How We Successfully Produced Life-Saving Bend-Free Vascular Guidewires When Others Failed

artistic rendering of vascular system in chest (where medical guidewires may be used)

When a Salt Lake City-based biotechnology firm approached us in 2019, they were working with our competitor to help them manufacture specialty neurovascular guidewires, a critical device component designed for two stroke intervention procedures: thrombectomy and endovascular coiling. Upon reconnecting with them a year later, the firm revealed that their current vendor was struggling to provide good parts amid growing demand for its neurovascular guidewires. The issue: the wires bent during high-volume production runs.

As the guidewire order volumes grew, the medtech firm was forced to reject an alarming number of defective parts, returning them to our competitor and spurring a costly production delay. Worried that its supply chain would dry up and threaten its gaining market acceptance, this medtech team needed immediate help. 

In this post, we’ll summarize this seemingly monumental challenge of developing bend-free vascular guidewires, the multi-faceted solution we devised, and the results we helped this medtech firm achieve.

The challenge of developing bend-free vascular guidewires

At the start of the project, our medtech client’s lead engineer flew to our Philadelphia-area manufacturing facility with great urgency after recently rejecting a large shipment of defective parts for an order they needed to produce quickly. We spent a couple of days with our client developing a production strategy and preparing for a whirlwind validation process that we completed in a record two months.

Finally, we were ready to help our new client get their production back on track. So, we produced a test run, only to encounter our competitor’s same challenge: bent wires. In fact, they arced so sharply that it rendered our client’s proprietary device unreliable – even unusable. At this rate, the vascular guidewires could not accomplish their mission of reaching blood clots faster and deeper than any other access device or therapy on the market.

There was no doubt about it – the stakes were high. So, we promptly began devising solutions for developing these intricate vascular guidewires, focusing on strategies for manufacturing them in mass production quantities without allowing them to bend.

Devising a multi-faceted solution

Working swiftly, our engineering and technical development teams dove deep to uncover the manufacturing solution that would prevent the guidewires from bending. We spent several days modifying aspects of workholding, tooling, the grinding wheel, and the grinding machine to reduce the stresses in the process to achieve sustainable production of bend-free corewires. In the end, we deployed a multi-faceted solution, drawing on our extensive experience working with all types of materials and in-depth understanding of the grinding process.

Our manufacturing process included a high-touch communication strategy involving weekly calls with our client’s management team. These meetings allowed us to share our progress and uncover valuable insights for greater clarity.

Achieving seemingly impossible results

Our client was ecstatic after we successfully produced several lots of these specialty neurovascular guidewires. It was the first time the firm had a stable supply chain in over a year. Before, they had to approach sales cautiously because their team lacked confidence in receiving good inventory. Knowing that 100% of the surgeons who tried their guidewires switched to using them, their apprehensiveness meant that they couldn’t target as many hospitals as they wanted, taking a toll on the firm’s bottom line.

We began manufacturing the parts according to our multifaceted protocol, starting with an initial production run of 2,000 pieces to rejuvenate our client’s production capabilities. After achieving success on small runs, we gradually increased the order quantities, eventually manufacturing about 25,000 parts over several months. 

Thanks to our team’s ingenuity and an in-depth understanding of precision medical device manufacturing and the intricacies of this project, our equipment modifications and expert-driven strategies allowed us to produce bend-free specialty guidewires successfully.

With a reliable supply chain, our medtech client was finally ready to scale their business. Today, this firm is expanding, securing funding, and hiring an internal salesforce to help them grow with confidence.

To learn more about how guidewires are made, visit our blog. Or contact our team for more on how we help solve the seemingly impossible component manufacturing challenges.

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