Although I can’t speak from personal experience, I believe that poor planning during project initiation can affect the project negatively in different ways. For instance, if a project starts without clearly outlining the people, money, and materials needed, it…   Read more»

Hi everyone ,   My name is Endri Shkjau and I’m a BME Masters student at NJIT. Here is my LinkedIn page: https://www.linkedin.com/in/endri-shkjau-670336191/ I look forward to connecting with you all! Thanks, Endri

A project’s decision to be pursued with the possibility of future patenting, even in the absence of funding, might be influenced by a variety of factors. It would be a smart idea to move on with the project if it…   Read more»

I agree with the majority of the comments above that fulfilling deadlines is one of the most crucial and challenging aspects of a project. There are a few essential components of project management that can improve the efficiency of meeting…   Read more»

The type of manager that is best for a certain project should rely on the assignment. An academically focused project manager may be preferable for projects in highly technical or research-intensive fields due to their analytical and research skills. Furthermore,…   Read more»

The preference for a hands-off or micro-managerial leadership style often depends on the team members and  project.  The hands off leadership style requires highly skilled and motivated team members. Also in this style sometimes there might be a lack of…   Read more»

In my opinion , it is not necessary that all team members contribute equally to projects. However, it is very important that each team member accomplish their goal. Some strategies that can help ensure that all team members are contributing…   Read more»

The Plan-Do-Check-Act (PDCA) cycle has four phases which are plan , do ,check and act. During these phases there are many specialities like biomedical engineers, clinicians, project managers, regulatory experts, and quality assurance specialists that work together to ensure the…   Read more»

Misclassifying a medical device can result in a number of issues and difficulties that could compromise regulatory compliance. Misclassifying a medical device might end up in submitting the wrong type of pre-market submission (e.g., 510(k) instead of PMA, or vice…   Read more»

The regulatory role is crucial in the development of medical devices in order to meet all the requirements set by the FDA. As we can see from the lecture, the regulatory role breaks down in product development and post-market management….   Read more»

I think that the success of working in large or small groups and with people from different backgrounds depends on the particular project, its objectives and the dynamics of the team. Some of the advantages of working in smaller project…   Read more»

It is very important to understand the differences between the three classes early on in a project because it can help save money and time. Typically, Class I devices are low-risk devices, which are known devices with a long history…   Read more»

  Drugs and medical equipment are very important for the safety of our health. Medicines and medical devices have many differences that may include their mechanism, their interaction with the human or animal body, their regulatory agencies that are within…   Read more»

Both the PMA and the 510(k) are the most important documents required by the FDA for medical devices to receive market approval. PMA is technically required for all Class III devices. Typically, medical devices that are classified as Class III…   Read more»

Gift-giving to doctors is a delicate and complicated topic, with different national and local laws and standards applying. In my opinion, it’s fine to give a physician small gifts that are under $100, but not often. Also, it is ok…   Read more»

This is a very good question. In my opinion, if you invite a physician to a dinner to talk about the product you can promote and they bring their spouse to the dinner, it is very disrespectful to only pay…   Read more»

When I first started this class I thought it would be more of a medical device prescription class. However, I was surprised and at the same time happy to learn about the different jobs Biomedical Engineers can do and the…   Read more»

Depending on personal preferences, professional aspirations, and strengths, one may choose between Upper and Middle Management. Some people are ideally suited for upper management because they have a natural gift for imaginative thinking and like leading an organization. Others work…   Read more»

Establishing a project team is an essential first step in making sure a project is successful. Creating a project team that works requires a deliberate approach that considers each member’s unique capabilities as well as the group’s combined abilities. Working…   Read more»

In my opinion, the best organizational structure is the matrix organization. I think this way because the resources in this type of organization are very well managed. The same resources can be used for several projects like  a marketing manager…   Read more»