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Product Lifecycle Management in a New Era of Nuclear Medicine

For more than a decade, EmbedTek has provided embedded computing solutions to NorthStar Medical Radioisotopes, a radiopharmaceutical company where success has required deep customer knowledge. The delicate nature of handling nuclear medicine called for EmbedTek to be aware of the end user application, stay updated on FDA regulations and have a comprehensive understanding of their entire supply chain. The result: a partnership that has evolved from an embedded technology provider to a true extension of the engineering team.

The EmbedTek team was brought on over a decade ago to provide hardware, software, and lifecycle management to one of NorthStar’s industry leading technologies, the RadioGenix® System. The RadioGenix System (technetium Tc-99m generator) is used by radiopharmacies nationwide to produce Sodium Pertechnetate Technetium-99m (Tc-99m) from Mo-99. In the U.S. alone, products labeled with Tc-99m are used in more than 40,000 imaging studies per day.

“Reliability is key because there is a short timeline to vet the chemistry and get it out the door. Once radiopharmacies use the RadioGenix System to produce Tc-99m, the half-life is 6 hours,” said Vicki Bull, Senior Strategic Sourcing Specialist for NorthStar. “The FDA requires robust traceability for everything that goes into that injection – from the computer, special software, consumable packaging, sterilization, reagents to dilute the product – everything has a lot number so if there ever is a problem down the road, we can trace it all back.”

EmbedTek is uniquely suited to support NorthStar because of our holistic approach to designing embedded solutions based on customer requirements. EmbedTek engineers leverage proven technologies, commercial off the-shelf (COTS) components, and existing supply chains where possible. Once a solution is implemented, EmbedTek provides product lifecycle management that prevents unexpected component changes, disruption to production, and increased costs.

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