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Plastics for Orthopedic and Medical Applications
PressReady.indd 1 6/1/2011 1:27:00 PM PressReady.indd 2 6/1/2011 1:27:36 PM Welcome Letter Thank you for choosing OMTEC! Our mission is to provide access to the intelligence, the expertise, the companies and the people that will help you overcome your most critical challenges, identify the most lucrative opportunities and excel. A crucial component of that mission is weeding out the hype and the fluff. Use the pages of this program to prioritize your booth visits and educational sessions. Note that several complimentary meals and snacks alleviate the need to burn time and dollars trekking down the street or across town. We have also added a business center to further enhance your show floor productivity. A new poster/ display area houses current musculoskeletal-specific research projects. The Welcome Reception on Wednesday afternoon in the Exhibit Hall affords targeted networking time…previous attendees will affirm, business gets done, so please plan to attend. Table Of Contents Schedule Of Events...................... 4 Floor Plan...................................... 6 Keynote Addresses...................... 8 Lectures & Workshops................. 9 Exhibitor Listing..........................16 Index Of Exhibitors By Capability...........................44 Attendee Resources................... 46 We encourage you to grab any of us during the conference for assistance of any kind. Our team is always present in the ORTHOWORLD booth or the registration area. Don’t waste a moment wondering if we might know or be able to help…just ask. We are honored to be of service to you. We know this to be certain: Education fuels knowledge. Networking builds relationships. The right people with the right knowledge and skills net us increased levels of performance and success. These fundamentals are promoted at OMTEC to guide you and your business to prosperity during times of uncertainty and change. Thank you again for choosing OMTEC. We are committed to delivering return on your investment. On behalf of the entire ORTHOWORLD team, we wish you a productive and enlightening meeting. Onward! Best regards, April C. Bright General Manager ORTHOWORLD, Inc. Page 3 PressReady.indd 3 6/1/2011 1:27:38 PM Schedule Of Events Wednesday June 15 8:00 AM Breakfast Keynote Address: Room 51 - Hospital + Surgeon: Your Changing Customer Marshall Steele, M.D., Marshall Steele & Associates Breakfast Served at 7:30 AM Sponsored by Bradshaw Medical 9:00 AM Exhibit Hall Opens 9:00 - 10:00 AM Coffee Break Served in Exhibit Hall, Sponsored by JPMC 10:30 AM Educational Sessions Begin Lecture 10:30 a.m. - 12:00 p.m. Planning For and Managing FDA Inspections: Logistics/Process Architecture/QSIT John Gagliardi, MidWest Process Innovation Lecture 10:30 a.m. - 11:30 a.m. Getting Started with CE Marking: Your Passport to Europe Suzanne Halliday, Ph.D., BSI Group Lecture 10:30 a.m. - 12:00 p.m. Supply Chain Management: Lessons Learned Lecture 10:30 a.m. - 12:00 p.m. High Performance Medical Plastics Mahender Singh, Ph.D., Massachusetts Institute of Technology Maria Gallahue-Worl, Solvay Advanced Polymers 12:00-1:30 PM Luncheon Served in Exhibit Hall, Sponsored by Rochling Workshop 1:30 p.m. - 3:45 p.m. Planning For and Managing FDA Inspections: Working With Actual Scenarios from FDA Inspections John Gagliardi, MidWest Process Innovation Lecture 1:30 p.m. - 2:30 p.m. The Fundamentals of Reimbursement: Understanding How Coverage, Coding and Payment Impact a Medical Technology Kelli Hallas, Emerson Consultants Lecture 1:30 p.m. - 3:00 p.m. Advanced Mechanical Inspection: How to Make Inspection Better, Faster and More Cost-Effective Kelly Lucenti, Millstone Medical Outsourcing Workshop 1:30 p.m. - 3:45 p.m. Sales & Operations Planning: The Basics and Beyond Tom Wallace, T.F. Wallace & Company 2:00-2:30 PM Refreshments Served In Exhibit Hall, Sponsored by Onyx Medical 2:00-2:30 PM Poster Presentation In Exhibit Hall: Cartilage-on-Cartilage articulating system as a wear benchmark for artificial replacement systems Workshop Cont. Discussion Panel 3:00 p.m. - 4:00 p.m. Best Practices in OEM/Supplier Relationships: Getting the Most Value from the Supplier Perspective Lecture Cont. Workshop Cont. 4:00-5:30 PM Reception in Exhibit Hall, Sponsored by Greatbatch Medical 5:30 PM Exhibit Hall Closes Page 4 PressReady.indd 4 6/1/2011 1:27:43 PM Schedule Of Events Thursday June 16 8:00 AM Breakfast Keynote Address: Room 51 - The Global Orthopaedic Industry: A High Altitude View Don Urbanowicz, Urbanowicz Consulting, LLC Breakfast Served at 7:30 AM Sponsored by Orchid Orthopedic Solutions 9:00 AM Exhibit Hall Opens 10:00 AM Educational Sessions Begin Lecture Lecture 10:00 a.m. - 11:00 a.m. 10:00 a.m. - 11:30 a.m. The Secret to a Successful Clinical Evaluation 101: A Product Launch: The Key Requirement to Gaining Integration of ReimburseAccess to the European ment, Clinical, Regulatory Market and Marketing Strategies Suzanne Halliday, Ph.D., Kelli Hallas, Emerson BSI Group Consultants Lecture 10:00 a.m. - 11:30 a.m. Orthopaedic Biomaterials: Using History to Inform Innovation Additional Education TBA. Ayyana Chakravartula, Ph.D., Exponent Failure Analysis Associates 11:30 PM Luncheon Served in Exhibit Hall 2:00-2:30 PM Poster Presentation In Exhibit Hall: Optimized follower load system for lumbar spine flexion/extension testing Lecture 1:00 p.m. - 2:00 p.m. Vesting for Success: Ten Must Have Elements for a Successful Business Supplier Agreement Workshop 1:00 p.m. - 2:30 p.m. The Toolbox for High Speed Innovation and New Product Development Kate Vitasek, University of Tennessee Greg Githens, PMP, NPDP, Catalyst Management Consulting Lecture 1:00 p.m. - 2:00 p.m. The View from Washington: What Device Makers Need to Know about FDA’s Latest Priorities and Initiatives Exhibitor & Attendee Feedback Session 3:00 p.m. - 4:00 p.m. Open Invitation to all OMTEC participants to share any and all feedback. Martin Browning, EduQuest, Inc. 3:00 PM ADJOURN - BREAKDOWN EXHIBIT HALL Please reference pages 8-15 in the Final program for speaker bios and session abstracts. Many presentations and handouts are available for download at www.omtecexpo.com. You can make use of this resource immediately, or look for an email notification following the event. Follow OMTEC on Twitter: @OMTEC_2011 Page 5 PressReady.indd 5 6/1/2011 1:27:44 PM Esp Floor Plan 34 HALL G Autoc Med 246 140 245 l oo g AT C& eerin in Eng m Ca mics a cer Bio 142 on ag Par dical Me MAIN ENTRANCE New Entrance Location Shaded booths indicate event sponsors. 7 -24 Donald E. Stephens Convention Center June 15-16, 2011 l ica ed h M atc b t a Gre BAR O S F H 126 Centex Machining Aisle 100 Aisle 200 Aisle 300 226 127 227 Precision Metal Products Bradshaw Medical 224 124 125 Pulse Technologies Ensinger 326 Carpenter Technology Jarvis Surgical 225 Partmaker S 324 Surface Dynamics Titanium Industries O 122 PCC Structurals 120 Forecreu America 118 Pacific Instruments 121 220 221 320 Tegra Medical rose plastic USA Tornos Hangsterfer's Laboratories 119 218 United Orthopedic Emerson Consultants 115 214 215 Trigon Market Wire Curbell Plastics 113 212 318 X X R Triangle X L 116 American Tool & Die 114 LAB Medical Manufacturing MAIN ENTRANCE 112 213 Rochling Millstone Medical Engineering Outsourcing Plastics E Te 312 ZOLLER Medin O BAR Rolled Alloys 314 Vulcanium Metals REGISTRATION X X X X X X X X X X X X 109-208 X X Juno X 209 308 Pro-Dex Hoosier X DESK Email Station New Business Center 100 101 102 SAYAN Orthopaedics Level 3 Inspection Electropolishing Systems 200 X X X Knigh Mechan Testin Concession ENTRANCE Entr Page 6 PressReady.indd 6 6/1/2011 1:27:47 PM Esprit/DP Technology Floor Plan 345 346 442-443 Autocam Medical MediTECH Medical Polymers Southeastern Technology Orchid Orthopedic Solutions 432 433 532 533 632 PMC Medical Onyx Medical Arcam Teleflex Medical OEM Norman Noble 430 X Aisle 300 Jarvis urgical Seabrook International Marox AIP 420 321 Rollomatic 319 Advantage Manufacturing Technologies 524 Precision Piece Parts 421 520 Donson Machine ASTRO Medical Devices Solvay Specialty Polymers 630 631 730 Minnesota Rubber & Plastics Promimic 832 APS Materials 731 OTEC Precision Finishing 830 Canwell Medical Durr Ecoclean Email Station 527 626 Total Plastics Bob, Inc. 525 624 RTI International Boedeker Plastics Aisle 600 726 627 NeedleTech Products Aisle 700 Twin City EDM 724 625 International Professional Titanium Plastics Association 727 826 TeroLab Surface Micro Machine 725 824 Aisle 800 825827 Okuma America Kens FineMedtech 412 313 Orthoplastics Supra Alloys X 415 FMI Medical Instruments 413 Mahar Tool 309 408 409 Hoosier SS White Medical Hansa Medical Tecomet 519521 Rosler Metal IonBond 620 621 British Standards Institute Piper Plastics 618 619 gSource Fairview Machine 514 515 614 615 Fort Wayne Metals Brown Precision SHL Infinity Plastics 513 612 512 Makino 508 PAK Manufacturing Medivative Technologies 509 Metal Craft Alliance Global Technology 613 Praxis Technology TESco Associates 608 609 Deloro Stellite GEHRING CUT 720 718 Pacific American Medical Service 714 Universal Precision 712 Bodycote 721 X 821 820 NSE Automatech Tenergy 719 818 American Express Open 815-819 414 315 Esprit/DP CaP Technology Biomaterials 518 X X 308 715 814 AccelLAB 713 Electrolizing Corp of Ohio 813 812 Richards MicroTool Sonoscan 708 Vistek Medical BAR X 526 Aisle 500 Microware Precision 418 Gibraltar Laboratories 312 Medin 425427 531 Endo Manufacturing In'Tech Medical 733 Finishing Innovations X 314 lcanium Metals Aisle 400 X 732 Walter, a United Grinding Company X 318 riangle 424 Oak View Tool 320 ngsterfer's boratories NewScience Insurance 325 324 tanium dustries 426 327 326 530 X Aeromed 633 Acme Manufacturing Restrooms 331333 Cafe 200 Knight Mechanical Testing 201 Avalign Technologies 402 Eptam Plastics Entrance to Educational Sessions 500-501 Branch Medical 502 Maetta 600 601 PPD Meditech Dexcowin 602 Arwood Machine STAGE New White Papers Session Area Page 7 PressReady.indd 7 6/1/2011 1:27:48 PM Keynote Addresses 8:00 a.m., Wednesday June 15 Keynote: Hospital + Surgeon: Your Changing Customer Marshall Steele, M.D. Chief Executive Officer Marshall Steele & Associates The business climate for device manufacturers is rapidly changing. No longer is the surgeon the only customer. Physicians and hospitals are increasingly finding ways to align their incentives, and hospitals and physicians are beginning to speak with one voice. In the future, vendors may have many customers: the partnership of the hospital and the surgeon, patients, group purchasing organizations and even the payers themselves. New device manufacturers are springing up that will provide generic versions of our current implants at half the cost. Established device manufacturers have a choice: Do they just focus on the technical aspects of their products? Do they compete on price? Do they partner with hospitals, surgeons, patients and insurers in a new and different way? Transparency is quickly emerging caused by patients, physicians, insurers and hospitals. Medical device companies will need to collect outcomes on their products in the hands of all users, not just the elite few. This trend creates both concern as well as opportunity for medical device companies. They must become partners, not suppliers. They must create value for all stakeholders and work with them to improve healthcare from a quality perspective, and an economic one, as well. Woe to those that persist in the old economic model. We will discuss why these trends are occurring, how fast they will occur and what device manufacturers should consider doing to face all new challenges. Dr. Marshall Steele is a board certified orthopaedic surgeon, founder and Chief Executive Officer of Marshall Steele & Associates, a firm that implements musculoskeletal service lines and programs in hospitals. The firm creates Destination Centers in orthopaedics and spine, provides data collection tools for both patient- and hospital-reported outcomes and a nascent national registry for benchmarking and best practices. Dr. Steele started his orthopaedic practice in 1977 as a solo practitioner and grew it to 16 sub-specialized orthopaedic surgeons. Between 1996 and 2005, he also served as the Medical Director of Surgical Business Development at Anne Arundel Medical Center in Annapolis, Maryland. He was instrumental in helping to develop many very successful specialty surgical programs that have received national attention. He has received numerous awards, including the Pascal Award for Youth Sports, The Leadership Award given by his peers, and was recently inducted into the Anne Arundel County Business Hall of Fame. Dr. Steele has long been passionate about defining, measuring and improving quality. His most recent book is Orthopedics and Spine, Service Line Strategies for Superior Performance (Healthleaders 2009). 8:00 a.m., Thursday June 16 Keynote: The Global Orthopaedic Industry: A High Altitude View Don Urbanowicz Principal Urbanowicz Consulting, LLC Don will provide a high altitude view of the global orthopaedic industry, including the resultant opportunities and issues expected to be encountered over the next five years. His presentation will include an overview of worldwide market growth and competition, and a discussion of the resultant impact of post-recession, post-reform and the current FDA climate on medical device companies (and each of their key departments, including marketing, product development, regulatory, reimbursement, operations and quality), hospitals, surgeons, patients and payers. This session will address these specific points: • What is the state of the worldwide orthopaedic business and its major players? • How will the recession, healthcare reform and current FDA climate impact the variety of stakeholders? • What are the expected opportunities and risks over the next five years? Attendees will receive these tools to put to immediate use: • Identification of relevant industry trends/opportunities and their impact on you and your customers • The ability to incorporate issues, trends and opportunities into your strategic planning process; confirming whether each validates, alters or completely changes your goforward strategy • Identification of new skills or processes that you and/or your team may need to develop and implement Urbanowicz Consulting, LLC (UC) is a medical device advisory firm with a musculoskeletal focus, seeking to enable prospective clients to achieve their strategic and transaction-related goals by capitalizing on market opportunities. Don Urbanowicz, UC’s principal, has a 30-year track record in the healthcare industry, with a deal-making focus over the past ten years. Don has held prior senior management/leadership positions at Stryker, Smith & Nephew, Sofamor Danek and Aircast. He has successfully developed and implemented strategic planning and business development transaction life cycle processes. He has also successfully concluded numerous pre-revenue and bolt-on transactions, many of which were outside the U.S. Don has a deep understanding of how strategics think about, approach and place value on potential transactions. Page 8 PressReady.indd 8 6/1/2011 1:27:52 PM Lectures and Workshops Lecture: The View from Washington: What Device Makers Need to Know about FDA’s Latest Priorities and Initiatives Martin Browning President and Co-Founder EduQuest, Inc. Martin Browning, co-author of the original 21 CFR Part 11, a former field investigator and senior executive in FDA’s Office of Regulatory Affairs, will help you review your operations to better align them with FDA expectations. Included will be scrutiny of the highly volatile issue of orthopaedic device accessories and tools that cumulatively trigger a huge number of MDRs and recalls. Martin will also discuss FDA’s heightened concerns for more vigorous, ongoing supplier evaluations. These specific points will be addressed: • FDA’s top concerns about orthopaedic device manufacturers • Enforcement targets and priorities for 2011 and beyond • Potential minefields for device makers: accessories and tools • Latest FDA and international expectations for supplier selection and controls • Lessons learned from internal audits of facilities in seven different countries Attendees will receive these specific tools to put to immediate use: • Actionable list of FDA “hot button” issues • EduQuest Advisory Report on “The Hot Potato of Responsibility: How to Manage Outsourcing and Not Get Burned” • Free subscription to EduQuest-ions & Answers, a monthly Q&A with FDA compliance professionals at EduQuest Martin Browning is the President and Co-Founder of EduQuest, Inc., a global team of FDA compliance experts based near Washington, D.C. Martin has more than 30 years of regulatory experience at FDA and as a highly sought-after advisor to industry. His 22-year career at FDA included work as an investigator and as a senior manager in the Office of Regulatory Affairs at FDA headquarters. At EduQuest, Martin helps clients solve problems related to FDA regulation, quality assurance, software and systems engineering and compliance auditing, including the assessment of vendors and outsourced operations. Page 9 PressReady.indd 9 6/1/2011 1:27:52 PM Lectures and Workshops Lecture: Orthopaedic Biomaterials: Using History to Inform Innovation Ayyana Chakravartula, Ph.D. Associate Exponent Failure Analysis Associates This lecture gives the history of orthopaedic biomaterials, with focus on development trajectory. Materials used in orthopaedic implants will be examined in the context of those from other device fields, with areas for future exploration highlighted. Recent developments in biomaterials processing and regulatory affairs will also be covered. These specific points will be addressed: • History shows that orthopaedic biomaterial development has advanced in large steps vs. other medical device fields. • The current state of regulatory affairs is not favorable to changes. Attendees will receive these specific tools to put to immediate use: • Perspective on past failures and successes in orthopaedic biomaterials • Developments in other medical device fields that can inform R&D in orthopaedics • A summary of the regulatory path for common orthopaedic devices Dr. Chakravartula has particular expertise in the mechanics of biomaterials. Her research has addressed composition, manufacture and performance of natural and synthetic materials used in biomedical applications, including cartilage, hydrogels and polyethylene. She has experience with the FDA regulatory process and with test development and validation for biomaterials. Prior to joining Exponent, Dr. Chakravartula worked as a research scientist at Cambridge Polymer Group. She served as an adjunct lecturer at Boston University, teaching an undergraduate-level course entitled “Mechanics of Biomaterials,” and co-authored an undergraduate textbook by the same name. Lecture and Workshop: Planning For and Managing FDA Inspections John Gagliardi President MidWest Process Innovation, LLC Planning for and Managing FDA Inspections • 1.5-hour introduction and lecture in the morning • 2-hour workshop in the afternoon of the same day Learn how to develop and implement a coherent strategy and procedure for managing and documenting FDA inspections. A planned, pre-meditated approach will be of critical importance when the Notice of Inspection form, FDA-482, is presented. These specific points will be addressed: Part I (Lecture), Logistics/Using Process Architecture/QSIT • Preparing/Designating an Inspection Team • Limiting Missteps/Managing the Closeout Meeting • Responding to an FDA 483 Part II (Workshop), Working with Actual Inspection Scenarios • Choosing the appropriate objective evidence • Planning for and then answering the questions • Scenarios: FDA “hot buttons” Attendees will receive these tools to put to immediate use: • Effective preparation and behavior strategies for managing an FDA inspection • Knowledge of potential scenarios and response strategies Mr. Gagliardi’s successful 40-year track record in the Medical Device and Pharmaceutical industries stems from his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. John specializes in building systems in a compliant and business-ready manner. Lecture: High Performance Medical Plastics Maria Gallahue-Worl Global Business Manager - Healthcare Solvay Specialty Polymers This session will address the replacement of metal by high performance plastic in the healthcare industry, following trends and materials selection, design considerations and examples. The following specific points will be covered: • Trends in the healthcare industry affecting material selection for instruments and devices • Metal replacement by high performance plastic: key considerations for material selection • Examples and case studies Maria Gallahue is the Global Business Manager – Healthcare for Solvay Specialty Polymers, a leading global supplier of high-performance thermoplastics based in Alpharetta, Georgia. Maria’s 18-year career in the polymer industry spans activities including product and business management, marketing, manufacturing, quality control and design engineering. Maria has a long history of identifying and achieving cost reduction for customers in a wide range of metal replacement projects. Maria has been a member of the Society of Plastics Engineers since 2002. Workshop: The Toolbox for High Speed Innovation and New Product Development Gregory D. Githens, PMP, NPDP Managing Partner Catalyst Management Consulting LLC Page 10 PressReady.indd 10 6/1/2011 1:28:01 PM Tecomet_OMTEC2011:Ad 5/9/11 2:44 PM Page 1 Orthopaedic, Trauma, CMF, and Spinal Implants Net Shape & Closed Die Forging Conventional & CNC Machining Net & Near Net Shape Forging | Closed Die Forging | Upset Forging Mechanical and Screw Presses from 700 to 1600 Tons Tool Design and Fabrication 4 & 5-Axis CNC Milling | 8-Axis CNC Mill/Turn Centers High Speed Hard Die Milling | Wire EDM Sinker/Plunger/Ram EDM | Swiss Machining | Honing Grinding | Conventional Machining Photochemical Machining Laser & E-Beam Welding and Vacuum Brazing Automated 2D Etching Lines 3D Etching Line for Complex Shapes Photo Tool Design and Fabrication Automated Laser Feature Inspection Vacuum Brazing with Helium Backfill | Electron Beam Welding Laser Welding (4 Axis) | Sintering | Diffusion Bonding Pressure, Leak, and Flow Testing Custom Finishing LaunchQuick™ Rapid Prototyping Cleaning | Passivation | Alpha Case Removal | Belting Tumbling | Grit Blasting | Heat Treating | Laser Marking “Hi Bright” Polishing | High Speed Centrifugal Disk Finishing Functional prototyping from concept sketches or models Dedicated multi-axis CNC machining centers Full range of support for machining, finishing and inspection A Leader in Net Shape Forging, 115 Eames Street | Wilmington, MA 01887 Precision Machining, Photochemical Etching Phone: 978 642 2400 | Toll Free: 888 287 0400 and Joining of Critical Components [email protected] | www.tecomet.com ISO 9001:2000 | ISO 13485 | FDA Registered PressReady.indd 11 6/1/2011 1:28:01 PM Lectures and Workshops This session will provide useful practices for improving the speed and effectiveness of innovation programs. It draws from intensive study of strategic initiatives and new product launches. Effectiveness is found by focusing on four general areas: • Tools for fast and effective decisions • Tools for recognizing and managing uncertainty and ambiguity • Tools for integrating programs, products, portfolios and people • Tools for creating alignment and commitment Greg Githens possesses over 25 years of experience in strategic programs and innovation. He is skilled at building alignment in people that enables them to get the tough work done. A recognized authority, Greg has spoken to many high-profile groups and authored over three dozen articles, papers and books on the topic. Greg holds advanced degrees in business and science, and is a certified Project Management Professional and a certified New Product Development Professional. Lectures: The Fundamentals of Reimbursement: Understanding How Coverage, Coding and Payment Impact a Medical Technology The Secret to a Successful Product Launch: The Integration of the Reimbursement, Clinical, Regulatory and Marketing Strategies Kelli Hallas Executive Vice President, Reimbursement Services Emerson Consultants Lecture #1: The Fundamentals of Reimbursement: Understanding how Coverage, Coding and Payment Impact a Medical Technology This presentation will discuss: • The three drivers of reimbursement: coverage, coding and payment • How reimbursement impacts a technology • The importance of well designed clinical studies and data to reimbursement • Key reimbursement questions to ask yourself pertinent to your medical technology Attendees will actively participate in creating a reimbursement “Top Ten Checklist” for incorporation into strategic plans. Lecture #2: The Secret to a Successful Product Launch: The Integration of the Reimbursement, Clinical, Regulatory and Marketing Strategies This presentation will discuss: • Why it is critical to integrate strategies early • How to integrate four completely unique strategies • How successful integration will impact your business • When and what to integrate in the process Attendees will create a “blueprint” that will identify strategic initiatives by product phase for incorporation into product strategic plans. Kelli Hallas joined Emerson Consultants in 2004 as Vice President of Reimbursement Services. She focuses on developing and implementing strategic initiatives to remove reimbursement obstacles and drive business at all stakeholder levels. Kelli is a tenured professional with 20 years of medical technology experience. She has experience providing a range of services to hospitals, physicians, payers and medical technology companies. Her expertise includes IDE clinical trial reimbursement, financial modeling tools for products and procedures, healthcare policy and CMS and AHRQ focused initiatives. Kelli has secured new ICD-9 procedure codes for emerging procedures, successfully obtained pass-through status for new technologies and biologics, partnered with professional societies for the implementation of CPT® codes and worked with local and national payers to implement coverage decisions. Kelli has been a featured presenter at industry programs and is a contributing writer in industry-related publications. She has published Fundamentals of Reimbursement, a reference guide on how reimbursement impacts sales in today’s healthcare marketplace. Lectures: Getting Started With CE Marking: Your Passport to Europe Clinical Evaluation 101: A Key Requirement to Gaining Access to the European Market Suzanne Halliday, Ph.D. Team Leader for Orthopaedic and Dental Devices BSI Healthcare Lecture #1: Getting Started With CE Marking: Your Passport to Europe Are you interested in selling your orthopaedic device in the 27 countries that comprise the European Union (EU)? This session will help you gain a basic understanding of the CE Marking regulatory process and the Medical Device Directive (MDD) regulations that govern placement of products into the EU. Learn the thinking behind the different device risk classifications and understand when you need a Notified Body. Learning Objectives: • Overview of the European Union marketplace • Understand the purpose and basic requirements for CE Marking • Fundamentals of risk classification and routes to conformity • Learn the relationship of quality and risk management with the MDD • Understand the role of a Notified Body • Identify the steps required to place a device on the market in the EU market Page 12 PressReady.indd 12 6/1/2011 1:28:06 PM Inspiring Solutions for 20 Years Orthopedic companies know that a partnership with Onyx starts with our best-in-class quality systems, unparalleled technical leadership and deep-seated respect for serving the industry. This foundation allows us to do more than assist you with bringing new products to market—it ensures that together, we’re optimizing your supply chain for long-term success. We’re Onyx ... Where Ideas and Ingenuity Converge. ® PressReady.indd 13 800-238-6981 onyxmedical.net ISO 13485:2003 / FDA 1043653 6/1/2011 1:28:06 PM Lectures and Workshops Access to the EU marketplace can provide tremendous growth opportunities. It may make business sense to initiate the European process concurrently or even prior to obtaining FDA clearance. Lecture #2: Clinical Evaluation 101: A Key Requirement to Gaining Access to the European Market Are you aware of the impact Clinical Evaluation has on placing your Medical Device in the EU? Selling your product in Europe requires a CE Mark. This requires a device manufacturer to comply with the European Medical Device Directive (MDD) regulations in which clinical evaluation is a key requirement. Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify its clinical safety and performance. Learning Objectives: • Understand the European regulatory framework • Definition of clinical data • Learn the clinical evaluation process • How the scope of data required is proportional to the risk of the device • Obtain a listing of useful resources Dr. Suzanne Halliday is the Team Leader for Orthopaedic and Dental devices within BSI Healthcare. She oversees a team of product experts responsible for EN ISO 13485 and CE Marking for 175+ clients globally, along with numerous Mutual Recognition Agreements for compliance in Canada, the U.S., Japan, Taiwan and Australia. Dr. Halliday holds a Masters in Science from the University of Waterloo and a Doctorate in Design Engineering from University of Oxford. She has designed joint replacement implants, spinal and fracture fixation systems and has conducted post market clinical investigations. Lecture: Advanced Mechanical Inspection: How to Make Inspection Better, Faster and More Cost-Effective Kelly Lucenti President Millstone Medical Outsourcing LLC Medical device manufacturers are paying close attention to mechanical inspection. A quality issue could lead to a recall, but time-consuming bottlenecks raise concerns for growing companies, as well. Whether an OEM’s mechanical inspection cell is managed in-house or outsourced, this session will offer techniques to evaluate, strengthen and enhance mechanical inspection capabilities. Attendees will learn: • The biggest inspection pitfalls and how to avoid them • Innovative practices for enhancing mechanical inspection • Requirements – from equipment to protocols to training – for Best in Class mechanical inspection Session attendees will leave with: • Check list for evaluating existing mechanical inspection processes in-house or outsourced • Ideas on how to reduce time required for mechanical inspection • Information about qualifying an outsourcing partner • Tips on gaining the most from an outsourcing relationship Kelly Lucenti is President of Millstone Medical Outsourcing. Before becoming President, he was responsible for developing and directing Millstone’s quality systems as Vice President of Quality. Prior to joining Millstone, Mr. Lucenti was Director of Worldwide Operations for Flexcon Industries and served in a variety of capacities in the Orthopaedics and Codman divisions of Johnson & Johnson. He received a Bachelor of Science degree in Industrial Engineering and Operations Research from The University of Massachusetts at Amherst, and a Doctorate of Law from Southern New England School of Law. Lecture: Supply Chain Management: Lessons Learned Mahender Singh, Ph.D. Research Director MIT Supply Chain 2020 Project The U.S. healthcare system is undergoing a dramatic transformation. How this will affect various sectors and practices is essentially unknown. In such a situation, it is important that players pay greater attention to their strategies and strive to shape the future. Strategy is a choice and should reflect the desires and capabilities of the organization. In this presentation, we will share our learning from multiple industry projects that mapped and leveraged mental models of the supply chain team. Dr. Mahender Singh is a Research Director for the MIT Supply Chain 2020 Project, a multi-year research effort looking into the future of logistics and supply chain management. His research and teaching focus on operations and supply chain management, with particular interest in exploring the underlying structure of complex supply chains. Dr. Singh has over ten years of experience in the field of supply chain management and has worked on multiple global supply chain projects to analyze and redesign planning systems. He has taught Operations Management at the University of Tennessee, Knoxville, where he received his Ph.D.; he is also a graduate of MIT-CTL’s Master of Engineering in Logistics Program. Lecture: Vesting for Success: Ten Must-Have Elements for a Successful Business Supplier Agreement Kate Vitasek University of Tennessee This session will address: • How an outsourcing agreement differs from a contract for goods • Why it is important to have a “vested” agreement • The elements that comprise a successful business agreement Page 14 PressReady.indd 14 6/1/2011 1:28:12 PM Lectures and Workshops Attendees will receive these specific tools to put to immediate use: • Decision matrix and instructions on how to map your sourcing business model to your agreement • Checklist of ten elements of a successful agreement Author, educator and business consultant, Kate Vitasek is a nationally recognized innovator in the practice of supply chain management and outsourcing. Vitasek’s approaches and insights have been widely published in respected academic and trade journals. She is the co-author of the Council of Supply Chain Management Professionals’ best selling book, Supply Chain Process Standards, and has contributed to over 75 articles and five books, including her latest book, Vested Outsourcing: Five Rules That Will Transform Outsourcing. Vitasek is a faculty member at the Univ. of Tennessee’s Center for Executive Education and is the Founder of Supply Chain Visions, a boutique consulting firm specializing in Supply Chain Management. Vitasek has also served on the Board of Directors for the Council of Supply Chain Management Professionals. Workshop: Sales & Operations Planning: The Basics and Beyond Tom Wallace President T.F. Wallace & Company Executive S&OP helps companies balance demand and supply; integrate financial planning with operational planning; hit financial targets more effectively and launch new products faster and better. These specific points will be addressed, with time for Q&A and group discussion: • Part 1 will be an overview of the process, describing what it is and how it works. • In Part 2, we’ll cover benefits that companies have realized from using the process. • Part 3 will focus on implementation: how to make the process work. • Part 4 is the segment on “beyond the basics,” or advanced uses of the process. Tom Wallace is an author and teacher specializing in S&OP. He is a Distinguished Fellow of the Ohio State University’s Center for Operational Excellence, and teaches in conjunction with the Institute of Business Forecasting and Planning. He has taught 10,000+ business people in Australia, Belgium, Canada, China, France, Great Britain, Mexico, New Zealand and the U.S. Tom has written 12 books, including Sales & Operations Planning: the How-To Handbook, 3rd Edition (2007), Sales & Operations Planning: the Executive’s Guide (2006) and Sales & Operations Planning: the Self-Audit Workbook (2005). His books have been translated into seven languages. Tom has also produced a number of videos, most recently, The Education Kit for Sales & Operations Planning (2009), a multi-media teaching resource. Panel Discussion The Supplier Perspective: Best Practices in OEM/Supplier Relationships - Getting the Most Value Moderators: Howard Levy, Chief Procurement Officer, Biomet, Inc. and Mark Hall, Global Strategic Sourcing Manager, Smith & Nephew Orthopaedics, Inc. Panelists: Mauricio Arellano, President, Greatbatch Medical Jodie Gilmore, Vice President Strategic Business Development, Onyx Medical Matt Burba, Executive Vice-President of Implant Manufacturing at Orchid Orthopedic Solutions Discourse will focus upon building and nurturing successful, prosperous relationships. A preliminary sampling of questions posed to the panel may include: • Where are OEMs leaving value or money on the table while working with suppliers? • Much emphasis has been placed on getting suppliers engaged earlier in the new product development process. What should OEMs do to make early supplier engagement more successful? • Seems like suppliers’ new technologies or new capabilities can get overlooked in the day to day running of the business. What’s the best way to tap into your newest technologies and innovations to ensure a competitive advantage to a customer? OMTEC Poster Presentations Cartilage-on-cartilage articulating system as a wear benchmark for artificial replacement systems. Jonathan L. Stoia,1,2 Carol A. Pacione,2 Susanna Chubinskaya,3 Markus A. Wimmer1,2,3 Dept. of Bioengineering, University of Illinois at Chicago 1 Dept. of Orthopedic Surgery, Section of Tribology, Rush University Medical Center 2 Dept. of Biochemistry, Rush University Medical Center 3 Methods of articulating artificial materials in vitro against cartilage exist; however, a benchmark with which to compare the outcome is needed. The purpose of the study was to investigate the effects of articulating cartilage on cartilage and compare them to metal-on-cartilage wear experiments. Optimized follower load system for lumbar spine flexion/ extension testing. AbdulRahman Abutaleb, Kayla Andalina, Dean Khan, Amanda Vicich, University of Illinois at Chicago Applying a compressive load on the lumbar spine of physiological magnitude in vitro has been a challenge. Improved experimental capabilities provided by Spinomatix, a follower load system, will allow for future lumbar spine studies with deeper insights into the lumbar spine’s support function, disorders and degradation mechanisms. Page 15 PressReady.indd 15 6/1/2011 1:28:14 PM Exhibitor Listing 715. AccelLAB Inc. 1635 Lionel-Bertrand Boulevard Boisbriand, QC J7H 1N8 Canada 450-435-9482 (phone) 450-435-4795 (fax) www.accellab.com 424. AIP 724 Fentress Boulevard Daytona Beach, FL 32114 USA 386-274-5335 (phone) 386-274-4746 (fax) www.aipdaytona.com AccelLAB Inc. is a preclinical CRO that provides in life services needed to conduct high-quality product safety and efficacy studies from the proof of concept to regulatory submission in a GLP environment. Evaluation services include study design, on-site surgeries, histology, imaging, blood assays and clinical pathology. State-of-the-art imaging modalities include MRI, whole-body CT, high-definition radiography and Micro CT. Full histopathology and histomorphometry reports are provided by experienced veterinary pathologists. AIP has 30+ years of experience machining ultra high precision complex plastic components from polymer materials such as PEEK, PEEK-OPTIMA, CF-PEEK-OPTIMA, PTFE, RADEL-PPSU, TECANYL-MT, UHMW-PE, TECAPRO-MT, ULTEM, etc. AIP boasts an impressive customer list in each of the industries we serve, while maintaining a small, hungry company mentality to assure top notch service to all our potential and existing customers. ISO 9001:2008 and ISO 13485:2003 certified. 633. Acme Manufacturing Company 4240 North Atlantic Boulevard Auburn Hills, MI 48326 USA 248-393-4200 (phone) 248-393-4060 (fax) www.acmemfg.com 720. Alliance Global Technology Co., Ltd. 2F., No.92, Luke 5th Road Luzhu Dist., Kaohsiung City 821 Taiwan (R.O.C.) 886-7-695-6688 (phone) 886-7-695-5329 (fax) www.alliance-gt.com Acme Manufacturing Company Integrated Robotic Polishing, Grinding & Buffing Systems for Orthopaedic Components. Largest global manufacturer of robotic gate grinding and finishing systems. We focus on providing a complete, fully developed, risk-free finishing system to support the global medical implant industry. In-house technical support staff of engineers for applications, product and electrical controls, off-line programming and training. ISO 9001:2008 certified. Manufacturer of orthopaedic implants and instruments, including bone plates and bone screws, surgical instruments, etc. We offer precise CNC manufacturing skills and surface treatment of advanced medical devices. ALLIANCE is the first company to manufacture Class III medical devices in Taiwan. Our quality system is certified to ISO 13485 and Taiwan GMP. We cooperate with experts in many fields to provide good quality products and satisfying customer service. 526. Advantage Manufacturing Technologies, Inc. 14298 169th Drive Southeast Monroe, WA 98272 USA 425-485-3980 (phone) 425-483-1608 (fax) www.teamamt.com 719. American Express Open 200 Vesey Street New York, NY 10285 USA 212-640-2000 (phone) 212-640-0128 (fax) www.open.com We work with various metals, moving with you, incorporating every step from engineering design assistance through assembly and final packaging, performing work to your exact specifications. With consistency, our production and quality systems provide parts that meet your tight tolerance and specifications time after time. AMT’s exceptional team works as your silent partner towards the mutual success of each of our companies. American Express® Business Cards give you automatic access to the tools and resources that American Express OPENsm has to offer, including benefits that can help you save money, gain control over your practice expenses, earn valuable rewards and much more. 430. AeroMed, Inc. 2342 North Penn Road Hatfield, PA 19440 USA 215-997-2900 (phone) 215-997-0165 (fax) www.aerom.com Precision Medical Components. AeroMed specializes in multi-axis CNC machining, including Swiss turning and High Speed milling of components and assemblies. We manufacture medical devices such as orthopaedic implants and screws, ortho-fixation and implantable devices used in micro- and minimally invasive surgery. AeroMed provides full project and inventory management and is FDA compliant. Certified to ISO 9001:2000 FM514233 and ISO 13485:2003 FM507091. 116. American Tool & Die, Inc. 9470 E 14 1/4 Road Manton, MI 49663 USA 231-824-9772 (phone) x502 231-824-9790 (fax) www.americantooldie.com American Tool & Die, Inc., also doing business as American Instrument & Implant, is a precision manufacturer of “to order” orthopedic and spine instrumentation and implants of the highest caliber at one of the industry’s best price points. Whether you are looking for a source to provide prompt quoting and delivery, prototype or production capabilities, craftsmanship for difficult projects, or specific documentation, American Instrument & Implant can help. ISO 13485:2003. Page 16 PressReady.indd 16 6/1/2011 1:28:18 PM Exhibitor Listing 832. APS Materials 4011 Riverside Drive Dayton, OH 45405 USA 937-278-6547 (phone) 937-278-4352 (fax) www.apsmaterials.com 602. Arwood Machine Corp 95 Parker Street Newburyport, MA 01950 USA 978-463-3777 (phone) 978-463-0666 (fax) www.arwoodmachine.com APS is a leader in Plasma spray technology of both porous and bioactive coatings for the orthopaedic marketplace. The coatings consist of Commercially Pure (CP) Titanium and its alloys, specifically Ti 6Al 4V, as well as Hydroxyapatite, a calcium phosphate material that is used as a synthetic bone substitute. ISO13485:2003, ISO 9001:2000 and NADCAP certified. FDA Master files for all our coatings. Arwood Machine Corporation is a Veteran Owned, ISO 13485:2003 precision manufacturer of Medical Instruments. Since 1964 Arwood has invested in a wide variety of machine tools to accommodate “one stop procurement” for the medical industry. Our 81,000 square foot manufacturing facility includes 4&5 axis machining, Screw Machining, Twin Spindle Machining, Wire EDM, Plunge EDM, Gun Drilling, Assembly, Welding, Passivation, Laser Marking and packaging complete. 532. Arcam AB Kroslatts Fabriker 30 Molndal 431 37 Sweden 31-7103200 (phone) 31-7103201 (fax) www.arcam.com 520. ASTRO Medical Devices 7124 Industrial Park Boulevard Mentor, OH 44060 USA 440-269-6984 (phone) 440-602-6091 (fax) www.astromedical.com Additive Manufacturing of Orthopaedic Implants. Arcam’s Electron Beam Melting technology offers unique route to cost effective production of standard and custom implants designed with your trademark Trabecular Structure. Arcam offers a complete portfolio of equipment, software, metal powder, service and training. The Fine Art of Precision Machining. ASTRO Medical Devices specializes in implant production: spinal, orthopaedic, fixation and deformity, as well as instrumentation. ASTRO Medical Devices offers tight tolerance Swiss and 5 Axis CNC Machining capabilities, industry expertise and exceptional customer service. From prototypes to production, we make your parts look like “fine art” for the medical device industry. ISO 13485 certified. Page 17 PressReady.indd 17 6/1/2011 1:28:19 PM Exhibitor Listing Bronze Sponsor 345. Autocam Medical Global Headquarters 4436 Broadmoor SE Kentwood, MI 49512 USA 616-541-8080 (phone) 616-698-6876 (fax) www.autocam-medical.com 624. Boedeker Plastics, Inc. 904 West 6th Street Shiner, TX 77984 USA 361-594-2941 (phone) 800-444-3485 (toll-free) 361-594-2349 (fax) www.boedeker.com Single-source contract manufacturer of precision-machined complex, highly engineered metal implants, instruments and components. Applications include orthopedic, spine, trauma, and reconstructive surgery. A member of the Autocam group of companies, which includes 12 facilities on four continents. Using lean manufacturing, value engineering, and continuous improvement principles, Autocam Medical leverages the entire production system to get a better product to market faster. ISO 9001 and ISO 13485 Certified. Boedeker is the country’s largest single-location stocking distributor of high performance & industrial plastics in sheet, rod and tube. All ready for shipment at a moment’s notice. Our experience, personal attention to detail and passion for customer service will provide you with excellent results every time you do business with us. 201. Avalign Technologies 272 East Deerpath Road, Suite 208 Lake Forest, IL 60045 USA 800-996-2121 (toll free) 260-480-5223 (fax) www.avaligntech.com Premier, full-service supplier of implants, instruments and delivery systems. Our expert engineering, diverse manufacturing capabilities and complete dedication to your project ensure success from start to finish. We comprise three innovative companies: Nemcomed (Implants and Instruments); NGInstruments (Premium Cutting Instruments) and Advantis Medical (Cases and Trays). As a whole, Avalign Technologies brings the highest quality standard and custom products to our OEM customers across multiple surgical specialties. 626. Bob, Incorporated 8740 49th Avenue North Minneapolis, MN 55428 USA 763-533-2261 (phone) 763-533-1735 (fax) www.bobinc.com Bob, Inc. specializes in close tolerance machining of implants for applications such as, orthopedics, spinal, dental, ENT, neurology and urology. Prototype to production assistance. Capacity to support large volume contracts utilizing 60+ CNC machines that include 9-axis CNC swiss machines, robotic loading CNC twin spindle lathes, high speed 5-axis CNC machining centers and CNC horizontal machining centers. Partnered with customers in ship-to-line, JIT, Kanban, supplier managed inventory and other programs as a result of consistently shipping high quality products on-time. These programs supported by industry leading ERP solution that has integrated MRP capabilities. ISO 9001:2008, ISO 13485:2003 and AS9100 Certified. Platinum Sponsor 127. Bradshaw Medical, Inc. 10325 58th Place Kenosha, WI 53144 USA 262-925-1374 (phone) 877-201-7661 (toll free) 262-925-1380 (fax) www.bradshaw-medical.com Quality Surgical Instruments. Premier manufacturer of instruments for OEM companies within the orthopaedic, trauma and spinal markets. BMI’s goals are to provide innovative products to our customers with careful consideration to price and delivery along with best-in-class customer service and technical support to aid both existing and developing programs. ISO 13485:2003, ISO 9001:2000 certified. FDA Registered. 500-501. Branch Medical Group 200 Schell Lane Phoenixville, PA 19460 USA 484-923-1073 (phone) 877-992-7262 (toll free) www.branchmedicalgroup.com We are contract manufacturers making world class spinal, orthopaedic, cardiovascular, dental and other implants. We design and manufacture the graphic cases that house the implants and instruments. We do sterile packaging, labeling and assembly. Our mission is to make “parts for life.” Our driving passion is to help customers LAUNCH products ON TIME. Why do we do it? We do it for life. 712. Bodycote 710 Burns Street Cincinnati OH 45204 USA 513-307-4727 (phone) 513-921-2536 (fax) www.bodycote.com 621. British Standards Institution (BSI) 12110 Sunset Hills Road, Suite 200 Reston, VA 20190 USA 703-437-9000 (phone) 703-437-9001 (fax) www.bsiamerica.com/healthcare Operating an international network of facilities and serving a wide range of industries, including medical, aerospace, defense and power generation. Bodycote is the world’s largest and most respected provider of thermal processing services. Thermal processing is a vital part of any manufacturing process, and includes a variety of techniques and special engineering processes which improve the properties of metals and alloys, extending the life of components. Surface Coating, HIP (Hot Isostatic Pressing), Heat Treatment and Metal Joining representatives will be present at OMTEC 2011 to assist with any support Bodycote can provide. BSI Healthcare is a world class full-service Notified Body and Registrar, providing robust regulatory and quality management reviews and product certification for medical device manufacturers. We contribute to our clients’ success in the global medical device industry by accelerating access to international markets. BSI services include CE Marking, IVD, ISO 13485, CMDCAS, Clinical Strategy Reviews, Japan PAL, FDA ThirdParty Programs, Standards and Training. We are committed to providing programs that combine speed with experience, integrity, independence and predictability. Page 18 PressReady.indd 18 6/1/2011 1:28:23 PM Contract manufacturing as sophisticated as your implants. CAPABILITY, MEET CAPACITY. When it comes to spinal and extremity implants, no one matches our technology, experience and reputation for quality. With over ten 7-axis contour milling machines, no one takes you from prototype to full-scale production faster. No one. ✓ Orthopedic implants manufactured and finished complete ✓ Single operation milling and turning of complex geometries ✓ Tolerances of +/-.0001" ✓ Dedicated equipment for manufacturing PEEK implants Vertically Integrated Contract Manufacturing: • • • • • • • 7-AxisContourMilling AthermalLaserMachining LaserMicromachining LaserWelding&Marking Electropolishing CNCTurning NiTinolShapeSetting • PrototypeMachining Departments ElectrochemicalGrinding SwissMicromachining Wire&ConventionalEDM CleanroomAssembly, WeldingandPackaging • • • • Corporate Headquarters 5507 Avion Park Drive Highland Heights, OH 44143 ISO 9001:2008 / ISO 13485:2003 PHONE: 800-474-4322 / 216-761-5387 PressReady.indd 19 NN_SpineAd_BoneZone210.indd 1 EMAIL: [email protected] WWW.NNOBLE.COM 6/1/2011 1:28:23 PM 2/11/2010 10:39:30 AM Exhibitor Listing 515. Brown Precision, Inc. Chase Industrial Park 90 Shields Road Huntsville, AL 35811 USA 256-746-0533 (phone) 256-746-0511 (fax) www.brownprecisioninc.com Brown Precision, Inc. (BPI) has gained 40 years experience in machining and manufacturing in a diverse marketplace. AS9100 and ISO 13485 Certified, specializing in precision machining, we offer our customers multi-axis CNC milling and turning, swiss turning, EDM machining, CNC gundrilling, abrasive waterjet machining and reverse engineering. Quality Engineers, Machine Operators, Project Engineers and Executive Management provide dedication to achieving excellence in the following areas: Engineering, Precision Machining, Custom Fabrication, Third-Party CMM Verification, Quality and Customer Satisfaction. 414. CaP Biomaterials LLC 2485 Corporate Circle, Unit 1 East Troy WI 53120 USA 262-642-2760 (phone) 262-642-2764 (fax) www.capbiomaterials.com CaP Biomaterials serves as a partner in bioceramics testing, speeding time to market, improving existing products and assisting in the development of new applications. CaP manufactures consistent, high-quality, custom calcium phosphates including hydroxylapatite (HA), tricalcium phosphate (TCP) & biphasic (HA/TCP). Forms available: granulates, coatings, porous blocks, porous putty, press feed, spray feed & plasma spray. Applications: orthopedic, trauma, spine, dental & soft tissue implants. ISO 9001 Certified. 245. C&A Tool Engineering, Inc. 4100 North U.S. 33, PO Box 94 Churubusco, IN 46723 USA 260-693-2167 (phone) 260-693-3633 (fax) www.catool.com 227. Carpenter Technology Corporation 101 W. Bern Street Reading, PA 19601 USA 610-208-2000 (phone) 800-654-6543 (toll free) www.cartech.com A world class full service medical device contract manufacturer of high precision implants and instrumentation. With the individuals and equipment in place to hold 0.000040” (1-micron) tolerance and a state of the art metrology lab to provide qualification, C&A provides customer peace of mind knowing that the tolerance requirements will be met. Allow our technological expertise to be your solution for ultra high precision. Leading fully integrated developer, manufacturer and distributor of a wide range of specialty alloys including biocompatible BioDur® alloys, stainless steels and titanium alloys. Alloys have been used in surgical, diagnostic, orthopedic, cardiovascular and dental applications. Forms include billet and long form bar, wire, precision strip, fine wire and ribbon, and custom shaped bar and wire. Service centers on four continents. Free, comprehensive technical information database at www.cartech.com. ISO 9001:2008. 142. Cam Bioceramics Leiden Bio Science Park Zernikedreef 6 Leiden 2333 CL The Netherlands 31-71-5240600 (phone) 31-71-5240650 (fax) www.cambioceramics.com 126. Centex Machining, Inc. PO Box 1479 Round Rock, TX 78680 USA 512-255-1477 (phone) 512-388-3606 (fax) www.centexmachining.com We Help Bone Grow. We were the first company to apply a bioceramic calcium phosphate (hydroxyapatite) coating to medical prostheses like hips and knees as well as spinal implants, both metals and polymers. We have quick turnaround times and an excellent quality system. Cam Bioceramics is a renowned producer, key supplier and partner (B-to-B) of synthetic bioactive and osteoconductive biomaterials, such as coating powders and granulates, to the orthopaedic and spinal industries worldwide. Manufacturing Support for the Orthopaedic Industry. Exclusive manufacturing support for U.S. orthopaedic companies. Customer design collaboration and new product launches are our specialty. We realize the importance of being a market leader, and we’ll dedicate whatever resources are required to ensure that your new product launch comes off without a hitch. Hips, knees, shoulders, spinal devices. Implants, provisionals & instruments. FDA-registered. 731. Canwell Medical Ltd. No. 466 South Xianhua Str. High-tech Industrial Zone Jinhua, Zhejiang, 321016 P. R. of China 86-579-8223-9098 (phone) 86-579-8223-9558 (fax) www.canwell.com.cn 215. Curbell Plastics, Inc. 7 Cobham Drive Orchard Park, NY 14127 USA 716-667-3377 (phone) 888-287-2355 (toll free) 716-667-3432 (fax) www.curbellplastics.com Canwell Medical Ltd., an Orthopaedic Products & Instruments OEM Solution Provider in China mainland, was founded in May 1994. We started by manufacturing CPM and then successfully stepped into the orthopaedic industry led by some world-famous orthopaedic giants in 2003. Today, we are one of the largest suppliers of trauma, spine and joint instruments & implants to many of the world’s top 10 orthopaedic companies. Medical-grade polymers including Radel® R, Celcon® M25 Acetal, PEEK, Ultem®, Polyproylene and Polysulfone. Curbell’s ISO 9001:2008 quality system ensures lot and batch traceability, appropriate paperwork and certifications with every order. Our medical-grade materials comply with agency standards including USP Class VI, ISO 10993-5 and FDA. We also offer material selection and technical assistance. Page 20 PressReady.indd 20 6/1/2011 1:28:26 PM ▲ Fold on dashed lines. Align A to B. ▲ A B Start Finish Passivate Ship Design Engineer Schedule Package Mill Test Clean Process Clean Ship Pack Coding Shrink-Wrap Storage Unpack Inspection Box Inventory Turn Laser Etch Polish Prototype Porous Coat Diamond Coat Passivation Test Fabrication Integrate Raw Material Micro Debur Qualification Label Machine Machine Pilot Program Pilot Program Label Forge Troubleshoot TPS Coat Code Coat Delivery Micro Debur Drill Ship Inspection Gage Design Shrink-Wrap Storage Unpack Process Box Inventory Design Laser Etch Mill Process HA Coat Engineer Electro Polish Ship Pack Coding ▲ Development ▲ A Concept B Think of everything you’ll simplify if you go lean. Like operations, processes and workload, for starters. We’ve found that lean manufacturing is the best way for our customers to lose the wait. By tying our value stream to theirs, we’re able to implement principles that remove waste, decrease cost and shorten lead times. The end result? Less effort, investment, inventory and logistics for you. And more overall customer value for us. Find out how lean manufacturing with Orchid can simplify your life. Contact: [email protected] Visit us at OMTEC, Booth 331-333 ORCHID ORTHOPEDIC SOLUTIONS (517) 694-2300 www.orchid-orthopedics.com ©2008 Orchid Orthopedic Solutions LEA-1-3 PressReady.indd 21 6/1/2011 1:28:26 PM Exhibitor Listing 608. Deloro Stellite Group (c/o ATS Stellite) ZI De Brueges - BP 80286 30106 Ales Cedex France 33-4-66-30-47-03 (phone) 33-4-66-78-75-64 (fax) www.stellite.com Deloro Stellite serves the orthopedic and medical industries with state-ofthe-art manufacturing services, to help them produce advanced implants and instruments with the highest quality. Partner of our customers product developments, we propose appropriate solutions. We offer complete supply-chain management tools, to help our customers to implement just-in-time programs, with single source accountability. With 13 sites worldwide, Deloro Stellite is in a position to support local loop and deploy expertise. 713. Electrolizing Corp. of Ohio, The 1325 East 152nd Street Cleveland, OH 44112 USA 216-451-8655 (phone) 800-451-8655 (toll free) 216-451-4729 (fax) www.electrohio.com The Electrolizing Corp. of OHIO is a proven leader in specialty coatings for the medical device and implant industry. All processes are validated to Global Harmonization Task Force guidelines, including our proprietary Medcoat 2000 and Ti-Med processes. Visit www.medcoat2000.com for more information on all of our completely validated processes. ISO 9001:2008. 601. Dexcowin Co., Ltd #606 Woolim Lions Vally II Gasan Dong 153-803 GeumCheon Gu, Seoul Korea 82-2-2027-2880 (phone) 82-2-2027-2884 (fax) www.dexcowin.com 102. Electropolishing Systems, Inc. 24 Aldrin Road Plymouth, MA 02360 USA 508-830-1717 (phone) 508-830-1789 (fax) www.electropolishingsystems.com Dexcowin Co., Ltd was established in 2004 in South Korea. We are a manufacturer of a portable, battery-powered X-ray machine. Our goal is to contribute to healthier and better humans. Our advanced and creative technology focuses on easy carry and fast diagnosis in a mobile environment. Dexcowin’s products have been sold for five years in over 40 countries. We have all kinds of product registrations and local country level certificates including CE and FDA. Electropolishing Systems provides high-quality, close tolerance metal finishing services to the medical device industry. ESI uses various statistical tools including FMEA and DOE to meet specific validation requirements, including Biocompatibility. Our formal control plans and Quality Systems yield highly reliable and repeatable results. Services include ultrapure electropolish, multialloy passivation, titanium and aluminum anodizing, chemical polishing of nitinol, laser marking and cleanroom packaging. ISO 9001 & ISO 13485 certified. 421. Donson Machine Co. 12416 South Kedvale Avenue Alsip, IL 60803 USA 708-388-0880 (phone) 708-388-4308 (fax) www.donsonmachine.com 218. Emerson Consultants, Inc. 12701 Whitewater Drive, Suite 120 Minnetonka, MN 55343 USA 952-374-6000 (phone) www.emersonconsultants.com Donson is a specialized contract manufacturer of precision machined components for orthopaedics and medical equipment. We focus on complex designs and demanding applications requiring state of the art equipment and engineering. Donson supplies implants and instruments to industryleading manufacturers and is geared for quick-turn prototyping, short-run customs/specials and production. Emerson Consultants, Inc. is a Consulting Firm and Contract Research Organization (CRO) for the medical technology and biologic sectors. Emerson provides strategic consulting in the areas of Reimbursement, Regulatory Affairs, Clinical Research, and Sales and Market Development. Emerson’s experienced team of consultants collaborates with clients, comprising both emerging and established market leaders, to design and implement strategies that generate revenue and clearly differentiate their products and services in the marketplace. 830. Durr Ecoclean Inc. Cleaning and Filtration Group 31077 Durr Drive Wixom, MI 48393-2435 USA 248-560-2100 (phone) 248-560-2080 (fax) www.durr-ecoclean.com 531. ENDO Manufacturing Co., Ltd 5-3 Chuo Dori Tsubame-shi, Niigata-ken 959-1244 Japan 81-256-63-6610 (phone) 81-256-64-2466 (fax) www.endo-mfg.co.jp With innovative standard solutions and individually customized cleaning systems, Dürr Ecoclean meets international requirements on cleanness in diverse industries such as the production of mechanical components, aviation and space flight, medical technology, the food industry, electronics and laboratory equipment. Established in 1950. 215 employees. Supported by the techniques in precision forging, machining and polishing, we supply high-performance forged joint implants fast. We apply an “Integrated manufacturing system” allowing us to achieve outstanding lead-time and competitive cost performance. Recently, we have been offering “Custom-made” forging to supply higher value-added products. We are capable of delivering top quality products which satisfy your requirements with competitively short lead-time. Page 22 PressReady.indd 22 6/1/2011 1:28:27 PM PressReady.indd 23 6/1/2011 1:28:37 PM Exhibitor Listing 125. ENSINGER INC. 365 Meadowlands Boulevard Washington, PA 15301 USA 724-746-6050 (phone) 724-746-9209 (fax) www.shopforplastics.com 733. Finishing Innovations, LLC 578 Highway 70 Mason, TN 38049 USA 901-294-2848 (phone) 901-294-3070 (fax) www.finishinginnovations.com Autoclavable plastic shapes in a variety of colors supported with ISO 10993 testing for the intended use of surgical instruments in contact with blood and tissue. Radiolucent carbon composites with high stiffness and radio opaque grades for safety and to accommodate MIS procedures. Beginning with H900 heat treat thru polishing, hard chrome electroplating, electro polish and laser etch, Finishing Innovations sets the standard for delivering validated orthopedic metal finishing services in today’s rapid turnaround environment. Simply put, Finishing Innovations delivers unmatched quality, delivery and service in the orthopedic surface finishing industry. ISO 13485 Registered. For more information, visit www. finishinginnovations.com 402. EPTAM Plastics 2 Riverside Road Northfield, NH 03276 USA 866-443-7826 (toll free) 603-286-3977 (fax) www.eptam.com 415. FMI Medical Instruments 505 Production Avenue Madison, AL 35758 USA 256-461-0900 (phone) 256-461-0929 (fax) www.fmi-medical.com ISO 13485:2003 & ISO 9001:2008 Registered; specializing in machining precision polymer components. Offering 7, 5 and 3 Axis machining, with dry machining technology. Our skilled machinists fabricate complex components and instruments from Acetals, Ultem, Radel, PEEK and carbon fiber, as well as implants from UHMW-PE and PEEK. Our experience and strong systems support ensure that the quality of your components meets your specifications and exceeds your expectations. Contract manufacturer of precision machined implants and instruments. FMI utilizes the latest technology in 3D solid modeling and multi-axis CNC programming software, as well as the latest advancements in multitasking CNC machines. We have extensive experience manufacturing spine and small bone devices. We can manufacture your most demanding applications. 315. Esprit/DP Technology 1150 Avenida Acaso Camarillo, CA 93012 USA 805-388-6000 (phone) 800-627-8479 (toll free) 805-388-3085 (fax) www.dptechnology.com 120. Forecreu America Inc. 4118 North Nashville Avenue Chicago, IL 60634 USA 773-539-8501 (phone) 773-539-8627 (fax) www.forecreu.com DP Technology is a computer-aided manufacturing (CAM) software market leader with a mission to provide CNC programmers with the most powerful CAM software ever. DP Technology’s flagship product, ESPRIT, captures the company’s vision of technology’s potential and its passion for excellence. Forecreu America Inc. offers heavy wall tubing (cannulated bars) in titanium and stainless steel for medical instruments/implants. Sizes range from 0.156 in. to 0.625 in OD and 0.031 in. to 0.169 in. ID. Some larger IDs are available for IM nails or specific applications. The company also offers solid 455C and 465C. 619. Fairview Machine Company, Inc. 427 Boston Street Topsfield, MA 01983 USA 978-887-2141 (phone) 978-887-3689 (fax) www.fairviewmachine.us 514. Fort Wayne Metals 9609 Ardmore Avenue Fort Wayne, IN 46809 USA 260-747-4154 (phone) 260-747-0398 (fax) www.fortwaynemetals.com Fairview Machine is an ISO 13485 & ISO 9001 registered precision manufacturer of orthopaedic implants, spinal products and medical devices. Within a lean manufacturing environment with an extensive range of CNC capabilities, such as 5-axis high speed machining, 8-axis combination turning and milling in one operation and 5-axis Wire EDM, Fairview is able to achieve superior surface finishes and hold the tightest of tolerances on metal and plastic devices with the most challenging part geometries. Services include rapid prototyping, product launch, high production and vendor management inventory. We provide the best overall value for our customers. Precision Wire and Cable for Medical Products. Round wire, centerless and precision ground rod, strands, cables, flat wire and DFT™ wire. Starting stock for the most popular orthopaedic alloys including: 316LVM, titanium/ titanium alloys, L605, CCM®, Custom® 455, 17-7PH®, 17-4PH®, MP35N®, Nitinol, 304V and others. All of our production facilities and quality systems are geared specifically for producing medical grade products. Page 24 PressReady.indd 24 6/1/2011 1:28:40 PM Exhibitor Listing Premier Sponsor 609. GEHRING CUT AG Alte Poststrasse 5 9548 Matzingen Switzerland 011-41-52-369-6969 (phone) 011-41-52-369-6978 (fax) www.gehringcut.com 246-247. Greatbatch Medical 10000 Wehrle Drive Clarence, NY 14031 USA 716-759-5540 (phone) 716-759-2562 (fax) www.greatbatch.com GEHRING CUT AG from Switzerland is a very reliable contract manufacturer for challenging applications. Complete production of instruments and implants for orthopaedic surgery. For more than two decades, we’ve learned an extensive experience manufacturing hip, spine and knee instruments. With a state of the art machine shop, we guarantee quality you demand, from prototypes to long runs to the final inspection of assemblies. ISO 9001:2000 and ISO 13485:2003 certified. Greatbatch Medical is committed to the design and manufacture of critical technologies that enhance the reliability and performance of medical devices and procedures. We do this to ensure that our customers can continuously provide clinicians with better treatment options to improve patient outcomes. 319. Gibraltar Laboratories 122 Fairfield Road 16 Montesano Road Fairfield, NJ 07004-2405 USA 973-227-6882 (phone) 973-227-0812 (fax) www.gibraltarlabsinc.com 618. gSource, LLC 19 Bland Street Emerson, NJ 07630 USA 800-978-1119 (toll free) 201-599-2277 (phone) 201-599-3306 (fax) www.gSource.us ISO 17025 certified, A2LA accredited, FDA registered laboratory. An outstanding record with FDA and the broad outsourcing industry. Our advantages include a validated electronic reporting system and BSL-3 laboratory to provide consistent, rapid, and reliable results. Offering friendly, dependable and excellent customer service, customer loyalty has been an established result. We are always focused on quality, turnaround time and lasting strong relationships. The Orthopaedic reSource for Surgical Instruments. gSource is a trusted and reliable partner to many world leaders in orthopedics and spine. We provide superior instrumentation in a time-critical fashion and at realistic prices. From prototypes to full-run production, we are committed to being a valuable business partner, always providing a real return on investment. Page 25 PressReady.indd 25 6/1/2011 1:28:44 PM Exhibitor Listing 320. Hangsterfer’s Labs 175 Ogden Road Mantua, NJ 08051 USA 856-468-0216 (phone) 856-468-0200 (fax) www.hangsterfers.com 530. In’tech Medical Inc. 2851 Lamb Place #15 Memphis, TN 38118 USA 901-375-1109 (phone) 901-367-2977 (fax) www.intech-medical.com Coolants and lubricants used in all sectors of the metalworking industry. We are a family owned and operated company born in 1937. Together we will overcome costly machining problems, reduce down-time and maintenance costs and dramatically improve your company’s bottom line. Hangsterfer’s engineering staff and knowledgeable representatives are ready to answer your questions and solve your problems! Manufacturing Solutions for the Orthopaedic Industry. Contract manufacturer of orthopaedic and spinal instruments and implants. Management team with over 20 years of experience making products for the world’s leading orthopaedic companies. State of the art machinery and innovative processing techniques combine to provide comprehensive turnkey manufacturing solutions to your outsourcing projects. Let us be your manufacturing partner. ISO 13485:2003 certified. 625. International Titanium Association 2655 West Midway Blvd, Suite 300 Broomfield, CO 80020 USA 303-404-2221 (phone) 303-404-9111 (fax) www.titanium.org 408. Hansa Medical 11430 Tamiami Trail East Naples, FL 34113 USA 239-775-9090 (phone) 239-793-2940 (fax) www.hansa-medical.com Our main focus is the medical industry, creating precision devices for uses from vascular to orthopedics. Not only do we specialize in devices, but we fabricate high precision molds along with the core pin, core pin handles, holders and cavities. In order to provide extraordinary parts for our customers, we have a full range of machines and software to meet the stringent demands and tight tolerances that engineers demand. The quality scope of Hansa is ISO 13485 & 9001:2008 Certifications detailing the ability of our company to produce orthopedic implants and instruments, along with passivation & Class 10,000 clean room services. The International Titanium Association (ITA) is a membership based, international trade association dedicated to the titanium metal industry. ITA’s mission is connecting the public interested in using titanium with specialists from across the globe who may offer sales and technical assistance. ITA also sponsors workshops, committees and hosts the only annual TITANIUM conference. www.titanium.org. 308. Hoosier, Inc. 1152 California Avenue Corona, CA 92881 USA 951-272-3070 (phone) 951-272-8090 (fax) www.hoosierinc.com 518. Ionbond, Inc. 200 Roundhill Drive Rockaway, NJ 07866 USA 973-586-4700 (phone) 973-586-4729 (fax) www.ionbond.com With 3, 4, 5 and 7 axis machining, we offer the widest range of machining applications and complexity. We’ve done it all: implants, surgical instruments, inserters, plates, sizers, screws, fixation systems, caddies, trays, trials. We machine wet and dry, with dedicated cells for strictly dry implant machining. Plastic, SS, titanium, you pick the material, “We Will” deliver. Our Swiss turn capabilities utilize the latest in new technology to make your parts fast and to print. Ionbond is the leading international provider of BioCeramic coating products and services for the medical device industry. We offer state of-theart biocompatible coatings with technical consultation for instrument and implant applications. Our products have been tested for biocompatibility according to the complete ISO10993-1 protocol and are FDA Master Filed. Ionbond processes are well documented and are in conformance with ISO 9001:2008 and ISO13485:2003 Quality Management Systems. The processes are validated and meet the requirements of the Medical Device industry. 615. Infinity Plastics Group 5520 Industrial Road Mt. Vernon, IN 47620 USA 812-831-5106 (phone) 812-838-9301 (fax) www.infinity-mai.com INFINITY INFINITY PLASTICS GROUP Discover an easier way to develop new plastics products with a manufacturing partner who understands. Infinity Plastics Group understands what “speed to market” means to new programs. We understand what “well designed parts” means to new programs. Infinity understands what “total support” means to new programs. Why do we understand? Our engineers are experienced design experts who have launched thousands of successful injection molded plastics programs during our 29-year history. We can help you succeed. 326. Jarvis Surgical, Inc. 53 Airport Road Westfield, MA 01085 USA 413-562-6659 (phone) 413-562-1988 (fax) www.jarvissurgical.com Manufacture and Polishing of Orthopaedic Implants and Instruments. Contract manufacturer of hip femoral/acetabular and knee femoral/ tibial components, knee augmentation blocks, specialty screws, bipolar shells, standard and modular humeral components, including heads, trial components, instruments, spinal and trauma products. Our integrated hand and robotic polishing services are utilized by top orthopaedic OEMs. Page 26 PressReady.indd 26 6/1/2011 1:28:46 PM Risks are hiding everywhere in the orthopedic industry. This even includes the document that is meant to protect you from risks - your insurance policy. Our NewScience Insurance advisors will conduct a no-risk review of your current policy and let you know where your exposures lie. Call us at 440-248-4711 and let us shine a light on the risks in your policy. Visit NewScience Insurance at Booth 426 at OMTEC July 15-16, 2011 800-607-4711 | www.newscienceinsurance.com PressReady.indd 27 6/1/2011 1:28:48 PM Exhibitor Listing 109-208. Juno Inc. 1040 Lund Boulevard NW Anoka, MN 55303 USA 763-427-6141 (phone) 763-427-7252 (fax) www.junoinc.com Juno Inc. is an ISO 13485 registered full-service contract manufacturer specializing in micromolding, single and multishot injection and insert molding of engineering resins in various levels of clean environments from ISO Class 7 to Class 9. The company also manufactures custom sterilization cases and trays in anodized aluminum and stainless steel. Level 3 Inspection, a full-service ISO 9001 registered inspection & engineering firm, proudly introduces its Smart Inspection Station™, a supercomputer-equipped turnkey White Light Scanning solution ready for the orthopedic manufacturing floor. The SiS™ provides complete surface digitization to accuracies of 0.000040”, complete Computer Aided Inspection reports in minutes and traceable/trendable/trackable data with minimal operator training. 502. Maetta 75, De Mortagne Boulevard, Suite 109 Boucherville, Quebec J4B 6Y4 Canada 450-641-07534 (phone) 450-641-5468 (fax) www.maetta.ca 725. Kens FineMedtech Sdn. Bhd. Plot 19, Hilir Sungai Keluang 2, Phase 4, Free Industrial Zone, Bayan Lepas, Penang 11900 Malaysia 60-4-616-1356 (phone) 60-4-616-1353 (fax) www.kensfinemedtech.com Kens FineMedTech was incorporated in Malaysia in 2007. The company was formed to undertake the contract manufacturing of orthopaedic devices, dental devices, cases, trays and instruments. Our engineering team is enriched with the state-of-the-art technology to ensure superior quality products at all times to meet customers’ requirements and expectations. We offer design & development of orthopaedic & dental devices and instruments, prototyping and process development. ISO 13485: 2003 and FDA-510(k) Approval. 200. Knight Mechanical Testing 6016 B Highview Drive Fort Wayne, IN 46804 USA 260-489-1444 (phone) 260-818-2036 (fax) www.knighttesting.com ISO/IEC 17025:2005 Accredited - Independent Mechanical Test Laboratory KMT offers independent ISO/IEC 17025:2005 accredited mechanical testing services focused on ASTM, ISO and customer specified test methods for orthopaedic devices. Orthopaedic OEM laboratory experience - all MTS laboratory equipment. Can pot hips, knees and extremities and can design and fabricate specialty fixturing for trauma and spine products. 114. LAB Medical Manufacturing Inc. 28 Cook Street Billerica, MA 01821 USA 978-663-2475 (phone) 978-663-4364 (fax) www.labmedical.com 101. Level 3 Inspection/Smart Inspection Systems 3123 East Center Street Warsaw, IN 46582 USA 888-4AS-9102 (888-427-9102) (phone) 561-775-7911 (sales) www.level3inspection.com www.smartinspectionsystems.com LAB Medical Manufacturing, Inc. ISO 13485 certified and FDA approved manufacturer that has manufactured and supplied the highest quality instrumentation and implants to leading OEMs for over 25 years. Design assistance, precise dimensioning, process validating and fatigue-stress testing of implant components. We value and work hard to develop long-term relationships. Some of our customers have been with us since our inception. We partner with them on technical issues and understand their unique needs, the intangibles that make the difference in project success. Ready, we stand, to provide your company with prototyping and economical solutions. Maetta specializes in net-shape manufacturing of metallic and ceramic parts using the powder injection molding (PIM) manufacturing process. Client service is enhanced by working at all stages of the PIM process, “from powder to product,” to reduce costs and meet specific mechanical, chemical and dimensional requirements. Maetta works closely with its clients to reduce development and manufacturing costs of parts, improve design and create new materials with unique properties. Maetta also develops PIMbased prototyping tools, manufacturing equipment and engineering tools (the Maetta System™) aimed at increasing its clients’ product development capacity and prototyping flexibility as well as reducing time-to-market of products by accelerating transferability to high volume production. 413. Mahar Tool Supply Company, Inc. 3568 U.S. 30 East Warsaw, IN 46580 USA 574-267-0032 (phone) 800-456-2427 (toll free) 574-267-0076 (fax) www.maharmedical.com Distribution & Commodity Management in Cutting Tools & More! Specializing in metal-removal and distribution since 1947. Offering products, services and consultation to meet your tooling & inventory management needs. We take pride in offering custom solutions that generate bottom-line savings. ISO 9001:2000 and WBENC certified. 512. Makino 7680 Innovation Way Mason, OH 45040 USA 513-573-4584 (phone) 513-573-7360 (fax) www.makino.com A world leader in advanced CNC machining centers, Makino provides a wide range of high-precision metal-cutting and EDM machinery, including horizontal, vertical, 5-axis and graphite machining centers and wire and Ram EDMs. Our flexible automation solutions provide reduced labor costs and increased throughput in a variety of production volumes and designs. With Makino engineering services, we offer industry leading expertise for even the most challenging applications across all industries. Page 28 PressReady.indd 28 6/1/2011 1:28:50 PM Exhibitor Listing Event Co-Sponsor 214. Marketwire 200 West Adams Chicago, IL 60606 USA 312-261-4218 (phone) 312-261-4220 (fax) www.marketwire.com Marketwire advances the way the world communicates. We deliver news to traditional and social media audiences and leverage the latest in search engine optimization, multimedia, content management and social media analytics to maximize the power of our clients’ communications. For more information, visit us online at www.marketwire.com, www.marketwireblog. com, or on Twitter @marketwire. 425-427. Marox Corporation 373 Whitney Avenue Holyoke, MA 01040 USA 413-536-1300 (phone) 413-534-1829 (fax) www.marox.com Manufacturer of Standard and Custom Sterilization Containers, Cases, Trays & Devices. Experience with aluminum, SS, thermoformed plastics and hybrids. Computer-driven Total Process Control enables us to meet critical launch deadlines because we don’t outsource. Punching, bending, machining, milling, riveting, welding, clear or color anodizing and hard coating, nylon coating, surface or deep cavity silkscreening and laser etching. ISO 13485:2003 Certified. 513. Medivative Technologies 2950 North Caterwood Avenue Indianapolis, IN 46219 USA 317-547-3640 (phone) www.medivative.com Manufacturer of Implants, Instruments, Devices. Precision machining and assembly of orthopaedic, spinal and trauma implants and instruments. Specialties include CNC milling (up to 5-axis), CNC 7-axis mill/turn, CNC Swiss screw machining (up to 12-axis), CNC thread whirling, CNC wire/ ram EDM and assemblies. Services include prototypes, product launching, production, project management and vendor managed inventory. ISO 13485 registered. www.cambioceramics.com 312. Medin Corporation 90 Dayton Avenue, Building 16C Passaic, NJ 07055 USA 973-779-2400 (phone) 800-922-0476 (toll free) 973-779-2463 (fax) www.medin.com Design and development, prototyping, engineering, high and low volume manufacturing, Uniquely positioned to provide contract development and manufacturing services to orthopaedic companies. Whether your product is a powered surgical instrument, complex diagnostic instrument, high volume disposable or instrument case, our quality systems ensure the consistent quality and traceability that your products require. booth 142 OMTEC 2011 Page 29 PressReady.indd 29 6/1/2011 1:29:00 PM Exhibitor Listing Gold Sponsor 509. Metal Craft Machine & Engineering 13760 Business Center Drive Elk River, MN 55330 USA 763-441-1855 (phone) 763-441-0798 (fax) www.metal-craft.com 631. Minnesota Rubber & Plastics 1100 Xenium Lane North Minneapolis, MN 55441 USA 952-927-1400 (phone) 952-927-1470 (fax) www.mnrubber.com Metal Craft and Riverside are proud to be Woman Owned, World Class suppliers to the top OEM’s for over 30 yrs. With two state of the art fully validated facilities and dedicated staff of 190+, we provide superior quality in complex assemblies, surgical instruments & implants. We maintain a collaborative partnership with our customers in dFMEA and pFMEA to ensure quality in and cost out. We bring the Quality, Service and Innovation to you. Certifications: ISO 9001 & 13485, AS9100. Minnesota Rubber and Plastics: custom molder of components and assemblies. Specializing in silicone over-molding of surgical instruments and medical grade high-performance materials for implants. Services include product development, prototyping, manufacture and packaging. Class 10,000 & 100,000 clean rooms. Global manufacturing, ISO 13485 certified, FDA registered, FDA Class 1, 2 and 3 products including CE products. 826. Micro Machine Company 2429 North Burdick Street Kalamazoo, MI 49007 USA 269-388-2440 (phone) 269-388-5466 (fax) www.micromachineco.com 627. NeedleTech Products, Inc. 81 West Street Attleboro, MA 02703 USA 508-431-4000 (phone) 508-431-2156 (fax) www.needletech.com Micro Machine Company is a privately owned medical device contract manufacturer, offering full product support for concept, design for manufacturability, product launch and sustained manufacturing. Our core competencies include, complex surgical instrumentation, implants (including PEEK), packaging, labeling, VMI and a custom “cost-plus” fast Time to Market prototype program. Excellence in Everything We Do. Full service, ISO 13485:2003 certified manufacturer of specialty needles and related medical devices. Supplying the orthopaedic market with K-Wire, Steinmann Pins, Trocars and Guide Wires. Servicing the Vertebroplasty markets with Access Needles, Reamers, Biopsy Devices, Cement Delivery and Aspiration Needles. We satisfy our customers every day. Plastic components up to 14 ounces. Complete design, prototyping, tool making, R&D, compounding, clean room and testing services. 524. Microware Precision Co., Ltd. No.12, Keyuan 2nd Rd., Situn District Taichung City 40763 Taiwan 886-4-2463-6275 (phone) 886-4-2463-6276 (fax) www.microware.com.tw 426. NewScience Insurance, A Division of Britton-Gallagher & Associates Inc. 6240 SOM Center Road Cleveland, OH 44139 USA 440-264-1326 (phone) 800-607-4711 (toll free) 440-248-5406 (fax) www.newscienceinsurance.com www.Britton-Gallagher.com World leading manufacturer in metal machining for complicated geometric parts with high precision. We provide a total solution for any kind of metal cutting, especially for medical use stainless steel and titanium. In addition to providing top manufacturing service, we also offer design recommendations to help customers obtain better efficiency in manufacturing and cut the manufacturing cost. Platinum Sponsor 113. Millstone Medical Outsourcing, LLC 580 Commerce Drive Fall River, MA 02720 USA 508-679-8384 (phone) 508-679-8414 (fax) www.millstonemedical.com Millstone Medical Outsourcing is a leading and innovative provider of customized outsourcing solutions to the medical device industry. The company offers advanced inspection, sterile and non-sterile packaging, loaner kit processing and distribution to medical device and product manufacturers worldwide. Millstone operates three state-of-the-art facilities, the company’s two facilities in Fall River, Massachusetts and the strategically-located loaner processing and distribution center in Memphis, Tennessee. Superior quality service and improved ROI are advantages clients expect from Millstone Medical Outsourcing. We design a total insurance solution for the risks faced by orthopaedic device manufacturers and distributors, with a tailored portfolio of property and liability products to help protect your company’s balance sheet from the financial devastation of a loss or lawsuit. Orthopaedic companies are in a highly regulated environment and have very little time to sort out complicated insurance and risk management issues. We can help. 632. Norman Noble, Inc. 5507 Avion Park Drive Highland Heights, OH 44143 USA 216-761-5387 (phone) 216-761-0455 (fax) www.nnoble.com Norman Noble manufactures medical devices and implants to customer specifications in compliance with FDA regulations and ISO 13485:2003. Full capabilities include orthopaedic implant manufacturing, 7-axis contour milling, Swiss machining, laser machining & welding, EDM services and nitinol shape setting. Prototype services are also available. Page 30 PressReady.indd 30 6/1/2011 1:29:02 PM e v i s n o p t s n e R rume t s In utions Sol pinal S r fo ations c i l p p A PAK MANUFACTURING has been serving satisfied customers in the SPINAL market for more than ten years. Our style of superior service and responsiveness has made us a leader in the production of custom and specialty spinal instruments, with well over 45 active customers. Having our own facilities and equipment here in the USA has allowed us to distinguish ourselves by offering and performing to highly aggressive lead-time commitments while maintaining superior quality and competitive pricing. We understand your needs, let us be your instrument partner! • 90,000 Forgings In Stock Experienced manufacturer of all custom spinal instruments including cervical, thoraco-lumbar • and disc replacement Multi-axis CNC equipment and only certified materials provides optimal assurance of instrument • • • integrity Forging-based production insures highest value and aggressive lead times US manufactured in our own 30,000 square foot facility State of the art inspection equipment and facilities assures strict conformance to customer • requirements Unmatched responsiveness! "Manufacturers of custom and specialty hand held orthopaedic instruments from forgings" 704 South 21st Street, Irvington, NJ 07111 Tel (973) 372-1090 • Fax (973) 372-1091 Email [email protected] Website www.pakmanufacturing.com © 2006 PAK Manufacturing, Inc. All rights reserved. PressReady.indd 31 6/1/2011 1:29:07 PM Exhibitor Listing Platinum Sponsor 721. NSE-Automatech 790 boul. Industriel Granby, Québec J2G 9J5 Canada 450-378-7207 (phone) 450-378-9651 (fax) www.nse-automatech.com 331-333. Orchid Orthopedic Solutions 1489 Cedar Street Holt, MI 48842 USA 517-694-2300 (phone) 517-694-2340 (fax) www.orchid-orthopedics.com NSE-Automatech is specialized in the manufacturing of complex mechanical assembly for various industries: Aviation (Aircraft parts); Medical (complex surgical tools); Electronic; Automotive and Aerospace Worldwide leader in contract design and manufacturing for the orthopaedic, dental and cardiovascular markets. Our mission is to be the leader in contract medical design and manufacturing by compressing time to market, providing new technology and being the best total supplychain value. Comprising five divisions that offer an array of implants and instruments within the five core capabilities: design, forging, machining, plastics and coatings. Available Processes include: High precision CNC 3, 4 and 5 axes machining of typical and exotic materials; Unigraphics and Catia software programming; Wire and electrode EDM; TIG and MIG welding; Assembly room; Passivation room; Laser and dot peen marking and CMM inspection. 325. Oak View Tool Company 724 East Swihart Street Columbia City, IN 46725 USA 260-244-7677 (phone) 260-244-7466 (fax) www.oakviewtooling.com Oak View Tool, sister company to SGS Tool, is a global leader in production of rotary carbide cutting tools. This relationship provides Oak View Tool with a global reach and SGS Tool with local access to the orthopaedic industry. OVT specializes in state of the art quality cutting tools for the medical & industrial marketplace (certified to ISO 9001:2008 & ISO 13485:2003). Special carbide end mills & unique, custom designed stainless steel instruments are our competence. Located near Warsaw, Indiana (the orthopaedic capital). Let our experienced personnel provide you with quality, from design to delivery…fast. 313. Orthoplastics, Ltd. Grove Mill, Todmorden Road, Bacup Lancashire OL13 9EF United Kingdom 44-1706-871-200 (phone) 44-1706-875-726 (fax) www.orthoplastics.com Uniquely focused on Orthopaedic Plastics. Orthoplastics is the genuine one-stop-shop for both implantable and instrument grade materials. Quality and Process Controls are unsurpassed anywhere in the world. Our products include UHMWPE, PEEK, PMMA, POM (Acetal), PEI (Ultem), PPsu (Radel) plus a range of specialist materials. All certified using our inhouse laboratory that is also available for bespoke research. 825-827. Okuma America Corporation 11900 Westhall Drive Charlotte, NC 28278 USA 704-588-7000 (phone) 704-588-6503 (fax) www.okuma.com 730. OTEC Precision Finish Inc 44 Cross Park Avenue North Kingstown, RI 02852 USA 401-398-0045 (phone) 401-398-0056 (fax) www.otec.de Okuma America Corporation is a leading provider of CNC machine tools horizontal and vertical lathes, machining centers and grinders. Developer of the world’s first open-architecture machine tool control, THe Intelligent Numerical Control (THINC®), Okuma strives to provide metal-cutting operations with manufacturing solutions to increase productivity, improve quality, reduce costs and help them meet the exacting demands and quality required of the high precision medical device industry. Founded in 1996, OTEC has established itself as one of the most innovative and technologically advanced mass finishing equipment suppliers in the world. With offices and sales partners worldwide, OTEC can provide state of the art, high energy polishing and deburring systems for all orthopaedic implants and tools, bone plates and screws, spinal products, orthodontic devices and dental implants and tools. OTEC offers a wide range of centrifugal disc and drag finishing machines, from simple bench top units to fully automated systems. Put us to the test by sending us your samples. ISO 9001:2000 certified. Silver Sponsor 433. Onyx Medical Corporation 1800 North Shelby Oaks Drive Memphis, TN 38134 USA 901-323-6699 (phone) 901-454-0295 (fax) www.onyxmedical.net Onyx is your world-class manufacturing partner, offering vertically integrated solutions from concept design through dock-to-stock inventory for orthopedic cutting, nailing, fixation and navigation devices. Onyx is FDA registered, ISO certified and committed to delivering on your specifications and exceeding expectations – always. 718. Pacific American Life Science Learning Center 5288 Eastgate Mall San Diego, CA 92121 USA Life Science 866-943-4589 (phone) Learning Center 858-866-0760 (fax) www.LifeScienceLearningCenter.com The Life Science Learning Center is San Diego’s only private bio-skills facility designed for hands on training and education for medical professionals. Now offering a 10 station lab, complete with full locker rooms and a state-of-the-art auditorium with seating for up to 50 attendees. Check out a photo tour of our lab on YouTube: www.youtube.com/user/ pamsLSLC. Page 32 PressReady.indd 32 6/1/2011 1:29:09 PM BoneZone_OctAd_snipe:Layout 1 4/3/11 4:08 PM Page 1 Powerful Solutions From Concept Through Production & Every Step In Between Whether you’re starting with a napkin concept or a fully-designed product that you’d like to outsource, Pro-Dex delivers reliable electromechanical solutions for your medical/surgical products. Offering turn-key design, regulatory, and manufacturing expertise means no more dropped balls, restarts or finger-pointing - just peace of mind Product Feasibility Proof of Concept Detailed Design Validation & Verification Testing 13485 Manufacturing Post-Market Surveillance 800.562.6204 • www.pro-dex.com Pro-Dex, Inc., 2361 McGaw Avenue, Irvine, CA 92614 USA PressReady.indd 33 ISO 13485:2003-Certified Facility O Vi M si T t E u C s #2 at 09 and pure execution. 6/1/2011 1:29:10 PM Exhibitor Listing 118. Pacific Instruments Inc. 438 Hobron Lane, Suite 204 Honolulu, HI 96815 USA 808-941-8880 (phone) 808-941-8833 (fax) www.pacificinstruments.biz 122. PCC Structurals, Inc. 4600 SE Harney Drive Portland, OR 97206 USA 503-652-4643 (phone) 503-794-2047 (fax) www.pccstructurals.com Founder and President Holger Gruenert, formerly of KMEDIC, started Pacific Instruments in 2005 in his living room and has catapulted the company to become a top globally recognized contract manufacturer and procurement source of orthopedic and custom surgical instruments. Now, equipped with its ISO 13485 certification and well-positioned as a proven player in the industry, this year of 2011 marks the company’s debut with the largest OEMs in the industry and will continue its relentless pursuit to source them the best surgical instruments while contributing its technical expertise in the process. PCC’s manufacturing casting technologies have been built up by blending the combined knowledge of our highly trained technical staff across more than 50 years. We have the engineering strength, technical knowledge and manufacturing resources to support any project whether it is tool design, tool transfer, quick to cast or problem solving a “Barrier to entry” issue on any project. We encourage you to work with PCC Medical and join our long lasting tradition of excellence in supporting the medical market casting needs. ISO 13485 Certified. 508. PAK Manufacturing, Inc. 704 South 21st Street Irvington, NJ 07111 USA 973-372-1090 (phone) 973-372-1091 (fax) www.pakmanufacturing.com Custom & Specialty Handheld Surgical Instruments. Hand-finished, forged surgical instruments made in the USA! We specialize in custom configurations, built from raw forgings (not other instruments). Prototypes often shipped within 10 days for your approval; production quantities typically shipped within 8 weeks. In-house manufacturing capabilities include milling, grinding, heat treating, passivation, polishing. FDAregistered. 140. Paragon Medical 8 Matchett Industrial Park Drive Pierceton, IN 46562 USA 574-594-2140 (phone) 41-21-320-37-85 (Europe) 574-594-2154 (fax) www.paragonmedical.com Paragon Medical is a turnkey supplier of world-class solutions for design and development, cases and trays, surgical instrumentation and implantable components to the medical device marketplace. Headquartered in the orthopaedic capital of the world, Paragon has created strategic centers of excellence within the U.S., Europe and Asia. Dynamic acquisitions have brought some of the industry’s most talented craftsmen to our team while regional centers of manufacturing excellence have made us more versatile. 620. Piper Plastics, Inc. 1840 Enterprise Court Libertyville, IL 60048 USA 847-367-0110 (phone) 847-367-0566 (fax) www.piperplastics.com Piper Plastics, Inc. is a full service materials processing, machining, fabrication and polymer development company. We offer innovative polymer-based products and services for medical applications. As an ISO 9001:2008 and 13485 certified manufacturer, Piper specializes in high performance polymers such as implantable and medical grades of PEEK, CF PEEK, PrimoSpire, Ultem and Radel. With facilities in Arizona, Illinois, China and Thailand we support global manufacturing. Solutions in medical polymers for orthopedic implants and trials, devices, instruments, imaging components and assemblies. 432. PMC Medical 2181 Grand Avenue Cincinnati, OH 45214 USA 513-921-5040 (phone) 513-921-5883 (fax) www.pmcsmartsolutions.com PMC Medical is an ISO 13485 certified contract manufacturer of Orthopedic biomaterial implants and surgical devices. PMC has proprietary processing techniques for PEEK, bioresorbables and high-temperature thermoplastic materials. With over 80 years of experience, PMC’s services include design for manufacturability, hyper-precision injection molding, assembly, packaging, and sterilization management. PMC is based in Cincinnati, Ohio, with facilities in Indiana, Mexico and Germany. 224. PartMaker 540 Pennsylvania Avenue, Suite 315 Fort Washington, PA 19034 USA 215-643-5077 (phone) 215-653-0105 (fax) www.partmaker.com 600. PPD Meditech 50 Raymond Waterville, Quebec J0B 3H0 Canada 819-837-2491 (phone) 819-837-3083 (fax) www.ppdgroup.com PartMaker is the world-leading CAM system for automating the programming of multi-axis Turn-Mill centers and Swiss-type lathes. Having pioneered the market in CAM software for multi-axis turning, PartMaker is more experienced and provides the most advanced technology in the market today. We work with all multi-spindle, multiaxis and applies a Patented Visual Programming approach to make CNC programming quicker and easier. Your medical device outsourcing partner. 100% medical manufacturing facility. ISO 13485:2003. Proprietary direct compression molding technology and precision dry machining. Prototyping and production runs. Clean rooms. Molding capabilities: Delrin®, PEEK-Optima®, PEEK continuous strand CF, PLLA, Radel®, UHMWpe, Vit E UHMWpe, e-CIMA/CIMA crosslinked UHMWpe, Ultem®. Page 34 PressReady.indd 34 6/1/2011 1:29:12 PM Exhibitor Listing 613. Praxis Technology 604 Queensbury Avenue Queensbury, NY 12804 USA 518-812-0112 (phone) 518-812-0115 (fax) www.praxisti.com 420. Precision Piece Parts, Inc. 712 South Logan Street Mishawaka, IN 46544 USA 574-255-3185 (phone) 574-255-2086 (fax) www.ppp-inc.com Praxis Technology offers powder titanium to manufacture implants with innovative features at a significant cost savings. Our tagline is “Leading the titanium revolution from powder to parts.” Praxis specializes in Titanium Metal Injection Molding “TiMIM” for vascular access, cardiac and dental applications, and our porous 3DT™ for ingrowth applications in spine and orthopedics. Innovative Precision Machining and Outstanding Customer Service since 1942. Implant machining since 1991. Five-axis machining, CNC Swiss machining. Extensive bone screw and accessory manufacturing experience. FDA registered. ISO 9001 certified. 226. Precision Metal Products 850 West Bradley Avenue El Cajon, CA 92020 USA 619-448-2711 (phone) 619-448-2005 (fax) www.pmp-elcajon.com Orthopaedic Implant Forgings in Titanium, Cobalt-Chrome-Molybdenum, Stainless Steel and Customer Specific Alloys. We are ISO 9001:2000 certified, and our in-house capabilities include heat treating, lab testing, 4-axis and 5-axis CNC machining, chemical milling, secondary finishing operations and complete tool design and fabrication. ISO 9001:2000 certified. 209. Pro-Dex Inc. 2361 McGaw Avenue Irvine, CA 92614 USA 949-769-3200 (phone) 800-562-6204 (toll-free) 949-769-3280 (fax) www.pro-dex.com Pro-Dex, Inc. designs, manufactures and assembles powered medical devices, motors and motion control products for leading OEMs in the medical, dental, factory automation and scientific research markets. ProDex specializes in manufacturing safe and reliable devices to withstand environments where saline, high pH solutions and biomatter are common. As a FDA-registered, 13485-certified manufacturer, Pro-Dex offers full regulatory support to help get products to market quickly and effectively. Page 35 PressReady.indd 35 6/1/2011 1:29:14 PM Exhibitor Listing 724. Professional Plastics 1810 E. Valencia Drive Fullerton, CA 92831 USA 814-440-1245 (phone) 814-864-0082 (fax) www.ProfessionalPlastics.com 813. Richards Micro Tool 250 Cherry Street Plymouth, MA 02360 USA 800-233-9956 (toll free) 800-642-8665 (fax) www.richardsmicrotool.com Professional Plastics is a global plastic distributor for sheet, rod, tubing, machined and formed parts. Products in our line include: PEEK, Ultem, PTFE, PFA, FEP, Delrin, Nylon, PET, UHMW, Meldin, Evonik PEEK resin, and Solvay Radel resin as well as the Rochling line of Medical Grade materials to name a few. Visit us on the web at www.ProfessionalPlastics. com. Richards Micro Tool, where ingenuity, technology and 45+ years of experience combine to provide the finest Rotary Cutting Instruments (drills, taps, reamers, burrs) for leading dental, orthopaedic and neurological OEMs. Richards also offers contract manufacturing services & an extensive line (890+ products) of industrial off-the-shelf cutting tools. Gold Sponsor 630. Promimic AB Stena Center 1b Gothenburg, SE-412 92 Sweden 46-31-772-80-22 (phone) www.promimic.com MIMICING HUMAN BONE 212. Rochling Engineering Plastics 903 Gastonia Technology Parkway Dallas, NC 28034 USA 704-884-3506 (phone) www.roechling-plastics.us The HAnano Surface™ is an osteoconductive interface between human tissue and implant. The 20nm thin HAnano Surface will dramatically accelerate osseointegration. It can be applied on all implant materials, giving a thin layer of synthetic bone. The surface has excellent compatibility with ceramics, metals, pyrocarbon as well as PEEK and can even be applied on porous structures. Promimic is looking for partners in the global implant industry. Röchling Engineering Plastics provides a complete line of Medical Grade plastics for medical devices, medical instrumentation and orthopedic trials such as surgical instruments and devices, orthopedic sizing trials, imaging and monitoring, surgical trays, diagnostic equipment, dental equipment and devices, pharmaceutical manufacturing and biotechnology. Featured products are SustaPEEK MG, Sustason PPSU MG (Radel® R), SustaPEI MG (Ultem®), Sustarin® C MG Acetal. Röchling offers the following certificates: ASTM, USP Class VI & FDA compliant (as applicable), lot & batch traceability and ultrasonic testing. 124. Pulse Technologies, Inc. 2000 AM Drive Quakertown, PA 18951 USA 267-733-0200 (phone) 267-733-0201 (fax) www.pulsetechinc.com 112. Rolled Alloys 125 West Sterns Road Temperance, MI 48182 USA 734-847-0561 (phone) 800-521-0332 (toll free) 734-847-6917 (fax) www.rolledalloys.com We are an ISO 9001:2000 and ISO 13485:2003 Certified and FDA registered contract manufacturer of precision-machined components. Our team approach has successfully provided our customers on-time quality products. Capabilities: Swiss screw machining, wire/RAM EDM, CNC milling, titanium anodizing, wire forming, laser welding/marking and assembly. Materials: platinum, gold, stainless steel, titanium, MP35N, Nitinol. Exotic plastics: PEEK, Radel, Ultem and HDPE. Rolled Alloys is a premier approved source for titanium and stainless in medical and aerospace applications. We are certified to ISO 9001:2000 and AS9100 Revision B. We offer Ti 6-4 ELI to the ASTM F136 specification and 6-4 to the ASTM F 1472 specification. Rolled Alloys offers 17-4, 300 series, and 400 series. Material is offered in precision ground rod, bar, and plate. Value added processes such as precision saw cutting, water-jet cutting and shearing are all performed on site. Our main focus is on providing quality material to specifications and providing excellent service. 346. Quadrant/MediTECH Medical Polymers 2710 American Way Fort Wayne, IN 46809 USA 260-479-4290 (phone) 260-478-1074 (fax) www.meditechpolymers.com 321. Rollomatic, Inc. 1295 Amour Boulevard Mundelein, IL 60060 USA 847-281-8550 (phone) 847-281-8558 (fax) www.rollomatic.ch Quadrant EPP is the world leader in stock shape engineering plastics with a full line of Life Science products tested for biocompatibility to ISO 10993 and USP requirements. Quadrant EPP is the parent company of MediTECH, the leading supplier for decades to the orthopedic industry with its UHMW-PE. We work closely with you to anticipate your future needs while continually searching for ways to exceed your expectations. Your success and satisfaction is the measure of our performance. Rollomatic is a leading Swiss manufacturer of CNC grinding machines serving the medical, industrial and aerospace industries. Our ShapeSmart series grinders offer the tightest tolerances and highest accuracy for grinding all manner of cutting tools. We offer unique workholding applications and proven solutions for the precision manufacturing of medical & dental drills, burs, taps, reamers, shavers and other orthopedic cutting tools. With a full range of models to accommodate diameters from 0.05 mm – 31.75 mm, Rollomatic has your medical grinding solution. Page 36 PressReady.indd 36 6/1/2011 1:29:16 PM Curbell_Omtec_Full_Page_Ad.qxp:Layout 1 5/5/11 10:41 AM Page 1 CURBELL PLASTICS Plastics for Orthopedic and Medical Applications AVAILABLE MEDICAL-GRADE POLYMERS: • Radel® R (Sustason PPSU MG) • PEEK (SustaPEEK MG) • Acetal (Celcon®) (Sustarin® C MG) • Polysulfone (Sustason PSU MG) • Polypropylene (Polystone® P MG) • Noryl® (Susta PPO MG) • Ultem® (SustaPEI MG) Medical-grade materials comply with agency standards including USP Class VI, ISO 10993-5, and FDA, call your Curbell Plastics sales rep for more information HOW CURBELL PLASTICS CAN BENEFIT YOUR BUSINESS: • ISO 9001:2008 quality management system • Lot and batch traceability • Providing paperwork and certifications • Material selection assistance • Technical support Put us to work – for you! TM Curbell Plastics has been supplying plastic sheet, rod, tube, films, adhesives, sealants, tapes, prototyping and tooling materials, and fabricated parts for over 65 years Our medical-grade partner NATIONWIDE 1.888.452.6027 www.curbellplastics.com ©2011 Curbell Plastics, Inc. All other trademarks and service marks are property of their respective manufacturers. MAP1010B 0511 PressReady.indd 37 6/1/2011 1:29:17 PM Exhibitor Listing Gold Sponsor 220. rose plastic, USA LP P.O. Box 698 California, PA 15419 USA 724-938-8530 (phone) 724-938-8532 (fax) www.rose-plastic.us 327. Seabrook International, LLC 15 Woodworkers Way Seabrook, NH 03874 USA 603-474-1919 (phone) 603-474-1833 (fax) www.seabrookinternational.com rose plastic has offered protective plastic packaging services for 50+ years. The company provides a range of protective plastic packaging for various applications, including medical, school, hobby, home, office, cutting tools and sports. rose plastic’s packaging provides protection during shipping, handling and storage. We Are Dedicated To Our Customers’ Success! Leading contract manufacturer of highly engineered precision instruments, implants and other devices for the orthopaedic industry. Seabrook has become an integral supplier to many of the world’s largest orthopaedic device manufacturers through its differentiated approach toward customer service, medical device quality systems and dedication to true partnerships. 519-521. Rosler Metal Finishing 1551 Denso Road Battle Creek, MI 49037 USA 269-441-3000 (phone) 269-441-3001 (fax) www.rosler.us Rosler Metal Finishing offers the widest range of surface finishing equipment in the industry, including mass finishing and shot blasting equipment, media, compounds and effluent treatment. We serve North American customers from our 300,000 sq. ft. manufacturing campus in Battle Creek and support global customers through our worldwide network. Our company slogan “finding a better way...” is exactly what we do. After evaluating what the end result should be, our highly-trained employees choose from the most extensive product range in the industry to develop unbiased, cost-effective solutions. Send us your challenge. 525. RTI International Metals 827 Marshall Phelps Road Windsor, CT 06095 USA 860-688-8393 (phone) 860-683-2337 (fax) www.rtiintl.com RTI International Metals has over 50 years of titanium mill manufacturing experience and produces the highest quality titanium alloy mill products available. Our U.S. based mill capabilities are complemented by our full service U.S. and International distribution operations that can provide our biomedical customers 6AL-4V ELI sheet, plate, round and rectangle bar. In addition to Titanium, we are a distributor of Nickel, Stainless and Alloy Steels with added value capabilities. 614. SHL Automation, Inc. 5126 South Royal Atlanta Drive Tucker, GA 30084 USA 770-934-0526 (phone) 770-934-3384 (fax) www.shl-automation.com SHL offers the latest innovations in automated surface finishing. For grinding, polishing, measuring, brushing, milling, deburring, etc., SHL offers a customized, turn-key operation. From consulting and design through project management, production, programming and training, we do it all in-house. SHL creates custom solutions that are made to measure. Platinum Sponsor 418. Solvay Specialty Polymers, LLC 4500 McGinnis Ferry Road Alpharetta, GA 30005-3914 USA 770-772-8580 (phone) 800-621-4557 (toll free) 770-772-8454 (fax) www.solvayadvancedpolymers.com We offer more ultra and high-performance medical plastics than any other company in the world. This includes Radel R polyphenylsulfone, Udel polysulfone, PrimoSpire self-reinforced polyphenylene, Ixef polyarylamide, KetaSpire PEEK and AvaSpire modified PEEK. Our polymers can be sterilized using all conventional sterilization methods and comply with ISO 10993:1 requirements for limited exposure applications. 100. SAYAN Orthopaedics Ltd. Karacaoglan Mahallesi Isiklar Carsisi, 6172 Sokak No:1/2 35070 Isikkent/Izmir Turkey 90-232-472-27-78/79 (phone) 90-232-472-27-76 (fax) www.sayan.com.tr 812. Sonoscan, Inc. 2149 E. Pratt Boulevard Elk Grove Village, IL 60007 USA 847-437-6400 (phone) 847-437-1550 (fax) www.sonoscan.com SAYAN, highly skilled in orthopaedics, was founded in November 2005 to design and manufacture orthopaedic instruments and instrument sets as well as OEM implants by using the knowledge and experience gained in producing orthopaedic implants for more than 15 years. The company continues to operate as a global provider of orthopaedic instruments and implants on OEM basis.With headquarters in Izmir/Turkiye, SAYAN Orthopaedics serves 15 customers in 11 different countries. Sonoscan is a manufacturer of Acoustic Microscope Imaging (AMI) systems for laboratory and production needs, and provides contract analytical laboratory services. AMI is a nondestructive inspection technique that utilized high-frequency ultrasound to image and detect a wide variety of material flaws, defects, and/or failures. The bond quality between materials, such as ceramics, plastics, metals, etc., is easily seen and quantifiable, too. AMI can also be used to characterize or screen a material prior to further processing. Page 38 PressReady.indd 38 6/1/2011 1:29:25 PM Full Service Finishing Solutions for the Orthopedic Industry • • • • • • • Chrome Plating Electropolish Passivation Heat Treatment Hand Polishing Laser Etching Heavy Gritt Validated processes ISO 13485 Certfified When you turn to Finishing Innovations, you turn to the market leader in orthopedic metal finishing. We specialize in finishing instrument components to completion for assembly and delivery to market. We provide superior customer service and quality crasmanship Put over 60 years of combined orthopedic metal finishing experince to work for you www.finishinginnovations.com Main: 901-294-2848 / Fax: 901-294-3070 / 578 Hwy 70 / Mason TN, 38049 PressReady.indd 39 6/1/2011 1:29:26 PM Exhibitor Listing 442-443. Southeastern Technology 905 Industrial Drive Murfreesboro, TN 37129 USA 615-890-1700 (phone) 877-789-2500 (toll free) 615-890-2914 (fax) www.southeasterntech.com 409. Tecomet Wilmington Facility 115 Eames Street Wilmington, MA 01887 USA 978-642-2400 (phone) 978-658-4334 (fax) www.tecomet.com Manufacturer of Orthopaedic Implants and Instruments. SET’s supply chain solutions are designed to reduce cost and enhance overall customer performance. Our sales engineers have the technical knowledge and skill required to be your project liaison from concept through completion. SET is your single source solution. ISO 13485:2003, ISO 9001:2000, compliant to CFR 21 Part 820. Extreme Performance in Orthopedics™. Tecomet is an innovative manufacturing partner with the capacity and flexibility to perform under extreme conditions. We bend over backwards to provide engineered solutions, reduced time-to-market and contain costs. State of the art technologies, innovative, on-demand manufacturing and flexible management has made us a leader for more than 30 years. ISO 9001:2000, 13485:2003 Certified. Foreign Manufacturer Certified/Japan. 309. S.S. White Medical 151 Old New Brunswick Road Piscataway, NJ 08854 USA 732-474-1717 (phone) 732-474-1817 (fax) www.sswhitemedical.com 121. Tegra Medical 9 Forge Park Franklin, MA 02038 USA 508-541-4200 (phone) 508-553-4100 (fax) www.tegramedical.com S.S. White Medical is a leading designer and manufacturer of outstanding hand held surgical instruments for the orthopedic market. We specialize in torque and ratcheting handle instruments as well as flexible shaft based devices. We have expertise in complicated instruments requiring tight tolerancing and precision assembly work. We are an ISO 9001 company and have partnered with most of the leading orthopedic OEMs in North America. Our engineering team is always available to work with your designers to create great performing instruments quickly. We look forward to the opportunity to work with you on your next project. Tegra Medical is a leading supplier of implants, reusable instruments and single use devices for orthopaedics. We offer Swiss-style turning, gun drilling, CNC milling/turning, EDM, wire/tube forming, stamping, centerless grinding, laser processing, electrochemical machining, needle pointing, finishing, insert molding and assembly. We are ISO 13485:2003 and ISO 9001:2008 registered with 200,000 sq. ft. of modern manufacturing space in four sites, including Boston, Memphis and Costa Rica. Visit us online at www.tegramedical.com. 412. Supra Alloys, Inc. 351 Cortez Circle Camarillo, CA 93012 USA 805-388-2138 (phone) 800-647-8772 (toll free) 805-987-6492 (fax) www.supraalloys.com 533. Teleflex Medical OEM 5307 95th Avenue Kenosha, WI 53144 USA 262-657-2800 (phone) 800-295-8505 (toll free) F262-657-2800 (fax) www.teleflexmedicaloem.com Titanium for Medical Devices. Plate, sheet, strip, foil, billet, bar and wire. Bar inventory is centerless ground to +/-.0005” and to precision tolerances of +/-.00025” or better. In-house sawing, shearing and waterjet capabilities. Ti 6AL4VELI in various rectangular bar sizes. Inventory certifiable to ASTM F136, F67, F1472 specifications. Testing and certification can be provided for other OEM specifications. We transform ideas into market-ready products! As your product development partner, we will guide your latest innovation through engineering, prototyping, manufacturing and assembly. We are known for our surgical instruments for orthopaedic and spinal procedures, rod management systems, ratcheting drivers, torque-limiting and measuring instruments, implant systems, sutures, performances fibers and bone fixation devices. 225. Surface Dynamics LLC 231 Northland Boulevard Cincinnati, OH 45246 USA 513-772-6635 (phone) 513-772-0825 (fax) www.sdbiocoatings.com 821. Tenergy Corporation 436 Kato Terrace Fremont, CA 94539 USA 510-687-0388 (phone) 510-687-0328 (fax) www.tenergybattery.com Surface Dynamics is a medical device coating company with manufacturing plants in Cincinnati and Memphis, offering the following: Controlled Atmospheric Plasma Spray or Vacuum Plasma Sprayed, Air plasma Spray, Titanium & Hydroxyapatite Coatings on PEEK (new breakthrough technology), metallurgical laboratories, as well as, Laser and E-Beam Sintering. SD is also in the process of introducing Rapid Manufacturing services. Tenergy is a market leader in offering rich selection of innovative and conventional power related products, including batteries, chargers, custom power solutions and mobile power accessories. Our product lines are specifically engineered and designed for markets including Consumer Electronics, RC Hobby & Airsoft, Tactical & Law Enforcement, Industrial, Medical and OEM Application. Located in the heart of the Silicon Valley, California, Tenergy is the ideal partner for domestic sales, support, distribution and large scale production. Page 40 PressReady.indd 40 6/1/2011 1:29:27 PM Exhibitor Listing 727. TeroLab Surface SAS ZI Rue Jean Pierre Timbaud BP 3 Villeneuve le Roi, F-94290 France 33-1-49-61-3434 (Phone) 33-1-45-97-0784 (Fax) www.terolabsurface.com 324. Titanium Industries 18 Green Pond Road Rockaway, MJ 07866 USA 973-983-6229 (phone) 973-983-8015 (fax) www.titanium.com Surface engineering, coating and repair solutions. By using modern management techniques and respecting human, environmental and lifefriendly values, TLS is a successful, profitable and high quality international enterprise. TLS is a wholly-owned subsidiary of TeroLab Surface. An innovator with long experience in coatings for Implantable Medical Devices, we are the partner of choice for the world’s best known manufacturers. With more than 900,000 orthopaedic implants coated in more than 20 years of excellence, TeroLab Surface SAS has contributed to the success story of the cementless prosthesis, now the leading implant on the world market. Titanium Mill Products. We are the premier distributor of titanium mill products used for surgical implant applications. Throughout our titanium service center network across the U.S. and Canada, we stock the most extensive inventory of ASTM specifications of titanium bar, billet, plate, sheet and wire products. ISO 9001:2000 and AS9100A certified. 612. TESco Associates 500 Business Park Drive Tyngsboro, MA 01879 USA 978-649-5527 (phone) 978-649-5529 (fax) www.tescoassociates.com 221. Tornos Technologies 840 Parkview Boulevard Lombard, IL 60148 USA 630-812-2040 (phone) 630-812-2039 (fax) www.tornos.us “Your Name is on it, with our reputation built into it!” For a quarter century, TESco Associates has been a leader in absorbable device development and manufacturing. Let our expertise and state-of-the-art facility work for you. With proven experience in a wide range of polymers, we take your device fromAM-OMTECHalfPageProgram5-10-11.pdf concept to manufacturing. We are ISO 13485:2003 certified and 1 5/10/11 11:53 AM maintains 12 class 10,000 cleanrooms all devoted to Biomaterials. Solutions Provider for the Medical Industry. Tornos builds “Swiss” type turning machines, used in the manufacture of various components from many medical fields. Components include but are not limited to bone screws, spinal and dental implants, arthroscopic devices and instruments. Let Tornos review your requirements and work with you to find a solution. C M Y CM MY CY CMY K Page 41 PressReady.indd 41 6/1/2011 1:29:29 PM Exhibitor Listing 527. Total Plastics, Inc. 7508 Honeywell Drive Fort Wayne, IN 46825 USA 260-490-3500 (phone) 800-288-1444 (toll free) 260-490-3600 (fax) www.totalplastics.com 119. United Orthopedic No 57 Park Avenue 2 Science Park Hsinchu 300 Taiwan 866-3-577-3351 (phone) 866-3-577-7156 (fax) www.uoc.com.tw We partner with leading manufacturers, raw material suppliers and related industry resources to bring you the highest level of service and technical support. Specializing in thermoplastics such as acetal copolymer, Ultem, Radel R, UHMWPE (implantable grade), heat stabilized polypropylene, carbon-filled and unfilled grades of PEEK. Recent product offerings include PEEK for long term human implantation. We also offer a complete line of medical grade tubing and tape. Founded in 1993, the United Orthopedics Corporation (UOC) manufactures orthopedic implants, instruments and precision medical devices. UOC is one of the only orthopedic manufacturers based in Asia that is fully certified by internationally recognized quality standards including cGMP, ISO, CE mark and FDA 510(k). Since 1993, the company has developed a full range of prostheses with more than 100,000 successfully implanted worldwide. In addition to producing its own branded products, UOC has also served as an OEM supplier for various industry conglomerates. 318. Triangle 116 Pleasant Avenue Upper Saddle River, NJ 07458 USA 201-825-1212 (phone) 201-236-9814 (fax) www.trianglemfg.com 714. Universal Precision Instruments, Inc. 1120 D.I. Drive Elkhart, IN 46514 USA 574-264-3997 (phone) 888-941-3997 (toll-free) 574-262-8937 (fax) www.universalpi.com Engineering and Manufacturing Partners for Medical Device Breakthroughs. For 50+ years we have been a customer focused, value-added engineering and manufacturing partner. Design, development, prototyping and preproduction to volume production to get you from concept to market faster and more economically. With emphasis on innovative manufacturing solutions, Triangle achieves the highest quality standards. Registered ISO 13485:200321, CFR Part 820 and ISO 9001:2008. Precision Machined Instruments, Implants & Guidewires for Orthopedic & Spinal Applications. Providing reliable, respected and high quality contract manufacturing since 1978. Utilizing state of the market equipment to satisfy a wide range of needs including but not limited to Swiss Turning, MultiAxis Milling, Wire EDM, Laser Etching, Complex Threading, Gundrilling and Metal Finishing. 115. Trigon International 999-C Remington Boulevard Bolingbrook, IL 60440 USA 630-378-9990 (phone) 866-TRIGON3 (toll free) 630-378-9991 (fax) www.etrigon.com 708. Vistek Medical 153 Railroad Avenue Ivyland, PA 18974 USA 215-357-6956 (phone) 215-357-3675 (fax) www.vistekmfg.com State of the art manufacturing facilities are only the beginning. Every person at Trigon takes tremendous pride in the quality of our products and service we provide to our customers. We are a manufacturer of precision machined components and assemblies, short runs through high production. Our focus is to be the most highly regarded manufacturing resource to our customers. Vistek Medical is an ISO 13485 certified contract manufacturer focusing on partnerships serving the orthopedic and spine markets. Vistek has the machining capability and expertise to support your contract manufacturing needs across a variety of applications. Whether you need implants for spine, trauma, or extremity applications, Vistek provides the production expertise and the customer service to support your program from cradle to grave. 726. Twin City EDM and Manufacturing 7940 Ranchett Road Northeast Fridley, MN 55432 USA 763-783-7808 (phone) 763-783-7842 (fax) www.twincityedm.com 314. Vulcanium Metals Incorporated 3045 Commercial Avenue Northbrook, IL 60062 USA 847-498-3111 (phone) 888-326-7556 (toll free) 847-498-2810 (fax) www.vulcanium.com We are a 51-year-old contract manufacturer of precision machined medical products with core competencies of Milling, Swiss Turning, Wire and Sinker EDM, Micro-Hole Popping and Laser Marking. We do not make molds or dies, but piece parts and assemblies. We excel at manufacturing medical and dental components and surgical instrumentation. Quick-turn prototypes, short-, medium- and high volume manufacturing. Our robotic integration allows us to run higher volume jobs very competitively in a lights-out environment. We provide design for manufacturability advice and are very good at developing solutions for difficult parts. Vulcanium Metals Incorporated carries a full range of medical titanium 6AL-4V ELI, 6AL-4V and commercially pure grades of bar, sheet and plate. Our FIRSTCUT+ Services include First-Stage Processing: Water Jet, Cut-to-Length, Laser, Precision Shearing, Sawing, Chamfering, First Stage Machining, Deburring and Finishing; Inventory Management - JIT, Kanban; Epak electronic documentation within 24 hours of order shipment; Same/ Next Day shipping; Consignment Programs. ISO 9001:2000 Certified. Lean. Page 42 PressReady.indd 42 6/1/2011 1:29:32 PM Exhibitor Listing 732. Walter (A United Grinding Company) 5160 LadLand Drive Fredricksburg, VA 22407 USA 540-898-3700 (phone) 540-898-6819 (fax) www.grinding.com World leader in grinding machine technology and support. We combine a proven, patented machine design, linear motors, superior coolant delivery and innovative new software to bring you NXis Ortho: shorter cycle times for lowest cost-per-part, whether implants or instruments; a better endproduct that minimizes post-processing; versatility for a wide variety of components; fast programming and setup; superior support to maximize up-time and help you adapt to changing requirements. Special Thanks A very special thank you to these industry exhibitors who have been with us from OMTEC 2005 to OMTEC 2011. Thank you for your support! Acme Manufacturing Co. Ensinger Inc. FMI Medical Instruments Inc. Ionbond-Medthin 213. ZOLLER Inc. 3753 Plaza Drive Ann Arbor, MI 48108 USA 734-332-4851 (phone) 734-332-4852 (fax) www.zoller-usa.com ZOLLER’s focus is tool presetting, tool measuring and inspection, and tool management software. Our products are used in factories all over the world. Everywhere you find CNC machines, you will find ZOLLER. Our preset and inspection machines make CNC machines more efficient as a tool’s measurements can be fully automatically and accurately determined while the CNC machine is still running. Accuracy means less waste, less CNC machine downtime and more profit. Marox Corp. Medin Corporation Metal Craft NewScience Insurance Onyx Medical Corp. Orchid Orthopedic Solutions PAK Manufacturing Inc. Paragon Medical Inc. Tecomet Teleflex Medical OEM Vistek Medical Vulcanium Metals Inc. Page 43 PressReady.indd 43 6/1/2011 1:29:36 PM COMPANY Las er Pro ces sin Im g pla nt/ Ins t rum Pro ent du ct Ma De chi sig nin n/D Pa g cka ev/ gin Inc g/S ub ter Re i liza g/C tio lin n Aff airs Ra / T wM ech ate Wr rial itin So s g ftw are So lut Su ion rfa s c Tre e Pre atm p/ ent s Ot her Booth # Co mp on ent Pa De rts live ry Sys t em De vic s eT est ing Eq uip me nt/ Ma Fo chi rgi ner ng y COUNTRY Ca stin g Index of Exhibitors by Capabilities CA CP LP DS DT EM FO MM Canada 715 AccelLAB Inc. USA 633 Acme Manufacturing Company CP USA 526 Advantage Manufacturing Technologies, Inc. CP USA 430 AeroMed, Inc. MM USA 424 AIP MM Taiwan USA 720 719 Alliance Global Technology Co Ltd American Express Open MM USA 116 American Tool & Die, Inc. MM USA 832 APS Materials Sweden 532 Arcam AB USA 602 Arwood Machine Corp CP USA 520 ASTRO Medical Devices CP USA 345 Autocam Medical CP USA 201 Avalign Technologies CP USA 626 Bob, Incorporated CP USA 712 Bodycote USA 624 Boedeker Plastics Inc. 127 Bradshaw Medical, Inc. USA USA EM LP EM SP MM PS SP PS MM PD DS SP MM SP MM SP MM SP CP RM MM DS MM 515 Brown Precision, Inc. DT USA 245 C&A Tool Engineering, Inc. Netherlands 142 Cam Bioceramics China 731 Canwell Medical Ltd. USA 414 CaP Biomaterials, LLC USA 227 Carpenter Technology Corporation USA 126 Centex Machining, Inc. USA 215 Curbell Plastics, Inc. France 608 Deloro Stellite Group Korea 601 Dexcowin Co., Ltd USA 421 Donson Machine Co. USA 830 Durr Ecoclean Inc. USA 713 Electrolizing Corp. of Ohio, The USA 102 Electropolishing Systems, Inc. USA 218 Emerson Consultants, Inc. Japan 531 ENDO Manufacturing Co., Ltd USA 125 Ensinger Inc. USA 402 EPTAM Plastics USA 315 Esprit/DP Technology USA 619 Fairview Machine Company, Inc. USA 733 Finishing Innovations, LLC USA 415 FMI Medical Instruments USA 120 Forecreu America Inc. USA 514 Fort Wayne Metals Switzerland 609 GEHRING CUT AG USA 319 Gibraltar Laboratories PS RA MM RA MM RM SP RM SP MM PD DT RM MM RM CA MM RM EM MM EM SP MM SP LP SP RA MM RM CP MM RM SO MM CP LP MM LP MM SP PS MM SP RM RM CP MM SP DT 246-247 Greatbatch Medical DS USA 618 gSource, LLC USA 320 Hangsterfer's Laboratories Inc. USA 408 Hansa Medical CP USA 308 Hoosier, Inc. CP USA 615 Infinity Plastics Group CP USA 530 In'Tech Medical Inc. USA 625 International Titanium Association USA 518 Ionbond, Inc. USA 326 Jarvis Surgical, Inc. MM FO EM MM FO SP MM PD LP MM SP MM PD PS MM RM SP MM CP DS SP PD Malaysia 725 Kens Fine MedTech Sdn Bhd USA 200 Knight Mechanical Testing USA 114 LAB Medical Manufacturing, Inc. USA 101 Level 3 Inspection / Smart Inspection Systems Canada 502 Maetta Sciences, Inc. USA 413 Mahar Tool Supply Company, Inc. EM USA 512 Makino EM USA 214 Marketwire CP MM PS PS DT CP LP DT MM SP EM SO MM OTHER CP USA 312 Medin Corporation USA 513 Medivative Technologies CP USA 509 Metal Craft Machine & Engineering CP USA 826 Micro Machine Company Page 44 USA Taiwan 524 Microware Precision Co., Ltd. 113 Millstone Medical Outsourcing USA 631 Minnesota Rubber & Plastics USA 627 NeedleTech Products, Inc. 426 NewScience Insurance 632 Norman Noble, Inc. USA OTHER MM USA USA 44 PressReady.indd FO LP DT 425-427 Marox Corporation SP MM British Standards Institution (BSI) USA SO SP CA 500-501 Branch Medical Group 109-208 Juno Inc. RM OTHER 621 USA RA RA MM DS USA USA PD PS MM MM DS DS DT MM LP CP MM PS MM PS MM PS LP PS CP SP SO SP PD EM LP MM PS SP LP MM PS SP OTHER 6/1/2011 1:29:39 PM USA 320 Hangsterfer's Laboratories Inc. USA 408 Hansa Medical CP USA 308 Hoosier, Inc. CP USA 615 Infinity Plastics Group CP USA 530 In'Tech Medical Inc. USA 625 International Titanium Association EM FO SP MM PD LP 518 Ionbond, Inc. USA 326 Jarvis Surgical, Inc. MM RM Kens Fine MedTech Sdn Bhd 200 Knight Mechanical Testing USA 114 LAB Medical Manufacturing, Inc. USA 101 Level 3 Inspection / Smart Inspection Systems Canada 502 Maetta Sciences, Inc. USA 413 Mahar Tool Supply Company, Inc. USA 512 Makino USA 214 Marketwire USA USA COUNTRY 425-427 Marox Corporation 312 513 # Booth Medin Corporation Medivative COMPANY Technologies CP CP EM OTHER CP Micro Machine Company Acme Manufacturing Company CP Microware Precision Co., Ltd. Advantage Manufacturing Technologies, Inc. CP USA 113 430 Millstone Outsourcing AeroMed, Medical Inc. USA 631 424 Minnesota Rubber & Plastics AIP USA Taiwan USA 627 720 426 719 NeedleTech Products, Inc. Co Ltd Alliance Global Technology NewScience Insurance American Express Open USA 632 116 Norman Noble, American Tool &Inc. Die, Inc. Canada USA 721 832 NSE-Automatech APS Materials USA Sweden 325 532 Oak View Arcam AB Tool Company CP DS CP DS 118 624 508 127 Pacific Instruments Inc. Boedeker Plastics Inc. PAK Manufacturing, Inc. Bradshaw Medical, Inc. CP 224 621 Partmaker British Standards Institution (BSI) USA 515 122 Brown Precision, Inc. Inc. PCC Structurals, USA 245 620 C&A Engineering, Inc. PiperTool Plastics, Inc. CP Netherlands USA 142 432 Cam Medical Bioceramics PMC CP China Canada 731 600 Canwell Medical Ltd. PPD Meditech Curbell Plastics, Inc. Pro-Dex Inc. 608 724 Deloro Stellite Group Professional Plastics Korea Sweden 601 630 Dexcowin AB Co., Ltd Promimic USA 421 124 Donson Machine Co.Inc. Pulse Technologies, USA 830 346 Durr Ecoclean Inc. Quandrant/MediTECH Medical Polymers USA 713 813 Electrolizing Corp. Richards Micro Toolof Ohio, The USA USA USA 102 212 218 112 Electropolishing Systems, Inc. Röchling Engineering Plastics Emerson Consultants, Inc. Rolled Alloys Japan USA USA USA USA USA USA USA DT Fairview Machine Company, Inc. S.S. White Medical Finishing Innovations,Ltd. LLC SAYAN Orthopaedics USA USA USA USA 415 327 120 614 USA USA Switzerland USA 514 418 609 812 FMI Medical InstrumentsLLC Seabrook International, Forecreu AmericaInc. Inc. SHL Automation, Fort Wayne Metals Solvay Specialty Polymers, LLC GEHRING CUT Sonoscan, Inc. AG PS MM PS LP MM PS MM PD PS LP MM PS SP LP MM PS SP OTHER SP SP SO MM PD SP FO MM PS LP MM PD PS RM SP RA SP RM SP SP MM RA MM LP MM MM MM PS RA MM DS DT RM RM MM DT CP SP SO RA MM FO SP RM PD DT CA OTHER SP LP DT PS RM SP MM PD RM FO MM PD RM SP FO MM RM SP CP MM CP MM PD RM MM RM CA SP EM SP MM CP EM SP RM MM PD SP LP SP RM RA RM ENDO Manufacturing Co., Ltd Rollomatic, Inc. Ensinger Inc.USA LP rose plastic, 402 EPTAM Metal Plastics Rosler Finishing 519-521 315 Esprit/DP Technology 525 RTI International Metals 619 309 733 100 SP SP MM MM 531 321 125 220 USA USA USA Turkey SO MM DS USA 215 209 RM LP EM 140 ParagonMedical MedicalGroup 500-501 Branch France USA RA FO CP USA USA USA USA RA PS EM CP CP Centex Machining, Inc. Precision Piece Parts, Inc. MM PD PS MM SP EM OTECIncorporated Precision Finish Inc.E Bob, Pacific American Life Science Learning Center Bodycote 126 420 LP LP EM DS CA 730 626 718 712 USA FO OTHER USA USA Carpenter Technology Corporation Precision Metal Products EM EM 331-333 Orchid Orthopedic 345 Autocam Medical Solutions Orthoplastics, Ltd. 313 201 Avalign Technologies CaP Biomaterials, Praxis Technology LLC DT CP Onyx Medical ASTRO MedicalCorporation Devices 414 613 DS CP Okuma 825-827 602 Arwood America Machine Corporation Corp 227 226 MM DS 524 526 USA SP SO MM 826 633 USA MM EM EM Taiwan USA USA LP DT USA USA United Kingdom USA PS CA CP Metal Craft Machine & Engineering AccelLAB Inc. 433 520 MM PS DT 509 715 USA SP PD CP USA Canada USA DS Co mp on ent Pa De rts live ry Sys tem De vic s eT est ing Eq uip me nt/ Ma Fo chi rgi ner ng y Las er Pro ces sin Im g pla nt/ Ins tru Pro me du nt ct Ma De chi sig nin n/D Pa g cka ev/ gin Inc g/S ub t e Re riliz g/C atio lin n Aff airs Ra /Te wM ch ate Wr rial itin So s g ftw are So lut Su ion rfa s c Tre e Pre atm p/ ent s Ot her 725 USA USA SP MM 109-208 Juno Inc. Malaysia PS Ca stin g USA SP MM PD Index of Exhibitors by Capabilities USA MM MM EM CP RM RM RM MM FO RM CP LP CP CP CP LP LP CP EM SP SO MM MM MM MM SP SP MM MM MM MM PS PS SP SP RM SP RM RM CP USA USA USA USA 319 442-443 246-247 412 Gibraltar Laboratories Southeastern Technology Greatbatch Medical Supra Alloys, Inc. USA 225 Surface Dynamics LLC USA 409 Tecomet USA 121 Tegra Medical USA 533 Teleflex Medical OEM CP USA 821 Tenergy Corporation CP France 727 TeroLab Surface SAS USA 612 TESco Associates USA 324 Titanium Industries USA 221 Tornos Technologies USA 527 Total Plastics Inc. USA 318 Triangle USA 115 Trigon International USA 726 Twin City EDM and Manufacturing CP Taiwan 119 United Orthopedic CP USA 714 Universal Precision Instruments Inc. USA 708 Vistek Medical USA 314 Vulcanium Metals Incorporated USA 732 Walter (a United Grinding Company) USA 213 ZOLLER Inc. DS DS DT DT MM EM LP SP MM MM PS RM MM FO DS DT EM DS LP FO FO SP MM SP PD LP MM PD SO PS RM SP EM SP CP MM PD RM EM RM CP LP MM SP LP MM SP LP MM MM CA FO LP MM LP MM PS RM EM DT MM SP EM Page 45 PressReady.indd 45 6/1/2011 1:29:40 PM Attendee Resources Speaker Presentations A selection of OMTEC speakers has agreed to make their presentations available online at www.omtecexpo.com. Presentations will be available for a limited time. We will remind you of presentation availability via email post-event. Business Center To best serve you, a business center is located on the exhibit floor. Most services are complimentary and a hostess is available to assist you. Meals In keeping with our mission to help you stay focused on the business at hand, a full hot breakfast will be served both mornings and a complete lunch both afternoons…with catered snacks and beverages in between. Adult beverages and hors d’oeuvres will be served at the Welcome Reception held on the exhibit floor Wednesday from 4:00pm – 5:30pm. Exhibit Floor Hours Wednesday, June 15: 9:00am – 5:30pm (Welcome Reception on the floor from 4:00pm – 5:30pm). Thursday, June 16: 9:00am – 3:00pm Keynotes: Wednesday, June 15: 8:00am – 8:45am (Open to all. Breakfast will be served at 7:30am.) Thursday, June 16: 8:00am – 8:45am (Open to all. Breakfast will be served at 7:30am.) Sessions: Wednesday, June 15: 10:30am – 4:00pm. (Break for catered lunch in Exhibit Hall 12:00pm – 1:30pm) Thursday, June 16: 10:00am – 2:30pm (Break for catered lunch in Exhibit Hall 11:30am – 1:00pm) Need help? Members of the ORTHOWORLD/OMTEC team will always be available at the Registration Area as well as the ORTHOWORLD booth, 815-819. Hostesses and additional staff will be monitoring the exhibit floor, session rooms, café area and business center. Please let us know how we can be of service to you. Advisory Panel A world-class panel of industry advisors steers BONEZONE toward relevant and timely educational content that is consistent with the needs of OEM companies. This panel also guides OMTEC’s educational curriculum. Acumed LLC Robert Johnson Director of Operations Alphatec Spine, Inc. Thomas Solowczuk Director, Global Sourcing Arthrex, Inc. Lance Provance Supply Chain Manager Biomet, Inc. Howard Levy Chief Procurement Officer Biomet, Inc. Troy W. Hershberger Vice President of Patient Matched Products DePuy Orthopaedics, Inc. Tom Camino Worldwide Director, Hip Product Development DePuy Orthopaedics, Inc. Rod Wilson Director, Procurement Operations/ Business Excellence Medtronic Spinal and Biologics Rodney Ballard Director of Product Development Stryker Orthopaedics, Inc. Matthew Poggie Senior Director, Applied Technology Exactech, Inc. Ronald Green Director, Manufacturing Engineering Ortho Development Corporation Bob Weston Director of Operations Stryker Orthopaedics, Inc. Kenneth Trimmer Senior Director, Advanced Operations Globus Medical, Inc. David Davidar Vice President, Operations Orthofix, Inc. Paul J. Vasta, Ph.D. Vice President of Research & Development Tornier, Inc. James Kwan Vice President, Global Supply Chain Smith & Nephew Orthopaedics, Inc. Mark Hall Global Strategic Sourcing Manager Wright Medical Technology, Inc. Skip Flannery Vice President, Logistics & Materials Integra LifeSciences Corp. Dale Davison Vice President Engineering, Spine Integra LifeSciences Corp. John Kemnitzer Director of Regenerative Technologies Product Development K2M, Inc. Rich Woods Senior Vice President, Engineering Smith & Nephew Orthopaedics, Inc. David D. Kelman Group Director, Hip Development Zimmer, Inc. Erin Johnson Vice President, Trauma Research & Development Page 46 PressReady.indd 46 6/1/2011 1:29:44 PM Please visit our Booth # 432 Lecture Speaker June 15, at 10:30 High Performance Medical Plastic PMC, LLC • 2181 Grand Avenue, Cincinnati, Ohio 45214 • USA ©2011 PMC. All rights reserved. PressReady.indd 47 6/1/2011 1:29:44 PM Visit us at Booth #140 PressReady.indd 48 6/1/2011 1:29:44 PM
