A non-conforming material report (NCMR) is something that must get taken up with the current vendor to prevent the incorporation of defective equipment into a medical device project. An NCMR is generated by either the quality department or during a…   Read more»

One of the main reasons people leave work is poor management. This can occur when a manager is not competent enough to keep track of all members on a team which leads to an imbalanced assignment of tasks where qualified…   Read more»

This course has definitely given me a better understanding of how contract research organizations (CRO) are managed, which is of particular interest to me since I have been working in a CRO for almost a year now. Knowledge of a…   Read more»

Tunnel vision is generally defined as the tendency to focus on a single goal with a limited point of view. The definition itself indicates that it is not an ideal element for project management, especially that of a Class III…   Read more»

One motivation for working on designing a medical device project is to finally get a chance to apply all that you learned in the years of being an undergraduate and going through grad school. It is also known that a…   Read more»

I currently work in a project-based organization, which as we learned in lecture is run by project managers who govern project teams consisting of members from all vital departments (production, quality control, quality assurance, etc). One of the most imperative…   Read more»

Procurement management is a process carried out by a project manager that requires them to collaborate with the purchasing department to determine the most optimal vendor for any particular provision. A few essential requirements for project procurement is to have…   Read more»

It goes without say that communication management is an essential aspect of a company’s environment as it ensures a consistent flow of information to each entity in a company in order for them to fulfill their respective duties. As we…   Read more»

The primary difference between quality control (QC) and quality assurance (QA) is that QA correlates the industry’s standards to the project at hand, whereas QC ensures that the standards are being met as a project proceeds. From an industry perspective,…   Read more»

As learned in lecture, stakeholders can be a wide variety of individuals ranging from patients to the financial investors that support the project. This goes to state that risk can come in many forms and can actually become more prominent…   Read more»

Planned value (PV) and actual cost (AC) are values that are implemented during the monitoring and controlling phase to give the project manager an idea of their progress in terms of time and budget. The degree of progress made is…   Read more»

The diagram explaining the relationship between PM processes and design controls (from the Initiating and Planning lecture) indicates that design controls can easily exist in more than one PM process. Design input, output, and planning for example, are shown to…   Read more»

One of the changes that occurs in my company is the managing of the bill of materials (BoM). Whenever a general change control is carried out, it must include a justification as to why the change is being implemented as…   Read more»

I currently work at a project-based clinical research company where I process and manufacture cell-based infusion products for the treatment of conditions that are not easily treatable (myelomas, melanoma, renal carcinomas, etc). We hold daily meetings at the start of…   Read more»

It seems that the difference between planned value (PV) and earned value (EV) is a project’s way to determine whether or not it is on track on a financial level. If a project is budgeted at $5 million with a…   Read more»

If a vendor is providing a medical device project with defective equipment/packaging, then they need to be made aware of it immediately so that they can either address it, or at least prevent it from happening to other clients. Whether…   Read more»

Based on what we have learned so far, one could say that the execution process is rather one of the more simpler phases of the design cycle (assuming one has a competent project team). This is the phase where all…   Read more»

As we learned earlier in the course, emotional intelligence determines approximately 70% of success, which without a doubt applied to the MiniSim. The only real way to fail the first part of the MiniSim was to take a condescending approach…   Read more»

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…   Read more»

One of the major driving factors of a project is determining the project’s cost and budget, which without a doubt becomes more complicated the longer a project’s duration is. The PMBOK guidebook dedicates an entire chapter towards project cost management…   Read more»