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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
ITA’s Medical Technology Committee Updates
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.

The annual TITANIUM conferences offer insights into the current state of the titanium industry, as well as provide high-value networking opportunities for titanium producers, original equipment manufacturers, distributors, fabricators, metallurgists, engineers and designers, and vendors who offer products and services to the global titanium community. To register for TITANIUM 2018, visit the ITA website (www.titanium.org) or contact the ITA at 1-303-404-2221.

ITA’s Medical Technology Committee Updates
Distinguished speakers set the tone for the proceedings at TITANIUM USA 2018, the 34th annual international conference and exhibition, which was held Oct. 7-10, 2018 at the Bellagio Resort in Las Vegas, organized and sponsored by the International Titanium Association (ITA). The conference gathered 960 professionals from 30 different countries and proved to be one of the highest attended ITA events in recent years.


Gene Kulesha of Onkos Surgical presented information on “a true industrial revolution” in the 3D printing of medical devices. Customized implants using titanium 3D printing have improved and the technology can support patient-specific printing, according to Kulesha. Titanium 3D printing for medical applications “has gone mainstream, but is still an untapped market. Regulatory agencies understand and embrace the technology.” Click here to watch the proceedings.
    
He estimated that 3D printing of titanium medical devices registered $1 billion in 2017. “Demand is outpacing supply,” he said. “There are few qualified contact manufacturers. Mass customization (of this market) is a maybe; clinical benefits must outweigh costs.”

    

The global orthopedic device market was $52 billion in 2017, and the United States accounts for 50 percent of that market. Titanium accounts for up to 70 percent of hip, spine and trauma implants. He described 3D printed titanium knee implants as a “success story in the making;” a potential $4-billion market opportunity. Knee surgery, which requires numerous bone cuts and soft tissue manipulation, is more complex than hip surgery, he said.
    
Prabhu Gubbi, Ph.D., a technical specialist and scheme manager with BSI Group America reported on “Medical Device Regulatory Changes in Europe.” BSI, a global company, with 81,000 clients in 180 countries, is involved in certification, consulting, and standards-related products and services. Gubbi said regulatory changes include classification rules (Annex VIII), conformity assessment (Annex IX to XI), general safety and performance (Annex I), technical file documentation (Annex II), risk management and clinical evidence. Click here to watch the proceedings.
    
Gubbi said that, for dealing with medical device regulatory changes, BSI helps customers bring their medical device products to market. “We ensure patient safety while supporting timely access to medical device technology globally. “We provide our customers with conformity assessments, evaluations and certifications that are recognized and accepted worldwide. We provide added value to customers through information, training, knowledge and management systems solutions to anticipate, maintain and exceed compliance with internal and external requirements.”


    
Mathew Thoppil, Ph.D., associate professor, Cedric W. Blazer endowed professors in biomedical science, addressed “Tribocorrosion Aspects of Titanium-Based Biomedical Implants: Current Concerns and New Directions.” Thoppil said that the U.S. Center for Disease Control has estimated 78 million people will suffer from arthritis by the year 2040. “Titanium is widely used in hip and other joint replacement surgeries such as shoulder, elbow or knee or spinal fixation devices and in dentistry applications.” Click here to watch the proceedings.
    
Thoppil defined tribocorrosion as an irreversible transformation of material in tribological contact caused by simultaneous physicochemical and mechanicals surface interactions. “Upon implantation, electrochemical interactions are induced by corrosion between the implant materials. As a result, complications like pitting, fretting, galvanic corrosion, and stress corrosion occur. Implant failure has been also associated with several other causes, such as infections in the implanted area, mechanical loosening, bone resorption, and an increase in time taken for osseointegration to occur apart from the fibrous tissue formation.”


    
Thoppil’s study also examined micro-arc oxidation and plasma electrolytic oxidation for titanium implants, as well as titanium nanotube corrosion resistance. He concluded that further research is needed to develop new surface coatings and modification methods to minimize tribocorrosion.

 

Research and Analysis on Current Tariffs
Jeffrey Orenstein, a representative from the international law firm Reed Smith LLP, shared his thoughts on “Current Tariffs and Their Impact.” Specifically, he analyzed the current situation of tariff battles between China and the United States. Click here to watch the proceedings.
          
Regarding the origin and overview of U.S. tariffs on Chinese imports, the authority for the tariffs falls under Section 301 of the Trade Act of 1974. The President ordered the office of the United States Trade Representative (USTR) to investigate whether China’s practices related to technology were unreasonable or restricted U.S. commerce. The USTR team found that China’s policies harmed the U.S. economy by at least $50 billion per year. In response to this, President Trump ordered 25-percent ad-valorem duties on certain Chinese-origin goods; initiated a World Trade Organization (WTO) case on China’s licensing practices; and placed restrictions on Chinese investment aimed at obtaining key U.S. technologies.
          
The analysis for the “pro” side of these measures by the United States suggested that, because China engages in unfair trade practices, these tariffs may pressure China to make concessions. Domestic producers of covered products will benefit from a cost advantage. However, on the “con” side, Orenstein said that a tax or tariff on Chinese imports is effectively a tax on U.S. manufacturers that will, at a minimum, increase costs and likely cause job losses and other disruptions to U.S. industries. In addition, there is retaliation by China covering U.S. agricultural products, cars, aircraft, and high-tech industries, all of which hurts the ability of U.S. companies to compete both in the domestic market and abroad.
          
The likely impact of the tariffs would mean inevitably lead to higher prices for products that use titanium—a range that spans jet planes to medical implants, according to Orenstein. As a result, capital investments may decline and U.S. titanium producers may need to expand their operations.
Orenstein suggested strategies for coping with the current situation involving U.S. and Chinese tariffs:

•    Confirm Applicability by making sure you have the right Harmonized Tariff Schedule (HTS) classification and country of origin
•    Shifting Supply: In many cases, importers will shift to non-Chinese suppliers
•    Passing On the Costs: If Chinese origin goods are the only option, the cost increase will typically get passed on to customers
•    Absorbing the Costs: Companies that cannot pass-on the full 10 percent due to price competition may have to absorb some or all of the cost increase
•    Stockpiling in a Bonded Warehouse: Delay payment of duties by keeping imported goods in a bonded warehouse. This has its own costs, but it is an option if: (1) payment at the time of entry is not practical: or (2) if you want to see if the tariff will be repealed (e.g., due to a trade deal or political change)
•    Drawback: Goods manufactured with imported components subject to tariff may be eligible for “drawback” if the finished products are exported
•    Product Exclusions: Product exclusion requests can be submitted by “interested persons,” which would include various parties impacted by the tariffs, such as U.S. importers, U.S. manufacturers, consumers, brokers, and trade associations representing parties impacted by the tariffs.


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.

 

Titanium USA 2018 Executive Summary
Titanium Europe 2018 Executive Summary
Titanium Asia 2018 Executive Summary

 

ITA’s Medical Technology Committee Members:

Stephen Smith, Edge International (Chair)
Eric Baum, Laboratory Testing Inc.
Alex Fadick, VSMPO-Tirus, US
Bob Fletcher, Structure Medical, LLC
Viv Helwig, Vested Metals Intl’, LLC
Colin McCracken, Oerlikon Metco (Canada) Inc.
Ric Snyder, Fort Wayne Metals
Tom Zuccarini, Dynamet Incorporated
Jennifer Simpson, International Titanium Association

 

Medical editions of Titanium Today

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