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Final Program-Final-FInal-Final.indd 1 5/31/2012 11:04:13 AM
RULE #1: IF WE DON’T TAKE CARE OF OUR CUSTOMERS, SOMEONE ELSE WILL.
STOP AND SEE OUR NEW INNOVATIVE PRODUCTS @ OMTEC BOOTH 224 & 226
CALL TOLL FREE: 877.201.7661
ISO 13485:2003 Certified
© 2012 Bradshaw Medical10325 58th PlaceKenosha, WI 53144Phone: (262) [email protected]
FromConcept
ToConception
Bradshaw’s experienced design and manufacturing team will work with existing concepts or design input specifications to develop instrumentation to fulfill your needs. Early involvement in working with your engineers in the design of the instrument will provide cost effective designs and the ability of having instruments available when they are needed.having instruments available when they are needed.
Final Program-Final-FInal-Final.indd 2 5/31/2012 11:04:17 AM
Page 3Page 3
Welcome Letter
Thank you for choosing OMTEC!
Our singular mission is helping orthopaedic companies and individuals improve their performance. You have selected OMTEC 2012 to increase your personal and professional net worth. Thank you for the opportunity!
This program will help maximize the time you’ve invested in OMTEC. Use the Schedule Of Events and Floor Plan to navigate the exhibitors and the education you’ve come to OMTEC for, and let the Attendee Resources help navigate your environment, from exhibit floor hours, local information and more.
What’s new for 2012? Two fully-loaded Poster Session areas now reside in opposite corners of the exhibit floor. (See this year’s poster titles on page 5.) A dedicated Seminar Area, next to the Business Center, will feature rapid-fire and in-depth technical presentations, geared to inspire your engineering team. Finally, a new Power Networking session has been added on Wednesday, allowing device companies to meet with participating suppliers in five 5-minute “dates.”
What hasn’t changed? Reaffirm current connections and make new ones at the Welcome Reception on Wednesday evening. Allow the onsite Business Center, complimentary meals and refreshment breaks to save you time off the floor and keep you fueled up. And, as always, look for any member of the ORTHOWORLD team in the registration area or cafe-side lounge to help with any question or need that may arise.
And the mission of OMTEC remains the same: to provide access to the intelligence, the expertise, the companies and the people that will help you overcome your most critical challenges, identify the most lucrative opportunities and thrive.
Thank you for choosing OMTEC. We wish you a productive and enlightening meeting.
Best regards,
April C. BrightGeneral ManagerORTHOWORLD, Inc.
@OMTEC_expo
Table Of Contents
Schedule Of Events ..................... 4
Floor Plan ..................................... 6
Keynote Addresses...................... 8
Educational Sessions .................. 8
Exhibitors .....................................16
Attendee Resources .................. 38
Colored Badge Holder Key:
Exhibitor
Vis itor
Attendee
(ORTHOWORLD staff can be identified by the green ribbon attached to their badges.)
Final Program-Final-FInal-Final.indd 3 5/31/2012 11:04:22 AM
Page 4
Schedule Of Events
Please reference pages 8-14 in the Final Program for speaker bios and session abstracts.
Many presentations and handouts are available for download at www.omtecexpo.com.You can make use of this resource immediately, or look for an email notification following the event.
Stay tuned to the very latest OMTEC happenings on Twitter: @omtec_expo
8:00 AM Opening Panel Discussion – All WelcomeThe State & Future of the Orthopaedic Industry: A High Altitude View
12:00-1:30 PM Networking Lunch in Exhibit Hall(sponsored by Greatbatch Medical)
9:30 AM - 10:30 AM Morning Break (sponsored By FMI Hansa)
Afternoon Break (sponsored by Onyx Medical)
4:30-6:00 PM Networking Reception in Exhibit HallAll Welcome (sponsored by Orchid)
6:00 PM Adjourn
9:00 AM Exhibit Hall Opens
Sponsored by Bradshaw Medical
Panelists: Wall Street: Bill Plovanic w/Canaccord Genuity Device Co.: Bill Kolter w/Biomet Supplier: Brian Moore, former CEO of Symmetry
Moderator: David Floyd w/OrthoWorx
Breakfast Served at 7:30 AM
Wednesday June 13
Tuesday June 12: Welcome Cocktail Reception at Gibson’s Steakhouse 6:00-7:30 pm, sponsored by ORTHOWORLD
A review of the only graduate program in the U.S. designed
specifically by and for orthopaedic regulatory and
clinical a�airsprofessionals.
Prof. Allyn Decker
Running a Clinical Trial: How to Navigate Through the
Regulatory Maze
Sandra Maddock
A Lesson in E�ective Strategic Planning
Don Urbanowicz How to Mechanically Evaluate a Technology with No Available Guidance Documents or Test
StandardsDawn Lissy
Vested Outsourcing: Five Rules That Will Transform Outsourcing
Kate Vitasek
Orthopaedic Surgery and Aerospace Materials: Can a Joint
Implant Fly?
Paul Wooley
Dissecting the FDAWarning Letter
John Gagliardi
Custom-Tailored Imaging Analytics for Orthopaedic Research &
Product DevelopmentTim Kulbago & Amit Vasanji
The Ten Ailments of Outsourcing
Kate Vitasek
Shared Pain, Shared Gain: Creating a More
Collaborative Chain for Implantable Devices
Karen Conway
Auditing and Managing Suppliers & Contract
ManufacturersMartin Browning
Design Controls: Concept & Feasibility to
Commercialization
John Gagliardi
Who Am I? Tools to Improve Personal Performance (Q&A
last 30 minutes)
Brian MooreSusan Germaine
9:30-10:00Technical
PresentationDr. Eric Ledet will present
a brief history of smart implants and introduce new technology, under
development at Rensselaer Polytechnic Institute, that enables
implantable sensors to be incorporated into
orthopaedic practice.
10:15-10:55Rapid-fire Technical
PresentationsZimmer’s V.P. of Trauma and
R&D, Erin Johnson, moderates 3 presentations
followed by Q&A.#1 Hydroxyapatite-based
coating for implants,#2 Development of Material
Testing Apparatus for In Vitro Biomechanical Testing
of Rodent Spines underCombined Loads,
#3 Automating Generation of a Lumbar Spine Finite Element Model from a CT
Scan.
11:15-12:00Power Networking!
(a.k.a. Speed Dating for Orthopaedics)
Leading orthopaedic device companies will meet with participating suppliers in
five 5-minute power-networking “dates.”
Exhibit FloorActivities
In the NEW seminarroom near 600-800 aisles!
8:00 am
10:00 am10:30 am
9:00 am9:30 am
11:00 am
11:30 am
12:00 pm
12:30 pm
1:00 pm
1:30 pm
2:00 pm
2:30 pm
3:00 pm
3:30 pm
4:00 pm
4:30 pm
5:00 pm
5:30 pm
6:00 pm
Final Program-Final-FInal-Final.indd 4 5/31/2012 11:04:25 AM
Page 5Page 5
Schedule Of Events
9:00 AM Exhibit Hall Opens
Thursday June 14
Exhibit FloorActivities8:00 am
10:00 am10:30 am
9:00 am
11:00 am
11:30 am
12:00 pm
8:00 AM Keynote Address – All WelcomeOrthopaedics and the Vampire Economy, Lee Hieb, M.D.
Breakfast Served at 7:30 AM 9:15-9:45Technical PresentationDr. David Trinh responds to
industry’s heightened interest in obtaining
regulatory approval for implants manufactured with
additive technologies.
10:00-10:30
Technical PresentationDr. Steven Mell presents the results of a project focused
on automating the generation of a Lumbar
Spine Finite Element Model from a CT scan.
12:00 PM Adjourn
Improving Manufacturability: GD&T as a Tool – Not a Weapon
Joe Soistman
Supply Chain Management: Supplier Panel Discussion
Moderator: Howard Levy, Biomet
Price, Quality, Speed:Choose All Three
Bill Greene
FDA InspectionsWorkshop
John Gagliardi
Posters on display on the Exhibit Floor
• Design of Femoral Component for Total Knee Arthroplasty in Athletic Patients
• Development of 3D Lumbar Spine Model Directly from CT Scan
• Development of Material Testing Apparatus for In Vitro Biomechanical Testing of Rodent Spines under Combined Loads
• Development of Specimen-Specific Kinematic Model for the Assessment of Labral Base Excision and Repair
• Implantable, Wireless Sensors Share Secrets of Healing Tissues
• Modifying the Bone-Implant Interface using Electrostatic Self-Assembly
• Specimen-Specific Model for Kinematic Assessment of Cervical Facet Joints
Final Program-Final-FInal-Final.indd 5 5/31/2012 11:04:30 AM
Page 6
Floor Plan
Center
Business
ENTRANCE
DONALD E. STEPHENS CONVENTION CENTER
BAR
SeminarArea
SeminarArea
Poster SessionArea
Refresh
men
t
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Poster SessionArea
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resh
men
t
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a
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NEW Seminar Area
Poster SessionArea
Post
er S
essi
onA
rea
Business
Center
133
230
232
231 330 331
333
431
137 236 237 336 337 436 437 536 537 636 637 736
812
814
818
820
824
826
819
821
825
827
831833
430
432 433
530
532531533
630
632
631
633
730
732
731 830
832733
726
508 509 608 609 708
406307306207
206
107
808
813
815
100
414
724
413113
115
119
121
125
127
212
218
220
224
214 515
226
719
721
725
727
409408309308209208109
506 507 606 607 706407
709
718
720
131
101 102 600 601
112114
118
124
213 312
314
313
315
512
514
513 612
614
200 201 500 501 502
120
126
613
615
712
714
713
715
412
Cafe
OMTEC 2012Marox
BoedekerPlastics
F>ool & Die
CentexMachining
AutocamMedical
BradshawMedical
Ensinger
TegraMedical
APSMaterials
Arcam AB TeroLabSurface
MSK PrecisionProducts
SurfaceDynamics
C&A ToolEngineering
KnightMechanical
Testing
WestlakePlastics
OnyxMedical
AcmeMfg
Orthoplastics
MetalCraft
gSource FairviewMachine
Promimic
True ToolInnovations
On-X LifeTechnologies
North AmericanSpine Society
QuebecGovernment
Office
MahrFederal
CanwellMedical
CIBOR LH MedicalGilbraltar
LaboratoriesPAKMfg
MaharTool
DonsonMachine
PiperPlastics
Medin
MicronProducts
CaPBiomaterials
Maple LeafTooling
VistekMedical
ForecreuAmerica
ParagonMedical
Pro-DexFMI Hansa Medical
Products
PMC
AIP
TecometSeabrookInt’l
SoutheasternTechnology
Sonoscan
ORCA,Grace College
Triangle
BrittonGallagher
CamBioceramics
NeedletechProducts
ANCA BOB Inc.
LABMedical
AceCoPrecision
Rosler Metal Finishing
Juno
BodycoteThermal
Processing
FosterDeliveryScience
Bejing FuleScience &
Technology
PrecisionMetal
Products
Teleflex Medical
OEM
TitaniumIndustries
RolledAlloys
MicrowarePrecision
BranchMedical
Hangsterfer’sLaboratories
CarpenterTechnology
Rollomatic
WilseyTool
Ft WayneMetals
PacificInstruments
DirectedLight
MicroMachine
MastinMedical
VorzeigenMedical
UnitedGrinding
SummitManufacturing
& Machining
UniversalPrecision
Instruments
SyntecScientific
Corporation
TiconaEngineering
Polymers
SheffieldPrecisionMedical
AdvantageManufacturingTechnology
OxfordPerformance
Materials
ZappMedicalAlloys
PrecisionMedical
Technologies
MedicalGroup
Haas CNCMachine
RichterPrecision
SeleniumMedical
DCElectronics
BioMedSCR-LEP
3DSystems
FinishingInnovations
AmericanTool & Die
HNMMedical
LISIMedical
PrecisionPiece Parts
Geomagic
IonbondImage IQTotalPlastics
NormanNoble
EmpiricalTesting
JarvisSurgical
OrchidOrthopedic
Greatbatch Medical VSMPO-TIRUS US Phillips PrecisionMedicraft
PutnamPlastics
PPDMeditech
TrigonInternational
Quadrant/MediTECH
MedicalPolymers
FH
Concession
Escalators
Women
Men
400300Aisle Aisle AisleAisleAisle
600Aisle
700Aisle
Stairway to EducationalSessions
500 800Aisle
OR
THO
WO
RLD
Lou
ng
e A
rea
MAINENTRANCE
100 200
REGISTRATION
Shaded booths indicate event sponsors.
HALL GDonald E. Stephens Convention CenterJune 13-14, 2012
Final Program-Final-FInal-Final.indd 6 5/31/2012 11:04:31 AM
Page 7Page 7
Floor Plan
Center
Business
ENTRANCE
DONALD E. STEPHENS CONVENTION CENTER
BAR
SeminarArea
SeminarArea
Poster SessionArea
Refresh
men
t
Area
xx
xx
xx
xx
xx
xx
xx
x
Poster SessionArea
Ref
resh
men
t
Are
a
xx
xx
xx
xx
xx
xx
xx
x
NEW Seminar Area
Poster SessionArea
Post
er S
essi
onA
rea
Business
Center
133
230
232
231 330 331
333
431
137 236 237 336 337 436 437 536 537 636 637 736
812
814
818
820
824
826
819
821
825
827
831833
430
432 433
530
532531533
630
632
631
633
730
732
731 830
832733
726
508 509 608 609 708
406307306207
206
107
808
813
815
100
414
724
413113
115
119
121
125
127
212
218
220
224
214 515
226
719
721
725
727
409408309308209208109
506 507 606 607 706407
709
718
720
131
101 102 600 601
112114
118
124
213 312
314
313
315
512
514
513 612
614
200 201 500 501 502
120
126
613
615
712
714
713
715
412
Cafe
OMTEC 2012Marox
BoedekerPlastics
F>ool & Die
CentexMachining
AutocamMedical
BradshawMedical
Ensinger
TegraMedical
APSMaterials
Arcam AB TeroLabSurface
MSK PrecisionProducts
SurfaceDynamics
C&A ToolEngineering
KnightMechanical
Testing
WestlakePlastics
OnyxMedical
AcmeMfg
Orthoplastics
MetalCraft
gSource FairviewMachine
Promimic
True ToolInnovations
On-X LifeTechnologies
North AmericanSpine Society
QuebecGovernment
Office
MahrFederal
CanwellMedical
CIBOR LH MedicalGilbraltar
LaboratoriesPAKMfg
MaharTool
DonsonMachine
PiperPlastics
Medin
MicronProducts
CaPBiomaterials
Maple LeafTooling
VistekMedical
ForecreuAmerica
ParagonMedical
Pro-DexFMI Hansa Medical
Products
PMC
AIP
TecometSeabrookInt’l
SoutheasternTechnology
Sonoscan
ORCA,Grace College
Triangle
BrittonGallagher
CamBioceramics
NeedletechProducts
ANCA BOB Inc.
LABMedical
AceCoPrecision
Rosler Metal Finishing
Juno
BodycoteThermal
Processing
FosterDeliveryScience
Bejing FuleScience &
Technology
PrecisionMetal
Products
Teleflex Medical
OEM
TitaniumIndustries
RolledAlloys
MicrowarePrecision
BranchMedical
Hangsterfer’sLaboratories
CarpenterTechnology
Rollomatic
WilseyTool
Ft WayneMetals
PacificInstruments
DirectedLight
MicroMachine
MastinMedical
VorzeigenMedical
UnitedGrinding
SummitManufacturing
& Machining
UniversalPrecision
Instruments
SyntecScientific
Corporation
TiconaEngineering
Polymers
SheffieldPrecisionMedical
AdvantageManufacturingTechnology
OxfordPerformance
Materials
ZappMedicalAlloys
PrecisionMedical
Technologies
MedicalGroup
Haas CNCMachine
RichterPrecision
SeleniumMedical
DCElectronics
BioMedSCR-LEP
3DSystems
FinishingInnovations
AmericanTool & Die
HNMMedical
LISIMedical
PrecisionPiece Parts
Geomagic
IonbondImage IQTotalPlastics
NormanNoble
EmpiricalTesting
JarvisSurgical
OrchidOrthopedic
Greatbatch Medical VSMPO-TIRUS US Phillips PrecisionMedicraft
PutnamPlastics
PPDMeditech
TrigonInternational
Quadrant/MediTECH
MedicalPolymers
FH
Concession
Escalators
Women
Men
400300Aisle Aisle AisleAisleAisle
600Aisle
700Aisle
Stairway to EducationalSessions
500 800Aisle
OR
THO
WO
RLD
Lou
ng
e A
rea
MAINENTRANCE
100 200
REGISTRATION
Final Program-Final-FInal-Final.indd 7 5/31/2012 11:04:32 AM
Page 8
Opening Panel DiscussionThe State and Future of the Orthopaedic Industry: A High Altitude ViewJune 13, 8:00 am - 8:45 amIn light of the unrelenting challenges facing the orthopaedic industry today, the Opening Panel Discussion aims to extract actionable advice and insight from respectable industry leaders on how best to respond. Each panel member represents a sector of the supply chain: Wall Street, Device Company, Supplier. Their breadth of industry knowledge com-bines to make this discussion invaluable and a must attend for all at-tendees!
Moderator:David Floyd, Chief Executive Officer, OrthoWorx
Mr. Floyd, a 25-year veteran of the orthopaedic device indus-try, served as President of Centerpulse Orthopedics, Presi-dent and CEO of AxioMed Spine, President of Abbott Spine and Worldwide President of DePuy Orthopaedics. A found-
ing Board member of OrthoWorx in 2009, he joined as CEO in 2011.
Panelists:Bill Plovanic, Managing Director, Equity Research, Medical Devices Analyst, Canaccord Genuity, Inc.
Mr. Plovanic joined Canaccord in 2007 as a Managing Director, Medical Technology Equity Research Analyst.
He has been a publishing sell-side analyst with coverage of medical devices for over 15 years.
Bill Kolter, Corporate Vice President of Government Affairs, Public Affairs, and Corporate Communica-tion, Biomet, Inc.
Bill Kolter is a 27-year veteran of the orthopaedic device industry and a 24-year employee of Biomet, Inc., where he
has served as Vice President of Marketing and Senior Vice President of Commercial Operations for Biomet’s U.S. joint replacement division.
Brian Moore, Chief Executive Officer A Day With A CEO
Please see Mr. Moore’s biographical information with his educational session notes on page 12.
Keynote AddressOrthopaedics and the Vampire EconomyJune 14, 8:00 am - 8:45 am
Lee D. Hieb, M.D., P.C., Orthopaedic Surgeon
Although once the bastion of a free market economy, America has become overtaxed and overregulated by an ever-growing bureaucracy. These policies target all busi-nesses, but are especially damaging to entrepreneurs
and manufacturers. It is instructive to examine the history of similar economies and how businesses adapted to survive. Dr. Hieb will dis-cuss the principles of our current economic system and the implications of these for business investment and organization.
Dr. Lee Hieb has served in private practice for over 20 years, and this experi-ence led her to become an outspoken advocate for the free market solution to healthcare. Dr. Hieb has served on the board of the Arizona Medical Associa-tion, is immediate past president of the Association of American Physicians and Surgeons and a lifelong member of Alpha Omega Alpha Honor Medical Society.
Sessions
Martin Browning President and Co-Founder EduQuest, Inc.
Auditing and Managing Suppliers & Contract ManufacturersJune 13, 10:00 am - 11:00 amThrough recalls, seizures, injunctions and more, FDA has considerable reach throughout each link of your supply chain. To survive FDA in-spections, you need to identify and fix weak spots before they compro-mise product safety and effectiveness. Learn FDA’s latest expectations for supplier management from a former senior FDA official and field investigator who helped to write the Agency’s Quality System Regula-tion for medical devices.
Martin Browning is the President and Co-Founder of EduQuest, Inc., a global team of FDA compliance experts based near Washington, D.C. Martin has more than 30 years of regulatory experience at FDA and is a highly sought-after advisor to industry.
Karen Conway Director, Industry Relations GHX
Shared Pain, Shared Gain: Creating a More Collaborative Supply Chain for Implantable Devices June 13, 1:30 pm - 2:30 pmDevice manufacturers deliver advanced medical technology to patients every day, while the processes and technology from the point of manu-facture to the point of use remain relatively archaic, costing the industry more than $5 billion in waste annually. Nearly half of those costs are borne by manufacturers, primarily in the form of low inventory turns and lost and expired product; the rest by their customers. This shared in-dustry problem demands a collaborative solution. Learn how, by jointly automating shared business processes, manufacturers and healthcare delivery systems can improve efficiencies, lower costs and gain access to more accurate and timely data to support critical functions such as demand planning, inventory management and regulatory compliance.
Karen Conway works with industry associations, standards bodies, government agencies, analyst firms and academic institutions to identify opportunities to op-timize supply chain operations and improve business and clinical performance. Karen was recently elected to the board of directors of AHRMM, the supply chain organization for the American Hospital Association. She has served as a Company Representative to the Medical Device Supply Chain Council since 2007 and serves as co-chair of the HIMSS Supply Chain Special Interest Group.
KNOWLEDGE IS POWER
Final Program-Final-FInal-Final.indd 8 5/31/2012 11:04:40 AM
A world of mAnufActuring expertise in every pArt.
Michigan • Massachusetts • California • Brazil
877 633 8080 www.autocam-medical.com
Industry leader Autocam Medical is now VISA certified in Brazil.
ISO 13485, ISO 9001, VISA
Global partnerships welcome. Venha nos visitar em São Paulo!
+55 19 3206-2120 São João da Boa Vista, São Paulo, Brasil
Autocam has over 30 years of single-source precision-manufacturing experience in South America. Our Brazilian facility and associates can help you meet exacting standards and distribution requirements.
• Precision-grade implants, instruments and components
• Local manufacturing and support
• One source of supply from the USA to Brazil
• Uniform quality system and ERP consistency
Ask how Autocam Medical can help bring your product to market in Brazil.
Visit us at Booth 127
AM-OMTECProgramFullPageAdRev2-1-12.indd 1 5/11/12 3:00 PMFinal Program-Final-FInal-Final.indd 9 5/31/2012 11:04:41 AM
Page 10
Allyn Decker, M.A., CPLP, Director of Graduate Program in Orthopaedic Regulatory and Clinical Affairs (ORCA), Grace College
Review of the Grace College Graduate Program for Regulatory and Clinical Affairs in Orthopaedics June 13, 11:15 am - 11:45 amThe OrthoWorx Center for Excellence in Orthopaedics offers the nation’s only graduate program designed specifically by and for orthopaedic regulatory and clinical affairs professionals. Students can earn a graduate certificate or a M.S. in Regulatory and Clinical Affairs in this accelerated, one-year program. Allyn Decker, Program Director, will explain key features of the program and share highlights from its inaugural year.
Mr. Decker chaired the Communication Department at Grace College from 1986 to 1997. From 1998 to 2010, he was a Vice President for Lake City Bank in Warsaw, Indiana, where he developed and directed Lake City University. In addition to directing the ORCA graduate program, Professor Decker teaches organizational management courses in the adult degree-completion program at Grace College.
John GagliardiPresidentMidWest Process Innovation, LLC
Design Controls: Concept and Feasibility To and Including Commercialization June 13, 10:00 am - 11:45 amThis scenario-driven session will use the design controls traceability matrix as the backbone for discussion and design strategy. Using a simple Class II orthopaedic medical device as an example, attendees will watch the process from concept and feasibility through and including commercialization and post-commercialization processes.
Dissecting the FDA Warning LetterJune 13, 3:15 pm - 4:00 pmJoin a step-by-step walk through all parts of an FDA Warning Letter. Come prepared with questions to leave with the most thorough understanding of all of a letter’s elements and what must occur after one is delivered.
FDA InspectionsJune 14, 10:00 am - 12:00 pmThis session is all about preparing for and handling FDA inspections as a manufacturer specializing in orthopaedic medical devices and assemblies. This session will enable you to procedurally direct an inspection using your quality management system to its best advantage.
Mr. Gagliardi’s successful 40-year track record in the Medical Device and Pharmaceutical industries stems from his practical approach to process orienta-tion and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. John specializes in building systems in a compliant and business-ready manner.
Bill GreeneChief Executive OfficerLevel 3 Inspection, LLC
Price, Quality, Speed: Choose All ThreeJune 14, 10:00 am - 10:45 am American manufacturing firms can’t afford to ignore opportunities to reduce new product development time by 30% or more—and improve product revision program speeds by upwards of 50%+. We will look at ways to achieve all three aspects of success in orthopaedic device project management using Computer Aided Inspection (CAI), borrowing from the Triple Constraint model wherein quality, schedule and cost are usu-ally assumed to exist in tension.
Bill Greene is a co-founding Director of Level 3 Inspection, LLC and is leading the Strategy Development efforts while serving as Chief Executive Officer and Vice President Business Development for the company. Having engineered and automated most manufacturing processes, Mr. Greene is well versed in the needs, opportunities and ROI requirements of modern manufacturing enterprises.
Tim KulbagoPresident and Chief Executive OfficerImageIQ, Inc.
Amit Vasanji, Ph.D.Chief Technology OfficerImageIQ, Inc.
Custom-Tailored Imaging Analytics for Orthopaedic Research & Product DevelopmentJune 13, 1:30 pm - 2:15 pmImaging Analytics is a new and rapidly growing methodology for extracting quantitative data that is buried deep within images. What the human eye fails to see or quantify, imaging analytics can measure quickly, objectively and reproducibly. The resulting data is highly quantitative and can be “visualized” to facilitate communication of device performance or safety to key stakeholders. Attendees will learn about the powerful impact imaging analytics can have on orthopaedic device research, product development, regulatory submissions and clinical studies.
Timothy J. Kulbago has 14+ years of experience in the medical imaging industry. He also spent several years as a Research Assistant at the Applied Research Laboratory at The Pennsylvania State University, developing virtual reality training and visualization systems.
Amit Vasanji has 10+ years of experience with basic and clinical research image acquisition, processing, analysis, visualization and software programming. He was the founder of Cleveland Clinic’s Biomedical Imaging and Analysis Center, and served as its Executive Director since 2005.
Page 12
Dawn LissyPresident & CEOEmpirical Testing Corp.
How to Mechanically Evaluate a Technology with No Available Guidance Documents or Test Standards June 13, 3:30 pm - 4:15 pmEvery company’s goal is to have new and innovative products available to their consumers, as quickly as possible. With technology moving at lightning speed and as the societies responsible for defining scientific testing methodologies work hard to keep up, companies are often chal-lenged to determine the best way to mechanically evaluate their devices for measures of safety and efficacy. Fortunately, there exist repeatable parameters and objectives that, when asked and answered properly, can be applied to any technology. This presentation will arm you with a pro-cess that will allow you to be prepared for answering the critical ques-tion, “How is my device tested when there are no applicable ASTM/ISO standards?”
Ms. Lissy graduated with a Masters Degree in Biomedical Engineering from the University of Akron and founded Empirical Testing Corp. in 1998. She has been actively participating in ASTM committees since 2001, holds an inventor patent for the “Stackable Cage System for Corpectomy and Vertebrectomy,” has presented as an industry innovator at conferences internationally, chaired several panel discussions and has been published multiple times. Ms. Lissy prides herself in educating customers through training seminars while partnering with them during their product testing and development.
Sandra Maddock, RN, BSN, CCRA
PresidentIMARC Research, Inc.
Running a Clinical Trial: How to Navigate Through the Regulatory MazeJune 13, 1:30 pm - 2:45 pmWhether you are a company owner, project manager, engineer or assistant, you may be called upon to run a clinical trial or be involved in one, in some way. Attendees will learn about the FAIR Shake™ concept, which takes a complicated set of regulations and breaks it into four very simple questions to enable you to make educated decisions as you move through a trial.
Under Sandra Maddock’s leadership, IMARC Research was founded in 1999 to deliver the highest-quality clinical research monitoring, auditing, training/development and consulting services. Sandra offers 15+ years of expertise covering a wide variety of medical devices. She is an active member of the National Association of Clinical Research Professionals and a founding member of the Northeastern Ohio Chapter of the Association of Clinical Research Professionals, where she has served as President, Membership Chair and Program Chair.
Brian MooreChief Executive OfficerA Day With A CEO
Susan GermaineFounderGermaine Consulting, LLC
Who Am I? Tools to Improve Personal Performance June 13, 10:00 am - 11:30 amWho am I? This session recognizes that the most important task we all have is to manage ourselves, and acknowledges our fundamental need to do a good job in this important process. We will focus on two of our key roles in a business environment: the first being that of Business Executive. Next, we’ll address how to be aware of how you appear as both a leader and team member, and what level of energy and engagement that you bring to these roles. We will finish with a Q&A session with an energy coach.
Brian Moore formerly served as the Chief Executive Officer of Symmetry Medical and of Mettis in the U.K. He now has his own consulting firm providing mentoring services to executives and senior management, and he is a strategist in the buying and selling of companies.
Susan Germaine has been a management consultant for over 20 years, working in the areas of leadership development and organizational effectiveness. She founded Germaine Consulting, LLC in 1999.
Joe SoistmanPrincipalQuality Manufacturing Solutions, LLC
Improving Manufacturability: GD&T as a Tool, Not a WeaponJune 14, 11:00 am - 11:45 am
Join a brief review of the principles of Y14.5M 1994, a national standard commonly known as Geometric Dimension and Tolerance (GD&T). Attendees will gain a better understanding of the use of GD&T as a tool to improve manufacturability while maintaining design intent.
Joe Soistman’s 30+ years of work experience include years at RAM Optical Instrumentation and Optical Gaging Products. He also served in a quality engineering role with an orthopaedic implant manufacturer, where he focused upon process improvement with an emphasis on metrology techniques. His successful projects include design for manufacturability improvements, manufacturing improvements and metrology process improvements with an emphasis on GD&T implementation.
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FMI Hansa Medical Products, LLC was formed when FMI Medical Products, LLC in Huntsville, AL and Hansa Medical Products, LLC in Naples, FL decided to join forces to provide each other technical expertise and contingency planning while providing manufacturing capacity and capabilities to customers. We believe that FMI’s and Hansa's combined expertise, with over 65,000 square feet of manufacturing space, has created one of the strongest and most technically competent contract medical manufacturers in the United States.
FMI Hansa has extensive experience in all phases of metal working machines. Our customer-focused team of highly skilled Engineers, Tool Makers and Programmers will transform your ideas and needs into powerful solutions. Our commitment to quality and guaranteed on-time delivery insures your complete satisfaction.
Come visit us at OMTEC 2012 in Chicago, IL on June 13th-14th.
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Don UrbanowiczPrincipalUrbanowicz Consulting, LLC
A Lesson in Effective Strategic Planning June 13, 3:00 pm - 4:00 pmAt companies everywhere, business executives are in some stage of an annual strategic planning process. They collect financial and operational data, make forecasts and prepare lengthy presentations with the CEO about the future direction of the business. Unfortunately, at the conclusion of the process, these same executives express frustration by the lack of impact on either their own actions or the strategic direction of the company. Although the annual planning process plays an essential role, the operative question is how to make the process more effective. Don offers suggestions that executives can employ to make existing processes run better—and be more effective.
Urbanowicz Consulting, LLC is a medical device advisory firm with a musculoskeletal focus, seeking to enable prospective clients to achieve their strategic goals by capitalizing on market opportunities. Don Urbanowicz has a 30-year track record in the healthcare industry, holding prior senior positions at Stryker, Smith & Nephew, Sofamor Danek and Aircast. He has successfully developed and implemented strategic planning and business development transaction lifecycle processes, pre-revenue and bolt-on transactions.
Kate VitasekUniversity of Tennessee
The Ten Ailments of OutsourcingJune 13, 1:30 pm - 2:30 pmMany outsourcing deals are structured with fundamental flaws in the business model that prevent transformational results through outsourcing. This interactive session will allow attendees to diagnose their own customer/supplier relationships to identify whether they have any of the most common outsourcing ailments that prevent success.
Vested Outsourcing: Five Rules That Will Transform OutsourcingJune 13, 3:00 pm - 4:00 pmThe University of Tennessee has researched leading companies that are challenging conventional outsourcing. Learn the Five Rules that will transform outsourcing, and find out why the Vested Outsourcing approach works.
Kate Vitasek is a nationally recognized innovator in the practice of supply chain management and outsourcing. She is a faculty member at the University of Tennessee’s Center for Executive Education and is the Founder of Supply Chain Visions, a boutique consulting firm specializing in Supply Chain Management.
Paul H. Wooley, Ph.D. Chief Scientific OfficerCIBOR
Orthopaedic Surgery and Aerospace Materials: Can a Joint Implant Fly?June 13, 2:30 pm - 3:15 pmThe majority of joint arthroplasty is conducted with material components that are approaching 50 years of age, namely, polyethylene-based plastics and metals, although some migration to advanced materials has been accomplished in spine surgery. Improvements through the use of aerospace materials are focused on three major deficiencies of current orthopaedic implants: wear, stress shielding and material biocompatibility.
Paul H. Wooley, Ph.D. is Chief Scientific Officer for the National Center of Innovation for Biomaterials in Orthopaedic Research (nCiBOR) and Director of the Orthopaedic Research Institute in Wichita, Kansas.
Supplier Panel DiscussionThe Supplier Perspective: Best Practices in OEM/Supplier RelationshipsJune 14, 10:00 am - 11:15 am
Moderator: Howard Levy Chief Procurement Officer, Biomet, Inc.
Howard Levy has served as Chief Procurement Officer for Biomet since 2007. Prior to joining Biomet, Mr. Levy gained 20+ years of supply experience across diverse industries,
including leadership of all global strategic sourcing initiatives at CSX, Navistar, Case New Holland and Ryerson.
Panelists:Guy Bradshaw, Chairman and Chief Executive Officer, Bradshaw Medical, Inc.
Guy Bradshaw formed Bradshaw Medical in January 2006. The company specializes in the design and manufacture of
spinal and orthopaedic instrumentation for its OEM customers.
John Ruggieri, Vice President of Engineering and Technical Sales, Seabrook International
John Ruggieri is responsible for Seabrook’s manufacturing engineering group as well as sales, marketing and business development functions. Founded in 1973, Seabrook
specializes in surgical instruments, implants and devices for the orthopaedic market.
Trisha Mowry, Chief Executive Officer, Metal Craft and Riverside Machine and Engineering
Metal Craft and Riverside are leading partners in manufacturing for medical device surgical instrumentation and implants. Metal Craft has been providing exacting
quality, unparalleled service and innovation in machining since 1978.
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As the leader in UHMW-PE, and with almost 50 years’ of application experience, Ticona helps meet the needs of orthopedic surgeons with proven long-term materials performance in joint replacements.
Outstanding properties profile
n Low wear n Excellent lubricity n Biocompatibility n Abrasion resistance n High energy absorption n Exceptional impact strength n Vitamin E filled premium grades n High purity n Conforms to ASTM F648, ISO 5834-1
GUR UHMW-PE for:
n Hip, knee and shoulder arthroplasty n Other joint replacements n Spine applications
To learn more visitwww.ticona.com/products/uhmw-pe or call 1.800.833.4882
Ticona Engineering Polymers 8040 Dixie Highway, Florence, KY, USA 41042
© 2012 TiconaExcept as otherwise noted, trademarks are owned by Ticona or its affiliates.Ticona is a business of Celanese Corporation.
Orthopedic Implant Material-of-Choice.
GUR® UHMW-PEUltra-High Molecular Weight Polyethylene
Visit Us At Booth#826
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115. APS Materials4011 Riverside DriveDayton, OH 45405USA937-278-6547 (phone)937-278-4352 (fax)www.apsmaterials.com
APS is a leader in plasma spray technology of both porous and bioactive coatings for the orthopaedic marketplace. The coatings consist of Commercially Pure (CP) Titanium and its alloys, specifically Ti 6Al 4V, as well as Hydroxyapatite, a calcium phosphate material that is used as a synthetic bone substitute. ISO 13485:2003, ISO 9001:2000 and NADCAP certified. FDA Master files for all our coatings.
825. American Tool & Die9470 E 14 1/4 RoadManton, MI 49663231-824-9772 x 502 (phone)231-824 9790 (fax)www.americantooldie.com
American Tool & Die, Inc., also doing business as American Instrument & Implant, is a precision manufacturer of “to order” orthopedic and spine instrumentation and implants of the highest caliber at one of the industry’s best price points. Whether you are looking for a source to provide prompt quoting and delivery, prototype or production capabilities, craftsmanship for difficult projects, or specific documentation, American Instrument & Implant can help. ISO 13485:2003.
508. AIP724 Fentress BoulevardDaytona Beach, FL 32114 USA386-274-5335 (phone)386-274-4746 (fax)www.aipdaytona.com
The global leader for precision machined plastic components in the orthopaedic marketplace. Machining of carbon fiber PEEK and woven carbon fiber TECATEC CW60 PEKK for radiolucent components used in external fixation, targeting, intramedullary nailing and retractor systems. Validated machining of PEEK OPTIMA and UHMW-PE implants. Machining of RADEL, ULTEM and PEEK trials and surgical instruments. TECAPRO MT or PROPYLUX HS2 custom machined caddie systems. ISO 13485:2003.
200. ANCA Inc. 31129 Century DriveWixom, MI 48393USA248-926-4466 (phone) 248-926-4475 (fax)www.anca.com
ANCA Total Precision, Manufacturer of World Class Precision Grinding Machines. ANCA’s innovation & flexibility permits grinding, drilling, milling, threadmilling, belting & polishing of implants, instruments & industrial cutting tools. See how the ANCA Advantage is redefining how Medical/Dental OEMs & Contract Manufacturers compete on a global level.
718. Advantage Manufacturing Technologies, Inc.14298 169th Drive SEMonroe, WA 98272 USA425-485-3980 (phone)425-483-1608 (fax)www.teamamt.com
We work with various metals, moving with you, incorporating every step from engineering design assistance through assembly and final packaging, performing work to your exact specifications. With consistency, our production and quality systems provide parts that meet your tight tolerance and specifications time after time. AMT’s exceptional team works as your silent partner towards the mutual success of each of our companies.
515. Acme Manufacturing Company4240 North Atlantic BoulevardAuburn Hills, MI 48326 USA248-393-4200 (phone)248-393-4060 (fax)www.acmemfg.com
Integrated Robotic Polishing, Grinding & Buffing Systems for Orthopaedic Components. Largest global manufacturer of robotic gate grinding and finishing systems. We focus on providing a complete, fully developed, risk-free finishing system to support the global medical implant industry. In-house technical support staff of engineers for applications, product and electrical controls, off-line programming and training. ISO 9001:2008 certified.
818. 3D Systems333 Three D Systems CircleRock Hill, SC 29730USA 803-326-3900 (phone)803-324-8810 (fax)www.3dsystems.com
3D Systems is a leading provider of 3D content-to-print solutions including 3D printers, print materials and on-demand custom parts services for healthcare and medical industry. Its expertly integrated solutions replace, displace and complement traditional methods and reduce the time and cost by printing real parts directly from digital input. These solutions are used to rapidly design, communicate, prototype and produce functional parts and anatomic models, empowering its customers to create with confidence.
107. AceCo Precision Manufacturing4095 South Gekeler LaneBoise, ID 83716 USA208-850-4449 (phone)208-343-1237 (fax) www.acecoprecision.com
An ISO 9001:2008 and ISO 13485:2003 certified facility and a diversified solutions provider of precision CNC machined components. Our focus for 25+ years has been high-tech industries (Semiconductor, TFT-LCD, Solar), and we are always expanding our capabilities and certifications to serve a wider audience that seeks complex, high-quality and competitive machining solutions. Our engineering and design capabilities, coupled with our machining and quality disciplines, provide a perfect fit for the stringent requirements of the medical industry.
Exhibitors
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More than responsive to your needs.
800-238-6981
onyxmedical.net
ISO 13485:2003 / FDA 1043653
As strategic partners, we anticipate them.As technical innovators, we fulfill them.As quality-driven contract manufacturers,we deliver on them. Onyx is more than your supplier.We are Where Ideas and Ingenuity Converge.
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820. BioMed SCR-LEP41 Hallamshire CloseSheffield S10 4FJEngland44-114-2303254 (phone)www.biomedsheffield.com
The BioMed SCR-LEP Group represents a collaboration of 60+ private and public sector Healthcare Technology specialists working together in the Sheffield and Leeds City Regions to stimulate innovation and create conditions for both business and economic growth, Locally, Nationally and Globally. Through the Local Enterprise Programme, the group links Clinicians, Hospitals, Universities and Businesses to drive innovation around the Manufacturing skills and expertise that make the two cities internationally synonymous with service and quality.
212. Beijing Fule Science & Technology Development Co. No. 50, Mangfang West Industrial ZonePinggu District, Beijing 101204China86-106-099-9862 (phone)86-106-099-9863 (fax)www.fulekeji.com
Established in 1996 and a leader in orthopedic equipment R&D, production and sales. We have a rich experience in mechanical design, materials production and biomechanics. We specialize in clinical medicine Product Design and Development using 5-axis systems, vertical machining centers, CNC lathes and additional milling equipment. Our products mainly include fixed series, multifunctional external fixation of the spine, knee joint meniscus suture and rehabilitation support.
314. Arcam ABKroslatts Fabriker 30 Molndal 431 37 Sweden46-31-7103200 (phone)46-31-7103201 (fax)www.arcam.com
Arcam develops and manufactures systems for Additive Manufacturing of complex metal parts directly from 3D CAD drawings. Arcam’s EBM® (Electron Beam Melting) technology enables production of metal parts with optimized properties in small and medium-size volumes. Arcam’s market is global, with customers within primarily the implant and aerospace industries who capitalize on the EBM® technology’s capacity for cost-efficient manufacturing of products with extended functionality.
127. Autocam MedicalGlobal Headquarters4436 Broadmoor SEKentwood, MI 49512 USA 616-541-8080 (phone)877-633-8080 (toll free)616-698-6876 (fax)www.autocam-medical.com
Autocam Medical is a single-source contract manufacturer of precision-machined complex, highly engineered metal implants, instruments and components. Applications include orthopedic, spine, trauma and reconstructive surgery. We are a member of the Autocam group of companies, which includes 12 facilities on four continents. Using lean manufacturing, value engineering and continuous improvement principles, Autocam Medical leverages the entire production system to get a better product to market faster. ISO 9001 and ISO 13485 Certified and VISA Certified in Brazil.
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224-226. Bradshaw Medical, Inc.10325 58th Place Kenosha, WI 53144 USA 262-925-1374 (phone) 877-201-7661 (toll free) 262-925-1380 (fax) www.bradshaw-medical.com
Bradshaw Medical, Inc. will design, develop, manufacture and distribute innovative spinal and orthopedic instrumentation to our global OEM customer base within the medical industry. We are committed to supporting our customers’ most demanding requirements by delivering cost effective, reliable and quality solutions of strategic value with the foundation of best-in-class customer service and technical support. ISO 13485:2003, ISO 9001:2000 certified. FDA Registered.
119. Bodycote Thermal Processing Inc.12700 Park Central Drive, Suite 700 Dallas, TX 75251USA513-307-4727 (phone)513-921-2536 (fax)www.bodycote.com
Operating an international network of facilities, Bodycote is the world’s leading provider of thermal processing, surface coatings, HIP and metal joining services. Experienced in supporting large multi-national customers and their supply chains, as well as local niche specialists, Bodycote provides a vital link in the manufacturing process for virtually every market sector including aerospace and defense, automotive, power generation, oil & gas, construction, medical and transportation.
201. Bob, Incorporated 8740 49th Avenue North Minneapolis, MN 55428 USA 763-533-2261 (phone) 763-533-1735 (fax) www.bobinc.com
We specialize in close tolerance machining of implants, supporting your complete Prototype to Production process. We support large-volume contracts with more than 60 CNC machines including 9-axis CNC swiss machines, robotic loading CNC twin spindle lathes, high speed 5-axis CNC machining centers, etc. We partner with customers in ship-to-line, JIT, Kanban, supplier managed inventory and other lean programs, supported by an industry leading ERP solution with integrated MRP capabilities. ISO 9001:2008, ISO 13485:2003 AS9100 Certified.
232. Boedeker Plastics, Inc.904 West 6th StreetShiner, TX 77984USA361-594-2941 (phone)800-444-3485 (toll-free)361-594-2349 (fax)www.boedeker.com
Boedeker is the country’s largest single-location stocking distributor of high performance & industrial plastics in sheet, rod and tube. All ready for shipment at a moment’s notice. Our experience, personal attention to detail and passion for customer service will provide you with excellent results every time you do business with us.
306. Cam BioceramicsLeiden Bio Science ParkZernikedreef 6Leiden 2333 CLNetherlands31-71-5240600 (phone)31-71-5240650 (fax)www.cambioceramics.com
We Help Bone Grow. We were the first company to apply a bioceramic calcium phosphate (hydroxyapatite) coating to medical prostheses like hips and knees as well as spinal implants, both metals and polymers. We have quick turnaround times and an excellent quality system. Cam Bioceramics is a renowned producer, key supplier and partner (B-to-B) of synthetic bioactive and osteoconductive biomaterials, such as coating powders and granulates, to the orthopaedic and spinal industries worldwide.
307. C&A Tool Engineering, Inc.4100 North U.S. 33Churubusco, IN 46723 USA260-693-2167 (phone)260-693-3723 (fax)www.catool.com
Whether it be grinding, turning, milling, EDM, inspection, or engineering, C&A is able to assist you with your needs. C&A expertise, experience and specialized resources provide you with the support you require. Today’s metalworking suppliers must be prepared to partner and C&A is the partner you need for absolute precision in tomorrow’s advanced products.
112-114. Branch Medical Group200 Schell LanePhoenixville, PA 19460 USA484-921-3000 (phone)877-992-7262 (toll free)www.branchmedicalgroup.com
We are contract manufacturers making world class spinal, orthopaedic, cardiovascular, dental and other implants. We design and manufacture the graphic cases that house the implants and instruments. We do sterile packaging, labeling and assembly. Our mission is to make “parts for life.” Our driving passion is to help customers LAUNCH products ON TIME. Why do we do it? We do it for life.
308. Britton GallagherLife Sciences Division - One Cleveland Center1375 East 9th Street, 30th FloorCleveland, OH 44114USA216-658-7100 (phone)800-607-4711 (toll free)216-658-7101 (fax)www.brittongallagher.com
Do you have a Risk Advisor or just an insurance salesman? As an orthopaedic device manufacturer or distributor, you need a customized insurance solution tailored to your unique and changing needs. We know you are in a highly regulated environment and have very little time to sort out complicated insurance and risk management issues. With a tailored portfolio of property and liability products to help protect your company’s balance sheet from the financial devastation of a loss or lawsuit, Britton Gallagher wants to help you succeed.
Platinum Sponsor
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Net Shape & Closed Die ForgingNet &Near Net Shape Forging | Closed Die Forging | Upset Forging
Mechanical and Screw Presses from 700 to 1600 TonsTool Design and Fabrication
Conventional & CNC Machining4 & 5-Axis CNC Milling | 8-Axis CNC Mill/Turn Centers
High Speed Hard Die Milling | Wire EDMSinker/Plunger/Ram EDM | Swiss Machining | Honing
Grinding | Conventional Machining
Photochemical MachiningAutomated 2D Etching Lines
3D Etching Line for Complex ShapesPhoto Tool Design and FabricationAutomated Laser Feature Inspection
Laser & E-Beam Weldingand Vacuum Brazing
Vacuum Brazing with Helium Backfill | Electron Beam WeldingLaser Welding (4 Axis) | Sintering | Diffusion Bonding
Pressure, Leak, and Flow Testing
Custom FinishingCleaning | Passivation | Alpha Case Removal | BeltingTumbling | Grit Blasting | Heat Treating | Laser Marking
“Hi Bright” Polishing | High Speed Centrifugal Disk Finishing
LaunchQuick™ Rapid PrototypingFunctional prototyping from concept sketches or models
Dedicated multi-axis CNC machining centersFull range of support for machining, finishing and inspection
Orthopaedic, Trauma, CMF, and Spinal Implants
ISO 9001:2000 | ISO 13485 | FDA Registered
A Leader in Net Shape Forging, Precision Machining,Photochemical Etching and Joining of Critical Components115 Eames Street | Wilmington, MA 01887Phone: 978 642 2400 | Toll Free: 888 287 [email protected] | www.tecomet.com
Visit us at OMTEC 2012
Booth #407
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126. Centex Machining, Inc. 1513 Sam Bass RoadRound Rock, TX 78681 USA512-255-1477 (phone)512-388-3606 (fax)www.centexmachining.com 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.
609. CaP Biomaterials, LLC2485 Corporate Circle, Unit 1East Troy, WI 53120 USA262-642-2760 (phone)262-642-2764 (fax)www.capbiomaterials.com
Manufacturer of a broad range of calcium phosphate implants, providing consistently high quality, cost effective & reliable bioceramic solutions. CaP’s founders originated calcium phosphate bioceramics. Standard offerings include Hydroxylapatite, Beta-Tricalcium Phosphate, Biphasic Calcium Phosphate, calcium phosphate cement & Fluorapatite in physical forms of porous granulate & blocks, powders (sintered and unsintered) & dense blocks. Source of calcium phosphate testing including dissolution & solubility testing.
713. Canwell Medical Co., Ltd.466 South Xian Hua Str.High-tech Industrial ZoneJinhua, Zhejiang, 321016P. R. of China 86-579-8911-9226 (phone)86-579-8223-9558 (fax) www.canwell.com.cn
With 500 employees and over 300,000 square feet of workshop, Canwell Medical is one of the most reliable high-end orthopaedic contract manufacturers in China. Canwell was founded in Jinhua, China in 1994. We initially manufactured CPM and then successfully transitioned into orthopaedic industry in 2003, led by some world-famous orthopaedic giants. Today, we have become one of the largest trauma, spine and joint instruments & implants suppliers in China.
231. Carpenter Technology Corporation101 West Bern StreetReading, PA 19601USA800-654-6543 (toll free)610-208-2000 (phone)www.cartech.com
Leading fully integrated developer, manufacturer and distributor of a wide range of specialty alloys including biocompatible BioDur® alloys, stainless steels and titanium alloys. Alloys have been used in surgical, diagnostic, orthopedic, cardiovascular and dental applications. Forms include billet and long form bar, wire, precision strip, fine wire and ribbon and custom shaped bar and wire. Service centers on four continents. Free, comprehensive technical information database at www.cartech.com. ISO 9001:2008.
409. Donson Machine Co.12416 South Kedvale AvenueAlsip, IL 60803708-388-0880 (phone)708-388-4308 (fax)www.donsonmachine.com
Donson is a specialized contract manufacturer of precision machined components for Orthopedics and Medical Equipment. Registered to ISO 13485:2003, Donson focuses on complex designs and demanding applications requiring state-of-the-art equipment and engineering. Donson currently supplies implants and instruments to industry-leading manufacturers and is geared for quick-turn prototyping, short-run customs/specials and production requirements.
532. Directed Light, Inc. 633 River Oaks ParkwaySan Jose, CA 95134USA408-321-8500 (phone)800-468-2326 (toll free)408-321-8466 (fax)www.directedlight.com
Directed Light Inc. provides contract laser processing for a wide variety of materials. We pride ourselves on being your complete outsourcing partner. Our diverse selection of lasers offers processing solutions from UV to Far IR. We provide contract manufacturing services for laser welding, including hermetic sealing, cutting, drilling, marking and ablation. Our vast applications expertise and years of experience have earned us the reputation as the industry’s most trusted resource.
613. CIBOR (National Center of Innovation for Biomaterials in Orthpaedic Research)9229 East 37th Street North #200Wichita, KS 67226USA316-247-7900 (phone)316-247-7899 (fax)www.ncibor.org
CIBOR, a not-for-profit company, offers contract research and development services for orthopedic medical devices. We can take a concept from Design through Prototyping, Mechanical and Biological Testing, Analysis and Manufacturing Transfer. Our engineering expertise stretches across a broad range of materials, including composites, biologics and traditional orthopedic metals and polymers. CIBOR has a flexible service offering, ranging from managing full, turn-key projects to a menu of individual services to suit your needs. In short: ORTHOPAEDICS FOCUS, ENGINEERING EXPERTISE, SPEED, VALUE.
821. DC Electronics 1870 Little Orchard StreetSan Jose, CA 95125USA408-947-4500 (phone)408-947-4510 (fax)www.dcelectronics.com
Production, design and engineering liaison of custom wire harness and cable assemblies. More than 30 years of experience and innovation in electronics cable assembly gives us an unparalleled advantage. We are known for quick response to every inquiry, a deep culture of customer service and consistently producing the best product, manufactured to rigorous quality standards, on time every time. ISO 13485, ISO 9001/AS9100 certified and UL/CSA safety-approved with a Class 1000, Class 10,000 Clean Work Area and an ESD Safe Manufacturing Area.
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Ad
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age
Man
ufac
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olog
ies
How Can AMT Serve You?
Before you begin your next project, talk to us. We have the manufacturing expertise and resources to take your project from concept to completed part—finished, as specified, and delivered from our dock to your stock.
As your silent partner, we will commit our full resources to providing the trusted results you need to succeed in the medical device market. To learn more, call 425.485.3980 or visit us at www.teamamt.com.
Trusted Outsourcing Partner
Advantage Manufacturing Technologies is a contract manufacturer of precision-machined surgical implants, instruments and trays for OEMs in the orthopedic industry.
Leading medical device manufacturers rely on us for providing single source solutions to their outsourcing needs. That’s because they know they can trust the quality, reliability and deliverability of our work—at a cost significantly below our competitors.
Integrity in Every Part
Advantage Maufacturing Technologies14298 169th Drive SEMonroe, WA [email protected] T: 425.485.3980 F: 425.483.1608
TRUSTWe Deliver it CompleteReduce costs, increase capacity and get to market faster.
Choose AMT as your complete solution for:
l Manufacturing Engineeringl Productionl Finishingl Cleaning/Passivatingl Laser Markingl Assembly/Kittingl Packagingl Delivery
Single Source Solutions
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714. Fairview Machine Co., Inc. 427 Boston StreetTopsfield, MA 01983USA978-887-2141 (phone)978-887-3689 (fax)www.fairviewmachine.us
ISO 13485 & ISO 9001 registered precision manufacturer of Orthopaedic Implants and Spinal Products. Within a lean manufacturing environment with an extensive range of CNC capabilities (5-axis high speed machining, multi axis turning, 3D surfacing and 5-axis wire EDM) we achieve superior surface finishes and hold the tightest of tolerances on plastic and metal devices with the most challenging part geometries. Rapid prototyping, product launch, high production and VMI.
125. Ensinger365 Meadowlands BoulevardWashington, PA 15301 USA724-746-6050 (phone)724-746-9209 (fax)www.ensinger-inc.com
Autoclavable plastic shapes in a variety of colors supported with ISO 10993 testing for the intended use of surgical instruments in contact with blood and tissue. Radiolucent carbon composites with high stiffness and radio opaque grades for safety and to accommodate MIS procedures.
430. Empirical Testing Corp. 4628 Northpark DriveColorado Springs, CO 80918USA719-264-9937 (phone) 719-264-1926 (fax)www.empiricaltesting.com
With 13 years of experience in orthopaedic medical device testing, Empirical Testing Corp., an accredited ISO/IEC 17025:2005 facility, performs static/dynamic mechanical testing & wear/simulation testing while offering research support, including sterilization validation/testing, protocol generation & training seminars, etc. Our broad industry knowledge allows us to be part of your team while offering an unparalleled commitment to your success.
230. F&G Tool and Die Co., Inc. 3024 Dryden RoadDayton, OH 45439USA937-294-1405 (phone)937-294-3862 (fax)www.fgtool.com
F&G Tool and Die has 35 tool makers and five designers to design and build gauges, fixtures, dies and special tooling for the medical, aerospace, automotive and other industries. Additionally, we have Swiss turning to 32mm diameter, 5-axis machining, jig grinding, EDM, laser etching and more. We stamp prototypes and production on progressive die, deep draw and four slide stampings. F&G is ISO 17025, ISO/TS 16949 and ISO 14001 certified. F&G can calibrate and certify gauges.
432. Fort Wayne Metals 9609 Ardmore AvenueFort Wayne, IN 46809USA260-747-4154 (phone)260-747-0398 (fax)www.fwmetals.com
Precision Wire and Cable and Centerless Ground Bar for Medical Products. Round wire, centerless and precision ground rod, strands, cables, flat wire and DFT™ wire. Starting stock for the most popular orthopaedic alloys, including: 316LVM, titanium/titanium alloys, L605, FWMtm1537, Custom® 455, 17-7PH®, 17-4PH®, MP35N®, Nitinol, 304V and others. All of our production facilities and quality systems are geared specifically for producing medical grade products.
606. Forecreu America, Inc.4118 North Nashville AvenueChicago, IL 60634USA773-539-8501 (phone)773-539-8627 (fax)www.forecreu.com
Forecreu America 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. Finishing Innovations, LLC578 Highway 70Mason, TN 38049USA901-294-2848 (phone)901-294-3070 (fax)www.finishinginnovations.com
Beginning with H900 heat treat thru polishing, hard chrome electroplating, electropolish and laser etch, Finishing Innovations sets the standard for delivering validated orthopedic metal finishing services in today’s rapid turnaround environment. Simply put, Finishing Innovations delivers unmatched quality, delivery and service in the orthopedic surface finishing industry. Finishing Innovations LLC ISO 13485 Registered. For more information, visit www.finishinginnovations.com.
502-600. FMI Hansa Medical Products 505 Production AvenueMadison, AL 35758 USA256-461-0900 (Huntsville, AL)www.fmihansa.com239-775-9090 (Naples, FL)www.hansa-medical.com
Contract Manufacturer of precision machined implants and instruments. FMI utilizes the latest technology in 3D solid modeling and multi-axis CNC programming software, as well as the latest advancements in multi-tasking CNC machines. We have extensive experience manufacturing spine and small bone devices. We can manufacture your most demanding applications.
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615. gSource, LLC19 Bland Street Emerson, NJ 07630 USA 201-599-2277 (phone) 800-978-1119 (toll free)201-599-3306 (fax) www.gsource.com The Orthopaedic reSource for Surgical Instruments. gSource is a trusted and reliable partner to many world leaders in orthopaedics and spine. We provide superior instrumentation in a time-critical fashion and at realistic prices. From prototypes to full-run production, and an inventory of 3,500 off-the-shelf instrument patterns, we are committed to being a valuable business partner, always providing a real return on investment.
513. Gibraltar Laboratories122 Fairfield Road16 Montesano RoadFairfield, NJ 07004 USA973-227-6882 (phone)973-227-0812 (fax)www.gibraltarlabsinc.com
Gibraltar Laboratories is a 42-year-old contract testing lab operating at two sites in Fairfield, NJ. ISO 17025 certified and FDA registered for studies in research and quality control testing in chemistry, microbiology and molecular biology, Gibraltar provides fast, reliable results to the pharmaceutical, biotechnology, device, chemical and other industries. Gibraltar also offers contract steam sterilization services to the medical device or orthopedic industries.
831-833. Geomagic, Sensable Group181 Ballardvale StreetWilmington, MA 01887USA781-939-7489 (phone)www.sensable.com
Geomagic® is the leading provider of 3D software for capturing, creating, inspecting and interacting with digital models of physical objects. Solutions include the newly acquired Sensable Freeform® 3D sculptural software used to design and manufacture medical study models, implants and prosthetics; Sensable Phantom® haptic devices, used in computer-based medical simulations to provide a “sense of touch,” and Geomagic’s award-winning Studio®, Qualify®, Wrap™ and Probe™ solutions. Geomagic is dedicated to advancing and applying 3D technology for the benefit of humanity.
113. Foster Delivery Science 45 Ridge RoadPutnam CT, 06260USA 860-928-4102 (phone)860-928-4226 (fax)www.fostercomp.com
Delivery Science, a business unit of Foster Corporation, specializes in custom blending and hot melt extrusion of polymers for highly regulated applications, including long term and bioresorbable implants, combination products and oral dose pharmaceuticals. Services include formulation, feasibility, process development and production in an ISO 8 cGMP clean room environment.
237-336. Greatbatch Medical 10000 Wehrle DriveClarence, NY 14031 USA716-759-5600 (phone)716-759-2562 (fax)www.greatbatchmedical.com
Greatbatch Medical is committed to the design, development 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.
827. HNM Medical20855 NE 16th AvenueSuite C15Miami, FL 33179USA866-291-8498 (phone)888-608-9788 (fax)www.hnmmedical.com
HNM Medical specializes in OEM for Orthopedic, Spine & Neuro surgical instruments and medical devices. We can help your organization develop, design and customize any surgical instrument to meet your demands. We work hand-to-hand with our network of contract manufacturers around the world to shape your ideas into finalized products. Our goal and mission is to develop and source the highest quality German instruments with manufacturers who comply with GMP, CE, FDA and ISO regulations. Our wide-reaching client base includes hospitals, universities, implant companies, distributors and physicians.
724. HFO Midwest (HAAS Factory Outlet)1993 Case Parkway NorthTwinsburg, OH 44087USA330-405-4227 (phone)800-833-0246 (toll free)330-405-0567 (fax)www.haascnc.com
Haas Factory Outlet is a distributor for Haas Automation, the largest machine tool builder in the United States. Haas Automation manufactures a full line of CNC vertical and horizontal machining centers, CNC lathes, rotary tables, mini mills, super mini mills and 5C indexers. Haas machine tools and rotary products are built to deliver high accuracy, repeatability and durability.
124. Hangsterfer’s Labs175 Ogden RoadMantua, NJ 08051 USA856-468-0216 (phone)856-468-0200 (fax)www.hangsterfers.com
Coolants and lubricants used in all sectors of the metalworking industry. We are a family owned and operated company born in 1937. Together we will overcome costly machining problems, reduce down-time and maintenance costs and dramatically improve your company’s bottom line. Hangsterfer’s engineering staff and knowledgeable representatives are ready to answer your questions and solve your problems!
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331. Jarvis Surgical, Inc.53 Airport RoadWestfield, MA 01085 USA413-562-6659 (phone)413-562-1988 (fax)www.jarvissurgical.com
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.
631. Ionbond1823 East Whitcomb Madison Heights, MI 48071 USA 248-398-9100 (headquarters) 800-929-1794 (toll-free) 248-398-2110 (fax)www.ionbond.com
Highest Quality Thin-film Coatings. IonBond is the leading international provider of BioCeramic coating products and services for the medical device industry, offering state of the art biocompatible coatings with technical consultation for instrument and implant applications. IonBond processes are ISO driven, meeting all of the strict “Quality System Standards” of the medical device industry.
206-208. Juno Inc. 1040 Lund Boulevard NWAnoka, MN 55303 USA763-427-6141 (phone)763-427-7252 (fax) www.junoinc.com
Juno is an ISO 13485 registered full-service contract manufacturer specializing in micromolding, single and multishot injection and insert molding of engineering resins in various levels of clean environments from ISO Class 7 to Class 9. The company also manufactures custom sterilization cases and trays in anodized aluminum and stainless steel.
630. ImageIQ, Inc.10000 Cedar Avenue Mailstop #18 Cleveland, OH 44106USA216-445-4054 (phone) 855-462-4347 (fax)www.image-iq.com
ImageIQ is an imaging CRO that combines custom-tailored software engineering and biomedical expertise to improve data quality, accelerate timelines and reduce cost for research. Orthopedic projects include biomaterial performance, objective bone growth assessment detailed cartilage analysis and many others. A spinout of Cleveland Clinic Innovations, ImageIQ’s customers utilize services for pre-clinical, clinical, post-market and manufacturing purposes, ensuring robust data and reducing process-related costs.
309. Knight Mechanical Testing3205 Clairmont Court, Suite BFort Wayne, IN 46808USA260-489-1444 (phone)260-818-2036 (fax)www.knighttesting.com
ISO/IEC 17025:2005 Accredited, Independent Mechanical Test Laboratory. KMT offers independent ISO/IEC 17025:2005 accredited mechanical testing services focused on ASTM, ISO, and customer specified test methods for orthopaedic devices. Orthopaedic OEM laboratory experience - all MTS laboratory equipment. Can pot hips, knees and extremities and can design and fabricate specialty fixturing for trauma and spine products.
727. LISI Medical950 Borra PlaceEscondido, CA 92127USA760-432-9785 (phone)760-432-9364 (fax)www.lisi-medical.com
With manufacturing facilities located in the United States, Europe and North Africa, we are part of a worldwide contract manufacturing company of distinction with over 200 years of corporate legacy. LISI Medical has extensive expertise in manufacturing orthopedic and bone fixation devices including total joints, trauma, extremities and spinal related implants and instruments. Our multi-continental onsite capabilities include metal forging, screw machining, multi-axis milling, EDM, passivation, anodization and clean room assembly.
712. LH Medical6932 Gettysburg Pike Fort Wayne, IN 46804 USA260-432-5670 (phone)260-432-5691 (fax)www.lhindustries.com/lhmedical
Partnership Driven. Complexity Simplified. Through developing processes, advanced prototyping and efficient production we help our customers achieve the extraordinary! LH Medical is a high quality manufacturing leader that is constantly growing with the ever changing orthopedic market. Our vision is to be daring, be first, and to be better! LH Medical continually seeks new production methods and procedures that streamline operations, and new technologies that drive down waste and drive up quality and speed to market.
109. LAB Medical Manufacturing, Inc.28 Cook StreetBillerica, MA 01821USA978-663-2475 (phone)978-663-4364 (fax)www.labmedical.com
LAB Medical Manufacturing 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 a passion for problem-solving with comprehensive in-house resources, exceptional engineering, unmatched application expertise and highly flexible, integrated manufacturing.
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408. Mahar Tool Supply Company, Inc.3568 U.S. 30 EastWarsaw, IN 46580 USA574-267-0032 (phone)800-456-2427 (toll-free)574-267-0076 (fax)www.maharmedical.com
Distribution & Commodity Management in Cutting Tools & More! Specializing in metal-removal and distribution since 1947. Offering products, services and consultation to meet your tooling & inventory management needs. We take pride in offering custom solutions that generate bottom-line savings. ISO 9001:2000 and WBENC certified.
632. Mastin Medical Co.528 Shunfeng Road, Qianjiang Economic Development ZoneHangzhou, Zhejiang 311106China86-571-8635-3288 (phone)86-571-8635-8128 (fax)www.rejoin-medical.com
REJOIN devotes itself to being an outstanding contract manufacturing solutions provider for global orthopaedic, spinal, trauma and sports medicine markets. REJOIN offers OEM customers value-added supply chain services, from design & engineering to prototype, first article development and volume product launches. CNC precision 5-axis grinding, milling, turning, EDM and surface treatment are specialties. BSI certified to ISO 13485:2003 & FDA registered.
708. Maple Leaf Tooling SolutionsP.O. Box 682 Alliston, Ontario L9R 1V8 Canada800-456-2427 (toll free)989-799-5530 (fax)www.mapleleaftooling.com
If you machine to tolerance, Maple Leaf is your answer. We promise to provide you the proper tools, abrasives and fluids at the best prices while improving your manufacturing process. Our services include: Inventory Management (resharpening, repairing and coating), Cutter Grind/Preset, Gage Management (sales, repair, design, build, calibration and certification), Technical Services, Vending/Scanner Solutions and Cost Reporting.
137-236. Marox Corporation373 Whitney Avenue Holyoke, MA 01040 USA 413-536-1300 (phone) 413-534-1829 (fax) www.marox.com
Manufacturer of medical implants, instruments and devices. Precision CNC machining and assembly of orthopaedic, spinal and trauma implants and instruments. Specialties include CNC milling (up to 5-axis), CNC turning, CNC Swiss screw machining (up to 12-axis), CNC 7-axis contour machining, CNC wire/ram EDM and assemblies. Services include product launching, production, project management and vendor managed inventory. ISO 13485 registered.
730. MedicalCoating5 Chemin du CatupolanVaulx-en-Velin 69120France33-4-72-81-22-62 (phone)33-4-72-81-22-72 (fax)www.medicalcoating.fr
MedicalCoating is providing medical coating technology for implants in the orthopaedic, dental, trauma and spine fields to facilitate biological fixation. We offer the possibility of applying several types of metallic, ceramic or multi-layer coatings. With 22 years of experience, MedicalCoating is one of the most important providers of coating in Europe.
607. Medin Corporation90 Dayton Avenue, Building 16CPassaic, NJ 07055 USA973-779-2400 (phone)800-922-0476 (toll free)973-779-2463 (fax)www.medin.com
Manufacturer of Standard and Custom Sterilization Containers, Cases, Trays & Devices. Experience with aluminum, SS, thermoformed plastics and hybrids. Computer-driven Total Process Control enables us to meet critical launch deadlines because we don’t outsource. Punching, bending, machining, milling, riveting, welding, clear or color anodizing and hard coating, nylon coating, surface or deep cavity silkscreening and laser etching. ISO 13485:2003 Certified.
206-208. Meier Tool and Engineering Inc. 875 Lund BoulevardAnoka, MN 55303USA763-427-7275 (phone)763-427-9242 (fax)www.meiertool.com
Meier Tool & Engineering Inc. is a supplier of stamped components for minimally invasive and micro-invasive surgical devices, test instruments and implantable medical devices. The company provides miniature stamped needles, biopsy jaws, laparoscopic forceps, lances, blades and titanium implantables. The company is ISO 9001 and ISO 13485 certified.
813. Megatech AQ 340 Galilée Quebec, Québec G1P 4M9 Canada418-688-4351 (phone)418-688-4354 (fax)www.megatechaq.qc.ca
MEGATECH specializes in high precision machining of titanium, PEEK, Ultem 1000, UHMWPE, polycarbonates and other performance materials. With more than 20 years of experience, MEGATECH A.Q. has been using the most modern equipment to prototype medical devices as well as serving customers in aerospace, advanced optics and other demanding industries. With 75 employees on a 24/7 basis, MEGATECH A.Q. has over 20 CNC machines for maximum precision, fast prototyping and rapid response for production runs.
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118. Microware Precision Co., Ltd.No.12, Keyuan 2nd Road, Situn DistrictTaichung City 40763 Taiwan886-4-2463-6275 (phone)886-4-2463-6276 (fax)www.microware.com.tw
Full-service medical device development and manufacturing contractor. We focus on manufacturing solutions for orthopedic and spinal implants and instruments. Our focus is on helping our customer to reduce lead-time and cost from process engineering to high-volume production while maintaining the integrity and the quality of the product. In Microware, each product that is delivered reflects our mission to improve the quality of life and standard care for patients. ISO 13485 certified with FDA 510(k) clearance and CE approval.
608. Micron Products, Inc.45 Sawyer Passway Fitchburg, MA 01420USA978-602-1482 (phone)978-602-1282 (fax)www.micronproducts.com
Micron Products’ sustainability and competitiveness are based on Lean/six sigma principles. Our fully integrated manufacturing capabilities are supported by a team of engineers to facilitate product development, process validations to manufacturing. We are a ISO 9001:2008 & ISO 13485:2003 certified manufacturer of 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, etc.
514. MSK Precision Products, Inc. 10101 NW 67th StreetTamarac, FL 33321954-776-0770 (phone)800-992-5018 (toll Free) 954-776-3780 (fax)www.mskprecision.com
We manufacture complex components and finished assemblies for the medical industry. Specializing in difficult to manufacture parts like reamers, drills, trocars, guides, implants, hand tools and full assemblies, managing them from design to delivery. Our focus is producing tight tolerance components utilizing Swiss/CNC/Multi-Spindle Precision turning and milling, CNC Ultra-Precision grinding, laser marking, EDM, passivation, heat treat and brazing. SPC Data Collection, Certified to ISO 13485:2003, ISO 9001:2008, AS9100:2004 Rev B, Clean Room - Class 10,000, FDA Registered, Export Licensed.
531-533. Micro Machine Company, LLC2429 North Burdick StreetKalamazoo, MI 49007USA269-388-2440 (phone)269-388-5466 (fax)www.micromachineco.com
Micro Machine is a precision contract manufacturer of medical products principally to the orthopedic and spinal industries. The company specializes in prototyping and production of high-quality, close tolerance instruments, tools and implants used by orthopedic, spinal and medical device industry. Micro Machine serves as a full service supplier with wire-EDM, CNC machining, PEEK machining, finishing, packaging and marking as well as vendor managed inventory support all within its ISO 13485:2003 certified facility.
614. Metal Craft & Riverside Machine and Engineering13760 Business Center Drive Elk River, MN 55330 USA 800-964-1395 (toll free) 763-441-0798 (fax)www.metal-craft.comwww.riversidemachine.com
Dedicated partners, Metal Craft & Riverside Machine and Engineering, provide inhouse 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. We are eager to assist in engineering and design of your projects to reduce cost of manufacturing. WBENC, ISO 13485, 9001, AS9100 registered.
431. Norman Noble, Inc.5507 Avion Park Drive Highland Heights, OH 44143 USA 216-761-5387 (phone) 216-761-0455 (fax) www.nnoble.com
Norman Noble manufactures medical devices and implants to customer specifications in compliance with FDA regulations and ISO 13485:2003. Full capabilities include orthopaedic implant manufacturing, 7-axis contour milling, Swiss machining, laser machining & welding, EDM services and nitinol shape setting. Prototype services are also available.
812. North American Spine Society7075 Veterans Boulevard Burr Ridge, IL 60527USA630-230-3600 (phone) 630-230-3700 (fax)www.spine.org
The North American Spine Society is a multidisciplinary medical organization dedicated to fostering the highest quality, ethical, value-based and evidence-based spine care through education, research and advocacy. Join us at NASS’ 27th Annual Meeting taking place October 24-27 in Dallas, Texas. Go to www.NASSAnnualMeeting.org for more information.
207. NeedleTech Products, Inc. 452 John L. Dietsch BoulevardNorth Attleboro, MA 02763 USA508-431-4000 (phone)508-431-2156 (fax)www.needletech.com
Excellence in Everything We Do. Full service, ISO 13485:2003 certified manufacturer of specialty needles and related medical devices. Supplying the orthopaedic market with K-Wire, Steinmann Pins, Trocars and Guide Wires. Servicing the Vertebroplasty markets with Access Needles, Reamers, Biopsy Devices, Cement Delivery and Aspiration Needles. We satisfy our customers every day.
Platinum Sponsor
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413. Onyx Medical Corporation1800 North Shelby Oaks DriveMemphis, TN 38134 USA901-323-6699 (phone)901-454-0295 (fax)www.onyxmedical.net
Onyx is your world-class manufacturing partner, offering vertically integrated solutions from concept design through dock-to-stock inventory for orthopedic cutting, nailing, fixation and navigation devices. Onyx is FDA registered, ISO certified and committed to delivering on your specifications and exceeding expectations – always.
131-133. Orchid Orthopedic Solutions 1489 Cedar StreetHolt, MI 48842 USA517-694-2300 (phone)517-694-2340 (fax)www.orchid-orthopedics.com
Worldwide leader in contract design and manufacturing for orthopedic and dental markets. Our mission is to be the leader in contract medical design and manufacturing by compressing time to market, providing new technology and being the best total supply-chain value. We provide design and development, implant manufacture, quality and regulatory, advanced machining, plastic technology, instrument manufacture, implant coatings and surface treatments, packaging services, investment casting and complex instrumentation.
209. ORCA – Grace College200 Seminary DriveWinona Lake, IN 46590USA855-267-6722 (toll free)574-372-5120 (fax)www.grace.edu/orca
The graduate program in Orthopaedic Regulatory and Clinical Affairs (ORCA) at Grace College is located in the heart of the Orthopaedic Capital of the World, Warsaw, Indiana. This one-year master’s program brings up to 30 students together in a cohort model to learn under some of the finest minds the industry has to offer. Each course is one month long and blends classroom instruction, online/independent learning and group projects to equip professionals for successfully managing the rigors of orthopaedic regulatory and clinical affairs.
814. On-X Life Technologies, Inc.1300 East Anderson Lane Building B Austin, TX 78752USA888-339-8000 (phone)888-339-3636 (fax)www.onxlti.com
On-X Life Technologies’ extensive engineering and manufacturing experience along with proprietary processing technologies provide medical device manufacturers a superior source for pyrolytic carbon components and assemblies. On-X LTI welcomes the opportunity to discuss applications that can benefit from our services, especially those involving use of On-X pyrolytic carbon.
612. Orthoplastics, Ltd.Unit A, Beech Industrial EstateBacup, Lancashire OL13 9EL United Kingdom44-1706-871-200 (phone)44-1706-879-826 (fax)www.orthoplastics.com
Uniquely focused on Orthopaedic Plastics. Orthoplastics is the genuine one-stop-shop for both implantable and instrument grade materials. Quality and Process Controls are unsurpassed anywhere in the world. Our products include UHMWPE, PEEK, PMMA, POM (Acetal), PEI (Ultem), PPsu (Radel) plus a range of specialist materials. All certified using our in-house laboratory that is also available for bespoke research.
709. Oxford Performance Materials, LLC30 South Satellite RoadSouth Windsor, CT 06074 USA860-698-9300 (phone)860-698-9978 (fax)www.oxfordpm.com
Founded in 2000, OPM is a privately held advanced materials and manufacturing technology company focused on developing solutions that enhance fundamental human sustainability. For more information, please visit www.oxfordpm.com.
433. Pacific Instruments, Inc.438 Hobron Lane, Suite 204Honolulu, HI 96815USA808-941-8880 (phone)808-941-8833 (fax)www.pacificinstruments.biz
Pacific Instruments, a globally recognized contract manufacturer in orthopedics, began in 2005 and now marks its second year as an OMTEC exhibitor. Within seven years, it obtained ISO 13485 certification, has been awarded twice by Pacific Business News as one of the Top 50 Fastest Growing Companies and was bestowed nationally by INC Magazine’s Top 500/5000 list. Undoubtedly, Pacific Instruments has demonstrated that customers rely on its technical expertise and global procurement program to obtain the best surgical instruments while they focus on their core business. Let us help you!
512. PAK Manufacturing, Inc.704 South 21st Street Irvington, NJ 07111 USA 973-372-1090 (phone) 973-372-1091 (fax) www.pakmanufacturing.com
Custom & Specialty Handheld Surgical Instruments. Hand-finished, forged surgical instruments made in the USA! We specialize in custom configurations, built from raw forgings (not other instruments). Prototypes often shipped within 10 days for your approval; production quantities typically shipped within 8 weeks. In-house manufacturing capabilities include milling, grinding, heat treating, passivation, polishing. FDA-registered.
INSTRUMENTS
®
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819. Precision Medical Technologies2059 N Pound Drive WWarsaw, IN 46582USA 574-267-6385 (phone)574-268-9240 (fax)www.premedtec.com
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, each with its own Quality and Production Engineering. Concentration of effort has been key to driving high quality and on-time performance.
506. PMC, LLC2181 Grand Avenue Cincinnati, OH 45214 USA 513-921-5040 (phone) 513-921-5883 (fax) www.pmcsmartsolutions.com
PMC is the orthopedic industry’s leader in injection molding and contract manufacturing of biomaterial based implants and complex molded instruments. PMC specializes in high-temperature materials, with extensive experience in implants and metal-to-plastic conversions. With 80 years of experience, PMC is ISO 13485 certified, providing services including design for manufacturability, hyper-precision injection/insert molding, assembly, sterile packaging and sterilization management.
509. Piper Plastics, Inc.1840 Enterprise Court Libertyville, IL 60048USA 847-367-0110 (phone) 847-367-0566 (fax)www.piperplastics.com
Piper Plastics, Inc. is a full service materials processing, machining, fabrication and polymer development company. We offer innovative polymer-based products and services for medical applications. As an ISO 9001:2008 and 13485 certified manufacturer, Piper specializes in high performance polymers such as implantable and medical grades of PEEK, CF PEEK, PrimoSpire, Ultem and Radel. With facilities in Arizona, Illinois, China and Thailand, we support global manufacturing. Solutions in medical polymers for orthopedic implants and trials, devices, instruments, imaging components and assemblies.
437-536. Phillips Precision Medicraft7 Paul Kohner Place 50 Bushes LaneElmwood Park, NJ 07407USA201-797-8820 (phone)201-797-3039 (fax)www.phillipsmedicraft.com
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 for the health care industry.
507. Paragon Medical8 Matchett Industrial Park Drive Pierceton, IN 46562USA 574-594-2140 (phone) 800-225-6975 (toll-free) 41-21-320-37-85 (Europe) 86-519-8989-0066 (Asia)www.paragonmedical.com
Paragon Medical is a tier 1, turnkey supplier of world-class solutions for cases & trays, surgical instrumentation, implantable components and design & development services to the medical device marketplace. Headquartered in the orthopaedic capital of the world, Paragon has created strategic centers of excellence within the United States, Europe and Asia. Dynamic acquisitions have brought some of the industry’s most talented craftsmen to our team while regional centers of manufacturing excellence have made us more versatile.
813. Pega Medical, Inc. 1111 Autoroute ChomedeyLaval, Quebec H7W 5J8Canada 450-688-5144 (phone)450-688-1977 (fax)www.pegamedical.com Pega Medical is a company specializing in the design, development, evaluation and manufacturing of medical devices. Our innovative staff of bioengineers, industrial designers and ergonomists utilizes full 3-D modeling, Finite Element Analysis, static and fatigue testing equipment to bring the highest quality products and designs to both the surgeon in particular and the healthcare industry in general.
214. Precision Metal Products850 West Bradley AvenueEl Cajon, CA 92020USA619-448-2711 (phone)619-448-2005 (fax)www.pmp-elcajon.com
Orthopaedic Implant Forgings in Titanium, Cobalt-Chrome-Molybdenum, Stainless Steel and Customer Specific Alloys. We are ISO 9001:2000 certified, and our in-house capabilities include heat treating, lab testing, 4-axis and 5-axis CNC machining, chemical milling, secondary finishing operations and complete tool design and fabrication. ISO 9001:2000 certified.
636. PPD Meditech50 Raymond Waterville, Quebec J0B 3H0Canada 819-837-2491 (phone) 819-837-3083 (fax) www.ppdgroup.com
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®.
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830. Precision Piece Parts712 South Logan Street Mishawaka, IN 46544 USA 574-255-3185 (phone) 574-255-2086 (fax) www.ppp-inc.com
Innovative Precision Machining and Outstanding Customer Service since 1942. Implant machining since 1991. Five-axis machining, CNC Swiss machining. Extensive bone screw and accessory manufacturing experience. FDA registered. ISO 9001 certified.
537. Putnam Plastics 130 Louisa Viens DriveDayville, CT 06241USA860-774-1559 (phone)860-774-6439 (fax)www.putnamplastics.com
Putnam Plastics manufactures small diameter medical device tubing, solid profile and monofilament from traditional thermoplastics through high performance polymers such as PEEK, polyimide, and fluoropolymers. Custom tubing is available in multi-lumen, coextrusion, tapered and wire/fiber reinforced. Component fabrication capabilities include CNC grinding and lathe turning, thermal forming, over molding, precision drilling and pad printing.
720. Promimic ABStena Center 1bGothenburg, 412 92 Sweden46-31-772-80-35 (phone)46-31-772-80-91 (fax)www.promimic.com
Promimic markets a unique nano coating for implants - HAnano Surface™. It is a 20 nm thin surface that greatly accelerates osseointegration. The surface has excellent coating ability with all implant materials from ceramics and metals to pyrocarbon and PEEK. HAnano Surface can be applied on all implants including inside a porous, trabecular structured implant. The coating technology is easy adjustable and can be used directly at the implant production line.
500-501. Pro-Dex2361 McGaw AvenueIrvine, CA 92614 USA949-769-3200 (phone)800-562-6204 (toll free)949-769-3281 (fax)www.pro-dex.com
Pro-Dex, Inc. designs, manufactures and assembles powered medical devices and motors that successfully withstand sterilization processes including high pH dishwashers and autoclave for leading Medical Device OEMs. As a FDA-registered, ISO 13485:2003 certified manufacturer, Pro-Dex offers a broad range of services including full regulatory support to help OEMs get products to market quickly and effectively.
736. Quadrant/MediTECH Medical Polymers 2710 American Way Fort Wayne, IN 46809 USA 260-479-4290 (phone) 260-478-1074 (fax) www.meditechpolymers.com
Quadrant Engineering Plastic Products is the world leader in stock shape engineering plastics with a full line of Life Science products tested for biocompatibility to ISO 10993 and USP requirements. Quadrant EPP is the parent company of MediTECH, the leading supplier for decades to the Orthopaedic industry with its UHMW-PE. 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.
120. Rolled Alloys125 West Sterns RoadTemperance, MI 48182 USA734-847-0561 (phone)800-521-0332 (toll free)734-847-6917 (fax)www.rolledalloys.com Rolled Alloys is a premier approved source for titanium and stainless in medical and aerospace applications. We are certified to ISO 9001:2000 and AS9100 Revision B. We offer Ti 6-4 ELI to the ASTM F136 specification and 6-4 to the ASTM F 1472 specification. Rolled Alloys offers 17-4, 300 series and 400 series. Material is offered in precision ground rod, bar, and plate. Value added processes such as precision saw cutting, water-jet cutting and shearing are all performed on site. Our main focus is on providing quality material to specifications and providing excellent service.
725. Richter Precision 1021 Commercial Avenue East Petersburg, PA 17520 USA 717-560-9990 (phone) 717-560-8741 (fax) www.richterprecision.com
Richter Precision Inc., an ISO 13485:2003 certified company, is pleased to offer our Medikote™ line of Physical Vapor Deposition (PVD) coatings: specialized PVD processes designed to meet the highest requirements of medical device manufacturers. Medikote™ is available in the following compositions: TiN, CrN, AlTiN, TiAlN, ZrN, DLC & more!
813. Quebec Government Office444 North Michigan Avenue, #3650Chicago, IL 60611USA312-645-0395 (phone)www.quebec-chicago.org
Quebec is an aerospace manufacturing powerhouse with growing involvement in orthopaedic manufacturing. Quebec suppliers offer orthopaedic contract manufacturing services to the very highest standards, as well as specialized expertise in process and prototype development, engineering, testing and international regulatory compliance.
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330. Rollomatic, Inc.1295 Amour BoulevardMundelein, IL 60060 USA847-281-8550 (phone)847-281-8558 (fax)www.rollomatic.ch
Rollomatic is a leading Swiss manufacturer of CNC grinding machines serving the medical, industrial and aerospace industries. Our GrindSmart series machines offer the tightest tolerances and highest accuracy for grinding all manner of cutting tools. We offer unique workholding applications and proven solutions for precise manufacturing of medical & dental drills, burs, taps, reamers, shavers, saw blades and other orthopedic cutting tools. With a full range of models to accommodate diameters from 0.05 mm – 31.75 mm, Rollomatic has your medical grinding solution.
406. Seabrook International, LLC15 Woodworkers WaySeabrook, NH 03874 USA603-474-1919 (phone)603-474-1833 (fax)www.seabrookinternational.com
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.
101-102. Rosler Metal Finishing1551 Denso RoadBattle Creek, MI 49037 USA269-441-3000 (phone)269-441-3001 (fax)www.rosler.us
Rosler Metal Finishing USA, LLC offers the widest range of surface finishing equipment in the industry, including mass finishing and shot blasting equipment, media, compounds and effluent treatment. We serve North American customers from our 300,000 sq. ft. manufacturing campus in Battle Creek and support global customers through our worldwide network. Our company slogan, “finding a better way,” is exactly what we do. After evaluating what the end result should be, our highly-trained employees choose from the most extensive product range in the industry to develop unbiased, cost-effective solutions. Send us your challenge.
721. Selenium Medical40 rue Chef de BaieZI Chef de Baie17000 La RochelleFrance33-5-46-44-40-82 (phone) 33-5-46-31-62-71 (fax)www.selenium-medical.com
Selenium Medical is a sub-contracting company, expert in medical device finishing and innovative packaging solutions development. Its main activities are innovative packaging material, chemical treatments, laser marking, cleaning, disinfection, clean room packaging and sterilization management. Selenium Medical is 100% dedicated to medical devices with 100% of its processes IQ/OQ/PQ/PPQ validated. Selenium Medical is looking for USA contract manufacturer partners and distributors.
824. Sheffield Precision Medical Ltd.Unit 1 - Wylcut HousePetre StreetSheffield, S4 8LUUnited Kingdom 11-42-431-011 (phone)11-42-447-912 (fax)www.sheffieldpm.co.uk
Sheffield Precision Medical is the UK’s leading independent instrument manufacturer, offering product in low to high volumes, and supplying a growing global client base. QA to 13485, with advanced MRP. Facilities include full finishing with laser welding, 4 axis laser marking. 5 axis CNC grinding for volume Rasps, Reamers & Drills... A highly motivated workforce is supported by a manufacturing team using the latest CAD & CAM (Solid Works & Unigraphics). Offering the finest quality & competitively priced product.
Shef f ield
Precision
Medical
733. Summit Manufacturing & Machining723 High RoadBremen, IN 46506USA574-546-4571 (phone)www.summitmmi.com
Summit Manufacturing & Machining, Inc. was established in 1993. The company became ISO 9001:2000 certified in September 2006. We currently specialize in prototypes and production work for the medical, heavy equipment, and transportation industries. We also do work for various manufacturers in northern Indiana and southern Michigan. 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.
213. Sonoscan, Inc.2149 East Pratt BoulevardElk Grove Village, IL 60007USA847-437-6400 (phone)847-437-1550 (fax)www.sonoscan.com
Sonoscan is a manufacturer of Acoustic Microscope Imaging (AMI) systems for laboratory and production needs, and provides contract analytical laboratory services. AMI is a nondestructive inspection technique that utilizes high-frequency ultrasound to image and detect a wide variety of material flaws, defects, and/or failures. The bond quality between materials, such as ceramics, plastics, metals, etc., is easily seen and quantifiable, too. AMI can also be used to characterize or screen a material prior to further processing.
414. Southeastern Technology905 Industrial DriveMurfreesboro, TN 37129 USA615-890-1700 (phone)877-789-2500 (toll free)615-890-2914 (fax)www.southeasterntech.com
Manufacturer of Orthopaedic Implants and Instruments. SET’s supply chain solutions are designed to reduce cost and enhance overall customer performance. Our sales engineers have the technical knowledge and skill required to be your project liaison from concept through completion. SET is your single source solution. ISO 13485:2003, ISO 9001:2000, compliant to CFR 21 Part 820.
Gold Sponsor
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218. Teleflex Medical OEM5307 95th Avenue Kenosha, WI 53144 USA 262-657-2800 (phone) 800-295-8505 (toll free)262-657-8505 (fax) www.teleflexmedicaloem.com
We transform ideas into market-ready products! As your product development and outsourcing partner, we can take your project through design, engineering, regulatory affairs, prototyping, manufacturing and assembly. Our exhibit showcases a new, high-performance rod cutter for cobalt chromium and titanium rods, Force Fiber® UHWMPE suture for orthopedic procedures, surgical instruments and micro-machined implants.
407. Tecomet115 Eames StreetWilmington, MA 01887 USA978-642-2400 (phone)978-658-4334 (fax)www.tecomet.com
Extreme Performance in Orthopedics™. Tecomet is an innovative manufacturing partner with the capacity and flexibility to perform under extreme conditions. We bend over backwards to provide engineered solutions, reduced time-to-market and contain costs. State of the art technologies, innovative, on-demand manufacturing and flexible management has made us a leader for more than 30 years. ISO 9001:2000, 13485:2003 Certified. Foreign Manufacturer Certified/Japan.
726. Syntec Scientific Corporation 2, Kung San Road Chuan Shing Industrial ZoneShen Kang, Chang Hua Hsien Taiwan02-2778-7396 (phone)02-2778-6079 (fax)www.syntec.com.tw
Syntec Scientific Corporation was found in 1995 by a group of doctors and engineers to develop and to manufacture surgical skeleton products. Syntec Scientific Corporation is now the leading company in Taiwan specialize in skeleton products and medical instruments in the Orthopedic Industry. Syntec Scientific Corporation will always achieve this position by professional pursuing excellence and by dedicating ourselves in improving the quality and serving all our customers. Our products of Osteosynthesis implants and instruments are not only qualified with the certification of FDA, CE, GMP regulations, but also compliant with ISO Quality Assurance Standards.
121. Tegra Medical9 Forge ParkFranklin, MA 02038USA508-541-4200 (phone)508-553-4100 (fax)www.tegramedical.com
Tegra Medical is a leading supplier of implants, reusable instruments and single use devices for orthopaedics. We offer Swiss-style turning, CNC milling/turning, EDM, wire/tube forming, stamping, centerless grinding, laser processing, electrochemical machining, needle pointing, gun drilling, finishing, insert molding and assembly. We are ISO 13485:2003 registered with 200,000 sq. ft. of modern manufacturing space in four sites, including Boston, Memphis and Costa Rica. Visit us online at www.tegramedical.com.
313. Surface Dynamics LLC231 Northland Boulevard Cincinnati, OH 45246 USA513-772-6635 (phone)513-772-0825 (fax) www.sdbiocoatings.com
Surface Dynamics is a medical device coating company with State-of-the-Art manufacturing facilities in Cincinnati and Memphis offering the following: CP- Titanium, TiGrowth-C & Hydroxyapatite (HA) Coating, Osprovit coatings can also be applied to PEEK (new breakthrough technology being reviewed by the FDA), metallurgical laboratories, as well as Additive Manufacturing. SD is ISO 9001 and ISO 13485 Approval/21 CFR 820 Compliant.
220. Titanium Industries18 Green Pond Road Rockaway, NJ 07866 USA 973-983-6229 (phone) 973-983-8015 (fax) www.titanium.com
Titanium Mill Products. We are the premier distributor of titanium mill products used for surgical implant applications. Throughout our global titanium service center network across the U.S., Canada, Europe and Asia, we stock the most extensive inventory of medical grade and approved melt source titanium bar, billet, plate, sheet and wire products. ISO 9001:2008 and AS9100 Rev-C registered.
315. TeroLab Surface SASZI Rue Jean Pierre Timbaud BP 3 Villeneuve le Roi, F-94290 France 33-1-49-61-3434 (Phone) 33-1-45-97-0784 (Fax) www.terolabsurface.com
TLS provides surface engineering, coating and repair solutions. By using modern management techniques and respecting human, environmental and life-friendly values, TLS is a successful, profitable and high quality international enterprise. TeroLab Surface SAS is a wholly-owned subsidiary of the Swiss Group TeroLab Surface. An innovator with long experience in coatings for Implantable Medical Devices, we are the partner of choice for the world’s best known manufacturers. With more than 1,000,000 orthopaedic implants coated in more than 20 years of excellence, TeroLab Surface SAS has contributed to the success story of the cementless prosthesis, now the leading implant on the world market.
826. Ticona Engineering Polymers8040 Dixie HighwayFlorence, KY 41042USA800-833-4882 (phone)859-372-3125 (fax)www.ticona.com/products/uhmw-pe
As the leader in UHMW-PE, and with almost 50 years’ of application experience, Ticona helps meet the needs of orthopedic surgeons with proven long-term material performance in joint replacements. GUR® UHMW-PE exhibits an outstanding property profile including low wear, excellent lubricity, biocompatibility, high energy absorption, exceptional impact strength and high purity with conformance to ASTM F648, ISO 5834-1. Vitamin E filled premium grades are available.
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530. Total Plastics, Inc – Life Sciences Division7508 Honeywell DriveFort Wayne, IN 46825-6271 USA260-489-3656 (phone)888-874-1771 (toll free) 260-489-9848 (fax)www.totalplastics.com
We partner with leading manufacturers, raw material suppliers and related industry resources to bring you the highest level of service and technical support. Specializing in thermoplastics such as acetal copolymer, Ultem, Radel R, UHMWPE (implantable grade), heat stabilized polypropylene, carbon-filled and unfilled grades of PEEK. Recent product offerings include PEEK for long term human implantation. We also offer a complete line of medical grade tubing and tape.
637. Trigon International Corp4000 Sussex AvenueAurora, IL 60504USA630-978-9990 (phone)630-378-9991 (fax)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.
312. Triangle116 Pleasant AvenueUpper Saddle River, NJ 07458 USA201-825-1212 (phone)201-825-0402 (fax)www.trianglemfg.com
For more than 55 years, Triangle has been a customer focused, value-added engineering and manufacturing partner to the medical device industry. From design, development, prototyping and pre-production to volume production, we help you get to market faster and more economically. With emphasis on innovative manufacturing solutions, Triangle achieves the highest quality standards. We excel at holding the tightest of tolerances, producing the toughest components and most complex assemblies with a special expertise in powered instrumentation. We attribute our success to an unrelenting commitment to innovation and quality. Registered ISO 13485:2003 and ISO 9001:2008.
715. True Tool Innovations381 NH Route 10 Croydon, NH 03773 USA603-863-1079 (phone)603-676-0474 (fax) www.truetoolinnovations.com
ISO 9001:2008 and ISO 13485:2003 Certified. We offer high precision outsource prep and grinding of cutting tools and components for surgical applications and manufacturing. Also featuring in-house precision machining, wire EDM, turning and centerless griding by AXARD. We offer product engineering which allows us to work with your individual needs from the aspect of design and application.
732. United Grinding510 Earl BoulevardMiamisburg, OH 45342USA937-859-1975 (phone)937-859-1115 (fax)www.grinding.com
World leader in grinding machine technology and support. We combine a proven, patented machine design, linear motors, superior coolant delivery and innovative new software to bring you NXis Ortho: shorter cycle times for lowest cost-per-part, whether implants or instruments; a better end-product that minimizes post-processing; versatility for a wide variety of components; fast programming and setup; superior support to maximize up-time and help you adapt to changing requirements.
633. Vorzeigen Medical5650 Industrial Avenue Connersville, IN 47331USA765-827-1500 (phone)765-827-1515 (fax)www.vorzeigen.com
Vorzeigen Medical, Inc. is a supplier of world class Sterilization cases, Surgical Instruments and Implantable components to orthopedic device manufacturers. We design, develop and produce products for all segments of the medical device market. Established in 2000, we are responsible for providing outstanding service from engineering to full production in the medical industry.
731. Universal Precision Instruments, Inc.1120 D.I. DriveElkhart, IN 46514USA574-264-3997 (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.
706. Vistek Medical153 Railroad AvenueIvyland, PA 18974USA215-357-6956 (phone)215-357-3675 (fax)www.vistekmfg.com
Vistek Medical is an ISO 13485 certified contract manufacturer focusing on partnerships serving the orthopedic and spine markets. Vistek has the machining capability and expertise to support your contract manufacturing needs across a variety of applications. Whether you need implants for spine, trauma, or extremity applications, Vistek provides the production expertise and the customer service to support your program from cradle to grave.
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337-436. VSMPO-AVISMA CORPORATION 401 Riverport Drive Leetsdale, PA 15056 USA 724 251-9400 (phone) 724 251-9401 (fax)www.vsmpo-tirus.com
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, the U.K. and China.
815. Mahr Federal, Inc. 1144 Eddy St.Providence, RI 02905USA401-784-3100 (phone)401-784-3246 (fax)www.mahr.com
Mahr Federal Inc., “The Application Specialist” and a member of the Mahr Group, has been providing dimensional measurement solutions to fit customer application needs for over 150 years. We offer calipers, micrometers, dial and digital indicators; mechanical, plug, air, and electronic gages; height gages and dimensional standards; calibration systems and lab gages; form, surface roughness and contour; gear and shaft measurement systems; custom design and build gages; gage repair, calibration, and field services.
333. Wilsey Tool Company, Inc. 140 Penn AM DriveQuakertown, PA 18951USA215-538-0800 (phone)215-538-0860 (fax) www.wilseytool.com
Wilsey Tool Company, Inc. is an ISO 13485:2003 certified, world-class contract manufacturer of orthopedic, spinal, cardiac and trauma medical implants & instrumentation. We consistently deliver quality, tight tolerance machined components and assemblies from concept through completion – prototype through production. Our reputation is built on 46 years of repeatability, dependability and unmatched quality. Wilsey Tool is the single-source solution of choice. Choose wisely.
412. Westlake Plastics490 West Lenni Rd.Lenni, PA 19052 USA610-459-1000 (phone)800-999-1700 (toll free)610-459-1084 (fax)www.westlakeplastics.com
Westlake Plastics Company is a world leader in extrusion and compression molding technologies of High Performance and Medical thermoplastics, including implant and instrument grades for surgical application. Our advanced technologies allow us to convert the full range of thermoplastic resins into stock shapes and film. The medical division of Westlake has assisted numerous device manufacturers in qualifying products for specific applications. Our experienced and highly trained medical team is available to help you choose from our extensive line up of products, which will meet the stringent requirements of the medical industry.
601. Zapp Medical Alloys GmbH475 International CircleSummerville, SC 29483USA843-851-0700 (phone)843-851-0010 (fax)www.zapp.com
Zapp Medical Alloys GmbH is a global supplier of semi-finished products for medical applications. We offer premium wires, bars, near-net shape profiles, precision strips, plates, blanks and tubes. Our product portfolio includes the following grades: stainless steel, pure titanium, titanium alloys, nickel- and cobalt-based alloys as well as other special grades for implants and medical instruments. Our products are manufactured to meet the highest quality demands and comply with all relevant international standards.
Special Thanks
A very special thank you to these industry exhibitors who have been with us from OMTEC 2005 to OMTEC 2012. Thank you for your support!
Acme Manufacturing
Britton Gallagher (formerly NewScience Insurance)
Ensinger
FMI Hansa Medical Products (formerly FMI Medical Instruments)
Ionbond-Medthin
Marox
Medin
Metal Craft
Onyx Medical
Orchid Orthopedic Solutions
PAK Manufacturing
Paragon Medical
Tecomet
Teleflex Medical OEM
Vistek Medical
Last Minute Exhibitor!
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Attendee Resources
Need help?Members of the ORTHOWORLD and OMTEC teams can be found at the Registration Area and the ORTHOWORLD Lounge, located at the corner of the Cafe. We’re the ones with green ribbons on our badges. How can we be of service to you?
Speaker PresentationsA number of OMTEC speakers have agreed to make their presentations available online at www.omtecexpo.com. Simply select the speaker of your choosing from the educational lineup and download the presentation from there.
MealsStay focused on the business at hand! Get a full, hot breakfast both mornings and a complete lunch on Wednesday afternoon. Enjoy catered snacks and beverages in between. Adult beverages and hors d’oeuvres will be served at the Welcome Cocktail Reception held on the Exhibit Floor Wednesday, from 4:30 pm to 6:00 pm.
Business CenterYou’ll find this next to the NEW Seminar Area on the Exhibit Floor. Most services are complimentary and a hostess is on hand to help.
Exhibit Floor HoursWednesday, June 13: 9:00 am to 6:00 pm (Welcome Cocktail Reception from 4:30 pm to 6:00 pm.)Thursday, June 14: 9:00 am to 12:00 pm
Opening Panel and KeynoteWednesday, June 13: 8:00 am to 8:45 am Opening Panel in Banquet Hall. All welcome. Breakfast served at 7:30 am.Thursday, June 14: 8:00 am to 8:45 am Keynote in Banquet Hall. All welcome. Breakfast served at 7:30 am.
SessionsWednesday, June 13: 10:00 am to 4:15 pm. All welcome. Break for catered Networking Lunch in Exhibit Hall from 12:00 pm to 1:30 pm.Thursday, June 14: 10:00 am to 11:45 am.
NEW Exhibit Floor ActivitiesWednesday, June 13: 9:30 am to 12:00 pm in new Seminar Area. Technical/Rapid-fire Technical Presentations and Power Networking sessions.Thursday, June 14: 9:15 am to 10:30 am in new Seminar Area. Technical Presentations. Both days: Technical posters on display in Poster Areas on the exhibit floor.
A world-class panel of industry advisors steers BONEZONE toward relevant and timely educational content that is consistent with the needs of device companies. This panel also guides OMTEC’s educational curriculum. We’re grateful for their service.
Acumed LLC Robert Johnson Vice President of Operations & Engineering
Alphatec Spine, Inc.Thomas SolowczukDirector, Global Sourcing
Arthrex, Inc.Lance ProvanceSupply Chain Manager
Biomet, Inc. Howard LevyChief Procurement Officer
DePuy Orthopaedics, Inc.Brandon HipsherManager, Regulatory Affairs
Exactech, Inc.Ronald Green Director, Manufacturing Engineering
Globus Medical, Inc.David Davidar Vice President, Operations
Integra LifeSciences Corp. Dale DavisonVice President Engineering, Spine
K2M, Inc. Rich WoodsSenior Vice President, Engineering
Ortho Development CorporationBob WestonDirector of Strategic Business Planning
Smith & Nephew Orthopaedics, Inc. Mark HallGlobal Strategic Sourcing Manager
Smith & Nephew Orthopaedics, Inc. David D. KelmanVice President, Hip Product Development|Advanced Surgical Devices
Stryker Orthopaedics, Inc. Matthew Poggie Senior Director, Applied Technology
Stryker Orthopaedics, Inc. Kenneth Trimmer Senior Director, Knee Implant Product Development
Tornier, Inc.Thierry Manceau Vice President Global Manufacturing
Wright Medical Technology, Inc. Skip FlanneryVice President, Logistics & Materials
Zimmer, Inc. Erin JohnsonVice President, Trauma Research & Development
Advisory Panel
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a Cleveland Clinic Innovations company
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When it comes to your inventory levels, less is definitely more with Orchid lean — more cash from lower carrying costs, more space from fewer products being stored. And most importantly, more quality. By using the lean principles of single-piece flow, waste minimization and process simplification in our
operations, we can expose and resolve quality issues sooner which will speed delivery, save time and lower your manufacturing costs significantly.
Find out how Orchid lean can lessen your inventory burden. Contact: [email protected].
©2011 Orchid Orthopedic Solutions LLC FOR-1-2
ORCHID ORTHOPEDIC SOLUTIONS (517) 694-2300 www.orchid-orthopedics.com
Shrink inventory with Orchid lean.
Visit O
rchid
at O
MTEC
Booth #
131
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