How One Medical Device Program Became a Long-Term Manufacturing Partnership

Step One: Fixing a Critical Weld Failure

The manufacturer initially approached Hart after experiencing repeated failures in a laser weld joining two stainless steel tubes in a long endoscopic needle. The inner and outer components were separating. This is a critical risk in a device used to manage active internal bleeding.

The Hart team acted quickly, producing a pilot run using their laser welding expertise. The change was immediate and measurable: Hart’s welds resulted in stronger joints, consistent performance, and successful qualification testing. The client shifted production of the welded subassembly to Hart, trusting the team with one of the most critical elements of the device.

Step Two: Solving the Hub Connection Failure

Not long after stabilizing the weld, another issue surfaced. The plastic hub attached to the opposite end of the needle was detaching during use. The bonding agent couldn’t hold up under the stress of real-world conditions.

Hart proposed an alternative attachment method, developed sample runs, and supported validation testing. Once qualified, Hart expanded its role, now handling both the laser-welded stainless subassembly and the hub installation.

At this point, the Hart team was no longer just fixing isolated issues. They were steadily becoming embedded in the production process and success of the device.

Step Three: Identifying the Root Cause of Material Variability

As production continued, inconsistent performance raised new concerns. Hart sent Bob Striebel, their Quality Assurance Manager, onsite to observe the client’s process firsthand.

The issue turned out not to be assembly at all. It was raw material. While the tubing supplied matched the customer specification, the customer’s specification did not match the material initially qualified. When the material was made in compliance with the specifications, the device did not meet performance standards consistently. Hart traced the issue across facilities, worked directly with the tubing supplier, and helped the client correct their specification..

By uncovering the true root cause, Hart prevented further downstream failures and restored consistency to the device.

Step Four: Redesigning the Assembly Flow to Unlock Capacity

While onsite, Hart also observed something else: severe inefficiencies in the client’s assembly line.

Operators were manually threading springs, spacers, and components onto seven-foot-long needles—one part at a time—while expensive automated equipment sat idle. Most of the cycle time was spent loading parts, not running the machine.

Hart proposed a different approach:

• Take over the multi-part subassembly
• Pre-orient components in custom thermoform trays
• Ship ready-to-run assemblies directly to the client

Instead of minutes of manual loading time, operators could now load a tray, press a button, and run seven parts in seconds. The improvement dramatically increased throughput without adding expensive machines or headcount.

Step Five: Eliminating a Time-Consuming Coating Process

One final bottleneck remained. After assembly, parts were dipped in lubricant and left to dry, sometimes for up to 72 hours, before they could move forward.

Hart worked with the client to transition to a permanent dry coating, eliminating drying time altogether. Parts arrived fully finished, ready for use, and production flow became significantly smoother.

What began as a single weld issue became a multi-faceted manufacturing collaboration. Over time, Hart assumed responsibility for welding, hub attachment, material validation, subassembly, packaging, and coating—simplifying the client’s supply chain and improving reliability at every step.

The result was:

• No failures
• Higher throughput
• Reduced handling and scrap
• A scalable, long-term manufacturing relationship

Hart continues to manufacture devices for this customer—proof that solving problems thoroughly builds partnerships that last.