The recent growth in Nitinol Components has required material manufacturers to shift their production practices to respond quickly to demand changes. A complex and limited Nitinol supply chain has made it difficult for many in the industry to meet this growing demand but recent investments have allowed Confluent to make these necessary changes and offer the quickest response time in the industry for Nitinol Tubing. Why were these changes necessary? What is causing this recent growth? And what has Confluent accomplished to meet this goal? This article will dive deeper into the complexity of the Nitinol supply chain and how Confluent has been able to meet this demand while others in the industry have not.
What is causing the growing demand for Nitinol? Nitinol’s super elastic and shape memory properties make it ideal for a number of medical device applications particularly for interventional therapies like structural heart valves and neurovascular stents. These therapies require devices that can be delivered minimally invasively within some pretty tortoise arteries or veins and then provide structural support to restore anatomical function. Some of these applications require that the structural support has a very high fatigue life (think of how many times your heart beats in a year or for some of these applications, decades).
Why was the previous Nitinol Supply Chain unable to meet this growing demand? The production of medical-grade Nitinol is a highly complex process that requires extensive industry knowledge. Two key material requirements that are part of this complex process are transition temperature and high-fatigue resistance. The transition temperature is the temperature at which the Nitinol material changes from one phase (austenitic) to another phase (martensitic). This phase change triggers the material’s shape memory properties. The temperature window that the material has to transition is pretty tight (Think room temperature vs body temperature differences). This means the material needs to have a precise and repeatable transition temperature.
Medical-grade Nitinol also requires high-fatigue resistance. As alluded to above, a number of Nitinol device applications require high fatigue resistance. It has been shown that the size and amount of non-metallic inclusion in the Nitinol material can affect the device’s fatigue resistance.
Not to mention, there are strict standards for medical-grade Nitinol. Most medical devices require the Nitinol material to conform to ASTM F2063 which defines these transition temperatures and non-metallic inclusion levels.
The complexity of this process results in a limited number of material manufacturers. On top of a limited number of material manufacturers, the supply chain itself is rather large, spanning a number of different independently owned companies that each have their part in getting the Nitinol raw material into the correct form factor that meets the ASTM specifications. Most of these independent companies have manufacturing lines that share Nitinol capacity with other alloys that support a number of different industries like defense and aerospace. As the demand in these industries has gone up significantly over the recent years, the available capacity for Nitinol is strained.
What has Confluent done to address these complex challenges and claim to now offer the fastest lead times for Nitinol material in the industry? Confluent has been pioneers of Nitinol since our founding as NDC over 30 years ago and has recognized these challenges early on. Recent significant investments in the supply chain have ensured there are dedicated medical Nitinol capacity for our customers. Their recent partnership with ATI has allowed Confluent to invest over $50 million over the next several years in ATI’s Nitinol melt and materials conversion infrastructure. This investment will more than triple ATI’s melt capacity for medical-grade Nitinol and has allowed Confluent to become ATI’s fulfillment partner and provide a suite of value-added services and order fulfillment for ATI’s medical-grade Nitinol mill product.
The result of this partnership means Confluent can now guarantee Nitinol material to their customers despite the fluctuation in demand while keeping costs down and reducing lead times.
It has been one year since this partnership and Confluent now has the capacity to offer 4-6 week lead times for production-ready qualification builds for Nitinol tubing. This means less disruption and cost for customers.
Overall, with speed-to-market for high-quality Nitinol material, a vertically integrated supply chain that responds quickly to demand changes, and industry-leading lead times of 4-6 weeks for Nitinol tubing, the work Confluent has put into their Nitinol business over the past 30 years has resulted in a manufacturing partner that powers their customers to create life-saving devices.
