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					the Players

 Metal Craft Machine &            Medical Instrument Manufacturing from Start to Finish. State of
 Engineering, Inc.                the art contract manufacturer utilizing advanced CNC machine
 12797 Meadowvale Road            technology serving the Medical Device Industry in both instru-
 Elk River, MN 55330 USA          ments & implants; specializing in close tolerance precision man-
 763-441-1855 (phone)             ufacturing including Design, Prototype, Short and Long Run
 800-964-1395 (toll free)         Production, Laser Etch, Passivation and Value Added Assembly.
 763-441-0798 (fax)               ISO 13485 & 9001 registered.
 tmowry@metal-craft.com
 www.metal-craft.com



 Microcision LLC                  Precision Miniature Components & Assemblies.
 5805 Keystone Street             Consistent, Accurate, On Time, On Budget. Microcision is
 Philadelphia, PA 19135           a custom manufacturer of precision machined miniature
 USA                              components and assemblies with tolerances as tight as
 215-744-0770 (phone)             .0001". From prototypes to production, Microcision's
 215-744-3787 (fax)               capabilities include complex drilling, cross-drilling,
 microcision@microcision.com      threading and milling of small parts made of exotic, pre-
 www.microcision.com              cious and base metals as well as machinable plastics.




 Microfinish                      Medical Implant and Instrument Finishing. Microfinish is one of
 865 Scholz Drive                 the nation's largest component finishing companies. We have a
 Vandalia, OH 45377               state of the art 32,000 sq. ft. metal finishing facility that pro-
 USA                              vides polishing, ultrasonic cleaning, electro-polishing, abrasive
 937-836-6622 (phone)             blasting, laser marking, deburring and vibratory deburring, pas-
 937-836-2359 (fax)               sivation and inspection. We are ISO 9001:2000 and AS9100-
 microfinish@microfinishusa.com   2004 certified.
 www.microfinishusa.com




 MicroGroup, Inc.                 Precision Manufacturing Services: Components to Assemblies.
 7 Industrial Park Road           Stocking over 7,000,000 feet of stainless steel, nickel alloy and
 Medway, MA 02053                 titanium tubing under 1" in diameter, combined with in house
 USA                              redraw to size and shape means short lead times. Tube forming,
 508-533-4925 (phone)             bending, CNC bending, swiss type multi-axis machining, wire
 800-255-8823 (toll free)         and ram edm, laser welding and cutting, passivation and elec-
 508-533-9881 (fax)               tropolishing under one roof. Send your prints/requirements for
 dohmann@microgroup.com           an estimate. FDA-registered, ISO 9001:2000 certified.
 www.microgroup.com




 Miraclean Ultrasonics            Advanced Medical Cleaning Equipment and Chemistries.
 4743 Cramer Drive                Miraclean® supplies high performance ultrasonic cleaners, ultra-
 Ashville, NY 14710               sonic cleaning tanks and lines for parts cleaning and mold
 USA                              cleaning, parts washers with agitation and ultrasonics, automat-
 716-763-4343 (phone)             ed passivation and penetrant inspection lines, corrosion
 716-763-3555 (fax)               inhibitors, and pretreatment chemistries. Miraclean’s heavy-duty
 soundwaves@miraclean.com         programmable hoists may be retrofitted over existing process
 www.miraclean.com                lines.




48     BONEZONE • Spring 2009
the Players

Modern Plastics, Inc.          Medical Grade Plastic Products. ISO 9001:2000 Certified ·
678 Howard Avenue              Unparalleled Quality Standards · Bar Coding of all Plastic
Bridgeport, CT 06605           Products · Complete Certifications on All Shipments Complete
USA                            Material Traceability/Lot & Batch · Materials Certified to USP
203-333-3128 (phone)           Class VI and ISO 10993 · Major Medical Industry Customers and
800-243-9696 (toll free)       Approved Supplier Status · Test Reports / Material Inspection
203-333-4625 (fax)             Sampling Reporting · Now offering Medical Grade Implantable
bcarbone@modernplastics.com    UHME PE
www.modernplastics.com




Mound Laser & Photonics        Innovative Solutions for Materials Processing. ISO 9001:2000
Center Inc.                    certified. Expertise in laser-material interactions. Contract manu-
965 Capstone Dr.               facturing/R&D services microfabrication: laser welding, laser
Suite 308                      micromachining, laser marking. Pioneer in laser-processing
Miamisburg, OH 45343           applications from surface modification to micromachining.
USA                            Synergistic combinations of technologies offer innovative
937-865-4070 (phone)           approaches to medical device fabrication.
937-865-3680 (fax)
sales@mlpc.com
www.mlpc.com



NeedleTech Products, Inc.      Excellence in Everything We Do. A full service, ISO 9001:2000
81 West Street                 certified manufacturer of specialty needles and related medical
Attleboro, MA 02703            devices. Supplying the orthopaedic market with K-Wire,
USA                            Steinmann Pins, Trocars and Guide Wires. Servicing the
508-431-4000 (phone)           Vertebroplasty markets with Access Needles, Biopsy Devices
508-431-2156 (fax)             and Cement Delivery Needles. Double digit growth every year
sales@NeedleTech.com           since 1988 means we satisfy our customers every day.
www.needletech.com




Norman Noble, Inc.             Microprecision Medtech Manufacturing. Norman Noble manu-
5507 Avion Park Drive          factures medical devices and implants to customer specifica-
Highland Heights, OH 44143     tions in compliance with FDA regulations & ISO 13485:2003.
USA                            State of the art processes include laser machining & welding,
216-761-5387 (phone)           swiss turning & milling, conventional and wire EDM, 78-axis con-
216-761-0455 (fax)             tour milling, and nitinol shape setting. Prototype services are
sales@normannoble.net          available in separate and fully dedicated departments.
www.nnoble.com



                               CNC Machining, Metal Stamping, Assembly and Nitinol
NORWOOD Medical
                               Processing for the Medical Community. Three state of the art
2122 Winners Circle
                               facilities with over 180,000 sq. ft. and the latest technology
Dayton, OH 45404
                               allow us to take products from concept/prototype through pro-
USA
                               duction. Producing instruments and implants for over 25 years
937-228-4101 (phone)
                               utilizing a wide variety of materials such as Stainless, Titanium,
937-228-1608 (fax)
                               Cobalt chrome, Nitinol and plastics. FDA registered/ISO
marketing@norwoodmedical.com
                               9001:2000 certified, ISO 13485:2003.
www.norwoodmedical.com




50      BONEZONE • Spring 2009
the Players
Oberg Medical                  Provide Technology and Manufacturing Solutions... to support
2301 Silverville Road          OEMs focused on Orthopaedic, Spinal and Trauma Markets.
Freeport, PA 16229-0315        Specialize in precision grinding, multi-axis machining, wire and
USA                            plunge EDM, near-net stamping, surface finish development and
724-294-1277 (phone)           automated manufacturing and assembly systems. A $125 million
724-295-0395 (fax)             company, employing over 700 craftsmen. We support volume
inquire@oberg.com              product launches, prototype and first article development.
www.oberg.com


Onyx Medical Corporation       Strategic Manufacturing Support for the Orthopaedic Industry.
152 Collins Street             A trusted manufacturing partner to leading orthopaedic compa-
Memphis, TN 38112              nies worldwide for wires, guide pins, half pins, drills and screws
USA                            manufactured from stainless steel, titanium, cobalt chrome and
901-323-6699 (phone)           Nitinol. Strict adherence to FDA cGMP with an ISO 13485:2003
901-454-0295 (fax)             certified Quality System. Complete finishing, etching, packaging
jodieg@onyxmedical.net         and inventory management services offered.
www.onyxmedical.net


Orchid Orthopedic              Orchid Orthopedic Solutions is made up of six successful con -
Solutions, LLC                 tract manufacturers that, in combination, have been serving the
1489 Cedar Street              orthopedic community for more than 75 years. Together, we
Holt, MI 48842                 provide a full range of the capabilities needed to produce quali-
USA                            ty implants and instruments; individually, we will continue to
517-694-2300 (phone)           provide the high level of service our customers have come to
517-694-2340 (fax)             expect. ISO 13485:2003 Certified.
sales@orchid-orthopedics.com
www.orchid-orthopedics.com

PAK Manufacturing, Inc.        Custom & Specialty Handheld Surgical Instruments. Hand-fin-
704 South 21st Street          ished, forged surgical instruments made in the USA! We special-
Irvington, NJ 07111            ize in custom configurations, built from raw forgings (not other
USA                            instruments). Prototypes often shipped within ten days for your
973-372-1090 (phone)           approval; production quantities typically shipped within eight
973-372-1091 (fax)             weeks. In-house manufacturing capabilities include milling,
info@pakmanufacturing.com      grinding, heat treating, passivation, polishing. FDA-registered.
www.pakmanufacturing.com


Paragon Medical, Inc.          Instrumental in Your Success. Paragon Medical is a single source
8 Matchett Industrial Park     turnkey supplier of custom and standard surgical instrumenta-
Drive                          tion, implantable components and cases & trays to the world-
Pierceton, IN 46562            wide medical device marketplace, with a concentration in the
USA                            hip, knee, spine, trauma, and sports medicine disciplines. Office
574-594-2140 (phone)           and production facilities are located throughout the United
800-225-6975 (toll free)       States and in Europe.
574-594-2154 (fax)
info@paragonmedical.com
www.paragonmedical.com



Precimed, a subsidiary of      Design, Development & Manufacture of Precision Surgical
Greatbatch, Inc.               Products. Founded in 1988, Precimed is focused on the manu-
4532 Park 30 Drive             facture of implants and instruments for orthopaedic and trauma
Columbia City, IN 46725        surgery. Reamers, drill and taps, broaches, handles, screw-
USA                            drivers, screws, trauma sets. U.S. FDA-registered facilities
260.244.6300 (phone)           opened in 1998. Worldwide sales and support including Europe,
260.244.6345 (fax)             North & South America, Africa, Asia & India. ISO 9001:2000
www.precimed.com


52      BONEZONE • Spring 2009
the Players
Precision Edge Surgical        Manufacturer of Surgical Cutters, Instruments & Implants.
Products Company LLC           Small and large bone cutting tools including blades, burs, drills,
415 West 12th Avenue           reamers, trocars, taps, screws, etc. Custom products including
Sault Ste Marie, MI 49783      instruments & implants for joints and spine. CNC machining
USA                            and grinding, laser cutting, welding and marking, Swiss turn-
906-632-4800 (phone)           ing, milling, stamping, EDM, gundrilling, electropolish, passivat-
906-632-5619 (fax)             ing, FPI, coatings. ISO 13485:2003 registered.
contact.us@precisionedge.com
www.precisionedge.com


Precision Metal Products,      Orthopaedic Implant Forgings in Titanium, Cobalt-Chrome-
Inc.                           Molybdenum, Stainless Steel and Customer Specific Alloys.
850 West Bradley Avenue        We are ISO 9001:2000 certified, and our in-house capabilities
El Cajon, CA 92020             include heat treating, lab testing, 4-axis and 5-axis CNC
USA                            machining, chemical milling, secondary finishing operations
619-448-2711 (phone)           and complete tool design and fabrication.
619-448-2005 (fax)
sales@pmp-elcajon.com
www.pmp-elcajon.com


Precision Technology, Inc.     Innovation in Plastics Machining. Orthopaedic Implants, Trial
50 Maple Street                Components and Surgical Support Instrumentation. Our plastics
Norwood, NJ 07648              machining processes provide exceptional quality, timely delivery
USA                            and better ROI from your overall manufacturing expenditure.
201-767-1600 (phone)           PTI Fabrication Mediums: Celcon®, Delrin®, LEXAN®, PEEK™,
201-767-6739 (fax)             polypropylene, Radel®, Teflon® PTFE, UHMWPE and cross-linked
lwhitney@ptiplastics.com       UHMWPE, Ultem®. Our plant operates 24/7. FDA-registered.
www.ptiplastics.com

Preferred Tool & Die,          A Premiere Stamping and Precision CNC Machined Part
Inc./Preferred Precision       Manufacturer. Complex precision machined & stamped compo-
30 Forest Parkway              nents for the medical device industry for over 20 years. CNC
Shelton, CT 06484              multi- axis machined surgical implants. Titanium, Nitronic60,
USA                            Ultem, Cobalt Chromium. Orthopaedic implants: screws, plates,
203-925-8525 (phone)           couplers, rods, surgical instrument components. Complex turn-
800-297-8665 (toll free)       ing/milling utilizing the latest advanced Swiss type machining
203-925-8535 (fax)             centers.
info@preferredtool.com
www.preferredtool.com

President Titanium             Established in 1973, President Titanium provides the largest
Company, Inc.                  inventory of domestic 6AL/4V, 6AL/4V ELI, and Grade 4 titani-
243 Franklin Street            um bar, sheet and plate in the country. Whether serving a small
Hanson, MA 02341               mill shop or delivering to a large government agency, President
USA                            Titanium is committed to building lasting relationships by offer-
781-294-0000 (phone)           ing the highest quality product at the most competitive price.
781-293-3753 (fax)
smacleod@president
titanium.com
www.presidenttitanium.com

Sandvik                        A leading supplier of cast, forged and finished orthopedic
13963 Fir Street               implants and instruments, serving medical markets worldwide.
PO Box 1990                    By combining this offering with a broad materials portfolio and
Oregon City, OR 97045-         research capabilities, Sandvik offers medical device manufactur-
0043                           ers a powerful strategic supplier relationship.
USA
503-656-9653 (phone)
medicalsolutions@sandvik.com
www.smt.sandvik.com/medical



54      BONEZONE • Spring 2009
the Players
Seabrook International, LLC     We Are Dedicated To Our Customers' Success! Seabrook
15 Woodworker's Way             International is a leading contract manufacturer of highly engi-
Seabrook, NH 03874              neered precision instruments, implants and other devices for the
USA                             Orthopedics industry. Seabrook has become an integral supplier
603-474-1919 (phone)            to many of the world's largest orthopedic device manufacturers
603-474-1833 (fax)              through its differentiated approach toward customer service,
pab@seabrookinternational.com   medical device quality systems and dedication to true partner-
www.seabrookinternational.com   ships.


Siora Surgicals Pvt.Ltd.        We offer a comprehensive range of products in variety of mate-
1649, 2nd Floor, Main Bazar     rial options like SS 316 L, SS 316 LVM, Titanium etc. With a
Paharganj, New Delhi 110 055,   trained pool of more than 125 dedicated workers and techni-
India                           cians, combined with a modern manufacturing unit, we are able
91-11-23583853 (phone)          to offer Bone Screws – Self Tapping, Cannulated etc.; Plates –
91-11-23584947 (fax)            DCP, LC-DCP, RE-CON, DHS, DCS plates; Hip Prosthesis; Locking
siora@siaora.net                Plates; Tubular External Fixators & Ring Fixators; Titanium
www.siora.net                   Elastic Nails; Carbon Fiber Products; Interlocking nailing for
                                Tibia, Femur, Humerus etc.; Instruments & Sterilization
                                Containers for Orthopaedic Surgery.



Southeastern Technology         Manufacturer of Orthopaedic Implants and Instruments. SET's
905 Industrial Drive            supply chain solutions are designed to reduce cost and enhance
Murfreesboro, TN 37129          overall customer performance. Our sales engineers have the
USA                             technical knowledge and skill required to be your project liaison
615-890-1700 (phone)            from concept through completion. SET is your single source
877-789-2500 (toll free)        solution. ISO 13485:2003, ISO 9001:2000, compliant to CFR 21
615-890-2914 (fax)              Part 820.
lbutner@southeasterntech.com
www.southeasterntech.com


Structure Medical Inc.          Orthopaedic Implant Manufacturer. By investing in the very best
2975 South Horseshoe Drive      multi-axis machinery and coupling it with over 100 years of
Namples, FL 34104               management experience in creating high tolerance parts, we
USA                             have developed a medical manufacturing business that delivers
239-262-5551 (phone)            exceptional manufacturing quality at costs comparable to off-
888-446-6862 (toll free)        shore manufacturers. Ultra-modern manufacturing with multipe
239-643-6530 (fax)              5-axis milling and swiss-type machines. ISO 13485 certified.
lzaiser@structuremedical.com
www.structuremedical.com


Supra Alloys, Inc.              Titanium for Medical Devices. Plate, sheet, strip, foil, billet, bar
351 Cortez Circle               and wire. Bar inventory is centerless ground to +/-.0005"" and
Camarillo, CA 93012             to precision tolerances of +/-.00025"" or better. In-house saw-
USA                             ing, shearing and waterjet capabilities. Ti 6AL4VELI in various
805-388-2138 (phone)            rectangular bar sizes. Inventory certifiable to ASTM F136, F67,
800-647-8772 (toll free)        F1472 specifications. Testing and certification can be provided
805-987-6492 (fax)              for other OEM specifications.
craig@supraalloys.com
www.supraalloys.com

Symmetry Medical Inc.           Specializing in product development, high precision technology,
3724 North State Road 15        professional services, project management, manufacturing, and
Warsaw, IN 46580                prototyping, Symmetry Medical makes it easier to get your
USA                             products to market faster. With Total Solutions, every detail of
574-268-2252 (phone)            product development, from idea generation through quality
574-267-4551 (fax)              assurance, is handled by Symmetry Medical saving you time and
parker@symmetrymedical.com      money. With 200 + years experience in design and manufacture
www.symmetrymedical.com         of implants, instruments, and cases, our team will ensure quality
                                customer service and design.


56      BONEZONE • Spring 2009
the Players
T & L Sharpening, Inc.             Manufacturer of Orthopedic Cutting Tools. We specialize in all
2663 South Freeman Road            types of cutting tools for the Orthopedic Industry. We have
PO Box 338                         been the industry leader of hand ground bone rasp for over 25
Monticello, IN 47960               years. Now we also have the capability of machine ground rasp.
USA                                From design assistance to prototyping to production we pro-
574-583-3868 (phone)               vide only the highest quality products. Available services
574-583-9250 (fax)                 include but are not limited to Reamers, Twist Drills, Taps, Calcar
tools@ffni.com                     Cutters and Bone Rasps. All instruments are manufactured and
www.cutting-tools.com              tailored to exacting customer requirements and done so under
                                   ISO conditions.

Tecomet                            Extreme Performance in Orthopedics™. Tecomet is an innovative
Wilmington Facility                manufacturing partner with the capacity and flexibility to per-
115 Eames Street                   form under extreme conditions. We bend over backwards to
Wilmington, MA 01887-3379          provide engineered solutions, reduced time-to-market and con-
USA                                tain costs. State of the art technologies, innovative, on-demand
978-642-2486 (phone)               manufacturing and flexible management has made Tecomet a
978-658-4334 (fax)                 leader for more than 30 years. FDA registered - ISO 9001:2000,
sales@tecomet.com                  13485:2003 Certified. Foreign Manufacturer Certified/Japan.
www.tecomet.com

Teleflex Medical OEM-        SMD is a market leader in precision-machined medical implants,
Specialized Medical Devices  components and devices used in arthroscopic, cardiac,
300 Running Pump Road        catheterization, dental, endoscopic, spinal, neurological and
Lancaster, PA 17603          orthopedic procedures, and in other vital areas of healthcare.
USA                          The SMD team provides a full range of prototyping, engineering
717-392-8570 (phone)         and testing services, along with full-scale production machining,
717-392-8578 (fax)           assembly and contract packaging. SMD’s capabilities include
JackF@specializedmedical.com CNC 5-axis vertical milling and CNC 10-axis screw machining of
www.specializedmedical.com complete implant systems as well as complementary disposable
www.teleflexmedicaloem.com   and reusable instruments.

Thorn Industries                   Implants, Instruments, Assemblies, Product Development,
732 Cottage St.                    micro-machining. Thorn Industries, a Contract Manufacturer of
Springfield, MA. 01104             Medical Implants including; Spinal Reconstruction and Joint
USA                                Replacement as well as related Surgical Instruments. Thorn pro-
413-737-2464 (phone)               vides its customers with competitive pricing and quality prod-
413-737-4205 (fax)                 ucts that are on-time. Thorn is a lean manufacturer who utilizes
sales@thornind.com                 the latest technology in both Manufacturing and Quality to
www.thornind.com                   meet your requirements. Thorn’s Manufacturing Technology
                                   capabilities includes; 7-axis screw machining, 5-axis milling, 5-
                                   axis Wire EDM, CNC Turning, 4-axis laser marking/engraving,
                                   Welding, Passivation, Polishing & Assembly. Thorn’s QMS is cer-
                                   tified to ISO-13485 and ISO-9001.

Tornos Technologies                Solutions Provider for the Medical Industry. Tornos builds
840 Parkview Blvd                  "Swiss" type turning machines, used in the manufacture of vari-
Lombard, IL 60148                  ous components from many medical fields. Components include
USA                                but are not limited to bone screws, spinal and dental implants,
630-812-2040 (phone)               arthroscopic devices and instruments. Let Tornos review your
630-812-2039 (fax)                 requirements and work with you to find a solution.
info-us@tornos.com
www.tornos.us
Triangle Manufacturing Co., Inc.   Manufacturing & Engineering Solutions for Industry. For more
116 Pleasant Avenue                than 50 years Triangle Manufacturing has been a customer
Upper Saddle River, NJ             focused, value-added engineering and manufacturing partner
07458                              to some of the most advanced medical device companies in the
USA                                world. With emphasis on innovative manufacturing solutions,
201-825-1212 (phone)               Triangle achieves the highest quality standards including on
201-236-9814 (fax)                 time delivery. We provide lean manufacturing solutions to the
dstrohmeyer@trianglemfg.com        medical industry. ISO 13485:2003, ISO 9001:2000 and 21 CFR
www.trianglemfg.com                Part 820 certified.



58       BONEZONE • Spring 2009
the Players
Trigon International              State of the art manufacturing facilities are only the beginning.
999-C Remington Boulevard         Every person at Trigon International takes tremendous pride in
Bolingbrook, Illinois 60440       the quality of our products and the quality of service we pro-
USA                               vide to our customers. We are a manufacturer of precision
630-378-9990 (phone)              machined components and assemblies, short runs through high
866-TRIGON3 (toll free)           production. Our focus is to be the most highly regarded manu-
630-378-9991 (fax)                facturing resource to our customers.
sales@etrigon.com
www.etrigon.com

Vaupell, Inc.                     Injection Molding and Prototyping for the Medical Device
485 Florence Ave.                 Industry. Focusing on implants and instruments, using PEEK
Constantine, MI 49042             OPTIMA and other engineering plastics as well as resorbable
USA                               materials. Multiple plants with ISO 13485 certification, clean
269-435-8414 (phone)              rooms and full inhouse toolbuilding.
206-784-9708 (fax)
Medical.sales@vaupell.com
www.vaupell.com

Veridiam Medical                  Veridiam Medical (www.veridiammedical.com) is a leading
PO Box 609036                     custom metal fabrication specialist to the medical device,
San Diego, CA 92160               orthopedic and dental industry with over 50 years of expe -
USA                               rience. Veridiam manufactures assemblies, sub-assemblies,
619-596-4340 (phone)              machined components, precision metal tubing and tubular
619-562-5776 (fax)                components under a quality system that is ISO 9001:2000
sales@veridiam.com                and 13485 compliant. We stock cannulated bar in 17-4 & 455
www.veridiam.com                  materials.


Vistek Precision Machine          Vistek Precison Machine Company: Contract Manufacturer of
Company                           Orthopaedic Devices specializes in multi-axis Swiss turning, 3-D
153 Railroad Drive                and 5-Axis milling in titanium, stainless steel and PEEK to pro-
Ivyland, PA 18974                 duce precision implants such as bone screws, fixation plates,
USA                               cages, connectors, and hooks; other dental, spine, neck, hip and
215-357-6956 (phone)              knee implants are also produced. Vistek Precision Machine
215-357-3675 (fax)                Company provides EDM, bead blasting, laser marking and
vvisco@vistekmfg.com              assembly services as required. Certified vendors also provide
www.vistekmfg.com                 anodize, passivation, electro-polishing, heat treating, and coat-
                                  ings and to meet your specifications. From prototype to pro-
                                  duction to assembly, there’s no need to turn anywhere else.

Vulcanium Metals Incorporated     The Best in Titanium. Vulcanium Metals Incorporated carries a
3045 Commercial Avenue            full range of medical titanium 6AL-4V ELI, 6AL-4V and
Northbrook, IL 60062-1912         Commercially Pure grades of bar, sheet and plate. FirstCut+
USA                               Services include Water Jet; Cut-to-Length; Laser; Precision
847-498-3111 (phone)              Shearing; Sawing; Chamfering; Facing; First Stage Machining;
888-326-7556 (toll free outside   Deburring; Finishing; Inventory Management - JIT, Kanban;
IL)                               Consignment Programs. ISO 9001:2000 and AS9100 Certified.
847-498-2810 (fax)
titanium@vulcanium.com
www.vulcanium.com/vmi

West Penn Testing Group           To Be The Standard By Which All Other Testing Laboratories
1010 Industrial Boulevard         Are Measured. We are a full-service, independent testing labora-
New Kensington, PA 15068          tory with diverse inspection and testing capabilities since 1952.
USA                               With emphasis in specialty metals and ceramics, West Penn
800-367-9785 (phone)              Testing provides an extensive array of non-destructive, chemical,
724-334-9785 (fax)                metallographic, failure analysis and mechanical evaluation serv-
jcdechellis@westpenntest-         ices. Three locations in New Kensington, Pennsylvania and
ing.com                           Richburg, South Carolina, performs testing nationally and inter-
www.westpenntesting.com           nationally.


                                         Visit www.orthosupplier.com/players/ to connect
60      BONEZONE • Spring 2009                to all of the Players listed in this index.
       THE BIG PICTURE




                                          Shirley A. Engelhardt
                                          Knowledge Ventures, LLC




Orthopaedics – An Industry for
All of Time
When I began my “career” in orthopaedics in the late 1980s, glob-       time, with only four of the ten largest companies having reported
al sales of hip and knee replacement products had just reached $1       2008 numbers, we see that growth for the past year could very
billion. (They topped $11 billion last year.) Back then, spinal prod-   well come in at under ten percent, a first since the early 1990s.
ucts generated barely $100 million. (Last year they brought in          That may be slower than last year but it represents more than $3
more than $6 billion.) We didn’t pay much attention to the nascent      billion in incremental revenues!
markets for arthroscopy, biologics and fracture repair – we had
enough business on the joint replacement side, with the market          While few of us can predict the degree to which the economic tur-
enjoying growth in excess of 20 percent per year. The industry          moil will affect our industry, we can say with some certainty that
was ripe for exceptional performance and that’s what it experi-         we’ll be less dramatically impacted than other businesses. I, for
enced for more than 20 years. By 2007, the global orthopaedic           one, remain bullish on orthopaedics even amid all the looming
market was valued at more than $32 billion.                             economic uncertainty. Here’s why:

Exhibit 1 illustrates the rise of the orthopaedic market since 1993,      1) We’re getting older.
the first year ORTHOWORLD fully tracked the market.                       2) We’re becoming more demanding, both mentally and
Now, all has not been rosy since the 1990s. We’ve faced down-                physically.
turns in overall orthopaedic market growth here and there, for a          3) We’re not taking such good care of our bodies, even at a
variety of reasons – price pressure and use of less expensive tech-          young age.
nologies like DRG stems (early 1990s), contracts and severe dis-          4) We’re continuing to believe, at 40 or 50, that we’re still 25.
counting (late 1990s) and mix shift hitting a wall (2003). By all         5) We’re prone to falls, accidents and other foibles of daily
accounts, we appear to be on track for another slowing in growth,            living (and always will be).
our first as a result of overall global economic challenges. At press



                                                     EXHIBIT 1
                                   THE GLOBAL ORTHOPAEDIC MARKET ($BB): 1992 TO 2007




 62        BONEZONE • Spring 2009
                                                                                                    THE BIG PICTURE




As we humans age, our joints undergo natural wear and tear,              drinks represent the primary source of phosphorus in the
eventually leading to osteoarthritis (OA). OA is the underlying          American diet, and excess phosphorus has been linked to the
diagnosis for more than 92 percent of the three million or so hip        development of OA. (Fun facts to know and tell: Americans con-
and knee replacement procedures performed worldwide in 2007.             sume 216 liters of soft drinks per person per year vs. 120 liters in
More than half of these joint replacement patients were over the         Norway, 84 in New Zealand and 22 in Japan.)
age of 65, a group growing four times faster than the population
overall.                                                                 So, we as a people will age, eat and drink our ways to orthopaedic
                                                                         treatment. So too will we run, jump and play to our hearts’ con-
Furthermore, 39 percent of primary total hip and knee replace-           tent and the detriment of our bones and joints and soft tissues.
ment procedures in 2006 were performed on those between the
ages of 45 and 64. This same group comprised just 26 percent of          Some 200 million people worldwide play soccer. Another 100 mil-
joint replacement patients in 1997. We expect this trend of joint        lion or so ski, with 280 million playing basketball. Golf consumes
replacement in younger patients to continue as Baby Boomers              the weekends of an estimated ten to 12 percent of the world’s
flex their attitudes within the healthcare system.                       population and runners contend for first place in more than 800
                                                                         marathons each year. Nearly one-third of all childhood injuries
I am one of more than 450 million Baby Boomers worldwide. We             are sports related and each of these sports brings with it attendant
are not our parents’ generation. We do not stand back and stoical-       injuries, many of which will require orthopaedic treatment.
ly accept pain as part and parcel of our existence. Quite the con-
trary. We are a generation that demands action and we will seek          Injuries to the anterior cruciate ligament (ACL) typically befall
relief early in the disease continuum before the pain affects our        skiers and basketball and soccer players. Golfers incur elbow and
quality of life. For us, if joint replacement can relieve our pain, it   shoulder injuries and back problems, with the latter also affecting
is anything but elective surgery. In our minds it is mandatory to        curlers. Some physicians are seeing four times as many overuse
ensuring a quick return to our active lives.                             injuries in youth sports than they did five years ago and more
                                                                         kids are having surgery for chronic sports injuries.
While the elderly and their entitled Baby Boomer children com-
bine to create a robust future for joint replacement, so too do the      Worldwide in any given year, we cause more than 600,000 injuries
demographics of obese and overweight people worldwide, as                to our ACLs, most as a result of sporting activities. Procedures to
obesity has been linked to OA.                                           repair knee soft tissue injuries number more than three million
                                                                         worldwide, with shoulder repair procedures exceeding 1.2 mil-
According to one study, for every five kilograms of weight gain,         lion, many as a result of our propensity to play and play hard.
the risk of knee OA increased by 35 percent. Other researchers           Every age group falls victim to sprains, dislocations and soft tis-
found that every 11 pounds gained over a ten-year period result-         sue disorders. Those between 25 and 44 incur most knee sprains,
ed in a 50 percent increase in the risk of developing OA. By their       while the elderly present with most rotator cuff problems diag-
40s and 50s, today’s overweight people are expected to have the          nosed in physicians’ offices. People under the age of 25 suffer
joints of a typical senior citizen.                                      about one-third of all fractures, dislocations and sprains.
Obese individuals are five to six times more likely to have plantar
fasciitis than other people and three times more likely to sustain       And then there’s back pain, which afflicts 80 percent of us at some
meniscal tears. Obesity has also been linked to back pain. Today,        point in our lives and 90 percent of people over 30. It is the most
approximately two billion people worldwide are overweight or             frequent cause of activity limitation in people younger than 45,
obese and, within six years, their numbers could rise to three bil-      the second most common reason for visits to doctors’ offices (after
lion. This increase in girth should lead to a concomitant increase       upper-respiratory infections) and the most prevalent medical dis-
in the need for orthopaedic interventions to treat OA, back prob-        order in industrialized societies. In fact, the lifetime prevalence of
lems and soft tissue damage.                                             back pain exceeds 70 percent in many industrialized countries.
                                                                         According to the North American Spine Society, “some consider
Our largesse extends to our younger generations, as well.                the symptom of low back pain to be a part of the human experi-
Estimates indicate that as many as one out of three children 19          ence.”
and younger is either overweight or obese. We can expect to see
joint problems manifest themselves in this group at younger ages.        While not all back problems will lead to orthopaedic intervention,
Further damage to our musculoskeletal integrity may also come            for more than three million people worldwide, some sort of
from our drinking habits. That is, adolescents who consume soft          implant or instrument will be used in the treatment of a painful
drinks display a risk of bone fractures three to four-fold higher        or debilitating spinal condition from scoliosis to vertebral com-
than those who do not and soft drinks have replaced milk as the          pression fracture (VCF). Scoliosis afflicts two to three percent of
beverage of choice among American youngsters. In addition, soft          the population, mostly young girls, while VCFs typically befall


                                                                                                        BONEZONE • Spring 2009              63
       THE BIG PICTURE


An Industry forAll of Time... continued from page 63


the elderly, most often as a result of osteoporosis. Nearly 100 mil-   orthopaedics will feel the brunt. But, fractures will still require
lion people worldwide have osteoporosis, and millions more             repair, as will torn rotator cuffs and ACLs. Spinal fusion and joint
remain at risk of low bone mass. Estimates indicate that one in        replacement may be delayed, but patients can’t deny themselves
three women and one in five men over 50 will suffer an osteo-          quality of life for forever.
porotic fracture. In fact, each year more than 300,000 procedures
are performed worldwide to treat VCFs alone.                           In the U.S., scrutiny will intensify into physician/company rela-
                                                                       tionships. More legislation may result. We’re likely to see a more
All told, musculoskeletal injuries account for nearly half of all      conservative FDA emerge, particularly in light of recent food and
injuries in any given year. One in two adults reports a chronic        drug safety issues. We can expect a review of medical technolo-
musculoskeletal condition (twice the rate for heart or respiratory     gies in light of the economy. Let’s keep our fingers crossed that
conditions) and seven percent of adults in the U.S. report difficul-   value is defined within the context of its contribution to produc-
ty in performing even the most routine activities of daily living      tivity, quality of life and betterment for society, that it is not sim-
due to a musculoskeletal condition.                                    ply touted as some equation of cost and benefit to the “system.”
                                                                       After all, orthopaedic innovations over the past 20 years have
Exhibit 2 summarizes some of the demographics behind the               helped to reduce disability and improve quality of life in millions
health of the orthopaedic industry.                                    of people throughout the world.

As we move into the future, population demographics will play          Unlike some drugs and medical devices, orthopaedics works.
well into the orthopaedic hand. By our estimates, each year            When your mother’s joints are ravaged by arthritis, we can
between now and 2020, some 167 million people worldwide                remove her aches so she can return to gardening and golf. When
could encounter an orthopaedic problem that can be fixed by our        your brother fractures his clavicle motorcrossing down a moun-
industry. Exhibit 3 further breaks out the diagnoses for these         tain, we can plate him so he can go back out and do it again. And
incremental patients.                                                  when your young daughter can’t bear to be seen because of scol-
                                                                       iosis, we can give her back her life so she can stand tall and proud.
While I remain bullish about orthopaedics, I am not unrealistic.
Certainly the next 18 months or so will present their fair share of    This is what orthopaedics is really about. We’re not building
challenges. We’ve already seen some slowdown in the purchase           parts. We’re rebuilding people. And 6.5 billion people on the
of capital equipment. Hospital admissions have fallen in some          planet will one day need orthopaedic care. And the market
areas due to patients postponing elective surgeries. Price pressure    doubles in size about every six years. It doesn’t get much better
will undoubtedly ensue and all of us along the supply chain in         than that.



                                           EXHIBIT 2
           DEMOGRAPHIC FACTORS CONTRIBUTING TO THE HEALTH OF THE ORTHOPAEDIC INDUSTRY

                     Joint   Replacement
                        •    Mostly in the elderly, a group growing 4 times faster than the population overall
                        •    Increasing use in younger Baby Boomer population (450 million strong)
                        •    2+ billion obese/overweight people (more likely to get OA)
                        •    Rise in consumption of soft drinks (linked to OA and osteoporosis)

                     Fracture Repair
                        • All age groups – hundreds of millions of sports and activity enthusiasts
                        • Elderly – more than one million osteoporotic fractures per year
                        • Rise in consumption of soft drinks (linked to OA and osteoporosis)

                     Arthroscopy/Soft Tissue Repair
                       • All age groups – hundreds of millions of sports and activity enthusiasts

                     Spinal Implants & Instrumentation
                        • Ubiquitous back pain (90% of people over 30; 80% of us at some point in our lives)
                        • Hundreds of thousands of VCFs per year, most in the elderly



64       BONEZONE • Spring 2009
                                                                                                           THE BIG PICTURE




                                                  EXHIBIT 3
                         POTENTIAL INCREMENTAL ORTHOPAEDIC PATIENTS/YEAR THROUGH 2020




                                                                           (          )


Shirley A. Engelhardt is President and Founder of ORTHOWORLD                    stage musculoskeletal investment fund. She can be reached at 336-685-
Inc., a strategic services firm solely focused in orthopaedics. She is also a   5448 or shirley@orthoworld.com.
Founder and Managing Member of Knowledge Ventures, LLC, an early




                                                                                                               BONEZONE • Spring 2009             65
         INNOVATION




                                       Barry J. Smernoff, Ph.D.
                                       AlphaOmega Collaboration, LLC




  Update on the BioInnovation
  Institute in Akron


A History in Biomaterials and Orthopaedic Research                  BONEZONE readers remember from the Winter 2008 issue
                                                                    that the BioInnovation Institute in Akron (Institute) was recent-
Selected BioInnovation Researcher Profiles:                         ly formed in Northeast Ohio. The Institute will take advan-
  • Dr. Joseph Kennedy is Distinguished                             tage of polymer and materials research underway at The
     Professor of Polymer Science and                               University of Akron, and translational and clinical research
     Chemistry at The University of Akron. He                       performed at the Northeastern Ohio Universities Colleges of
     has had a long and prodigious career as                        Medicine and Pharmacy (NEOUCOM), Akron Children’s
     a researcher, scientist, educator and                          Hospital, Akron General Health System and the Summa
     inventor, both in industry and academia. During 2008,          Health System.
     his 100th patent was awarded. Dr. Kennedy is active in
     commercialization of his research, the most notable            The Institute capitalizes on Northeast Ohio’s rich history and
     being his invention of the polystyrene-                        strength in orthopaedic innovation. The region boasts more
     polyisobutylene-polystyrene block copolymer and                than 200 researchers in orthopaedics and biopolymers. In
     thermoplastic elastomer (SIBS). SIBS is the                    addition, more than 100 orthopaedic surgeons reside in the
     biocompatible polymer coating that is used on Boston           region’s clinical institutions. More than 50 companies in
     Scientific’s drug-eluting cardiovascular stent, which          Northeastern Ohio are directly linked with the orthopaedic
     has been implanted in aboutfive million patients               device industry, and greater than $750 million in venture cap-
     worldwide.                                                     ital investment has flowed into Northeast Ohio’s biomedical
                                                                    community since 2004.
  • William J. Landis, Ph.D., is a professor in
    the Department of Microbiology,                                 BioInnovation Institute Goals
    Immunology and Biochemistry and in                              The Institute’s goals are two-fold: 1) to become a global leader
    the Department of Orthopaedic Surgery                           at the intersection of biomaterials and orthopaedics research,
    at NEOUCOM. He earned his Ph.D. from                            education, clinical services and commercialization; and 2) to
    MIT in 1972 and holds joint faculty                             become the driver of transformative economic, social and
    appointments at Kent State University, The University           health benefits for greater Akron.
    of Akron, Case Western Reserve University and the
    University of Pennsylvania. Prior to his relocation             BioInnovation Institute Ten-Year Plan
    to Ohio in 1999, he was an associate professor of               The Institute’s ten-year vision is:
    Orthopaedic Surgery and Anatomy and Cellular                      • To become the #1 biomaterials and orthopaedics
    Biology at the Children's Hospital and the Harvard                   program in the world
    Medical School. Dr. Landis has research interests in              • To create nationally-ranked orthopaedic and wound
    biomineralization, tissue engineering and the effects of             care programs
    mechanical forces on mineralized tissues, and has                 • To attract $150 million in annual academic and clinical
    published more than 125 peer-reviewed journal articles,              research
    book chapters and reviews in these areas. His                     • To attract $50 million in annual private investment in
    long-standing research programs are supported                        biomaterials-based companies
                                                                      • To create 2,400 new jobs
                                     Sidebar continues on page 69



  68      BONEZONE • Spring 2009
                                                                                                       INNOVATION




Methods to Achieve the Goal                                                 principally by the National Institutes of Health and
Vehicles created within the Institute to achieve the Institute’s            the National Aeronautics and Space Administration. He
vision are the Center for Biomaterials and Medicine (CBMM),                 has been a Senior Fulbright Scholar at the Weizmann
the Institute’s research cornerstone, and the Medical Device                Institute of Science in Rehovot, Israel, and the recipient
Development Center (MDDC), the Institute’s commercializa-                   of several honors and awards for his research studies.
tion cornerstone. Seed funding of $80 million to build the
Institute was led by the John S. and James L. Knight                   Akron – A History of Polymers, Orthopaedics and Health
Foundation, the State of Ohio, First Energy Corporation and the        Care Innovation:
five partner institutions: NEOUCOM, Akron Children’s                     • 1839-Vulcanization of rubber discovered by Charles
Hospital, Akron General Health System, the Summa Health                     Goodyear.
System and The University of Akron.                                      • 1890-Akron Children’s Hospital was founded. Today
                                                                            the hospital cares for more than 400,000 patients
The Center for Biomaterials and Medicine                                    each year and performs more pediatric surgeries
The Institute’s initial focus will be to bolster biomaterials and           than any other hospital in Northeast Ohio.
orthopaedics research through the CBMM. It is the goal to                • 1892-Akron City Hospital was founded, the first of
recruit, within the next five years, 40 additional researchers and          the Summa Health System hospitals. Akron City
their laboratory teams in the fields of biomaterials,                       Hospital boasts the first accredited radiology
orthopaedics and wound care. This will bring the total number               department in the county.
of dedicated investigators in this program to 70 and total               • 1909-Buchtel College, now known as The University
researchers to over 400. Academic postings have been placed                 of Akron, offered the world’s first courses in rubber
and top researcher searches have begun. For a view of Akron’s               chemistry. Akron became known as the Rubber
deep history in biomaterials and orthopaedic research, see the              Capital of the World.
sidebar at left, A History in Biomaterials and Orthopaedic Research.     • 1914-Akron General Health System founded as
                                                                            Peoples Hospitals. Akron General has grown from a
The Medical Device Development Center                                       single hospital to a large, fully integrated health care
The Institute will seek strong commercial partners to accelerate            delivery system with 6,000 employees, medical
CBMM’s research pipeline into patentable technologies, com-                 professionals and volunteers. The system serves the
mercial products and advanced manufacturing processes. This                 health care needs of more than 1.2 million people.
will be the mission of the MDDC. Within ten years, the MDCC              • 1941-U.S. Government contracted with University of
aims to:                                                                    Akron to establish the Rubber Research Laboratory
                                                                            to aid in the development of the synthetic rubber
   • Increase annual investment in biomaterials-based                       needed for the war effort.
     companies to $50 million                                            • 1942-The University of Akron formed the Rubber
   • Increase annual licensing revenue from the partners to                 Technical Institute.
     $15 million                                                         • 1964-The University of Akron’s Institute for Rubber
   • Attract and accelerate an average of ten companies per                 Research was renamed the Institute for Polymer
     year                                                                   Science.
                                                                         • 1973-The Northeastern Ohio University’s College of
The MDDC will collaborate with several regional biomedical                  Medicine was founded to meet a critical need for
commercialization efforts, including:                                       primary care physicians in Northeast Ohio.
                                                                         • 1974-Drs. Howard Igel and Aaron Freeman at Akron
   • BioEnterprise, a business formation, recruitment, and                  Children’s Hospital were the first to successfully
     acceleration initiative designed to grow regional health               grow human skin in the lab to treat burn victims.
     care companies and commercialize bioscience                         • 1977-Dennis Weiner, M.D., mandated that
     technologies                                                           orthopaedic research projects be necessary for
   • The Akron Global Business Accelerator, an incubator                    orthopaedic residents at Akron Children’s Hospital.
     located in downtown Akron that supports early stage                    The Pediatric Orthopaedic Department at Akron
     ventures with low-cost space and entrepreneurial                       Children’s has been highly active in biomedical
     services                                                               research for more than 30 years, publishing nearly
   • The Akron Biomedical Corridor, a development zone                      100 scientific articles, two books and more than 800
     in the heart of the city that leverages Akron’s health                 scientific presentations at various meetings.
     care strengths to attract and grow bioscience companies                                                 Sidebar continues on page 70




                                                                                                  BONEZONE • Spring 2009             69
       INNOVATION


Update on the BioInnovation Institute... continued from page 69




• 1980s-Akron earned a reputation as the “Polymer                         • Akron’s recent public/private collaboration that
  Valley” of the U.S. Akron’s expertise in polymers grew                    invested in Targetech, an Israeli incubator, resulting in
  largely out of its history in the rubber industry. The                    new technologies and companies flowing into the
  University of Akron has graduated more people in                          region
  polymer engineering than any other university in the
  country, providing the many polymer companies in the                 Potential commercial innovations are forecasted in medical
  area with a steady stream of talent. The University of               devices, tissue engineering and drug delivery. There is a
  Akron’s solid polymer academic programs and                          robust regional cluster of orthopaedic companies that have
  research have also led to a great deal of                            attracted significant private and public investments over the
  commercialization in Northeast Ohio.                                 last several years, including the recent acquisition of Akron’s
• 1988-The University of Akron established the world’s                 Theken Companies by Integra Lifesciences for $75 million in
  first College of Polymer Science and Polymer                         cash and up to $125 million in milestone payments. For more
  Engineering, following the establishment of the Akron                detail, see the sidebar at right, Selected Akron-area Orthopaedic
  Polymer Engineering Center and the Biomedical                        Companies.
  Engineering Department.
• 1989-St. Thomas Hospital merged with Akron City                      If you would like to know more about this initiative, please contact:
  Hospital to become Summa Health System.
• 1998-Summa was recognized by USNews & World                          Aram Nerpouni
  Report as one of “America’s Best Hospitals,” and the                 Interim Executive Director
  health system received its first ranking for its                     BioInnovation Institute in Akron
  orthopaedic services.                                                330-253-1700 (phone)
• 2000-US News & World Report ranked The University                    anerpouni@bioenterprise.com
  of Akron’s Polymer Science and Polymer Engineering                   www.bioinnovationinstitute.org
  Program second in the nation.         Sidebar continues on page 71
                                                      INNOVATION




  • 2001 -Newsweek named Akron one of nine
    “high-tech havens” alongside Barcelona,
    Spain and Oakland, California. Akron General
    Medical Center tied with the Cleveland Clinic
    to receive the National Research
    Corporation’s Consumer Choice Award. The
    hospital has gone on to win this award for
    seven consecutive years.
  • 2004 -FDA cleared Boston Scientific’s TAXUS
    drug-eluting cardiovascular stent system. The
    polymer matrix was conceived and created at
    the University of Akron.
  • 2005 -US News & World Report ranked Akron
    General and Summa Health System among
    the 50 best hospitals in the country.
  • 2008 -Business Facilities magazine ranked
    Ohio fourth in the nation in biotechnology
    strength. NASA Glenn Research Center
    announced a partnership with Akron’s
    Goodyear Tire and Rubber Company to
    improve tire technology to be used on lunar
    vehicles for future exploration missions.
    Summa and the Crystal Clinic broke ground
    on the new Crystal Clinic Orthopaedic
    Center located on Summa’s Akron City
    Hospital campus.
  • 2008 -$200 million
    BioInnovation Institute
    launched with $80 million
    in seed funding from its five Akron partners
    plus the Knight Foundation, the State of Ohio
    and FirstEnergy.




Selected Akron-area Orthopaedic Companies:




   A Division of Integra LifeSciences (formerly the
            Theken family of companies).
                                                      CALENDAR
                                                        March 23-26
                                                        American College of Healthcare Executives 2009
                                                        Congress on Healthcare Leadership
                                                        Chicago, IL
                                                        www.ache.org

                                                                          April 2009
                                                        April 1-2
                                                        MicroManufacturing & NanoManufacturing
                                                        Conference & Exhibits 2009
                                                        Minneapolis MN
                                                        www.sme.org/micro
                                                        www.sme.org/nanomanufacturing

                                                        April 1-2
                                                        2009 RAPS Horizons Conference & Exhibition
                                                        San Francisco, CA
                     March 2009                         www.raps.org

     March 2-4                                          April 5-8
     Investment in Innovation West: Growing your        International Materials Symposium MATERIAIS
     Medical Technology Business through Financing,     2009
     M&A, and Strategic Partnerships                    Lisbon, Portugal
     Las Vegas, NV                                      www.demat.ist.utl.pt/materiais2009
     www.windhover.com
                                                        April 5-9
     March 2-4                                          International Society of Arthroscopy, Knee
     Software Validation: Requirements and Industry     Surgery & Orthopaedic Sports Medicine - 7th
     Practice                                           Biennial ISAKOS Conference
     Sponsored by the Association for the               Osaka, Japan
     Advancement of Medical Instrumentation             www.isakos.com
     Arlington, VA
     www.aami.org                                       April 22-26
                                                        Mid-America Orthopaedic Association Annual
     March 9-11                                         Meeting
     Design Control Requirements and Industry           Amelia Island, FL
     Practice                                           www.maoa.org
     Sponsored by the Association for the
     Advancement of Medical Instrumentation             April 28-May 1
     New Orleans, LA                                    Radiation Sterilization for Medical Devices
     www.aami.org                                       Sponsored by the Association for the
                                                        Advancement of Medical Instrumentation
     March 12-13                                        Minneapolis, MN
     20th North American Research/Teaching              www.aami.org
     Symposium on Purchasing and Supply Chain
     Management                                         April 28-May 1
     Tempe, AZ                                          Spine Arthroplasty Society 9th Annual Global
     www.ism.ws                                         Symposium on Motion Preservation Technology
                                                        London, England, United Kingdom
     March 15-19                                        www.spinearthroplasty.org
     Association of periOperative Registered Nurses
     (AORN) 2009 Congress                               April 29-May 2
     Chicago, IL                                        Pediatric Orthopaedic Society of North America
     www.aorn.org                                       Annual Meeting
                                                        Boston, MA
                                                        www.posna.org


72       BONEZONE • Spring 2009
                                                  CALENDAR
April 30-May 3                                      May 25-27
Arthroscopy Association of North America Annual     2009 International Medical Device Industry
Meeting                                             Compliance, Regulatory & IP Conference
San Diego, CA                                       Sponsored by the Advanced Medical Technology
www.aana.org                                        Association
                                                    Rome, Italy
                  May 2009                          www.advamed.org

May 3-6                                             May 27-30
94th Annual ISM International Supply Management     American College of Sports Medicine Annual
Conference and Educational Exhibit                  Meeting
Charlotte, NC                                       Seattle, WA
www.ism.ws                                          www.acsm.org

May 3–7                                             May 28-29
Nanotech 2009 Conf. & Exposition                    Implants 2009
Houston, TX.                                        Lyons, France
www.nsti.org/Nanotech2009                           www.implants-2009.com

May 4-7                                                              June 2009
2009 International Thermal Spray Conference and
Exposition:                                         June 1-2
Expanding Thermal Spray Performance to New          Integrating Risk Management into the Quality
Markets and Applications                            System
Las Vegas, NV                                       Sponsored by the Association for the
www.asminternational.org                            Advancement of Medical Instrumentation
                                                    Minneapolis, MN
May 10-16                                           www.aami.org
2009 National Biomedical/Clinical Engineering
Appreciation Week                                   June 6-8
www.aami.org/tmc                                    Association for the Advancement of Medical
                                                    Instrumentation 2009 Conference & Expo
May 12-14                                           Baltimore, MD
RAPID Product Development & Manufacturing           www.aami.org
Solutions
Chicago, IL                                         June 10-13
www.sme.org/rapid                                   American Orthopaedic Association Annual
                                                    Meeting
May 13-17                                           Bonita Springs, FL
The Association of Bone and Joint Surgeons          www.aoassn.org
Annual Meeting
Maui, Hawaii                                         June 24-25
www.abjs.org                                         OMTEC 2009: The 5th Annual
                                                     Orthopaedic Manufacturing &
May 17-20                                            Technology Exposition and Conference
Current Concepts in Joint Replacement Spring         Donald E. Stephens Convention Center
Meeting                                              Rosemont, IL
Las Vegas, NV                                        www.orthosupplier.com
www.ccjr.com
                                                                      July 2009
May 18-20
World Conference on Quality and Improvement         July 2-5
Sponsored by the American Society for Quality       American Society for Healthcare Engineering
Minneapolis, MN                                     (ASHE) 46th Annual Conference and Technical
wcqi.asq.org                                        Exhibition
                                                    Anaheim, CA
                                                    www.ashe.org


                                                                        BONEZONE • Spring 2009     73
                                                          CALENDAR
     July 9-12                                             September 13-16
     American Orthopaedic Society for Sports Medicine      TITANIUM 2009
     Annual Meeting                                        Waikoloa, HI
     Keystone, CO                                          www.titanium.org
     www.sportsmed.org
                                                           September 13-16
     July 13-15                                            2009 RAPS Annual Conference & Exhibition
     Institute for Supply Management: Best Practices in    Philadelphia, PA
     Procurement                                           www.raps.org
     Baltimore, MD
     www.ism.ws                                            September 22-26
                                                           American Spinal Injury Association Annual Meeting
     July 15-18                                            Dallas, TX
     American Orthopaedic Foot & Ankle Society 25th        www.asia-spinalinjury.org
     Annual Summer Meeting
     Vancouver, British Columbia, Canada
     www.aofas.org                                                        October 2009
     July 19-22                                            October 2-4
     Association for Healthcare Resource & Materials       Knee Society Interim Meeting
     Management Annual Conference & Exhibition:            Denver, CO
     Mapping the Future                                    www.kneesociety.org
     Tampa, FL
     www.ahrmm.org                                         October 4-9
                                                           American Society for Precision Engineering 24th
                                                           Annual Meeting
                     August 2009                           Monterey, CA
                                                           www.aspe.net/meetings
     August 10-12
     Materials & Processes for Medical Devices             October 8-10
     Conferences & Exposition (MPMD 2009)                  Orthopaedic Trauma Association Annual Meeting -
     Minneapolis, MN                                       25th Anniversary
     www.asminternational.org                              San Diego, CA
                                                           www.ota.org

                   September 2009                          October 25-29
                                                           Materials Science and Technology - In conjunction
     September 3-5                                         with the 96th ASM International Annual Meeting
     American Society for Surgery of the Hand 64th         Pittsburgh, PA
     Annual Meeting                                        www.asminternational.org
     San Francisco, CA
     www.assh.org
                                                                         November 2009
     September 3-6
     31st Annual International Conference of the IEEE      November 10-14
     Engineering in Medicine and Biology Society           North American Spine Society 24th Annual
     Minneapolis, MN                                       Meeting
     www.embc09.org                                        San Francisco, CA
                                                           www.spine.org
     September 7-12
     Annual Meeting of the European Society for            November 25-27
     Biomaterials 22nd European Conference                 International Conference on Bioinformatics and
     Lausanne, Switzerland                                 Biomedical Engineering 2009
     www.esb2009.org                                       Sydney, Australia
                                                           www.waset.org/wcset09/sydney/icbbe




74       BONEZONE • Spring 2009
       SOURCING




                                         John A. Engelhardt, MS,
                                         FAIMBE
                                         Knowledge Ventures, LLC




Adventures in Offshoring: Costa Rica
This is the third installment in my series, Adventures in Offshoring.    Manufacturing Infrastructure
The last one appeared in the Fall 2007 issue of BONEZONE and             Most modern manufacturing is located in Free Trade Zone parks.
chronicled my then-recent rip to the Dominican Republic. That            There are several in Costa Rica, and the government offers signif-
country, although a beautiful Caribbean paradise, had no preci-          icant incentives to companies wishing to locate there. If a compa-
sion manufacturing infrastructure. I looked forward to the day I         ny is large enough, it can acquire standalone Free Trade Zone sta-
would discover such a beautiful place that actually could manu-          tus. Costa Rican free trade initiatives target precision manufactur-
facture orthopaedic implants and instruments. At last, I have            ing, but also services such as call centers. There is significant focus
found it.                                                                on high tech medical manufacturing.

This past November, I visited Costa Rica to tour their medical           Unlike the Dominican Republic, Costa Rica does indeed have the
manufacturing infrastructure. We were hosted by CINDE, the               facilities, infrastructure and expertise to manufacture precision
Costa Rican Investment Promotion Agency, and were able to see            orthopaedic components of all types.
a number of manufacturing facilities, The Engineering School at
the University of Costa Rica, and The National Learning Institute        The country has in place a sophisticated university structure, and
(INA), which is a national vocational college.                           most impressive, the National Vocational college mentioned ear-
                                                                         lier. We were able to visit one of INA’s several locations.
Costa Rica is a long, thin strip of breathtaking tropical beauty
extending from Nicaragua in the north to Panama in the south. It         The INA curriculum encompasses a broad spectrum of technical
is bounded by the Caribbean on the east and the Pacific Ocean on         education, from computer-aided design and manufacturing to
the right. Slightly smaller than West Virginia, it has mountains         CNC machine operation and manufacturing methods. Its goal is
(with volcanoes), white sand beaches, rainforests and more               to produce skilled talent for the growing manufacturing econo-
species of birds than anywhere else in the world. You can tour the       my. Its facilities and equipment are up to date and extensive. (See
old growth rainforests, surf and play golf on the same day. The          Exhibit 1.) Many of the manufacturing facilities we visited recruit
temperature stays a balmy 76 degrees all year in the central val-        from INA. Everyone we spoke to noted a good labor pool avail-
ley. Plants and other greenery grow everywhere, even from the            able to them.
roof tiles of buildings. They sell fresh fruit on the street corners.

Costa Rica boasts the oldest democracy in Central America, and                                EXHIBIT 1
its gross national product has risen consistently over the past                  STUDENTS AT THE NATIONAL LEARNING
decade. It has a national initiative to attract high tech manufactur-                      INSTITUTE (INA)
ing with a focus on medical markets. This is not a third world
country by any stretch. Yes, they have roads and running water.
Much of the population seems to speak better English than I do.

The flight from Atlanta takes a little over three hours and all of the
country is on central time, making business dealings with the
States a piece of cake compared to Asia. The telecom infrastruc-
ture and service is known to be excellent.

Most of the manufacturing infrastructure exists around its capital
city, San Jose, in the central valley, flanked on two sides by the
most resplendent mountain views in the hemisphere. Fine hotels
are available very near the airport.



76     BONEZONE • Spring 2009
The facilities we toured were equal to best in class in any other
country. The equipment and facilities are modern and clean and
the people we talked to as professional and knowledgeable as
any in Northern Europe and the States. Most are ISO certified.
Exhibits 2 through 4 show some highlights of the facilities we
toured.

                 EXHIBIT 2
 MANUFACTURING FLOOR AT OLYMPIC MACHINING




                      EXHIBIT 3
            EDM CELL AT OBERG INDUSTRIES




                     EXHIBIT 4
             TECHSHOP’S METROLOGY LAB
        SOURCING


Adventures in Offshoring... continued from page 77




Wages                                                              A good example is the presence of ArthroCare in Costa Rica.
Exhibit 5 shows comparative labor rates for Costa Rica and
other locations. You will recall that Level 1 is an entry level    In 2002, ArthroCare began manufacture of certain compo-
“unskilled” position, and Level 4 is the equivalent of an          nents and systems in one of the free trade parks. Since that
experienced CNC programmer/operator.                               time the facilities have been expanded. and currently Costa
                                                                   Rica manufactures 100% of ArthroCare’s products there.
                   EXHIBIT 5
                                                                   The current facility is 43,550 square feet and includes fabri-
        HOURLY COMPENSATION FOR MEDICAL
                                                                   cation, assembly, QA, clean room packaging, etc. (See Exhibit
                MANUFACTURING*
                                                                   6.) I must admit to being more impressed with this facility
                                                                   than most I have ever visited. It is an excellent state of the art
 Location                                Level 1      Level 4      operation to be sure, but that is only part of it. I have never
                                                                   seen such motivated, excited, happy and enthusiastic people
 Mexico                                     $2.30       $6.75      than the management and employees there.


 Taiwan                                     $6.25     $10.60                           EXHIBIT 6
                                                                                CLEANROOM AT ARTHROCARE
 Warsaw IN, USA                           $14.35      $30.10

 Memphis TN, USA                          $14.95      $27.35

 China                                      $0.60         n/a

 Dominican Republic                         $1.70         n/a

 Costa Rica                                 $2.00       $7.10


         * Includes company paid portion of benefits.

While this shows that the wage structure is comparable to
other places, a critical distinction needs to be made. While
Costa Rica is relatively sophisticated in both infrastructure
and knowledge base, we therefore do NOT consider it an
attractive location for extremely low skilled labor and what-
ever advantage that might provide. Remember that those
types of labor generally do not apply to orthopaedic prod-
ucts. The value of Costa Rica to us is as a cost effective loca-
tion for levels of manufacturing one step beyond the shop          A gorgeous tropical paradise, attractive economics and infra-
floor. It may make sense for the following:                        structure, beautiful happy people. You might ask, “What’s
                                                                   the catch?”
     • Manufacture of precision parts, assemblies and
       systems that have relatively high labor components          Costa Rica has some issues, to be sure. After decades of eco-
                                                                   nomic growth, its efforts to eliminate poverty have yielded
     • Pilot production and pre- and post- manufacturing           little results. While not as bad as the Dominican Republic,
       operations                                                  driving can be a harrowing experience. (If you drop off the
                                                                   side of the road, you actually drop off the side of the road.)
     • Design, development and technical services                  It also rains the entire month of October.




78      BONEZONE • Spring 2009
                                                                                                   SOURCING




The only other downside we experienced was being attacked           Knowledge Ventures, LLC
by gypsy cab drivers upon arrival at the airport. For a             3168 Benny Lineberry Road
minute, I thought I was in Newark.                                  Climax, North Carolina 27233
                                                                    336-685-5449 (phone)
Note: Although we were hosted by CINDE, we paid all our             www.kvllc.net
own expenses. The CINDE folks are incredibly helpful, pro-
fessional, dedicated and great hosts. I urge you to contact
them if you choose to visit.                                           Update

                                                                       In the Summer 2006 issue of BONEZONE I described
John Engelhardt is a founding partner of Knowledge Ventures,           my visit to the Doncasters’ facility in Mexico. The
LLC, a venture firm focused on the musculoskeletal industry. A         company has since discontinued operations there,
former executive of AcroMed Corp. and DePuy, Mr. Engelhardt            due to the fact that it did not yield the economies that
is a futurist and recognized authority on technology trends in         were anticipated. We reiterate that the decision to off-
orthopaedics. He holds 19 patents covering large and small             shore should be taken with the utmost care and dili-
joints, spine and trauma. Mr. Engelhardt is a Member of the            gence. One can imagine the huge expense associated
College of Fellows, American Institute for Medical and Biological      with set up and subsequent shut down of such an
Engineering. He can be reached via email at                            operation.
john@orthoworld.com.




                                                                                               BONEZONE • Spring 2008             79
        SOURCING

Adventures in Offshoring... continued from page 79


                 COSTA RICA AT A GLANCE                           • Young - 34.2% of population aged 15 to 35
                                                                  • Life expectancy at birth: 77.4 years (U.S. 78.1,
                                                                    World 65.8)
                                                                  • Socialized medicine and education
                                                                  • 9,400 educational institutions with 6% of GDP
                                                                    allocated to education
                                                                  • 89 technical high schools + National Training Institute,
                                                                    which is funded by 1.5% of companies’ payrolls
                                                                  • 94.9% literacy rate among adults; developing
                                                                    multilingual capabilities in its labor market
                                                                  • 2.7% growth in labor pool annually
                                                                  • Democratic republic for >100 years; no armies since the
                                                                    late 1940s; highest ranked in Political Stability index in
                                                                    Latin America
                                                                  • 97.5% of energy from renewable sources – hydroelectric,
     • Nestled between Nicaragua and Panama                         geothermal and wind
     • 51,100 square kilometers/19,730 square miles (slightly     • Greatest density of species in the world (5% of the world’s
       smaller than West Virginia and a bit larger than             biodiversity), with 23% of land protected
       Switzerland)
     • Average temperature range in central Costa Rica (14      Sources:
       to 24°C/57 to 75°F) in December and 17 to 27°C/63 to     Costa Rican Investment Promotion Agency (www.cinde.org)
       81°F in May                                              The CIA World FactBook
     • 4.5 million people (on par with the state of South       (www.state.gov/r/pa/ei/bgn/2019.htm)
       Carolina; smaller than Norway, larger than               Wikipedia (www.wikipedia.org)
       New Zealand)                                             World Resources Institute, EarthTrends (earthtrends.wri.org)




80      BONEZONE • Spring 2008
      MATERIALS




                                       Michael J. Walter
                                       Carpenter Technology Corporation




Higher Performance Material Solutions for
a Dynamic Spine Market
After cancer and heart disease, back pain is the third most cost-   also allow us to continue our active lifestyles. We are receiving
ly medical disorder in the U.S. The spinal surgery segment of       implants earlier in life and expect them to perform better and
the orthopaedic industry is already the fastest growing portion     last longer. Clearly, the growing demands on implant perform-
of the market and with changing demographics of the U.S. pop-       ance will require higher performance material solutions.
ulation, the spinal devices segment is expected to continue to
outpace other segments of the industry. Treatment of disorders      Given the dynamic nature of the spine segment, in recent years
of the spine has been a very dynamic marketplace for a number       there has been a dramatic increase in the number and types of
of years and is expected to continue over the next decade.          devices designed for the treatment of the four major types of
                                                                    spinal disorders: deformity, degenerative, spinal trauma and
The demographics of the U.S. population are in a state of flux.     spinal tumors. Each of these disorders presents unique chal-
We are physically larger, more active and living longer than        lenges to the surgeon and, likewise, the device designer.
past generations. We want immediate relief of our symptoms          However, regardless of the type of disorder being treated, there
and expect spinal implants that not only relieve our pain, but      are two broad-based trends that have been consistent: the need




82     BONEZONE • Spring 2008
                                                                                                          MATERIALS



for higher performance/longer lasting implants, and the desire                             EXHIBIT 1
to provide better clinical outcomes for the patient.                    IMPROVED MICROSTRUCTURES ARE TYPICALLY
                                                                           PRODUCED IN Ti6AI-4V ELI HOT ROLLED
The following review of current spinal surgery trends will              WROUGHT BAR STOCK (top) VERSUS CUT FROM
demonstrate where higher performance alloys and products               PLATE (bottom). TRANSVERSE MICROGRAPHS WERE
may be used to satisfy the increased expectations of today’s                             TAKEN AT 200X
device designers, surgeons and patients.

Improvements in Fusion/Fixation
Historically, the most frequently selected treatment procedure
for many spinal disorders has been spinal fusion and fixation
treatments. These treatment options utilize devices such as
plates, screws, rods, hooks, spacers and cages. Most of the met-
als consumed within this subsegment are titanium-based alloys
such as Ti-6Al-4V, Ti-6Al-4V-ELI, Ti-6Al-7Nb and CP Ti.
However, stainless and cobalt are utilized as well. The compo-
nents for fusion are typically either machined from round or
flat bar stock or cut from flat plate. For that reason, minimizing
yield loss during machining and providing starting material
closer to near net shape has been an increasing trend. In the
case of cervical plates, for example, the titanium flat products
offered by Dynamet Incorporated, a subsidiary of Carpenter
Technology, have provided consistently closer-to-finish toler-
ances, improved surface finishes and better shape consistency.
There is also an added benefit of enhanced mechanical proper-
ties and improved grain structure characteristics when com-
pared to Ti products typically cut from plate. (See Exhibit 1.)

For some fusion applications that utilize stainless rods and                              EXHIBIT 2
screws, medical device designers have requested higher                 BioDur® 108 ALLOY IS CAPABLE OF STRENGTHS IN
strength components with enhanced galling resistance. In these        EXCESS OF 250KSI AND HAS BEEN USED FOR SPINAL
cases, BioDur® 108 alloy has proven beneficial. BioDur 108             COMPONENTS REQUIRING SUPEROIR STRENGTH
alloy is a high nitrogen, essentially nickel-free stainless that is               AND GALLING RESISTANCE
capable of very high strengths in excess of 200ksi and also
demonstrates improved galling resistance when compared to
BioDur® 316LS and 22Cr-13Ni-5Mn. (See Exhibit 2.)

Motion Preservation Technologies
While in many cases traditional fusion/fixation devices have
proven successful, they do tend to limit patient mobility.
Recently, in order to satisfy one of the needs of the high
demand patient, an increasing trend has arisen toward nonfu-
sion alternatives, including dynamic stabilization, artificial
discs and other motion preserving techniques. In these cases,
higher performance alloys may be required that exhibit
enhanced wear resistance, finer microstructure or higher
fatigue strength. These attributes can be achieved when utiliz-
ing alternative alloy processing techniques like Carpenter’s
proprietary Micro-Melt® process. In this process, the alloy is
melted and then atomized into a fine powder by introducing
the molten metal to a high-pressure stream of gas. This powder        Emerging artificial disc and dynamic stabilization applications
is then blended and screened to a controlled diameter and final-      have benefited from two high-performance alloys that are man-
ly consolidated into a solid ingot of material which can then be      ufactured using the Micro-Melt process.
processed to the required finished diameters. (See Exhibit 3.)


                                                                                                  BONEZONE • Spring 2008          83
        MATERIALS

Higher Performance Material Solutions... continued from page 83



                  EXHIBIT 3                                                          EXHIBIT 4A
  SCHEMATIC OF MICRO-MELT® POWDER PROCESS                              CONVENTIONALLY PRODUCED HIGH CARBON
                                                                      CAST/WROUGHT CCM. NOTE BANDS OF PRIMARY
                                                                        CARBIDE ASSOCIATED WITH SEGREGATION.




                                                                                     EXHIBIT 4B
                                                                     BIODUR® CCM PLUS® ALLOY PRODUCED USING
                                                                    THE MICRO-MELT® POWDER PROCESS. NOTE FINE
                                                                     DISTRIBUTION OF CARBIDE AND HOMOGENOUS
Artificial Discs                                                                    STRUCTURE.
Many disc designs are either already on the market or current-
ly in product development. Some of these designs utilize titani-
um alloys, some use stainless, some use cobalt and others use
ceramics, PEEK or elastomer components. Each shares one
common attribute: the need for a wear resistant and highly pol-
ishable bearing surface. BioDur® CCM Plus® alloy has shown
to be beneficial for this type of application. BioDur CCM Plus
alloy is manufactured using the Micro-Melt process. As such, it
results in an alloy that meets ASTM F1537 Alloy 2 high carbon
chemistry, but has the added benefit of superior microstructur-
al uniformity versus other high carbon cobalt-chrome-moly
grades on the market. (See Exhibits 4a and 4b.)

The high-performance microstructure of BioDur CCM Plus              Deformity Treatment
alloy also results in superior fatigue strength and enhanced        When it comes to the effective treatment of spinal deformities
mechanical properties when compared to the more widely used         like scoliosis, kyphosis and lordosis, in many cases how an
cast/wrought version of ASTM F1537 Alloy 1. (See Exhibit 5 on       implant feels in the hands of the surgeon becomes a driving fac-
page 86.)                                                           tor for the type and condition of the alloy selected for use with-
                                                                    in the device. The use of higher performance alloys and alter-
Dynamic Stabilization                                               native strength conditions of already cleared alloys has been an
Another active trend in the spine segment is the adoption of        increasing trend to satisfy this demand. Specifically, spinal rods
dynamic stabilization devices. Like artificial discs, numerous      for the treatment of spinal deformities have typically utilized
systems are either already introduced, in development or sub-       stainless steel and titanium; however, cobalt based alloys are
mitted for clearance by FDA. The use of higher performance          now being used in certain circumstances due to the elevated
alloys or existing alloys in higher strength conditions has been    stiffness, higher modulus and mechanical properties that these
a trend for these devices. For example, utilizing already cleared   alloys possess.
Ti alloys like Ti-6Al-4V/ELI, Ti-6Al-7Nb and Ti-15Mo in a
strain hardened condition or an annealed + heat treated condi-      Micro-Melt BioDur Carpenter CCM® cobalt chrome alloy has
tion provides enhanced mechanical properties, which helps           seen increasing use in small diameter (under 8mm) spinal rod
meet the needs of these more demanding applications. (See           applications. This alloy, manufactured using the proprietary
Exhibit 6 on page 86.)                                              powder process, develops higher strength, finer grain structure



84      BONEZONE • Spring 2008
       MATERIALS

Higher Performance Material Solutions... continued from page 85


  EXHIBIT 5: BIODUR® CCM PLUS® ALLOY EXHIBITS SUPERIOR ROOM TEMPERATURE MECHANICAL AND
FATIGURE PROPERTIES WHEN COMPARED WITH COVENTIONALLY PRODUCED ASTM F1537 ALLO 1 (TESTED
                                     AT 37MM DIAMETER).

                                                             0.2% Yield         UTS        EL       RA      Fatigue
                             Hot Worked
                                                                  ksi           ksi         %        %        ksi
              Alloy 1 ASTM F1537                                  134           197        33       26       115

             Alloy 2 BioDur® CCM Plus® alloy                      147           188        21       19       135


    EXHIBIT 6: ENHANCED MECHANICAL PROPERTIES ARE POSSIBLE ON ALREADY APPROVED ALLOYS LIKE
                                TI-GAI-4V, TI-6AI ELI AND TI-15MO

                                    Alloy                           0.2% Yield (ksi)   UTS (ksi)   EL (%)   RA (%)
             Ti-6AI-4V-ELI Annealed                                       125            135        15        45
             Ti-6AI-4V-ELI Anl + Cold Worked                              140            160        16        45
             Ti-6AI-4V Annealed                                           133            150        16        46
             Ti-6AI-4V Annealed + Age                                     158            170        15        52
             Ti-15Mo Beta Annealed                                         95            115        30        80
             Ti-15Mo Alpha + Beta Annealed                                135            145        15        60
             Ti-15Mo Alpha + Beta Annealed + Aged                         180            190        40        40
                                                                                                               MATERIALS


and increased fatigue strength over conventional cast/wrought
produced ASTM F1537 Alloy 1 cobalt chrome alloys. (See
Exhibit 7.)

In addition to the titanium and cobalt products already men-
tioned, when designing for deformity treatment the designers
should also keep in mind that customized ultra-high strength
conditions of current stainless alloys are also available to round
out the alloy portfolio. (See Exhibit 8.) Whether the designer
needs titanium, cobalt or stainless as their material solution,
options are available that can provide that customized feel that
some surgeons require.

Minimally Invasive Surgical (MIS) Techniques
In addition to implants that last longer and provide better solu-
tions for the patient, there has also been a trend toward the adop-
tion of surgical techniques that are less invasive for the patient.
Higher performance alloys produced to tighter tolerances can
help facilitate MIS technology by allowing for the design of small-
er, more durable, more flexible and higher strength instruments
and implants. For example, Carpenter’s Custom 465® stainless
has helped provide numerous design solutions for instruments
that require higher strength and improved toughness. (See
Exhibit 9 on page 88.) Additionally, Dynamet’s Titanium ULTRA-
BAR product has provided the ultra tight dimensional tolerances
and exceptional diameter uniformity required for some titanium
MIS implants. Titanium ULTRABAR can provide diameter toler-
ance control down to 0.00015” in bar sizes from 3-12mm and
lengths up to 14 feet in a variety of implantable titanium alloys.


   EXHIBIT 7: IMPROVED STRENGTH PROPERTIES AND ENHANCED GRAIN STRUCTURES ARE POSSIBLE BY
   USING MICRO-MELT CCM ALLOY VERSUS CONVENTIONAL CAST/WROUGHT PRODUCED F1537 ALLOY 1.
                              SAMPLES TESTED AT 0.3125” DIAMETER

                                                   0.2% Yield                                                  ASTM Grain
                       Alloy/Condition                (ksi)           EL (%)         RA (%)    Fatigue (ksi)      Size
              Cast/wrought F1537 Alloy 1               150             199            21            120           12.5
              Micro-Melt® CCM alloy                    162             206            24            130           13.6


   EXHIBIT 8: CUSTOMIZED MECHANICAL STRENGTH CONDITIONS OF TITANIUM, STAINLESS AND COBALT
  ALLOYS PROVIDE THE SURGEON WITH THE FEEL NEEDED TO TREAT SPINAL DEFORMITIES AND OPENS UP
                             CUSTOM SOLUTIONS FOR THE PATIENT.

                         Alloy/Condition               0.2% Yield (ksi)      UTS (ksi)     EL (%)    RA (%)     Modulus (ksi)
              Ti-6AI-4V-ELI Annealed                         125               135            15          45       16,500
              Ti-6AI-4V-ELI Anl + Cold Worked                140               160            16          45
              BioDur® 316LS annealed                          45                90            50          80       28,000
              BioDur 316L CW - B                             110               140            30          70
              BioDur 316L CW - C                             140               180            20          60
              BioDur annealed                                 85               145            52          75       30,000
              BioDur 108 CW - B                              140               180            25          70
              BioDur 108 CW - C                              190               230            18          60
              Micro-Melt® CCM alloy                          160               200            28          24       33,000

                                                                                                     BONEZone • Spring 2008     87
       MATERIALS


Higher Performance Material Solutions... continued from page 87


 EXHIBIT 9: HIGH-PERFORMANCE INSTRUMENT ALLOYS LIKE CUSTOM 465 STAINLESS HAVE PROVIDED
 DESIGN SOLUTIONS FOR APPLICATIONS IN WHICH FRACTURING AND TOUGHNESS ARE A CONCERN.

                          Alloy/Condition                         0.2% Yield (ksi)   UTS (ksi)   % EI     %RA       Charpy Toughness

        Type 420 stainless (400OF temper)                               215            250         8       25                15
        Custom 630 (17-4) stainless (H900 age)                          183            198        15       52                16
        Custom 465® stainless (CW +H950 age)                            280            286        13       59                20



Summary                                                                       Dynamet manufactures titanium bar, wire, fine wire and shaped prod-
Patients who suffer from back pain demand faster recovery                     ucts. Carpenter Technology is a manufacturer and distributor of
times and longer lasting implants. These demands require                      stainless steels, high-strength alloys and other specialty alloys and
innovation in both device design and surgical technique.                      metallic powders.
However, innovation does not end there; high performance
alloys and products now available in the marketplace and                      Carpenter Technology Corporation
those in current development are helping to satisfy the needs                 101 West Bern Street
of the device designer, the surgeon and, ultimately, the                      Reading, PA 19612-4662
patient.                                                                      610-208-3819 (phone)
                                                                              www.cartech.com
                                                                              mwalter@cartech.com




88     BONEZone • Spring 2008
                                                                    CLASSIFIEDS
Complete details available at OrthoCareers.com.                              enable individuals with disabilities to perform the essential functions.
                                                                             While performing the duties of this job, the employee is regularly
For the most current orthopaedic employment                                  required to stand; walk, and sit for extended periods of time.
opportunities, or to browse Candidate Profiles
from qualified orthopaedic talent, visit                                     Compensation: DOE
OrthoCareers.com.
                                                                                                  Sales Representative
                          R&D Engineer                                                             Gauthier Biomedical, Inc
                            OrthAlign, Inc.                                                        Various U.S. Territories
                          Irvine, California                                               Qualified individuals may contact us at
Please submit resume to info@orth-align.com. In the subject line,                             sales@gauthierbiomedical.com.
 please enter the job title: R&D Engineer. Please, no phone calls.
                                                                             Product Description:
OrthAlign, Inc. is a privately held medical device company, estab-           Orthopedic Surgical Instruments, Spinal Instruments, Proprietary
lished in the summer of 2008. The technology we are developing pro-          Instruments
vides the critical features and benefits of large surgical navigation sys-
tems in a non- invasive, disposable and palm-sized device.                   Job Description:
                                                                             We are a fast growing, innovative, established leader that is expand-
It is our mission to assist medical professionals in improving patient       ing our sales network within the U.S. We offer turnkey solutions for
outcomes by providing easy to use and affordable computer assisted           new and existing orthopedic instruments. This individual will work
surgical devices. This will make consistent and measurable results           closely with customers in territories to develop existing accounts and
accessible to all orthopedic surgeons and patients.                          find new opportunities to sell patented, proprietary instruments and
                                                                             contract instrument manufacturing services to orthopedic OEMS.
Job Summary:
Our rapidly growing company is currently seeking an accomplished             Potential representatives should be highly motivated individuals with
and professional R&D Engineer. The position will report directly to          experience and contacts in selling similar products and services in
the Director of Operations & Engineering. In this dynamic role, the          orthopedics.
candidate will be responsible for the design and development of sur-
gical instruments for a computer assisted orthopedic surgical system.                           Independent Distributor
The candidate will interact closely with surgeons to develop new                                      Integra LifeSciences
instruments and modify existing designs to fulfill their needs. The                             Various Territories Available
ideal candidate’s experience will include having worked at one of the            For further information, please contact Les Burrows, U.S.
“Big 5”orthopedic companies such a Zimmer, Stryker, Biomed,
                                                                              Director of Sales at lburrows@integra-ls.com or visit www.inte-
Depuy-J&J, and/or Smith & Nephew; this is preferred but not neces-
                                                                                                    graorthobiologics.com.
sary.

Essential Duties and Responsibilities:                                       Product Description: OrthoBiologics
• Work closely with our key target audience: orthopedic surgeons
   and internal marketing and QA departments to create designs for new       Job Description:
   products, product revisions, components, assemblies and/or tools.         Integra LifeSciences Corporation is a world leader in developing and
• Conduct testing to verify that the design meets the engineering            marketing high quality surgical instruments, as well as innovative
   specifications.                                                           devices and products for use in neurosurgery, reconstructive sur-
• Assess failure modes and conduct technical risk analysis.                  gery, general surgery and soft tissue repair. Integra has increased
• Document engineering work in compliance with the company’s                 revenues over 40% annually over the last 10 years. We anticipate our
   quality system.                                                           significant growth to continue. In 2005, 2006, and 2008 Integra
• Some travel will be required.                                              LifeSciences was named to the Forbes 200 Best Small Companies list.
                                                                             In 2007 Integra was named Medical Device Manufacturer of the Year
Minimum Qualifications:                                                      by Medical Device & Diagnostic Industry Magazine, and was select-
• BS in Mechanical Engineering, Biomedical Engineering, or equivalent.       ed as the New Jersey Technology Council's Master Technology
  Masters preferred.                                                         Company of the Year.
• 5 years of experience in medical device design, development, and
  commercialization.                                                         Integra OrthoBiologics, a division of Integra LifeSciences, Inc., is seek-
• Ability to achieve results in a startup environment.                       ing qualified distributors, independent sales agents and sub-reps in
• Track record of working well with surgeons and turning their ideas         key geographic areas throughout the United States.
  into workable engineering outcomes.
• Large joints experience. Knowledge and hands-on experience with            Integra OrthoBiologics manufactures and markets a broad portfolio of
  total knee and hip replacement systems is desired.                         proprietary bone regeneration technologies, including the Accell™
• Ability to work in cross functional teams                                  Demineralized Bone Matrix product line and Mozaik™ Collagen
• Possess analytical & problem solving thinking skills                       Ceramic Matrix. The Integra OrthoBiologics’ product line represents a
• Ability to develop and write test protocols and IQ/OQ/PQ\ and              significant opportunity for enhanced revenue for the well-positioned
  conduct verification testing                                               organization or individual.
• Knowledge of FDA and ISO GMP and design control regulations
                                                                             Additional Information:
Physical Demands:                                                            Candidates must be able to demonstrate a proven track record of suc-
The physical demands described here are representative of those that         cessful sales and established relationships in spine, reconstructive
must be met by an employee to successfully perform the essential             orthopedics and/or trauma. Comprehensive product training and
functions of this job. Reasonable accommodations may be made to              field sales support will be provided.




                                                                                                           BONEZONE • Spring 2009                     89
90   BONEZONE • Spring 2009

				
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