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reward the effort, that hard work people put in to go the extra mile. We reward and recognize that in front of everyone at monthly employee meetings. That, and empowering them to make improvements. When they do, it’s recognized, it’s appreciated and acted upon.”


The Community The propagation of STEM education in the next genera- tion, the partnerships with schools and other organizations in Erie to develop skilled workers—these aren’t the only way these two companies are impacting their community. Plas- tikos, with its much larger workforce, works with the Catholic Charities’ Refugee Resettlement Program to hire international employees—they’ve employed people here from Somalia, Nepal, Iraq, Ethiopia and Eastern Europe—and has collabo- rated with the nonprofi t Multicultural Community Resource Center’s Refugee Social Services program. And the two com- panies team up for community service efforts, ranging from a beach clean-up at a nearby state park, a local breast cancer walk for which the companies matched employee donations, and a back-to-school drive: “We collected backpacks and art supplies, notebooks, pens and other things for kids who are in a homeless shelter here. I’m proud of the team for that one,” Philip said.


The companies understand their interdependence with their community—and again, it’s a recognition that goes way back.


“As I mentioned,” Philip said, “When my dad and Dave


Mead fi rst hung out the Micro Mold shingle in 1978, they were working with used equipment in rented space in part of a garage. No telephone—and our mom was eight-and-a-half- months pregnant with our sister. “This was long before cell phones, of course. Since they


didn’t have a phone in the work space, my dad walked down the street to a residential house, knocked on the door, intro- duced himself to the man who lived there, and said some- thing like, ‘Hi, I’m Tim Katen, just started a business down the street. Just wanted to introduce myself—and ask you a favor. If my wife would happen to go into labor while I’m working, would you be willing to let her call you? And would you then run down the street and knock on my door so that I can hightail it down to the hospital?’ And the neighbor agreed.


“My mom went into labor early in the morning before work, so in the end the neighbor wasn’t involved in my sis- ter’s birth. But when my dad turned to him for help, he was ready. That’s what communities do for each other,” Phil Katen fi nished.


Developing the ‘Smart- Phone’ Insulin Pump


Unsurprisingly, the Katen brothers need to be wary when discussing specifi c customers and projects in order not to break confi dentiality agreements. But one customer they can talk about is Tandem Diabetes Care (San Diego). Tandem wanted to bring a new insulin delivery pump to market, one that was streamlined, small and simple to use—the “smart phone” version of an insulin pump.


The pump had to be able to deliver a slow continuous supply of basal insulin to control blood glucose levels at a rate as low as 1 μl—that’s 0.000,001 liter—per hour. Additionally, the pump needed to be able to deliver a bolus dose—that’s a quick, larger dose—of insulin during meals or when the blood glucose levels are elevated. Bolus increments on what was named the t:slim Insulin Pump ranged as low as 0.1 μl. The stringent perfor- mance qualifi cations of the device were a considerable challenge, the Katens remember.


A close partnership among Plastikos, Micro Mold and Tandem Diabetes Care was formed to ensure this type of micro-dosing performance could be attained on a dis- posable cartridge. Components the size of a single plas- tic pellet with a critical tolerance of ± 0.0127 mm would play an integral role in the micro-dosing performance. The project became exponentially more challenging when designing and constructing multicavity molds that ranged up to 32 cavities, with fully interchangeable inserts among all cavities.


Upon mold delivery, each tool was vigorously tested dur- ing the OQ/PQ (operation qualifi cation and performance qualifi cation) phases of the mold validation to ensure the process was repeatable from shot to shot. Plastikos’ process engineers, who are certifi ed Master Molder Level II employees, spent weeks meticulously validating each mold. To further mitigate the risk of shipping a single defective part, every cavity on each mold was designed and built with a cavity pressure sensor. This in-mold sen- sor technology is used to monitor every cycle in produc- tion and provides 100% traceability.


The Katens credit early team collaboration between the Micro Mold and Plastikos team and Tandem Diabetes Care as essential to successfully bringing the t:slim to market. “The continuous-improvement mindset at both companies enabled us to push the tooling and injection molding limits and help make our customer a new force in insulin delivery pumps,” Philip Katen affi rmed.


87 — Medical Manufacturing 2015


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