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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.
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Call for Papers

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Sponsorship Opportunities

For more information about sponsorship opportunities call 781-778-7782 or email sponsorships.canon@ubm.com.

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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!

 

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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. 

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Learning Labs Schedule

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

9:00am - 11:00am

  • 9:00 Design Creativity Workshop   more details ▾

    Seminar

    Design

    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

    About Tor Alden

    Tor Alden is principal of HS Design (HSD), a product development firm specializing primarily in the medical and healthcare marketplace. HSD has built a 40-year record of innovative design leadership, solving complex usability and interface issues for medical devices and instrumentation, high-technology products, and new ventures. HSD’s focused specialization in medical user research, interface, industrial design, human factors, and mechanical engineering has led to many successful market launches.

    As Principal in HS Design, Alden has expertise in new product development, design research, strategy, project management and new business development. During his more than 20 years in product design and development, Alden has received over 30 patents and several design awards including MDEA, IDEA, CES Innovations and Good Design.

    An active member of the Industrial Designers Society of America, Alden has served as both chair and section chair, most recently as medical section chair. He currently sits on the advisory board of the department of design at Kean University, where he is an adjunct professor. He has served as a juror for the Medical Design Excellence Awards (MDEA), CEA Innovations Awards and the Industrial Design Excellence Awards (IDEA). Tor is currently serving on the AAMI Human Factors committee that develops standards such as HE75.

    Alden has been involved in several start-up companies, most recently as an officer of the surgical device company Vesatek, Inc., where he co-developed a novel guidewire manipulation device now in development. Alden received his Bachelor’s degree in industrial design from Syracuse University and his Master of Science degree in Technology Management from Stevens Institute of Technology.

    Improve your practical knowledge on product development and create breakthrough solutions to simple, as well as your most demanding design challenges.

  • 9:00 Panel Discussion: Utilizing new sensor technologies for implantable devices   more details ▾

    Seminar

    R&D

    • 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

    About Michael O’Neil

    Michael J. O’Neil is an inventor, innovator, and tinkerer with over 30 years of experience in medical devices.  With more than 40 patents, he has established a track record of inventing a wide variety of medical products including catheters, total knee arthoplasty systems, bone substitutes, and spinal devices.  Michael is a co-author of several publications on patella femoral biomechanics, spinal disc replacements, and spinal fusion constructs.  He is currently focused on the development, and implementation of new intra-operative and implantable sensor technologies to deliver procedural solutions for the treatment of spinal disorders.  Michael earned his BS and MS in Plastics Engineering from the University of Lowell.

    Keep your finger on the pulse of the latest breakthroughs in materials, get up-to-speed on scientific pathways to improving product performance and gather new ideas for tough technical challenge.

11:30am - 1:30pm

  • 11:30 Human Factors Workshop   more details ▾

    Seminar

    Design

    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

    About Jeff Morang

    As Senior Human Factors Engineer, Jeff studies clinical use and applications of medical devices by performing voice of customer research and contextual inquiry sessions, developing user and workplace profiles and usage scenarios, and conducting task analyses. He also leads early phase use error analyses and preliminary hazard analyses, whereby he helps inform product designs by identifying critical design inputs and usability requirements. 

    Jeff utilizes user input to design and develop safe and effective medical devices. He has extensive experience generating hardware and software design concepts (physical models and prototypes, graphical user interfaces, and product labels and graphics), as well as designing and conducting formative and summative usability evaluations to enhance product development design as well as fulfill regulatory requirements.

    As Senior Human Factors Engineer, Jeff studies clinical use and applications of medical devices by performing voice of customer research and contextual inquiry sessions, developing user and workplace profiles and usage scenarios, and conducting task analyses. He also leads early phase use error analyses and preliminary hazard analyses, whereby he helps inform product designs by identifying critical design inputs and usability requirements. 

    Jeff received his MS in Human Factors and Ergonomics from San Jose State University and has over 10 years of experience in a variety of regulated engineering environments conducting human performance research, task decomposition and analyses, generating hardware and software design concepts (physical models and prototypes, graphical user interfaces, interaction designs), as well as designing and conducting formative and summative usability evaluations to enhance product development design in order to fulfill regulatory requirements.

    Early in his career he worked as a researcher in aeronautical Human Factors for the Virtual Airspace Modeling and Simulation Project at the NASA Ames Research Center exploring capabilities related to human perceptual and cognitive performance for concepts exploring futuristic air traffic management concepts. Following his tenure at NASA, he joined the U.S. Army’s Future Combat Systems project at British Aerospace Systems responsible for mapping soldier roles and assessing their cognitive and physical tasks and workloads using real-time usability testing methods related to the various vehicle variants. Prior to joining the Ximedica team, Jeff was a member of the User Experience Design Team at Siemens Healthcare Diagnostics where he assumed the role and responsibilities of end user advocate conducting user research and testing methodologies for a wide variety of end users in Point of Care settings. His work helped to influence and shape device designs throughout the product design cycle to ensure implementation of safe, effective and synergistic medical device designs that provide proper affordances in environments of varying tasks and goals.

    Improve your practical knowledge on product development and create breakthrough solutions to simple, as well as your most demanding design challenges.

  • 10:00 Curved and folded bio-MEMs for drug delivery and surgery   more details ▾

    Seminar

    R&D

    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

    About David Gracias

    David Gracias is Professor of Chemical and Biomolecular Engineering and Russell Croft Faculty Scholar at the Johns Hopkins University (JHU). He received his Ph.D. from UC Berkeley, did post-doctoral research at Harvard and worked at Intel Corporation prior to starting his independent laboratory at JHU in 2003. His research interests lie in the areas of micro / nanosystems and self-assembly. Prof. Gracias has authored 93 journal publications in leading journals such as Science and PNAS; and holds 22 patents many of which have been commercialized. His notable awards include the NIH Director’s New Innovator Award, SPIE Nanoengineering Pioneer Award, NSF Career Award, Beckman Young Investigator Award, Camille Dreyfus Teacher Scholar Award and the DuPont Young Professor Award.

    Keep your finger on the pulse of the latest breakthroughs in materials, get up-to-speed on scientific pathways to improving product performance and gather new ideas for tough technical challenge.

  • 11:30 Market trends, opportunities, and challenges for implantable and portable medical device batteries   more details ▾

    Seminar

    Electronics

    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

    About Robert Rubino

    Robert Rubino is the Senior Manager of Secondary Battery Development at Greatbatch, Inc. He received a BS and MS in Chemistry from the State University of New York at Buffalo. Mr. Rubino began his career in drug discovery R&D with Merck and Co. From there, he moved to Greatbatch, Inc. where he has been part of the battery R&D group for the past 15 years; focusing primarily on batteries for implantable medical devices. Mr. Rubino was part of the team that commercialized QHR battery technology, which is now found in 35% of implantable defibrillators. His team developed and commercialized Greatbatch, Inc.’s current generation of rechargeable batteries for neurostimulators, cochlear implants and left ventricular assist devices. Currently, Mr. Rubino oversees implantable rechargeable battery R&D, next-generation QHR technology commercialization and cell development for portable medical batteries. He is the author or co-author of 7 publications, 18 US patents, and is a member of the AAMI Neurostimulator committee.

    Keep your finger on the pulse with face-to-face interactions and inspiration from the latest electronics technologies and marketplace insights.

  • 12:00 FDA’s battery-powered medical devices workshop: Challenges and opportunities   more details ▾

    Seminar

    Electronics

    • 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

    About Ken Skodacek

    Ken Skodacek is the co-founder and co-leader of the Center’s Battery-Powered Medical Devices Working Group, which was formed to improve the performance and reliability of all battery-powered medical devices. He has over 20 years of experience working with medical devices.  He started his career with Cardiac Pacemakers Incorporated as an electrical design engineer, designing and testing high voltage and telemetry circuitry for implantable defibrillators.  He then filled various leadership roles in his career with a focus on leading technical teams that served as the interface between engineering staff and physicians, preparing IDE and PMA submissions to FDA, as well as managing numerous IDE clinical studies.  He joined FDA five years ago and now works in FDA's Office of Device Evaluation.  He is responsible for pre-market regulation of cardiovascular devices, including pacemakers and defibrillators.  He previously served in the Office of Compliance's Division of Enforcement, overseeing orthopedic and physical medicine devices.  In addition to his routine duties, Ken has led and coordinated a number of cross-Center collaborative projects including the Entrepreneurs-in-Residence team focused on streamlining the path to reimbursement for innovative medical devices. Last year, he co-coordinated a productive public workshop in partnership with AdvaMed that was focused on the review and submission of manufacturing changes.

    Keep your finger on the pulse with face-to-face interactions and inspiration from the latest electronics technologies and marketplace insights.

  • 12:40 Converting body movements into electricity   more details ▾

    Seminar

    Electronics

    • 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

    Keep your finger on the pulse with face-to-face interactions and inspiration from the latest electronics technologies and marketplace insights.

2:30pm - 4:30pm

  • 2:30 Implementing ISO 13485:2012 Quality Management Systems effectively and understanding the new expectations from regulatory bodies   more details ▾

    Seminar

    Manufacturing

    • 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

    About Rob Packard

    Rob Packard is a regulatory consultant with 20 years of experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a Lead Auditor and instructor for BSI. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others.

    Find inspiration in new manufacturing technologies, processes, materials and emerging approaches that will have the greatest impact on production

  • 2:40 Case Study: Highly accurate prototyping for medical 3D printing   more details ▾

    Seminar

    Design

    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

     

    About Ankur Chandra

    Dr. Chandra is Associate Professor of Surgery and Biomedical Engineering at University of Rochester as well as Clinical Director, and one of the founding members of the Center for Medical Technology and Innovation. Dr. Chandra earned his undergraduate BME and medical degrees from Case Western Reserve University's School of Engineering and School of Medicine in Cleveland, Ohio. He later completed his internship and residency in general surgery, as well as a postdoctoral research fellowship, at the University of California, San Diego Medical Center. Prior to joining URMC, Dr. Chandra was a vascular surgery fellow at the UCLA School of Medicine, Division of Vascular Surgery, in Los Angeles, California. He is currently a Certified Registered Physician in Vascular Interpretation and is licensed to practice medicine in the states of California and New York. Dr. Chandra’s interest in device design and engineering began during his undergraduate degree in BME at Case Western during which he specialized in prosthetics with a minor in mechanical engineering. His focus is to generate a new paradigm of device development in an era of increasing health care cost constraints and limited commercial resources. He hopes that these efforts will directly improve patient care through increased efficiency of clinician-engineer communications, more targeted and effective devices, and shifting device R&D from profit-based to need-based development. In addition to being a National Merit Scholar and the recipient of numerous awards such as the Howard Hughes Memorial Institute Research Fellowship Award, Dr. Chandra has authored a wide variety of publications. He has served on various committees and has presented at meetings throughout the United States and Canada. Dr. Chandra is also a member of professional organizations including the American College of Surgeons, Society for Vascular Surgery, American Heart Association, Society of Clinical Vascular Surgery and Peripheral Vascular Surgery Society. His professional interests include the treatment of all aspects of vascular disease with an emphasis on minimally invasive treatment of lower extremity atherosclerosis and open/hybrid treatment of aortic aneurysms and cerebrovascular disease. His research focus is in vascular bioengineering, specifically novel imaging modalities to study vascular tissue properties and tissue-device interactions in the aortic arch.

    Improve your practical knowledge on product development and create breakthrough solutions to simple, as well as your most demanding design challenges.

  • 3:10 Advanced applications of 3D Printing; from inoperative to functional prototypes and parts   more details ▾

    Seminar

    Design

    • 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

    About Anthony Vicari

    Anthony Vicari is a Research Associate based in Lux Research’s Boston office. Anthony is a member of the Advanced Materials team, where he covers technological and market developments in emerging materials and manufacturing technologies. These include composites, coatings, and metals, as well as longer-term, potentially disruptive innovations such as metamaterials, smart materials, additive manufacturing, and graphene.

    Prior to joining Lux Research, Anthony was a Research and Development Scientist at InnovX Systems, developing improved elemental analysis capabilities for handheld x-ray fluorescence spectrometers.
    Anthony holds an M.S. in Materials Science and Engineering from Carnegie Mellon University, and a B.A. (magna cum laude) in Physics and Chemistry from Harvard University.

    Improve your practical knowledge on product development and create breakthrough solutions to simple, as well as your most demanding design challenges.

  • 3:45 New materials in 3D printing that are enhancing design and manufacturing   more details ▾

    Seminar

    Design

    • 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

    About Gerald Berberian

    Gerry started his employment at Stratasys working with Objet Geometries in the Applications Engineering group located in Billerica, MA. As an Applications Engineer, Gerry provided key applications guidance and expertise for rapid prototyping professionals across various industries including automotive, consumer goods & electronics, medical, and others. He also worked closely with Stratasys’ Dealer network to provide technical guidance, sales training, and product positioning for their sales force. Leaving that group as the Senior Applications Engineer and heading up Objet’s North America Presales Support Team, he moved over to a newly created position of Worldwide Account Manager for the Objet1000 product. He was the worldwide product focal point and worked closely with Stratasys’ Dealers to assist in all Objet1000 related activities from pre-sales support to post-sale account management. In his latest position with the company, he has taken the title of Territory Sales Representative for the Northeast Region. He mainly focuses on managing the Northeast sales through our regional dealer network.

    Prior to Stratasys, he worked with GE Aviation in Lynn, MA where he held the position of Project Manager and led several projects for GE’s gas turbine and engine designs. Gerry is the recipient of the Pratt and Whitney Design award and is a member of several key industry organizations. He holds a BS in mechanical engineering from Boston University.

    Improve your practical knowledge on product development and create breakthrough solutions to simple, as well as your most demanding design challenges.

  • 3:15 Implementing RoHS compliance   more details ▾

    Seminar

    Manufacturing

    • 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

    About Joe Langton

    Business Service Line Leader within Intertek's  Electrical Products business unit for six years, providing comprehensive compliance solutions for RoHS, Restricted Substances, CPSIA, REACH, End of Life Management and Electronics Recycling, Environmentally Preferable Materials, California Proposition 65.

    Joe has worked with numerous organizations delivering Environmental Management Systems and Restricted Substance auditing implementation and compliance training classes in the electronics manufacturing field.  

    He has managed environmental engineering projects on various product categories to understand environmental impacts, major manufacturing processes, typical material uses and recyclability assessments.

    Joe holds a Bachelors degree in Electrical Engineering, and is a Certified Quality Manager, Quality Systems Lead Auditor, Six Sigma Master Black Belt

    Find inspiration in new manufacturing technologies, processes, materials and emerging approaches that will have the greatest impact on production

  • 3:45 Meeting your electrical safety testing and quality requirements   more details ▾

    Seminar

    Manufacturing

    • 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

    About Vincent Crabtree, Ph.D.

    Vincent Crabtree is a Project Manager and Regulatory Advisor, with an emphasis on Project Leadership ensuring projects conform to consensus standards such as ISO14971, IEC60601-1 and managing clients setting-up Quality Management Systems that comply with ISO13485 and FDA Quality System Regulations. He is passionate about commercializing innovative technology, and brings an entrepreneurial perspective. Vincent has a Diploma and Bachelor’s Degree in Electrical Engineering, and a PhD in Optical Biomedical Engineering with over 20 years of experience in Electronics development, 17 years in Healthcare technology R&D and 10 years in medical device development and commercialization.

    Find inspiration in new manufacturing technologies, processes, materials and emerging approaches that will have the greatest impact on production

  • 2:30 Future medical applications in 3D printing: Clinical benefits, regulatory issues and manufacturing challenges   more details ▾

    Seminar

    Design

    • 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

    About Michael Drues

    Michael Drues, Ph.D., is President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including (but not limited to): stimulating & innovative educational programing, brain-storming sessions, prototype design, product development, benchtop & animal testing , regulatory strategy & clinical trial design, FDA presentation preparation & defense, reimbursement, clinical acceptance, business development & technology assessment.

    Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies.  He also works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world.

    Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs.  He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world. 

    Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, Dr. Drues teaches graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs & Product Development, Combination Products, Pathophysiology, Medical Technology & Biotechnology at several universities & medical schools on-ground & on-line.

    Improve your practical knowledge on product development and create breakthrough solutions to simple, as well as your most demanding design challenges.

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

9:00am - 11:00am

  • 9:00 Planning your Lean Implementation - Workshop   more details ▾

    Seminar

    Manufacturing

    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

     

    About Ron Pujalte

    Prior to joining GBMP, Ron spent twenty four years in manufacturing starting on the manufacturing floor of a transformer facility for 6 year before becoming a Cymbal Smith at the Avedis Zildjian Company and moving up the ranks to Director of Manufacturing where he became a practitioner of the Toyota Production System. . He left Zildjian after eleven years and was Director of Operations and COO for Warerite Distributors, a high volume countertop manufacturer for 7 years. Ron received his Black Belt in Six Sigma from the Juran Institute in 2002 and his Master Black Belt in 2006. He received his BSBA from Northeastern University. Ron has passed the Lean Gold exam and is currently working on his portfolio. Since joining GBMP in 2006, Ron has worked in hundreds of companies from many different industries.

    Find inspiration in new manufacturing technologies, processes, materials and emerging approaches that will have the greatest impact on production

  • Unique Device Identifier: Discussing UDI regulation’s impact on medical device labelers   more details ▾

    Seminar

    Manufacturing

    • 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

    About Jonathan Bretz

    Jonathan Bretz, President of RSQM Associates LLC, partners with our customers providing world class regulatory, quality management, marketing and product development/engineering support and services as they bring their medical devices to market and beyond.  Jon has worked in the medical device field - private and provider sectors – for nearly 40 years.  Previously employed at AliMed, inc, he held various senior executive positions – in marketing/sales, operations, and then coordinating, managing and staffing a regulatory department.  During his tenure at AliMed, Jon was responsible for regulatory submission to the FDA, EU and Health Canada and managing the Quality systems. Jon recently completed the Regulatory Affairs Professional Society certificate program in Medical Devices and Pharmaceuticals.  He earned his Executive MBA from Anna Maria College and a BS in Occupational Therapy from Tufts-University.

    Find inspiration in new manufacturing technologies, processes, materials and emerging approaches that will have the greatest impact on production

  • 9:40 Manufacturer Case Study: The next steps in UDI implementation   more details ▾

    Seminar

    Manufacturing

    • 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

    About Doreen Taylor

    Doreen Taylor - Director of Quality Assurance at Medrobotics in Raynham, Massachusetts.
    Led Medrobotics through ISO13485 certification and working to get new product CE Marked and FDA approved.

    Holds a Master’s Degree from Regis College in Health Product Regulations, BSEE from Worcester Polytechnic Institute and an Operations Management certificate from Northeastern University.

    Find inspiration in new manufacturing technologies, processes, materials and emerging approaches that will have the greatest impact on production

11:30am - 1:30pm

  • 11:30 Collaborative robotics; aligning your human and robotic workforce   more details ▾

    Seminar

    Manufacturing

    • 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

    About Carl Palme

    As the Applications Product Manager for Rethink Robotics, Carl Palme is responsible for developing new manufacturing applications for the Baxter robot and for leading the collection, description, and analysis of requests for new product functionality from customers and prospects. He has also installed a number of robots in the field in order to better understand what it takes to have a successful deployment and how to improve the process.

    Prior to Rethink Robotics, Carl was the founder and General Manager of Palme Precision Machining, a high-precision machine shop that produces components for a variety of industries. Carl also spent several years as a Manufacturing Engineer setting up, moving, and supporting manufacturing lines for the Medical Device and Aerospace industries. Carl received his B.S. in Manufacturing Engineering, M.S. in Information Systems, and MBA from Boston University.

    Find inspiration in new manufacturing technologies, processes, materials and emerging approaches that will have the greatest impact on production

  • 12:45 Introducing flexible and lightweight robotics into your factory floor   more details ▾

    Seminar

    Manufacturing

    • 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

    About Julie Shah

    Julie Shah is an Assistant Professor in the Department of Aeronautics and Astronautics and leads the Interactive Robotics Group of the Computer Science and Artificial Intelligence Laboratory. Shah received her SB (2004) and SM (2006) from the Department of Aeronautics and Astronautics at MIT, and her PhD (2010) in Autonomous Systems from MIT. Before joining the faculty, she worked at Boeing Research and Technology on robotics applications for aerospace manufacturing.  She has developed innovative methods for enabling fluid human-robot teamwork in time-critical, safety-critical domains, ranging from manufacturing to surgery to space exploration. Her group draws on expertise in artificial intelligence, human factors, and systems engineering to develop interactive robots that emulate the qualities of effective human team members to improve the efficiency of human-robot teamwork. This work was recognized by the Technology Review as one of the 10 Breakthrough Technologies of 2013, and has received international recognition in the form of best paper awards and nominations from the International Conference on Automated Planning and Scheduling, the American Institute of Aeronautics and Astronautics, the IEEE/ACM International Conference on Human-Robot Interaction, and the International Symposium on Robotics.

    Find inspiration in new manufacturing technologies, processes, materials and emerging approaches that will have the greatest impact on production

  • 11:30 Converting a legacy device into a wireless device   more details ▾

    Seminar

    R&D

    • 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

    About Nicholas Abbondante

    Nicholas Abbondante serves as chief EMC engineer at Intertek. In his 13 years with the company, Nick has been involved in testing a wide range of radio and electronic equipment to EMC requirements for regulatory domains around the world, specializing in transmitters. He is a member of the TCB Council and participates in the ANSI C63.10 and ANSI C63.26 radio standards writing committees. Nick has a Bachelor’s degree in physics from the Worcester Polytechnic Institute (WPI).

    Keep your finger on the pulse of the latest breakthroughs in materials, get up-to-speed on scientific pathways to improving product performance and gather new ideas for tough technical challenge.

  • 12:00 Regulatory guidance on mHealth and wireless medical devices   more details ▾

    Seminar

    R&D

    • 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

    About Keith Barritt

    Keith A. Barritt is Principal in Fish & Richardson’s Washington, DC, office and a member of the firm’s Regulatory and Government Affairs group.  His practice focuses on all aspects of medical device regulation by the U.S. Food and Drug Administration, including obtaining marketing authorization for medical devices, use of new devices for investigational purposes, and import and export issues.  Examples of his FDA work include preparing and filing 510(k) pre-market notifications with the FDA for various types of medical devices and advising clients on issues involving quality system regulations, device labeling, medical device reporting obligations, recalls, device listing, establishment registration, and import/export regulations.  Keith earned his J.D. from the University of Virginia, where he was an editorial board member for Virginia Journal of International Law.

    Keep your finger on the pulse of the latest breakthroughs in materials, get up-to-speed on scientific pathways to improving product performance and gather new ideas for tough technical challenge.

  • 12:45 Mobile medical devices: A risk based approach   more details ▾

    Seminar

    R&D

    • 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

    About Sameer Jaiswal

    Sameer Jaiswal is Senior Manager for Quality and Regulatory Assurance for Voluntis Inc, a Paris based manufacturer of Connected Health solutions. His responsibilities include managing quality and regulatory compliance with the US notified bodies as well as working with his European colleagues to develop a globally compliant quality system for Voluntis. Currently his primary focus in the US is obtaining FDA clearance for Insulia, Voluntis's first, name branded, mobile medical device for the US market. 

    Previously Sameer spent four years with Boston Scientific as Manager of Corporate Software Quality Assurance and eleven years at Abbott Laboratories where he was an IS Senior Project Manager in Abbott Diagnostics and Abbott Corporate Information Systems.

    His accomplishments include managing the validation of BSC's global next gen mobile environment which included over 2500 iOS and Android tablets, 250 mobile apps and 150 social media assets as well as managing the development of various global IT solutions for Abbott Laboratories.

    Keep your finger on the pulse of the latest breakthroughs in materials, get up-to-speed on scientific pathways to improving product performance and gather new ideas for tough technical challenge.

  • 10:20 Common pitfalls of UDI implementation and how to avoid them   more details ▾

    Seminar

    Manufacturing

    • 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

    About Debara R. Reese

    Debara R. Reese has over 32 years of experience in FDA and USDA regulated industry. She has worked in a wide variety of quality and regulatory areas including regulatory compliance, regulatory submissions, labeling, quality assurance, and quality control. Ms. Reese is currently Vice President of Quality and Compliance for Maetrics LLC, a full service life sciences consulting firm. Ms. Reese recently rejoined Maetrics after spending nearly five years as Vice President of Corporate Quality and Regulatory Compliance at Zimmer Inc., a leader in the orthopedic device industry. Prior to her time with Maetrics and Zimmer, Ms. Reese spent 25 years at Roche Diagnostics. At Roche, Ms. Reese held various positions in quality and regulatory including Vice President of Divisional Quality and Regulatory. She also served on a joint FDA-Industry grass roots recall initiative, is a past board member of the Indiana Medical Device Manufacturing Council (IMDMC) and a current member of the IMDMC education committee. Ms. Reese holds a BS in Microbiology from Purdue University. She attained RAC certification in 1993, is a member of RAPS and ASQ, is a trained Lead Assessor and was trained as an Association for the Advancement of Medical Instrumentation (AAMI) faculty member for the Quality System Regulation.

    Find inspiration in new manufacturing technologies, processes, materials and emerging approaches that will have the greatest impact on production

2:30pm - 4:30pm

  • 2:30 Ensuring data security of wireless medical device   more details ▾

    Seminar

    Electronics

    • 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

    About Matt Neely

    As the Director of Strategic Initiative at SecureState, Matthew Neely leads SecureState’s Research and Innovation (R&I) team which focused on developing tools and techniques to assess and secure new and emerging technology. SecureState’s R&I team pioneered techniques for testing medical devices and components at all levels of the smart grid. In addition to Matt’s technical background, his strong understanding of business processes and organizational structure allow him to meet the security needs of the business world. Matt has given more than 100 presentations on security at local, national and international conferences and meetings. He has published a book Wireless Reconnaissance in Penetration Testing.

    Keep your finger on the pulse with face-to-face interactions and inspiration from the latest electronics technologies and marketplace insights.

  • 2:40 Tailoring polymer properties and biomedical degradation characteristics to device function   more details ▾

    Seminar

    R&D

    • 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

    About Dennis Jamiolkowski

    Dennis D. Jamiolkowski, Distinguished Research Fellow at ETHICON, Inc. a Johnson & Johnson Company, has over 39 years of experience with absorbable polymers. This includes synthesis of new monomers for absorbable polymers, new absorbable polymers, absorbable polymer processing, and mechanical design innovations. He has a degree in Chemistry (Honors) from Seton Hall University and has done post-graduate work at Polytechnic University (Brooklyn, NY). He is a named inventor on 88 issued United States patents, and has contributed over 40 articles, including chapters in eight books, to the open technical literature. He has been a speaker at academic institutions and society meetings; he was an invited keynote speaker at the 7th World Biomaterials Congress. Dennis has been a contributor to the development of medical devices made from absorbable polymers that have enjoyed a great deal of commercial success. The most recent of these is the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device, used for mesh fixation in endoscopic procedures. Dennis has received J&J's Philip B. Hofmann Research Scientist Award an unprecedented four times. He additionally received Johnson and Johnson's highest honor for research and development, the prestigious Johnson Medal.

    Keep your finger on the pulse of the latest breakthroughs in materials, get up-to-speed on scientific pathways to improving product performance and gather new ideas for tough technical challenge.

  • 3:10 Utilizing zinc for bioresorbable stents   more details ▾

    Seminar

    R&D

    • 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

    About Jaroslaw Drelich

    Dr. Jaroslaw Drelich came to Michigan Tech in 1997 and currently is a professor of materials science and engineering. His main research interests are in applied surface chemistry and interfacial engineering for ore dressing and materials processing, biomaterials, and formulation of antimicrobial materials. Dr. Drelich has edited 6 books, published more than 160 technical papers, holds 9 patents and has more than 60 conference presentations, including several keynote addresses, to his credit. Dr. Drelich has recently been named the Editor-in-Chief for the Surface Innovations journal. 

    Keep your finger on the pulse of the latest breakthroughs in materials, get up-to-speed on scientific pathways to improving product performance and gather new ideas for tough technical challenge.

  • 3:55 Failure analysis in polymer-based medical devices   more details ▾

    Seminar

    R&D

    • 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

    About Gavin Braithwaite

    Dr. Gavin Braithwaite is the Vice President of Research at Cambridge Polymer Group, Inc. He received his BS in Physics from Edinburgh University, his MS in Electrical Engineering from Southampton University, and his Ph.D. in Chemical Engineer from Imperial College. He was a post-doctoral fellow at Harvard University and the Massachusetts Institute of Technology, where he designed and tested a micro-shear rheometer. Dr. Braithwaite holds several patents on hydrogel formulations, analytical instrumentation, and natural polymers. At Cambridge Polymer Group, Dr. Braithwaite is in charge of sponsored research programs as well as CPG's internal research efforts. He is also heading up a new division at CPG involving device design and validation.

    Keep your finger on the pulse of the latest breakthroughs in materials, get up-to-speed on scientific pathways to improving product performance and gather new ideas for tough technical challenge.

  • 3:30 Addressing the security concerns of wireless and cloud connected medical devices   more details ▾

    Seminar

    Electronics

    • 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

    About Ravi Kuppuraj

    Ravi is a medical industry veteran, with over 20 years of experience in cardiology patient monitoring and technology development. Prior to InfoBionic, Ravi served as the Vice President of Research and Development at Draeger Medical, a global powerhouse in patient monitoring, anesthesia delivery, and respiration technology. Before Draeger Medical, Ravi headed R&D efforts at SpaceLabs Medical, in Seattle. He was instrumental in driving the development of key technologies and products in patient monitoring solutions, as well as managing SpaceLabs India R&D operations. Ravi was involved with several successful med-tech startups, including CardioNet, where he served as Director, ECG Analysis, and was an integral team member that developed and launched CardioNet’s revolutionary Mobile Cardiac Outpatient Telemetry (MCOT) product. Ravi holds an MBA from the University of North Carolina at Chapel Hill, a PhD and MS in biomedical engineering from Louisiana Tech University and University of Miami respectively, and a BSEE from Bangalore University.

    Keep your finger on the pulse with face-to-face interactions and inspiration from the latest electronics technologies and marketplace insights.

  • 2:30 The future of biomaterials: Challenges for future medical devices and combination products   more details ▾

    Seminar

    R&D

    • 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

    About Michael Drues

    Michael Drues, Ph.D., is President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including (but not limited to): stimulating & innovative educational programing, brain-storming sessions, prototype design, product development, benchtop & animal testing , regulatory strategy & clinical trial design, FDA presentation preparation & defense, reimbursement, clinical acceptance, business development & technology assessment.

    Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies.  He also works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world.

    Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs.  He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world. 

    Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, Dr. Drues teaches graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs & Product Development, Combination Products, Pathophysiology, Medical Technology & Biotechnology at several universities & medical schools on-ground & on-line.

    Keep your finger on the pulse of the latest breakthroughs in materials, get up-to-speed on scientific pathways to improving product performance and gather new ideas for tough technical challenge.

 

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.

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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

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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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