security in embedded computing. He currently is Vice President of Chip Card & Security ICs for Infineon Technologies North America and during 2011 he also is serving as President and Chairman of the Trusted Computing Group.

Born in Hamburg, Germany, Borchert studied Mechanical Engineering and Business Administration at the Technical University of Darmstadt, Germany, then achieved his PhD in Economics before he joined Siemens AG in 1988. In 1992 he joined Siemens Semiconductor which became Infineon Technologies in 1999. A US resident since 1998, Borchert now leads a team working on chip-based security for the smart grid and mission critical embedded systems. Along the way, he contributed to four patent filings in this area and was instrumental in the implementation of smart cards for payment applications and the U.S. electronic Passport program.

Wednesday, Sept. 28
9:30 am - 10:30 am

Revolutionizing Medical Device Design

Keynote by Charles G. Sodini, LeBel Professor EECS MIT

In his Keynote Address, Dr. Sodini will discuss specific areas that show promise for medical devices. This could include wearable or minimally invasive monitoring devices, medical imaging, laboratory instrumentation, and the data communication from these devices and instruments to healthcare providers and caregivers.

Other areas of discussion will include medical electronic systems for monitoring and imaging, systems that require state-of-the-art mixed-signal ICs and systems with extremely low energy dissipation.

Keynote Bio: Charles G. Sodini received the B.S.E.E. degree from Purdue University, in 1974, and the M.S.E.E. and the Ph.D. degrees from the University of California, Berkeley, in 1981 and 1982, respectively.

He was a member of the technical staff at Hewlett-Packard Laboratories from 1974 to 1982, where he worked on the design of MOS memory. He joined the faculty of the Massachusetts Institute of Technology, in 1983, where he is currently the LeBel Professor of Electrical Engineering. His research interests are focused on medical electronic systems for monitoring and imaging. These systems require state-of-the-art mixed signal integrated circuit and systems with extremely low energy dissipation. He is the co-founder of the Medical Electronic Device Realization Center at MIT.

Along with Prof. Roger T. Howe, he is a co-author of an undergraduate text on integrated circuits and devices entitled "Microelectronics: An Integrated Approach." He also studied the Hong Kong/South China electronics industry in 1996-97 and has continued to study the globalization of the electronics industry.

Dr. Sodini was a co-founder of SMaL Camera Technologies a leader in imaging technology for consumer digital still cameras and machine vision cameras for automotive applications. He has served on a variety of IEEE Conference Committees, including the International Electron Device Meeting where he was the 1989 General Chairman. He has served on the IEEE Electron Device Society Administrative Committee and was president of the IEEE Solid-State Circuits Society from 2002-2004.

He is currently the Chair of the Executive Committee for the VLSI Symposia and a Fellow of the IEEE.