The International Titanium Association’s (ITA) Medical Technologies Committee has revised its strategic plan for assessing business in the global medical market, with a focus on 3D/additive manufacturing as well as underlining the importance of distributors as the key players in the supply chain.
Even though medical applications for titanium, most notably in the field of joint replacements, bone reinforcements and dental applications, has been gaining momentum for a number of years as a growth market, the Medical Technologies Committee—led by co-chairs Viv Helwig, the founder of Vested Metals Inc., and Stephen R. Smith, the president of Edge International—sees its updated strategic plan as a way to re-evaluate the medical field as an emerging market. The thrust behind this fresh perspective is to explore 3D/additive manufacturing as a means to develop “customized” implants when and where they’re needed.
Helwig explained that the committee will explore 3D/additive manufacturing technology, which offers the potential for continued growth for titanium in the medical sector. The additive process will provide the means for the use of new alloys and smaller material lots to target the needs of specific medical applications, such as implants that enable greaterosseointegration andbio-compatibility.
Distributors seek to add value for customers by providing specific alloy grades and servicing the subcontract manufacturers, Helwig said. As always, the challenge for titanium distributors is to deliver consistent material in the supply chain, with the realization thatthe titanium industry and its primarily markets can be cyclical in nature with long lead times and occasional supply constraints.Titanium also competes with stainless/cobalt alloys for medical implants. Helwig said distributors have the capability to maintain the correct type and level of inventories to service their customers. He added that Vested Metals’ primary focus is the North American supply chain.
Information posted on the Vested Metals website (www.vestedmetals.net) states that Helwig founded Vested Metals in late 2014 and serves the company in the role of president, overseeing all of the company’s activities. Their focus is on hard-to-find grades, alloys, sizes, and overall raw material metals requirements within the markets they serve. Vested Metals is based in St. Augustine, FL.
Smith agrees with Helwig regarding the potential for 3D/additive manufacturing technology in medical implants and devices. He said that, as the leaders of the ITA’s Medical Technologies Committee, he and Helwig will look to promote and educate the market on the opportunities for 3D/additive manufacturing. While titanium enjoys a strong position as a material of choice for orthopedic and trauma implants, external prosthetics and instrumentation, Smith sees the potential for titanium to be expanded in applications for spinal implants and facial/cranial implants, especially in jaw reconstruction. Smith said titanium will remain a strong player in the medical market for the foreseeable future given its inherent properties of light weight, resistance to body fluids, biocompatibility and being a non-ferromagnetic metal (for MRI safety).
As a speaker at the TITANIUM ASIA 2018 conference and exhibition, which was held last February in Singapore,Smith gave a presentation on “Titanium Technology in Medical Applications.” He estimated that the global growth for titanium medical devices for “head to toe” biomedical implants, such as internal fixation (bone plates, screws and pins), prosthetics, extremity and joint replacements, dental implants, inner body devices, and surgical instruments will see a compound annual growth rate of 3 to 5 percent during the next 10 years, with North America, Asia and Europe all expected to be competitive markets. He estimated the total medical devices market for Titanium to be 5/7,000 metric tonnes.
“The future for medical grade titanium looks bright,” Smith said. “The aging baby boomer demographic wants to stay active. The health industry is pushing all ages to lead more active lives. Growth for medical grade raw materials is projected to be three to five percent per annum over next five years. Medical industry will continue researching new and innovative uses for titanium.Distributors play a key role in the medical grade titanium supply chain.”
He also provided his insights during an earlier presentation to the ITA on “The Role of the Distributor for Medical Grade Raw Materials.” Smith’s list of medical grade raw materials included as cobalt-based biomaterials (CoCrMo; L605); plastics (ultra-high molecular weight polyethylene, polyether ether ketone) specialty metallic biomaterials (ceramics); specialty steel (Stainless 316L; 455; 17-4PH); and titanium-based biomaterials (commercially pure and Ti6Al-4V).
As for the customers for medical grade raw materials, Smith said there are five major original equipment manufacturers (OEMs), representing 59 percent of the worldwide market (as of 2016, down from 61 percent in 2015), with their own in-house manufacturing, supplemented by contract manufacturers. By comparison, he said there are fewer than 100 smaller OEMs with limited in-house production capabilities, which predominantly use contract manufacturers to produce the component parts.
“Distributors play a key role in the medical grade raw material supply chain,” Smith declared. He noted that distributors provide value-added services such as just-in-time delivery to manage inventory costs, precision grinding and sawing, small quantities for prototyping, and supplying non-standard grades of material.
Defining the role of the distributor, Smith urged OEMs to “work with a distributor on blanket orders whenever possible. This commitment enables the distributor to negotiate long-term price agreements and raw material hedge contracts with the mills, thereby enabling the distributor to offer firm pricing, with material always available on the shelf, for delivery as you need it to meet your production schedule.”
According to information on its website (http://www.edgeintl.com),Edge International,based in Dayton, OH, is a division of Titan Metal Fabricators Inc. Edge is a stocking distributor ofmedical grade raw materialsfor the manufacture of implants and instruments used in the orthopaedic, spine and trauma sectors of the medical device industry.Titan Metal Fabricators, headquartered in Camarillo, CA, a reactive metal design, fabrication and metals distribution organization, acquired the assets of the metals division of Edge International in April 2017.
Other voices also recently contributed their expertise on titanium’s business opportunities in the global medical sector.Don Urbanowicz, principal at Urbanowicz Consulting LLC, appearing at the TITANIUM USA 2017 gathering, held last October in Florida, presented a talk on “Market Dynamics Impacting the Orthopedic Industry.” According to Urbanowicz’s market overview projections, orthopaedic product sales—(joint reconstruction, spine, trauma, arthroscopy/soft tissue and orthobiologics)—will reach an estimated $49.8 billion in 2017, $51.5 billion in 2018, and will climb to $57.3 billion by the year 2021, all of which presents an attractive growth-market opportunities for titanium (and other metal competitors).
He also pondered the near-term role of additive/3D printing as a viable technology to produce titanium orthopaedic products. Urbanowicz said 3D printing would be appealing to surgeons for solving complex trauma and joint replacement cases. He also wondered whether 3D printing might “disrupt the current business model by eliminating off-the-shelf implants and instead be printed by hospitals.”
Prabhu Gubbi, Ph.D., materials scientist/research manager for Zimmer Biomet Dental, discussed “The Role of Titanium in Implant Dentistry.” Citing a study by Grand View Research Inc., Gubbi said the global dental implants market is expected to reach $6.8 billion by the year 2024.
He confirmed that titanium is the “de facto metal of choice in implant dentistry,” due to its superiority in resisting corrosion and toxicity in tissues, lack of allergic reaction and mechanical strength. “Commercially pure titanium has the highest resistance to corrosion and is often regarded as the most biocompatible metal due to its stable/inert oxide layer,” Gubbi said. “Over 50 years of clinical research with higher than 95 percent overall success/survival rate make dental implants the best option for replacement of missing teeth.”
Dean Hutchinson, product manager, Arthrex Shoulder Arthroplasty, spoke about the “Opportunities for Materials Innovation in Orthopedics.” Hutchinson said the typical cost of an arthroplasty procedure—the surgical reconstruction/replacement of a joint to relieve pain and restore range of motion—is $40,000 for a hip; $35,000 for a knee; and $21,000 for a shoulder.
Hutchinson emphasized titanium’s properties as being perfectly matched for on-growth fixation to bones. Clinicians and original equipment manufacturers are “truly passionate” about this advantage for titanium. He suggested that producers of titanium implants should consider forming alliances with coatings suppliers to develop products with enhanced antimicrobial properties and on-growth compatibility with bones.
Jan Palan of Comtes FHT, a speaker at TITANIUM EUROPE 2017, held last May in Amsterdam, the Netherlands, shared thoughts on the “Development of Pure Titanium-Based, High-Strength Wires; Possibilities for the Medical Industry.” Palan began the talk first by stating the importance of the topic, noting that pure titanium is considered the most biocompatible metal for medical implants (resistance to corrosion from bodily fluids, bio-inertness, capacity for osseointegration, and high fatigue limit).
However, for some applications, he pointed out that commercially pure (CP) titanium doesn’t have sufficient mechanical properties. “One way to improve mechanical properties is by adding alloying elements, but this could negatively affect biocompatibility. Another way to increase the mechanical properties is to refine the structure to the level of nanometers using Severe Plastic Deformation (SPD).” Utilizing SPD is a method to “refine the structure to the level of nanometers, thus improving mechanical properties.”
Comtes FHT’s “Conform SPD” technology, typically used for continuous extrusions of various profiles from nonferrous alloys, is used for the production of nanostructured, high-strength wires. Palan said the company has developed a system for combining Conform SPD withequal-channel angular pressing (ECAP), which provides a process for the cold extrusion of titanium. As a result, the nanostructured CP titanium retains its biocompatibility combined with even higher strength than a Ti6Al4V alloy.
Achieving improved mechanical properties, combined with titanium’s inherent biocompatibility, enables designers to create smaller, stronger medical implants, according to Palan. “This is a product with high added value, where the use of nanostructured (CP) titanium delivers improved properties, and therefore increases the price,” he said. “However, the effect of the higher material prices on total manufacturing costs will be minimal.”
The Medical Technology committee will be ready to announce their slate of speakers for the upcoming TITANIUM USA 2018 conference soon.
ITA’s Medical Technology Committee Members:
Viv HelwigPresident, Vested Metals (Committee Chair)
Bob FletcherVP Purchasing, Structure Medical, LLC
Ric SnyderProduct Manager, Fort Wayne Metals
Stephen SmithPresident, Edge International
Thomas Zuccarini Director, Medical Market, Carpenter Dynamet
In case you missed it:
Past Medical Editions of Titanium Today
Industry Spotlight with Melanie Cunningham, Titanium Finishing Company
TITANIUM USA 2018 Registration