Upgrade your Experience with Premium Education

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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 twelve for $899. One-day passes also available for $599.

 

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Call for Paper

UBM Canon is accepting submissions for its upcoming advanced design and manufacturing conferences. Please click here to submit an abstract.

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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. Now, 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 – get a full copy of the agenda a brochure here!

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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 here. Ready to sign up? Click here to get your free expo badge and purchase your Learning Lab program, or call us at 310-445-8535 for fast and simple sign up. 

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Learning Labs Schedule

Day 1 - Wednesday, May 7

10:00 AM - 11:45 AM

  • Air Activated Self Heating Packaging   more details ▾

    Seminar

    Design

    • Historic self-heating successes and challenges
    • How is Air Activated different – features & benefits (with hands-on demo)
    • Technology background – how it works, how it is made and how it is integrated into packaging
    • Current commercial and development applications

    Adam Laubach, Chief Executive Officer, RBC Technologies

    About Adam Laubach

    Adam Laubach joined RBC Technologies in 2011 to finalize the development and lead the scale-up of the CookPak® self-heating technology in military, consumer, medical and industrial applications. Adam is a "lab-to-fab" specialist, with 10 technical product launch engagements to date, ranging from new polymers to electrochemical cells including medical diagnostic devices and self-heated systems. His 13 year career with Dow Chemical gave him experience in R&D, new business development and market management across the automotive, consumer electronics, packaging and durable goods industries. During his last 3 years at Dow, he co-led a JV with Motorola and Xerox focused on printed electronics; and later, co-led the spin-out and successful venture capital funding of Aveso Displays, a printed electrochromic display company. While at Aveso, he served as Managing Director for Europe and later as the parent company CTO, leading the company through a rapid technology baseline reset and establishing its external development supply chain. In his role with GSI Technologies, he served as General Manager for the Functional Printing Division and Company CTO, earning industry accolades including the IDTechEx award for "Best Printed Electronics Commercialization" for scaling to 1 Billion + electrochemical biomedical sensors and the MIT Enterprise Forum "Under the Radar" Award for the innovative "Lab to Fab®" business model implementation, which serves spin-outs and starts-up in the printed electronics space. Adam also served as the CTO for ReVolt Technologies in Zurich, Switzerland, where he led the company's technology development efforts in addition to being part of the fund raising team. Adam has an MBA (concentration in venture finance) from The University of Texas, Austin as well as bachelor degrees in Chemistry (concentration in polymers) and German Language Studies. He currently has 10+ patents and patents pending for new electrochemical cells (batteries/displays/heaters), printed electronic systems and novel polymers.

  • Optimizing the institutionalization of User Experience (UX)   more details ▾

    Seminar

    Design

    • Outlining how mature UX practices are faster, cheaper, and better
    • Understanding executive support, infrastructure, governance, organizational structures, and staffing
    • Identifying international design strategies

     

    Dr. Eric SchafferFounder and Chief Executive OfficerHuman Factors International, Inc.

    About Dr. Eric Schaffer

    Eric is the world’s thought-leader on mature and industrial strength user experience (UX) operations—with methodology, tools, standards, training, certification, and cost-effective staffing. His book Institutionalization of UX: A Step-by-Step Guide (now in its second edition) provides a roadmap for companies to follow in order to make usability a systematic, routine practice throughout their organization. He co-developed The HFI Framework™, an ISO-certifiable process for user-centered design, built on principles from human-computer interaction, ergonomics, psychology, computer science, and marketing.In the last three decades, Eric has become known as the visionary who recognized that usability would be the driving force in the “Third Wave of the Information Age,” following both hardware and software as the previous key differentiators. He foresaw that the most profound impact on corporate computing would be a positive online UX. Also, he has more recently asserted that “Usability is no longer enough,” pushing ahead UX strategy, innovation, and persuasion engineering.His unparalleled range of experience includes UX design consulting and training projects for more than 100 Fortune 500 clients. He has worked extensively in the financial, insurance, manufacturing, government, healthcare, and telecommunications industries. He continues to lead projects in digital strategy, innovation, design, and persuasion engineering.Eric has a long-standing interest in persuasion design. He has pioneered the development of methods that optimize Persuasion, Emotion, and Trust (PET Design). He has applied these methods to increase conversion for organizations such as the California State Government, Fidelity, Macys, MetLife, REI, Taj Hotels, and Vodafone. He developed the HFI courses on persuasion engineering and has taught them worldwide.Recently Eric has been overseeing the ongoing development of UX Enterprise™, a relational database of UX objects. This is an enterprise software product that allows practitioners to design based on their organization's cloud of UX data. It is a fully interlinked model of customer ecosystems, design projects, design specifications, standards, and methods. UX Enterprise will change the way UX design work is done.Eric has also created the UX Marketplace, which allows a global trade in UX objects.In addition, Eric has brought an array of certification programs to the UX field:- Certified Usability Analyst™ (CUA)- Certified User Experience Analyst™ (CXA) – advanced courses for UX practitioners- Certified Practice in Usability™ (CPU)- Certified Usable Design™ (CUD) – programs for organizationsEric is a Certified Professional Ergonomist (CPE). He earned his PhD in Applied Psychology, specializing in Human Performance, from Stevens Institute of Technology. Before co-founding HFI in 1981, he worked at CL Mauro Assoc, AT&T Long Lines, and Bell Labs.Eric is actively engaged with HFI staff and clients around the world and is working to disseminate UX design methods globally.

  • Regulatory Design Update: guidance on incorporating human factor (HF) engineering into design and risk management   more details ▾

    Seminar

    Design

    • Understanding the increased consideration of HF/Usability at the FDA and device reviews in new submissions
    • Addressing the information gap on what regulatory knows and what FDA looks for from devices
    • Update of IEC 62366:2007: Usability engineering and AAMI/ANSI
    • Application of HE75:2009: Human factors engineering-Design of medical devices, for safety and effectiveness

     

    Elise EdsonManager Human Factors EngineeringCovidien

    About Elise Edson

    Elise Edson is the manager of the Human Factors Engineering group at Covidien Respiratory & Monitoring Solutions in Boulder, CO. She is a member of HFES and sits on the AAMI Human Factors Standards Committee. In her current role, Elise is responsible for leading the planning, execution and reporting of human factors engineering, user interface and industrial design studies across all RMS programs according to current regulations and guidelines within the medical device industry. Elise has previously held human factors roles at St. Jude Medical CRMD and Abbott In-Vitro Imaging Systems. Elise has an MS in Computer Science from Washington University in St Louis, MO and a CUA from Human Factors International.

  • Incorporating human factors in medical device design   more details ▾

    Seminar

    Design

    Chair: Andy Schaudt, M.S., M.B.A., Director of Usability Services, National Center for Human Factors in Healthcare

    • An introduction to human factors within a healthcare system - a systems approach
    • Meeting the challenge of identifying the proper user groups during medical device design
    • Understanding the unique challenges with the typical systems engineering process when users are involved
    • Carefully incorporating usability throughout the entire medical device development process

    Andy Schaudt, M.S., M.B.A., Director of Usability Services, National Center for Human Factors in Healthcare

    About Andy Schaudt, M.S., M.B.A.

    Andy Schaudt is the Director of Usability Services for the National Center for Human Factors in Healthcare at the MedStar Institute for Innovation. He has significant experience in usability, safety, and human-factors engineering, having managed more than $6 million of contracted research. For the Center, he plans, coordinates, and manages the projects and daily operations for Usability Services, which is chartered to conduct medical device and health IT usability evaluations, both for industry and MedStar Health. Schaudt earned his M.B.A. in Business Administration from Virginia Tech, and holds a Bachelors degree in Psychology and a Masters degree in Human Factors from the University of Idaho.

  • Interactive packaging technology for engaging customers and product differentiation   more details ▾

    Seminar

    Design

    • Exploring possibilities for empowering consumers at the point of sale: product information, consumer recommendations, and/or discounts
    • Investigating developments in Printing RFID Tags and Other Smart Packaging Solutions
    • Assessing practical applications for Augmented Reality (AR) and Near Field Communication (NFC)
    • Overcoming challenges from prototyping to volume production
  • Achieving improved package usability through engineering – benefitting from technical market changes for greater client engagement   more details ▾

    Seminar

    Design

    • How to translate end-user insight into your packaging development
    • Developing a blueprint for sound user-testing requirements in packaging R&D processes
    • Best design practices in facilitating positive end-user impact: ergonomics, look, feel and implementing your R&D findings
  • Developing a package that communicates product quality and connects with customer needs   more details ▾

    Seminar

    Design

    • Highlighting recent consumer trends and the impact on purchase behavior and packaging
    • Utilizing a focused design process to meet those consumer trends and improve speed to market
    • Examine the packaging design process and strategies to ensure technical and commercial feasibility

     

    Robert Ziegler, President and Creative Director, Brandimation

    About Robert Ziegler

    Whether via strategy, marketing, or design, Robb has helped leading brand companies explore the future of brand innovation for the past 20 years. As a creative principal, Robb especially enjoys facilitating user-centered product and packaging development with clients. He leads diverse talent teams and has generated dozens of patented packages for Fortune 500 companies. Brandimation has developed several proprietary approaches and processes to provide clients with strategic advantages in new product development. Robb also teaches Industrial Design and Design Practice at two universities. Prior to co-founding Brandimation in 2000, Robb held New Media and Design Director positions at international design and brand communications agencies. He received his BS in Industrial Design from The University of the Arts in Philadelphia and studied at Universität Duisburg-Essen in Germany. He speaks English and German and is verrryyy sslowwwlly learning Mandarin Chinese. Robb and his wife Lucy live outside New York.

1:00 PM - 2:45 PM

  • Reducing hidden costs in development and accelerating time to market   more details ▾

    Seminar

    R&D

    • Devising scale-up strategies for the transition from rapid prototyping to rapid manufacturing
    • Balancing materials, risk management and processing costs
    • Outline how to work together with manufacturers to benefit time-to-market (TTM), time-to-volume (TTV), and time-to-profit (TTP)
    • Analysing risk management strategies during development & manufacturing of devices

     

    Charlotte Christou, MBA, MSEE, President, Christou Strategic Consulting

    About Charlotte Christou, MBA, MSEE

    Charlotte Christou is educated with an MBA from Rice University, and an MSEE and BSEE from the University of Central Florida. A true technologist at heart, she has been in the Aerospace Defense, the Semiconductor, and the Consumer Electronics industries, spending much of her efforts in digital imaging. Her background includes product marketing, market strategy, executive management, sales management, market research, business planning, marketing, engineering development, strategic planning, operations, outsourcing, and finance. Charlotte is currently a Management Consultant and an established Public Speaker for Christou Strategic Consulting. She has helped many SMB companies develop and launch products in multiple markets. She has spoken about technology worldwide. Before consulting, she worked as Brand Manager for iBiquity Digital Corporation, promoting HD Radio™ Technology to OEM and ODM manufacturers, developing strategic marketing plans between receiver manufacturers and retailers, and ran direct marketing programs. Prior to iBiquity Digital Corporation, she founded a consumer electronics company, patented and manufactured Digital Picture Frames in the digital imaging sharing market segments. She launched multiple products and utilized outsourcing to implement an innovative company with an emerging product category, taking products from the cradle to the grave.

  • Using process to develop a pipeline of innovative projects: Need finding through proof of concept   more details ▾

    Seminar

    R&D

    • How to seed your development pipeline with projects that meet your strategic needs
    • Guidelines and characteristics of identifying outstanding unmet clinical needs
    • Using filters to bring the best new projects to the top of your list of development pipeline

     

    Evan Anderson, Research & Development Manager, Spiracur

    About Evan Anderson

    Evan Anderson received his BS in Biomedical Engineering with a concentration in Material Science and a minor in Psychology from Johns Hopkins University in 1998. While pursuing his MS degree in Biomedical Engineering at Case Western Reserve University, Evan performed research on the mechanics of heart valves at the Cleveland Clinic Foundation. As an R&D engineer at Guidant Corporation beginning in 2001, Evan worked on multiple projects for less invasive cardiac and vascular surgery. In 2004, Evan left to do research in medical device innovation at the Stanford Biodesign Program and to work as a Biomedical Engineer at the FDA in the Medical Device Fellowship Program. From September of 2005 until July of 2008 Evan led development at Boston Scientific of a minimally invasive valve product up through design freeze for first in man. He then joined the venture backed startup Spiracur as R&D Manager. After two years leading development of the SNaP™ Wound Care System he transitioned over to direct sales and then managed distribution for Spiracur’s second product. He left Spiracur in May of 2013 to explore several early stage Medtech opportunities.

  • Overcoming regulatory pitfalls of medical device development with early clinical involvement   more details ▾

    Seminar

    R&D

    Chair: Charlotte Christou, MBA, MSEE, President, Christou Strategic Consulting

    Regulatory requirements are designed to reduce errors in medical device development. However, the rigors of input gathering and iterative concept testing for FDA requirements may slow down the medical device innovation process and increase costs. Clinician and design practitioner teams build on the model of user-centered medical device design. This helps the team to understand the needs of user groups and their work in context early and can help reduce the frequency of design control testing while maintaining conformity.

    Learning Objectives
    Participants will:

    • Discover a new model for collaboration between clinicians and design practitioners that leads to faster and more informed outcomes.
    • Observe how co-creation between clinicians and design practitioners can expedite the pre-design control process.
    • Learn how to navigate design control with fewer formal usability tests due to streamlined early-stage iteration coupled with clinical concurrence

    Mark Moyer, Director Quality Engineering, New Product Development, Advanced Wound Services, Smith & Nephew
    Chris Hammond, Director of Insight & Innovation, Kaleidoscope
    Sean J. Barnett, MD, MS, FACS, FAAP, Chief Medical Officer, Kaleidoscope

    About Mark Moyer

    Mark Moyer has over 20 years experience in the Medical Device industry, from start-ups to Fortune 500 companies, designing and manufacturing, catheters, tubing sets, sharps, micro-instruments, monitors, RF generators, pumps and other capital equipment.  With a current focus on design controls and usability engineering, he has extensive and progressive experience in; quality, regulatory, compliance, engineering, lean product development, manufacturing, customer service and document control.  Mark is an engineer (BSME/MBA) with multiple patents for ophthalmic devices.
    Mark is currently serving on the ASQ Technical Communities Council, is co-chairing the ASQ Performance Awards Recognition committee and is a Biomedical Division Past Chair.  In addition to serving in other Biomedical Division volunteer roles, Mark has recently join the AAMI IEC 62A/JWG 4 (Medical devices- general requirements for safety and essential performance – Usability) representing the ASQ Biomedical Division membership. Mark has received ASQ Certifications for both auditing (CQA, CBA, CHA) and quality management (CQM), and is a validated ASQ course instructor.

3:15 PM - 5:00 PM

  • A look at the past, present and future of additive manufacturing in prototyping and product design   more details ▾

    Seminar

    Design

    This session will cover the benefits of 3-D printing including:

    • Conserving Capital and Iterative Design Process
    • Providing Quality Feedback
    • Design, Prototype, Redesign, Test,
    • End user quality without the manufacturing

    Mike Rainone, Founder & Vice President, PCDworks, Inc.

    About Mike Rainone
  • Sustaining Excellence through Outcome Segmentation Analysis (SESOTA)   more details ▾

    Seminar

    Automation

    Workshop of a strategy to sustain excellence in a public health and regulatory outcome control through an application of a combination of quality management tools, the presenter refers to this strategy as “Setosa” or “Sustained Excellence through Outcome Segmentation Analysis.” This workshop with introduce a variation on risk analysis and apply it to the segments as well as identifying control factors and action targets.

    • Explore the background on historical behavior control and how the Information Age makes it ineffective
    • Detailing techniques for identifying the segments for the analysis

    Lawrence Sproul, Quality Manager, FDA

    About Lawrence Sproul

    Lawrence Sproul grew up in Pahrump, Nevada where he graduated from Pahrump Valley High School in 1984.  He served as a Missionary for the LDS Church in Paraguay South America from 1986 – 1988 and enlisted in the US Navy in May 1990 as a Hospital Corpsman. He was commissioned as an Environmental Health Officer in 1999.  During his military service he visited 37 countries and 26 states.Upon retiring from military service, Lawrence accepted a position with the US Food and Drug Administration where he currently serves as a Quality Manager.
    Quality and Organizational Excellence are the one common thread throughout Lawrence’s career.
    Military decorations include the Navy & Marine Corps Achievement Medal, Army Commendation Medal, Navy Commendation Medal, Humanitarian Service Medal, and various campaign and service awards.  He is married to Jennifer Sproul, a High School English teacher from Carlsbad, CA and they have three sons: Joshua, Benjamin and Samuel.

  • Advanced applications of 3D Printing; from inoperative to functional prototyping   more details ▾

    Seminar

    Design

    • Discovering and integrating functional 3D printing into your current applications and exploring future Developments in 3D printing
    • Exploring new software and innovative tools to increase 3D printing functionality
    • Discussing how this technology is used for tooling, assembly fit checks, production and unique applications

     

    Michael MoussaProduct Development Engineer, PartSnap

    About Michael Moussa

    Mike is a licensed Professional Engineer (TX) with over a decade of mechanical design and product development experience. He has an engineering degree from LeTourneau University and has worked in a variety of industries including automotive, manufacturing, heavy civil construction and consumer goods. He is a co-inventor on over eight US and international patents and patents-pending. In 2011 he founded PartSnap, a 3D printing and product development firm, where he continues to work with clients ranging from individual inventors to University research labs and Fortune 500 companies to bring their prototypes and product designs to life quickly and efficiently.

  • 3D printing case study; Detailing this technology’s ability to enhance manufacturing   more details ▾

    Seminar

    Design

    This session will explore highly accurate prototypes that look and feel as the finished manufactured item, including printing with multi materials. It will also include a look into how this technology is transforming the advanced manufacturing world.

    Darin Everett, Territory Manager - South Central US, Stratasys

    About Darin Everett

    Darin Everett has spent his career working with manufacturers to improve design and manufacturing processes that satisfy technical and financial challenges, after receiving a degree in Mechanical Engineering. With 25 years as a Sales Engineer/Manager and 14 years working with FDM technology, Darin's expertise is in evaluating manufacturing environments, recommending customized solutions, and assisting implementation related to Additive Manufacturing. His experience includes high-requirement industries such as, aerospace, defense and general manufacturing. As a Stratasys Territory Manager, Darin works with Authorized Distributors and Customers to assess their opportunities for improved efficiency, assemble the appropriate team of experts and manage the deployment of the solution. Stratasys completed its merger with Objet in December 2012 and remains the Industry Leader and the Leader in the 3D Printer and Additive Manufacturing Market.

Day 2 - Thursday, May 8

10:00 AM - 11:45 AM

  • Selection of SAL, Evaluation of Bioburden Data, Alert and Action Levels and Bioburden Excursions   more details ▾

    Seminar

    Quality

    Introduction: Understanding sterility assurance and bioburden data is essential to every sterilization method. Of interest to medical device OEMs is the absolute necessity of a 10-6 sterility assurance level (SAL), use of “less-than” values with bioburden data and properly establishing alert and action levels. These topics are applicable to all forms of sterilization (e.g. ethylene oxide, radiation, etc.). Time for questions will be allotted for each discussion topic.

    Selection of SAL for a Terminally Sterilized Product

    • Historical perspective on SAL
    • What impact can 10-6 SAL have on innovation?
    • ST67 concepts
    • Selection of SAL based on surgical site infections

    Evaluation of “Less-Than” Values in Bioburden Data

    • When are less-than values used?
    • Potential issues with use of less-than values – particularly in radiation sterilization
    • Options for reducing less-than values
    • Calculating a more true value when using less-than numbers

    Setting Alert and Action Levels for Product and Environmental Bioburden Counts

    • The Normal Distribution
    • What should be done at alert and action levels? What should not be done?
    • Establishing alert and action levels for various sterilization methods
    • What is a bioburden spike? An option based on normality/abnormality of the data.

    Martell Winters, B.S., RM/SM(NRCM), Senior Scientist, Nelson Labs

    About Martell Winters, B.S., RM/SM(NRCM)

    Mr. Winters received a B.S. in microbiology with a minor in chemistry from Brigham Young University. He has been at Nelson Laboratories for 20 years and spent most of that time working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue and pharmaceutical products. He is currently a Senior Scientist for Nelson Laboratories. Mr. Winters serves on many AAMI Sterilization Working Groups. He is also on the AAMI Sterilization Standards Committee and is the AAMI liaison to the AATB Standards Committee. In 1995 he received his Registered Microbiologist (RM) certification, and in 2001 his Specialist Microbiologist (SM) certification in consumer products and quality assurance microbiology from the U.S. National Registry of Microbiologists.

  • Are you ready for where packaging sustainability is heading?   more details ▾

    Seminar

    Design

    • Understanding a whole system approach to packaging by considering the principles of Sustainable Materials Management (SMM)
    • Demonstrate how SMM and life cycle design serve as the intellectual framework for guiding packaging design decisions
    • Investigating how organizations will use the sourcing of raw materials, selection of safer chemicals and materials and end-of-life considerations, to help the packaging industry develop the next generation of more sustainable packaging
    • Explore how the industry is standardizing what and how to measure, and what companies can do to prepare for shifts towards greater measurement and disclosure in B2B relationships and with end consumers

    Minal Mistry, Senior Manager of Sustainability Solutions, GreenBlue

    About Minal Mistry

    In his current role, Minal Mistry provides support to a wide range of projects with an emphasis on sustainable materials management strategies. He is product owner of COMPASS® (Comparative Packaging Assessment), a life cycle analysis (LCA) software designed for packaging professionals to factor in environmental performance at the earliest design steps. Minal leads the international outreach and education efforts for the SPC. His background includes ecology, analytical chemistry, information technology, and environmental policy. He has contributed to various sustainability framework and standard development efforts including for packaging, textiles, nano-scale materials, and carbon reporting. Minal has traveled extensively in developing countries, and he enjoys working with companies and industry to help develop pathways leading to improved environmental and social accountability.

  • Showcasing effective use of reused and recycled packaging materials   more details ▾

    Seminar

    Design

    • Evaluating how to use the latest recyclable materials in your packaging concepts
    • Integrating reusable packaging initiatives into the product development process
    • Reviewing the latest strategies in Eco-friendly packaging and packaging made from a high percent of post-consumer waste

     

    Abelia Sloey, Senior Mechanical Engineer - Packaging Mobility Products, Dell

    About Abelia Sloey

    Abelia Moreno Sloey has 15+ years growing her professional passion: Great Packaging! Since graduating from San Jose State University, Abelia has strived and succeeded in her packaging endeavors at Dell Inc. She has created innovative packaging solutions utilizing new sustainable packaging materials in the industry. She is a key global fulfillment packaging influence at Dell Inc., too. Abelia’s additional favorite passions would be her family, painting art/design, and off-roading on her 4x4! You can contact her at Abelia_Sloey@dell.com.

  • Expanded uses and new applications for alternative packaging materials   more details ▾

    Seminar

    Design

    • Examining the latest developments in bioplastics and renewable plastics for packaging
    • Plastic packaging from responsibly-sourced plant or renewable materials
    • Identify alternative materials that have a high potential to become available on a commercial level within the near future
    • Recognizing novel material growth potential and opportunities for alternative materials in packaging
      • Moldable pulp
      • Algae
      • Bamboo
      • Agricultural waste

    Jim Warner, Founder & Principal Industrial Designer, Jim Warner3D, LLC

    About Jim Warner

    Jim Warner is Founder and Principal Industrial Designer of JimWarner3D, LLC. He is the visionary force behind a new, fresh approach to client engagement that provides clients with what they need and want most in an industrial design and innovation consultative relationship – invaluable experience and extraordinary talent. This unique approach enables JW3D to focus on elevating a person’s emotional experience with a brand above other choices in context of the venue to achieve immediate purchase intent and build a deeper emotional connection for long-­term market share growth. JW3D utilizes Deconstructive Strategy to define the opportunity at -­ hand through the understanding of brand emotionality, analysis of competitive or inspiring offerings, and most importantly the client’s specific Success Criteria. The learning fuels Demonstrative Design to iteratively shape, refine and define design solutions that enable people the very best way to experience the brand through the way they See It (aesthetics) and Use It (functionality), and for the client to Make It. Jim has strategically, creatively and technically helped to define and produce many of the most iconic and powerful branded products and packages in the world today. Prior to JimWarner3D, LLC, Jim held global leadership roles as Managing Design Director of Kaleidoscope, Managing Director of Brandimage, Founder/Partner of One80 Design, President of Futurebrand; and EVP of Deskey Associates. He’s held professorships at the Parsons School of Design and the Pratt Institute of Design in NYC. Jim is the recipient of numerous design awards and has been issued over 75 patents. He has written numerous articles, featured in trade journal columns and bylines, and presented at conferences all over the world. Last year, he was a proud recipient of the Massachusetts College of Art and Design Alumni Award.

  • Lean Manufacturing & Six Sigma   more details ▾

    Seminar

    Quality

    Lean Manufacturing is a front loaded, knowledge based method focused on customer value and eliminating waste of rework. This presentation introduces Lean manufacturing and how it is applied to understand customer needs, reduce risk, establish critical characteristics and process control and use failure analysis to improve manufacturing. Attendees will understand how a Lean transformation can dramatically empower and engage the workforce with an effort to remain agile, dynamic and successful as demands grow more complex.

    • Create a lean management system that engages frontline staff
    • Discovering ways to reduce nonproductive costs in a machine shop using lean practices
    • A case study example of how Value Stream Mapping has been practically applied

    Edwin Garro, Chairman and President, PXS Performance Excellence Solutions
    Rolando Guido, Consultant, Atomix S.A.
    Javier González, Director of Operations Lean Six Sigma, PXS Performance Excellence Solutions

    About Edwin Garro

    Edwin Garro is Chairman and President of PXS Performance Excellence Solutions, an organizational excellence training and consulting firm from San José, Costa Rica. He has over 25 years of experience working with major local and multinational companies in North and Central America in the areas of Lean, Six Sigma and Innovation. Since 2001, he has prepared and mentored close to 1,000 professionals for ASQ certifications. Currently Mr. Garro holds six ASQ certifications CQE, CMQ/OE, CQA, CSSGB, CSSBB and CQI. He is also a certified trainer in Lateral Thinking and Six Thinking Hats. Along with PXS Edwin is also partner at Atomix, a software company and Ludovico, a commercial printing company. Mr. Garro is a Past President for ASQ Costa Rica and he is an ASQ Senior Member. He is part of the “Influential Voices of Quality” group of ASQ bloggers. He has a B.S. in Industrial Production Engineering from the Instituto Tecnológico de Costa Rica and an M.S. in Manufacturing Engineering from the University of Massachusetts, Lowell.

1:00 PM - 2:45 PM

  • Ask the experts: Q&A session   more details ▾

    Seminar

    Manufacturing

  • Creating a Process Driven Culture via Coaching   more details ▾

    Seminar

    Quality

    If you are trying to create a process-driven culture in a workplace that is not only change resistant, but also doesn’t believe in process, then this session is for you. Learn how the presenters took small but specific steps to change an old-school government style to one based on processes and data-based decision-making.

    About Nicole Dunn

    Nicole Dunn is Principal and Founding Partner of Whiteboard Consulting Group Inc. Prior to creating Whiteboard, she had more than 10 years of experience with the Ontario Public Service allowing her to build a strong and successful professional portfolio with expertise in finance, leadership, and process improvement. She pairs a strong technical background in both HR and statistics & data analysis with superior project management and presentation skills, using a creative and vibrant approach to process improvement. Among other major project successes, Nicole designed and launched ground-breaking processes which introduced time-saving service delivery improvements. A focus on customer service, change management, and innovation allow her to communicate easily with all levels of management to ensure successful change. Nicole’s formal education includes a BA from the University of Toronto and an MBA from Sir Wilfred Laurier University. She is pursuing certification in Appreciative Inquiry, and is certified in Method Time Motion studies, a critical part off reliable data collection and analysis. Nicole is a fitness instructor, a traveler, a vegetarian chef, and an actor.

    Ruth HendersonPartnerWhiteboard Consulting Group

  • Implementing improved reliability and consistency in the design through manufacturing process   more details ▾

    Seminar

    Manufacturing

    • Acquiring and agreeing on stable and sufficient product requirements before embarking on development
    • Contrasting short time-frame needs for the product development environment and long-term needs of ramp-up and steady manufacturing
    • Ensuring machine design that allows for changing materials, specifications and energy requirements/laws
    • Improving precision for medical components and disposable parts

     

    Gary Kelly, BEng, MSc., Principal R&D Engineer, Medtronic Vascular

    About Gary Kelly

    Gary Kelly has worked with Medtronic for over six years, having moved to the US three years ago to deploy the Design, Reliability & Manufacturability methodology. Gary owns the integration & continuous improvement of the Design, Reliability & Manufacturability (DRM) methodology in Medtronic Santa Rosa for the Coronary & RDN Business unit. The DRM initiative is designed to create a process which fosters innovation & develops world leading medical technology, it helps maintain the robust quality profile of the product, all while balancing the business needs of the organization.

  • Optimizing medical device development with quality in mind   more details ▾

    Seminar

    Manufacturing

    • 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.
    • Discussing shared best practices  that can help manufacturers better manage products liability risk and ensure successful transition to manufacturing

    Jim Dunbar, Senior Quality Engineering Manager, Medtronic

    About Jim Dunbar

    Jim Dunbar has been with Medtronic for over 10 years with increasing levels of responsibility in the Quality function. He has had responsibility for pre-market Quality on multiple medical device product development programs including PTCA catheters, bare metal and drug eluting stent delivery systems and trans-catheter heart valves.

  • Meeting the demands of tomorrows’ patient: User-centric design and development, current design and development trends   more details ▾

    Seminar

    Manufacturing

    Chair: Siddharth Desai, Vice President of Engineering, Pro-Dex, Inc.

    • Recognizing what the evolving patient requires and expects from their device
    • Identify how device manufacturing and materials can best deliver on the device that the end-user requires
    • Recognizing manufacturing and supply chain considerations for design driven development
    • Managing device requirements across a product line and throughout the product lifecycle

    Siddharth Desai, Chief Executive Officer and Idea Engineer, Solo-Dex, Inc.

    About Siddharth Desai

    Siddharth Desai, Chief Executive Officer and Idea Engineer at Solo-Dex, Inc., is focused on delivering innovative technical solutions in the medical device and pharmaceutical industry for the last 30 years. He has started Solo-Dex, Inc. with two clinicians with the sole purpose of changing human lives through innovative medical solutions. While he enjoyed being a bureacrat at large companies like American Hospital Supply, Allergan, Baxter and I-Flow, he relishes the ideas of focused products with a different lingo like Connectivity, Robotics, and Open Innovation. He has been integral to the development of several product solutions in a variety of different therapeutic areas including Orthopedics, Anesthesia and Pain Management, Plastic Surgery, Ophthalmology and Infusion Systems. Among the innovative solutions, Siddharth has introduced Modular Powered Surgical Instruments, Arthroscopy Systems, Phacoemulsification Systems, Intra Ocular Lenses, Disposable Elastomeric Infusion Pumps and a host of other systems. His product development philosophy is making a ‘true’ difference’ in the lives of customers including clinicians and patients. He holds multiple patents.  He has presented in many seminars on the topics of New Product Development, Design for Manufacturing and Affordable Care Act.    

3:15 PM - 5:00 PM

  • Ask the experts: Q&A session   more details ▾

    Seminar

    Design

  • Advances in breakthrough MEMS and biomedical nanotechnology   more details ▾

    Seminar

    Design

    • Exploring the latest applications being considered in the broad area of microelectromechanical systems (MEMS) and biomedical nanotechnology
    • Discussing some of the regulatory challenges medical professionals face when working on new frontiers
    • Overcoming the challenges of integrating MEMSs and NEMs into medical devices
    • Comparing multiple case studies from a variety of medical applications to develop strategies in the material and nanotech areas

     

    Chris Folk, Ph.D. candidate, Principal Engineer, Device Strategy, Amgen

     

    About Chris Folk, Ph.D. candidate

    Chris Folk loves making medical devices. He has an extensive background in micromachining/MEMS and microfluidics, which is the subject of his PhD at UCLA. For ten years, he contributed to both the processes and designs at Microfabrica, a startup with a unique 3-D microfabrication platform. An NIH-sponsored collaboration between Microfabrica, Boston University, and Harvard resulted in the first published all-MEMS surgical tool. For three years, Chris led the catheter R&D team for Covidien Neurovascular, resulting in three sets of product launches. Most recently, he has joined the Device Strategy team at Amgen, where he will co-develop IP strategy and identify new technologies to deliver drug therapies.

  • A physician's perspective on medical robotics: Clinical needs & future technology   more details ▾

    Seminar

    Design

    • Identifying key aspects of medical robot capabilities that physicians require for adopting a new technologies 
    • Reviewing examples of medical robots that have crossed the chasm for procedure adoption
    • Exploring future robotic technology developments that will shape medical procedures

    John Meehan, MD, Associate Professor of SurgerySeattle Children's International Robotic Surgery Center

    About John Meehan, MD

    Dr John J. Meehan MD, FACS is an Associate Professor of Surgery at the University of Washington and Seattle Children’s Hospital. After graduating from Washington University – St. Louis with an engineering degree, he began his professional career as an electrical engineer for McDonnell Douglas Aircraft Company and worked on the design of military fighter aircraft including the F/A-18, F-15, and the AV-8B. Although he loved the engineering field, his passion for medicine was greater. He was accepted into medical school at the University of Iowa College of Medicine and graduated in 1993. He completed residencies in general surgery at the University of Alabama at Birmingham, surgical critical at Children’s Mercy Hospital in Kansas City, and pediatric surgery at Children’s Hospital – Los Angeles. During his general surgery residency, he worked on many research projects as pediatric laparoscopy began to develop. Following completion of his fellowship in pediatric surgery, Dr. Meehan returned to Iowa and began investigating the applications of new technologies in pediatric robotic surgery and robotic simulation. He has written more than 30 first author publications on robotic pediatric surgery and dozens of book chapters. He is considered one of the world’s leading authorities in pediatric robotic surgery and has been invited to speak all around the world. Dr. Meehan also has pioneered dozens of world’s “first” surgeries using robotic technology and has discovered methods to adapt the current robotic technology for infants and neonates. Outside of medicine, Dr. Meehan has also been extensively involved in professional cycling. Although recently retired from racing himself, he remains active as team physician with his former team the Bissell Pro Cycling Team. Dr. Meehan also combines his passion for pro cycling with philanthropy and founded the internationally known UCI Jingle Cross, a professional cyclocross race in Iowa City, Iowa with all proceeds donated to the University of Iowa Children’s Hospital. Although he moved away from Iowa City after the 2007 race, he remains the Promoter and Race Director and has grown the Jingle Cross into the largest Pro Cyclocross event in the Western hemisphere.

  • Antimicrobial Conformal Coating to Reduce Healthcare Associated Infections   more details ▾

    Seminar

    Design

    Chair: Dick Molin, Senior Medical Market Specialist, Specialty Coating Systems

    • HAIs and antimicrobial Needs
    • Antimicrobial Parylene Technology
    • Evaluation Test Results
    • Regulatory Aspects

    Dick Molin, Senior Medical Market Specialist, Specialty Coating Systems

    About Dick Molin

    Dick Molin is Sr. Medical Market Specialist for Specialty Coating Systems. In addition to market education, his focus includes facilitating SCS medical applications and trials on existing as well as emerging medical technologies. Molin has spent over 28 years in Engineering roles focusing on product and process development, including 14 years at SCS, where he actively worked with advanced materials and processes for Parylene technologies. Dick earned his Bachelor’s degree in Materials Engineering from the University of Arizona and holds a Master of Business Administration in Technology Management from the University of Phoenix.

  • Quality Supplier Management   more details ▾

    Seminar

    Quality

    • 4 Things You Need to Know about MedTech Suppliers
    • What you can do to help improve the business relationship
    • What would you like to hear from your suppliers?
    About Jim Shore

 

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