Medical Manufacturing Automation Machine producing reagent packs

Case Study

INCREASING CAPACITY WHILE TRANSFORMING A SUPPLY CHAIN

A global diagnostic consumable company turns to Comar Medical to reduce waste and increase throughput by leveraging press-side automation.

Diagnostics

CHALLENGE HIGHLIGHTS

  • Redesigned mold to address cooling issues and tool maintenance issues.
  • Increased cavitation from 4- and 6- to 8-cavity.
  • Integrated scientific injection molding (SIM) principles to improve consistency.
  • Introduced pack-out automation and reusable packaging.

"One of our goals was to tie together both ends of the supply chain by creating automation where it previously didn’t exist, and we saw that Comar would be a great partner. Comar came on board as a consultant early in the project and ended up winning the business."

Senior Engineering Manager for the diagnostics company

Situation

A global diagnostics company manufactures immunoassay analyzers for the detection and identification of specific substances in clinical samples. These devices are used in hospitals and laboratories to test for over 60 medical conditions. The success of the company’s immunoassay analyzers led to increased demand for its consumable reagent packs. As the molded reagent packs had been produced from the same molds for years, this represented an opportunity to increase the number of cavities in the molds to potentially double the output.

However, the complex and outdated part design presented a substantial roadblock to this effort. To create the individual wells that hold the reagents, the mold cavity required thin metal blades that tended to warp or bend, requiring frequent mold maintenance. The blades also had to be cooled before part ejection, slowing down the cycle time substantially. Finally, quality and consistency of the molded parts was a constant concern. Scaling up the exact same mold design would only scale up the problems.

One way to address the molding challenges would have been to simplify the design of the part itself. However, the FDA-approved status of the existing commercial reagent pack made it cost-prohibitive to change the design. Any change would require extensive requalification.

Finally, the labor and packaging involved in transporting reagent packs was excessive. The molded parts were triple-bagged and shipped 1,000 miles in corrugated cardboard boxes on wooden pallets to the diagnostic company’s facility, where they were unpacked and manually loaded onto a production line for filling. Packaging materials and any parts that had broken in transit were then disposed.

Since the company had an urgent need and the incumbent supplier’s plant was a substantial distance from the filling location, management sought a new manufacturing partner. The partner would need to have the development resources while also offering the benefits of proximity with coast-to-coast facilities. Comar Medical was the perfect fit.

"Key to our decision to engage Comar was that we knew their team was very innovative and had high capability in design for manufacturing (DFM) and automation development. We collaborated early on and co-developed the automation specification, so we were building our respective automated production lines concurrently."

Manufacturing Engineering Manager for the diagnostics company

Solution

Comar’s engineering team was familiar with the customer’s diagnostics products, as the two companies were already collaborating on a new process to produce the elastomeric cover for the reagent pack. As with that project, Comar had to develop innovative solutions to meet the key engineering challenges.

Without the freedom to redesign the part, Comar focused on tackling the inefficiencies in the current mold design. Since cooling time can account for more than two-thirds of the total cycle time in the production of molded parts, mold cooling was a good place to start. Comar’s new mold design replaced the cooling channels in the thin metal blades with advanced heat conductive alloys.

Another upgrade to the mold was to add mechanical interlocks on the tips of the blades to provide additional structural support. This feature was intended to reduce the constant deformation the blades experienced during a typical cycle, thereby increasing longevity and reducing maintenance.

With these enhancements in mind, Comar ordered an 8-cavity mold and fit it to a 385-ton press. Standard practice at Comar is the use of scientific injection molding (SIM), and the reagent pack project was no exception. The engineering team fit sensors in the mold to monitor the pressure of each cavity as an early warning of process deviations and to ensure consistent product quality.

The next step was to design a dedicated work cell that could effectively leverage press side automation. As automation had the potential to deliver labor savings at both the production and receiving sites, its design and implementation was a joint team effort.

The manual process of bagging and boxing finished parts was replaced with integrated automation. Robotic arms capture the ejected parts from the mold and position them in custom-designed thermoform trays. The full trays are then stacked onto reusable plastic pallets and delivered by Comar trucks to the diagnostic company’s facility just a few miles away. The entire process is reversed at the diagnostics company, where robots unload the reagent packs from the trays for reagent filling on the production lines. The trays and pallets are then returned to Comar for reuse to close the loop.

Highlights
• Redesign mold to address cooling issues and tool maintenance issues.
• Increase cavitation from 4- and 6- to 8-cavity.
• Integrate scientific injection molding principles to improve consistency.
• Introduce pack-out automation and reusable packaging.

RESULTS

Now that the new manufacturing work cell is producing commercial product, Comar’s effort in designing a new mold, increasing cavitation and integrating automation has delivered beyond the original. By increasing the mold to eight cavities, the clinical diagnostics company has seen a significant increase in output—an additional 1.3 million parts per year—with a decrease in unit costs. Improvements in the mold’s cooling efficiency have resulted in a 16% reduction in cycle time versus the previous mold design. Automation has reduced material handling to such an extent that labor costs due to material handling are down by 65%. Raw material costs have decreased by approximately 15%. By using reusable trays and pallets, all single-use packaging has been eliminated.

“Each company built, specified, and installed the automation at their respective facilities, but we collaborated heavily on the packaging configuration,” the senior engineering manager said. “We co-developed the layer packing and the palletizing and made the position requirements for the packaging specification together. We teamed up to make sure there would be a seamless transition and hand-off of product between the two companies, and we pulled it off with no major design issues or significant delays on either side. Looking at the value stream, Comar took a lot of waste out of the process, such as single-use packaging materials and product damaged in transit. Since human hands never touch the products, we have now cut the number of broken parts due to handling in half or better. There has also been a significant reduction in labor because both production and receiving facilities are fully automated at the pallet level.”


Substantially increased throughput and lowered unit cost

Cut in production labor costs through use of robotics

Elimination of single-use packaging with custom reusable trays and pallets

Improvement in cycle time through more effective cooling

Reduction in raw material costs
Medical Manufacturing engineer scanning product in a clean room

WHAT THE CLIENT THINKS

“We appreciated Comar’s design for manufacturability expertise and their consultation on how to improve processes. We improved quality because of Comar’s commitment to SIM-based process control and validation. Also, their execution was aggressive, and their project management was on point with very good attention to detail, timely response and good interaction across both groups and teams. Comar Medical has been a very good partner.”

 

– Senior Engineering Manager for the diagnostics company

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