On Thursday, May 16th Confluent’s Senior Director of Material Infrastructure, Jonathan Howe, hosted a webinar discussing the Nitinol supply chain and the steps Confluent has taken to address the supply chain gap. Here is the written account of that presentation:

1. Confluent Introduction
   • Confluent’s Mission: Confluent is committed to being the medical device industry’s most trusted partner. We are dedicated to integrity, exceptional quality, and operational excellence. Our team is passionate about providing solutions to our customers for improving lives. Key to our mission is creating an environment of growth, leadership, and innovation in which our employees can impact the world by doing work that matters.
   • Specialization: Confluent specializes in the expert design, development, and large-scale manufacturing of interventional catheter-based devices and implants.
   • Global Presence:
     • 8 facilities worldwide
     • Over 2,000 employees
     • 200+ engineers
     • Over 350,000 square feet of operational space
   • Key Capabilities
     • Nitinol
       • Nitinol Components
       • Nitinol hollows, tubes, and wires
     • Other Capabilities
       • Balloons and balloon catheters
       • Complex catheters and catheter components
       • High-Precision Polymer Tubing
       • Implantable textiles
2. Confluent Invested to Secure Supply to the Medical Nitinol Market

   ATI was ready to leave the medical Nitinol market: this small, difficult-to-make product line was not core to the aerospace and defense leader’s strategic priorities. By collaborating, ATI and Confluent committed to a path that secures the supply of this life-saving material. Confluent’s investment was paramount to securing the Nitinol supply chain.

3. Saving Lives Starts with Melting

   Melting is a key process in the Nitinol supply chain and without it, our industry can not make life-saving medical devices and components.

   If you are an OEM customer that designs, develops, and sells Cardiovascular Nitinol heart valves, your supply chain would look something like this: Melt, gun drill, tube draw, and components.

   Here are the outputs of each step:

   • Melt – mill product which is a 1 to 0.5 (or for our non-US customers) 25.4-12.7mm bar used typically as the input for a gun drill hollow or a coil (0.25”) that is used typically to be converted to a wire
   • Gun Drill – Hollow, typically 4 ft lengths with a long very precise hole drilled into it that can be used for a tube drawing converter to make tubing
   • Tubing drawing – Tubing.. or hypotube
   • Component – laser cut or wire drawn component

   More specifics into the melt and gun drilling portion of the supply chain:

   • For Melt… to some extent calling this step melting is a bit of a misnomer. The raw material (ni and Ti) starts off needing to be melted in these big furnaces but then to get them ready to be that 1 or 0.5” bar, they need to be ground, forged, rolled, lab tested, annealed, and final draw to go from a 24” in melted ingot that weighs thousands of lbs to a 1” bar read for gun drilling to put a whole in it. There are a lot of manufacturing steps here with lots of opportunities for bottlenecks and constraints. Part of our partnership with ATI was to identify these constraints and mitigate them. Confluent is proud to report that over the last 18 months of hard work and collaboration, we are seeing a lot of amazing improvements.
   • Over the last 10 years, Confluent has been adding capabilities to ensure that we have a stable supply chain for our OEM customers
   • “Drilling” into our gun drilling investments
     • We’ve heard from some of our customers and through some recent conferences that there are some concerns about the gun drilling portion of the supply chain.
     • We can confirm that we have plenty of gun drilling capacity; over 30K ft of open capacity with the ability to double this. Our standard gun drilling lead times are 8-12 weeks.
4. Timeline of Nitinol Stabilization
   1. 1991: Founding of NDC, initial focus on Nitinol.
   2. 2017: Investment in Eli material furnaces.
   3. 2019: Acquisition of Tube Hollows to secure gun drilling supply.
   4. 2022: Expansion of wire operations in India
   5. Recent: Invested over $50 Million in ATI’s Nitinol melt and materials conversion infrastructure
5. Key Players in Nitinol Melt Space

   There are 4 key Nitinol melt players with two main sources supplying almost all of the high-performance ASTM F2063 material

   • 75% of Medical Grade NiTi comes from two melt sources.
   • 100% of high-performance NiTi comes from just two sources, Resonetics and ATI
6. What was going on with Nitinol Supply?

   There are three main challenges that have impacted the Nitinol supply over the last couple of years:

   • Demand for Nitinol is increasing
     • Nitinol demand was doubling every 4-5 years. Nitinol’s superelastic and shape memory properties makes it an ideal material for Cardiovascular, Neurovascular, and Peripheral Vascular components.
   • Supply is not following the growth in demand
     • Supply was under-invested and in 2023, ATI experienced a 35% supply reduction.
   • Supply Chain Gap
     • Limited melt sources, supply reductions, and growing demand all lead to a supply chain gap for Nitinol material.
7. Partnership with ATI

   Our mission to be the most trusted partner, lead to our strategy to secure the supply chain gain, and this nitinol supply gap driven by growing demand and under investment in supply lead us to partner with ATI.

   • History:
     • 25+ years of collaboration: Early work with ATI on the fundamentals of Medical Grade Nitinol
     • ELI Material: Starting in 2017, our partnership grew, and started to invest in ELI bar
     • Strategic Partnership: Recognition of growing challenges and opportunities around Melt. Formed joint technology agreement to solve process issues and increase capacity.
     • Long-Term Partnership: Multi-decade partnership and opportunities to improve material access
8. Investment and Capacity Expansion
   • Investment: $50 million in ATI melt and conversion infrastructure.
   • Capacity Increase: 300% increase in capacity by 2027.
   • Order Fulfillment: Confluence as ATI’s medical Nitinol order fulfillment partner. Confluent is the commercial arm for ATI’s Medical Nitinol business, managing customer-facing interactions including orders and pricing as well as prioritizing allocation of supply per historical supply proportions to ensure a fair and balanced approach.
9. Long-Term Partnership Details
   • Partnership Overview:
     • 20+ year agreement
     • Dedicated Technical & Supply Chain Continuous Improvement Teams
     • Leverage each other’s core strengths: Market Access & Melt Know How
     • Confluent stepped and invested over $50 Million to increase capacity 3x by 2027
     • Confluent becomes the exclusive fulfillment partner for Medical Nitinol Material
     • ATI needed the Medical Nitinol market to provide value commensurate with the rest of ATI’s portfolio.
10. The Industry’s Most Trusted Partner

    Confluent is the only true vertically integrated Nitinol partner and will continue to provide customers with the most reliable supply chain delivering the broadest level of Medical Nitinol services in mill products, hollows, tubes, wires, and components.

    Confluent has material NOW with lead times of 10 weeks for Nitinol Hollows, 14 weeks for Nitinol Tubing, and 20 weeks for Nitinol Wire.

    Learn more at www.nitinol.com or email [email protected]