Two Great Educational Opportunities

For 2014 BIOMEDevice San Jose provides a wealth of great educational opportunities. Benefit from the six individual 2-hour BIOMEDevice seminars, or the 2-day multi-track Wireless Medical Devices Conference. Both are detailed below. Early Bird discounts end October 31, so register early to secure the best rates.

Visit here to sign-up to receive a copy of the official event brochure when it’s published.

 

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Conference Pricing

Seminar registration includes...

  • Expo admission and entry to the Club Connect VIP area on the expo floor
  • Access to presentation materials after the event (as approved by each presenter)
  • Networking opportunities, including a guaranteed spot at our space-limited Speed Networking event (optional; details to be emailed to you after you register)
  • Possible professional development or re-certification points.  Delegates may contact us after its completion at tshowreg@ubm.com for a certificate of attendance, which may be used for your re-certification journal or application to organizations such as ASQ, AAMI and RAPS

Registration for the Wireless Conference includes everything listed above, plus...

  • Free access to any of the 2-hour BIOMEDevice seminars being held on the same days
  • Complimentary refreshments, snacks and a catered lunch provided daily

Special discounts are available. Register 3 or more people for a 10% group discount, or 10+ people for a 20% discount. Academic discounts are available to students and those employed at higher-education institutions. To register as a group, or find out more about academic discounts, call our booking manager Jane Sullivan at 310-445-8538. For a press pass please email your credentials to ts.publicity@ubm.com.

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Sponsored by

For more information about sponsorship opportunities call 310-445-4245 or email sponsorship@ubm.com.

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The TÜV Rheinland Group is a leading provider of technical services worldwide. Founded in 1872 and headquartered in Cologne, the Group employs 17.000 people in 500 locations in 65 countries. It generates annual revenues of € 1.531 billion. The Group’s mission and guiding principle is to achieve sustained development of safety and quality in order to meet the challenges arising from the interaction between man, technology and the environment.

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Fish & Richardson is a leading global law firm practicing in the areas of intellectual property and litigation. Founded in 1878, the firm prosecuted and litigated many fundamental patents of the industrial age: the telephone, the airplane, the lightbulb, and the radio. Today, with over 350 attorneys and technology specialists, Fish remains the go-to IP firm for the world's greatest innovators in cutting-edge technologies.

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The San Jose State University Biomedical Engineering Society is composed of graduate and undergraduate students from various engineering and science disciplines, alumni, faculty and industry professionals. SJSU BMES has been consistently recognized by both San Jose State University and the National Bioengineering Society for outstanding work in promoting the biomedical engineering career- from industry tours, professional speakers, poster sessions, networking events, and community service.

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Session Details

 

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Schedule

Wednesday, December 3, 2014

Morning Sessions

  • DESIGNING AND INNOVATING WITHIN A HIGHLY REGULATED ENVIRONMENT   more details ▾

    Seminar

    Biomed

    Wednesday, December 3, 2014
    10:00 am - 11:45 am

    Chair: Chirag Tilara, Director of Coronary Quality, MEDTRONIC CARDIOVASCULAR

    10:00 am - 10:25 am
    Innovating in a changing marketplace: Designing with regulations and reimbursement in mind

    • Discussing how to continue to design innovative products in a highly regulated environment and in an era of unclear and diverse guidance
    • Exploring the challenges of generating data aligned with country-specific reimbursement models
    • What do you need to include in your design process to accommodate global these evolving and diverse reimbursement requirements?
    • Reviewing key questions to consider during the design or development process

    Susanne F. Machacz, MPH, Senior Manager, Market Access Department, ABBOTT VASCULAR

    10:25 am - 10:50 am
    Building international speed to market and compliance into your medical device design

    • Addressing international speed to market and cost challenges
    • How will this impact your product development cycle when designing for a global market?
    • Balancing the innovation process with various global regulatory requirements

    Chirag Tilara, Director of Coronary Quality, MEDTRONIC CARDIOVASCULAR

    10:50 am - 11:10 am
    Case study: From the drawing board to market in 9 months

    • Understand how a CE Class-1/FDA Class 2 system was developed rapidly
    • Recognize how multiple design houses were used in parallel to develop the product quickly
    • Recognize lessons learned from clearing the product through an international regulatory body
    • Exploring the challenges that brought TGA compliance

    Johnny Chan, Senior Director, R&D, Global Operations, ISONEA LIMITED

    11:10 am - 11:45 am
    Panel discussion: Entrepreneurship vs. regulation – balancing creativity and speed with compliance

    • Exploring how successful entrepreneurs are becoming more creative with their designs and innovations
    • Discussing a real-world tug-of-war example of entrepreneurship vs. regulation
    • Assessing how large organizations can behave in a more entrepreneurial way
    • How do you innovate in a large bureaucracy?

    Kathy Hibbs, Chief Legal and Regulatory Officer, 23ANDME
    Johnny Chan, Senior Director, R&D, Global Operations, ISONEA LIMITED
    Susanne F. Machacz, MPH, Senior Manager, Market Access Department, ABBOTT VASCULAR
    Chirag Tilara, Director of Coronary Quality, MEDTRONIC CARDIOVASCULAR

    About Chirag Tilara

    Chirag has been with Medtronic Cardiovascular for over 8 years and has worked in the Medical Device and Pharmaceutical Industry for over 11 years.  As a Director of Quality, Chirag is responsible for overseeing product development and post commercialization Quality activities for the global coronary business and managing health of the coronary products throughout the entire product lifecycle in global markets.

    In the pre-market area, Chirag is responsible for Quality in the product development phase of Medtronic’s next generation Coronary Drug Eluting and Bare Metal Stents. In this area, he is responsible for various aspects of combination product quality including design verification testing, risk management, component qualification, test method development and validation, shelf life and drug stability, process controls and process validation. In the post-commercialization area, he is responsible for oversight, management and resolution of Quality challenges globally. This responsibility includes managing manufacturing challenges, regulatory inspections, customer satisfaction and meeting Quality metrics for the business.  

    He completed his BE in Chemical Engineering from L.D College of Engineering, Ahmedabad, India and ME in Chemical Engineering from Widener University, Chester PA. Chirag is currently pursuing Masters in Business Administration at University of San Francisco, CA

    Previous to Medtronic, Chirag worked as Quality Manager at San-Mar Laboratories in Elmsford, NY and Premier Brands of America, Mount Vernon, NY.

    Click here for additional speakers' biographies

  • NEW TECHNOLOGIES & STRATEGIES TO ADVANCE WIRELESS MEDICAL DEVICE DEVELOPMENT   more details ▾

    Conference

    Wireless

    Wednesday, December 3, 2014
    9:00 am - 11:45 am 

    9:00 am - 9:55
    Registration & Refreshments

    9:55 am - 10:00 am
    Chair’s Opening Remarks

    Phil Raymond, Wireless Architect & Senior Global Product Manager, PHILIPS HEALTHCARE & INFORMATICS

    10:00 am - 10:35 am
    Keynote Speaker: Exploring the Wireless Frontier: Plotting Your Role in Next-Generation Mobile Health Technology

    • How will the medical device industry take things to the next level?
    • How will medical and non-medical innovation merge?
    • Bringing the consumerization of healthcare into your outlook planning

    10:35 am - 11:10 am
    Clarifying FDA Guidance on Mobile Platforms & Connected Health – Next Steps

    • How is the FDA moving forward in addressing Connected Health?
    • Updates on cyber security and adherence
    • Compliance requirements for the latest Medical Device Data Systems (MDDS) guidelines

    Bakul Patel, Senior Policy Advisor – Digital Health, FOOD & DRUG ADMINISTRATION, CENTER FOR DEVICES & RADIOLOGICAL HEALTH

    11:10 am - 11:45 am
    Advancements in Energy Harvesting with Wearable & Implantable Applications

    • Harvesting body heat and bodily fluids to generate energy in mobile medical devices
    • Capturing the electron generation mechanism through “in-body” devices
    • Subcutaneous and implantable technology powered by body heat or fluid
    • Mechanical and electrical power stimulants
    • Exploring electroceuticals: How to exploit a neuron network in the body to change or operate organs for proper functioning

    Yonggang Huang, Ph.D., Professor of Mechanical Engineering, NORTHWESTERN UNIVERSITY

    About Phil Raymond

     

     

     

    Click here for additional speakers' biographies

Afternoon Sessions

  • NEW DEVELOPMENTS AND APPLICATIONS IN 3D PRINTING   more details ▾

    Seminar

    Biomed

    Wednesday, December 3, 2014
    1:00 pm - 2:30 pm

    Chair: Gene Kulesha, Director, Platform Technology Engineering, STRYKER CORPORATION

    1:00 pm - 1:25 pm
    Using 3D printing for complex, high volume medical devices

    • History of 3D printing research and development at one of the big 5 orthopaedic companies
    • Leveraging 3D printing to address previous design and clinical challenges
    • Integrating manufacturing and regulatory concerns into the development lifecycle
    • Managing partnerships with 3D printer and raw material providers

    Gene Kulesha, Director, Platform Technology Engineering, STRYKER CORPORATION

    1:25 pm - 1:50 pm
    Case Study: Exploring patient driven R&D in medical 3D printing

    • Understanding how to pair surgeons and medical device R&D together
    • How 3D printing is revolutionizing spine surgeries
    • Patient specific implants: impact for the patient, for the surgeon and for medical device manufacturers

    Pierre Olivier, CEO, MEDICREA USA

    1:50 pm - 2:15 pm
    Case study: 3D custom printed medical implants that deliver antibiotics and chemotherapeutics

    • Exploring 3D printing for personalized medical applications
    • Designing biological implants to transport therapeutic drugs directly to target area
    • Exploring design challenges and opportunities for the use of new materials
    • View a live demonstration of a novel 3D print gun for dental and orthopedic applications

    Dr. David K. Mills, Professor, Biological Sciences and Biomedical Engineering, Institute for Micromanufacturing, LOUISIANA TECH UNIVERSITY
    Jeffery Weisman, MD/Ph.D. Candidate, Biomedical Engineering, LOUISIANA TECH UNIVERSITY/LSU HEALTH SCIENCES CENTER SHREVEPORT

    2:15 pm - 2:30 pm
    Ask the Experts: Q&A Session

    About Gene Kulesha

    Gene Kulesha has been part of the Stryker organization for 18 years. He started off in manufacturing where he was responsible for titanium thermal spraying operations and hydroxyapatite powder production. He then lead the technology transfer of various implant coating techniques into Stryker’s European manufacturing sights. Following his tenure in operations he then took on Project and Product Manager roles in Stryker’s bone substitutes business where he was responsible for design, marketing and distribution of allograft tissue and synthetic bone products. For the last 9 years he has been an integral part of Stryker Orthopaedics Advanced Technology department where his early responsibilities included the development of various porous biologic fixation hip and knee implants. Currently he is the Director of the Platform Technology Engineering group where he and his team are responsible for the development of novel materials and implants using additive manufacturing. He has engineering and science degrees in Materials Science from Stevens Institute of Technology.

    Click here for additional speakers' biographies

  • USER EXPERIENCE AND USABILITY ENGINEERING CONSIDERATIONS WHEN DESIGNING YOUR MEDICAL DEVICE   more details ▾

    Seminar

    Biomed

    Wednesday, December 3, 2014
    2:45 pm - 4:00 pm

    Chair: Jason Farnan, Senior User Experience Designer, TANDEM DIABETES CARE

    2:45 pm - 3:25pm
    A structured approach to usability testing through the iterative design process

    • The importance of defining a requirements document
    • The design process using user experience and iterative design
    • Understanding when and how to start usability testing
    • Exploring the best methods for conducting usability tests
    • Reviewing the test plan and key elements for regulatory perspective

    Jason Farnan, Senior User Experience Designer, TANDEM DIABETES CARE
    Noel Schaffer, Ph.D., Manager, User Experience Research, TANDEM DIABETES CARE

    3:25 pm - 3:45 pm
    FDA update on usability and usability expectations

    • Update on the redraft of ISO / IEC 62366 and what it means for the design process
    • Addressing the information gap between your product and what FDA looks for from device manufacturers
    • Understanding the changes in required documentation that may accompany a device submission

    Robert North, Ph.D., Chief Scientist and Owner, HUMAN CENTERED STRATEGIES

    3:45 pm - 4:00 pm
    Panel discussion: Improving usability experience and engineering from a manufacturer's perspective

    • Exploring usability challenges and managing the design process
    • What it takes to submit a device for FDA approval
    • How to work with the intended user and gather date effectively

    Jason Farnan, Senior User Experience Designer, TANDEM DIABETES CARE
    Noel Schaffer, Ph.D., Manager, User Experience Research, TANDEM DIABETES CARE
    Robert North, Ph.D., Chief Scientist and Owner, HUMAN CENTERED STRATEGIES

    About Jason Farnan

    Jason Farnan is the Senior User Experience Designer for Tandem Diabetes Care and is the lead designer of their flagship product, the t:slim® Insulin Pump. With a BFA from the Rochester Institute of Technology and over 10 years of design experience, he has worked in e-commerce, social networking, and handheld product design. Working with Tandem for almost 5 years, his role involves user research and design, as well as understanding regulatory requirements and patient needs for a wide user demographic.

    Click here for additional speakers' biographies

  • OVERCOMING WIRELESS INFRASTRUCTURE CHALLENGES   more details ▾

    Conference Track A

    Wireless

    Wednesday, December 3, 2014
    1:00 pm - 4:00 pm

    Chair's Opening Remarks

    Phil Raymond, Wireless Architect & Senior Global Product Manager, PHILIPS HEALTHCARE & INFORMATICS

    1:00 pm - 1:30 pm
    Ensuring Your Device is Secure for Hospital & Consumer Use

    • Mobile health data security technologies, their costs, and varying levels of protection
    • How are smaller devices keeping pace with evolving, more sophisticated encryption levels and algorithms?
    • Navigating cyber security regulations and protecting against cyber weaknesses
    • How do you design to prevent an attack while staying compliant with HIPAA?
    • Safely transmitting data to electronic medical records (EMR)
    • Using standardized solutions vs. custom solutions

    Chris Gough, Lead Solutions Architect, INTEL HEALTH & LIFE SCIENCES

    1:30 pm - 2:00 pm
    Creating Patient Data Privacy Protection & Robust HIPAA Compliance Programs

    • Identifying and mitigating privacy-specific risks within the context of a secure product design process
    • Complying with HIPAA regulations in the hospital ecosystem
    • Adapting wireless protocols to be compliant with HIPAA standards (i.e. ZigBee, Bluetooth, etc.)
    • Preferred wireless transmitters and protocols for securing data in the Cloud and mobile devices

    Steve Abrahamson, Director of Product Security Engineering & Privacy, GE HEALTHCARE

    2:00 pm - 2:45 pm
    Meeting Regulatory Challenges for Mobile Medical Devices

    • The FCC's role in the regulation of wireless devices
    • An overview of FDA medical device regulations
    • FDA regulation of wireless technology, mobile medical apps, and medical device data systems
    • What is the impact of FCC/FDA/ONC Joint Report on Health IT?

    Keith Barritt, Principal, FISH & RICHARDSON P.C.

    3:00 pm - 3:30 pm
    Application-Specific Wireless Communication Protocol Selection: How to Choose & Implement the Right Medium

    • Bluetooth and BLE (Bluetooth Low Energy) high-performance applications
    • ZigBee-friendly applications and project parameters
    • How to design for WiFi requirements and limitations
    • Is a commercially-standard protocol in sight?

    Upkar Dhaliwal, Chief Executive Officer, FUTURE WIRELESS TECHNOLOGIES & Chair, IEEE ENGINEERING IN MEDICINE & BIOLOGY SOCIETY

    3:30 pm - 4:00 pm
    Navigating Standards for Medical Device Communication & Compatibility

    • How can medical devices benefit from the 802.11 ac standards?
    • Improvements to 802.ac to help its usage and prevent interference
    • What is being done to digitize and add 802.11 ac earlier in the chain to enable more unique and robust communication?
    • Short range and long range communications
    • An overview of the IEEE – 11073 series
    • ZigBee health care standards in health-related applications

    Chuck Parker, Executive Director, CONTINUA & Vice President, CONTINUA HEALTH ALLIANCE

    About Phil Raymond

     

     

     

    Click here for additional speakers' biographies

  • WIRELESS PRODUCT DEVELOPMENT & DESIGN   more details ▾

    Conference Track B

    Wireless

    Wednesday, December 3, 2014
    1:00 pm - 4:00 pm

    Chair's Opening Remarks

    Dan Pettus, Vice President of Connectivity & IT, CAREFUSION

    1:00 pm - 1:30 pm
    Biocompatibility & Biomaterials Considerations for Implantable Devices

    • Advancements in new safe and efficacious synthesis of polyurethanes
    • Introduction of  tunable functional groups for designer biomaterials
    • Structure function relationships in phase separated biomaterials

    James Hedrick, Advanced Organic Materials Scientist, IBM RESEARCH

    1:30 pm - 2:00 pm
    Case Study: Wearable Diagnostic Innovation to Help Treat Chronic Disease
    An exclusive case study on a wearables industry influencer whose innovation marks a revolutionary departure from past advancements in wearable medical technology and its ability to improve health outcomes.

    Steve Axelrod, Ph.D., Chief Executive Officer, G-TECH MEDICAL - Fogarty Institute for Innovation

    2:00 pm - 2:45 pm
    The Always-On Experience: Combating RF Challenges in Medical Environments and Bluetooth Smart (Low Energy) Technology

    • Why use wireless technology for medical devices?
    • What are the medical environments?
    • Examining technologies and coexistence properties
    • Navigating spectrum usage and properties including WiFi, Bluetooth/Bluetooth Smart, and Cellular
    • Interoperability: Managing interference and coexistence mechanisms
      • WMTS (Wireless Medical Telemetry System)
      • MICS (Medical Implant Communication System)
      • MBAN (Medical Body Area Network)

    Bill Saltzstein, President, CODE BLUE CONSULTING

    3:00 pm - 3:30 pm
    Global Case Studies: IPs, Routers and Bears, Oh My! Best Practices Taken from Real-World Medical Cellular Deployment

    • Medical cellular motivations – Important aspects when considering a cellular deployment
    • The low-bandwidth medical cellular landscape in terms of 2G, 3G, and 4G/LTE
    • It ain’t just hardware – mitigations for problems encountered with sophisticated cellular firmware
    • SIM cards, the devil’s spawn – maximizing cost, minimizing outages, and keeping regulatory folks from going bald
    • Cellular Necrosis – What to expect in terms of cellular network problems
    • Cellular minefield battle plan – Strategies for medical cellular deployments

    Jim Sievert, Principal Software Engineer, BOSTON SCIENTIFIC

    3:30 pm - 4:00 pm
    mHealth at the Point of Care for Better Electronic Medical Record Integration

    • Mobile medical device market opportunities for increasing hospital compliance with EMR transmission and meaningful use
    • Examining the reimbursement landscape for EMR data metrics and integration
    • Adhering to FDA Medical Device Data Systems (MDDS) MDDS guidelines on transmitting data through the Internet

    Matt Gafencu, Director of Integrated Solutions, PATIENTSAFE SOLUTIONS

    About Dan Pettus

     

     

     

    Click here for additional speakers' biographies

Thursday, December 4, 2014

Morning Sessions

  • DISCOVERING SUCCESSFUL SCALE-UP STRATEGIES FROM DESIGN TO MANUFACTURING   more details ▾

    Seminar

    Biomed

    Thursday, December 4, 2014
    10:00 am - 11:45 am

    Chair: Chris Folk, Principal Engineer, Device Strategy, AMGEN

    10:00 am - 10:20 am
    Key points in reducing hidden costs when scaling-up your product

    • How do you overcome cost constraints and decreasing budgets?
    • Exploring how to shorten concept-to-market time frame and successfully balance cost and quality
    • Devising scale-up strategies for the transition from rapid prototyping to rapid manufacturing
    • Outlining how to improve partnerships to benefit time-to-market (TTM), time-to-volume (TTV), and time-to-profit (TTP)

    Herbert J. Bellucci, President and CEO, PULSE SYSTEMS

    10:20 am - 11:00 am
    Industry insights: The inside scoop to controlling costs when outsourcing contracts

    • When to use a contractor for R&D and manufacturing
    • Discussing how you can work more efficiently with contract R&D and manufacturers to reduce costs
    • Overcoming inherent quality challenges with CROs.

    Ryan Bethencourt, Senior Director, Life Sciences, XPRIZE FOUNDATION

    11:00 am - 11:30 am
    Fast tracking your scale-up strategy with limited time and money resources

    • Helpful hints directly from the manufacturer on ways to make the most of your resources to accelerate your scale-up strategy
    • Improving and balancing safety, reliability, and consistency
    • Maintaining consistency with suppliers, raw materials and product components
    • Deploying a efficient process for scale up repeatability

    Steven Badelt, Ph.D., Principle, SUTTONS CREEK, INC.

    11:30 am - 11:45 am
    Ask the Experts: Q&A Session

    About Chris Folk

    Chris is contributing to the innovation, evaluation, and on-boarding of device platform technologies at Amgen as a member of the Device Strategy team. Drug delivery platform technologies, such as microneedles, actuator and sensor technologies, and drug transport technologies are all areas of engagement.

    Chris first developed commercial and military aircraft engines for General Electric. Following his work at UCLA, Chris moved into medical device development with Microfabrica as the first non-founder employee. Chris next managed the research and development team of catheters at Covidien Neurovascular (formerly ev3).

    Chris holds a B.S. in Aerospace Engineering from University of Notre Dame, a M.S. in Engineering Mechanics from the University of Cincinnati, and a Ph.D. from UCLA. At UCLA, Chris’ thesis work was under the advisement of Dr. C.M. Ho, and titled, “Integrated Microfluidic Circuit with Discretized Micropumps”.

    Chris’ publications include four journal publications, fourteen conference publications, and four issued patents.

    Click here for additional speakers' biographies

  • NEW TECHNOLOGIES & STRATEGIES TO ADVANCE WIRELESS MEDICAL DEVICE DEVELOPMENT   more details ▾

    Conference

    Wireless

    Thursday, December 4, 2014
    9:00 am - 11:45 am

    9:00 am - 9:55
    Registration & Refreshments

    9:55 am - 10:00 am
    Chair’s Opening Remarks

    Phil Raymond, Wireless Architect & Senior Global Product Manager, PHILIPS HEALTHCARE & INFORMATICS

    10:00 am - 10:45 am
    The Internet of Things & M2M Communication in the Home & Hospital

    • How do you introduce IoT to the home care environment?
    • What's on the horizon for M2M communication in the hospital ecosystem?
    • Descriptions of IoT vulnerabilities at the device, application, and network level
    • The role of Real Time Location Systems (RTLS) and wireless automation
    • Managing data quality issues with IoT devices

    Moderator:
    David Snyder, President, 42TEK INC.

    Panelists:
    John Mattison, MD, Chief Medical Information Officer, KAISER PERMANENTE
    Marty Kohn, MD, Chief Medical Scientist, JOINTLY HEALTH
    Bill Saltzstein, President, CODE BLUE CONSULTING
    Alan Greene, MD, Chief Medical Officer, SCANADU
    Dan Pettus, Vice President of Connectivity & IT, CAREFUSION

    10:45 am - 11:15 am
    Case Study: Wearable Health Technology: Getting at the Heart of mHealth
    An exclusive case study on a mHealth influencer whose innovative mobile health solution enables users to take control of their heart health through the use of a mobile heart monitor and a free Apple/Android app.

    David Albert, Founder & Chief Medical Officer, ALIVECOR

    11:15 am - 11:45 am
    Building ROI: How to Maximize Reimbursement & Outcomes in Today's Healthcare Framework

    • What is the key criterion for making devices that qualify for reimbursement?
    • Organizing data to evidence clinical outcomes, value for payer adoption, and reimbursement
    • What is the role of preventative medicine in the reimbursement landscape?
    • How should device developers be evolving with new healthcare models?

    Matt Pickens, Vice President of Reimbursement & Professional Affairs, BAXANO SURGICAL

    About Phil Raymond

     

     

     

    Click here for additional speakers' biographies

Afternoon Sessions

  • QUALITY IN DESIGN AND EXECUTION: BALANCING QUALITY AND COST   more details ▾

    Seminar

    Biomed

    Thursday, December 4, 2014
    1:00 pm - 2:30 pm

    Chair: Jeff Semone, MPA Senior Director, Regulatory Affairs, Post Market Safety and Surveillance, VARIAN MEDICAL SYSTEMS

    1:00 pm - 1:30 pm
    Optimizing medical device development with quality in mind

    • Understanding the benefits of implementing design controls and quality processes early in the development and production of a device
    • Contrasting quality requirements necessary in early vs. late stage medical device development and avoiding quality issues that lead to warning letters, recalls etc.
    • Exploring real-world examples where a department and company have found the perfect balance of cost versus quality

    Al Torabi, Senior Director, Quality Engineering, SMITH & NEPHEW

    1:30 pm - 2:00 pm
    Improving your supplier quality: Selecting, monitoring and auditing suppliers

    • How is supplier quality becoming more complex?
    • Focusing on the areas of greatest risk by developing concrete plans to mitigate risk
    • Learning from past mistakes and the most common pitfalls in supplier quality management

    Prabhu Raghavan, Director, Global Supplier Quality, STRYKER

    2:00 pm - 2:30 pm
    Overcoming quality and design challenges when developing an HAI solution

    • How to address design and quality requirements when developing a device that provides an HAI solution
    • Discussing HAIs significant risk to public health and impact on hospital costs – how does this directly affect medical device manufacturers?
    • Addressing HAIs at the device level, through the use of antimicrobials, novel materials, combination devices, and device design

    Michael J. Brady, Ph.D., Head of Microbiology Services, TOXIKON 
    John Iannone, BME, Technical Specialist and Program Manager, TOXIKON

    About Jeff Semone

    Jeff recently took a new position at Varian where he has global responsibility for complaints, recalls, risk management and associated functions and activities.

    Prior to Varian, he worked nearly 14 years at Stryker Corporation, one of the world’s leading medical technology companies.  While there, he served in roles of increasing responsibility in Human Resources (US and Canada), Operations, Corporate Compliance and Regulatory Affairs/Quality Assurance.  His final responsibilities there included design, construction and implementation of a new global Complaint Handling System for the Corporation including electronic Adverse Event submission with capabilities to manage product holds and recalls improving compliance, communication and business intelligence.

    Jeff began his career in the United States Navy, with 10+ years on Active Duty.  A Lieutenant Commander, he served as a helicopter pilot, a staff officer in the Navy’s Bureau of Personnel, Personal Assistant to the Assistant Secretary of Defense (Force Management Policy) and Assistant Navigator aboard aircraft carrier USS Eisenhower (CVN-69).

    He holds a Bachelor’s degree of Science from Texas A&M University and a Master’s degree of Public Administration (Health Policy) from Troy State University.

    Click here for additional speakers' biographies

  • MATERIALS SELECTION AND SAMPLING TECHNIQUES FOR BIOCOMPATIBILITY (ISO 10993)   more details ▾

    Seminar

    Biomed

    Thursday, December 4, 2014
    2:45 pm - 4:00 pm

    2:45 pm – 3:05 pm
    Biocompatibility requirements: How materials could impact testing

    • What is ISO 10993-1?
    • Understanding cytotoxicity and why is it used for screening
    • Deciding what tests are best for your device
    • Examining the difference between USP class VI, Medical grade, and ISO 10993 compliant materials

    Thor Rollins, Biocompatibility Expert, NELSON LABORATORIES

    3:05 pm - 3:25 pm
    ISO 10993 updates: How will this affect you?

    • A review of the latest ISO/TC 194 meetings in Japan
    • Exploring the newest FDA guidance document on biocompatibility
    • Latest regulatory trends from the industry

    Thor Rollins, Biocompatibility Expert, NELSON LABORATORIES

    3:25 pm - 3:45 pm
    Justification trends: Where are we going?

    • Using chemical characterization to support and justify biocompatibility
    • Newest in vitro alternatives to animal testing

    Thor Rollins, Biocompatibility Expert, NELSON LABORATORIES

    3:45 pm - 4:00 pm
    Q&A Session

    About Thor Rollins

     

     

     

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  • OVERCOMING WIRELESS INFRASTRUCTURE CHALLENGES   more details ▾

    Conference Track A

    Wireless

    Thursday, December 4, 2014
    1:00 pm - 4:00 pm

    Chair's Opening Remarks

    Phil RaymondWireless Architect & Senior Global Product ManagerPHILIPS HEALTHCARE & INFORMATICS

    1:00 pm - 1:30 pm
    Opportunities for Wireless Power in Next-Generation Medical Devices

    • What power requirements do next-generation medical devices present in their need for more sophisticated battery technology?
    • Exploring applications for wireless power in extending battery lifetimes, improving reliability and availability, and simplifying device sterilization
    • How can Highly Resonant Wireless Power Transfer (HRWPT) to be used to help solve problems specific to wearable medical devices?

    Colin McCarthy, Product Marketing Specialist, WITRICITY CORPORATION

    1:30 pm - 2:00 pm
    Gatekeeping at its Finest – Expert Guidance on Intellectual Property Issues

    • Options for protecting your intellectual property
    • The changing landscape for patent eligibility
    • Litigation trends and realities
    • Protection strategies that make sense
    • Maximizing the value of your intellectual property

    Tamara Fraizer, Principal, FISH & RICHARDSON P.C.

    2:00 pm - 2:30 pm
    Topic TBD

    Speaker TBD, TUV RHEINLAND

    3:00 pm - 3:30 pm
    Capitalizing on The Cloud: Improving Big Data Analytics & Using Big Data for Clinical Decision Support

    • Translating multitudes of health-related Big Data into something diagnostically meaningful
    • Preventing patient deterioration: Integrating home monitoring data and personal feedback with longitudinal data to identify patients likely to experience deterioration
    • The advantage and limitations of Big Data in home monitoring systems
    • Driving better value out of Big Data analytics and cloudonomics

    Marty Kohn, MD, Chief Medical Scientist, JOINTLY HEALTH

    3:30 pm - 4:00 pm
    Needs Characterization as the First Step in Technology Development

    • What technologies need to accomplish within specific usage contexts, and why
    • How human factors-defined criteria sets accelerate the decision making process and increase development efficiency 
    • Driving user adherence towards better outcomes by delivering meaningful benefits and improved end results

    Carolyn Rose, Director of Research & Strategy, INSIGHT PRODUCT DEVELOPMENT

    About Phil Raymond

     

     

     

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  • WIRELESS PRODUCT DEVELOPMENT & DESIGN   more details ▾

    Conference Track B

    Wireless

    Thursday, December 4, 2014
    1:00 pm - 4:00 pm

    Chair's Opening Remarks

    Dan Pettus, Vice President of Connectivity & IT, CAREFUSION

    1:00 pm - 1:30 pm
    How the Human-Centered Design Process Can Improve Your Health

    • Identifying and documenting users’ needs and insights
    • Delivering desirability and usability to your project, while also balancing feasibility and viability
    • How the iterative design process can give you confidence, cut development risk, and deliver the best outcomes

    Brian Mason, Director of Medical Products, IDEO

    1:30 pm - 2:00 pm
    Designing Antennas to Fit Your Device & Maximize Performance

    • Customizing antenna length and shape to maximize wireless performance
    • How to set up and embed an antenna in a wireless medical device
    • Outfitting an existing mHealth device with a re-designed antenna

    David Hoglund, President, INTEGRA SYSTEMS INC.

    2:00 pm - 2:30 pm
    Hospital Interoperability Scenarios to Inform Future Product Design

    • How to establish protocols and make them more efficient
    • Bring Your Own Device (BYOD) rules and regulations in the hospital ecosystem
    • Interoperability between different standards under the same roof: How do devices share a medium (WiFi, Bluetooth, ZigBee)?

    Shawn Jackman, Director of Wireless Product Management & Engineering, KAISER PERMANENTE IT

    3:00 pm - 3:30 pm
    Innovating with the Latest Sensor Technologies

    • Frequency, power, communication – all the nitty-gritty of the technologies in use and their applications
    • Active and passive sensors, micro sensors, sensor arrays, and other capabilities for creating new solutions
    • Advancements in sensing biomaterials and sensor packaging
    • Integrating ultra-low power sensors into new or existing sensing products – over-engineering vs. sensing needs

    Steve Majerus, Ph.D., Electrical Engineer, ADVANCED PLATFORM TECHNOLOGY CENTER - VA MEDICAL CENTER

    3:30 pm - 4:00 pm
    Evolving Approaches in Additive Manufacturing Techniques Enabling Miniaturization

    • Evolving additive manufacturing techniques such as 3D printing and printed electronics
    • Adapting additive manufacturing techniques to enable miniaturization
    • Practical adoption of additive manufacturing for delivering products

    Girish Wable, Advanced Technology Manager, JABIL

    About Dan Pettus

     

     

     

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Uniting Northern California’s Medtech Community