Full Four-Day Agenda – Nov 27-30, 2012
MEMS in Medical Devices - Tuesday, November 27, 2012
KEYNOTE ADDRESS: Discovering the latest advancements in MEMS to establish the impact on the future direction of medical device technology
- Reviewing current successful applications of MEMS in medical devices by therapeutic area and MEMS functionality
- Examining the potential for new applications of existing MEMS technology in existing and new medical devices
- Discovering the latest developments in MEMS technology to understand the possible capabilities and property limitations
- Uncovering the latest biomarkers in the pipeline where MEMS sensors could be applied to determine which therapeutic areas and potential uses are upcoming
Jay Esfandyari, Ph.D.
MEMS Product Marketing Manager - STMicroelectronics
MEMS enabling a health and medical revolution through a convergence of consumer and medical markets
- Introduction of MEMS Industry Group
- Overview of programs and events
- MEMS Market Overview
- Overview of MEMS and Market trends in health and consumer applications
- MEMS Enabling a Health and Medical Revolution
- MEMS Enables, Wireless Propels the Convergence of Health and Consumer
- Factors Affecting Convergence of Health & Consumer Markets
- Examples of the convergence of consumer and medical markets
- Targets for Sensors/MEMS + Wireless Medicine
- MEMS-Enabling a Consumer Healthcare Revolution
- Challenges and opportunities
Karen Lightman
Managing Director - MEMS Industry Group
Networking Break and Refreshments
PRACTICAL CASE STUDY: Designing a MEMS-powered medical device 101 – understanding the specific design parameters to capitalize on the full potential and speed commercialization
- Examining real-world case studies to identify device type specific requirements for MEMS integration:
- Wearable
- Ingestible
- Implantable
- Aligning device needs with MEMS capability to identify foreseeable integration challenges in order to address them early on in the design process
- Utilizing an efficient problem solving model to overcome integration issues as they arise in the development process and speed device time to market
- Adapting the design process to enable the enhancement of MEMS effectiveness in your device in terms of sensitivity in sensors or power in actuators
Tim Kelliher
Senior Director of Customer Solutions - Movea
PANEL DISCUSSION: Incorporating end-user experience into MEMS-powered design through human factors engineering
- Addressing the physician perspective – ensuring ease of preparation, administration, data extraction, and awareness of the life of the device
- Understanding the patient perspective – enhancing device comfort, and minimizing intrusion on daily life and visits to physician for device maintenance or data extraction
- Examining challenges in home health and uncontrolled environments – mitigating against accidental device removal or potential unforeseen environmental factors causing malfunction.
Jeff Clark
Area Manager - Silex Microsystems
Asmita Khanolkar
Program Manager - SMC Ltd.
Vincent Fortin, Eng., M.A.Sc.
Vice President, Business Development - C2MI – MiQro Innovation Collaborative Centre
Networking Lunch
Overcoming challenges of integrating MEMS into medical devices – from product development to manufacturing
- Definition of medical device requirements and regulations
- Current offerings of ASIC packages modules suitable for medical applications
- Methodology of incorporating MEMS in medical devices – micro molding, molding, assembly, automation
- Challenges associated at various steps – merging electronics with device manufacturing
- Testing and Process Validation – taking to market
- Asmita Khanolkar
Program Manager - SMC Ltd.
From collaborative research to commercialization for MEMS in medical devices
- Advantages of having access to an industry-driven R&D environment
- Benefits of collaborative R&D activities and having access to a complete ecosystem
- Business model requirements to accelerate the development phase and launch new innovations faster on the market
- Vincent Fortin, Eng., M.A.Sc.
Vice President, Business Development - C2MI – MiQro Innovation Collaborative Centre
Networking Break and Refreshments
PRACTICAL CASE STUDY: Best practices for integrating MEMS into existing medical devices – development to production
- Identifying specific challenges in design and manufacturing and the effective solutions for overcoming them
- Practical example of repurposing a platform- reducing risk, development time and time to market
- System integration alternatives to reduce overall costs and complexity
Brian O’Loughlin
Sales Manager - IMT
MEMS for healthcare applications: What you need to know before you “Go MEMS”
- The growth of MEMS and MEMS in medical
- How MEMS can transform medical applications
- A survey of medical MEMS devices
- The challenges of executing a MEMS program
- What to look for in selecting a MEMS partner
- Jeff Clark
Area Manager - Silex Microsystems
End of MEMS Day
Day One - Wednesday, November 28, 2012
Registration and Refreshments
Analyzing consumer demands and trends to understand the implications for wireless medical devices and their application in different environments
- Understanding the impact of the “consumerization” of healthcare on medical device manufacturers
- Evaluating current wireless applications and future trends in acute care and procedure-based environments
- Facilitating a stronger adoption of wireless medical devices in ambulatory care and the broader clinical environments
- Discovering the opportunities for wireless-capable medical devices within the management of chronic conditions in the non-clinical or home environment
- Leveraging wireless within medical devices to connect all the key stakeholders and healthcare settings and ensure seamless end-to-end patient care
José Colucci
Director, Health and Wellness - IDEO
Wireless capable medical devices with significant software and data integration are the future
- Comparing the costs and benefits of developing a wired versus a wirelessly connected medical device
- Evaluating the customer needs and specifications of an existing medical device to determine the viability of developing a potential wireless add-on
- Understanding best practices for designing and developing a new commercially viable medical device with built-in wireless capabilities
- Adopting measures to mitigate risk in the design and development process for a wireless medical device
Shahid N. Shah
CEO - Netspective Communications
Networking Break and Supplier Showcase
Understanding current FDA guidance to determine the impact on future regulations and the implications for wireless medical devices
- Clarifying the Medical Device Data Systems (MDDS) final ruling for new wireless medical devices poised to enter the market
- Reviewing the Radio Frequency Wireless Technology in Medical Devices guidance document to summarize the least burdensome approach to the design and development of a device with RF connectivity
- Properly classifying a wireless medical device to determine which FDA requirements for evidence apply to a particular device
- Identifying filing procedures for wireless add-ons to existing devices and for new devices designed with wireless capability
Keith A. Barritt
Principal - Fish & Richardson P.C.
Coexistence testing for safe and effective RF wireless medical devices
- Analyzing the availability of medical frequency bands and the implications upon wireless coexistence communication
- Applying verification and validation techniques to ensure reliability of wireless medical devices
- Design suggestions for wireless coexistence testing to reduce the risk of systems disrupting another devices operation
- Coexistence testing methods to address the grey area between radio coexistence and RF immunity
- A critical case study to evaluate wireless coexistence for medical devices
Greg Crouch
Life Science Business Director - National Instruments
Networking Lunch and Supplier Showcase
Reviewing the latest wireless technical and market trends and test challenges
- Introducing key wireless technologies that can be applied to medical devices
- Examining integral specifications and attributes of these technology and where they are currently being used
- Evaluating testing challenges for these technology including RF signal quality, power, frequency bands and interference
Jung-ik Suh
Wireless Marketing Program Manager - Agilent Technologies – Electronic Measurement Group
PANEL DISCUSSION: Examining current and emerging industry standards for short and long range applications
- Evaluating the key issues in the medical device industry being addressed by wireless technology today
- Identifying the key challenges for wireless technology in medical applications
- Determining the technologies that provide the best fit for different use models and trade-offs in:
- Hospitals
- Urgent Care Facilities
- Emergency Medical
- Home/Home Health
- Examining the impact of the new BAN proposal and how it will this affect the usage of standardized technologies
Suke Jawanda
Chief Marketing Officer - Bluetooth SIG
Phil Raymond
Wireless Architect - Philips Healthcare
Richard Lincoff
Medical Devices Practice Leader - Cognizant Business Consulting
Rick Hampton
Wireless Communications Manager - Partners HealthCare System
Networking Break and Supplier Showcase
Highlighting architectural essentials in low power design to increase the ease of use and effectiveness of wireless medical devices
- Identifying effective strategies for developing a low power wireless medical device to overcome concerns over the emission of radiation and the possible effect on patient health
- Extending battery life to reduce the need for frequent battery turnover and patient visits
- Improving energy efficiency through alternative sources to support continuous power supply
Michael J. Ferri
Founder and Principal - Untethered Healthcare Consulting
PRACTICAL CASE STUDY: Medical device integration using current 802.11 wireless infrastructures in the unlicensed RF band
- Reviewing outcomes based on 350,000 wireless infusion pump integrations at over 700 hospital environments
- Identifying characteristics of a “medical grade” hospital wireless network and assessing what works and what does not
- Implementing changes necessary to core wireless software that enable connectivity, roaming, and security
- Analyzing case study results of hospital onsite testing for authentication, bandwidth needs, and security to determine if this is the best approach or there is a better method
Robert Schad
Director of IT and Connectivity Solutions - CareFusion
Networking Reception and Supplier Showcase
Day Two - Thursday, November 29, 2012
Registration and Refreshments
KEYNOTE ADDRESS: Examining market trends and developments to determine the future direction of wireless capability and growth opportunities in the medical device industry
Wireless Health is permeating our everyday lives with the great promise of changing behaviors while improving health and wellness outcomes. Solutions are being rushed to market to address all stages of human life, from birth to end of life. The growth of sensors and smartphones is altering the health care landscape, placing affordable clinical quality medical diagnostics and monitoring tools in everyone’s hands, with early offerings already demonstrating a significant impact. Increasing amounts of venture capital is pouring into related startups. The future of wireless health is here today.
Jack J. Young
Managing Director, Qualcomm Life Fund - Qualcomm Ventures
PANEL DISCUSSION: Identifying the needs of a wireless medical device end-user to ensure usability
- Establishing user expectations around connectivity speed and network reliability
- Determining the desired requirements around the user interface and ergonomics of the physical device
- Understanding the different needs of the various end-users – doctors, nurses, at-home caretakers, and patients – and factoring these criteria into device design
Scott Thiel
Senior Regulatory Consultant - Anson Group
Tracy Rausch
Chief Technical Officer - Doc Box Inc
Julian Goldman
Medical Director, Biomedical Engineering - Partners HealthCare System- Rick Hampton
Wireless Communications Manager - Partners HealthCare System
Networking Break and Supplier Showcase
PRACTICAL CASE STUDY: Preparing your wireless medical device system for operating in real world acute care environments
- Understanding the wireless requirements which will impact your verification activities
- Medical device and wireless infrastructure considerations which can affect how you design and test your solutions
- Managing verification challenges in dealing with multiple infrastructure vendors
- Successfully deploying your device system in the real world to maximize commercial success
Ken Fuchs
Senior Principal Architect, Enterprise Systems - Mindray North America
IEC/AAMI/ANSI 80001-1:2010 and 80001-2-3 wireless guidance
- Clarifying the requirements for medical IT networks outlined in IEC/ANSI 80001
- Examining the impact of these risk management requirements on wireless medical device manufacturers
- Practical strategies for medical device manufacturers to help customers leverage IEC/ANSI 80001
- Phil Raymond
Wireless Architect - Philips Healthcare
Networking Lunch and Supplier Showcase
PRACTICAL CASE STUDY: Advancing patient care with an implantable, programmable drug delivery microchip
- Examining the MicroCHIPS clinical trial, a demonstration of accurate and convenient remote controlled drug delivery
- Exploring the benefits of wirelessly controlled implants from compliance, efficacy, and cost perspectives
- Identifying the specific technical and clinical requirements of wirelessly controlled medical implants
- Evaluating who should have access for programming, control, and data
- Reviewing the use scenarios and their influence on product design
Robert Farra
President and Chief Operating Officer - MicroCHIPS
Maintaining data privacy in integrated patient management systems
- Understanding the intricacies of the integrated patient management system to undertake effective risk assessment of the medical device within that system
- Implementing preventative risk management methods to safeguard patient health and privacy
- Ensuring data protection compliance for areas like HIPAA, EU Directive and PIPEDA through implementation of the recommended procedures and testing measures
- Building quality assurance into medical device design and network maintenance to ensure data privacy in acute care, ambulatory and home environments
Michael C. McNeil
Global Chief Privacy & Security Officer - Medtronic
Achieving Connectivity was the first step – what about Interoperability?
- Getting your device data to play well with other devices as an essential building block of modern healthcare information systems
- Understanding the various “itys” such Connectivity, Integratability, Security and Interoperability which are required to provide a “complete” solution
- Understanding the different levels of Interoperability in order to apply them to your medical device systems
- Making sense of the roles of SDOs, IHE, Continua, and the FDA to understand how they may affect your medical device system interface design
- Choosing which Interoperability path to pursue in order to improve the odds of a successful hospital integration effort
- Ken Fuchs
Senior Principal Architect, Enterprise Systems - Mindray North America
End of Main Conference
Mobile Medical App Workshop - Friday, November 30, 2012
Reviewing the trends that are driving the industry toward adoption of mobile apps for medical device connectivity and remote healthcare
- Uncovering what constitutes a medical mobile app and the role of apps in medical device systems
- Reviewing the evolution of hardware platforms and exploring market segmentation
- Evaluating the key drivers for growth in mobile apps in medical applications
- Addressing the challenges and barriers to market entry for a medical device manufacturer
Bridget Moorman, CCE
President - BMoorman Consulting LLC
Examining current and upcoming FDA regulations impacting mobile medical app approvals
- Clarifying FDA jurisdiction and software regulation
- Understanding why FDA behaves differently with seemingly similar software
- Evaluating both current and future guidance documents influencing mobile medical apps
- Analyzing examples of FDA approved medical mobile apps
- Scott Thiel
Senior Regulatory Consultant - Anson Group
Assessing the applicability of FCC, EU and international radio regulations and EMC standards to mobile medical apps
- Overview of FCC and EU radio regulations in relation to medical mobile application reliability
- Overview of European and international EMC (Electromagnetic Compatibility) standards in relation to medical mobile application reliability
- Incorporation of IEC 60601-1-2 and international EMC standards in risk assessment of IEC 60601-1 3rd Edition
- Overview of wireless transaction security standards
- Review of FCC proposal to release new spectrum for Medical Body Area Networks (MBANs)
Joe Danisi
WiSE Project Lead - Underwriters Laboratories
Networking Break and Refreshments
Overcoming compliance challenges with technology specific to mobile medical apps
- Current trends in “systems of systems” and common issues across standards involving interoperability of medical devices, smart-grid, and machine control
- Analyzing technologies for safety and security vulnerabilities in medical “systems of systems”
- The role of standards’ compliance in facilitating integration and mitigating risk (ISO 14971, ISO 13485, IEC 60601-1 3rd Ed., IEC 62304)
- Standards in a regulatory context in the US and EU and the application of recognized/harmonized standards
- Future directions and trends – emerging technologies, emerging standards, and some gaps that are yet to be filled
Anura S. Fernando
Principal Engineer - eHealth - Underwriters Laboratories
CASE STUDY: Designing, developing and commercializing a successful FDA-cleared mobile medical app
- Identifying the market need and how to reach the market
- Understanding the issues that impact design, usability and end-user implementation
- Obtaining FDA clearance – identifying and addressing the safety and effectiveness criteria
- Becoming a strategic supplier – using an app to leverage your company strategy
Kyle Peterson
Director, Regulatory & Corporate Affairs - Calgary Scientific
