Case Studies

Product Development Program Management – Pharmaceutical Company

The client was working on a drug/device combination product and needed help on the device side. The client engaged Rasdal Associates to project manage the development of the device and supporting materials.

The product team was geographically distributed across the United States and Europe. Activities included in the project:

  • Created and maintained master program schedule in Microsoft Project
  • Maintained product requirements document
  • Oversaw evolution of product specifications
  • Coordinated review and feedback for product prototypes and development progress
  • Managed the creation of a “Quick Reference Instruction” for the product including several focus groups
  • Coordinated usability studies
  • Supported clinical program needs for devices and documentation
  • Developed “Product Requirements Trace Matrix” for product testing
  • Coordinated risk analysis activities
  • Researched disinfection solutions

Rasdal Associates came up to speed quickly on all aspects of the device program with little involvement from the client. Consultant’s ability to work independently was important as client was focusing resources on other critical projects. Completed all device activities on schedule to support required clinical programs. A major pharmaceutical company acquired the program.