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Final Program
1 Innovations in BIOLOX® The next steps Visit us at booth 112 June 11th –12th , 2014 CeramTec GmbH Luitpoldstraße 15 91207 Lauf · Germany [email protected] www.ceramtec.com BIOLOX® is a registered trademark. Thank you for choosing OMTEC®! SCHEDULE AT A GLANCE Now in its 10th year, OMTEC’s singular mission remains the same—to help you and your company improve performance. During the next two days, you’ll be joined by nearly 1,000 orthopaedic industry professionals from Tuesday, June 10 8:00 am - 5:00 pm Exhibitor Registration & Set-up 6:00 pm - 7:30 pm Welcome/Cocktail Reception nearly 20 countries. Bolster this time away from the office to network, Wednesday, June 11 learn and secure new solutions and ideas. Here are a few opportunities that you shouldn’t miss this year. Education on the Exhibit Hall Floor. Follow the yellow and orange dots to the Knowledge Center and Technical Seminar Area. Here, you’ll find 8:00 am - 8:45 am Keynote Breakfast 9:00 am Exhibit Hall Opens 9:30 am - 12:00 pm Educational Sessions 12:00 pm - 1:30 pm Networking Lunch in Exhibit Hall 1:30 pm - 4:30 pm Educational Sessions 4:30 pm - 6:00 pm Networking Reception in collaborative discussion and instructive teaching surrounding Exhibit Hall manufacturing processes and supply chain solutions. Thursday, June 12 Breakfast with the Experts. Join roundtables facilitated by industry experts on UDI, packaging, materials, design controls and supplier quality. Several seats are still available for this Thursday morning breakfast. Come learn and share with your contemporaries. 7:30 am - 8:45 am Networking Breakfast 9:00 am Exhibit Hall Opens 9:00 am - 12:00 pm Educational Sessions 12:00 pm - 1:30 pm Keynote Lunch Address (Exhibit Hall Closed) The Networking Lunch and Networking Reception are both great opportunities to reaffirm connections and make new ones. These events take place in the Exhibit Hall Café on Wednesday. The lists of exhibitors and education on the following pages will help you further maximize your time at OMTEC. As always, look for any member of the ORTHOWORLD team to assist with questions that may arise or to provide feedback on how to improve your experience for OMTEC 2015. Thank you for the choosing OMTEC. We wish you a successful two days. Best regards, Carolyn LaWell Content Manager ORTHOWORLD® Table of Contents Industry and Exhibitor Advisory Panels .......................................... 4 Schedule of Events ................................................................................. 6 Floor Plan .................................................................................................... 8 Keynote Addresses ............................................................................... 10 Educational Sessions ............................................................................ 12 Exhibitor Listing ..................................................................................... 28 Attendee Resources ............................................................................. 44 OMTEC 2015 ............................................................................................ 46 3 1:30 pm - 4:30 pm Educational Sessions 5:00 pm Adjourn/Exhibitor Teardown Thank you to industry advisors who guided all aspects of OMTEC 2014! Thank you to our attendees and exhibitors for choosing OMTEC 2014! Your voices are integral in making improvements each year. We’re listening. Please help us serve you better by taking a survey at www.OMTECexpo.com. Advisory Panel Acumed LLC Loren Blanchard Executive Director of Manufacturing Globus Medical, Inc. David Davidar Vice President, Operations Stryker Orthopaedics, Inc. Kenneth Trimmer Senior Director, Chief Engineer, Knees Alphatec Spine, Inc. Thomas Solowczuk Director, Global Sourcing K2M, Inc. Rich Woods Senior Vice President, Global Research, Development & Engineering Tornier, Inc. Thierry Manceau Vice President, Global Manufacturing & Supply Chain Medtronic, Inc. Randall Ours Senior Manager Strategic Sourcing, Spinal and Biologics Wright Medical Technology, Inc. Jeremy Townsend Senior Manager, Global Supply Chain Arthrex, Inc. Lance Provance Supply Chain Manager Biomet, Inc. Howard Levy Chief Procurement Officer, Worldwide Operations Ortho Development Corporation Bob Weston Director of Strategic Business Planning DePuy Synthes, Inc. Mary Gray Regulatory Affairs Project Manager, Spine Smith & Nephew Orthopaedics, Inc. Mark Hall Global Strategic Sourcing Manager Exactech, Inc. Ronald Green Senior Director, Manufacturing Operations Zimmer, Inc. Erin Johnson Vice President, Trauma Research & Development Matthew Poggie Independent Industry Advisor Smith & Nephew Orthopaedics, Inc. David D. Kelman Vice President, Hip Product Development, Advanced Surgical Devices Exhibitor Advisory Panel Ensinger, Inc. Fran Alder Medical Market Development Manager Medin Corporation Jay Schainholz President Metal Craft and Riverside Machine & Engineering Trisha Mowry Chief Executive Officer Onyx Medical Corporation Jodie Gilmore Owner, Managing Director Orchid Orthopedic Solutions LLC Joe Zuzula Vice President of Sales & Marketing Paragon Medical, Inc. Greg Hall Director of International Business Development Don’t wait until next June to continue your industry education. Subscribe to the monthly eNewsletter at www.OMTECexpo.com. You’ll receive: • OMTEC 2015 updates • BONEZONE® articles focused on design and development, regulatory processes, supply chain optimization and emerging trends • Latest supplier news 4 ISO 13485:2003 ISO 9001:2008 FDA REGISTERED VISA BRAZIL A WORLD OF MANUFACTURING EXPERTISE IN EVERY PART. SUPERIOR PERFORMANCE A TRUSTED PARTNER WHEN QUALITY IS CRITICAL. PRECISION-MACHINED IMPLANTS AND INSTRUMENTS LET’S TALK! CONTRACT MANUFACTURER OF SURGICAL TAPS, DRILL BITS, DRIVERS, SCREWS AND PLATES. ALL PARTS DFM ENGINEERED FOR EXACTING FIT AND OPTIMAL PERFORMANCE. IN-HOUSE SECONDARY PROCESSES, SHARED SYSTEMS, ONGOING PARTNER SUPPORT ENSURE DOCK-TO-STOCK SATISFACTION. 877-633-8080 MICHIGAN • CALIFORNIA • MASSACHUSETTS • BRAZIL AUTOCAM-MEDICAL.COM OMTEC® 2014 VISIT US AT BOOTH 126 Tuesday June 10: 6:00 pm-7:30 pm Welcome Cocktail Reception at Hofbräuhaus, Chicago Sponsored by Wednesday June 11 7:30 am 7:45 am 8:00 am 8:30 am Breakfast Served at 7:30 am Keynote Breakfast - CEO Discussion at 8:00 am Room 51 Panelists: Michael Butler, Life Spine; Dirk Kuyper, IlluminOss Medical Moderator: Mike Matson, Needham & Company Sponsored by Tecomet 8:45 am 9:00 am Exhibit Hall Opens Room 49 9:30 am 10:00 am 10:30 am 11:00 am 11:30 am Technical Seminar Area Knowledge Center Additive Manufacturing UDI How to Improve Supplier Scorecards Best Practices for Final Preparation Morning Break Sunshine Act and Beyond: Improving Compliance Processes and Strategies Injection Molding 12:00 pm 12:30 pm 1:00 pm 1:30 pm 2:00 pm 2:30 pm 2:45 pm 3:00 pm 12:00 pm-1:30 pm Networking Lunch in Exhibit Hall Sponsored by Bradshaw Medical Best Practices for Design Verification and Validation Coating Implants Afternoon Break Sponsored by Onyx Medical 4:00 pm 4:30 pm 5:00 pm Emerging Trends in Medical Device Packaging Sterile Barrier Packaging: Common Causes of Failures and How to Correct Them Value Drivers: Considerations for the M&A Process Room 47 3:15 pm 3:30 pm Packaging IP Due Diligence from Product Idea to Launch Oral Poster Presentation Networking Reception in Exhibit Hall All Welcome Sponsored by Metal Craft 5:30 pm 6 FDA Priorities: Pre- and Post-Market Data Requirements and PMAs Thursday, June 12 7:30 am 7:45 am Breakfast Served from 7:30 am-8:30 am Breakfast with the Experts from 7:45 am-8:45 am 8:00 am Exhibit Hall Café 8:30 am Sponsored by Orchid Orthopedic Solutions 8:45 am 9:00 am Exhibit Hall Opens Room 49 Room 47 Knowledge Center Lean Manufacturing: Achieving Performance Results and Employee Engagement Power Networking How to Comply with SEC Conflict Minerals Requirements Power Networking 9:00 am 9:30 am FDA Expectations for Supplier Quality 10:00 am 10:30 am 11:00 am 11:30 am 12:00 pm 12:30 pm 1:00 pm Morning Break Six Steps to Design Planning Core Competency Keynote Lunch - The Past, Present and Future of the Implant Market: A Surgeon Inventor Perspective Exhibit Hall Closed Room 49 1:30 pm 2:00 pm 2:30 pm 2:45 pm 3:00 pm Room 51 Sponsored by Siemens Eliminating Supply Chain Waste: Manufacturer and Hospital Collaboration Technical Seminar Area Design for Manufacturability Knowledge Center Raw Materials A Supplier’s Perspective on the Shifting Global Regulatory Environment Afternoon Break Materials Roundtable: Titanium, Stainless Steel, Polymers The Excise Tax: Lessons on Constructive Pricing 3:15 pm 3:30 pm 4:00 pm Supplier Panel on Globalization Tray Sterilization 4:30 pm 5:00 pm Adjourn and teardown All attendees and exhibitors are invited to attend education sessions and networking events. 7 View the alphabetical listing of Exhibitors on page 28. Acme Manufacturing Company............................532 Evonik Corporation ..................................................630 MedicalGroup ............................................................313 REJOIN Mastin Medical Instruments Co., Ltd ...236 Advantage Manufacturing Technologies ............514 EZM Edelstahlzieherei Mark GmbH ....................714 Medin Corporation ...................................................607 rms Surgical ................................................................206 AIP Precision Machining .........................................207 Finishing Innovations LLC......................................832 Metal Craft ..................................................................314 Rolled Alloys ..............................................................508 Alden Tool Company ...............................................107 FMI Hansa Medical Products .................................200 Micro Machine ...........................................................308 Rollomatic ...................................................................430 Alhenia AG .................................................................533 Forecreu America, Inc...............................................724 Micron Products ........................................................814 Rosler Metal Finishing USA, LLC .........................432 American Instument & Implant.............................115 Gauthier Biomedical .................................................719 Microware Precision Co Ltd ...................................122 Seabrook International, LLC ...................................406 Ametek - Reading Alloys.........................................119 Gibraltar Laboratories, Inc.......................................609 MK Precision ..............................................................600 Sheffield City Region ................................................725 APS Materials .............................................................500 Grace College.................................................................... MSK Precision ............................................................706 Sheffield Precision Medical, Ltd. ...........................537 Arcam AB ....................................................................808 Greatbatch ...................................................................237 MTS Systems Corporation ......................................712 SMC Ltd.......................................................................602 Arcamed ......................................................................608 gSource.........................................................................515 N2 Biomedical ............................................................736 Solvay ..........................................................................809 Aristotech Implant Precision Forgings GmbH ...531 Hangsterfer’s Laboratories Inc. ..............................513 Nelson Laboratories, Inc. .........................................812 Southeastern Technology.........................................414 Autocam Medical ......................................................126 HD Surgical (a division of Harwood Norman Noble, Inc. ..................................................218 Spec Engineering .......................................................118 Baum Precision Maching .........................................102 Design, Inc.) ................................................................100 North American Spine Society ...............................815 Summit Manufacturing & Machining ..................731 Beijing Changhang Investment Casting Co. .......433 Huron Tool & Cutter Grinding ..............................132 Onyx Medical .............................................................413 Surface Dynamics ......................................................106 Bob, Incorporated ......................................................306 IHI IonBond ................................................................330 Orchid Orthopedic Solutions..................................133 Symmetry Medical, Inc. ...........................................431 Bradshaw Medical.....................................................224 IMR Test Labs .............................................................536 Orthoplastics...............................................................509 Syntec Scientific Corporation..................................720 C&A Tool Engineering, Inc. ....................................512 In’Tech Medical ..........................................................730 OsteoMed ....................................................................501 Tecomet ........................................................................407 Cam Bioceramics .......................................................709 Interstate Plastics .......................................................118 Pacific Instruments ....................................................124 Tegra Medical .............................................................220 Carpenter Technology Corporation ......................127 Iotron Industries ........................................................614 PAK Manufacturing..................................................506 TESco Associates........................................................632 Centex Machining, Inc..............................................108 J&J Machine, Inc.........................................................101 Paragon Medical ........................................................412 Third Wave Systems .................................................830 CeramTec GmbH.......................................................112 JALEX Medical...........................................................502 PCC Structurals..........................................................437 Thortex .........................................................................824 Changzhou KangDing Medical Instrument ......633 Jarvis Surgical .............................................................331 Phillips Precision Medicraft ....................................818 Titanium Industries...................................................213 Changzhou Yonghua Industries ...........................109 JG&A Metrology Center ..........................................636 PMC SMART Solutions LLC ..................................606 Total Plastics, Inc. - Life Sciences Division ...........315 Cool Clean Technologies..........................................829 Kapstone Medical......................................................708 Polymer Solutions .....................................................727 Triangle ........................................................................212 Costa Rican Investment Promotion Agency .......821 Knight Mechanical Testing......................................113 PPD Meditech.............................................................436 Trigon International ..................................................700 CTE Solutions .............................................................116 LAB Medical Manufacturing..................................826 Precision Edge Surgical ............................................811 Universal Precision Instruments ............................637 Danco Anodizing.......................................................209 Layerwise ....................................................................312 Precision Engineered Products ..............................333 Universal Punch Corp ..............................................733 DiSanto Technology, Inc. .........................................808 Leeds and Partners ....................................................725 Precision Medical Technologies, Inc. ....................718 Vistek Medical ............................................................307 Donson Machine Co. ................................................408 Li Wai Precision International ................................631 Precision Metal Products, Inc. ................................125 VMH International....................................................134 DOT GmbH ................................................................114 LISI Medical ................................................................823 Pro-Dex, Inc. ...............................................................507 VSMPO-Avisma ........................................................613 ECA Medical Instruments .......................................737 LMG..............................................................................819 Promimic AB ..............................................................214 Westlake Plastics ........................................................813 Electrolizing Corp. of Ohio......................................121 Lucideon ......................................................................820 puracon GmbH ..........................................................337 Wilsey Tool Company, Inc. .....................................726 EMCM..........................................................................601 Mark Two Engineering ............................................825 Pyxidis .........................................................................732 Windsor Beach Technologies ..................................612 Ensinger .......................................................................231 Marle Group ...............................................................713 Quadrant EPP/MediTECH Medical Polymers...817 Zapp Medical Alloys ................................................530 EPTAM ........................................................................309 Marox Corporation ...................................................137 Quintus Composites .................................................827 ® WHAT’S AHEAD FOR THE ORTHOPAEDIC INDUSTRY? The OMTEC 2014 Keynotes provide CEO-level insights on the healthcare market, regulatory environment, technology trends and supplier relationships. CEO Discussion June 11, 8:00 am – 8:45 am Sponsored by Tecomet Companies that adapt to complex regulatory and economic changes will be best positioned to succeed as orthopaedics moves forward. The Keynote Breakfast will offer CEO-level insights on topics that populate the entire OMTEC 2014 agenda: U.S. and international changes to the healthcare market, emerging technologies and trends and solidifying supplier partnerships. Michael Butler President and CEO Life Spine Panelist Dirk Kuyper President and CEO IlluminOss Medical Panelist Mike Matson Senior Research Analyst Needham & Company Moderator Mr. Butler has turned Life Spine into one of the fastest-growing spine companies in the world, bringing to market 32 new product families, derived from over 100 patents and distributing in 22 countries since the company’s inception in February 2004. Life Spine is his fourth professional start-up company and is among four companies that he currently operates, which include Gizmo Medical, LLC; Gizmo Medical Ltd. (Hong Kong & China) and Fortis Medical. His business career spans more than 18 years with expertise in product development, business development and financial management. Mr. Butler has served in various management capacities at companies such as Abbott Laboratories, Inter-Med, Richard Wolf Medical, Visionary Biomedical, Microbrush and Eli Lilly. During that time, he successfully brought more than 200 distinct medical devices and pharmaceuticals to market and created significant investor value. He graduated from Marquette University in 1995 with a B.S. degree in Biomedical Mechanical Engineering. Mr. Kuyper joined IlluminOss in 2013 and brings to the company 25 years of experience in commercializing medical devices. He was previously President and CEO of Alphatec Spine, where he led the company to triple revenue of $200 million and expanded the brand globally into 52 markets. Prior to Alphatec Spine, Mr. Kuyper served as President of Aesculap, where he successfully launched spinal and orthopaedic divisions while creating a strong infrastructure and foundation for sustained, market leading growth for surgical instrumentation and implants focused on a variety of surgical procedures including neuro, micro-vascular, cardiovascular and laparoscopic surgeries. Additionally, Mr. Kuyper served on active duty for four years in the U.S. Army as an artillery officer, where he achieved the rank of captain. He holds a B.S. in Biology from the University of Miami and an Executive Education Certificate from the Graduate School of Sales and Marketing at Syracuse University. Mr. Matson joined Needham & Company in 2013 to cover Medical Technologies & Diagnostics. Prior to Needham, Mr. Matson spent nine years covering the medical supplies and devices industry for Mizuho Securities and Wells Fargo Securities. Previously, he served in Stryker’s Orthopaedics and Endoscopy divisions in marketing and product development. Mr. Matson was ranked first for earnings estimating in the medical device industry in the 2013 FT/StarMine World’s Top Analysts survey, ninth in the orthopaedic subsector in the 2010 Greenwich Associates survey, second for stock picking in the medical device industry in the 2008 FT/StarMine World’s Top Analysts survey and fourth in the medical device industry for stock picking in the 2007 Wall Street Journal Best on the Street. He has a B.S. in Mechanical Engineering from North Carolina State University with a minor in Economics and a MBA from Duke University’s Fuqua School of Business, with a concentration in Health Sector Management. Mr. Matson holds a medical device patent (U.S. Patent No. 6,919,914). The Past, Present and Future of the Implant Market: A Surgeon Inventor Perspective June 12, 12:00 pm – 1:15 pm Sponsored by Siemens Robert S. Bray, Jr., M.D. CEO and Founding Director, DISC Sports & Spine Center Co-Founder and Inventor, RSB Spine What does the future hold for the orthopaedic implant market? Dr. Bray, a globally recognized spine surgeon, entrepreneur and inventor, provides a look at the industry, past and present, and answers the question: How will the development and sales of orthopaedic implants change in the future? Dr. Bray is the CEO and Founding Director of DISC Sports & Spine Center (DISC), state-of-the art, multi-disciplinary facilities in California. He co-founded RSB Spine, LLC, and serves as its inventor. He has multiple patents on a wide variety of implants and surgical instruments and regularly consults the world’s leading medical manufacturers on the design and use of their products. Dr. Bray had a successful tenure at Cedars-Sinai, where he founded The Institute for Spinal Disorders and built it into one of the country’s largest spine programs. He also served as the director of neurosurgery and headed the spinal programs at St. John’s Medical Center, Century City Hospital and Daniel Freeman Memorial Hospital. 10 Tecomet_Launchquick_BoneZone_OMTEC2014_AdvProgram 4/29/14 2:35 PM Page 1 From Concept to Completion Tecomet offers a dedicated rapid prototyping center for the purpose of accelerating product and process development. LaunchQuick™ center is staffed with CNC programmers and engineers, and set up with dedicated CNC equipment and CAD workstations to rapidly turn our customer's concepts into products. Additionally, Tecomet makes available our considerable company wide experience and resources to assure the successful transfer of our customer's products from pilot production, through validation, and transfer to manufacturing. IMPLANTS | Functional prototyping from concept sketches or models ■ Dedicated multi-axis CNC machining centers ■ Support for finishing, assembly and inspection ■ CAD work stations for customer collaboration ■ Design expertise early in the design cycle ■ Metallurgical expertise and processing advice ■ Full manufacturability assessment ■ Ongoing support for high value and low volume production ■ INSTRUMENTS | I N N O VAT I O N 888.287.0400 | www.tecomet.com | www.beeremedical.com Visit us at OMTEC® 2014, Booth #407 Part-3.indd 65 04/05/2014 12:59:47 PM KNOWLEDGE CENTER Regulatory and economic shifts have demanded efficiencies of process and greater collaboration amongst internal and external colleagues. The Knowledge Center provides a more holistic view of the challenges and opportunities of UDI, packaging and raw materials. Join the discussion. Just follow the yellow dots on the Exhibit Hall Floor. To find the education that meets your needs, look for the colored dot that best matches your title. Buyer/Planner Materials/Commodity Manager Product Management Purchasing Quality Control Regulatory/Clinical Affairs Research/Development/Design Supply Chain Management Executive Management Manufacturing UDI AdvaMed Auto-Identification Committee since 2006 and serving as an advisor to the International Medical Device Regulators Forum. Ms. Elkin is a founding member of GS1 Global Healthcare and has maintained a leadership role in the organization since its inception in 2005. June 11, 9:30 am – 11:15 am Best Practices for Final Preparation Tom Jones, Unique Device Identifier Program Director, Customer Logistics & Services, Johnson & Johnson Mr. Jones works with leaders from multiple franchises to drive UDI compliance across the J&J family of companies. He joined J&J in 1996 and has led other large initiatives within the company while holding leadership roles in IT, business intelligence and supply chain. Prior to joining J&J, Mr. Jones served as a management consultant at Ernst and Young and worked in design roles at GE Aircraft Engines. Orthopaedic device manufacturers will need to comply with FDA’s Unique Device Identification (UDI) rule by September 24, 2014, with similar regulation in the works in Europe and other global regions. Session Takeaways: • Update on U.S. regulatory requirements and status of global regulatory movement on UDI, including similarities with and differences from U.S. requirements • Best practices and lessons learned from manufacturers that have mature UDI compliance programs • How FDA is incorporating UDI into the regulatory framework from premarket approvals to postmarket surveillance • How to approach UDI in a manner that delivers value beyond compliance • How the rule relates to contract manufacturers and other third parties Packaging June 11, 1:30 pm – 3:15 pm Emerging Trends in Medical Device Packaging Laura Bix, Ph.D., Associate Professor, School of Packaging, Michigan State University Karen Conway, Executive Director of Industry Relations, GHX Ms. Conway works internationally with standards bodies, government agencies, analysts and academic researchers, industry associations and both suppliers and their customers to identify opportunities to optimize supply chain operations and improve business and clinical performance. She recently chaired a UDI conference in Europe and led the healthcare supply chain discussion at the inaugural Cisco Internet of Things Global Forum. For a full understanding of medical device packaging, this presentation reviews past and current approaches, as well as trends and forthcoming changes. To support understanding of how packaging changes affect each manufacturer, Dr. Bix will walk through Lockhart’s matrix, a framework for the myriad considerations that must be weighed during the packaging of a device. Session Takeaways: Jackie Rae Elkin, Global Process Owner of Standard Product Identification, Global Regulatory Affairs, Medtronic Ms. Elkin has worked in the medical device sector for more than 27 years. She is recognized as a leader in global product identification standards development and implementation, co-chairing the 12 • Emerging trends changing the approach and future of medical device packaging • Understanding of the concept of affordances and how they can be leveraged during the design process • Tools for assessing label design ...on the Exhibit Hall Floor. raw materials used in implantable and nonimplantable devices. This presentation will discuss the more challenging global regulatory obstacles regarding raw materials and suggest strategies to enable successful registrations. Dr. Bix was named one of the 100 most notable people in the medical device industry by Medical Devices and Diagnostics Industry in 2008, and has served as an expert to the PROTECT and PROTECT Rx initiatives, part of the Center for Disease Control and Preventions Medication Safety Program, since 2012. Work from Dr. Bix’s group has been published or cited in The Proceedings of the National Academy of Sciences of the U.S., PLoS One, Consumer Reports and Men’s Health. Session Takeaways: Sterile Barrier Packaging: Common Causes of Failures and How to Correct Them Wendy Mach, RM (NRCM), CQA (ASQ), Packaging Section Leader, Nelson Laboratories • Specific global regulatory challenges related to raw materials for medical devices • Current regulations in the U.S., Europe, China, Brazil and Japan • How to develop strategies to facilitate successful registrations Ms. Shorrock joined Solvay in 2000 and has worked in the medical market since 2004. In 2007, Ms. Shorrock led Solvay Specialty Polymers’ entrance in the biomaterials market with the launch of Solviva® Biomaterials. In her role with Solvay, she works closely with customers as well as testing agencies, regulatory bodies and all other aspects of the supply chain to support the use of polymers in demanding healthcare applications. This presentation will provide a brief overview of the types of tests that are available to validate a sterile barrier system. While performing these tests, though not expected, failures can happen. Ms. Mach will also review common failures within these tests and provide understanding of their causes. Session Takeaways: • Packaging attributes and validation testing • Discovering the root cause of a failure identified during package validation testing • Tools to assist in determining the appropriate tests for validation Download Speaker Presentations at www.OMTECexpo.com Since 2004, Ms. Mach has overseen the integrity, strength and microbial barrier tests in Nelson Laboratories’ packaging department. Before joining Nelson Labs, she worked as a lab supervisor for testing of sterility, microbial limits, bioburden, limulus amebocyte lysate and antimicrobial effectiveness. Ms. Mach is the technical contact for ASTM F1608 on the F02 committee for flexible barrier packaging of the American Society for Testing and Materials and is a member of the Association for the Advancement of Medical Instrumentation packaging work group. Materials Roundtable Titanium Industries, Carpenter Technology, Interstate Plastics Suppliers will focus on titanium, stainless steel and polymers, providing updates on the materials availability, common applications, manufacturing processes and regulatory status. Mary Moynihan-Downes is the Medical Director at Titanium Industries (T.I.), overseeing the global sales and marketing of all medical products. She worked for 17 years at TIMET, a major domestic titanium mill, and spent the past decade at T.I. Raw Materials June 12, 1:30 pm – 3:15 pm Fred McMann is a Staff Specialist Regional Metallurgy, Midwest US, at Carpenter Technology Corp. Mr. McMann joined Carpenter 34 years ago, and prior to that was a welding engineer for Ford Motor Co. He has authored industry articles on stainless steel and has 35 U.S. patents for stainless alloy development. Mike Feld has been with Interstate Plastics and in the plastics distribution industry for over 30 years. For the last seven years he has managed the Medical Division at Interstate Plastics. Mike has concentrated and focused on USP Class VI/ ISO 10993 certified materials. A Supplier’s Perspective on the Shifting Global Regulatory Environment Shawn Shorrock, Director of Global Regulatory Affairs, Solvay Specialty Polymers Medical device manufacturers face increasing pressures related to the biological safety of 13 TECHNICAL SEMINAR AREA Learn efficiencies and trends in implant and instrument development from exhibiting suppliers. Follow the orange dots to the training. • Additive Manufacturing June 11, 9:30 am – 10:30 am Material selection based on performance requirements of devices, e.g., sterilization, radiolucency and radio opacity Mr. Cislaghi has over 15 years of experience in the injection molding and polymer industry in Germany and Brazil. His focus includes aligning customers’ needs with Ensinger’s capacities and developing new applications for high performance plastics. Prior to Ensinger, Mr. Cislaghi worked for Johnson Controls and Dana Molded Products, injection molders focusing on the automotive market. ir. Ruben Wauthle, Medical Application Engineer, LayerWise This presentation will elaborate on Selective Laser Melting metal additive manufacturing technology, its advantages, possibilities and limitations. Session Takeaways: Coating Implants • An overview of materials used and their mechanical properties • How to create added value to orthopaedic implants by integrating porous bone replacement structures June 11, 1:30 pm – 2:30 pm Parimal Bapat, Ph.D., Research Engineer, Orchid Orthopedic Solutions During his Master’s thesis, Mr. Wauthle performed research in collaboration with LayerWise on “Reducing Thermal Stresses in Selective Laser Melting.” He started his career at LayerWise in September 2010 and focuses on customer and R&D projects. He is finishing his Ph.D. thesis, “Improved periprosthetic fixation of orthopaedic implants using novel Selective Laser Melting techniques.” This session will review the process and properties of traditional plasma-sprayed HA coating and give insight into new technologies. Session Takeaways: • Processes and properties of plasma-sprayed HA coatings • New HA coating techniques and processes • Regulatory hurdles to bring new-age HA coatings to the market Injection Molding June 11, 11:00 am – 12:00 pm David Cislaghi, Product Development Manager, Ensinger Brazil Dr. Bapat develops and investigates new coatings technologies. As a Graduate Research Assistant at the Center for Nanoscale Material and Biointegration at the University of Alabama in Birmingham, he worked toward his Ph.D. thesis, “Gas Phase Laser Synthesis of Calcium Phosphate Nanoparticles for Biomedical Applications.” Among Dr. Bapat’s expertise is nanomaterial characterization techniques. He is an active ASTM member. The discussion will focus on conversion of traditional machined metal and plastic devices to fit the performance needs of an application while harmonizing the design for injection molding. Session Takeaways: • Product design considerations for conversion to injection molding • Prototyping options of machining stock shapes for design and functionality verification Oral Poster Presentation June 11, 3:30 pm – 4:30 pm The latest research regarding orthobiologics, hip and spine will be on display. Listen to reviews of the research and ask questions. To find the education that meets your needs, look for the colored dot that best matches your title. Buyer/Planner Materials/Commodity Manager Product Management Purchasing Quality Control Regulatory/Clinical Affairs Research/Development/Design Supply Chain Management Executive Management Manufacturing 14 ...on the Exhibit Hall Floor. Tray Sterilization Design for Manufacturability June 12, 3:30 pm – 4:30 pm June 12, 1:30 pm – 2:30 pm Sean Miller, Engineering Manager, Paragon Medical Daniel Prince, Ph.D., President, Gibraltar Laboratories In the past, Design for Manufacturability (DFM) brought design and manufacturing together to exchange ideas, but today DFM harmonizes engineering groups to optimize product value. Through examples of screening 14 different tray systems, this session will provide a clear understanding of the regulatory and sterilization science factors which are critical to success and safety for patients. Session Takeaways: Receive a broad view of DFM and market trends that drive: • Cost management: Designing for advanced manufacturing processes to achieve a target price • Quality management: Aligning inspection methodology and process control with specifications • Risk management: Ensuring supply continuity and planning for critical process failure • Timeline and capacity management: Level loading engineering and machine capacity in harmony with milestones Session Takeaways: Mr. Miller has filled multiple roles within Paragon Medical over the past six years, including project management, development engineering, manufacturing engineering, supply chain development and special process validation support. He currently manages the Bioskills Lab for cadaveric research and learning. Mr. Miller will complete his MBA this year from Indiana Wesleyan University. • Keys to successful ST 79 steam sterilization are instrument and tray design, Steam Penetration, Item heat penetration, testing at the cold spot • Differences between ANSI/AAMI/ISO 17665-1:2006 • Sterilization of health care products—moist heat—Part 1 Requirements for the development, validation and routine control of sterilization process for medical devices • Annex D and ANSI/AAMI ST79:2010 & A1:2010 & A2: 2011 & A3:2012 Dr. Prince, a respected specialist in the fields of microbiology and molecular biology, received his bachelor’s from Clark University and his doctorate from Rutgers University/University of Medicine and Dentistry of New Jersey. As president of Gibraltar Laboratories, Dr. Prince has led the company’s exceptional expansion and growth since 1987. He is the author of many relevant publications and presentations. To find the education that meets your needs, look for the colored dot that best matches your title. Buyer/Planner Materials/Commodity Manager Product Management Purchasing Quality Control Regulatory/Clinical Affairs Research/Development/Design Supply Chain Management Executive Management Manufacturing Download Speaker Presentations at www.OMTECexpo.com 16 WEDNESDAY, JUNE 11 SESSION ROOMS SPONSORED BY Lectures and Panel Discussions How to Improve Supplier Scorecards struggle with designing or enhancing their reporting process and systems in preparation for future submission dates. Further, concerns linger regarding impact on customer relationships and other downstream compliance issues arising from the disclosure of required data. This presentation will provide an overview of current challenges and key strategies for enhancing compliance. June 11, 9:30 am – 10:30 am Rob Packard, Founder, Medical Device Academy Session Takeaways: This presentation educates OEMs and suppliers alike. OEMs will learn how to collect data to create a more useful supplier scorecard without wasting precious human resources, and suppliers will learn how to interpret scorecards so that they understand where they need to improve. The presentation will cover common mistakes that frequently result in discrepancies between perceived excellence and a poor supplier score. Session Takeaways: • What should be measured and what’s an acceptable score • How often scorecards should be issued • How to gather supplier metrics with less effort and greater accuracy • Advice on what to do when you give or receive a poor score • Brief overview, with the latest updates to guidance, of Open Payments and analogous state laws/regulations applicable to medical device manufacturers • Key challenges for manufacturers in capturing, tracking and reporting required data prior to submission • Best practices and actionable strategies for enhancing compliance with Open Payments and analogous laws/ regulations pre- and post-submission of required data • A survey of the current and forthcoming foreign “Sunshine” laws and industry codes Mr. Minassian is a licensed attorney with experience advising medical device manufacturers on legal and operational issues related to the Physician Payment Sunshine Act and state aggregate spend laws, lobbying disclosure laws, the Anti-Kickback Statute, the False Claims Act, off-label promotion and other compliance regulations. Mr. Packard is a regulatory consultant with 20 years of experience in the medical device, pharmaceutical and biotechnology industries. His specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE Marking applications, Canadian medical device applications and 510(k)s. Best Practices for Design Verification and Validation June 11, 1:30 pm – 2:30 pm Martin Browning, President and Co-Founder, EduQuest The Sunshine Act and Beyond: Improving Compliance Processes and Strategies Design control is required for all medical devices sold in the U.S., European Union, Japan and other major countries. Attend this session and learn how FDA expects you to develop, implement and manage design control throughout the entire lifecycle of a product. Emphasis will be placed on best practices for design validation and verification, as well as lessons learned by other device companies that have been cited by FDA for deficient design controls. June 11, 11:00 am – 12:00 pm Vahan Minassian, Manager, Compliance & Ethics, Compliance Implementation Services Deadlines for submitting required data pursuant to Physician Payment Sunshine Act (now referred to as “Open Payments”) are all but past; however, companies continue to To find the education that meets your needs, look for the colored dot that best matches your title. Buyer/Planner Materials/Commodity Manager Product Management Purchasing Quality Control Regulatory/Clinical Affairs Research/Development/Design Supply Chain Management Executive Management Manufacturing 20 WEDNESDAY, JUNE 11 Session Takeaways: • Latest FDA guidance for design control • Design verification and validation: Understanding the crucial differences • Best practices for device design validation, verification and transfer to manufacturing • Lessons learned from FDA warning letters and enforcement actions primarily pre-revenue/technology and revenue-generating bolt-ons. Such deals have included stock and asset purchases, exclusive licenses, supply/distribution agreements, equity investments and divestitures. FDA Priorities: Pre- and Post-Market Data Requirements and PMAs June 11, 3:30 pm – 4:30 pm Michael M. Gaba, Partner, Holland & Knight Mr. Browning’s 22-year career at FDA included work as an investigator and as a senior manager in the Office of Regulatory Affairs. He also took part in the FDA groups that drafted the original 21 CFR Part 11 regulations and the medical device Quality System Regulation (QSR). At EduQuest, he helps clients solve problems related to FDA regulation, quality assurance, software and systems engineering and compliance auditing. This session will address recent FDA regulatory developments with a focus on CDRH’s 2014-2015 priorities and implications for orthopaedic device manufacturers. Emphasis will be placed on efforts to speed products to market through a rebalancing of pre- and post-market data requirements, as well as CDRH’s efforts to help companies accelerate the PMA approval process for particular technologies. Mr. Gaba will also address how to communicate effectively with FDA and the implications of the agency’s globalization efforts. Value Drivers: Considerations for the M&A Process June 11, 2:45 pm – 3:15 pm Session Takeaways: Don Urbanowicz, Principal, Urbanowicz Consulting Value drivers are the attributes that differentiate—and distinguish—successful companies. These value drivers can show the strength of a company’s business model, customer base, products and technology, and better position the company next to its competitors. This session reviews ways that sellers can identify and tell a compelling story about their value drivers and identifies buyers’ best practices for strategizing during acquisitions. • Understanding of two recently released Draft Guidance documents: Data Requirements to Support a PMA and Expedited PMA Process • Grasp of CDRH’s efforts to revise its regulatory framework to become a leader in the ever-contracting global marketplace Session Takeaways: What strategics look for when acquiring revenue-generating companies • A typical strategics’ M&A transaction process • Identification of key value drivers, along with the characteristics that prospective buyers may find more— or less—desirable about each driver • • Mitigating risk and “ensuring that your house is in order” Mr. Urbanowicz has a 30-year successful track record of performance with multinational healthcare companies. In January 2011, he founded Urbanowicz Consulting as a medical device advisory firm with a musculoskeletal focus. He has successfully concluded 40+ transactions (35 percent outside the U.S.), Every year, more orthopedic implant OEMs use Precision Metal Products. PMP offers: • • • • • State-of-the-art forging / machining and engineering capabilities Fast turn-around from initial design to full scale production Precision forgings to reduce your overall total costs Expertise in forging titanium, cobalt-chrome, stainless-steel and more Your technical specifications, schedules and cost targets will be met For assistance, contact: 619/448-2711 • [email protected] www.pmp-elcajon.com • www.hbdindustries.com 21 WEDNESDAY, JUNE 11 • Moderator: Knowledge to make more informed business decisions as a result of having a greater gasp on CDRH’s renewed mission Jeff Tyber, CEO and President, Tyber Medical Mr. Tyber has served in the orthopaedic industry for 12 years in roles of product development, research and management at Aesculap Implant Systems, Extremity Medical and MedShape Solutions, the latter which he also co-founded. He is a named inventor on more than 40 domestic and international patents and patent applications. Mr. Gaba is the Federal policy leader of Holland & Knight’s national Healthcare & Life Sciences Team. He counsels and represents device companies before FDA, CMS and the U.S. Congress. Mr. Gaba advises clients on get-to-market strategies, including de novo or 510(k) pathways, labeling and promotional claims, clinical study design and quality system regulation compliance. He also counsels clients on post-market surveillance issues, including product recalls, 483s and Warning Letters and Class III high risk products. Panelists: John W. Boger, Partner, Heslin Rothenberg Farley Mesiti P.C. Mr. Boger is Chairman of Heslin Rothenberg Farley Mesiti P.C.’s Medical Products and Technology Practice Group. Before attending law school, Mr. Boger worked for eight years with a large orthopaedic device manufacturer in various product development and marketing positions. IP Due Diligence from Product Idea to Launch June 11, 3:30 pm – 4:30 pm A panel of experts will walk through IP steps during the critical stages of project initiation, concept phase, design and development phase and product release. This discussion will provide best practices to ensure that the right stakeholders are brought to the table and the proper investments are made to protect your company’s product portfolio. David W. Meibos, Founder, Maywood IP Law Mr. Meibos has been a registered patent attorney for more than 13 years. As Senior Director of Intellectual Property for IMDS, he helped doctors, startups and OEMs establish freedom-to-operate for new products, design around competitive patents, obtain patent protection for their ideas and license or sell their technologies. He now operates Maywood IP Law. Session Takeaways: • The role of design patents in the medical industry • When to start a patent search • When to file a Provisional vs. Utility patent • Tips for filing internationally • When and how to pursue patent enforcement and apply evergreening for product success Diane Dobrea, Legal Counsel, Kapstone Medical Ms. Dobrea is in-house legal counsel with Kapstone Medical. Throughout her career, Ms. Dobrea has focused on identifying, protecting and licensing her clients’ innovations. Ms. Dobrea earned her bachelor’s and Master’s degree in biochemistry and her JD from Case Western Reserve University. She is a member of the Ohio Bar and is admitted to practice before the USPTO. To find the education that meets your needs, look for the colored dot that best matches your title. Buyer/Planner Materials/Commodity Manager Product Management Purchasing Quality Control Regulatory/Clinical Affairs Research/Development/Design Supply Chain Management Executive Management Manufacturing All attendees and exhibitors are invited to attend educational sessions. 22 THURSDAY, JUNE 12 FDA Expectations for Supplier Quality Session Takeaways: June 12, 9 am – 10:30 am How Lean Manufacturing strengthens a company’s continuous improvement initiative • How to set targets, integrate plans and remain focused to achieve company-wide priorities while managing change • How to align and integrate all employees and functions to work together • How to develop a model to share and implement best practices Martin Browning, President and Co-Founder, EduQuest • Through recalls, seizures, injunctions and more, FDA has considerable reach throughout each link of your supply chain. To survive FDA inspections and protect yourself and your shareholders, you need to identify and fix weak spots before they compromise the safety and effectiveness of your products. Learn FDA’s latest expectations for supplier management in this practical presentation, which will include lessons learned from the front lines of FDA’s enforcement initiatives. Mr. Mazzeo recently retired from General Motors where he was an executive with broad global experience in manufacturing and quality. He assists small- to medium-sized companies, including medical device manufacturing companies, with lean manufacturing and quality management consulting services. Session Takeaways: • FDA’s latest expectations for managing supplier quality • List of the links in your supply chain that you should and must audit • Where FDA rules and ISO requirements overlap and diverge • Importance of incorporating suppliers into your CAPA system • Using FDA’s Quality System Regulation (QSR) as a roadmap for effective supplier management Six Steps to Design Planning Core Competency June 12, 11:00 am – 12:00 pm Robert Packard, Founder, Medical Device Academy The ability to get products to market quickly is the most important core competency for a company to develop. Learn how to improve the performance of your design teams by sharing best practices in design planning, including organization of your design plan for regulatory compliance, how to perform an internal audit of design controls and what aspects of the design process to measure as a quality objective. Please see Mr. Browning’s bio on page 20. Lean Manufacturing: Achieving Performance Results and Employee Engagement Session Takeaways: June 12, 9:30 am – 10:30 am A template for a design plan • A template for a regulatory pathway document • Examples of quality objectives for the design control process (ready for a Management Review) • A turtle diagram with auditor checklist questions for internal auditing of design controls • Examples of preventive actions to improve your design process Joseph Mazzeo, Owner, Integrated Lean and Quality Solutions • The use of Lean Manufacturing methods has yielded significant reductions in waste, improved quality, lower operating costs and increased profitability. However, most companies have not taken the next step in the Lean Manufacturing journey. To reach the next level of performance and results, the use of a Business Plan Deployment Process enables the organization to set targets, integrate plans and remain focused to achieve company-wide business priorities while managing change. Please see Mr. Packard’s bio on page 20. To find the education that meets your needs, look for the colored dot that best matches your title. Buyer/Planner Materials/Commodity Manager Product Management Purchasing Quality Control Regulatory/Clinical Affairs Research/Development/Design Supply Chain Management Executive Management Manufacturing 24 THURSDAY, JUNE 12 How to Comply with SEC Conflict Minerals Requirements Moderator: June 12, 11:00 am – 12:00 pm Panelists: Ronald Klein, Partner, Holland & Knight Bob Vitoux, Vice President Commercial Operations, Biomet Prior to being named Vice President of Commercial Operations, Mr. Vitoux was Vice President of Finance for Biomet’s US Orthopedics. This presentation provides an overview of the Securities & Exchange Commission’s new conflict minerals due diligence rules, enabling executives to understand the how, when and why of complying with the new requirements. Attendees will receive concrete knowledge on how to start building a compliance program, how to build an internal team that can manage the process from start to finish and how to communicate with relevant stakeholders (customers, suppliers, employees, industry groups, NGOs, etc.). Steve Chyung, Vice President of Supply Chain, SCL Health System Mr. Chyung joined SCL Health System in November 2011 and has established a systemwide supply chain group to drive significant productivity programs that have been a critical component of SCL’s financial turnaround. Prior to SCL, Mr. Chyung held several leadership positions with Novartis where his responsibilities included establishing global Centers of Excellence in Europe, Asia and Latin America. Session Takeaways: • The context and intent of the rule • The scope and structure of the rule • The most challenging aspects of complying with the rule and how to approach them • The broader elements of the compliance process that are critical for success, including navigating regulatory, outreach, strategic communication and corporate responsibility efforts Mr. Klein is a former U.S. Congressman who has worked in the private sector as a business and transactional attorney for over 20 years, as well as the public sector as an elected official in Florida and Washington. Mr. Klein has led strategic efforts on behalf of a large manufacturer to implement and comply with Dodd-Frank’s conflict minerals due-diligence requirements. Eliminating Supply Chain Waste: Manufacturer and Hospital Collaboration June 12, 1:30 pm – 2:30 pm The implantable device supply chain is ripe with waste—more than $5 billion in inefficiencies has been documented in the U.S. alone. Awareness provides a unique opportunity for orthopaedic device manufacturers and their customers to collaborate in reducing these costs. Biomet and SCL Health System will come together to discuss methods identified for successful collaboration, implementation and cost saving results. Session Takeaways: • Prevalent supply chain inefficiencies and how to reduce them • How OEMs and their customers can work together to develop best practices • How OEMs and their customers can work together to reduce costs Karen Conway, Executive Director of Industry Relations, GHX Please see Ms. Conway’s bio on page 12. 25 THURSDAY, JUNE 12 • The Excise Tax: Lessons on Constructive Pricing June 12, 2:45 pm – 3:15 pm How suppliers have used strategic alliances with partners to penetrate geographic markets Moderator: William D. Ault, CPA, Director, Crowe Horwath This session will provide practical lessons learned since the Federal Excise Tax on medical devices went into effect in January 2013. It will focus on how to confirm that you are paying the lowest possible excise taxes based on constructive pricing, exclusions and exemptions. You will leave knowing how constructive pricing should work for imports, sales at retail, sales to retailers and sales to wholesalers. Andrew Miclot, Executive Vice President, MicroTechnologies Mr. Miclot has a career record of success in startup, turnaround and growth arenas from early stage to Fortune 500 firms. His insight and vision have led to gains in global market share, revenue, profit and competitive advantage with medical device suppliers and OEMs. He has held leadership positions at ArthroCare, Ascension Orthopedics and Symmetry Medical. Session Takeaways: Panelists: • Know that you’re applying the correct constructive price based on your distribution channels • Know that you’re claiming all available exemptions • Know the taxability of services included with the sale, and any contract manufacturer, export, resale, not for profit and government exemptions Thomas W. Barrett, Senior Vice President and Chief Commercial Officer OEM Solutions, Symmetry Medical Mr. Barrett has served in his position since February 2013. Prior to this, Mr. Barrett had served as Senior Vice President Worldwide Instruments since joining the company in November 2011. Prior to joining Symmetry Medical, Mr. Barrett held leadership positions at Medrobotics, Keystone Dental, Accellent and Stryker. Mr. Ault leads Crowe Horwath’s Federal excise tax consulting practice. He provides compliance and consulting services to manufacturers, importers and service providers, including taxability analysis, tax calculation reviews, return preparation and review services, refund analysis and IRS tax audit assistance. Mr. Ault’s experience includes extensive consultation with respect to the excise tax on medical devices. Greg Hall, Director of International Business Development, Paragon Medical Mr. Hall joined Paragon over 20 years ago and has served in sales and marketing roles for the U.S. and European markets. Mr. Hall was responsible for creating the Business Development and Engineering office in Lausanne, Switzerland. He continued to gain international business experience by taking a leadership role in establishing strategic direction in Asia. These efforts resulted in the creation of a wholly owned foreign enterprise located in Changzhou, China. Supplier Panel on Globalization June 12, 3:30 pm – 4:30 pm Keeping pace with complex global economic and regulatory changes is imperative for success in any company. Suppliers come together to provide advice on managing the commercialization process and supply chain in multiple markets, as well as ways to identify strategic partners to assist in worldwide operations. Christopher Norbye, Executive Vice President Global Operations, Orchid Orthopedic Solutions Mr. Norbye joined Orchid in 2012 as the Executive Vice President, Global Operations for Orchid Connecticut when Orchid acquired Sandvik Medical Solutions, where he held the title of President. He previously held several global positions within operations, business development and mergers and acquisitions. He holds a Bachelor of Science degree from Louisiana State University and an M.B.A. from the University of Miami. Session Takeaways: • Challenges and opportunities—economic, regulatory and government—encountered in supplying a global market • Quality requirements that suppliers are increasingly being asked to meet • Where suppliers have set up global operations, and why • Advice on expanding in the U.S., Western Hemisphere To find the education that meets your needs, look for the colored dot that best matches your title. Buyer/Planner Materials/Commodity Manager Product Management Purchasing Quality Control Regulatory/Clinical Affairs Research/Development/Design Supply Chain Management Executive Management Manufacturing 26 EXHIBITOR LISTING 532. Acme Manufacturing Company 119. AMETEK - Reading Alloys 4240 North Atlantic Boulevard Auburn Hills, MI 48326 USA 248-393-7300 (phone) | 248-393-4060 (fax) www.acmemfg.com Acme Manufacturing Company is the largest and most experienced global manufacturer of integrated robotic polishing, buffing, grinding and deburring systems for orthopaedic components. Our automation technology and applications offer the most current, productive and cost efficient installations in the industry. Acme maintains a complete in-house technical support staff of engineers and service technicians for after sale machine servicing worldwide. 220 Old West Penn Ave Robesonia, PA 19551USA 610-693-5822 (phone) | 610-693-5542 (fax) www.ametekmetals.com AMETEK - Reading Alloys is a global leader in producing high purity medical grade titanium and titanium alloy powders. Our titanium powders are used for coatings on implants as well as additive parts manufacturing. We are an approved and preferred supplier for many of the world’s most discerning medical device manufacturers and contractors. Please see us in booth 119 to learn more about our capabilities. 514. Advantage Manufacturing Technologies, Inc. 500. APS Materials AMT is your one stop manufacturing resource for all of your implant, instrument and complex assembly needs. If you are looking for a vertically integrated manufacturing partner specializing in complete project assistance, look no further. AMT will assist you from application of design through production manufacturing and timely dock to stock inventory. AMT is an ISO 13485 certified and FDA registered supplier eager to add value to all of your medical device needs. APS Materials Inc. (The Leader in Biomedical Implant Coatings). Providing rough/porous and bioactive coatings for improved implant fixation using Plasma spray technology. APS provides Commercially Pure Titanium (CPTi), Ti6Al4V,and Hydroxyapatite (HA) coatings on orthopaedic, spinal and dental implants. ISO 9001/13485 Certified, FDA Registered and Master Files for coatings, and onsite Metallurgical Lab (Nadcap Certified). 207. AIP Precision Machining 808. Arcam AB The global leader of custom precision machined plastic components for the orthopedic marketplace. RADIOLUCENT CARBON FIBER BIOMATERIALS for bone fracture fixation devices, tissue retractors and surgical instruments used under fluoroscopy. Process validated machining of INVIBIO PEEK OPTIMA and SOLVAY ZENIVA IMPLANTABLE PEEK biomaterials. ISO 13485:2003. FDA Registered.. Arcam provides a cost-efficient Additive Manufacturing solution for production of implants. Arcam’s EBM® technology is used for production of FDA-cleared and CE-certified orthopedic implants. EBM is used for production of acetabular cups with Trabecular Structures™ for improved osseointegration, augments, femoral stems and spinal cages. Arcam is an innovative partner for manufacturing in the orthopedic implant industry. 107. Alden Tool Co., Inc. 608. Arcamed 199 New Park Drive Berlin, CT 06037 USA 860-828-3556 (phone) | 860-828-8872 (fax) www.aldentool.com 2801 Fortune Circle East, Suite B Indianapolis, IN 46241 USA 877-545-6622 (phone) | 317-375-7717 (fax) www.arcamed.com Alden Tool is a world class contract manufacturer of surgical cutting tools and instruments for Orthopedic and Spinal. We are ISO 9001, ISO 13485 and FDA certified. Specializing in drills, reamers, taps and hand instruments. ARCAMED is committed to being the fastest and most reliable designer / manufacturer of innovative, sophisticated and durable case-tray systems for the orthopaedic and surgical industries. Arcamed understands the daily challenges and obstacles which can be associated with case and tray systems and surgical sets. Cases and trays can make or break a launch date and we know how any delay can critically impact your success. 533. Alhenia AG 531. Aristotech Implant Precision Forgings GmbH Taefernstrasse 39 Daettwil, 5405 Switzerland 41-0-56-622-01-33 (phone) | 41-0-56-622-36-59 (fax) www.alhenia.com Im Biotechnologiepark Luckenwalde, 14943 Germany 49-0-3371-40 640-0 (phone) | 49-0-3371-40 640-215 (fax) www.aristotech.de Alhenia is a leading provider of medical implants and instruments to orthopaedic device manufacturers. Our one-stop-shop concept offers our customers machined components, bio-compatible coatings and finishing services, all from one source. Recently, new coatings have been developed providing a considerable new spectrum of potential applications in the future endo-prostheses. ARISTOTECH provides long-term experience in the manufacturing of medical products and processing of implants. Due to our highly qualified engineers we offer cost effective solutions. We offer standard products without additional costs for processing and tools, and assist you with developing your own medical products. Aristotech supplies semi-finished, finished, packed and sterile products. 115. American Instrument & Implant 126. Autocam Medical 4011 Riverside Drive Dayton, OH 45405 USA 937-278-6547 (phone) | 937-278-4352 (fax) www.apsbiomedical.com 14298 169th Drive SE Monroe, WA 98272 USA 425-485-3980 (phone) | 425-483-1608 (fax) www.teamamt.com 724 Fentress Boulevard Daytona Beach, FL 32114 USA 386-274-5335 (phone) | 386-274-4746 (fax) www.AIPprecision.com Kroslatts Fabriker 30 Molndal 431 37 Sweden 46-31-7103200 (phone) | 46-31-7103201 (fax) www.arcam.com 9470 E 14 1/4 Road Manton, MI 49663 USA 231-824-9772 (phone) | 231-824-9790 (fax) www.instrumentandimplant.com 4152 East Paris Avenue SE Kentwood, MI 49512 USA 877-633-8080 (toll free) | 616-698-6876 (fax) www.autocam-medical.com American Instrument & Implant is a precision manufacturer of medical instruments and implants. Product experience includes plates, hooks, cages, cannulas, drivers, drill guides, etc. We can satisfy requirements such as coatings, laser marking and passivation. American Instrument & Implant provides prompt quoting and delivery, prototype or production capabilities, specific documentation and exceptional craftsmanship. ISO 13485:2003, FDA registered. A WORLD OF MANUFACTURING EXPERTISE IN EVERY PART. Autocam Medical is a contract manufacturer of precision-machined surgical drill bits, drivers, screws, plates, cutting tools and other complex, highly engineered medical parts. We offer a value-added approach to high-precision manufacturing, with specialties in CNC milling, turning and cutter grinding. State-of-the-art equipment and design for manufacturing engineering add value to the entire manufacturing process. ISO13485:2003/ISO 9001:2008, FDA Registered, VISA (Brazil). 28 102. Baum Precision Machining, Inc. 127. Carpenter Technology Corporation 5136 Applebutter Road Pipersville, PA 18947 USA 215-766-3066 (phone) | 215-766-9776 (fax) www.baumprecision.com 101 West Bern Street Reading, PA 19601 USA 800-654-6543 (toll free) | 610-208-2000 (phone) www.cartech.com Baum Precision is passionate about serving the medical device industry. We focus on manufacturing complex implants and instruments for orthopedic, spinal and trauma applications. We consistently delight our customers with exceptional responsiveness, quality, customer service and on-time performance. We specialize in Complex 3, 4 & 5 Axis Milling, Turning, Wire EDM, Finishing and Assembly. A fully integrated developer, manufacturer and distributor of a broad range of specialty alloys including biocompatible BioDur® alloys, stainless steels and titanium alloys. Applications have included surgical, diagnostic, orthopedic, cardiovascular and dental. Product forms: billet and bar, wire, precision strip, fine wire and custom-shaped bar and wire. Service centers on four continents. Free, searchable technical database at www.cartech.com. 433. Beijing Changhang Investment Casting Co. 108. Centex Machining, Inc. Beijing Changhang Investment Casting is a foundry specialized in manufac manufacturing orthopaedic implant castings which are mainly Co-Cr-Mo hip joint castings and knee joint castings, etc. We are the leading supplier of China implant castings, providing implant castings with good quality and performance. We have established a sound quality management system and acquired ISO 9000 approval in 2004. 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. 306. Bob, Incorporated 112. CeramTec GmbH – Medical Engineering Division We specialize in close tolerance machining of implants to support your complete Prototype to Production process. We support large volume contracts with 65+ CNC machines including 9-axis CNC swiss machines, robotic loading CNC twin spindle lathes, high speed 5-axis CNC machining, etc. We partner with customers in JIT, Kanban, supplier managed inventory and other lean programs. ISO 9001:2008, ISO 13485:2003, AS9100C Certified, FDA registered. In most cases, they are as invisible as they are indispensable – CeramTec ceramic products are used worldwide for key applications in medical devices. CeramTec advanced ceramics are present in all kinds of medical devices & equipment. Furthermore, CeramTec bioceramics are used successfully in orthopedics and help maintain and increase the quality of life with implant components for artificial hip joints and knee replacements. 224. Bradshaw Medical, Inc. 633. Changzhou KangDing Medical Instrument Co. Ltd. BMI gives you the competitive edge in today’s highly specialized design and development of OEM orthopedic and spinal instruments. We manufacture world class instruments to meet your most demanding requirements. BMI has the manufacturing capabilities to develop innovative instruments in time for your next critical product launch. We invite you to contact us at the earliest concept phase to ensure a seamless transition from prototype through production. Condyn/KangDing is dedicated to the design and manufacture of orthopedic instruments. We make instruments and cases for spine, trauma and joint surgery. Material capabilities include stainless steel, aluminum and plastic. Condyn has Swiss turning, EDM, 4-5 axis mill, laser weld, RO water system, CMM, hardness tester, thickness meter and surface finish processes. Condyn is your reliable contract manufacturing partner and always delighted to work with you! 512. C&A Tool Engineering, Inc. 109. Changzhou Yonghua Medical Instruments Co.,Ltd. C&A Tool is a full service machining Contract Manufacturer of medical implants and instruments. Please visit us at booth #512, and be sure to ask about our DMLS capabilities. Our factory is devoted to R&D and OEM. We are the professional medical instrument manufacturer for orthopedics. We can produce all kinds of drills, taps, all kinds of instruments for trauma, spine, hips, etc. 709. Cam Bioceramics 829. Cool Clean Technologies, LLC Shahe Industrial Park, Changping District Beijing, 102206 China 86-10-8072-5350 (phone) | 86-10-8072-5352 (fax) www.chcasting.com 1513 Sam Bass Road Round Rock, TX 78681 USA 512-255-1477 (phone) | 512-388-3606 (fax) www.centexmachining.com 8740 49th Avenue North Minneapolis, MN 55428 USA 763-533-2261 (phone) | 763-533-1735 (fax) www.bobinc.com Luitpoldstrasse 15 Lauf a.d. Pegnitz, 91207 Germany 49-0-9123-77-530 (phone) | 49-0-9123-77-443 (fax) www.ceramtec.com 10325 58th Place Kenosha, WI 53144 USA 262-925-1374 (phone) | 877-201-7661 (toll free) 262-925-1380 (fax) www.bradshaw-medical.com No. 9, West Lingxiang Road, Wujin Economic Development Zone Changzhou, China 213249 86-134-0155-8913 (phone) | 86-519-8166-0111 (fax) www.condyn.cn 8 Hehong Road, Wujin Economic Development Zone Jiangsu, China 213145 86-519-86882801 (phone) | 86-519-86882805 (fax) www.yong-hua.com 4100 North U.S. 33 Churubusco, IN 46723 USA 260-693-2167 (phone) | 260-693-3633 (fax) www.catool.com Leiden Bio Science Park Zernikedreef 6 Leiden, 2333 CL Netherlands 31-71-5240600 (phone) | 31-71-5240650 (fax) www.cambioceramics.com 915 Blue Gentian Road #400 Eagan, MN 55121 USA 651-842-8600 (phone) | 651-842-8699 (fax) www.coolclean.com Cool Clean Technologies is the worldwide leader in CO2 cleaning, machining and extraction solutions. Innovative uses of carbon dioxide in all phases, liquid, solid, and gas, enable Cool Clean to solve the most challenging applications. All processes are waterless and eco-friendly. Find out how to become Dry, Green and Clean today. Cam Bioceramics is an ISO 13485 certified contract manufacturer of orthobiologic calcium phosphates. We engineer and manufacture orthobiologic calcium phosphate powders, porous granules, dense granules, shapes and supply HA plasma coatings. We manufacture alpha tricalcium phosphate, beta tricalcium phosphate, hydroxyapatite and biphasic materials of the highest purities as ceramic raw materials and components for medical devices. 29 821. Costa Rican Investment Promotion Agency 737. ECA Medical Instruments The Costa Rican Investment Promotion Agency (CINDE) is a private, nonprofit organization that promotes Costa Rica as a competitive, low-risk location for manufacturing operations and specialty services. CINDE provides first-hand information and the support needed for the decision-making and installation processes, as well as post-establishment services in areas such as human capital development and infrastructure. ECA Medical Instruments is the leading designer and manufacturer of singleprocedure/disposable torque-limiting and fixed-driver instruments & procedural kits for orthopaedic and spine OEMs and surgeons worldwide. Since 1979, ECA is the trusted surgical solution with >25 million single-use torque-limiting instruments fielded for CRM, Neuro, CV & Orthopaedic & Spine implant procedures. The company is ISO 13485:2003, ISO 9001:2008, CE Mark and is FDA Registered. 116. CTE Solutions 121. Electrolizing Corporation of Ohio, The 1901 Walter Glaub Drive Plymouth, IN 46563 USA 574-935-9611(phone) | 574-935-9612 (fax) www.culvertool.com 2193 Anchor Court Thousand Oaks, CA 91320 USA 805-376-2509 (phone) | 805-990-6177 (fax) www.ecamedical.com Culver Tool & Engineering, Inc. Plaza Roble, Los Balcones Building Escazu, San Jose Costa Rica 506-2201-2800 (phone) | 506-2201-2877 (fax) www.cinde.org 1325 East 152nd Street Cleveland, OH 44112 USA 216-451-8655 (phone) 216-451-4729 (fax) www.electrohio.com I n t e g r i t y. Q u a l i t y. S e r v i c e. CTE Solutions (Culver Tool & Engineering) has supplied orthopedic OEMs for 27 years by building enduring partnerships with our clients. Our aim is a culture of excellence, based upon integrity. For prototypes, customs or production quantities, we offer single-source solutions to our customers’ implant and instrumentation needs. CTE Solutions is ISO 13485 certified, FDA registered and accredited with Japan as a foreign medical device manufacturer. The Electrolizing Corp. of Ohio is a proven leader in specialty coatings for the medical device and implant industry. Processes are validated to the Global Harmonization Task Force guidelines: Medcoat 2000 biocompatible coating for instruments and devices, Ti-Med titanium anodizing, aluminum anodizing, hard chrome, Electrolizing, electropolishing, and passivation. The company has specialized in medical coatings since 1948. 209. Danco Anodizing 601. EMCM Danco Anodizing provides Titanium and Aluminum Anodizing of machined parts, implants and instruments. Electropolishing, Passivation and LFCC services also provided to the medical community. Finishing includes de-burring, polishing, graining and blasting. Marking capabilities incorporate Full Color Deep Image®, Laser, Epoxy, and Silk-Screen techniques. Danco maintains facilities in Arcadia, Ontario, Santa Ana, CA and Warsaw, IN. NADCAP and ISO 9001:2008 certified. New location in Changzhou, China. Centre of excellence in developing and manufacturing sterile medical products in GMP and ISO accredited facilities, to the markets of Biomaterials, Pharmaceuticals and Tissue Engineering conforming to FDA, EMEA & ISO standards. Our focus lies on products which have unique qualities and where the skill and expertise of our organization can make a difference to the lives of millions tomorrow. 808. DiSanto Technology, Inc. 231. Ensinger Throughout our 25 years of consistent medical business growth, we have developed unique skills and manufacturing processes enabling the delivery of complex, high quality medical implants and instruments in plastic and metal along with EBM technology to major orthopedic and spine companies. 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. 408. Donson Machine Co. 309. EPTAM Plastics Donson is a specialized contract manufacturer of precision machined components and assemblies for Orthopedics and Medical Equipment. Registered to ISO 13485:2003, Donson focuses on complex designs and applications requiring stateof-the-art equipment and engineering. Donson currently supplies components, instruments and implants to industry-leading manufacturers and is geared for quick-turn prototyping, short-run specials and production. ISO 13485:2003 & ISO 9001:2008 Registered; specializing in machining precision polymer components. Offering 7, 5 and 3 Axis machining, dry machining and inhouse laser marking; our skilled machinists fabricate complex components and instruments from Acetals, Ultem, Radel, PEEK and carbon fiber, as well as implant components from UHMWPE and PEEK. 114. DOT GmbH 630. Evonik Corporation 2450 Deelyn Drive Warsaw, IN 46580 USA 574-269-5900 (phone) | 574-269-5966 (fax) www.danco.net Middenkampweg 17 Nijmegen, 6545 CH Netherlands 31-0-24-3715252 (phone) | 31-0-24-3715253 (fax) www.emcm.com 365 Meadowlands Blvd Washington, PA 15301 USA 724-746-6050 (phone) | 724-746-9209 (fax) www.ensinger-ind.com 10 Constitution Boulevard South Shelton, CT 06484 USA 203-712-1030 (phone) | 203-712-1032 (fax) www.disanto.com 12416 S. Kedvale Avenue Alsip, IL 60803 USA 708-388-0880 (phone) | 708-388-4308 (fax) www.donsonmachine.com Charles-Darwin-Ring 1a, Rostock, 18059 Germany 49-381-40335-0 (phone) | 49-381-40335-99 (fax) www.dot-coating.de 2 Riverside Road Northfield, NH 03276 USA 866-443-7826 (toll free) | 603-286-3977 (fax) www.eptam.com 299 Jefferson Road Parsippany, NJ 07054 USA 973-929-8000 (phone) | 973929-8100 (fax) www.evonik.com/vestakeep medical implant solutions Evonik, a global specialty chemicals company, develops and manufactures high performance polymers used in a variety of medical device applications. Evonik produces VESTAKEEP® PEEK biocompatible polymers for permanent implant and temporary contact medical device applications. VESTAKEEP® PEEK has received FDA 510(k) and CE Mark clearances for use in spine, sports medicine, cranial and other implant device applications. DOT offers a wide range of surface treatments for orthopedic and dental implants as well as instruments and also their cleanroom packaging such as: PVD coatings; Plasma Sprayed Titanium coatings; Electro-chemical CaP deposition (BONIT® coating), Anodic oxidation (DOTIZE®) and antimicrobial coatings. We are currently building our state of the art medical coatings facility in Columbia City, Indiana. 30 714. EZM Edelstahlzieherei Mark GmbH Grace College EZM EdelstahlZieherei Mark is one of the leading Stainless Steel and Titanium producers in Europe since 1906, supplying globally to medical device manufacturers. Our company is certified to ISO 9001 and has an experienced team to ensure the quality of our products. Grace College is located in the heart of the Orthopaedic Capital of the World, Warsaw, Indiana. Because of its strategic location and partnerships, Grace College is able to offer two accelerated degree programs designed to address the industry’s most pressing talent-development needs: Regulatory Affairs, Clinical Affairs and Quality Management. Programs are designed for working adults and offer classroom and distance learning options. Courses are designed and taught by medical device experts. 832. Finishing Innovations, LLC 237. Greatbatch When you turn to Finishing Innovations (ISO 13485), you turn to the market leader in validated orthopedic metal finishing. Our full-service company, based outside Memphis, TN, specializes in chrome plating, titanium anodization (Type II & Type III), passivation, laser etching, electropolish, heat treat and much more. Finishing Innovations will deliver a superior finished product at a service level unmatched in the orthopedic finishing market. Greatbatch 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. 200. FMI Hansa Medical Products, LLC 515. gSource, LLC 505 Production Avenue Madison, AL 35758 USA 256-461-0900 (Huntsville, AL) | 239-775-9090 (Naples, Fl.) www.fmihansa.com 19 Bland Street Emerson, NJ 07630 USA 800-978-1119 (toll free) | 201-599-2277 (phone) | 201-599-3306 (fax) www.gsource.com FMI Hansa is a contract manufacturer that supplies implants, instrumentation and precise cavities for molding applications to the medical device segment. Our company is equipped with state of the art machining and inspection technology. In addition, we maintain ISO 13485:2003 & ISO 9001:2008 certifications and are registered with the FDA. Our goal is to develop long term partnerships with customers by providing exceptional service and reliability. The Orthopedic and Spinal Source 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. ISO 13485:2003. FDA Registered. 200 Seminary Drive Winona Lake, IN 46590 USA 855-267-6722 (toll free) | 574-372-5120 (fax) www.grace.edu/orca NordstraBe 14 Wetter, 58300 Germany 49-2335-977-415 (phone) | 49-2335-977-462 (fax) www.ezm-mark.de 578 Highway 70 Mason, TN 38049 USA 901-294-2848 (phone) | 901-294-3070 (fax) www.finishinginnovations.com 2595 North Dallas Parkway, Suite 310 Frisco, TX 75034 USA 716-759-5600 (phone) | 716-759-5560 (fax) www.greatbatchmedical.com 724. Forecreu America, Inc. 4118 North Nashville Avenue Chicago, IL 60634 USA 773-539-8501 (phone) | 773-539-8627 (fax) www.forecreu.com Forecreu America Inc. offers heavy wall tubing (cannulated bars) in stainless steels and Titanium as an alternative to gun drilling for the manufacture of medical instruments and implants. Sizes range from 0.156” to 0.625” OD and 0.031” to 0.169” ID. Some larger IDs are available for IM nails or specific applications. The company also offers solid round stock in stainless steel and Titanium. 719. Gauthier Biomedical, Inc. 2221 Washington Street Grafton, WI 53024 USA 866-546-0010 (toll-free) | 262-546-0010 (phone) | 262-546-0011 (fax) www.gauthierbiomedical.com Gauthier Biomedical, Inc. is a proud manufacturer of high-quality instruments, off-the-shelf and contract manufacturing, for spine, trauma, hip, shoulder, knee, ankle and small bone surgical applications. At the core of Gauthier Biomedical instrumentation is our patent pending multi-color silicone overmolding product capability. We are a one-stop shop that offers in-house engineering and industrial design support. 609. Gibraltar Laboratories 122 Fairfield Road|16 Montesano Road Fairfield, NJ 07004 USA 973-227-6882 (phone) | 973-227-0812 (fax) www.gibraltarlabsinc.com Gibraltar Sterilization Services is a leading provider of moist heat steam sterilization services. We support cleaning/sterilization of aseptic manufacturing equipment and components, terminal sterilization and validation [FDA, AAMI/ ANSI ST79 and ISO 13485] of reusable instruments. Gibraltar also performs cleaning validations for reprocessing of reusable devices by examining markers such as protein, hemoglobin, carbohydrates, endotoxin and TOC. 31 513. Hangsterfer’s Laboratories, Inc. 118. Interstate Plastics 175 Ogden Road Mantua, NJ 08051 USA 856-468-0216 (phone) | 856-468-0200 (fax) www.hangsterfers.com 330 Commerce Circle Sacramento, CA 95815 USA 877-695-2594 (phone) | 916-422-1608 (fax) www.medicalgradeplastics.com PLASTICS FOR LIFE Mantua, NJ-based Hangsterfer’s Laboratories is a world leader in manufacturing metalworking lubricants that are REACH compliant. The ISO 9001 certified company offers coolant concentrates, cutting oils, metal forming compounds, EDM fluids, rust inhibitors, and solvent alternative cleaners. Contact [email protected]. Interstate Plastics is a medical elite stocking distributor of high-performance plastics. We specialize in medical-grade USP Class VI/ISO 10993 certified materials, such as Radel, Ultem, PSU, Celcon, PEEK, PEEK LSG, Classix, Polypro & Tecapro MT for applications as sizing trials, instruments, dental implants, surgical caddies and medical tooling and equipment. 100. HD Surgical (a division of Harwood Design, Inc.) 614. Iotron Industries USA, Inc. HD Surgical, State of the art contract manufacturer of Surgical Instruments and Implants for Medical Device Industry. We are an FDA registered, ISO 13485 certified company committed to delivering highest quality products, while providing unparalleled customer service. Top tier provider of crosslinking & sterilization services for the orthopedic, medical device and life science industries. Iotron uses the latest IMPELA® 10 MeV electron-beam accelerator to provide its customers with personalized cross linking of UHMWPE in addition to a full-range of bioburden reduction to sterilization services. All of Iotron’s facilities are ISO 9001, ISO 13485 & FDA registered. 132. Huron Tool & Cutter Grinding, Inc. 101. J&J Machine, Inc. PRECISION. PRODUCT. PERFORMANCE. In the world of orthopedic and arthroscopic cutting tools, one name distinguishes itself from the rest - and has for over two decades: Huron Tool & Cutter Grinding. From Specialty Drills & Reamers, to Taps, to Custom Bone & Specialty Screws and more – healthcare distributors demand the quality they receive from Huron Tool. We are recognized as the “goto” company for dependable instruments. It’s a reputation we’ve earned through hard work and dedication. J & J Machine Inc. has been a leader in precision machining for 37 years. We have serviced the medical device industry providing prototyping, short, and long run production. J & J Machine works with plastics, nonmetallic, metals and is ISO 13485:2003 certified. Our experienced staff is committed to helping you solve the tough challenges of medical manufacturing. 330. IHI Ionbond, Inc. 502. JALEX Medical 1823 East Whitcomb Madison Heights, MI 48071 USA 248-398-9100 (phone) | 248-398-2110 (fax) www.ionbond.com 33490 Pin Oak Parkway Avon Lake, OH 44012 USA 440-930-2015 (phone) | 440-933-7839 (fax) www.jalexmedical.com IHI Ionbond provides the highest performance PVD, CVD and PACVD wear protection, low friction and decorative coatings as well as coating equipment. With 38 service centers in 17 countries, Ionbond has one of the largest networks in the world. Our focus at Ionbond is to provide high quality standard coating portfolios for the cutting, molding and forming tool market and to offer customized solutions for our customers making OEM components. JALEX Medical has the ability to design and develop medical devices. JALEX can take your medical device from concept all the way through production and sterile packaging of products. JALEX Medical also offers regulatory and quality management consulting on the design, development and FDA approval or clearance of medical products. Our dedicated experts specialize in regulatory issues and seeking FDA compliance. 536. IMR Test Labs 331. Jarvis Surgical, Inc. IMR Test Labs is a world-class testing laboratory offering analytical services to the medical device industry. We are located in the U.S., Singapore & China and we specialize in metallic and nonmetallic materials. Our services include coatings evaluations, cleanliness testing, fatigue testing, raw material checks, passivation testing, XRD and extensive failure analysis capabilities. With fast turnarounds and superior customer service, IMR should be Your First Choice in Materials Testing. Manufacture and Polishing of Orthopaedic Implants and Instruments. Contract manufacture 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. 730. In’Tech Medical 636. JG&A Metrology Center In’Tech Medical is a leading custom contract manufacturer specialized in spinal, hip & knee instruments and implants. FDA registered and ISO 13485 certified, In’Tech Medical is internationally renowned for its global footprint (USA/Europe base), its high quality standard and its offering of generic instrumentation. Swing by our booth for our latest designs! JG&A Metrology Center is a global leader for industrial computed tomography scanning services. Clients are able to drastically reduce pre-production inspection costs and analyze internal failures quickly and accurately in 3-D. Some key types of analysis are porosity/void analysis, part to CAD/part comparison, reverse engineering, wall thickness, GD&T and assembly analysis. 4394 East Park 30 Drive Columbia City, IN 46725 USA Tel: (260) 212-1722 | Fax: (260) 244-2762 www.iotron.com 1507 Clyde Waite Drive Bristol, PA 19007 USA 215-826-8250 (phone) | 215-826-8253 (fax) www.spurrier-harwood.com 2045 Wellwood Avenue Farmingdale, NY 11735 USA 631-420-7000 (phone) | 631-420-7007 (fax) www.hurontool.com 12655 Industrial Boulevard Elk River, MN 55330 USA 763-421-0114 (phone) | 763-421-1605 (fax) www.jandjmachine.com 131 Woodsedge Drive Lansing, NY 14882 USA 607-533-7000 (phone) | 607-533-9210 (fax) www.imrtest.com 53 Airport Road Westfield, MA 01085 USA 413-562-6659 (phone) | 413-562-1988 (fax) www.jarvissurgical.com 2851 Lamb Place #15 Memphis, TN 38118 USA 901-375-1109 (phone) | 901-367-2977 (fax) www.intechmedical.com 269 Walker Street Detroit, MI 48207 USA 519-962-5300 (phone) | 519-962-5347 (fax) www.jgarantmc.com 32 708. Kapstone Medical 823. LISI Medical Kapstone Medical is a full-service product development firm. We partner with physician inventors, entrepreneurs and manufacturers to rapidly develop and commercialize new medical products. For OEMs we offer a complete suite of capabilities to support outsourced design and development work. For entrepreneurs we provide services to develop targeted product solutions for commercialization or licensing. Contact Kapstone today to learn how we can transform your ideas into solutions. LISI MEDICAL is a world-class manufacturing contractor dedicated to medical implants and instruments. We offer proactive and experienced project management, total manufacturing capabilities, state-of-the-art quality processes and superior customer service. As part of a global industrial company, we provide components and parts for leaders in the aerospace, automotive and medical fields. Please contact [email protected] for your partnership needs. 113. Knight Mechanical Testing 819. LMG 3205 Clairmont Court, Suite B Fort Wayne, IN 46808 USA 260-489-1444 (phone) | 260-818-2036 (fax) www.knighttesting.com 1733 Suburban Drive De Pere, WI 54115 USA 920-347-1983 (phone) | 920-347-9183 (fax) www.lmgpresses.com Knight Mechanical Testing (KMT) is an ISO/IEC 17025 accredited laboratory specializing in static and dynamic mechanical testing for orthopedic implants and instruments. KMT provides world class testing facilities and superior guidance on the appropriate test methods for your device. With expertise in extremities, sports medicine, trauma, large joint, spine, dental and cranial/maxillofacial repair, KMT has you covered, literally, from head to toe. LMG is the Orthopedic Industry’s technological leader in the design and building of compression molding presses. LMG builds conventional single opening, multiopening and vacuum presses. Typical presses for this industry are in the 30 to 100 ton range but we can build presses as large as 3000 tons. Our controls feature accurate heating and cooling ramping, pressure ramping, data collection and Ethernet capability. LMG also builds transfer molding presses and specialty injection presses. 826. LAB Medical Manufacturing, Inc. 820. Lucideon LAB Medical Manufacturing, Inc., is a world-class contract manufacturer of high-precision medical devices and implants for leading OEMs. Its high-quality, cost-effective solutions ultimately enable medical practitioners to achieve better patient outcomes while reducing health care expenses. The company combines exceptional engineering; unmatched application expertise and highly flexible, integrated manufacturing. We are a leading international provider of materials development, testing and assurance - and your one port of call for all your orthopaedic implants testing needs. Our services include: materials development and characterization, QA/ QC, regulatory approval packages, cleanliness validation, process troubleshooting and failure analysis. We also offer the complete tribology service – wear testing, surface and debris analysis for knee and hip implants. 312. LayerWise 825. Mark Two Engineering 100 East South Main Street Waxhaw, NC 28173 USA 704-843-7852 (phone) | 704-831-5535 (fax) www.kapstonemedical.com 950 Borra Place Escondido, CA 92127 USA 760-432-9785 (phone) | 760-432-9364 (fax) www.lisi-medical.com 28 Cook Street Billerica, MA 01821USA 978-663-2475 (phone) | 978-663-4364 (fax) www.labmedical.com 2210 Technology Drive Schenectady, NY 12308 USA 518-382-0082 (phone) | 518-382-1182 (phone) www.lucideon.com/omtec Kapeldreef 60 Leuven, 3001 Belgium 32-16-946-400 (fax) | 32-16-298-319 (fax) www.layerwise.com/medical 14000 Northwest 58th Court Miami Lakes, FL 33014 USA 305-889-3280 (phone) www.marktwo.com mark two Engineering LayerWise provides maximum patient comfort through serial and patient-specific implant manufacturing. The metal 3D printing process allows us to manufacture fully anatomic implant shapes with complex geometries which lead to increased functionality and improved osseo-integration. LayerWise offers cost-effective 3D printing of medical implants that are fully compatible with classical post-processing steps. The application reach spans orthopedic, CMF, spinal, veterinary and dental implants. Founded in 1996, Mark Two Engineering is a woman-owned contract manufacturing company specializing in high-precision machining and rapid prototyping for the orthopedic and spinal industries. Mark Two Engineering strives to be your one-stop shop, assisting in all stages of your product life cycle from design to prototype to full-scale production. 725. Leeds and Partners 713. Marle Group Leeds City Region represents a collaboration of private and public sector healthcare technology specialists working together to stimulate innovation and create conditions for both business and economic growth nationally and globally. The group links clinicians, hospitals, commissioners, universities and businesses to drive innovation around the manufacturing expertise that make the city region synonymous with service and quality. Manufacturer of cast, forged and finished orthopedic implants and broaches, Marle teams have the technical skill, the know-how and the orthopedic market experience to be your strategic partner to assist you in the development of your projects. Our 450 employees work with advanced manufacturing equipment, validated processes and finishing technologies including polishing, coating and packaging. ISO 14644, ISO 9001:2000 and EN 13485 certified. 631. Li Wai Precision International Ltd 137. Marox Corporation Aquila Tools is one of the premiere tool making manufacturers in China, with over 24 years of experience in the development high precision tools.We specialize in medical instrument for Orthopedics, Neurosurgery, Joint Replacement, Spine, Trauma, Sports Medicine, Dental, OEM custom made medical instruments and products. Our company is certified by ISO 13485:2008 for quality management. Aquila also has a R & D Center operated together with a Hospital and University. Manufacturer of medical implants and instruments. Precision CNC machining and assembly of orthopedic, spinal and trauma implants and instruments. Process capabilities include CNC milling (4& 5-axis), CNC 7-axis contour milling, CNC turning, CNC Swiss screw machining (12-axis), CNC wire/ram EDM and assemblies. Services include production, product launching and prototyping. Vendor managed inventory. ISO 13485 and FDA registered. City Exchange, 11 Albion Street Leeds LS1 5ES United Kingdom 44-113-3781555 (phone) www.leedsandpartners.com Z.I. rue Lavoisier BP 46 Nogent, 52800 France 33-325-318-579 (phone) | 33-325-316-265 (fax) www.ets-marle.fr Room 1804 18/F, Cheuk Nang Centre, No. 9 Hillwood Road, Tsimshatsui, Kowloon Hong Kong 852-2374-6238 (phone) | 852-2374-6962 (fax) www.aquilamedical.com 373 Whitney Avenue Holyoke, MA 01040 USA 413-536-1300 (phone) | 413-534-1829 (fax) www.marox.com 33 313. MedicalGroup Corp 600. MK Precision MedicalGroup is a contract manufacturer for the orthopedic, spine and dental implant markets. We specialize in ceramic and metallic plasma spray coatings (current MAF with FDA) and other surface treatments (RBM, thin layer deposition, etc.). In addition, we manufacture HA and calcium based powders as well as synthetic biologics and offer forging, cleaning, packaging and lab (ISO 17025) services. Since 1989, we serve customers all over the world. MK Precision is a leading medical device contract manufacturer that is ISO 13485:2003 and ISO 9001:2008 certified as well as FDA and ITAR Registered. The full-service company offers five-axis milling, multi axis Swiss screw, EDM, titanium anodize, laser marking, assembly, passivation, chrome plating, burr-free parts, exotic metals, PEEK and contaminate-free machining capabilities. 607. Medin Corporation 706. MSK Precision Products, Inc. Medin Corporation is a compliant, FDA Registered, ISO 9001 and EN13485 manufacturer of high quality sterilization Delivery Systems guaranteed to meet the most stringent sterilization guidelines. Working in aluminum, stainless steel, thermoformed and machined plastics and with total in-house processing for critical operations, we can assure delivery to the most aggressive timelines. MSK Precision Products specializes in precision parts manufacturing and assembly for the medical, telecommunication and aerospace industries. MSK is capable of providing individual parts or complete finished assemblies. Core competencies include Precision Swiss-Style Turning, Ultra-Precision Cutter Grinding, CNC Milling, CNC Turning, Laser Marking and Passivation. Complex medical and aerospace components are our specialty. 314. Metal Craft & Riverside Machine and Engineering 712. MTS Systems Corporation 115 Perimeter Center Place, Suite 640 Atlanta, GA 30346 USA 404-312-0407 (phone) | 770-351-0097 (fax) www.medicalgroup.fr 309 Camars Drive Warminster, PA 18974 USA 215-675-4590 (phone) | 215-359-2118 (fax) www.mkprecision.com 90 Dayton Avenue, Unit 16C Passaic, NJ 07055 USA 973-779-2400 (phone) | 973-779-2463 (fax) www.medin.com 10101 NW 67th Street Tamarac, FL 33321 USA 954-776-0770 (phone) | 954-776-3780 (fax) www.mskprecision.com 13760 Business Center Drive Elk River, MN 55330 USA 800-964-1395 (toll free) | 763-441-0798 (fax) www.metal-craft.com www.riversidemachine.com 14000 Technology Drive Eden Prairie, MN 55344 USA 952-937-4000 (phone) | 952-937-4515 (fax) www.mts.com Medical device manufacturers worldwide depend on MTS to provide test systems that offer precision monotonic, fatigue and durability testing solutions. Whether testing heart valves for regulatory compliance or characterizing bone staples for performance validation, MTS is the partner who understands how to optimize your test design and speed development. Dedicated partners, Metal Craft & Riverside Machine and Engineering, provide in house medical instrument & implant manufacturing from start to finish. We specialize in close tolerance precision contract manufacturing including prototype, complex assembly, and short & long run production. With years of experience, our team can assist in manufacturability in your design. WBENC, ISO 13485, 9001, AS9100 & FDA registered. 308. Micro Machine Company 736. N2 Biomedical LLC Micro Machine has been serving the medical device community since 1965. We have approximately 30,000 square feet of manufacturing space and the recent addition of a second facility, located in the “medical capital” of the world, Warsaw Indiana. Micro Machine can provide the services and expertise to deliver best in class service and support to our valued customers. We do things on time, on target and done right. N2 Biomedical is a leading provider of surface modification services for improving the performance of orthopedic and other medical devices. Previously under the name Spire Biomedical, we offer customized coatings and surface treatments to meet a variety of performance improvement needs, including reduced wear, enhanced bone in-growth, higher lubricity, antimicrobial properties, radiopacity and electrical conductivity/insulation. 814. Micron Products, Inc. 812. Nelson Laboratories, Inc. Micron Products is a ISO 9001:2008 & ISO 13485:2003 certified manufacturer of medical device components including, machined medical implants, molded medical components, precision medical assemblies in a class 10,000 clean room environment. Capabilities include prototype & production runs with secondaries that include, belting, buffing and high energy finishing, laser marking, ultrasonic cleaning/passivation and CMM inspection. Nelson Laboratories is a leading provider of full life-cycle microbiology testing services. We are known for exceptional quality, but we look beyond the testing process and partner with you to achieve your long-term business goals. It’s what we call The Science of Success™. Learn how we can help move your products to market quickly and safely. 122. Microware Precision Co., Ltd. 218. Norman Noble, Inc. We specialize solely in medical devices development and machining. We focus on tight tolerance, high precision swiss turning process. Our manufacturing solutions includes orthopedic (trauma), spinal, dental implants and cannulated instruments. In Microware, each product that was delivered reflects our mission to improve the quality of life and standard care for patients. We are ISO 13485 certified. Norman Noble manufactures orthopedic devices and implants to customer specifications in compliance with FDA regulations and ISO 13485:2012. Full capabilities include seven-axis contour milling, Swiss machining, laser machining and welding, wire EDM, sinker EDM, turnkey Nitinol manufacturing, metal finishing and packaging. Design for manufacturing and prototype services are also available. Visit the company’s Web site for more information. One Patriots Park Bedford, MA 01730 USA 781-275-2727 (phone) | 781-275-6010 (fax) www.n2bio.com 2429 North Burdick Street Kalamazoo, MI 49007 USA 269-388-2440 (phone) | 269-388-5466 (fax) www.micromachineco.com 45 Sawyer Passway Fitchburg, MA 01420 USA 978-602-1482 (phone) | 978-602-1282 (fax) www.micronproducts.com 6280 South Redwood Road Salt Lake City, UT 84123 USA 801-290-7500 (phone) | 801-290-7998 (fax) www.nelsonlabs.com 5507 Avion Park Drive Highland Heights, OH 44143 USA 800-474-4322 (phone) | 216-761-0455 (fax) www.nnoble.com No.12, Keyuan 2nd Road, Situn District Taichung City 40763 Taiwan 886-4-2463-6275 (phone) | 886-4-2463-6276 (fax) www.microware.com.tw 34 815. North American Spine Society 133. Orchid Orthopedic Solutions NASS 2014 will bring together over 3,000 spine care attendees and over 300 exhibitors for the largest conference in the world devoted to spine. Whether looking for OEMs or physician innovators, NASS offers you a single source. Join us in San Francisco, November 12-14, 2014. Go to www.exhibitatNASS.org to apply. Orchid is a worldwide leader in contract design & manufacturing for the orthopedic and medical device markets. We provide expertise in design & development, quality & regulatory; implant manufacture, advanced machining, plastics technology, instrument manufacture, implant coatings and surface treatment and packaging services. With 13 facilities around the globe, Orchid provides the products & services that improve the lives of patients worldwide. 413. Onyx Medical Corporation 509. Orthoplastics, Ltd. 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. More than merely responsive to your needs, Onyx is FDA registered, ISO certified and committed to delivering on your specifications and exceeding expectations—always. Uniquely focused on Orthopaedic Plastics. Orthoplastics is the genuine onestop-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 in-house laboratory that is also available for bespoke research. 7075 Veterans Boulevard Burr Ridge, IL 60527 USA 630-230-3600 (phone) | 630-230-3700 (fax) www.spine.org 1489 Cedar Street Holt, MI 48842 USA 517-694-2300 (phone) | 517-694-2340 (fax) www.orchid-ortho.com Unit A, Beech Industrial Estate Bacup, Lancashire OL13 9EL United Kingdom 44-1706-871-200 (phone) | 44-1706-879-826 (fax) www.orthoplastics.com 1800 North Shelby Oaks Drive Memphis, TN 38134 USA 901-323-6699 (phone) | 901-454-0295 (fax) www.onyxmedical.net Learn more about OMTEC 2014 Exhibitors in the Supplier Directory at www.BONEZONEpub.com. 10 years of excellence, creativity and innovation. Pyxidis specializes in the design and manufacture of customized sterilization cases and trays. We are one of the market leaders and preferred contract manufacturer of major orthopaedic OEMs. Our R&D capabilities enable us to implement your tray design and manage several of your projects at once. We multiply all combinations of materials to satisfy all expectations and market specifications on a worldwide basis. Pyxidis, quality and expertise are our first intention. Discover our products and innovations at www.pyxidis-medical.com 1050 Cross Keys Drive - Doylestown, PA. 18902 / USA Tel: +1 (215)-230-7307 meet us at OMTEC 2014 JUNE 11-12 Hall G - booth # 732 35 Sterilization Tray Experts 501. OsteoMed 606. PMC SMART Solutions LLC A highly nimble and responsive company, OsteoMed is a leading global innovator, developer, manufacturer and marketer of specialty medical devices, surgical implants and powered surgical instruments. PMC SMART Solutions is the orthopedic industry’s leader in injection molding and contract manufacturing of biomaterial implants, instruments and finished devices. PMC specializes in high-temperature materials, with expertise in implants and metal-to-plastic conversions. PMC is FDA Registered and ISO 13485 certified, with services including: DFM, hyper-precision injection/insert molding, assembly, sterile packaging and sterilization management. 124. Pacific Instruments, Inc. 727. Polymer Solutions 2181 Grand Avenue Cincinnati, OH 45214 USA 513-921-5040 (phone) | 513-921-5883 (fax) www.pmcsmartsolutions.com 3885 Arapaho Road Addison, TX 75001 USA 972-677-4600 (phone) | 972-677-4601 (fax) www.osteomed.com 438 Hobron Lane, Suite 204 Honolulu, HI 96815 USA 808-941-8880 (phone) | 808-941-8833 (fax) www.pacificinstruments.biz I 2903-C Commerce Street Blacksburg, VA 24060 USA 540-961-4300 (phone) | 540-961-5778 (fax) www.polymersolutions.com ME As a globally recognized contract manufacturer and procurement source, Pacific Instruments does more than deliver surgical instruments. We manage the instrument process, so you can focus on your core business. We streamline your instrument needs which support cost-effective goals. We commit as your instrument partner. We care. And with over 20 years of technical experience, quality is our strength and we have a superior quality assurance program. ISO 13485; FDA Registered. Polymer Solutions Incorporated (PSI) is a Virginia-based, FDA registered, ISO 17025 Accredited, cGMP compliant,and DEA licensed independent testing lab. We provide chemical analysis and physical testing for the medical device, pharmaceutical, defense, packaging and consumer products industries. Services include: chromatography, spectroscopy, microscopy and thermal analysis for plastics, rubber, metals and composites. 506. PAK Manufacturing, Inc. 436. PPD Meditech Custom & Specialty Hand-held Surgical Instruments. PAK Mfg. is the leading supplier of forging based specialty instruments to the spinal & orthopaedic industries. Extensive inventory of forgings & manufacturing allows us to provide quick solutions to customer’s needs. In house capabilities include milling, grinding, heat treating, passivation & polishing. We take great pride in our reputation for quality, value & on time delivery. FDA registered. 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®. 412. Paragon Medical 811. Precision Edge Surgical Products Company Paragon Medical offers turnkey solutions to the medical device marketplace and partners with its customers to share best practices and jointly develop and implement world-class methods of engineering and manufacturing. Paragon designs, validates and manufactures delivery systems, reusable & single-use surgical instrumentation, and implantable components in strategic centers of excellence throughout the USA, Europe and China. Contract Manufacturer of Surgical Cutting Tools & Instruments. Small and large bone cutting tools including blades, burs, drills, reamers, trocars, taps, screws, etc. Custom products per your prints including instruments for joints and spine. CNC machining and grinding, laser cutting, welding and marking, Swiss turning, milling, stamping, EDM, gundrilling, electropolish, passivating, FPI, coatings. ISO 13485:2003 registered. 437. PCC Structurals 333. Precision Engineered Products LLC (PEP) A Global Manufacturer of Investment Cast Structural Components, PCC Structurals specializes in nickel-based superalloy, titanium, stainless steel, and aluminum investment castings for aerospace, land-based turbine, medical, military armament and many other applications. ISO 9001:2008, ISO14001 (France), AS9100:2009, NADCAP (welding, Heat Treatment, NDT & Special Processes). Precision Engineered Products LLC (PEP) is a leading manufacturer of surgical and orthopedic devices, and precision micro components in metal and plastic for use in medical applications. We support our global customer base with ten manufacturing locations in the U.S., Dominican Republic, Mexico and China. The Precision Engineered Products brand family includes BE-ST®, Brainin, General Metal Finishing, Lacey, microPEP, Polymet and Wauconda. 818. Phillips Precision Medicraft 718. Precision Medical Technologies, Inc. PPM offers its clients a single source solution for advanced orthopedic implants, instrumentation, and sophisticated sterilization delivery systems, cases and trays. We employ a fully integrated ISO 13485 design control/quality management system to create world-class products. We develop programs and innovations that optimize customer satisfaction and supply chain needs by design. Precision Medical Technologies is an ISO 13485:2003 Certified contract manufacturer of orthopedic implants and instruments with a strong focus on spine, extremities, trauma and sports medicine. The company is organized into two operating Divisions: Implant Manufacturing and Instrument Manufacturing. Concentration of effort has been key to driving high quality and on-time performance. 704 South 21st Street Irvington, NJ 07111 USA 973-372-1090 (phone) | 973-372-1091 (fax) www.pakmanufacturing.com 50 Raymond Waterville, Quebec J0B 3H0 Canada 819-837-2491 (phone) | 819-837-3083 (fax) www.ppdgroup.com 8 Matchett Drive Pierceton, IN 46562 USA 574-594-2140 (phone) | 800-225-6975 (toll-free) | 574-594-2154 (fax) www.paragonmedical.com 415 West 12th Avenue Sault Saint Marie, MI 49783 USA 906-632-4800 (phone) | 906-632-5619 (fax) www.precisionedge.com 4600 SE Harney Drive Portland, OR 97206 USA 503-794-2099 (phone) | 503-652-4665 (fax) www.pccstructurals.com 110 Frank Mossberg Drive Attleboro, MA 02703 USA 508-226-5600 (phone) | 508-226-5677 (fax) www.pep-corp.com 7 Paul Kohner Place & 50 Bushes Lane Elmwood Park, NJ 07407 USA 201-797-8820 (phone) | 201-797-3039 (fax) www.phillipsmedicraft.com 2059 N Pound Drive W Warsaw, IN 46582 USA 574-267-6385 (phone) | 574-268-9240 (fax) www.premedtec.com 36 Leading the Conversion to single-procedure instruments and kits Join the move to disposable torque-limiting instruments and procedural kits. OEMs are securing new annuity revenue and save over $400 per procedure by reducing life cycle costs. Surgeons are gaining a sterile packed solution with guaranteed torque for every implant. Hospitals and ASCs are achieving cost savings, hassle free inventory management and reduced risk of surgical site infection. Collaborate with ECA Medical Instruments and enjoy competitive advantage—today. Call us and we’ll help you transform healthcare economics. ECA Medical Instruments • www.ecamedical.com • +1 (805) 376 - 2509 WF8127 Rev A 125. Precision Metal Products 827. Quintus Composites 850 West Bradley Avenue El Cajon, CA 92020 USA 619-448-2711 (phone) 619-448-2005 (fax) www.pmp-elcajon.com 684 Industrial Drive Camp Verde, AZ 86322 USA 928-567-3833 (phone) | 928-567-0232 (fax) www.quintus-inc.com Quintus designs, prototypes and manufactures non-implantable carbon fiber components that provide a unique combination of strength, stiffness, light weight and radiolucency. An ISO 13485 and ISO 9001 certified company, Quintus is proficient in compression molding, machining to tight tolerances, hand lay-up techniques, vacuum bag processing and foam core processing as well as high strength structural bonding and components assembly. Precision Metal Products, Inc. (PMP) produces superior net and near-net forged and machined orthopedic implants. PMP can provide you: • Precision forgings and dependable medical implant manufacturing service • State-of-the-art forging, machining & engineering • Fast turn-around from initial design to full scale production • Expert forging of titanium, cobalt-chrome & other metals • All your technical specs, project schedules and cost targets will be met. 236. REJOIN Mastin Medical Co. 507. Pro-Dex 528 Shunfeng Road Qianjiang Economic Development Zone Hangzhou, Zhejiang 311106 China 86-571-8635-3288 (phone) | 86-571-8635-8128 (fax) www.rejoin-medical.com 2361 McGaw Avenue Irvine, CA 92614 USA 800-562-6204 (toll free) | 949-769-3280 (fax) www.pro-dex.com Pro-Dex, Inc. develops and manufactures powered surgical devices for Spine, Ortho, CMF, Trauma and Small Bone applications. Leading manufacturers rely on Pro-Dex powered surgical devices to enable the placement of their devices while repeatedly withstanding harsh environments like high pH dishwashers and autoclave. As a FDA-registered, ISO 13485:2003-certified manufacturer, Pro-Dex offers turn-key solutions for all your powered surgical product needs. REJOIN devotes to being preferred total solutions contract designer & manufacturer for orthopaedic, sports med and dental markets. We serve OEM customers on design & development, prototype, mass production, implants & instruments and standard instruments. CNC 5-axis Grinding, Milling (up to 5-axis), Turning, Swiss Turning, Mill/Turn, Wire EDM, Laser Weld, EP and Passivation are specialties. ISO 13485 certified by BSi and FDA factory registered. 214. Promimic AB 206. rms Surgical Promimic markets the HAnano Surface, which is a unique 20 nm thin implant coating that greatly accelerates osseointegration. It can be used on all types of materials, including metals, PEEK, ceramics and pyrocarbon, and it can be used in all kinds of implant applications; from traditional screws and hip stems to complex geometries and porous materials. The coating technology can easily be adapted for direct use at the implant production line. rms Surgical is a contract manufacturer of custom sterilization Cases & Trays and surgical instruments. Formed through the consolidation of Juno Inc.’s sterilization Case & Trays with rms Company’s instrumentation operations, rms Surgical is an integral part of Cretex Medical which provides innovative and unique manufacturing solutions to medical device OEMs. rms Surgical and four other companies comprise Cretex Medical: rms Company, JunoPacific, Meier and Spectralytics. 337. puracon GmbH 508. Rolled Alloys puracon is your partner for cleaning, packaging, sterilization and logistics of medical devices. All from one hand we produce in our German headquarters in cleanrooms class C according to GMP. We are your partner from the initial product idea until the shipping of the sterile-packed products to your customer. Together with our worldwide logistics, including complete customs and customer management, we can offer the most cost-effective solutions. Rolled Alloys is the global leader in specialty alloys, offering heat and corrosion resistant, aerospace, titanium and stainless alloys. Our vast inventory includes more than two dozen grades of nickel, stainless, duplex, titanium and super alloys in plate, sheet, bar, pipe and fittings and welding materials. A large variety of alloys and extensive processing capabilities enable us to provide prompt shipment of stock size material and custom cut parts. 732. Pyxidis 430. Rollomatic, Inc. Pyxidis serves all the segments of the market for custom sterilizable trays for surgical instruments and implants. Pyxidis is the market leader in Europe and is active on a worldwide basis. Over 30 years of experience in metal and plastic design and manufacturing, Pyxidis leads the way. A 360° know-how strengthened by a young and innovative team allos us to master available technology and achieve unrivalled reactivity. Rollomatic is a leading Swiss manufacturer of CNC cutter & tool grinders serving the medical, industrial and aerospace industries. Our GrindSmart series machines offer the tightest tolerances and highest accuracy for grinding medical & dental drills, burs, rasps and other orthopedic cutting tools. With a full range of models to accommodate diameters from 0.05mm to 31.75 mm, Rollomatic has your grinding solution. 817. Quadrant EPP/MediTECH Medical Polymers 432. Rosler Metal Finishing USA, LLC Stena Center 1B Gothenburg, 412 92 Sweden 46-31-772-80-35 (phone) | 46-31-772-80-91 (fax) www.promimic.com 1220 Lund Blvd Northwest Minneapolis, MN 55303 USA 763-427-6141 (phone) | 763-427-7252 (fax) www.rmssurgical.com Isarstrasse 1 Rosenheim 83026 Germany 49-8031-90 0587-0 (phone) | 49-8031-90 0587-73 (fax) www.puracon.com 125 West Sterns Road Temperance, MI 48182 USA 800-521-0332 (phone) | 734-847-6917 (fax) www.rolledalloys.com 1050 Cross Keys Drive Doylestown, PA 18902 USA 215-230-7307 (phone) | 215-230-7670 (fax) www.pyxidis-medical.com 1295 Armour Boulevard Mundelein, IL 60060 USA 847-281-8550 (phone) | 847-281-8558 (fax) www.rollomatic.ch 2120 Fairmont Avenue Reading, PA 19612 USA 800-366-0300 (phone) | 800-366-0301 (fax) www.quadrantplastics.com www.meditechpolymers.com 1551 Denso Road Battle Creek, MI 49037 USA 269-441-3000 (phone) | 269-441-3001 (fax) www.rosler.us Rosler offers the widest range of surface finishing equipment in the industry, including mass finishing and shot blasting equipment, consumables and effluent treatment. We serve our North American customers from our 300,000 sq. ft. manufacturing campus in Battle Creek, Michigan, and support global customers through our worldwide network. Our company slogan “finding a better way…” is exactly what we do. Send us your challenge. Quadrant Engineering Plastic Products is the world leader in sock 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 Orthopaedic industry with its UHMWPE. We work closely with you to anticipate your needs while searching for ways to exceed your expectations. Your success and satisfaction is the measure of our performance. 38 406. Seabrook International, LLC 537. Sheffield Precision Medical Ltd. 15 Woodworkers Way Seabrook, NH 03874 USA 603-474-1919 (phone) | 603-474-1833 (fax) www.seabrookinternational.com Unit 1 - Wylcut House Petre Street Sheffield, S4 8LU United Kingdom 11-42-431-011 (phone) | 11-42-447-912 (fax) www.sheffieldpm.co.uk 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. Sheffield Precision Medical is an advanced U.K. orthopaedic instrumentation solutions provider, and has developed a global reputation for partnering with orthopaedic implant manufacturers. Core to our success is our dedicated manufacturing and design team, using Solid Works, NX (Unigraphics), together with advanced CAM processing to ‘fast track’ manufacturing solutions for NPI (New Product Introduction) through to volume production. 725. Sheffield City Region - Inward Investment Siemens The Sheffield City Region Investment team supports investors to grow successful businesses. It is home to the fDI rated #1 Enterprise Zone in the U.K. for Modern Manufacturing offering tax breaks. It is the UK home of orthopaedic manufacturing, and related medical engineering. We offer a FREE one stop shop for investors including: confidential property search, HR advice, support with routes to finance and 1 year Chamber of Commerce membership. Siemens PLM Software is a world-leading provider of product lifecycle management (PLM) software, systems and services with nine million licensed seats and 77,000 customers worldwide. Headquartered in Plano, Texas, Siemens PLM Software helps companies optimize their lifecycle processes, from planning and development through manufacturing and support. Our vision is to give everyone involved in making a product the information they need, when they need it, to make the smartest decisions. Advanced Manufacturing Technology Centre, Brunel Way Rotherham, S60 5WHG United Kingdom 44-0-114-254-1313 (phone) www.scrinvest.com 5800 Granite Parkway, Suite 600 Plano, TX 75024 USA 800-498-5351 (phone) | 314-264-8913 (fax) www.siemens.com/plm Learn more about OMTEC 2014 Exhibitors in the Supplier Directory at www.BONEZONEpub.com. Southeastern Technology is a tier one supplier to the medical device i n d u s t r y. I t t h r i v e s b y virtue of its continuing f o c u s u p o n q u a l i t y, reliability, and flexibility. It has developed a customer base that relies upon its skill set and p r o v e n p e r f o r m a n c e. Products supplied by SET include instruments, implants, electro-mechanical devices, patient specific components and more. Parts are manufactured u s i n g v a r i o u s a l l o y s, plastics, and ceramics and can be supplied as a finished sterile product. 905 Industrial Drive | Mur freesboro, TN 37129 | 615.890.1700 | Fax: 615.890.2914 | southeasterntech.com 39 602. SMC Ltd 431. Symmetry Medical, Inc. SMC Ltd’s years of experience in the medical device market, strength in (IQ/OQ/ PQ) validation, network of established and qualified suppliers and experience in custom manufacturing allow us to manage your program from concept to final distribution and everything in between. We’ve created a seamless process that ensures the highest level of quality while keeping your bottom line and timeline in mind. Accelerate your time to market with Symmetry Medical. Specializing in product development, professional services, high precision manufacturing and prototyping. With Symmetry Medical Total Solutions®, every detail of product development from idea generation thought quality assurance is handled by our global teammates saving you time and money. 809. Solvay Specialty Polymers 720. Syntec Scientific Corporation 3724 North State Route 15 Warsaw, IN 46582 USA 574-267-8700 (phone) | 574-267-4551 (fax) www.symmetrymedical.com 330 SMC Drive Somerset, WI 54025 USA 715-247-3500 (phone) | 715-247-4462 (phone) www.smcltd.com 4500 McGinnis Ferry Road Alpharetta, GA 30005 USA 770-772-8760 (phone) | 770-772-8747 (fax) www.solvayspecialtypolymers.com 2, Kung San Road Chuan Shing Industrial Zone Shen Kang, Chang Hua Hsien, Taiwan 02-2752-3216 (phone) | 02-2781-5936 (fax) www.syntec.com.tw Solvay, the makers of Radel® PPSU, offers the industry’s broadest selection of high-performance plastics for use in implantable & non-implantable medical devices. As a leading materials supplier to the healthcare industry for over 25 years, Solvay has the resources and expertise to help grow your global business. We specialize in metal replacement and provide global technical & regulatory support. Syntec Scientific Corporation specializes in medical implant/instruments for the Orthopedic Industry. We achieve this position by professional pursuing excellence and dedicating ourselves in quality and serving all our customers. Our products such as Osteosynthesis implants and instruments are qualified with the certification of FDA, CE, GMP regulations and compliant with ISO Quality Assurance Standards. 414. Southeastern Technology 407. Tecomet Southeastern Technology is a privately held company that has been providing manufacturing solutions for over 30 years. We utilize state-of-the art equipment and highly skilled personnel to produce close tolerance medical devices (implants & instruments) from stainless steel, titanium, plastics and various composites. We focus on project management from design support to prototype through production and final clean with sterile pack. Implant - Instruments - Innovation. Tecomet is a leading contract manufacturing, engineering and technology company specializing in net shape forging, precision machining, photochemical etching, surface texturing, vacuum brazing, laser/ electron beam welding, and rapid prototyping. Tecomet is ISO 13485 and ISO 9001 certified and supplies instruments, implants and components to medical markets including orthopedic, cranial maxillofacial, trauma and spinal. 905 Industrial Drive Murfreesboro, TN 37129 USA 615-890-1700 (phone) | 615-890-2914 (fax) www.southeasterntech.com 131. Spec Engineering 13754 Saticoy Street Van Nuys, CA 91402 USA 818-780-3045 (phone) | 818-780-4733 (fax) www.specengco.com 115 Eames Street Wilmington, MA 01887 USA 978-642-2400 (phone) | 978-658-4334 (fax) www.tecomet.com s SPEC E 220. Tegra Medical NGINEERING CO. 9 Forge Park Franklin, MA 02038 USA 508-541-4200 (phone) | 508-553-4100 (fax) www.tegramedical.com SPEC Engineering Co. was founded in 1987. We are a comprehensive contract manufacturing company specializing in close tolerance CNC machining of stainless steel and Carbon Fiber, complex assembly of components, marking and packaging for the medical industries. SPEC has firmly established a reputation for expertise, dependability, and producing products of superior quality. We are ISO 13485:2003, 9001:2000 Certified and FDA Registered. Tegra Medical is a leading supplier of centerless grinding, laser processing, Swiss-style turning, CNC milling/turning, EDM, stamping, electrochemical machining, insert molding and assembly. Wire and hypotube shipped overnight, easy online ordering. Quick turnaround prototyping, DFMA, pilot production. 200,000 sq. ft. of modern manufacturing space—25,000 sq. ft. for prototyping, and four manufacturing sites in Boston, Memphis and Costa Rica. ISO 13485:2003. 731. Summit Manufacturing & Machining 632. TESco Associates, Inc. Summit Manufacturing & Machining, Inc. was established in 1993. The company became ISO 9001:2000 certified in September of 2006. We currently specialize in prototypes and production work for the medical, heavy equipment, and transportation industries. Summit is located in a 12,000 square foot facility in Bremen, Indiana. Bremen is located in north-central Indiana near the intersection of U.S. 6 and State Road 331. TESco Associates, Inc., founded in 1980, is your bridge from raw material to a real product, focusing solely on bio-absorbable polymeric implants. TESco provides critical success in material selection and development, mold design and fabrication, and solution of manufacturing difficulties; from early concept stages through clinical trials. These services are continued with contract manufacturing of the bio-absorbable devices. 106. Surface Dynamics/Eurocoating 830. Third Wave Systems Surface Dynamics / Eurocoating are medical device coating companies with Stateof-the-Art manufacturing facilities in Cincinnati, Memphis & Trento-Italy offering the best in coating technology: CP- Titanium, TiGrowth-C & Hydroxyapatite (HA) Coating, (Osprovit) are applied to any device including PEEK. We also supply Additive Manufacturing Technology – DMLS & E-Beam Sintering services with full service metallurgical laboratories. SD & EC are ISO 13485 Approved/21 CFR 820 Compliant. Third Wave Systems provides physics-based material modeling software and services to optimize the machining process. Third Wave Systems has two software products: AdvantEdge and Production Module. AdvantEdge allows engineers to identify best case tooling and machining paths for specific projects and Production Module allows users to maximize the potential of current manufacturing resources. 723 High Road Bremen, IN 46506 USA 574-546-4571 (phone) | 574-546-4954 (fax) www.summitmmi.com 500 Business Park Drive Tyngsborough, MA 01879 USA 978-649-5527 (phone) | 978-649-5529 (fax) www.tescoassociates.com 231 Northland Boulevard Cincinnati, OH 45246 USA 513-772-6635 (phone) | 513-772-0825 (fax) www.sdbiocoatings.com 6475 City West Parkway Eden Prairie, MN 55344 USA 952-832-5515 (phone) | 952-844-0202 (fax) www.thirdwavesys.com 40 824. Thortex 733. Universal Punch Corp Thortex provides porous coating on implants manufactured from castings, forgings and bar stock with a complete machining and polishing shop designed to meet needs of orthopedic companies. We can manufacture your product to your exact specifications from procurement of forgings and castings that result in improved lead times. Thortex operates in lean manufacturing process of individual cell assignments. For over 40 years, Universal Punch Corp. has been providing quality tooling & gages and precision surgical screwdrivers to the medical industry. Our experience allows us to supply you with complete integrated solutions for superior fit between driver and screw. Our engineering and technical staff can assist you from research & development to prototypes and production runs. ISO 9001:2008 Certified; ISO 17025, 13485 and FDA compliant. 213. Titanium Industries 307. Vistek Medical Titanium Industries (T.I.) is the global leader in performance metal solutions for the aerospace, medical, industrial and oil & gas markets. Holding the world’s most complete inventory of performance metals across a global service center network, T.I. delivers supply chain solutions at all levels of sophistication and complexity. With a globally experienced and technically driven team, T.I. has been providing dependable, quality driven solutions to customers for over 40 years. Vistek Medical is a leading contract manufacturer of medical implants and components focused on the Orthopedic, Spinal, Trauma and Extremity markets. Vistek Medical provides material procurement, swiss turning, milling, testing, finishing, device assembly and shipping services to its customers. Vistek Medical is FDA registered as well as ISO 13485 and ISO 9001 certified. 315. Total Plastics, Inc Life Sciences Division 134. VMH International 4001 West MacArthur Boulevard Santa Ana, CA 92704 USA 714-556-4488 (phone) | 714-556-6314 (fax) www.universalpunch.com 15045 NE Mason Street Portland, OR 97230 USA 503-654-5726 (phone) | 503-654-9711 (fax) www.thortexinc.com 18 Green Pond Road Rockaway, NJ 07866USA 973-983-1185 (phone) | 973-983-8015 (fax) www.titanium.com 153 Railroad Avenue Ivyland, PA 18974 USA 215-357-6956 (phone) | 215-357-3675 (fax) www.vistekmfg.com 635 Trade Center Boulevard Chesterfield, MO 63005 USA 636-534-2806 (phone) | 636-536-2809 (fax) www.vmhinternational.com 7508 Honeywell Drive Fort Wayne, IN 46825-6271 USA 260-489-3656 (phone) | 888-874-1771 (toll free) | 260-489-9848 (fax) www.totalplastics.com VMH International is a value-added Platinum Reseller of product lifecycle management software with years of consultative experience– acting as the bridge between OEMs and companies by offering seamless software solutions with Siemens PLM and complimentary software systems. We also offer a full implementation services, from installation to training, to assist our customers in reaching the full value of their PLM software purchase. Total Plastics Life Sciences Division offers a versatile inventory of medical grade materials including sheet, rod, tubing and film (USP Class VI, FDA and ISO 10993 compliant materials). Our knowledgeable staff is trained to assist you with a variety of product and device applications through all stages of the development of manufacturing process. TPI Life Sciences facilities are ISO 13485:2003 certified. 212. Triangle 25 Park Way Upper Saddle River, NJ 07458 USA 201-825-1212 (phone) | 201-825-0402 (fax) www.trianglemfg.com Triangle has been in business for 59 years and is a leading provider of surgical implants, medical instruments with a special expertise in powered surgical instrumentation. Through our Triangle Advanced Engineering Group we collaborate with each customer to develop the industry’s most advanced products for the orthopedic, ENT, CMF, trauma, spine and sports medicine markets. FDA Registered, ISO 13485:2003, ISO 9001:2008. 700. Trigon International Corp 4000 Sussex Avenue Aurora, IL 60504 USA 630-978-9990 (fax) | 630-378-9991 (phone) www.etrigon.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. 637. Universal Precision Instruments, Inc. 2921 LaVanture Place Elkhart, IN 46514 USA 574-264-3997 (phone) | 888-941-3997 (toll-free) | 574-262-8937 (fax) www.universalpi.com 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, Mult-Axis Milling, Wire EDM, Laser Etching, Complex Threading, Gundrilling and Metal Finishing. 41 613. VSMPO-AVISMA Corporation 612. Windsor Beach Technologies VSMPO-AVISMA Corp. is one of the world’s largest integrated manufacturers of titanium products: ingot, billet, bar, sheet, plate and forgings in titanium alloys. The company has recently added small diameter/close tolerance titanium bar and coil capabilities. VSMPO-AVISMA’s distribution network is established in the U.S., Europe, U.K. and China. Windsor Beach Technologies is a contract manufacturer for precision machining and assembly. Windsor Beach caters to the medical device and aerospace industry; manufacturing implantable devices, complex instrumentation and critical components for gas turbine engines. Both the medical device market and aerospace have rigorous quality requirements – validation of the manufacturing process. Windsor Beach has the people, metrology and robust systems as to address these requirements. 813. Westlake Plastics Xact Spec Industries LLC Westlake Plastics Company offers a complete line of medical grade thermoplastic stock shapes for medical devices and instrumentation applications and has been a key supplier to the medical market for over 30 years. Westlake Plastics is both ISO 9001 and ISO 13485 certified. Shapes offered include film, sheet, slab and rod. Products include Pomalux® c-POM, Propylux® HS and HS2 PP, Radel® PPSU, Tempalux® PEI, Zelux® GS gamma sterilizable PC, Lennite® UHMWPE. Xact Spec has the perfect blend to provide cutting edge implants & instrumentation delivered with superb quality. Precision machining blended with deep hole drilling capabilities makes Xact Spec your partner for all your Spinal & Orthopedic systems. Prototype to production, Xact Spec can deliver on time the most highly engineered components. Our efficient machining centers, with CNC 5-axis milling, Swiss turning and Gun drilling, blends the elements for all your medical manufacturing needs. ISO 13485 certified. 726. Wilsey Tool Company, Inc. 530. Zapp Precision Wire Inc. For our customers, the WILSEY TOOL advantage is the summation of our commitment to the Quality of our Products and the Reliability behind our promises. We are a premier medical products manufacturer specializing in implants and instrumentation for orthopedic, spinal, cardiac and trauma. Please learn more about our fully integrated machining, EDM, and finishing capabilities at our web site. Zapp Precision Wire is a global supplier of metallic materials for surgical implants and instruments. We manufacture and supply high quality wire, bar, profile, strip and near-net shapes that meet international standards for surgical materials. The grades we produce include stainless steel, titanium, and cobalt-based alloys. 401 Riverport Drive Leetsdale, PA 15056 USA 724-251-9400 (phone) | 724-251-9401 (fax) www.vsmpo-tirus.com 7321 Klier Drive East Fairview, PA 16415 USA 814-474-4900 (phone) | 814-747-4849 (fax) www.windsorbeach.com 490 West Lenni Road Lenni, PA 19052 USA 610-459-1000 (phone) | (877) 789-0601 (fax) www.westlakeplastics.com 16959 Munn Road Chagrin Falls, OH 44023 440-543-8157 (phone) | 440-543-4582 (fax) www.xactspec.com 140 Penn AM Drive Quakertown, PA 18951USA 215-538-0800 (phone) | 215-538-0860 (fax) www.wilseytool.com 475 International Circle Summerville, SC 29483USA 843-851-0700 (phone) | 843-851-0010 (fax) www.zapp.com A very special thank you to the OMTEC 2014 Sponsors. 42 2014 ULBRICH STAINLESS STEELS & SPECIAL METALS, INC. W W W.ULBRICH.COM A very special thank you to the following exhibitors who have been with us since OMTEC 2005. Thank you for 10 years of support. Acme Manufacturing Ensinger FMI Hansa Medical Products IHI Ionbond Marox Medin Metal Craft Onyx Medical Specialty metals without limits. Ulbrich has an impressive number of high-performance metal products that provide infinite solutions to precision industries. By keeping pace with worldwide market demand, Ulbrich has always been—and always will continue to be — your trustworthy partner. Orchid Orthopedic Solutions PAK Manufacturing Paragon Medical Tecomet Vistek Medical 12 LOC ATIONS WORLDWIDE 43 800 243 -1676 BADGE KEY Yellow: Attendee Red: Visitor Blue: Exhibitor Green: Staff Purple: Press Black: Speaker Orange: Guest ATTENDEE RESOURCES Meals and Networking Speaker Presentations A number of speakers have agreed to make their presentations available online at www.OMTECexpo.com. Simply look for Speaker Presentations under the Education tab. Wednesday, June 11 7:30 am – 8:45 am Keynote Breakfast, Room 51 Keynote CEO Discussion Starts at 8:00 am Exhibit Floor Hours Wednesday, June 11: 9:00 am – 4:30 pm Thursday, June 12: 9:00 am – 12:00 pm, 1:30 pm – 5:00 pm 12:00 pm – 1:30 pm Networking Lunch, Exhibit Hall Cafe Additional Education Subscribe to BONEZONE® to continue learning from OMTEC speakers year-round. www.BONEZONEpub.com/subscribe 4:30 pm – 6:00 pm Networking Reception, adult beverages and hors d’oeuvres will be served in the Exhibit Hall Café Photography Only employees of ORTHOWORLD or their agents may take photographs freely in the exhibit hall and educational sessions. Exhibitors may only photograph their own booth space. Thursday, June 12 7:30 am – 8:45 am Networking Breakfast, Exhibit Hall Café Need help? Members of the ORTHOWORLD® and OMTEC® teams can be found at the Registration Area and throughout the Exhibit Floor and Education Sessions. We’re the ones with green ribbons on our badges. How can we be of service to you? 12:00 pm – 1:30 pm Keynote Lunch, Room 51 Breakfast with the Experts Discussion Starts at 7:45 am. Keynote Discussion starts at 12:30 pm. OMTEC Feedback What did you like about OMTEC 2014? What could be improved for OMTEC 2015? Tell us by dropping a card in the feedback boxes throughout the Exhibit Floor, filling out the session feedback forms and taking the survey at www.OMTECexpo.com. @OMTEC_expo ORTHOWORLD Group 44 OMTEC Contract Manufacturer of Orthobiologic Calcium Phosphates Engineering and Manufacturing of Medical grade Hydroxyapatite, Beta-TCP, Alpha-TCP and Biphasic Powders,Granules, Shapes and Coatings Raw materials, components or full service packaged and sterilized medical device contract manufacturing. ISO13485 and CFR820 compliant engineering and contract manufacturing. Visit us in booth #709 at OMTEC® 2014! www.cambioceramics.com Shorten time to market with Orchid lean. Want to lose the wait? Turn to Orchid Design. Our orthopedic-focused, clinically driven design teams leverage the lean principles of waste minimization and process simplification, bringing manufacturing and regulatory experts into the design process early on to streamline product development and mitigate risk. Design-for-manufacture best practices quickly generate costeffective, process-focused, robust product designs. Vertically integrated prototyping and testing facilitate rapid design iterations. With facilities designed around speed, flexibility and lean, Orchid Design has everything under one roof. Integration with Orchid manufacturing provides seamless design transfer to full-scale production. Find out how lean product development with Orchid can meet your need for speed. Contact: [email protected] Scan to learn more. ORCHID ORTHOPEDIC SOLUTIONS (517) 694-2300 www.orchid-ortho.com/designBZP ©2013 Orchid Orthopedic Solutions LLC ® C TE CLO-1-8-BZP Vi M O at 133 d # hi r c ot h t O Bo si
