The Value of a Vertically Integrated Nitinol Supplier—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief

As companies continue to develop advanced medical devices, they rely on materials that deliver a range of benefits. Often, these sophisticated options can be challenging to process. Nitinol is one such offering. The metal alloy provides rather unique characteristics, but can be so complex to manipulate that only a limited number of suppliers will achieve the desired results.

With this in mind, medical device organizations seeking to incorporate a Nitinol component into their product want to work with a firm that will handle all the necessary steps, from melt through to fabrication. Maintaining all the required aspects of development with a Nitinol part under one roof can result in a more beneficial outcome, saving costs and time to market for the OEM.

Sharing more about the value a vertically integrated Nitinol supplier brings to the table is Eric Veit, VP, Business Development at Resonetics. In the following Q&A, he explains the advantages of this novel material, the capabilities to seek in a supplier of it, and the ways vertical integration makes a substantial difference for the customer.

Sean Fenske: What is Nitinol? Where is it most commonly used in medtech? What makes it unique?

Eric Veit: Nitinol (pronounced as “night-in-all”) is a nickel-titanium alloy best known for two remarkable behaviors: shape memory (it can return to a programmed shape when warmed) and superelasticity (it can undergo large, reversible strains and recover its original form). In medtech, Nitinol is widely used in minimally invasive devices where flexibility, kink resistance, and reliable self-expansion are important. This includes applications such as guidewires, neurovascular and peripheral stents, heart valve frames, vena cava filters, occlusion devices, and a variety of catheter-based components.

What makes Nitinol unique is the way its properties can be tailored through composition and thermomechanical processing to achieve a specific force profile and transformation temperature, enabling devices that can be delivered through small access paths and then perform predictably in the body. In layman’s terms, Nitinol can be thought of as a material with the flexibility of an elastomer and the strength of a metal.

Fenske: When it comes to vertical integration at a Nitinol supplier, what is encompassed? What range of capabilities does this include?

Veit: Vertical integration at a Nitinol supplier typically means the supplier can manage more of the critical steps that influence final performance. The completely vertically integrated supplier is controlling the melt, the semi-finished materials (tube, wire, sheet), and the finished component. It all starts with raw material control and melting the nickel shot and the titanium sponge, progressing through hot and cold working (for example, ingot conversion), moving to bar/tube/wire processing heat treatment and shape setting, surface conditioning, and finally value-added manufacturing such as laser cutting, machining, electropolishing, and component assembly. It also often includes metallurgical support/development, process engineering, analytical testing, and quality systems support. The range of capabilities can vary by supplier, but the core principle is end-to-end control of the material and the processes that determine microstructure, transformation behavior, and functional performance.

Fenske: What’s the advantage of working with a company that performs the melt? What benefits can be realized at this stage?

Veit: Working with a company that performs the melt can provide a stronger foundation for consistency and traceability because the melt is where chemistry, cleanliness, and inclusion control begin. Benefits at this stage include tighter control of alloy composition, improved management of impurities that can impact fatigue and corrosion performance, and more direct insight into material history from the very start. It also enables faster learning cycles when a design needs a specific force/strain response or transformation temperature range because material adjustments and downstream processing can be coordinated as part of an integrated development approach. In short, melt capability can help reduce variability and de-risk programs by addressing performance drivers at their source.

Fenske: What’s the benefit of the development of a Nitinol component being performed all under one roof, from melt to finished product?

Veit: We refer to this as Melt-to-Market™. Why does it matter to me as a customer? Developing Nitinol components under one roof—from melt through finished product—creates a direct connection between material inputs and final device performance. Since Nitinol is highly sensitive to composition and processing, controlling the full value chain aligns melting, forming, heat treatment, laser processing, and finishing as one coordinated system, rather than handing off critical variables across suppliers. This end-to-end visibility helps teams understand and control the cause-and-effect relationships that drive transformation temperatures, microstructure, mechanical behavior, dimensional precision, and in vivo performance. For customers, the result is clearer specifications, more predictable outcomes, and faster iteration from prototype to production by leveraging proven process histories and established manufacturing “recipes,” reducing guesswork and the risk that a change in one step undermines another.

Vertical integration also improves speed and cost: in-house material and semi-finished inventory reduces lead times, eliminates margin stacking, enables rapid quoting and accelerated prototyping, and supports a smoother path to scale, all within a single quality system and consolidated documentation. Ultimately, a Melt-to-Market™ approach provides greater control, faster development, and more reliable outcomes for high-performance Nitinol devices.

Fenske: What aspect of Nitinol do you find device manufacturers don’t understand? What do they overlook or neglect to consider?

Veit: One common misconception is that Nitinol is “one material” with one predictable behavior. In reality, two Nitinol parts with the same nominal chemistry can behave very differently depending on melt practice, thermo-mechanical history, and heat treatment, especially when it comes to transformation temperatures, plateau forces, and fatigue performance. Device manufacturers sometimes focus primarily on geometry and overlook how specifications like transformation temperature range, surface condition, and microstructural consistency influence clinical performance and long-term durability. So transitioning between suppliers is often more difficult than expected, making it even more important to involve our expert teams early in the process.

Another area that can be underappreciated is how processing windows and downstream steps (for example, laser cutting, shape setting, electropolishing, or sterilization effects) interact, making early supplier engagement important when developing a robust design and manufacturing plan.

Fenske: Do the vertical integration capabilities extend beyond Nitinol? Are they provided for projects or customers that don’t involve Nitinol?

Veit: Yes. While Nitinol is a core area of expertise, our vertically integrated model extends to other materials and manufacturing platforms across Resonetics. For example, we have internal production of stainless-steel tubing, along with complementary capabilities that support a broad range of medical device programs—from precision laser processing and micromachining to component manufacturing, surface finishing, testing, and quality systems support. That means customers can leverage the same disciplined process controls and manufacturing infrastructure for projects that don’t involve Nitinol, while still benefiting from integrated workflows, traceability, and streamlined scale-up.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Veit: As Nitinol-enabled devices continue to move into more demanding clinical applications, we see two themes becoming increasingly important: designing for manufacturability early and partnering closely on material/process specifications. Nitinol can deliver exceptional performance, but it rewards a disciplined approach to requirements, validation, and change control because small process differences can have outsized effects. Our general advice to device manufacturers is to engage your material and manufacturing partners early, align on the performance attributes that matter most (e.g., force, fatigue life, transformation behavior, surface conditions), and build a specification and control strategy that supports scale-up. That collaboration helps reduce late-stage surprises and accelerates the path from concept to reliable production.

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