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Titanium Today Medical Q1 2015 Edition Text
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Titanium Today

Medical 2015

Q1 Issue 7, No.1

ITA’s ‘Women in Titanium’ Develops a Roadmap to Mentor STEM Students

Putting vision and policy into action, “Women in Titanium” (WiT), a new committee sponsored by the International Titanium Association (ITA), held its first meeting on Feb. 27 at the Manhattan Beach Marriott and Golf Club, Los Angeles, to officially approve the group’s charter as well as layout an initial slate of near-term goals.

Dawne S. Hickton, the vice chair, president and chief executive officer of RTI International Metals Inc., Pittsburgh, served as the keynote speaker for the event. Hickton, who last year was tapped as the first female president of the executive board for the ITA, announced plans to establish the committee, during TITANIUM USA 2014, the ITA’s annual industry conference and exhibition, which was held in Chicago last September.

As spelled out in the approved charter, the primary mission of the WiT committee is two-fold: first, to develop a networking group of collegial women presently in the titanium industry; and second, to promote, attract, and encourage high school and college female students to enter the titanium industry.

The objective of the committee is to contribute to the growth of the overall titanium industry by providing networking opportunities for women, and to take part in programs that advance gender equality in STEM (science, technology, engineering and mathematics) courses for high school and college women. WiT will look to attract, advance and retain professional women interested in the titanium field. Committee meetings will take place approximately three times a year, offering a mentoring lecture followed by an industry-related tour.

Hickton, during the 2014 conference in Chicago, in a spirit of stewardship and outreach, said she wanted to use her position on the ITA board to help establish a permanent path for other women to follow, so that they too can develop careers and leadership positions in the global titanium industry. The formation of the WiT committee is the result of Hickton’s vision. In recent years, Hickton and other ITA leaders have focused on the need for industry stewardship programs—dedicated efforts to cultivate the next generation of titanium designers, engineers, metallurgists and executives. The ITA’s WiT initiative is part of that overall effort.

The committee gathering in Los Angeles included more than 30 registrants: eight executive officers; five managers from human resources, quality, and export services; three technical representatives; 13 sales/procurement professionals; and three high school students. In addition, Jennifer Simpson, the ITA’s executive director, also attended the event.

Michelle M. Pharand, the director of sales and business development for Dynamet Inc., was selected as the vice chair of the WiT committee for the 2015-2016 term. Pharand will work with Hickton to develop and implement plans for the group. Dynamet, a subsidiary of Wyomissing, PA-based Carpenter Technology Corp., is an international supplier of titanium alloy products for the aerospace, medical, consumer and recreation industries.

Pharand said she looks forward to serving as a mentor. “I want to work with young women in the industry and provide perspective on their challenges by sharing my challenges. I want to give them confidence. Yes, they can be successful in the titanium industry.”

Another goal for the WiT committee will be to support women involved in STEM in high schools and universities. The STEM education movement has gained traction in the United States in recent years; a curriculum designed to attract students, female and male, by providing them with skills needed for 21st century manufacturing and engineering fields.

Since January 2013 Pharand has served as director of sales and business development for Dynamet Inc. She has global commercial responsibility for titanium customer satisfaction, sales, customer service, logistics, conversion and sales offices.

As for reflecting on her own success in the titanium sector, Pharand cited two factors: her business mentors, male and females; and her global experience. “I’ve had great bosses over the years, mostly men,” she explained. “They took an interest in my success. They supported me and were loyal to me. They took time to teach me the skills I needed.” As a result, she hopes to bring that same spirit of mentoring to WiT.

Pharand, who hails from Sudbury, Ontario, Canada, spent more than six years at Carpenter’s Asia/Pacific headquarters located in Singapore, where she focused on developing business opportunities in China. In 2007 the company relocated her to Reading, PA; two years ago she accepted her current position, which is based in Pittsburgh. Pharand, who is fluent in French and English, achieved an honors bachelor of commerce degree in marketing and finance from Laurentian University, Greater Sudbury, Ontario, Canada. She graduated in 1993.
Some of the ideas generated in the brainstorming session of the WiT committee’s recent Los Angeles meeting included:
•    Building a roadmap to educate and provide instruction on how WiT members can reach out to middle school, high school and college students that have an interest in STEM courses.
•    Connecting with ASM International to add basic titanium metallurgy to its ASM Summer Camp, which educates teachers interested in learning more about titanium (a service provided to teachers free of charge).
•    Contacting the Minerals, Metals & Materials Society (TMS) Diversity Committee to learn more about its activities and how WiT might be able to participate.
•    Organizing industry-related tours in conjunction with the annual ITA TITANIUM conferences in Europe and North America.
•    Hosting regional meetings with the long-term goal of establishing an annual women’s leadership forum, which would include a variety of high-level speakers, training and networking sessions, and joint efforts with other professional organizations.

The WiT gathering in Los Angeles also offered a “Fundamentals of Titanium” workshop taught by Dr. James Robison. The full-day workshop provided technical knowledge of titanium design properties, procedures, products, treatment and safety. In addition, attendees enjoyed a tour of SpaceX facilities located in Hawthorne, a city in southwestern Los Angeles County. According to information posted on its website, SpaceX, founded in 2002, SpaceX designs, manufacturers and launches advanced rockets and spacecraft, which utilize titanium components.

Interviewed last September, Hickton urged those working to promote STEM education to develop meaningful, long-term partnerships with business community in order to understand what types of STEM skill sets are needed in the workplace. Quoted in a 2013 online interview posted on the STEM Blog (http://blog.stemconnector.org), Hickton described how her company, RTI, has launched a comprehensive strategy to connect diversity awareness with the STEM education thrust. RTI, she said, has an ongoing interest in recruiting material science (metallurgy), accounting/finance, engineering and IT professionals.

“As a business leader and woman in the STEM field, I am passionate about finding ways to increase the number of women and minorities in the field,” she said. “We believe that committing early to student education in the STEM fields will build robust pipelines of future STEM employees. Top-notch STEM professionals are critical for American businesses to stay at the forefront of global innovation, but our technical schools, colleges and universities are not graduating enough of these professionals to meet the demand,” she warned. “We must develop and support rigorous math and science curriculums in all American elementary and secondary schools so that there is a wide and deep pool of graduating seniors that are genuinely prepared for technical school and college-level STEM studies.”

Hickton became the chief executive officer of RTI in April 2007 and serves as a member of RTI’s board of directors. She has over 25 years of diversified metals business experience, including more than 16 years in the titanium industry. She serves as a director of the Federal Reserve Bank of Cleveland, and a trustee for the University of Pittsburgh. She is a 1979 graduate of the University of Rochester, NY, and received her juris doctor degree from the University of Pittsburgh’s School of Law in 1983.

The next WiT meeting is slated for May 11 as part of the TITANIUM EUROPE 2015 conference and expo. A plant tour of RTI’s Tamworth, UK, facility will also be offered on May 13 following the conference. For additional information on the ITA’s WiT committee, contact ITA’s headquarters in Colorado USA www.titanium.org

 
EXECUTIVE PROFILE; WOMEN IN TITANIUM
Michelle Pharand

Michelle M. Pharand is the director of sales and business development for Dynamet Inc., a subsidiary of Carpenter Technology Corp., Wyomissing, PA, which is an international supplier of titanium alloy products for the aerospace, medical, consumer and recreation industries. Pharand will serve as the vice chair of the International Titanium Association’s (ITA) “Women in Titanium” (WiT) committee for the 2015-2016 term. She will work with Dawne S. Hickton, the vice chair, president and chief executive officer of RTI International Metals Inc., Pittsburgh, to develop and implement plans for the group. Hickton, who last year was tapped as the first female president of the executive board for the ITA, announced plans to establish the WiT committee, during TITANIUM USA 2014, the ITA’s annual industry conference and exhibition, which was held in Chicago last September.


PHARAND’S INITIAL GOAL AS WiT VICE CHAIR
‘I plan to make myself available for mentoring. I want to work with young women in the industry and provide perspective on their challenges by sharing my challenges. I want to give them confidence. Yes, women can be successful in the titanium industry. I look forward to connecting with female involved in STEM (science, technology, engineering and mathematics) studies and will determine how best to reach out to STEM-related organizations.


RECALLING HER MENTORS
‘I’ve had great bosses over the years, mostly men. They took an interest in my success. They supported me and were loyal to me. They took time to teach me the skills I needed. As a result, I hope to bring that same spirit of mentoring to WiT.’


WHAT ENERGIZES YOU TO GO TO WORK EACH DAY?
Dynamet/Carpenter Technology Corp. is a good place to work and they have great people.


WHAT IS YOUR STRONGEST SKILL SET AS AN EXECUTIVE AND AS A PERSON?
Enthusiasm and drive combined with my strong work ethic.


GLOBAL EXPERIENCE
Pharand, who hails from Sudbury, Ontario, Canada, spent more than six years at Carpenter’s Asia Pacific headquarters located in Singapore where she focused on developing business in the China market. In 2007 the company relocated her to Wyomissing; two years ago she filled her current position, which is based in Pittsburgh. As an executive with Carpenter, she’s worked in various divisions and has had global responsibilities. She is fluent in French and English.


RESUME
Since January 2013 she has served as director of sales and business development for Dynamet Inc. In this role she has global commercial responsibility for titanium customer satisfaction, sales, customer service, logistics, conversion and sales offices. She had developed long-range plan to identify growth, new products, and evaluate the global competitive landscape for Dynamet. Prior to her current post, she served for three years (February 2010 to January 2013) as the director of Carpenter’s wire, strip and plate business unit. In that position she focused on short- and long-term strategic planning as well as new market development.


MEET THE PRESS
In April 2012 Pharand, while serving as Carpenter’s director of wire, strip and plate business, was interviewed by the Reading Eagle Business Weekly for an article titled “Carpenter Technology Cuts a New Path.” The story offered a profile of Carpenter’s efforts to develop specialty steel alloys for high-end knife makers. As quoted in the feature, she said ‘custom knife makers are a point of entry for us.’ Carpenter’s CTS Series of alloys was developed specifically for making fine-edged blades such as scissors, shears, surgical instruments and commercial cutlery. The company reached out to knife makers through a series of symposiums and invited leading craftsmen to take part in plant tours and discussions about the alloys with Carpenter’s metallurgists and engineers.


EDUCATION
Pharand achieved an honors bachelor of commerce degree in marketing and finance from Laurentian University/Universite Laurentienne, Greater Sudbury, Ontario, Canada. She graduated in 1993.


Praxis Tames Metal Injection Molding Process to Produce Implantable Titanium Medical Parts

Utilizing the metal injection molding (MIM) process, Praxis Technology, Queensbury NY, shipped its first implantable titanium MIM orthopedic medical parts in early 2015.

Working as a full-service contract manufacturer, Praxis is focused on developing titanium parts for the medical market. “Historically, titanium MIM is a challenging process,” Joe Grohowski, Praxis president and chief executive officer said, adding that Praxis is among the select few companies doing titanium MIM, and touts itself as having the only qualified production line.

The Praxis MIM process was qualified for the production of Grade 5 titanium implants in late 2014. Grohowski declined to identify the customer or the type of titanium parts being made via MIM.

Praxis began implantable part production in 2008, manufacturing porous ingrowth surfaces using titanium powder metallurgy. Two years later, Praxis began to build out the titanium MIM production line. “Doing development work in a lab isn’t the same as a commercial manufacturing line,” he said.

According to company literature, Praxis’ OrthoMIM technology offers design flexibility and cost savings specifically for orthopedic devices. It combines the company’s high-fatigue performance material (TiRx™) with net-shape surfacing technology (3DT™) to create complex surfaces on medical implants.

Along with the MIM process, the company also developed technology to impart the proper porous surface and texture to facilitate osseointegration (bone growth) for orthopedic implants. Praxis’ third-generation porous surface technology creates net shape porous surfaces on high performance Ti-6Al-4V co-formed substrates. Net-shape osseointegration surfaces are achieved by placing additively manufactured “sacrificial” inserts, which mold the surface and the body of the implant in one injection step, he said.

A typical integration layer may include a fixation texture region—the portion of an implant that provides for initial fixation of the device during surgery. Grohowski said most orthopedic devices are manufactured with some type of integration surface. This surface may be a simple roughened “on-growth” surface or a more complex porous “in-growth” surface. In-growth surfaces are increasingly becoming the standard of care on many orthopedic devices. The in-growth region is the portion of implant that is intended to promote growth of tissue into the device for long-term fixation. By incorporating the formation of these surfaces into the molding process, he said value is added and overall cost is reduced for the TiMIM product.

TiMIM is a four step manufacturing process comprised of compounding, injection molding, debinding and sintering to produce a final geometry, Grohowski said. The compounded mixture is pelletized to form a feedstock suitable for injection molding. Praxis has validated Ti-MIM process in relation to ASTM F2885, as well as additional technologies that have been developed to enhance Ti-MIM’s applicability to the orthopedic market and other markets demanding high fatigue performance.

Praxis purchases its titanium powder from an outside vendor. The Ti-6Al-4V Grade 5 material is produced in an ISO-13485 certified environment. Titanium powder goes through a proprietary, computer-controlled compounding line, which includes the introduction of a thermoplastic binder to create the titanium MIM pellets. The titanium powder and thermoplastic are compounded at precise levels.

The production line includes a 4.5 cubic foot MIM sintering furnace and a single electric injection molding machine built by ARBURG GmbH & Co. KG, Lossburg, Germany. (Grohowski declined to provide details on the size or capabilities of the equipment.) “While we currently have one (injection molding) machine, our molding bay has room for four more,” he pointed out. The line operates in a dedicated facility to prevent contamination for medical-grade material and end products. He said special care is taken to prevent the buildup of combustible titanium dust.

After debinding, the MIM parts are placed on ceramic setters and loaded into a furnace for high-temperature processing. During the early stage of sintering, the remaining binder is thermally decomposed. Following this initial stage, the parts are heated to a high temperature where densification occurs, resulting is significant shrinkage of up to 20 percent. Once this process is complete, the part is hot isostatic pressed to achieve full density.

Grohowski said production includes a broad spectrum of parts; from net-shape components to parts that need secondary machining operations. Depending on the parts’ requirements and specifications, finishing operations may include machining, surface enhancements, coining, passivation, anodization, and assembly. Praxis has in-house CNC machining and surface-finishing capabilities.

Near-term plans call for Praxis to expand the operation to a second dedicated production line. Grohowski founded the company in 1999. The 18,500-square-foot facility has 40 employees and is ISO 13485 certified and will be AS9100 certified in the third quarter of this year.

Solving Titanium Implant Osseointegration Problems by Using Epoxy/Carbon-Fiber-Reinforced Composite By Richard C. Petersen

Introduction
This article, published online on Dec. 5, 2014 by the National Institute of Health Public Access (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4307950), presents recent developments in material research with bisphenyl-polymer/carbon-fiber-reinforced composite that have produced highly influential results toward improving upon current titanium bone implant clinical osseointegration success.

As indicated in the online posting, this is the publisher’s final edited version of this article. The text, as it appears here in Titanium Today, is a further condensed and edited version of the article by Petersen.

Petersen acknowledges that titanium is the standard intra-oral tooth root/bone implant material with biocompatible interface relationships that confer potential osseointegration. Titanium produces a TiO2 oxide surface layer reactively that can provide chemical bonding through various electron interactions as a possible explanation for biocompatibility. Nevertheless, titanium alloy implants produce corrosion particles and fail by mechanisms generally related to surface interaction on bone to promote an inflammation with fibrous aseptic loosening or infection, which can require implant removal.

To provide improved osseointegration many different coating processes and alternate polymer-matrix composite (PMC) solutions have been considered that supply new designing potential to possibly overcome problems with titanium bone implants. PMCs have decisive biofunctional fabrication possibilities while maintaining mechanical properties from addition of high-strengthening varied fiber-reinforcement and complex fillers/additives to include hydroxyapatite or antimicrobial incorporation through thermoset polymers that cure at low temperatures.

Petersen, in this article, reviews titanium corrosion, implant infection, coatings and the new epoxy/carbon-fiber implant results discussing osseointegration with biocompatibility related to nonpolar molecular attractions with secondary bonding, carbon fiber in-vivo properties, electrical semiconductors, stress transfer, additives with low thermal PMC processing and new coating possibilities.

Titanium for Dental Applications
Commercially pure titanium (CPTi) is generally reserved for dental applications due to an extremely stable oxide TiO2 thin surface layer that resists corrosion under physiologic conditions and forms a fine interfacial direct metal-to-bone contact as osseointegration. Titanium metal has a relatively low modulus for metal. Subsequent low-modulus materials close to bone reduce problems with “stress shielding” so that more uniform stress transfer occurs between the implant and bone to prevent bone resorption from periods with lack of pressure.

In addition, the workhorse titanium aerospace alloy, Ti-6Al-4V, is used for dental implants. Though stronger than CPTi, biocompatibility is a concern for this ally due to aluminum and vanadium ions. Ti-6Al-4V also has been used for orthopedic hip implant stems, but the alloy is particularly prone to geometrical notch sensitivity with crack propagation and further wears excessively as the chief concern.

Various titanium alloys are also used in medical applications to repair craniofacial defects caused by trauma, surgical removal of cysts and tumors, infections, fractures that do not join and congenital or developmental conditions.

Titanium failures in medical applications occur and appear related to factors that discourage stabilized bone osseointegration, such as trauma from overloading, micromotion and surgical burden to support inflammation without proper healing; and in a small percentage, due to infection next to exposed metal surface as the final destructive mechanisms for implant loosening. Also, the healing response involves serum-protein adhesion to the implant that can promote bacterial attachment to a biomaterial surface.

Recent technology, supported through aerospace/aeronautical development with epoxy/carbon-fiber-reinforced composites, has demonstrated far-reaching osseointegration increases for titanium implants when compared to Ti-6Al-4V alloy in animal research. Fiber-reinforced composite can offer superior mechanical properties than metals on a strength-to-weight basis for both strength and modulus.

Occlusal forces (the muscular force exerted on teeth when the jaws are closed or tightened) interact with titanium implants more harshly than natural tooth structure because of intimate bone osseointegration contact without a damping protective periodontal ligament where titanium metal cannot adsorb damaging energy similar to a PMC.

In-vivo animal testing with extreme loads produced defects lateral to osseointegration between bone and metal implant. Conversely, in relation to encouraging test results PMCs with carbon fiber reinforcement can supply densities/modulus much closer to bone than titanium for improved mechanical deformation providing viscoelastic damping energy adsorption/dissipation and healthy stress transfer with tissues/cell membranes.

Corrosion
Corrosion is a diffusion interfacial electron-transfer process that occurs on the surface of metals. Titanium reacts with oxygen electrochemically rapidly in the presence of water to form a fine oxide layer of TiO2 that prevents further oxidation. The TiO2 surface layer protects titanium under normal biologic conditions to regenerate if removed by reactive corrosion equilibrium products as passivation barrier formation and confers high corrosion resistance. Titanium can form an oxide layer 10 angstroms thick in a millisecond and 100 angstroms in a minute. In the passivated state, TiO2 biomaterials generally corrode less than 20 μm/year.

Different types of common corrosion have been classified for titanium implants. When acid breaks down the passive TiO2 oxide layer on a flat surface pitting corrosion occurs. On the other hand, geometric implant material confinement of acid produces increased metal dissolution known at crevice corrosion. Friction between the TiO2 oxide layer against another surface causes fretting corrosion. When titanium is in direct contact with a dissimilar metal that is common to both oral and orthopedic implants galvanic corrosion occurs.

Subsequent electrochemical corrosion products from metal implants are thought to be damaging on local tissues particularly with respect to low intensity electromagnetic fields that are known to develop by corrosion and can then inhibit osteoblast growth. Aseptic loosening of implants is thought to occur as a reaction to metal particles from corrosion that can produce an electric occurrence with electromagnetic field, where lower pH next to a titanium implant needs overall general consideration.

Titanium particles from implants are reduced in size by corrosion over time to commonly produce a dark blackened tissue stain. Titanium particles found in adjacent soft tissue have been known to produce inflammation, fibrosis and necrotic tissue while infection was found to be a key reason for implant failure where pain was further noted as a clinical concern. Microbial influences can also increase corrosion. In terms of inflammation, titanium metal alloy particle release from implants can result in bone destruction. Alternatively, after surgical implant placement, chronic inflammation that continually heals can eventually form a fibrous capsule union between the implant and bone that leads to failure.

Osseointegration and antimicrobial properties are hard to realize with titanium/titanium alloy implants, probably because biocompatibility with function is difficult using metal. Although polymers have been identified for biomaterial use because of high biologic functionality, polymers lack mechanical strength needed with hard tissue implants. In terms of polymer biocompatibility with sufficient strength, PMCs using high-strength fibers provide answers. Fibers are the strongest and possibly the stiffest forms of a substance matter.

When combined into a thermoset cure crosslinking polymer matrix, fiber-reinforced composite materials provide design possibilities for ultimate potential in bone implant osseointegration toward biocompatibility with biofunction. Most importantly, fiber-reinforced PMCs compete with metals especially on a strength-to-weight basis in required mechanical properties.

In comparison to a new bisphenol-epoxy/carbon fiber-reinforced composite implant material, titanium alloy Ti-6Al-4V produces significantly less bone forming near the implant with much lower levels of osseointegration contact in a bone-marrow animal implant model.

Conclusions
Osseointegration bonding occurs by different covalent electron sharing and ionic mineralization mechanisms. TiO2 osseointegration produces ionic bonds by even oxidation states that act in coordination with the mineralization phase of bone. PMC osseointegration appears to produce covalent bonds by free-radical crosslinking with exposed unpaired electrons of the polymer following acid degradation while organic portions of the bone matrix or bone-cell plasma membrane condense by covalent bonding onto acid or hydroxyl groups of the oxidized carbon fibers.

Further mechanical interlocking is achieved with rougher surfaces and with the PMC by acid degradation polymer removal can occur even with possible bone growth surrounding individual 7 μm diameter carbon fibers.

Low pH polymer softening by acid is considered now to aid in adsorbing excessive stresses by a protective damping mechanism. Low-temperature thermoset polymer cure allows fillers and organic additives to be incorporated by planned design with new tissue engineering for bone implants toward biosuccess. Fillers and additives can be included either in the bulk implant material that is polished to reduce microbial attachment colonization or in extremely mild resorbable coatings for rapid release to stabilize the initial implant surgical placement.

Future research directions should examine implications clinically for the robust benefits and also surgical problems particularly during possible revision taking into account such strong osseointegration for the bisphenol-epoxy/carbon-fiber implant.

(Information on the author: Richard C. Petersen, D.D.S., M.S., Ph.D., departments of Biomedical Engineering, Biomaterials and Restorative Sciences, University of Alabama at Birmingham, Birmingham, AL 35294; Email: ude.bau@embhcir; Phone: 205-934-6898.)

PER-INGVAR BRANEMARK, 85; PIONEERED OSSEOINTEGRATION FOR DENTAL IMPLANTS


The passing of Swedish physician Dr. Per-Ingvar Branemark on Dec. 20, 2014 marked the final chapter for the life of a titanium pioneer, whose legacy lives on as the “father of the modern dental implant.” Branemark, who was 85, succumbed in his hometown of Gothenburg, Sweden.

An obituary in the Dec. 27, 2014 edition of The New York Times, praised Branemark as the person who achieved a “major advance in dentistry, liberating millions of elderly people from painful, ill-fitting dentures, a diet of soft foods and the ignominy of a sneeze that sends false teeth flying out of the mouth.”

“Per-Ingvar Branemark, who was known as the father of the modern dental implant, played an integral role in advancing the oral health of millions of people,” Dr. Maxine Feinberg, the president of the Chicago-based American Dental Association (ADA), said. “The development and use of (titanium) implants was one of the greatest advances in dentistry during the past 40 years.”

The discovery that bone fuses to titanium—a process called osseointegration—led to permanent dental replacements, the Times obituary noted. With the fusing of titanium implants to bone, implants “locked into the jaw bone as cells attach to its titanium surface.” Gosta Larsson, a man with a cleft palate, jaw deformities and no teeth in his lower jaw, became Branemark’s first titanium dental implant patient during the mid-1960s.

According to the obituary, Branemark’s discovery of titanium osseointegration was an accident. “At the start of his career, he was studying how blood flow affects bone healing. In 1952, he and his team put optical devices encased in titanium into the lower legs of rabbits in order to study the healing process. When the research period ended and they went to remove the devices, they discovered to their surprise that the titanium had fused into the bone and could not be removed. Branemark’s research took a whole new direction as he realized that if the body could tolerate the long-term presence of titanium, the metal could be used to create an anchor for artificial teeth.”

However, despite demonstrating the success and potential of osseointegration in titanium dental implants, there were various challenges to convince the medical and dental establishment that titanium could be integrated into living issue. The conventional wisdom was that the introduction of any foreign material into the body would inevitably lead to inflammation and, ultimately, rejection. The Times article stated that, for years, Branemark’s applications for grants to study implants anchored in bone tissue were rejected. The United States National Institutes of Health finally financed the project, and in the 1970s, Sweden’s National Board of Health and Welfare approved the Branemark implants.

A turning point came in 1982 at a professional meeting in Toronto, where Branemark made the case for osseointegration and won widespread recognition for his materials and methods. Since then, millions of people worldwide have been spared dentures because of his work.

Branemark received an honorary ADA membership from the ADA Board of Trustees in 2008 for his dedication to the profession of dentistry. “I think what impresses me the most is that Dr. Branemark’s ability to think beyond his own medical specialty area allowed him to take a serendipitous finding and apply it to dentistry, leading to the development and widespread acceptance of dental implants,” said John Dmytryk, Department of Periodontics professor at the University of Oklahoma College of Dentistry and ADA Council on Scientific Affairs member. Dmytryk was quoted in an article in the Jan. 7, 2015 edition of ADA News. “Implants became a major advancement in dentistry after Dr. Branemark and his team accidentally discovered that titanium could fuse into bone safely.”

Branemark’s system of dental implants is now manufactured and sold by Nobel Biocare and still marketed as the “Branemark System. Headquartered in Zurich, Switzerland, Nobel Biocare is a global company that provides “innovative implant-based dental restorations…offering high-precision individualized prosthetics and CAD/CAM systems as well as diagnostics, treatment planning, guided surgery solutions and biomaterials,” according to information posted on the company’s website.

As it turns out, Branemark’s work in the development of titanium dental implants has extended to other medical applications. The Times obituary pointed out that osseointegration is now used in medical and veterinary applications. Examples include titanium implants for people with large facial injuries and those in need of external hearing aids.

Among his many accolades during his distinguished career, Branemark was awarded the Swedish Engineering Academy’s medal for technical innovation, the Swedish Society of Medicine’s Soderberg Prize and the European Inventor Award for Lifetime Achievement.

A close associate of Branemark was fellow Swedish citizen Dr. Tomas Albrektsson, who contributed to the development of osseointegrated oral and craniofacial clinical treatment, with international breakthroughs in 1982 and 1992. He also is a senior member of team that has developed new osseointegrated hip arthroplasties for clinical usage.

Albrektsson was a head of Bone Research Group at the Laboratory of Experimental Biology, Department of Anatomy, University of Göteborg, Sweden from 1980 to 1986. Today he serves as a member of the Department of Clinical Sciences at Sahlgren’s Academy, Göteborg University, and frequently speaks at medical and dental forums throughout the world. He is the author of about 650 abstracts, reviews and scientific papers on bone grafts, vital microscopy of bone, experimental implants, oral and craniofacial reconstructions and orthopaedic implants.

Market Observers Weigh Mergers by Medical Device Manufacturers

Much like the consolidation that has taken place in the titanium industry in recent years, presumably to fortify the global supply chain and reduce costs by integrating upstream and downstream operations, the original equipment manufacturers in the medical sector—companies that produce titanium orthopedic/surgical implants and related devices—are undergoing similar merger and acquisition activities.

One of the more active players has been Stryker Corp., Kalamazoo, MI, which, earlier this year, was the subject of market speculation for its acquisition strategy. Various news sources, including Bloomberg, reported Stryker was mulling the purchase of London-based Smith & Nephew Plc. A Stryker spokeswoman based in Kalamazoo, when questioned on the press reports, would only say that “as a matter of company policy, Stryker does not comment on merger and acquisition matters.”

Smith & Nephew, according to information posted on its website, describes itself as a global medical technology company producing implants and devices used in orthopaedic reconstruction (joint-replacement systems for knees, hips and shoulders); advanced wound-management products; sports medicine (minimally invasive joint surgery); and trauma (devices and inserts used to repair broken bones). Smith & Nephew has 14,000 employees, operates in more than 90 countries, including the United States, and in 2014 registered annual sales of $4.6 billion.

Stryker produces medical reconstructive, surgical, neurotechnology and spine products. Like Smith & Nephew, Stryker has a global reach, operating in over 100 countries. In 2014, Stryker’s net sales totaled $9.7 billion, with net earnings of $515 million.

In March, Stryker announced plans to buy back an additional $2 billion worth of shares, a move to boost shareholder value and, according to some business analysts, “quell speculation” it would bid for Smith & Nephew. The Wall Street Journal reported the Stryker board’s approval of the repurchase brings the company’s stock-buyback program to a total of roughly $2.58 billion.

Stryker Chief Executive Officer Kevin Lobo, quoted in various news wire stories, said the company remains committed to a capital allocation strategy that includes acquisitions, share buybacks, as well as dividends. “While (merger and acquisition) activity across the breadth of our product and service offerings will remain the primary focus of our long-term growth strategy, this new authorization recognizes that the strength of our balance sheet is sufficient to enable more significant share repurchases.”

While it declined to comment on any interest it may have in Smith & Nephew, Stryker, in February, opened its new European regional headquarters Amsterdam, the Netherlands. According to a company press release, Lonny Carpenter, Stryker’s group president for global quality and operations, and European business operations, said the opening of the Amsterdam site “is an exciting milestone for Stryker that demonstrates our long-term commitment to Europe and our global business. There is significant opportunity for growth in Europe. Stryker is committed to continuously improving our business in this region so we have established the new headquarters to support these aspirations.”

Along with eyeing business opportunities in Europe, Stryker has been active on the acquisition trail in order to diversify and strengthen its reach into the healthcare sector. In January, the company purchased the assets of privately-held CHG Hospital Beds Inc., based in London, Ontario, Canada. CHG sells hospital beds that serve markets across Canada, the United States and the United Kingdom.

In recent years, Stryker acquired Small Bone Innovations Inc., a producer of ankle replacement products, and Trauson Holdings Co. Ltd. of China, manufacturer of instruments and implants for trauma and spine. The Wall Street Journal, in its Sept. 25, 2013 edition, reported that Stryker agreed to acquire Mako Surgical Corp. and its robotic-surgery platform, “a move aimed at distinguishing Stryker’s line of replacement knees and hips for its increasingly cost-conscious hospital customers,” according to a company spokeswoman. She noted that Mako would help Stryker cater to hospital and insurance executives who increasingly want new devices to help reduce overall costs.

For its part, Smith & Nephew, in May 2014, finalized its acquisition of Austin, TX-based ArthroCare Corp., in a $1.5 billion deal to gain orthopedics products used in sports medicine for minimally invasive surgery.

Bloomberg recently reported that two large manufacturers of surgical products and medical supplies, Medtronic Inc. and Covidien Plc, are in the process of completing a merger, Zimmer Holdings Inc.’s agreement to buy Biomet Inc. for $13.4 billion is undergoing regulatory review.

What’s driving the merger and activity moves among producers of medical implants and devices? What will it mean for the titanium industry? All signs point to the critical need to reduce cost in the global supply chain as well increase product quality and make distribution more reliable and timely. It’s likely that a more consolidated titanium supply chain will be doing business with consolidated original equipment manufacturers in the medical device market.

Business executives, who have addressed the annual TITANIUM conferences during the last two years, have said that while many markets have suffered significant deterioration and employment cutbacks in the wake of the 2008/2009 financial crisis, the medical industry continues to expand. The orthopedic market in the United States is valued at $15 billion.

However, while titanium’s near-term opportunities in the medical field are lucrative, several experts offered words of caution regarding downward cost pressures and challenges to the global supply chain for medical devices. News reports note that medical device companies are looking to consolidate as hospitals and insurers demand better prices from suppliers to tame rising costs.

For example, Robert J. Daigle, senior vice president, Structure Medical, LLC, Naples, FL, outlined how medical device manufacturers are under mounting pressure to reduce costs—a trend that would impact the titanium industry. He said stakeholders in the healthcare industry “are communicating their plans to seek less expensive alternatives to brand-name medical devices that could provide similar clinical outcomes, potentially squeezing profits from manufacturers and the supply chain.

“Medical device manufacturers are reporting increasing pressure to lower prices, driven by stakeholders’ interest in lowering their cost,” he continued. “This pressure is being driven down through the supply chain. Hospital sustainability depends on their ability to reduce cost.”

He urged titanium companies that do business in the medical field to concentrate on supply-chain issues. “Remove the waste from your operations. Make it easy and cost efficient to do business with your company. Work closely with your customers to identify waste, and then remove it. Provide your customers with solutions; if not, someone else will.”

President Titanium Earns a Place on Biomet’s Approved Suppler List

President Titanium Inc., Hanson, MA, recently became qualified as an approved supplier of titanium mill products for Biomet Inc., Warsaw, IN, a global producer of orthopedic and musculoskeletal products—a move that could spark expanded business for President Titanium in the medical industry.

Shawn MacLeod, President Titanium’s vice president, said Biomet began auditing the titanium distributor’s operations last January and one month later placed President on its approved supplier list (ASL). “Biomet did a full quality audit and they were very impressed,” MacLeod said. “Our hope is that, by being on the ASL for Biomet, it will open new doors for us in the medical field.”

The ASL qualification is significant vote of confidence for a supplier like President. Ten years ago, off-spec titanium from Asia found its way into U.S. medical applications, creating significant quality issues for medical device and implant original equipment manufacturers. Since then, there has been greater scrutiny on companies participating in the medical supply chain. MacLeod said President stocks only titanium products melted and manufactured in the United States.

Established in 1973, President is a family owned global supplier of titanium mill products, working in the aerospace, medical and military business sectors. Joseph E. MacLeod, Shawn’s father, is the president and founder of the company. In addition to its 5,000 North American customers, President ships products to Australia, Singapore, Israel, South America, China, and Europe—an estimated 500 offshore companies. According to information posted on its website (http://www.presidenttitanium.com), President is ISO 9001:2008 registered and is an approved suppler for Pratt & Whitney (LCS), Boeing, Rolls Royce, GE and others.

President has a 40,000-square-foot facility in Hanson with 23 employees and 15 stations for cutting titanium bar and plate. MacLeod said the company can provide near-net-shape specialty sizes of material for its customers. On average, President carries over 1 million pounds of titanium inventory.

Biomet, founded in 1977, has annual sales over $2.5 billion with 9,000 employees. It designs and produces hip and knee implants, and products for trauma, spine, bone healing, and dental reconstruction.


Industry Executives Track Opportunities, Cost Pressures in Global Medical Market

Titanium industry executives, offering presentations at the annual TITANIUM conferences during the last two years, have underlined the importance of the medical sector as a global, high-growth market. They’ve pointed out that while some business sectors have suffered significant deterioration and employment cutbacks in the wake of the 2008/2009 financial crisis, the medical industry continues to expand. However, while titanium’s near-term opportunities in the medical field are lucrative, several speakers have offered words of caution regarding downward cost pressures and challenges to the global supply chain for medical devices.

Some industry sources said they don’t foresee any major material advances on the horizon, in terms of new titanium alloys that target medical applications. Instead, the expectation is for steady, incremental improvements in metal grades that offer enhanced strength, wear resistance, and properties that encourage bone to fuse to titanium—a process called osseointegration.

Members of the Baby-Boomer generation continue to age gracefully (and somewhat defiantly) while pursuing active, healthy lifestyles, which include an emphasis of a host of recreational pursuits such as golf, tennis, running, cycling, softball and swimming. As a result, the conventional wisdom is that there will be a steady, growing demand for medical implants and devices to repair and replace broken bones and worn-out joints. In addition, controlling healthcare costs remains a major economic and political issue in the United States and the hope among industry leaders is that titanium maintains its edge as a cost-effective material of choice for medical applications.

One example of the importance of the medical market for titanium is illustrated by the Remmele Medical unit of the Engineered Products and Service Segment business of RTI International Metals Inc., Pittsburgh. Remmele, based in Minneapolis, had revenues of $55.5 million in 2012. By contrast, revenues for aerospace that year by RTI’s Engineered Products and Service Segment totaled nearly $214 million. Products for the Remmele group include minimally invasive surgical tools (jaws, blades, and grips), spinal and dental implants, urology sling components, and drug infusion components. Production capabilities for the Remmele unit feature automated machining cells, 3-, 4- and 5-axis milling, laser machining, and various secondary operations.

Many titanium industry executives look to ongoing improvements in additive/3-D manufacturing technology and titanium alloys as areas that will yield significant advances in medical part production (see related story in this edition). Ric Snyder, product manager, Fort Wayne Metals, Fort Wayne, IN, said his company is one year into the roll out of 4TiTUDE™, which he said combines the strength of an alloyed titanium grade with the beneficial attributes of commercially pure Grade 4 Titanium. Snyder said the material is being evaluated for medical applications such as dental implants and orthopedic bone screws.

According to company literature, 4TiTUDE provides a balance between the beneficial properties of commercially pure Titanium and the strength of alloyed titanium such as TiZr or Ti 6Al-4V. “With a minimum tensile strength of 1,172 Mpa (170 ksi) in diameters up to 4 mm and 1,103 Mpa (160 ksi) in diameters from 4-6 mm, 4TiTUDE is just as strong as cold-worked alloyed titanium,” the company wrote. “This is a significant increase from cold-worked commercially pure Grade 4 titanium, which typically exhibits tensile strengths in the range of 950 Mpa (138 ksi). This means that 4TiTIUDE allows you to design smaller implants from unalloyed titanium, without sacrificing strength.”

Fort Wayne, on its website, states that, apart from a significant increase in strength, 4TiTUDE is “equivalent” to commercially pure Grade 4 titanium as it “meets all requirements of ASTM F67, which means that it won’t release toxic aluminum or vanadium ions. Since 4TiTUDE is commercially pure, it doesn’t only promote osseointegration, we also expect it to be compatible with osseointegrative coatings such as hydroxyapatite or calcium phosphate.”

The vast majority of Fort Wayne’s business is dedicated to the medical market, Snyder said. In addition to titanium, the company offers other materials such as stainless steel, cobalt/chrome and Nitinol. Products include helical hollow strand (HHS) tubing, wire, strands and cables, straight linear torque (SLT) wire, composites, and centerless ground bar.

Andy McElwee, vice president, sales and operations, VSMPO-Tirus, US in Leetsdale, PA, said orthopedic applications, especially hip and knee replacements, continue to drive medical market applications for titanium. Trauma applications, such as bone plates and screws, and spinal components represent the two other major sales areas for the medical market. Industry sources estimate the current United States orthopedic market is valued at $15 billion.

McElwee attributed this demand for orthopedic applications to Baby Boomer lifestyles. “As the Baby Boomer generation keeps getting older, there will be more demand for implants,” McElwee observed. “Baby Boomers are staying more active, playing sports and getting hurt more often. They’re wearing out their hips and knees.”

The technology for hip and knee implants, as well as the medical techniques to operate and replace these parts, also has gotten significantly better during the last 10 years—in part, due to the Baby Boomer attitudes as the “impatient” generation. “Boomers say they want to have their knee or hip fixed right away, and they want to be playing golf or tennis in six weeks,” he said with a chuckle. In addition, he said new generations of titanium materials and product designs have improved for medical applications, which translate into longer-lasting joint replacements and reduced pain and rehab time.

In terms of business trends, McElwee noted the ongoing consolidation among hospitals, treatment clinics and medical centers, as well as consolidation among the original equipment manufacturers that produce titanium implants. He said executives in the titanium industry would be wise to follow these developments and anticipate how it will affect business in the medium and long term. Some industry executives and observers anticipate there will be downward pressure on titanium pricing and profits due to this consolidation. (See the related market analysis article in this edition on speculation concerning Stryker Corp. and Smith & Nephew Plc.)

Another key business trend worth tracking is the global growth and demand for titanium medical products and implants. “Right now, a large majority of the medical business for titanium implants is in North America, Western Europe and Japan,” McElwee said. “But now we’re starting to see demand coming from places like China, India and South America. These are regions with a growing middle class. At the moment, these markets are in their infancy, but they represent growth markets for titanium medical applications.” Considering the emerging trends of global growth and downward pressure on titanium prices and profit margins, the titanium industry will need to closely monitor its supply chain metrics and logistics.

Like McElwee, a marketing executive with Vulcanium Metals International LLC, has observed the downward pressure to control prices in the medical market. He said this pressure comes from the hospital/medical center level, a highly leveraged group looking to keep costs low.

This Vulcanium executive said current market dynamics require metal distributors and service centers to provide a diverse portfolio of product choices. As such, in addition to titanium bar, plate and sheet, Vulcanium also offers specialty stainless steels grades and cobalt/chrome/molybdenum alloys. “Our strategy is to work with our customer base in a business development role, to provide the materials they need, whether it’s titanium or other metal alloys,” he said. Vulcanium is part of the high-performance metals group of O’Neal Steel Inc., Birmingham, AL.

The conversation with the Vulcanium executive also proved to be instructive regarding American business history, as he pointed out that nearby Warsaw, IN, is the global hub for the orthopedic device and implant business, with roots that date back to the 1890s.

The OrthoWorxIndiana website (http://orthoworxindiana.com) touted Warsaw’s orthopedic/medical device cluster of original equipment manufacturers and tier-two vendors (a total of over 40 companies and 13,000 employees) as “one of the most concentrated centers of economic activity anywhere in the United States.” The “who’s who” list of heavyweight companies includes Medtronic, Zimmer, DePuy (J&J), Symmetry and Biomet. Overall, the Warsaw cluster represents nearly one-third of the estimated $38-billion global orthopedic sales market, according to OrthoWorxIndiana.

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