As an extremely versatile product, nickel-titanium (nitinol) has been in high demand for the production of various medical devices since well before the start of the coronavirus pandemic. Today, a steep upward trajectory for nitinol continues post-pandemic as more minimally invasive procedures that utilize the metal alloy are more commonly being performed in outpatient clinics as elective surgeries again take rise compared to traditional open-surgical operations that require extended hospital stays. This has led to a resurge in demand, a trend that is unlikely to reverse course any time soon, according to industry experts and recent findings released through a comprehensive report on the global nitinol medical device market by the healthcare market research and consulting service iHealthcareAnalyst Inc.

The global market for nitinol devices is anticipated to reach $38.6 billion by 2031, driven by increasing demand for these types of procedures and new applications that will continue to require the advances of materials technology with improved mechanical and physical properties that nitinol can offer. Costs for the material are also expected to remain on the incline as global supply chain challenges and inflation combine to drive up prices when the intricacies of the production process had already positioned nitinol as a costly venture.

“The processing of nitinol is a large part of why the cost is so high for this metal,” explained Daivat Dholakia, vice president of operations at Essenvia, a medtech regulatory information management platform that assists in the management of regulatory workflows across the product lifecycle, among other services. “Because it’s sensitive to heat damage, it’s difficult to process, which means the operating costs are added on to the final product. Titanium is needed to produce nitinol as well, which is another very pricey metal. All of these factors contribute to the final cost of nitinol.”

As companies attempt different mitigation strategies related to nitinol’s production, there could be opportunity for more competitive pricing.

Global nitinol medical devices market: An overview

Nitinol-based stents, guidewires, surgical instruments, scoliosis rods, and embolic protection filters are commonly used in today’s medical applications. Self-expanding stents, graft support systems, filters, baskets, and various other devices for minimally invasive interventional and endoscopic procedures represent more rapidly developing areas of need for nitinol alloys as a material of choice.
According to the iHealthcareAnalyst report, the marketplace for nitinol has been dominated by peripheral vascular products, such as stents and guidewires, over the past decade, whereas more recent applications include endovascular aneurysm repair devices, inferior vena cava filters, and embolic protection devices. The ongoing success of the product has led to development in many other areas of healthcare, including general surgery, structural heart disease, and orthopedics.

Unique characteristics

Also known for its “super elasticity,” nitinol’s properties enable it to maintain shape memory characteristics while performing under fatigue and stress. These properties have led to the development of stents and heart valves that would otherwise not be possible to create using other conventional medical device materials, according to the iHealthcareAnalyst report.

Self-expanding nitinol stents are indicated for improving blood-flow in patients with symptomatic peripheral artery disease and most self-expandable bare-metal stents now use nitinol due to its ability to retain shape after implementation. Demand for novel instrumentation and implants as a result of more minimally invasive procedures being scheduled is increasing the number of devices that use nitinol as a critical component, with examples now also including a range of products from orthodontic archwires and endoscopic instruments to endovascular stents.

“Nitinol is a unique biomaterial with the strength of a metal and flexibility of a polymer,” said Rich LaFond, vice president of multi-site operations at Resonetics, a global organization that specializes in advanced engineering, prototyping, product development, and micro-manufacturing. “Consequently, this unique alloy is the material of choice for self-expanding catheter-delivered implants, sports medicine, and trauma devices intended to approximate the mechanical properties of human connective tissue, and delivery system pull wires and guidewires capable of maneuvering even the most tortuous anatomy without kinking.”

While the greater flexibility of the alloy drives many of its applications, there are also lesser-known advantages of nitinol in medical devices, according to the iHealthcareAnalyst report. For example, devices containing nitinol also provide solutions for issues that can be associated with undergoing minimally invasive procedures, such as infection, injury to other organs, risks of anesthesia, and bleeding. Additionally, the product’s superior biocompatibility properties are garnering attention, and nitinol wires are gaining importance in the medical industry to be used in other applications, such as catheter wall supports, custom springs, and ablation catheters, the report wrote.

Strategies in response to demand
From a geographical perspective, North America accounts for the largest share of the nitinol device market, followed by Europe. According to the iHealthcareAnalyst report, these regions are expected to maintain their positions, primarily due to growing geriatric populations and age-related diseases that are contributing to the increase in minimally invasive surgeries.

Demand for biological nitinol-based devices is notably high in North America as technological developments in the medical industry have also led to rising numbers of peripheral and coronary stent procedures as well as the growing usage of nitinol for the manufacturing of stents, the report claimed. With most companies domiciled in the US, this market is expected to remain the primary market for product launches and market penetration, which projects to high revenue generation, the report claims.
Despite demand and a limited number of nitinol production sites, LaFond estimated that supply will meet the targets even when considering post-pandemic challenges, thanks to certain strategies that his company and others are employing to meet needs.
“Although there are only a few melters of nitinol, the melting capacity far exceeds the overall worldwide demand,” he said. “In 2023 and prior, Resonetics operated its ingot melting furnaces at less than 50% capacity. Secondary melting and downstream conversion, specifically forging and hot rolling to bar, coil, and plate, is performed by a few large, sub-contract partners, all of whom primarily serve the aerospace and defense industries. Such industries have been enjoying very high activity, which slowed the ability of all nitinol melters to respond to post-COVID rebound demand.”
In an effort to help ensure that his organization remains ahead of further demand increases, LaFond said that Resonetics has initiated a major capital project to add in-house secondary melting by 2025.

“To mitigate any future conversion delays, Resonetics is committed to melting extra material to ensure the pipeline at all stages of nitinol production has sufficient safety stock,” he said. “The good news is that through collaborative efforts between Resonetics and its conversion partners, the forging and rolling bottleneck is being alleviated and inventory levels are returning to normal. Resonetics expects to be at normal inventory level by the end of quarter two and have a surplus beginning in quarter three. In commitment to sustaining an ample supply through 2025 and beyond, we can, if needed, increase our annual melting capacity by 50% in 2024. Furthermore, to reduce reliance on external conversion partners, we’re integrating some conversion processes in-house, a move that becomes increasingly vital as our volumes grow.”

Other strategies that LaFond recommended are reliable forecasting and open, collaborative communication. “Long-term supply agreements allow Resonetics to minimize the risk of inventorying excess material, while simultaneously providing end consumers with a stable price and supply of nitinol products. The more reliable and forward-looking that forecasting is, the easier it is for us to provide a stable, repeatable, economical supply in inventory.”

Negative consequences to consider
Although the benefits to nitinol have been widely acknowledged, there are some downsides to the biomaterial that is used to make the related medical devices, according to the iHealthcareAnalyst report. There have been known allergies and metal sensitivities triggered among some patients, which is contributing to scrutiny from FDA. As safety concerns arise, FDA is asking device makers to provide additional information on nitinol in their device submissions.

Article Source: MDDI