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SPR Builds Labeling & Workflow System for Radioactive Medical Device Manufacturer

CUSTOM DEVELOPMENT
A group of people in a hospital operating room.

A few years back, a medical device manufacturer hired SPR to create a label and certificate (L&C) program for a radioactive seeds product line used to treat prostate cancer. When the time came to develop a new product line of radioactive implant devices to fight liver cancer, the manufacturer again turned to SPR.

A 60-Hour Window To Deliver Treatment

There was a key difference between the radioactive prostate seeds and those used to treat liver cancer: The half-life of the radioactive materials. While the prostate seeds have a half-life of 60 days, the radioembolization beads used for liver cancer have a half-life of 64 hours. As a result, SPR built not only a labeling program but also a workflow system to measure the radioactivity of the treatment beads throughout order preparation – a process that can take up to 8 hours.

Displaying Radioactivity on Web App

SPR’s new system helps facilitate order fulfillment by calculating and measuring the radioactivity of the syringes as they are being produced, including bulk readings, rinse readings and filling of syringes. This includes getting a reading from a Dose Calibrator on the measured activity of the radioactive materials so they could be provided to the patient within an effective timeline. A desktop application needed to be written to capture this data from materials placed in the calibrator’s ion chamber and then streamed to the web application.

Keeping Time-Sensitive Workflow Moving

The workflow system also:

  • Searches and reviews orders from the order ingestion portal
  • Provides operators with the ability to select and fulfill orders in parts over extended time periods
  • Calculates amount of radioactive material needed to fill order today for use on implant date, taking into account the rate of decay
  • Manages decay calculations to account for time zone differences
  • Displays real-time radioactivity reading in the web application
  • Enables technicians to divide materials into multiple doses
  • Prints vial labels with 2D barcodes for processing and packaging

Certifying, Reporting and Labeling Materials

Finally, the system prints a certificate that aggregates and certifies the information across the whole order, such as how much radioactivity they started with, radioactivity on day of shipping, and expected radioactivity on day of treatment, etc. Through the workflow system for manufacturing, technicians are also able to trace inventory on hand and determine how current inventory matches future order demand.

Technologies used include: .Net Core, Web API, EF Core; SQL Server, SSRS; Vue.JS, Vuetify; SignalR; and WPF.