Each year, the OMTEC® Advisory Panel steers the conference agenda toward relevant and timely educational content that is consistent with the needs of Device Companies and that provides the tools needed to enhance performance.
The OMTEC 2013 Educational Conference includes an Opening Panel Discussion moderated by Blair Rhode, M.D., Orthopaedic Surgeon and founder of Rhode Orthopedic Group; a Keynote Address on the State and Future of the U.S. FDA moderated by John Gagliardi, President of Midwest Process Innovation, LLC and concurrent program sessions offered in four tracks: Research & Development; Legal, Clinical & Regulatory; Supply Chain Management and Business Critical.
Download Speaker Presentations here
| Tuesday, June 11 | ||
| 8:00 am - 5:00 pm | ||
| Exhibitor Registration & Set-up | ||
| 6:00 pm - 7:30 pm | ||
Welcome/Cocktail Reception Sponsored by ® |
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| Wednesday, June 12 | ||
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Track
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Concurrent Session Title | Speaker(s) |
| 7:30 am - 8:30 am | ||
| Full Breakfast Available | ||
| 7:45 am - 8:00 am | ||
| Opening Remarks | ||
| 8:00 am - 8:45 am | ||
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Opening Panel Discussion
Sponsored by
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Level: All
Healthcare reform. Price pressures. Market reduction. The orthopaedic industry faces a long list of unrelenting challenges today. The Opening Panel Discussion aims to extract actionable advice and insight from respectable industry leaders on how best to respond. Read More |
Panelists:
 Orthopaedic Surgeon
 Bill Kolter, Corporate Vice President of Government Affairs, Public Affairs, and Corporate Communication, Biomet, Inc.  Chief Executive Officer,
Orchid Orthopedic Solutions
Moderator:  Orthopaedic Surgeon and Founder of
Rhode Orthopedic Group
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| 9:00 am | ||
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Exhibit Hall Opens
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| 9:30 am - 10:00 am | ||
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Morning Break Sponsored by
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| 10:00 am - 11:00 am | ||
| Research & Development |
Continuing pressure on medical device manufacturing to reduce costs and improve quality has created a need for innovative ways to approach the quality control process. Utilizing a number of new image acquisition techniques, coupled with advanced processing and analysis software, it is becoming possible to address some of the most challenging quality assurance issues in a cost effective manner. Attendees will be exposed to the latest imaging techniques that can be applied to the manufacturing process. Read More
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 Amit Vasanji, Ph.D., Chief Technology Officer, ImageIQ, Inc.
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| Legal, Clinical & Regulatory | Unique Device Identification: From Compliance to Value
Level: Intermediate
Orthopaedic manufacturers will be among the first impacted by FDA’s Unique Device Identification rule, which could be final in time for this year’s OMTEC. According to the proposed rule, manufacturers of Class III devices will need to label their products with unique identifiers and be ready to publish data about those products to an FDA UDI database within a year. In this session, you will learn what you need to know and do in order to comply. Read More |
 Executive Director, GHX
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| Supply Chain Management |
Level: Intermediate
The establishment and maintenance of requirements, including quality requirements, is essential for orthopaedic manufacturers when dealing with component suppliers, consultants and contractors. This session will walk through the six phases of establishing controls: planning, selection of potential suppliers, supplier measurement and monitoring, feedback and communication, including the Corrective Action and Preventive Action process. Read More |
 President, MidWest Process Innovation, LLC
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| Business Critical |
Level: Basic Communication: One word that can result in so many problems, opportunities and dramas. Everyone communicates as a result of just being! It’s a cerebral and quantum physics point. This session will cover at a more basic level the role and nature of communications in the work place. Read More |
 Chief Executive Officer, A Day With a CEO
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| 11:00 am - 12:00 pm | ||
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Exhibit Floor Time
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Technical Presentation
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Level: All
Engineers will have the opportunity to participate in drill and suture training with Sawbones Worldwide functional demo models. The technical exhibit showcases innovative tools for surgical skills training, biomechanical test materials and custom medical device demonstration models. Read More |
 John James, Director of Engineering, Pacific Research Laboratories (Sawbones)
 Amy Johnson, Biomechanical Engineer, Pacific Research Laboratories (Sawbones)
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Business Critical
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Power Networking (Experience the Orthopaedics Version of Speed Dating)
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| 12:00 pm - 1:30 pm | ||
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Networking Lunch Sponsored by
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| 1:30 pm - 2:30 pm | ||
| Research & Development | Residual Stresses: Tools for Optimizing Component Performance Level: Basic The benefits of compressive residual stresses to enhance fatigue strength have long been recognized. Low plasticity burnishing (LPB) is a surface enhancement method that produces a deep layer of compressive residual stress with minimal cold working and a superior surface finish. The use of LPB and compressive residual stresses to enhance the fatigue strength of orthopaedic metals will be discussed. Read More |
 Doug Hornbach, President and Director of Laboratory Services, Lambda Technologies |
| Legal, Clinical & Regulatory | How to Design and Execute a Clinical Trial Level: Basic Just one in every five medical device clinical trials actually finishes on time. This presentation will discuss the causes of clinical trial delays, their impact, the role of reimbursement planning and ways that a clinical research organization can help device sponsor companies overcome the most common challenges of a clinical trial. Read More |
 Marcy Rogers, President and CEO, SpineMark Corporation |
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Supply Chain Management
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Panel Discussion with OEMs on Procurement and Sourcing Level: All OMTEC Advisory Panel members will discuss the sourcing and procurement challenges the industry faces. Attendees will hear how orthopaedic device manufacturers are handling the following trends: supplier consolidation, FDA quality requirements, emerging markets, cost reductions and supply chain limitations. Read More |
Panelists:
 Howard Levy, Chief Procurement Officer, Biomet, Inc.  Bob Weston, Director of Strategic Business Planning, Ortho Development Corporation  Thomas Solowczuk, Director, Global Sourcing, Alphatec Spine, Inc.
Moderator:  Steve Maguire, General Manager, Orchid Design |
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Business Critical
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Level: Intermediate
We all lead and serve in teams, large and small, both in and out of the workplace. The most important team is “Team Self,” with all its complications. But we also have to lead other people in other teams. This session will focus upon leading a team in the work place, covering key requirements to ensure that the team is energized, motivated and, above all, effective and successful. Read More |
Brian Moore, Chief Executive Officer, A Day With a CEO
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| Technical Presentation | Raw Materials Rapid Fire
Level: All
Are you looking for the latest information on raw materials? Providers will discuss the latest features, benefits and developments of stainless steel, chrome, titanium and ceramic. Each provider will have ten minutes to review their raw material, followed by a question and answer session with attendees. Read More |
Presenters:
Moderator:
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| 2:30 pm - 3:00 pm | ||
Afternoon Break Sponsored by  Sponsored by |
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| 3:00 pm - 4:00 pm | ||
| Research & Development |
Level: Intermediate
Design review is one of the key design control elements in a quality system. This session will provide research, development and design professionals with insight on why OEMs should review designs, as well as information on meeting design review requirements, preparing for reviews and the different types of design review meetings. Read More |
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Legal, Clinical & Regulatory
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The Role of Outcomes Data in the Development, Sales and Marketing of New Orthopaedic Technologies Level: Intermediate A confluence of trends is resulting in an increasing need for data to support the development of new technologies. This session will focus on the types of data that companies will need to present to various stakeholders, including hospitals, payers, patients and surgeons, to support the adoption of new orthopaedic products. Read More |
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| Supply Chain Management | How to Achieve ISO 13485 Certification
Level: Basic
If you want to sell a medical device in the U.S., you need a Quality System. But for Europe and Canada, you need a Quality System that is ISO 13485 Certified. Most Quality Managers learn how to achieve ISO certification the hard way—they learn by doing it. If a company wants to achieve ISO 13485 certification for the first time, this is the seminar to attend. Read More |
 Owner,
Packard Consulting
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| Business Critical | Redefine Winning in Business Relationships Level: Intermediate The 21st Century demands that businesses innovate, create value and get sustainable results. This session will share real stories of ways that large corporations and small businesses are achieving real results by redefining how they “win” in their business relationships. Read More |
 Kate Vitasek, Faculty, Center for Executive Education, University of Tennessee |
| 4:30 pm - 6:00 pm | ||
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Networking Reception Sponsored by
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| 6:00 pm | ||
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Adjourn
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| Thursday, June 13 | ||
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Track
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Concurrent Session Title |
Speaker(s)
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| 7:30 am - 8:30 am | ||
| Full Breakfast Available | ||
| 7:45 am - 8:00 am | ||
| Opening Remarks | ||
| 8:00 am - 8:45 am | ||
| Keynote Panel Discussion Sponsored by  |
The State and Future of the U.S. FDA
Level: All
FDA has considerable reach throughout each link of the supply chain. This Keynote Panel Discussion on Day Two of OMTEC brings together regulatory experts to talk about current and future FDA decisions that may affect your manufacturing processes. Actionable advice will shed light on how FDA changes will manifest themselves regarding innovation and new product releases. Professionals from all departments of medical device companies will leave armed with compliance insight for success. Read More |
Panelists:
 Martin Browning, President and Co-Founder, EduQuest, Inc.,
Matthew Krueger, Chief, Orthopedics and Physical Medicine Device Branch, Office of Compliance/Center for Devices and Radiological Health  Mary Gray, Manager Regulatory Affairs, DePuy Synthes Spine
Moderator: John Gagliardi, President, MidWest Process Innovation, LLC
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| 9:00 am | ||
| Exhibit Hall Opens | ||
| 9:30 am - 10:30 am | ||
| Research & Development |
Level: Advanced
The use of additive manufacturing in orthopaedic implants continues to grow as OEMs seek to produce better products, more efficiently. The medical industry as a whole comprises one of the larger market shares of additive manufacturing, and it’s expected to increase as additive manufacturing grows to a $3.5 billion industry by 2017. Additive manufacturing experts will discuss the state and future of the technology and its applications in orthopaedic devices. Read More |
Panelists:
 President and Owner,
Medical Modeling, Inc.
 President and Chief Executive Officer,
Oxford Performance Materials
 Chief Executive Officer,
Arcam AB
 Independent Consultant
Moderator:
 Matt Poggie, Senior Director of Applied Technology, Stryker Orthopaedics
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| Legal, Clinical & Regulatory |
Trends in FDA's Orthopaedic Device Recalls
Level: Basic New data on orthopaedic device recalls will be presented, providing device manufacturers with crucial insights into the development and commercialization of new products. Read More |
Matthew Krueger, Chief, Orthopedics and Physical Medicine Devices Branch, Office of Compliance/Center for Devices and Radiological Health
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| Technical Presentation |
Technical Poster Presentation
Level: Basic Learn more about the research presented in the posters on the Exhibit Floor. Research from the University of Copenhagen, University of Illinois and Edward Hines Jr. VA Hospital and Loyola University Chicago will be discussed followed by a QA. Read More |
Moderator:
 Don Urbanowicz, Principal, Urbanowicz Consulting
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| 10:00 am - 11:00 am | ||
| Supply Chain Management |
Level: Intermediate
OEMs are required to document the qualification of suppliers and the ongoing evaluation of those suppliers. Unfortunately, most companies manage to expend a lot of resources and get zero value from their efforts. This session will show how to sharpen antique supplier qualification tools and will provide three modern tools for supplier qualification. Read More |
Owner,
Packard Consulting
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| 10:45 am - 11:30 am | ||
| Technical Presentation | Electron Beam Melting in the Manufacturing Process: A Walkthrough Level: Basic Electron Beam Melting (EBM) technology manufactures parts by melting thin layers of metal powder. In this presentation, we will give you a practical demonstration of the EBM build process, from preparing your CAD models to extracting the final build report for validation purposes. Read More |
 Oscar Hedin, Senior Application Engineer, Arcam AB |
| 12:00 pm | ||
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Adjourn
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| 12:00 pm - 4:00 pm | ||
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Exhibitor Teardown
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View Technical Presentations and Posters for Orthopaedic Engineers at OMTEC 2013 here.
"OMTEC provides the convenience and opportunity to meet with my current supply base without having the interruption of the phone ringing or people knocking on my door. I also like to listen to the current marketplace trends from the seminars that are offered."
—Jeremy Townsend, Senior Procurement Specialist, Wright Medical Technology, Inc.
"OMTEC gives me the opportunity to learn about new technologies and supplier capabilities to help me fulfill my job responsibilities as a development engineer. In addition, I am able to gather valuable and insightful information from the seminars that are available."
—Justin Conway, Hip Development Engineer II, Smith & Nephew, Inc.
“I was impressed with OMTEC's educational presentations and benefitted from the opportunity of meeting new potential suppliers.”
—Itai Nemovicher, President, The Orthopaedic Implant Company