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 project’s life cycle from initiation to closing should assist anyone entering a project-based work environment because…[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 device. Its occurrence can be attributed to a stubborn personality in that a simple task that seemed straightforward at…[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 good amount of college students today are not capable of pursuing a degree in BME as they may have trouble keeping up with course…[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 skills to have in this organization is interpersonal skills, the ability to…[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 an adequate idea of the project’s evaluation criteria, know the project’s spending…[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 learned in lecture, there are 3 types of organizations: functional, project-based, and matrix-based…[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, QC is more engaged with real time testing while QA works more with documentation and…[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 as a project progresses. One method to identify risk is to generate a risk matrix, which associates a risk’s…[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 expressed in relation to a variance in pre-established scheduling and costs. Schedule variance is the difference…[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 come into effect at the end of project initiation and remain active until the…[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 well as the consent from all participating members via a signed approval. An example of a change control that recently occurred…[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 each shift to discuss the plans/processes that are to take place for the day as…[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 5 year duration, then its PV and EV fall under the same date and time in order to compare the two variables. At 2 years, the PV will…[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 or not there will be any resulting delays in a project is based on how the contracted vendor handles the…[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 the planning has already been done, the standard operating procedures have already been written and just need to be carried out. This…[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 to your liaison knowing that she had the least friendly characteristics in comparison to the rest of the…[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 chart will establish a list of milestones and the amount of allowable time that the project team has to complete the required…[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 as it acknowledges budget estimation as both a timely process and a potential roadblock down…[Read more]

I currently work in industry at a clinical research project-based company where I manufacture cell-based transfusion products intended for treating patients diagnosed with a variety of cancer. From what we learned in this course regarding corporation types, I would say that my company definitely fits the description of a project-based…[Read more]

The first factor in understanding Gantt charts is being able to associate tasks to one another in terms of their dependencies. These relationships are known as Finish to Start (FS), Start to Finish (SF), Finish to Finish (FF), and Start to Start (SS). A FS relationship indicates that the initiation of one particular task cannot commence until a…[Read more]