CONTRACT MANUFACTURING
Developing the ‘Smart-Phone’ Insulin Pump U
nsurprisingly, the Katen brothers need to be wary when discussing specific customers and projects in order not to break confiden- tiality 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 of 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 incre- ments on what was named the t:slim Insulin Pump ranged as low as 0.1 μl. The stringent performance qualifications 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 disposable cartridge. Components the size of a single plastic pellet with a critical tolerance of ± 0.0127 mm would play an
es both in plastic and in steel. We use a lot of engineering- grade resins. We barely use any commodity resins—it’s all specialty and engineering-grade raw materials.” What material is used and how it is chosen depends on the application and the kind of customer: According to Philip, mature OEMs that have been around a while tend to have a pretty robust knowledge of raw materials that work well with their applications, and already have good relations with the raw material suppliers. “Customers with less knowledge and less experience on the part of their engineers will come to us for guidance. We offer our own experience but also can bring in technical experts from our raw materials suppliers—in many cases their medical-specific technical experts.” Ryan and Philip agree that customer expectations have risen a lot over the years. “It’s quite challenging,” Philip said. “Across the board, customer expectations have increased,
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integral role in the micro-dosing performance. The project became exponentially more challeng- ing when designing and constructing multicavity molds that ranged up to 32 cavities, with fully inter- changeable inserts among all cavities. Upon mold delivery, each tool was vigorously tested during the OQ/PQ (operation qualification and performance qualification) phases of the mold validation to ensure the process was repeatable from shot to shot. Plastikos’ process engineers, who are certified Master molder Level II employ- ees, 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 sensor technology is used to monitor every cycle in production 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 affirmed.
which is no surprise. First and foremost is quality. The prod- uct quality itself, as well as all of the rigorous quality meth- odologies statistical analysis, systems qualification capability analysis and the like that go around ensuring a good quality part every single time.”
“And that applies not only to the finished molded plastic part but the tooling as well,” said Ryan. “And related to that is the OEMs’ expectations around the engineering and tech- nical capabilities of their suppliers—especially, I would say, their supplier base here in the US.” “At Plastikos, we typically purchase 2–4 brand-new injec- tion molding machines each year to replace older machines so that we remain on the cutting edge of technology. The vast majority of our presses are under seven years old,” Philip said. “Micro Mold has made two very large capital investments over the past two years in robotics & advanced manufacturing
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