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TABLE OF CONTENTS:

Quality of Life
Bio-Compatible
Titanium—A Global Material of Choice
Low Modulus of Elasticity
Food and Pharmaceutical
Anodizing
TITANIUM USA 2016 Executive Summary - Titanium in Medical Technology
ITA’s Medical Technology Committee Update
ITA’s Medical Technology Committee Members
Medical editions of Titanium Today

 

     

Medical Technology

Quality of Life
Titanium improves the quality of individual lives when it is used for medical and dental implants, prosthetic devices, eyeglasses and even lightweight wheelchairs. World product shipments are estimated at over 60,000 metric tons, of which at least 50% was used in applications other than aerospace.

Bio-Compatible
Titanium is the most bio-compatible of all metals due to its corrosion resistance, strength and low modulus. This excellent level of biocompatibility as determined by in vitro cell culture tests has been confirmed by in vivo observations directly in numerous patients with total joint prostheses. The unwanted biological effects are about 10 times less frequent in patients with titanium implants than in those patients with implants made from other alloys. Where Ti-6Al-4V has been used, the low concentration of titanium, vanadium and aluminum in body fluids from patients with heavy wear on the prosthesis demonstrates the low dissolution rate of the wear particles.

Titanium is thus widely used for implants, surgical devices and pacemaker cases. Its use for hip replacements and other joints, has been well established for some 40 years. Titanium not only fosters Osseointegration (joins with bones & tissues), it is non-magnetic and non-radio opaque. Titanium instruments are used for micro-surgical operations and in military light weight field trauma relief kits.

Some prostheses are engineered with roughened surfaces or porous coatings (such as hydroxy-apaptite) which hasten the bonding of titanium with adjacent hone. Surface treatment, including shot peening, nitriding and diamond like coatings may be used to provide enhanced wear resistance.

Commercially pure titanium. Ti-6Al-4VELI and Ti-6Al-7Nb (367) continue to be the most frequently specified materials for prosthetic use. Earlier concerns about release of vanadium and/or aluminum from alloys have been largely resolved.  Commercially pure titanium and most alloys are effectively nickel free and will not cause nickel dermatitis.

Titanium—A Global Material of Choice
Titanium in the 21st century has emerged as a high-performance metal specified for demanding industrial, medical and commercial applications throughout the world. A wide spectrum of applications verify titanium’s strong global profile: aerospace engine components and structural components built in North America and Europe; desalination systems in the Middle East; modern, high-profile architectural structures in Asia; offshore oil and gas exploration throughout the world; and an array of chemical processing and infrastructure projects in all major international markets. 

Further evidence of titanium’s global presence can be found in the recent expansion of metal and sponge production capacity at sites in Russia, China, Japan and the United States. And industry experts from the four corners of the world gather at the annual TITANIUM conference and exhibition, sponsored by the International Titanium Association, bringing news of titanium developments and success stories. Titanium indeed has come of age as a global material of choice.

Low Modulus of Elasticity
Titanium’s low modulus means excellent flexibility and strong spring back characteristics. This promotes its use in various springs for aircraft and valves, where a modulus half that of steel, but a strength equivalent to steel allows a titanium spring to be half as large and heavy. This property also benefits auto parts (which must absorb shock), medical implants (that must move with the body), architecture (where roofs must resist hail stones), as well as recreational gear (golf clubs, tennis racquets, mountain bikes and skis).

Food and Pharmaceutical
Titanium demonstrates excellent corrosion resistance, not only to various food products and pharmaceutical chemicals, but also to the cleaning agents utilized. As equipment life becomes a more critical factor in financial evaluations, titanium equipment is replacing existing stainless steel apparatus. Titanium can also eliminate the problems of metal contamination.

Titanium is thus widely used for implants, surgical devices and pacemaker cases. Its use for hip replacements and other joints, has been well established for some 40 years. Titanium not only fosters Osseointegration (joins with bones & tissues), it is non-magnetic and non-radio opaque. Titanium instruments are used for micro-surgical operations and in military light weight field trauma relief kits.

Some prostheses are engineered with roughened surfaces or porous coatings (such as hydroxy-apaptite) which hasten the bonding of titanium with adjacent hone. Surface treatment, including shot peening, nitriding and diamond like coatings may be used to provide enhanced wear resistance.

Commercially pure titanium. Ti-6Al-4VELI and Ti-6Al-7Nb (367) continue to be the most frequently specified materials for prosthetic use. Earlier concerns about release of vanadium and/or aluminum from alloys have been largely resolved. Commercially pure titanium and most alloys are effectively nickel free and will not cause nickel dermatitis.

Titanium’s remarkable combination of metallurgical and physical characteristics can generate an array of benefits for demanding industrial and commercial applications in global markets. It’s most successfully employed when the initial design exploits its unique attributes, rather than when it’s merely substituted for another metal. In some demanding applications, like jet engines and medical implants, titanium allows the item to perform to its maximum potential.

Titanium has been used in medical applications since the 1950’s. It’s the most biocompatible of all metals and in prosthetic and joint-replacement devices it actually allows human bone growth to adhere to the implants so they last longer. Pacemaker cases are made from titanium because it resists attack from body fluids, is lightweight, flexible and non-magnetic. Artificial heart valves are also made of titanium.

Anodizing
Titanium is one member of a family of metals (that includes niobium and tantalum) that color anodizes because it is “reactive”, i.e. it reacts when excited by heat or electricity in an electrolyte by creating a thin oxide layer at the surface.   The oxide layer presents itself in color due to an interference phenomenon. This layer is a very thin, transparent coating that derives its ‘color’ when white light reflects off the base metallic surface, only to be “interfered with” within the coating.   Some frequencies of light waves escape and recombine with surface light to be either reinforced or cancelled out—producing the color we see.

Anodized coatings can be applied to titanium for a number of reasons:  General color-coding, Product/part identification, Material Identification, Size identification, Corporate color matching, Product appeal enhancement, Aesthetics, and Enhanced properties.

Titanium anodizing provides some products with improved properties compared to those in a raw or “unfinished” state.   Test data validate numerous mechanical benefits, and observation with a 10x eyepiece reveals the leveling effects of the process.   Scars from machining and/or deburring are ‘leveled’ into a continuous, smoother, gray-colored surface. The two most common types of treatment are Type II anodizing and color anodizing.  Type II Anodizing Anodic treatment of titanium and its alloys is typically performed in accordance with SAE International’s AMS 2488 Standard. The process is covered under an Aerospace Material Specification, as it was first developed for treatment of parts associated with the air and space industries. Advantages associated with the Type II titanium anodizing process include increased lubricity, anti-galling, and increased fatigue strength. As these advantages have become increasingly apparent, the popularity and acceptance of this coating have grown considerably within the medical device industry, especially in terms of its applicability to the finishing of orthopedic implants.   The anodization process accelerates the formation of an oxide coating under controlled conditions to provide the desired result.   Since the coating is biocompatible as well as non-toxic, the process lends itself to achieving drastic improvement in implant performance.  The coating is created using various electrolytes, whereby the devices are made positive (anodic), with a corresponding negative (cathodic) terminal attached to a D.C. power supply. As the process creates a penetrating coating, there is no measurable dimensional change when measured with a micrometer accurate to 0.0001 inch (2.5 µm). Quality inspection (100% visual) is performed on completed parts. Controlling factors that impact the end result include: cleaning and surface preparation; solution limits and control; voltage limits and control; temperature limits and control; and post-anodizing treatment and packaging.

Products for which titanium anodization is applicable range from orthopedic and dental implants, to undersea mateable connectors, to aerospace components.  Within the orthopedic industry, products for which this type of treatment is often applied include bone plates and screws, intramedullary nails and rods, spine “cages,” and other hardware commonly associated with trauma or spinal surgery.


TITANIUM USA 2016 Executive Summary
Titanium in Medical Technology

In his presentation, “The Titanium Industry’s Role in the Medical Device Industry’s Growth,” Charlie Yarbrough, global sourcing director, Zimmer Biomet, laid out a comprehensive summary of titanium implants used in the global medical sector. The market for knees is $7.6 billion; hips, $6.4 billion; SET (sports medicine, extremities [shoulders, elbows, wrists], and trauma), $18 billion; spine, $9.3 billion; and dental, $3.4 billion.

He said global customer demands include high-quality products at significantly reduced prices, reduced premiums for high-technology products, and expanded solutions for patients beyond the implant. Moving forward, the demand for “personalized” therapies, implants, procedures and experience will steer the titanium medical applications.

Yarbrough declared that the titanium industry is a vital partner in every major market segment in every region for the medical device industry. His call was for the titanium industry to strengthen its supply chain to meet the medical industry’s needs. “The medical device industry is growing and we need the titanium industry to grow with us. Zimmer Biomet (ZB) can’t grow without the titanium industry meeting expectations to deliver on cost, quality, delivery and lead times. Our global operations are moving to a more balanced global footprint. We need the titanium industry to continue to meet this change.” Based in Warsaw, IN, Zimmer Biomet has annual revenue of about $8 billion, serving 100 countries and operating 25 global manufacturing facilities.

Much like Yarbrough’s presentation, Bob Fletcher, vice president of procurement and facilities, Structure Medical LLC, urged the titanium industry to keep pace with “Orthopedic Medical Device Precision Contract Manufacturing Trends.” Structure Medical is a leading tier-one manufacturer of medical implant products that are used by orthopedic surgeons to treat disorders of the musculoskeletal system.

Download Bob Fletcher's presentation Orthopedic Medical Device Precision Contract Manufacturing Trends here.

Fletcher noted the increasing price pressures in the healthcare field and stressed the need to reduce costs and lead times while increasing throughput. “We must invest in the latest technology on the market,” (like five-axis machining), he said. “We need access to readily available, quality titanium that meets the specs, tolerances, and mechanical properties required (by the medical field). “We pursue quality by constantly investing in the latest technology and equipment on the market, which allows us to reduce cost, reduce lead-time and continue pursuing innovation.”

Stephen Smith, president, Edge International, in his presentation, addressed “The Role of the Distributor for Medical-Grade Raw Materials,” which includes titanium-based biomaterials, along with cobalt, plastic, ceramic and stainless steel biomaterials. Smith said the customers for medical-grade raw materials are OEMs—five majors that make up 61 percent of the world market. According to an online report by Investing News, the five largest medical device companies are Johnson & Johnson, GE Healthcare, Siemens, Medtronic and Philips Healthcare. Smith said these companies do their own in-house manufacturing, but also use some outside contract manufacturers.

There are fewer than 100 smaller OEMs, with generally limited in-house production capability, mainly using outside contract manufacturers. According to Smith, OEMs anticipate 3 to 5 percent annual volume growth over the next five years, while contract manufacturers expect their revenues to reach nearly $6 billion by 2018, compared with $4 billion in 2015. “Medical is a relatively small percentage of overall titanium demand, so any change in demand, particularly from the aerospace sector, will have an impact on titanium pricing and availability,” he said.

Download Stephen Smith's presentation The Role of the Distributor in Medical Grade Raw Materials

Smith said distributors play a key role in the medical grade, raw material supply chain. Distributors need to be flexible and provide value-added services like precision sawing and grinding, as well as have the sources to supply non-standard grades of biomaterials, if required by an OEM or contract manufacturer. He said the successful distributor business strategy required quick, reliable response to a customer’s needs; using a “crystal ball” to determine what materials to order from the mills, and have material readily available from stock or from orders already in production to meet just-in-time manufacturing requirements.

Robin Young, chief executive officer of “Orthopedics This Week,” RRY Publications, participated on the World Industry Demand Trends session discussing “The Plasticity of Titanium in Orthopedics,” which outlined the size and significance of the orthopedics market and titanium’s evolving ability to innovatively meet the demands of this market.   Young is the founder, publisher and editor of Orthopedics This Week, the most widely read publication in orthopedics.


Robin Young, chief executive officer of Orthopedics This Week
Presented "The Plasticity of Titanium in Orthopedics"
Download presentation slides at Titanium.org

 

ITA’s Medical Technology Committee Update

All ITA Members are invited and encouraged to participate on committees. The ITA adheres to strict antitrust guidelines and abides by a separate resolution in which any conversation related to price, capacity or market forecasts are not permitted at any ITA gathering. Please contact Jennifer Simpson if you are interested in becoming a Member of the ITA or joining any ITA Committees.

 

 

 ITA’s Medical Technology Committee Members:

Viv Helwig    President, Vested Metals (Committee Chair)
Bob Fletcher    VP Purchasing, Structure Medical, LLC
Ric Snyder    Product Manager, Fort Wayne Metals
Stephen Smith    President, Edge International

 

 Medical editions of Titanium Today

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