Judith M. Andrews, Ph.D., RAC, CBA (ASQ)
Director, Quality and Compliance Services
Medical Device Consultants, Inc.
Strategies for Avoiding a Recall—and Surviving One If Necessary

FDA has started implementing its Postmarket Transformation Initiative and is looking at additional sources of product problem information. Europe has issued new guidelines for Medical Device Vigilance Systems. The number of recalls in the U.S. has increased almost every year since 2000. Strategies to avoid recalls should be part of every company’s post market surveillance plan. Companies must understand and evaluate their risks in the event a product recall is necessary; how many countries, what is required for each regulatory jurisdiction, options for correction. In today’s global environment, even small companies can face a worldwide recall and all of the communication and regulatory issues it entails. Planning is essential to minimize the disruption that a recall or corrective action can cause and to ensure an efficient and effective recall or correction of product. A clear policy and plan of action can also avoid unpleasant interactions with regulatory agencies.

Attendees will learn:

• How to conduct postmarket product monitoring in light of the FDA post market initiative
• How to assess your recall risks
• Implications of worldwide distribution and differences among regulatory bodies
• What is a recall and what is not in various regulatory jurisdictions
• What information the FDA, EU and Canada require and the format for that information
• Examples of recall processes and problems.

Bio: Judy has over twenty years of hands-on experience in FDA regulation of medical devices. She has held positions in product development, manufacturing, quality control and quality assurance at several companies including a Fortune 500 company and several start-up firms. Her demonstrated expertise in developing, implementing and auditing quality systems, together with a “value-added” approach, is a strong fit for medical device manufacturers seeking to comply with QSR, EN ISO 13485:2003, MDD, IVDD or Canadian Medical Device Regulation. Judy has expertise with immunology and in vitro diagnostic devices, as well as over-the-counter medical products. She assists clients with recalls, U.S. and EU medical device reporting and FDA 483s and warning letters. She holds a Ph.D. in chemistry from Case Western Reserve University and an M.B.A. from Simmons Graduate School of Management. She is an American Society for Quality Certified Biomedical Auditor and Regulatory Affairs Certified. She serves on the board of the New England chapter of the ASQ Biomedical Division. (top)

Bruce C. Arntzen, Ph.D.
Managing Director
Avicon Partners, LLC
Selling the Board Room on Engineering and Supply Chain Innovations

You’re not going anywhere without top level support. Any major innovation in Engineering or Supply Chain needs the support and commitment of top management. You also need the cooperation of Sales, Marketing, Finance and other functions. Their business practices all have a direct impact on the success or failure of your key initiatives. Yet most Engineering and Supply Chain managers do a poor job of communicating with other functions or rallying them behind their change programs. Their influence at the Board Level is weak at best.

Why is this true? How do we fix this? In this session, we will look at what you care about and more importantly, what the Board cares about. We will compare the finance-centric language and metrics used by top management versus the techno-detailed language and metrics used in the trenches.

This session will:

• Teach you how to speak the language of the Board Room
• Show how to recast your pitch in terms that excite them
• Demonstrate a powerful financial benchmarking tool that will get their attention
• Illustrate how to connect company financial goals to your change program
• Describe a case study where supply chain and engineering innovations raised a failing company to a position of market dominance
• Teach you a leadership technique to launch you on your way

Bio: As Managing Director of Avicon Partners, Dr. Arntzen helps companies recognize and understand their critical enterprise-wide processes and to overcome their functional barriers to make key innovations. He helps operating groups define their change programs and be more effective in leading those initiatives.

With over 25 years of experience in operations management, he has helped high-tech firms cut their time to market and re-engineer their new product introduction process. He has completed supply chain transformation projects for the process/chemical, high-tech/electronics, industrial equipment, logistics provider, consumer product, retail and distributor industries. His work includes strategic visioning, quantitative assessments, operations research and business process re-engineering. His clients have been in Engineering, Marketing, Operations and Finance. Dr. Arntzen is a frequent speaker at industry conferences including CSCMP, and executive education programs at MIT, Penn State, and other schools. He has published key articles in Operations Research, Interfaces, CSCMP Proceedings and Supply Chain Management Review. Dr. Arntzen holds a Ph.D. in Engineering from MIT, an M.S.E in Mathematical Modeling and Economics from the Johns Hopkins University, and a B.S. and B.A. in Civil Engineering and Biology from Bucknell University. (top)

Ron Bercaw
President
Breakthrough Horizons, Ltd.

Bob Broach, Co-Presenter
President
Broach Consulting Group, LLC
WORKSHOP: Lean New Product Development: Project Management

This workshop will describe how to apply lean tools to develop the project plan used in the introduction of new products to meet the strategic goals of the organization. Included in the workshop are hands on learning of the method.

• Develop a waste free project
• Insure collaboration of resources to maximize value
• Optimize use of human resources
• Eliminate project re-work reducing the project cycle time by 50-75%
• Deliver projects on-time
• Build organizational knowledge and create project standards

Bio: Breakthrough Horizons is a management consulting company teaching organizations how to deliver world class performance through continuous process improvement. Ron Bercaw has over 20 years of management experience in operations. His lean management experience was gained through multiple enterprise transformations in different industries including custom packaging, power reliability electronics assembly and test and measurement products.

Educated at Purdue University, he learned the details and disciplined applications of lean principles, habits and tools from both the Shingijutsu Sensei and their first generation disciples. Working in both shop floor and above the shop floor areas, Ron has worked to remove waste from businesses through the involvement and ideas of the people doing the work.

Ron has consulting experience in the commercial sector (administration, manufacturing, distribution, supply chain, engineering), healthcare sector (U.S. and Canada Health Systems including primary care, acute care and community applications of both clinical and back shop improvement), and the public sector (U.S. Army, U.S. Navy, U.S. Air Force including MRO, Pentagon and Surgeon General Assignments).

Bio: Bob Broach is principal owner of Broach Consulting Group LLC, providing Lean Sigma consulting, engineering and business solutions for the Commercial and Health Care Sectors.

Prior to starting his own firm, Bob was a Senior Consultant at a top tier consulting firm and performed dozens of events in Commercial, Military, R&D and Health Care Industries. Bob specifically pioneered Lean Business Development via 3P (product, process preparation) and 2P (process preparation) events in the Health Care sector.

Bob began Lean Sigma consulting after a management career spanning 25+ years in Quality & Reliability Engineering, Manufacturing Engineering, Design Engineering and Business Development functions for several Fortune 500 companies. Those companies include Emerson Electric, Mercury Marine, Whirlpool, Sunbeam and Pella Corporation.

Bob’s first lean experiences began 25+ years ago with the MerCruiser Division of Mercury Marine as Quality Engineering Manager implementing Quality Systems into a J.I.T. and one piece flow manufacturing environment. He then spent the majority of his career with Whirlpool Corporation and later with Sunbeam Corporation in management positions of Quality & Reliability Engineering, Engineering Brand management, Advanced Program management, R&D and New Business Development. Bob culminated his corporate career with Pella Corporation, a national leader in Lean Transformation, as Corporate Director of Design Engineering. A certified Quality Engineer, certified Reliability Engineer and certified 6-Sigma Black Belt, Bob has been able to leverage his knowledge of Lean Sciences into New Product Development via simultaneous engineering that integrates Product, Process and Quality systems. He has personally led hundreds of Lean 3P, 2P and Design Review events during his career. Bob has developed proprietary methodologies for Lean Business Development and New Product Development for both business to consumer and business to business industries. (top)

Mark Chockalingam, MBA, Ph.D.
Managing Principal
Demand Planning, LLC
Collaborative Supply Chain Planning for the Orthopaedic Industry

Whether you are a manufacturer or distributor in the orthopaedic industry, an integrated supply chain planning process with collaboration is a key requirement to improve customer satisfaction, speed up the time to market and improve profitability. Supply chain planning starts with a plan for customer demand, which then gets translated into a production and manufacturing plan, complemented by effective inventory management and network optimization for improved supply chain efficiencies in the long run. Traditional supply chains are driven by a halo mentality in which one function receives information from another and reacts with goods and service transfers or with more information. However, collaborative supply chains work on the basis of collective inputs from various supply chain participants including even the customer (CPFR) and the vendor (Co-managed Inventory and VMI).

In this session, we will discuss the key building blocks of supply chain collaboration including Demand Planning, New Product Development process, order fulfillment, manufacturing planning, integrated business planning (S&OP), customer focused planning, and a Supply Chain Score-card.

Bio: Dr. Mark Chockalingam is Managing Principal, DemandPlanning.Net, a Business Process and Strategy Consultancy helping clients across industries including   Pharmaceuticals, Consumer Products, Chemicals and Fashion Apparel.  His specialty consulting areas include Demand Forecasting, Supply Chain Analytics, and Sales and Operations Planning. Dr. Chockalingam has consulted for a variety of clients including Teva Pharmaceuticals, FMC, Celanese AG, Colgate-Palmolive, Abbott Labs, Miller Breweries, Au Bon Pain and Wyeth Pharmaceuticals. 

With significant expertise in business forecasting and modeling, he is a frequent speaker at major supply chain events on topics ranging from demand management to sales and operations planning. He has presented at the Supply Chain Planning Conference, The Forecasting Summit, Lnoppen and various IBF forecasting conferences. He has conducted numerous training and strategy facilitation workshops for a variety of clients in the US and abroad.  He has also presented numerous Webinars and published columns and articles on the Internet and through the website www.demandplanning.net.

Prior to establishing Demand Planning LLC, Mark worked with manufacturing companies in important supply chain positions.  Mark was Director of Market Analysis and Demand Planning for the Gillette Company, now a division of Proctor & Gamble.  During his corporate career, Mark worked in the Automotive, Health Care and Transportation sectors including such Fortune 500 companies such as Schering-Plough and Federal Express.  

Mark holds a Ph.D. in Financial Economics from Arizona State University and is a member of the Institute of Chartered Accountants of India and currently serves on the Board of the Boston APICS as VP, Programs. (top)

J. Paul Dittmann, Ph.D.
Director, Corporate Partnerships, and Managing Director of the Demand/Supply Integration Forums
University of Tennessee College of Business Administration
Collaboration with Your Suppliers: Is This Just Hype, or Does It Produce Bottom Line Results?

Supplier collaboration stands as one of the pillars of a world class supply chain. Yet successful collaborative relationships between a firm and its core suppliers are still rare, with more talk than real action. For every example like Toyota and its supply base or P&G/Wal-Mart, there are far more examples of failure. Successful collaboration between supply chain partners demands a lot of hard work, with mutual trust built slowly over a long period of time.

This presentation will examine two successful collaborative partnerships, and then assess why they were indeed successful. It will conclude with a summary of the three essential elements of a successful collaborative relationship.

Bio: Dr. J. Paul Dittmann is the Director of Corporate Partnerships and Managing Director of the Demand/Supply Integration Forums in the Department of Marketing and Logistics at the University of Tennessee. In this role, he is responsible for managing activities of the Demand and Supply Integration Forums, involving over fifty separate companies. Dr. Dittmann also leads Supply Chain Audits done by the faculty, recently involving firms like Lockheed Martin, Nissan, Johnson & Johnson and Estee Lauder. He also has a student and executive education teaching role in the department.

Dr. Dittmann has a range of consulting experience, working with firms such as Cooper Tire, Cummins, Rhodia, Radio Systems Corporation, N.A. Industries, Terra Firma-Malaysia, GAF Corporation, Race Trac Petroleum, Fiskars, Nissan, Lockheed Martin, Estee Lauder, Bush Brothers, Uster, Peerless Pump, United Smokeless Tobacco, U.S. Army, U.S. Air Force, Michelin, Johnson & Johnson, Brunswick, Office Max, Leggett and Platt, Maxitor, GlaxoSmithKline, Navistar, General Signal, The Keller Group and Sony.

Dr. Dittmann came to the University of Tennessee after a thirty-two year career in private industry. Positions included: Vice President, Supply Chain Strategy and Systems for Whirlpool Corporation; Vice President Global Supply Chain Systems; Vice President, Logistics; Director, Manufacturing Technology; Corporate Director, Manufacturing Planning; Corporate Director, Strategic Planning, Director Logistics; Director, Marketing Services.

Dr. Dittmann is a Registered Education Provider for Project Management Institute. He has conducted many seminars and spoken at many conferences in the areas of supply chain, Lean manufacturing, project management, global business and change management.

Dr. Dittmann is co-author of the recent Harvard Business Review article, “Are You the Weakest Link in Your Supply Chain?” and the soon to be published book by the Harvard Business Review Press: Driving Shareholder Value With Your Supply Chain. (top)

John A. Engelhardt, MS, FAIMBE
Founding Partner
Knowledge Ventures, LLC
Supplying the Increasing Demand for Orthopaedic Treatment - The Technology Challenge

The demand for total joint replacement will quadruple in the next 20 years. Spine surgeries will nearly triple. The number of activity-related injuries will increase dramatically. As industry addresses the needs of an increasing patient base, and an ever-younger one, new clinical issues not previously anticipated will emerge. This presentation will describe the technology challenges that will arise as a result, and the response of industry to those challenges.

The major unmet clinical needs will be presented for Hips, Knees, Small Bone, Trauma, Sports Medicine and Spine. For each segment, the technologies to address these challenges will be discussed. Finally, emerging opportunities will be identified along with how they can be most optimally realized.

Bio: John Engelhardt is a founding partner of Knowledge Ventures, LLC, a venture firm focused on the musculoskeletal industry. A former executive of AcroMed Corp. and DePuy, Mr. Engelhardt is a futurist and recognized authority on technology trends in orthopaedics. He holds 19 patents covering large and small joints, spine and trauma.

Mr. Engelhardt managed design teams in the early days of disc replacement, and, ironically, more than a decade later, became the first American to receive what is now known as the Prestige cervical disc prior to its release in the U.S.

He has published hundreds of articles in the academic and popular press, is Editor-in-Chief of Orthopaedic Product News and is a frequently requested speaker at industry events.

Mr. Engelhardt received his Bachelor of Science degree in Mechanical Engineering from Virginia Polytechnic Institute and State University, a Masters in Bioengineering from Louisiana Tech and performed post-graduate biomechanics research at LSU Medical Center. Mr. Engelhardt is a Member of the College of Fellows, American Institute for Medical and Biological Engineering.  (top)

Shirley A. Engelhardt
Founding Partner
Knowledge Ventures, LLC
The Orthopaedic Industry – The Good, the Bad and the Ugly

Shirley Engelhardt will present a review of the worldwide orthopaedic marketplace with a discussion of both positive and negative market dynamics and their potential impact on the industry over the next decade. She will offer some perspective on how the following factors might serve to spur or mitigate the market’s overall growth moving forward:

• Procedures, price and mix
• Population demographics
• Government regulations, policies and oversight
• Providers (surgeon, hospital, insurer) and their needs
• New companies and new technologies

Bio: Shirley A. Engelhardt is President and Founder of Knowledge Enterprises, Inc. and a founding partner of Knowledge Ventures, LLC. Mrs. Engelhardt is the world’s foremost authority on the global orthopaedic markets and has authored thousands of articles on current and emerging trends, market dynamics and factors affecting the markets. She has accurately predicted nearly every major market trend of the past decade, while developing an international client base of hundreds of public and private entities.

Prior to founding Knowledge Enterprises, Mrs. Engelhardt was Director of Market Research and Strategic Services for DePuy and Director of Marketing for the technology transfer arm of Case Western University. She holds a Bachelor of Arts in French from Virginia Polytechnic Institute and State University and an MBA from The Louisiana Tech School of Management. (top)

Gregory D. Githens, PMP, NPDP
Principal
Catalyst Management Consulting LLC
WORKSHOP: Practices and Skills for Innovation and High-Speed New Product Development

This session will provide practical tools and insights for improving the concept-to-customer process, including capturing and specifying correct requirements, improving decisions, eliminating waste, creating distinctive advantage and effectively leveraging technical knowledge. The focus is on proven, usable tools and insights.

Bio: Greg brings over 25 years of experience with a broad number of industries including consumer products, software, pharmaceuticals, medical devices, scientific instrumentation, biotechnology, agribusiness, engineering services and information technology. Clients have achieved improved time-to-market, better metrics, better strategic alignment and improved risk management, among other benefits.

He is an expert in innovation, new product development and project delivery. With Catalyst, Greg has designed and deployed organizational processes for new product development and portfolio management.

Greg is a Contributing Senior Editor to the Product Development & Management Association’s Visions magazine, in which he has authored over 25 articles on new product development performance. He has also written and spoken on NPD and innovation topics for Management Roundtable, the Project Management Institute, the International Institute of Research and other cutting-edge organizations.

Greg is the co-author of Successful Project Management, (4th ed. John Wiley, September 2005). He has contributed chapters to Volume I and III of the PDMA Toolbook for New Product Development (John Wiley, 2002 and forthcoming, 2008), and the Program & Portfolio Management chapter in Managing Multiple Projects (Marcel Dekker, 2002), as well as the chapter on Handling Unpleasant Project Tasks in People in Projects (PMI, 2001).

Greg holds an MBA from Bowling Green State University, an MEn. from Miami University, and a B.S. from The Ohio State University. He is a certified Project Management Professional and a certified New Product Development Professional. He also teaches the Metrics That Matter in NPD workshop for PDMA, Agile Project Management and Capture Customer Requirements for PMI. (top)

Michael Hill, CPM
President
Innovative Supply Management Solutions
Concurrent Development in New Product Launches

Is your development group getting pressure to speed up your new product introductions? If that is the case, you may want to modify your existing process to a more concurrent approach.

SPEED is what concurrent development teams are all about. To increase speed, teams should include marketing, operations, quality, regulatory, purchasing and multiple strategic suppliers early in the 1st stages of the process.

Adding these functions to the traditional technical development team will deliver design flexibility, market intelligence and manufacturing efficiency which will result in an increased speed to the market.

Additionally, during early development, business continuity and regulatory issues can be addressed, material capabilities and tolerances challenged, global market demands and supply availability assessed, and cost constraint alternatives can realize multiple solutions.

All of these issues need to be addressed at some point of the process. They should be addressed early in the process.

In this session we will discuss the difference between Concurrent Development and “Team Approach,” examine where Concurrent Development has the biggest impact, look at balancing “Meeting Business Needs and Perfecting Technology” and finally, discuss Roadblocks to Concurrent Commercialization.

Take away from this session: Your company’s market advantage often comes through innovation. This innovation drives new profit streams and new customers. Every month, every week, every day and every hour that can be eliminated from the product development cycle will results in cash and additional customers for your firm. This session will give you one more tool to improve your new product launch.

Bio: Mike Hill, C.P.M., provides consulting services for all phases of Purchasing Management. During a business career that spans over 25 years, Mike has been engaged by world-class firms including Johnson & Johnson, Select Comfort, Gerber, Ocean Spray, Welch’s, Sonoco, ICI Glidden and others to deliver Strategic Sourcing solutions focused on documentable, bottom-line sourcing cost savings. His projects have resulted in hundreds of millions of dollars saved.

Mike holds both a Bachelor of Science Degree in Business Management and a Master of Business Administration from Franklin Pierce College in Rindge, New Hampshire, and holds the professional certification of C.P.M. (Certified Purchasing Manager) issued by the Institute of Supply Management.

Mike has been involved in all facets of procurement, from buying to providing strategic sourcing leadership and procurement policy direction. He brings both the functional side of purchasing as well as the theoretical. Throughout his career, Mike has worked with many suppliers around the world in a range of industries including plastic resins, chemicals, packaging materials, manufacturing and warehouse equipment, MRO, marketing services, information technology equipment, consulting and legal services. This experience has given Mike a great deal of insight into strategies, techniques, tactics, tips and skill practices that need to be utilized by purchasing departments today in their efforts to stay competitive and keep their companies profitable. For additional information, please visit www.getisms.com. (top)

Jose M. Justiniano
Principal Quality Engineer
Ethicon Endosurgery
Design Controls, Design Transfer and Supplier Contributions

This lecture will:

• Introduce the design control requirements of the quality system regulation for medical devices
• Explain how design control requirements are a practical set of beneficial disciplines for business
• Introduce the application of concepts and quality tools, including Design for Six Sigma, to aid in FDA compliance
• Discuss how classic reliable engineering disciplines help to verify and validate design
• Clarify the role of the factory in design transfer
• Clarify how suppliers contribute to the compliance effort

WORKSHOP: Process Control, Process Qualification, Process Validation and Design Transfer for Medical Devices

Qualification and validation are two of the most commonly misunderstood and misapplied concepts in the medical device industry. This workshop will answer:

• Why is this requirement out there?
• Which guidance is acceptable?
• How can we use Six Sigma programs and tools to meet the regulation?
• What is the difference between qualification and validation?
• Do I always need to re-validate?
• What is a validation master plan?
• What does process validation have to do with design controls?
• How can suppliers of components help medical device firms to improve their level of compliance and minimize risks?
• Why some suppliers are adopting ISO 13485 as their quality system standard?
• What is worst case testing?
• How can DOE (Design of Experiment) help to simplify compliance?

Bio: Jose Justiniano has 19+ years of experience in quality engineering, reliability and technical product development management with several leading medical device companies. He specializes in the design, deployment and training of quality programs such as the Quality Systems Regulation from FDA and concepts such as Six Sigma. In 1990, he pioneered the adoption of Six Sigma concepts for medical devices, becoming a trainer and management champion of green and black belts.

Justiniano received his M.B.A. from the University of Cincinnati and his M.S. in Industrial Engineering and Operations Research from Cornell University. His undergraduate degree is in Industrial Engineering from the University of Puerto Rico. He learned the original concepts of Six Sigma directly from Genichi Taguchi and Mikel Harry. He has been recognized by the American Society for Quality as a Certified Quality Engineer, Certified Reliability Engineer, Certified Six Sigma Black Belt and Certified Quality Auditor. He has also attained ISO 9000 Lead Assessor certification by the Institute of Quality Assurance. He is the co-author of Practical Design Control Implementation for Medical Devices. (top)

Theodore Kucklick
Theodore Kucklick Design/Cannuflow, Inc.
A Medical Device Designer’s Innovation Toolkit

This session will answer the questions:

• Where do you go to find the building blocks for innovation?
• What are the key theories, practices and technologies used to get innovation done?
• Who are some of the leading innovators of the past and present, and what can they teach us now?
• What are their key insights that you can put to work in your work, and what are some of the new technologies available to help speed product realization?

Bio: Kucklick Design works with incubator, start-up and corporate product development teams to develop innovative medical devices from earliest concept stage through IP development, prototypes through production. Ted Kucklick is also President, CTO and co-founder of Cannuflow, Inc. a company dedicated to developing innovative medical devices for arthroscopic surgery. Ted has worked in product design and research and development of innovative medical devices for numerous start-up medical device companies and is inventor on several medical device patents. A member of the IEEE/EMBS, IDSA, AMI and SMIT professional societies, Ted has particular interest in the study of innovation, invention, and technology and is a frequent speaker and author on the subject. He authored/edited The Medical Device R&D Handbook (CRC Press/Taylor and Francis 2005) and wrote for the Medical Applications of Rapid Prototyping video produced by the Society for Manufacturing Engineering. (top)

Mark Lagunowich
Director of Sales
GHX Mobile Solutions
Orthopaedic Inventory: Overcoming Challenges in Tracking, Scheduling & Ordering

Medical device implant companies - and orthopaedic companies in particular - face extreme challenges managing inventory. Tracking trunk inventory, managing rep transfers, reducing consigned product inventory value and just knowing where to find a specific product when it is needed for a case are just some of the daily challenges that plague sales and operations management. They are also issues that are being tackled head-on by some companies that are improving processes and deploying new tools. This session will address:

• Common Challenges for Our Industry
• It’s 8 pm...Do you know where your implants are?
• What Options Are Available?
• New Technology on the Horizon
• Considerations When Evaluating Solutions

Bio: Mark Lagunowich is the Director of Sales for GHX Mobile Solutions, the leading provider of mobile sales force and inventory management solutions for the healthcare industry. Mark has spent the majority of his 20-year career working with medical device and life science companies including many of the world’s leading medical-surgical companies, such as J&J, Smith & Nephew, Medtronic and Stryker. He specializes in advising companies on solutions to improve sales effectiveness, automate supply chain processes and maintain regulatory compliance. Mark is a member of the Regulatory Affairs Professional Society.

Mark joined GHX from NoInk LLC where he served as Vice President of Sales. Earlier in his career, Mark was a sales field sales representative for several medical device companies including VISTAKON®, a division of Johnson & Johnson Vision Care, Inc. and Advanced Medical Optics, Inc. (AMO). He is a graduate of Dickinson College. (top)

Rebecca A. Morgan
President
Fulcrum ConsultingWorks Inc.

Nick Rennie, Co-Presenter
Chief Executive Officer
PHRED Solutions, Inc.
WORKSHOP: The Outsourcing Advantage: Thinking and Solving Problems WITH Your Supply Chain

Your competition can hire your people, buy your equipment, steal your IP. Yet somehow you must succeed. So what is your differentiator that they cannot buy or steal? Problem solving. If you can create a culture of effective problem solving, you have a major competitive advantage over those who don’t. So how do you know if your problem solving culture is effective?

• The absence of déjà vu
• Capturing, retaining and sharing the knowledge that each solved problem represents
• Complete confidence of your customers that you can and will think with them in resolving and preventing problems

A major international electronics company recently placed a requirement on its entire supply chain that it learn to think with them, that they learn to reason together in preventing and solving problems. It is becoming a requirement of outsourcing. In this workshop you will learn from the experiences of Toyota, Shell and others.

We will discuss:

• How do you as a leader convert your people to professional problem solvers?
• Why isn’t more 5-Why, 8D, A3 or root cause analysis training working?
• What is a business process for developing problem solving skills?
• How does that process fit your current organization?
• How much of the required components already exist in your organization?
• How to recognize and integrate them?
• How do you capture, retain and share knowledge gained?

You will take away:

• A way to assess where you are now and your biggest challenges
• A way to consider and develop a social and technical problem solving structure

Bio: Rebecca A. Morgan is a manufacturing strategy consultant skilled at clarifying complex ideas, finding creative solutions to problems and developing and leveraging operational strengths. She works with manufacturers to develop and execute an operations strategy that enables them to leverage resources to deliver profitable competitive advantage to their markets. Her ability to work as effectively with off-shift workers as with owners and C-level executives and her 30 years professional experience combine to support both strategic vision and daily execution.

Morgan’s experience spans Operations, Supply Chain Management, Accounting Systems, Information Systems, Strategic Planning, Consulting and Academe. She has been directly responsible for cost and revenue centers in single and multi-plant situations.

Ms. Morgan has B.A. and M.S. degrees in Economics and completed post-graduate work in Business Administration. She is Board Approved in Operations Management by the Society for Advancement of Consulting and is certified as a Fellow by The Association for Operations Management. She is also one of the few authorized facilitators nationwide to deliver the joint AME/SME/Shingo Lean Certification Review Program.

INC Magazine selected Morgan as its Operations Expert, a role she has fulfilled for several years. In addition, her expertise has been tapped by numerous national and industry publications including Fortune Magazine, Business Week, Dow-Jones Newswires and Industry Week on topics ranging from Lean Manufacturing to Steel Tariffs to B2B relationships. (top)

Bio: Since 1991 Nick has been a senior partner at PHRED Solutions Inc., www.phredsolutions.com. He designs software-based lean problem solving business systems. These take the variable processes of problem solving and turn them into standard business processes that reduce variability and improve problem solving performance. He has done this for Intel, Wellmont Health Systems, Toyota Motor Manufacturing, Alcoa, Hewlett Packard, Agilent, Coca Cola and many other companies. He brings experience in:

• Designing problem solving systems to quickly and accurately investigate problems across all functions in a lean environment
• Freeing up experts’ time so they change from firefighters to coordinators (lean problem solving coaches)
• Providing management with lean problem solving tools so they can manage problems as opposed to reacting to them
• Creating online databases of all problems so you can learn from the past
• Making knowledge institutional, not personal

This results in an increase in the accuracy and speed of problems solved, a decrease in problem re-occurrence and a transformation from individual problem solving to shared corporate knowledge. This all saves considerable amounts of money, as well as makes customers much happier. (top)

Magnus René
President, Arcam AB
Orthopaedic Implants with Rapid Manufacturing Technology

Electron beam melted titanium: Material characterization in vivo and current applications in the industry. Free Form Fabrication (FFF) provides new opportunities for the design and manufacturing of implants with shape and internal porosities to achieve improved biological and aesthetic results.

This session will give an overview of FFF implant applications in use today, and also presents an in-depth in vivo study of Electron Beam Melted (EBM) FFF material properties. The presentation includes aspects of biocompatibility of FFF materials as well as the challenges of industrialization of a new manufacturing method, and the cost structure for manufacturing of FFF implants.

Bio: Magnus René has served as President of Arcam AB since 2001. Previously, he worked for Micronic Laser Systems as Director of Sales within the Asian division, as well as Vice President of Customer Service between 1990 and 1999. From 1999 to 2000, he was active in Hogia Teknik, where he served as Chief Executive Officer and Business Area Manager. He holds a Masters of Science in Electrical Engineering from Chalmers University of Technology and further studied Business Administration for Graduate Engineers at the Stockholm School of Economics. (top)

Glenn Stiegman
Vice President, Regulatory Affairs
Musculoskeletal Clinical Regulatory Advisors, LLC
New Technologies and Their Impact on Regulatory Submissions

This session will provide a regulatory overview of 510(k)s, PMAs and IDEs. Through use of case examples, attendees will learn how to demonstrate 510(k) substantial equivalence, and how device design and materials can drive the regulatory pathway. For IDE/PMA submissions, this session will address how companies can get started on the right foot in terms of developing safety, addressing study design considerations and labeling considerations.

Bio: Mr. Stiegman manages and directs the regulatory affairs for Clinical Regulatory Advisers, LLC (MCRA) and its clients. Mr. Stiegman is responsible for management of approximately 10 regulatory professionals at MCRA. Mr. Stiegman leads the firm’s submission process, regulatory strategy, analysis and development: from pre-clinical testing, to FDA submissions, to market approval and post commercialization.

Prior to joining MCRA in February 2006, Mr. Stiegman served as the Chief of the Orthopedic Devices Branch for U.S. Food and Drug Administration. As Branch Chief, Mr. Stiegman managed a team of scientists, clinicians, and engineers in the regulation of all orthopedic devices marketed in the United States. In addition, Mr. Stiegman was responsible for overseeing all FDA guidance documents and FDA policy determinations for orthopedic devices marketed in the US. Furthermore, he assisted in and oversaw all integrity, compliance, and monitoring issues regarding the orthopedic industry in collaboration with the Office of Compliance.

Mr. Stiegman was also a member of several leveraging groups such as the Orthopedic Device Forum and Orthopedic Surgical Manufacturers Association, where he represented the FDA. As the head of the Orthopedic Devices Branch, Mr. Stiegman pursued the advancement and consistency in the regulation of all orthopaedic devices. This was evident by the pursuit of reclassifying several types of orthopaedic devices, developing guidance documents on state of the art orthopaedic devices, and educating and assisting the orthopaedic community in the regulatory strategies to get devices to market.

Prior to becoming Branch Chief, Mr. Stiegman was a reviewer in the Orthopedic Devices Branch where he was the team leader on many state of the art spinal technologies. He was a leader in the field of artificial disc replacements, nucleus replacements, posterior stabilization systems and many of the current widely used fusion spinal systems. He authored a guidance document for industry on spinal systems indicated for fusion, and also developed documents that assisted companies in getting other devices to market such as artificial disc replacements, nucleus replacements, and posterior stabilization systems. Mr. Stiegman received his Bachelor in Science at Tulane University in Biomedical Engineering and his Master in Science at Clemson University in Bioengineering with a focus on biomaterials and biomechanics. (top)

Gene Tyndall
Executive Vice President, Global Supply Chain Services
Tompkins Associates
Global Supply Chain Strategy and Its Value to the Industry

As more and more manufacturers and suppliers “go global” with sourcing and distribution, the importance of high-performing supply chains becomes more visible. International business means higher costs, longer lead times, and greater uncertainty. While inefficient or slow supply chains will certainly limit cost reduction programs, moving global supply chains to faster, better, and cheaper, should be everyone's goal. Product availability is critical in Health Care, but so, increasingly, is profit and growth.

This presentation will address what leading companies in all industries are doing to create high-performing supply chains that enable their business strategies—for both cost objectives and revenue growth—to succeed. It will also provide best practices that can be leveraged by ortho manufacturers and technology providers.

Bio: Prior to joining Tompkins Associates, Inc. in 2008, Gene served as President of Supply Chain Executive Advisors, LLC, (SCEA), a global firm comprised of senior executives who provide strategic advice and management counsel to senior business and public officials around the world. Gene is a globally experienced and recognized management consulting and business executive, having advised over 100 corporations in over 40 countries. He has co-authored four books (including Supercharging Supply Chains: New Ways to Increase Value Through Global Operational Excellence), written dozens of articles, and is frequently quoted in business and industry media. He is a frequent seminar/conference speaker, moderator and panelist around the world. He is a Director on Public and Private Boards.

Prior to founding SCEA, Gene was Executive Vice-President at Ryder System, Inc., a FORTUNE 500 global corporation based in Miami, Florida. He was also President of the company’s Global Logistics Division, a $1.8 Billion Business Unit. In addition to leading substantial improvements in profitability and shareholder value, he helped lead the corporation’s strategic planning process; transformed its business processes and operations; and initiated new technologies, change management and knowledge management programs, as well as a new product development process.

Prior to joining Ryder, Gene was a Senior Partner and Leader of the Ernst & Young Global Supply Chain Management Consulting Practice, growing the business to over $1 Billion annually. He advised and led business transformations for over 100 well-known global corporations during his consulting career – across several industries including High-Tech, Consumer Electronics, Health Care, Energy, Transportation/Logistics and Automotive. Examples of these global clients include P&G; Coca-Cola; 3M; Kellogg’s; Dell; HP; Cisco; Samsung; Philips; Ford; GM; Toyota; Harley-Davidson; J&J; Eli Lilly; Xerox; Exel Logistics and dozens of others. Many of the Supply Chain practices and processes in place in business today are due to his contributions. He has resided in four countries and worked in over 40 nations. He also was a member of the firm’s Strategic Planning Team, as well as a designer and lead facilitator with the firm’s Accelerated Solutions Center.

Gene was a U.S. Navy Officer, serving on an aircraft carrier and at the Pentagon. He graduated from the University of Maryland, The George Washington University, the Institute of Management Development in Switzerland and several executive training programs at Stanford, Harvard and the University of Miami.

Gene was recently awarded the “Global Logistics Person of 2007” by the Global Institute of Logistics, which also voted him into the Global Logistics Hall of Fame. Further, he was named one of the “Top Ten Innovators for 2002” by Information Week magazine. (top)

Perry E. Van Over, Esquire
Founding Member
Perry E. Van Over & Associates, PLLC
Intellectual Property Losses Occur by Design and Negligence

Intellectual property (IP) is the foundation of a company’s real value. Infringement of patents, design around efforts by competitors, industrial espionage and stolen trade secrets are all obvious external threats to the value of a company’s intellectual property. While many companies are aware of the need to guard the gates against such IP raiders from without, they fail to protect against the IP value that by design or negligence is lost out the back door due to poor employee IP discipline. Employment agreements can be crafted to provide protection for a company’s most valuable asset, its intellectual property; however, agreements alone are not enough. Also needed to better protect intellectual property values is a well-crafted incentive program to motivate employees to adhere to the agreement, an on-going training program to keep employees on track with the intent of the agreement, and a disciplinary aspect to the agreement that clearly discourages careless behavior when dealing with intellectual property. Legal aspects of each of these pillars of a sound intellectual property protection program will be discussed. Examples of what works and what doesn’t work will also be examined.

Bio: Perry Van Over, formerly of Pillsbury Winthrop Shaw Pittman LLP and DLA Piper, is the Founding Member of Perry E. Van Over & Associates, PLLC, an intellectual property law firm specializing in patent procurement, licensing and litigation in the technical fields of surgical instruments, medical devices, molecular biology, pharmaceuticals, biochemistry and polymer chemistry. (top)

Kate Vitasek
Managing Partner
Supply Chain Visions
Faculty, University of Tennessee and Wright State University
7 Steps to Making Your Benchmarking Effort Successful

One must know where one is, and where one wishes to go. Benchmarking helps determine your present location in comparison to others, and helps identify your desired future state. This presentation outlines a pathway which can be customized to your individual company. Participants will learn how to create their own “Benchmarking Roadmap” and a comprehensive list of benchmarking data sources will be shared.

WORKSHOP: Benchmarking the Procurement Process

This interactive workshop is designed to help you get started with your benchmarking efforts. Participants will benchmark the performance of their procurement/sourcing function – both learning the top five metrics and key benchmarks for a procurement/sourcing function as well as how their procurement and sourcing processes stack up against typical best practices. Participants will receive complimentary benchmarking tools and resources they can use as soon as they return to work.

Bio: Kate Vitasek is a thought leader in the area of Supply Chain Management and is a well-recognized authority on performance management and metrics implementation. Kate’s approaches to performance management have been widely published; she has authored over 75 articles which have appeared in publications such as Journal of Business Logistics, Supply Chain Management Review, Inside Supply Management, Aviation Week, Distribution Business Management Journal, The Manufacturer and APICS Performance Advantage. Kate recently authored a monthly column, “Measuring Up!” in DC Velocity Magazine which is read by over 50,000 practitioners monthly.

Kate has been recognized for her leadership in the profession. Most recently she was selected as a “Woman on the Move in Trade and Transportation” by the Journal of Commerce and was also recognized a as a “Rainmaker” in by DC Velocity Magazine for her efforts in helping to build the logistics and supply chain profession. She has given over 100 speeches at industry groups and universities on the topic of Supply Chain Management and Performance Management. Kate has also served on the Board of Directors for the Council of Supply Chain Management Professionals as well as on the Supply Chain Council’s Deliver Committee.

Ms. Vitasek currently teaches a four day course on Performance Based Logistics for the University of Tennessee’s Aerospace and Defense program and is one of the university’s lean implementation coaches as part of their Center for Executive Education. She also teaches MBA classes on performance management and lean supply chains for Wright State University and S.P. Jain Center of Management in Dubai as well as seminars for the Warehouse Education Research Council and the Council of Supply Chain Management Professionals. Kate is also a lean implementation coach for the U.S. Air Force.

Kate is the founder and Managing Partner of Supply Chain Visions, a small consulting practice that specializes in supply chain strategy and education. As a consultant, Ms. Vitasek brings a unique blend of consulting, practitioner and general management experience to the firms she works with. This blend of skills ensures that solutions are both practical and cost effective. Supply Chain Visions philosophy is to “teach a company to fish” rather than bring in herds of consultants costing thousands of dollars that generally wind up as “Vinyl Binder” studies. Kate is also a faculty member for the University of Tennessee’s Center for Executive Education and Wright State University.

Kate has worked for P&G, Kroger, Accenture’s Logistics Strategy Practice, Microsoft and Modus Media International, a global 3PL. As a practitioner, Kate has served in marketing, operations, and general management roles - including Director of Marketing, Director of Supply Chain, Vice President of Operations Services, and Vice President and General Manager for Global Accounts.

Ms. Vitasek graduated summa cum laude from the University of Tennessee with an MBA in logistics. She also holds a B.S. in Marketing. (top)