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 the project team, individual members from either department can communicate with one another in…[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 the patient to treat diseases/conditions such as cancer, HIV, hepatitis, etc. The risk present in this…[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 customer support as they have more experience with the customer’s personal needs.…[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 executives and project teams. Executives hire project teams to essentially do the work for them, however if the…[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 design, therefore its imperative for a PM of a medical device company to hire a supply chain manager (SCM). It is the SCM’s…[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 Administration, the Departments of Energy and Education (DOE), and so forth. If no external funding is…[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 state that success is dependent the various functions that the team can carry out with respect to their…[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 vectors that “reprogram” white blood cells to attack a specified illness that a patient may have (cancer,…[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 that a product may face and finding the appropriate methods for…[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 of is design changes, which is sensible for me since this step occurs before, during, and…[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 be considered as one of the most difficult phases of the cycle because it requires a substantial amount of…[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 device is packaged separately from the active drug. This would classify as a Class I 510(k) exempt device…[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, dental, immunology, neurology, etc) and correlating it with its associated citation…[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 products mainly act by interfacing intimately with a patient in such a way that even the…[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 skills require a PM to assign tasks and resolve conflicts among a project’s participating…[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 as controversial is because acquiring technical knowledge demands hard…[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 marrow aspirate, and white blood cells (WBCs) to treat patients with…[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 a major conflict if both companies are from different countries in which dialects can cause…[Read more]

I work at a clinical research company that is involved with recent breakthroughs in immunotherapy. This includes treating conditions such as cancer, HIV, hepatitis, or pro-inflammatory diseases by processesing cell-based products that are intended for patients in Europe (EU) and Canada (CA), and possibly Japan. A common reason for establishing a…[Read more]

As a master’s student approaching my last semester, I can say that this course is unlike any other course I have taken in that it provides an alternative and even a more practical perspective on the medical device field. We were first educated on the distinctions between working in academia versus industry, which gave us insight to the first…[Read more]