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…   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…   Read more»

The advantage to having a risk management team internally associated with a project team is the absence of “information silos”, in which departments withhold knowledge and information from one another as a norm. By having a risk management team within…   Read more»

The concept of a risk/benefit ratio is to acknowledge that the most promising rewards come at a price. Immunotherapy for example, extracts, amplifies, and expands a patient’s own white blood cells (WBCs) so that they can be infused back into…   Read more»

Formulating a Design Input Document (DID) can require participation from every department involved on any given project. As mentioned in lecture, while marketing has a strong influence over a product’s design, it is also imperative to include a member from…   Read more»

The most effective way of addressing scope creep is to determine its origin/source in a way that not only resolves its conflicts, but also prevents them from resurfacing. One main cause of scope creep is a lack of communication between…   Read more»

When it comes time for a medical device company to select a supply vendor, many factors must be taken into consideration. Medical devices are not the simplest products as they are expected to carry a lot more risk in their…   Read more»

If a company does not have funding for a project, then it can reach out to other entities for additional support, such as a federal organizations like the National Science Foundation (NSF), the National Institutes of Health (NIH), the Veteran’s…   Read more»

Selecting a project team can undeniably determine not just the success of a project, but also the potential for new contingent projects that expand on the work that was done. Any online source that regards selecting a project team will…   Read more»

The company I work at went through a similar situation in which we were performing two separate projects for two different clients, but only had enough supplies to fulfill one project. The materials we work with are highly expensive viral…   Read more»

The most appropriate time to conduct design verification is once all of the design inputs have been specified within the document known as the verification protocol. This requires one to know their product’s shape, function, dimensions, specifications and FDA/governmental regulations…   Read more»

I currently work in manufacturing/production at a cell-research company where I process autologous cell-therapy products that is in its clinical phase with the hopes of becoming marketed. The most imperative design control I’ve had the chance to be a part…   Read more»

As we learned in lecture, all projects have a life cycle that dictates how smoothly the design process is going to flow, which in turn determines the overall success of the product upon entering the market. The initiation phase can…   Read more»

The Ellipta inhaler is considered to be a combination product in the same sense that a pre-filled syringe is. The Ellipta inhaler contains a drug that is combined with a device to facilitate the drug’s delivery, regardless of whether the…   Read more»

A straightforward way to classify a medical device is to go on the FDA website under their device classification panels page. This web-page allows one to locate their classification regulations by selecting which field their device falls under (i.e. cardiology,…   Read more»

A quality management plan is defined in our PMBOK guidebook as “a component of the project or program management plan that describes how an organization’s quality policies will be implemented”. This is especially important in the biotech field in which…   Read more»

A general online look at job openings for project managers (PM) lists a variety of skills ranging from interpersonal leadership skills to math-based analytical skills such as time and budgeting, or any skill that will yield a progressive workflow. Leadership…   Read more»

I believe that in a perfect world, the ratio of success between interpersonal skills and technical knowledge should favor technical knowledge, especially in the science/medical field. One reason as to why the success equation regarding emotional intelligence (EI) is perceived…   Read more»

The company that I currently work at would be considered a project-based organization in that we conduct research on cell therapy-based products and processes. For example our projects focus mainly on optimizing the processing and transplantation of stem cells, bone…   Read more»

I think it’s quite clear that it is always more important to have an agreement transcribed into writing rather than have it established verbally, especially when occurring between two aspiring companies. A verbal agreement in this case can result in…   Read more»