Loading

 

 

2.1.5.1 Lifecycle Objective Milestone (LCO)

Stakeholders (project team, PI, collaborators, grant committee) assess the state of the project and must agree on the status of the following criteria at the end of Inception Phase which corresponded to the Phase 1 grant application submission:

  1. Define scope of the project.
  2. Initial requirements have been identified.
  3. Software development plan is realistic.
  4. Risks have been identified and are being managed appropriately.
  5. Business case for the project makes sense.
  6. Development process has been tailored appropriately.

As defined in the Phase I Grant application, the set of deliverables required to move from Inception Phase to Elaboration Phase, includes:

  • Establish a mature and cash-positive business plan based on the research market.
  • Publish an article on statistical analysis in flow cytometry in a peer-reviewed journal.
  • Establish and iterate upon the preliminary FlowDx design. Document it herein.
  • Establish a software methodology suitable for FDA approval of medical devices.
  • Present a poster at scientific congress explaining FlowDx concepts & soliciting feedback.
  • Conduct a survey of flow cytometry users, developing user profiles and comparing research vs. clinical users’ affinity for different software features.
  • Develop a primary and two secondary use cases to satisfy good design practices. Receive a commitment of participation and access to data for each case from the cooperating laboratories:
    • Quest Diagnostics Department of Hematopathology and Anatomic Pathology, San Juan Capistrano, California,
    • Division of Viral Pathogenesis, Department of Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts.
    • Terry Fox Laboratory, BC Cancer Research Centre, Vancouver, British Columbia, Canada (No grant funds will be used outside the U.S.)
  • Gather five letters of strong support from customers and FDA officials. The letters should attest to the feasibility, significance, and commercial potential of the project.

The work-products (artifacts) were the phase 1 grant application & funding approval.