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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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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

Design

IMPROVED PACKAGING DESIGN STRATEGIES & SMART PACKAGING DEVELOPMENTS TO BETTER MEET EVOLVING END-USER NEEDS

  • Developing a package that communicates product quality and connects with customer needs
    10:00am to 10:25am
    • 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

  • Achieving improved package usability through engineering – benefitting from technical market changes for greater client engagement
    10:25am to 10:50am
    • 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
  • Interactive packaging technology for engaging customers and product differentiation
    10:50am to 11:15am
    • 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
  • Air Activated Self Heating Packaging
    11:15am to 11:45am
    • 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 Technology Officer, RBC Technologies

CRITICAL GUIDANCE ON INCORPORATING HUMAN FACTORS INTO MEDICAL ENGINEERING

  • Incorporating human factors in medical device design
    10:00am to 10:35am

    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

  • Regulatory Design Update: guidance on incorporating human factor (HF) engineering into design and risk management
    10:35am to 11:10am
    • 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 Edson
    , Manager Human Factors Engineering, Covidien

  • Optimizing the institutionalization of User Experience (UX)
    11:10am to 11:45am
    • 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 Schaffer
    , Founder and Chief Executive Officer, Human Factors International, Inc.

1:00 PM - 2:45 PM

R&D

RAPID IDEATION & PROTOTYPING: DRIVING SPEED TO MARKET

  • Overcoming regulatory pitfalls of medical device development with early clinical involvement
    1:00pm to 1:35pm

    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

  • Using process to develop a pipeline of innovative projects: Need finding through proof of concept
    1:35pm to 2:10pm
    • 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

  • Reducing hidden costs in development and accelerating time to market
    2:10pm to 2:45pm
    • 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

3:15 PM - 5:00 PM

Design

3D PRINTING CAPABILITIES: INNOVATIVE TOOLS & NEW MATERIALS FOR DESIGN AND MANUFACTURING

  • 3D printing case study; Detailing this technologies ability to enhance manufacturing
    3:15pm to 3:50pm

    This academic led session will explore highly accurate prototypes that look and feel as the finished medical device, including clear and rubberlike materials. It will also include a look into how this technology is transforming the medical world.

    Darin Everett, Territory Manager - South Central US, Stratasys

  • Advanced applications of 3D Printing; from inoperative to functional prototyping
    3:50pm to 4:25pm
    • 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 Moussa
    , Product Development Engineer, PartSnap

  • Understanding the capabilities of 3D printing in your workplace now
    4:25pm to 5:00pm

    Representative from 3D Systems

Automation

SUSTAINING OPERATIONAL EXCELLENCE

  • Sustaining Excellence through Outcome Segmentation Analysis (SESOTA)
    3:15pm to 5:00pm

    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

Day 2 - Thursday, May 8

10:00 AM - 11:45 AM

Quality

NELSON LAB SPONSORED SESSION: MEDICAL DEVICE STERILIZATION: SELECTION OF SAL, EVALUATION OF BIOBURDEN DATA, ALERT AND ACTION LEVELS AND BIOBURDEN EXCURSIONS

  • Selection of SAL, Evaluation of Bioburden Data, Alert and Action Levels and Bioburden Excursions
    10:00am to 11:45am

    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

LEAN MANUFACTURING & SIX SIGMA

  • Lean Manufacturing & Six Sigma
    10:00am to 11:45am

    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

Design

NEW PACKAGING MATERIALS & SUSTAINABILITY CONSIDERATIONS FOR THE ENTIRE PACKAGING LIFECYCLE

  • Expanded uses and new applications for alternative packaging materials
    10:00am to 10:30am
    • 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

  • Showcasing effective use of reused and recycled packaging materials
    10:30am to 11:00am
    • 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

  • Are you ready for where packaging sustainability is heading?
    11:00am to 11:30pm
    • 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

1:00 PM - 2:45 PM

Automation

SUPPLIER DEVELOPMENT AND ENGAGEMENT DURING THE PRODUCT DEVELOPMENT LIFECYCLE

  • Supplier Development and Engagement during the Product Development Lifecycle
    1:00pm to 2:45pm

    Dan Panzica, Global Quality Executive, Motorola Mobility

Manufacturing

OPTIMIZING MEDICAL DEVICE DESIGN CONCEPTS FOR MANUFACTURABILITY

  • Meeting the demands of tomorrows’ patient: User-centric design and development, current design and development trends
    1:00pm to 1:35pm

    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.

  • Optimizing medical device development with quality in mind
    1:35pm to 2:10pm
    • 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

  • Implementing improved reliability and consistency in the design through manufacturing process
    2:10pm to 2:45pm
    • 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

  • Ask the experts: Q&A session
    2:30pm to 2:45pm

3:15 PM - 5:00 PM

Design

ADVANCED MATERIALS & DEVICE TECHNOLOGY

  • Wireless technology in medical devices from a systems perspective: mhealth, mobile, etc.
    3:15pm to 3:45pm

    Dick Molin, Senior Medical Market Specialist, Specialty Coating Systems

  • A physician's perspective on medical robotics: Clinical needs & future technology
    3:45pm to 4:15pm
    • 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 Surgery, Seattle Children's International Robotic Surgery Center

  • Advances in breakthrough MEMS and biomedical nanotechnology
    4:15pm to 4:45pm
    • 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

     

  • Ask the experts: Q&A session
    4:45pm to 5:00pm

Quality

RISK MANAGEMENT TOOLS

  • Creating a Process Driven Culture via Coaching
    3:15pm to 5:00pm

    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.

    Nicole Dunn, Partner, Whiteboard Consulting Group

    Ruth Henderson, Partner, Whiteboard Consulting Group

 

Learning Labs Sponsors

Nelson Laboratories is a leading provider of full life-cycle microbiology testing services for the medical device, pharmaceutical and tissue. While we are known for exceptional quality and rigorous testing standards, we are also keenly aware of the bigger picture. It’s what we call The Science of Success™. It’s looking beyond test results and partnering with you to achieve your long-term business goals—mitigating risk, being first to market, and succeeding with your customers. We deliver on this promise through: thought leadership and approachable experts, a customer-centric approach, a real-time project management portal, metric-driven testing processes, and global compliance expertise and support.
For more information, visit their website www.nelsonlabs.com

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