As a PM for BoneFix working on the Fset1 growth factor product, I would constitute organizational diagrams such as a Gantt chart, a design matrix, and a Pareto chart so that the project can be carried out fluently. A Gantt chart will establish a list of milestones and the amount of allowable time that the project team has to complete the required tasks. A design matrix is an organizational structure that the project team refers to when determining both the attributes of a project and how those attributes relate to one another as they’re being handled individually. Finally a Pareto chart is a form of risk analysis that presents all potential complications in a bar graph, prioritizing risk factors on the order of severity.

One of the most prominent challenges for a PM in this simulation is being able to prove that the product retains a shelf-life of 2 years with only about 6 months of testing time. In this case, an accelerated study may be substantial enough where environmental factors such as ambient temperature is slightly increased to account for the lack of prolonged exposure (i.e. 40-45 C over 6 months instead of 37 C over 24 months). Testing the efficacy of this method will also require preclinical studies, which may have to be performed in vitro as the time constraint may limit the possibility of conducting animal studies.

An important consideration of accelerated testing is being able to accurately assume that whatever is performed will match the actual outcome. Can having a limited time constraint be handled by risk management in any way? How can alterations in verification testing be justified as there are not yet any prominent results to dignify the product being tested? What might be more preferable for this project: Having a large budget but little time, or a lot of time but a limited budget?