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Upgrade your expo pass to include Learning Labs, 2-hour essential technical trainings devoted to identifying, exploring, testing and delivering practical solutions. Prices start at $299 for an individual learning lab, or choose the FlexiPass option for $899 and gain access to all twelve sessions!

Scroll down to view the full agenda and download the Learning Labs Brochure.

Five Key Reasons to Attend:

  1. Investigate 3D printing capabilities, functional prototyping and new materials that will change the future of product development
  2. Walk away with essential knowledge on security concerns of wireless devices, eHealth regulatory updates and how to transform a legacy device to a wireless device
  3. Explore new robotic technologies available for the factory floor and improve your practical knowledge of manufacturing modernizations
  4. Hear about the most advanced applications in new sensor technology and power management
  5. Essential technical training that won’t break the bank; Individual Learning Labs start at $299 or choose a FlexiPass to gain access to all six for $899. One-day passes also available for $599.

An expo allows you to see, touch and experience new innovations and technology. You can also learn how to apply these enabling concepts to your projects and business in the Learning Labs! This educational program is a perfect complement to your visit. View all the speakers and tracks – click here to get a full copy of the agenda!



Choose the day and track you want and click “Apply” to view the areas you’re interested in, or download the full agenda hereReady to sign up?   Click here to get your free expo badge and purchase your Learning Lab program, or call us at 310-445-8534 for fast and simple sign up. 


Learning Labs Schedule

Day 1 – Wednesday March 26, 2014 – 9:00AM-4:30PM

9:00 AM - 11:00 AM



  • 9:00 Design Creativity Workshop
    9:00am to 11:00am

    The goal of this creativity workshop is to provide attendees with concrete methods and tools they can use to break through their normal patterns of thinking when designing medical devices. We will explore the characteristics of creative thinkers and why it’s hard for most people to think creatively. Most importantly, we will provide examples of strategies delegates can use to access their own innate creativity and solve the complex problems they face. We will lead a people in a workshop where designers from HSD will demonstrate methods of idea development through hand sketching. Methods will include visualization techniques for:

    • Rapid ideation
    • Design thinking
    • Contextual research
    • System architecture

    Users will learn about visual communication methods that can be applied immediately to product development.  They will learn how to utilize their creative side to breakthrough “wicked” problems.

    Tor Alden, Principal, HS Design
    Steve Simantiras, Industrial Designer, HS Design



  • 9:00 Panel Discussion: Utilizing new sensor technologies for implantable devices
    9:00am to 10:00am
    • Analyzing present and prospective implantable sensor technology and capabilities
    • Identifying the promise of sensors in orthopedic and cardiovascular implant systems
    • Demonstrating the benefits of real time monitoring
    • An in-depth look at implantable sensors from the viewpoints of nanomaterials, biotechnology and sensor design

    Michael O’Neil
    , Principal Engineer, New Technologies, DePuy Synthes
    Monica Swinney, Ph.D., Staff Engineer, BD Medical – Diabetes Care

  • 10:00 Curved and folded bio-MEMs for drug delivery and surgery
    10:00am to 11:00am

    This learning lab will detail self-assembly strategies that leverage the precision of planar lithographic patterning techniques allowing the creation of precisely patterned 3D devices for biomedical applications. These include bio-origami hydrogels, precisely patterned multifunctional capsules, self-folding therapeutic drug release systems and miniaturized mimics of macro surgical tools such as grippers or drillers. This presentation will also uncover results on the first ever biopsy in a live animal using untethered dust sized surgical tools.

    David Gracias, Professor, John Hopkins University

11:30 AM - 1:30 PM



  • 11:30 Human Factors Workshop
    11:30am to 1:30pm

    Conduct a task analysis and usability evaluation for a home health product and work as a team to understand how to systematically document the required use steps and use tasks through the development of a task analysis. Then work through the use tasks to identify potential use errors. Following the development of a use error analysis, we will discuss how these documents feed into the product development process, the risk management process, and verification and validation testing.

    Participants will gain an understanding of the relationship between human factors, risk management, and product development. They will gain an understanding of:

    • The practical application and documentation of two essential Human Factors Engineering activities: task analysis and use error analysis
    • The inputs to a task analysis and a use error analysis
    • The influence of the task analysis and use error analysis on subsequent Human Factors Engineering activities
    • The relationship between Human Factors Engineering and other engineering activities (e.g. Mechanical Engineering, Software Engineering).
    • The value of Human Factors Engineering to the design process and the regulatory compliance process


    Jeff Morang, Senior Human Factors Engineer, Ximedica
    Elizabeth Roche, Director of Research & Strategy, Ximedica



  • 11:30 Market trends, opportunities, and challenges for implantable and portable medical device batteries
    11:30am to 12:00pm

    There is great opportunity for the future of portable and implantable medical device batteries. New developments in rechargeable and primary cell systems enable increased run time and greater longevity. OEMs are manufacturing smaller devices while demanding more power, enhanced functionality, increased safety, MRI compatibility and sterilization. With the proliferation of batteries in medical devices and a wider array of different battery types in the field, the challenge is to assure that these batteries can meet the unique requirements of each application, and that they perform with the reliability and safety that is expected for critical medical applications.

    Robert Rubino, Senior Manager R&D, Greatbatch Medical

  • 12:00 FDA’s battery-powered medical devices workshop: Challenges and opportunities
    12:00pm to 12:40pm
    • Creating awareness of the potential challenges related to battery-powered medical devices and to collaboratively develop ways of ensuring the continued performance and reliability of these devices
    • Focusing on the current and future challenges with batteries and battery-powered medical devices

    Ken Skodacek
    , Co-Leader CDRH's Battery Working Group, FDA

  • 12:40 Converting body movements into electricity
    12:40pm to 1:20pm
    • Developing  a method for integrating highly efficient energy conversion materials onto stretchable, biocompatible rubbers that could yield breakthroughs in implantable or wearable energy harvesting systems
    • Presenting a scalable and parallel process for transferring crystalline piezoelectric ribbons of lead zirconate titanate (PZT) from host substrates onto flexible rubbers over macroscopic areas
    • Discussing methods for synthesizing these materials from the bottom up, and for wireless energy transfer
    • Exploring fundamental characterization of the ribbons by piezo-force microscopy (PFM) indicates that their electromechanical energy conversion metrics are among the highest reported on a flexible medium
    • Integrating these materials into flexible energy harvesting devices yields high power output, sufficient to power an LED

    Huai-An Chin
    , Ph.D. Candidate - Electrical Engineering, Princeton University

2:30 PM - 4:30 PM



  • 2:30 Future medical applications in 3D printing: Clinical benefits, regulatory issues and manufacturing challenges
    2:30pm to 2:40pm
    • Where are we now? Where are we going?
    • What are the challenges and how do we overcome them?

    Michael Drues, Ph.D., President, Vascular Sciences

  • 2:40 Case Study: Highly accurate prototyping for medical 3D printing
    2:40pm to 3:00pm

    This session will explore highly accurate patient-specific 3D models that look and feel like real aortic aneurysms, including clear and rubberlike materials. It will also include a look into how this technology is transforming device design, imaging techniques, and device testing in the medical world.

    Ankur Chandra, Professor of Surgery and Biomedical Engineering & Clinical Director, Center for Medical Technology and Innovation (CMTI), University of Rochester


  • 3:10 Advanced applications of 3D Printing; from inoperative to functional prototypes and parts
    3:00pm to 3:45pm
    • Discovering and integrating functional 3D printing into your current applications
    • Exploring innovative hardware and software tools to increase 3D printing functionality
    • Discussing how this technology is used for tooling, assembly fit checks, production and unique applications
    • Predicting future developments in 3D printing

    Anthony Vicari
    , Research Associate, Lux Research

  • 3:45 New materials in 3D printing that are enhancing design and manufacturing
    3:45pm to 4:20pm
    • Evaluating existing and innovative materials that will take additive manufacturing technology into the future
    • Assessing new developments for multi-material printing to strengthen your current uses and prototypes
    • Developments with new materials for 3D printing: Availability and longevity 

    Gerald Berberian
    , Territory Sales Representative, Northeast Region, Stratasys



  • 2:30 Implementing ISO 13485:2012 Quality Management Systems effectively and understanding the new expectations from regulatory bodies
    2:30pm to 3:15pm
    • Explaining the key differences between the previous versions of EN ISO 13485 and EN ISO 14971 with EN ISO 13845:2012 and EN ISO 14971:2012 standards
    • Addressing technical issues within EN ISO 13845: 2012 and EN ISO 14971:2012 to improve risk management practices
    • Reviewing the FDA Voluntary Audit Submission Pilot Program

    Rob Packard
    , Founder and Instructor, Medical Device Academy

  • 3:15 Implementing RoHS compliance
    3:15pm to 3:45pm
    • Lessons learned from global consumer electronics manufacturers
    • Anticipating global RoHS compliance in China, Japan and North America
    • Tackling new challenges unique to the medical device industry

    Joe Langton
    , Business Service Line Leader, Chemical Services, Intertek

  • 3:45 Meeting your electrical safety testing and quality requirements
    3:45pm to 4:20pm
    • Discussing gap analysis approaches for 60601 3rd edition electrical safety testing
    • Addressing the differences between testing for older devices versus new products
    • Demonstrating the similarities and differences between reliability and regulatory test programs

    Vincent Crabtree, PhD
    , Regulatory Advisory & Project Manager, StarFish Medical

Day 2 – Thursday March 27, 2014 – 9:00AM-4:30PM

9:00 AM - 11:00 AM



  • Unique Device Identifier: Discussing UDI regulation’s impact on medical device labelers
    9:00am to 9:40am
    • Implications for patient safety, adverse event monitoring and electronic health record management
    • Review of UDI final regulation
    • Draft global UDI database (GUDID) guidance
    • Impact on entire organization
    • Infrastructure needed to implement UDI

    Jonathan Bretz
    , President, RSQM Associates

  • 9:40 Manufacturer Case Study: The next steps in UDI implementation
    9:40am to 10:20am
    • Understanding how medical device manufacturers can benefit from UDI
    • Best practices in implementing UDI standards
    • Understanding UDI as the foundation to regulatory master data

    Doreen Taylor
    , Director of Quality Assurance & Management Representative, Medrobotics Corporation

  • 10:20 Common pitfalls of UDI implementation and how to avoid them
    10:20am to 10:50am
    • How UDI implementation is similar to, and also different from, other projects
    • Achieving management commitment to ensure project success
    • How choosing the right implementation team can ensure sustainability of the process after the project ends

    Debara R. Reese
    , Vice President, Quality and Compliance, Maetrics


  • 9:00 Planning your Lean Implementation - Workshop
    9:00am to 11:00am

    If you are unsure why or how lean is so effective in increasing productivity and capacity and eliminating waste to ensure an organization’s ability to compete globally, increase capacity and create jobs, then attend this workshop to get an overview of its philosophies and techniques.

    • Lean Philosophies & Methods that are currently being used
    • When & why an organization should consider a Lean initiative
    • How to create a favorable environment/company culture for Continuous Improvement


    Ron Pujalte, Continuous Improvement Manager, GBMP
    Robert Elliott, Continuous Improvement Manager, GBMP


11:30 AM - 1:30 PM



  • 11:30 Converting a legacy device into a wireless device
    11:30am to 12:00pm
    • How to evolve your devices to incorporate wireless communication and charging functionality, ease of use is sure to reach new heights
    • Examining the regulatory issues involved in converting a legacy wired device to a wireless device
    • Outlining the requirements involved in selecting, implementing, and bringing a wireless design to market


    Nicholas Abbondante, Chief Engineer for EMC, Intertek

  • 12:00 Regulatory guidance on mHealth and wireless medical devices
    12:00pm to 12:45pm
    • Overview of FDA and FCC regulation of wireless medical devices
    • Update on the recent FDA guidance documents regarding:
      • Wireless Medical Devices
      • Mobile Medical Apps
    • Why should the industry take notice?


    Keith Barritt, Principal, Fish & Richardson

  • 12:45 Mobile medical devices: A risk based approach
    12:45pm to 1:20pm
    • Unraveling the FDA’s Mobility draft guidance and understanding the definitions
    • Investigating the grey areas of Mobile Medical Apps – when does a device require a 510(k) submission?
    • Understanding the politics of functionality vs. cost vs. culture and appearance when deciding on mobile technology


    Sameer Jaiswal, Senior Manager – Quality and Regulatory, Voluntis



  • 11:30 Collaborative robotics; aligning your human and robotic workforce
    11:30am to 12:45pm
    • Defining the emerging automation category of collaborative robotics - what they are, and what they are not, useful for
    • Outlining best practices when scoping, implementing and running these technologies
    • Recognizing and overcoming the most common challenges with deploying these robots on manufacturing lines

    Carl Palme
    , Applications Product Manager, Rethink Robotics

  • 12:45 Introducing flexible and lightweight robotics into your factory floor
    12:45pm to 1:20pm
    • Exploring flexibility and productivity benefits – building the case for investment
    • A look at what’s enabling lightweight robotics and how are they transforming the factory floor
    • Battling common maintenance and safety concerns when choosing a lighter more flexible robot

    Julie Shah
    , Professor - Computer Science and Artificial Intelligence Laboratory, Massachusetts Institute of Technology

2:30 PM - 4:30 PM



  • 2:30 Ensuring data security of wireless medical device
    2:30pm to 3:30pm
    • Addressing the challenges of integrating secure data across various integrated systems
    • Discussing how to stay compliant through the implementation of data protection regulations
    • How can you safeguard data security through product development and network maintenance?

    Matt Neely
    , Director - Strategic Initiatives, SecureState

  • 3:30 Addressing the security concerns of wireless and cloud connected medical devices
    3:30pm to 4:20pm
    • Detailing the radiofrequency technology regulatory guidelines
    • Managing the wireless spectrum to improve safety and security
    • Designing a wireless infrastructure for increased reliability, risk management and failure prevention
    • Describing how the National Institute of Standards draft framework for CyberSecurity will impact the basic security requirements for all new System Control and Data Acquisition (SCADA) equipment and Industrial Control Systems (ICS)

    Ravi Kuppuraj,
    Chief Technology Officer, InfoBionic



  • 2:30 The future of biomaterials: Challenges for future medical devices and combination products
    2:30pm to 2:40pm
    • Biocompatible vs. biofriendly materials
    • Engineered vs. biological polymers
    • Are ‘inert’ materials desirable?
    • Regulatory challenges and how do we overcome them?


    Michael Drues, Ph.D., President, Vascular Sciences

  • 2:40 Tailoring polymer properties and biomedical degradation characteristics to device function
    2:40pm to 3:10pm
    • Analyzing polymer breakdown processes and new enzymatically degraded polymers
    • Contrasting absorbable materials, the potential of bioresorbable metals and how to define/use such materials for bones, joints, hearts, splints, stents, valves etc.
    • Examining environmental factors influencing polymer degradation properties


    Dennis Jamiolkowski, Distinguished Research Fellow, Ethicon

  • 3:10 Utilizing zinc for bioresorbable stents
    3:10pm to 3:55pm
    • Reviewing the concept of biodegradable metallic stents and decade-long attempts to materialize it
    • Emerging novel testing methods for fast and inexpensive screening of candidate stent materials
    • Why zinc? – its advantages and disadvantages; what is known and what needs to be study
    • Recent advancements at Michigan Tech in formulating zinc-based alloys for biodegradable stents


    Jaroslaw Drelich, Professor, Material Science & Engineering, Michigan Technological University

  • 3:55 Failure analysis in polymer-based medical devices
    3:55pm to 4:30pm
    • Discussing a number of case studies where issues have occurred with polymers in biomedical devices 
    • Exploring biodegradable materials, the lessons learned can be applied across any use of polymers
    • Each case study describing the issue that has been highlighted, the diagnostics used to determine the cause in and the solution required to mitigate the issue


    Gavin Braithwaite, VP of Research, Cambridge Polymer Group


Learning Labs Sponsors

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. For more information, visit www.fr.com.


Ximedica is a full-service product development firm exclusively focused on delivering medical products to market.  Entrusted by the world’s leading medical companies and emergent start-ups for more than 25 years we have the requisite capabilities and knowledge to help our clients envision, develop and test their innovations.  Both ISO 13485 certified and FDA registered our Quality System ensures the breakthrough designs and intellectual property we create improve outcomes and enhance lives and achieve sustainable results for our clients. For more information, visit www.ximedica.com


Maetrics is a professional services firm that offers Compliance and Quality consulting services to the Pharmaceutical, Medical Device, Nutritionals, Biotech, and Healthcare industries. Maetrics brings a wealth of best practices, experience, knowledge, tools, and methods to design compliance and quality solutions that will withstand regulatory scrutiny and improve product quality. Headquartered in Indianapolis, Indiana, Maetrics works with clients around the world. For more information, visit www.maetrics.com


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