Case Studies

Product Development Program Management – Pharmaceutical Company

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

Action
The product team was geographically distributed across the United States and Europe. Project activities included:

  • 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

Results
Rasdal Associates was able to come up to speed quickly on all aspects of the device program with little involvement from the client. This was important as client resources were needed on other critical projects. All device activities were completed on schedule to support required clinical programs. Program was acquired by a major pharmaceutical company.