As the medical device industry continues to evolve, 2024 has been a year of valuable lessons and emerging trends that will shape the future of Medtech. From supply chain strategies to regulatory readiness, here are 4 key takeaways medical device manufacturers should embrace heading into 2025.

Invest in a Strong Supply Chain

The supply chain is more than just a logistical network—it’s the lifeline of your operations. This year underscored the importance of resilience, visibility, and agility in supply chains. 

A major topic of conversation this year was around the stabilization of the Nitinol supply chain. With demand for nitinol doubling every 4-5 years, the supply did not follow the growth in demand, which resulted in a supply chain gap. Confluent’s partnership with global melting supplier, ATI, helped bridge this gap and will increase capacity by over 300% by 2027. Confluent customers are now guaranteed material with industry-leading lead times of 12 weeks or less for tubing and 20 weeks or less for wire.

Manufacturers who prioritized robust supplier relationships with vertical integration have found themselves better equipped to navigate disruptions. The takeaway? A strong supply chain isn’t just a necessity; it’s a strategic advantage.

Prepare for Regulatory Changes

The regulatory landscape is constantly evolving, and 2024 has brought significant updates, from stricter quality standards to new compliance requirements for emerging technologies.

One of the potential changes discovered this year was the EPA’s finding on a solvent historically used in the Polyimide manufacturing process, NMP. In a recent finding that could have ramifications in the industry, the EPA found that NMP, as a whole chemical substance, presents “an unreasonable risk of injury to human health when evaluated under its conditions of use.”  This finding determined that NMP posed an unreasonable risk to health in 29 of 37 use cases, which include domestic manufacturing, import, processing in plastics manufacturing, various other industrial uses, as well as disposal.

To mitigate this risk to the medical industry’s supply chain, Confluent has developed an NMP-Free option with equivalent performance to historical polyimide along with a stable supply chain.  This material meets Europe’s REACH compliance requirements, avoids the impending EPA findings against NMP, and provides improved safety for our employees, vendors, and patients.

Staying ahead means investing in a strong supplier relationship with regulatory intelligence, maintaining clear documentation, and fostering a culture of compliance within your organization. Those who adapted quickly were able to bring innovations to market faster and with fewer setbacks.

Know Where Your Material is Coming From

Transparency in material sourcing has become a non-negotiable priority in 2024. Whether driven by sustainability goals, regulatory requirements, or the need to ensure uninterrupted production, knowing where and how your materials are sourced is critical.

Confluent’s vertically integrated Nitinol supply chain offers full transparency on where your material is coming from and mitigates potential disruption. From Alloy to Aorta, Confluent is involved in each step of the supply chain. 

Besides metals, Confluent has invested in strong material sourcing for our High-Precision Polymer Tubing. From PTFE to NMP-Free Polyimide, this investment in the sourcing of our materials allows us not only to meet the ever-changing regulatory requirements but also guaranteed lead times of 4 weeks or less. 

Partnering with transparent and reliable suppliers not only protects your supply chain but also enhances your brand’s trustworthiness in the eyes of regulators and customers alike.

Choose the Best Materials Science Partner

Innovative materials can make the difference between a device that’s functional and one that’s groundbreaking. This year emphasized the importance of collaborating with materials science experts who understand the nuances of your products.

Since Confluent’s founding in 1991 as NDC, Nitinol Devices and Components, we have invested over $100M in the advancement of Nitinol within the Medical Device industry. From helping create the ASTM industry standards in Nitinol to our Advanced Technology Agreement with ATI to create next-generation high-purity material, our materials science experts have been, and continue to be, the source of groundbreaking advances in Nitinol. 

By embracing these key takeaways, medical device manufacturers can build a future-ready foundation—one that prioritizes quality, compliance, and innovation at every step. As we look ahead, the lessons of 2024 will guide us in delivering the next generation of life-changing medical technologies.