AM Technical Solutions (AMTS) helped a Chicago-based firm ramp up Diagnostic Medical Electrode production with cost and capacity modeling for their cleanroom production lines.
We are particularly proud of this project because of the opportunity to provide strategic support for the printed electronics customer in addition to our typical scope of work delivering cleanroom construction for projects in the healthcare industry.
Our Strategic Cleanroom Production Support
We supported the customer in the selection of the best way to ramp up a new Diagnostic Medical Electrode for diabetes testing based on a flexible microelectronics product that could be produced using three alternate methods.
The key was to find the most cost-effective method to quickly produce 1.5 billion of the diabetes test strips per year and serve 20 percent of the worldwide market.
The customer has a very unique process, but they needed a cost model and manufacturing study to quickly help them optimize the cost elements for the production of a new type of medical electrode: a key element of test strips for diabetes.
To support this initiative, our team studied benchmark products from many market leaders. Specifically, AMTS engineers and cost modelers studied making these test electrodes in roll-to-roll format with our customer’s unique process and roll-to-roll manufacturing equipment. The study was performed in cleanrooms that we had helped the customer develop for a less stringent cosmetic patch product.
During the testing phase, we studied the process types, including their baseline expertise of screen printing as well as sputter with laser patterning, additive, and subtractive. Precious metal coatings were involved in all cases, contributing to the cost sensitivity.
AMTS cost estimators and process modelers worked closely together to optimize production processes, equipment, and facilities conditions with our customer to meet the product cost targets for affordable test strips, while also meeting the stringent FDA and GMP requirements.
Another key element of the study was phased capital equipment scale-up according to market demand and optimum manufacturing line size, which we supported as part of the project.
The Results of Our Strategic Support for Cleanroom Production
Our team embraced the opportunity to support the client’s goal of immediately producing 1.5 billion diabetes test strips to reach 20 percent of the market.
Once the initial goal was achieved, the company continued to find success with the chosen process. Our customer made their first 14 billion diagnostic medical electrodes within five years, which was an even faster ramp-up than expected.
“This project required tremendous collaboration between our team and the customer to support their process for manufacturing medical electrodes,” says Abbie Gregg, AMTS Chief Technology Officer. “Successful delivery of the project reflects our company’s ability to support each critical aspect of a regulated healthcare product launch with operational support, cleanroom design and construction, and tool install, preparing our customers for success.”
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