With what many users have posted and collectively agreed upon, having a group of hires that have broad skill sets that can be more versatile in their role would be the most ideal group and make a stronger team. It…   Read more»

Project slack is the difference between the late finish and the early finish. As long as the project is finished within that range, the project is okay. During project slack, the schedule can be juggled where the team can account…   Read more»

Scheduling tasks really depends on how difficult it is and how it affects the sequential events that come after that task or what needs to be done before or after that task. Most can be calculated with the Gantt chart…   Read more»

For my senior project during undergrad, my team and I had experienced the pitfalls of costs and resources. The academic project served as a way to allow biomedical engineering students to understand what it takes to develop and design a…   Read more»

In the lecture, the risk management process involves assessing, evaluating, managing, and measuring. You assess the situation with what can go wrong and make a list. Then, you evaluate the list to see how probable and if they can hurt…   Read more»

During the lecture, Dr. Simon had explained and defined these three inputs that make up the initiating process group of PM. The Enterprise Environmental Factor is everything you know about the organization’s culture and how the organization behaves around projects….   Read more»

A project manager chooses the people for a project team and that is part of the planning process group. They choose these people based on their skill sets, availability, knowledge, and sometimes compatibility. Everyone in the group would have the…   Read more»

The only industry example I have is in a biotechnology company, but with medical device development, I have an example for when I worked on creating a medical device prototype for my undergrad senior project with my group. With the…   Read more»

The best way to avoid this type of situation is communication. Communication plays the biggest role in project management to relay messages or any sort of changes in the project especially due to the time deadline, budget, and resources being…   Read more»

Business needs and customer satisfaction should both be markers in the goals they want to accomplish in project management. For example, with running a biotechnology business, the company’s needs are more than likely going to be getting clients, increasing production,…   Read more»

Like what many users have mentioned, involving regulatory experts and validation early into the development process is a way for organizations to find that balance between regulatory compliance and innovation. The use of regulatory compliance is to make sure that…   Read more»

Verification checks that the inputs equals the output, meeting design specifications, while validation checks that the inputs equal the user needs or intended use, satisfying the acceptance criteria. All of these testings are done by the project manager and project…   Read more»

If there are resource pressures or the lack of resources, during the planning stage, the project manager can identify what they need, what manufacturers produce those resources, and how abundant they are with availability, material wise and team member wise….   Read more»

According to the FDA, the classification of a medical device is based on finding the regulation number that is the classification regulation of the device. Project teams have to use a classification database or find the device panel. Device classification…   Read more»

As many users under this post have mentioned, a balance of both the medical device’s own regulatory experts and an outsource to consultants would be the best in both worlds. Both regulatory experts and consultants have their own skills and…   Read more»

To begin, PMA is one of the most rigorous applications out there for medical devices that can pose-high risk. This typically includes performing pre-clinical and clinical trials to ensure the safety and effectiveness of Class III medical devices. Many regulatory…   Read more»

There are slight differences between the works of a project manager and program manager in terms of scope, change, planning, management, success, and monitoring. Overall, they are kind of similar to each other in some aspects. To add onto gdecarvalho’s…   Read more»

Honestly at first, communicating in-person was the go-to method for companies, but it can be difficult to work fully in-person with a group of people working on a project. Working under a project manager that primarily communicates online would be…   Read more»

From many experiences with working in a project team as a member and as a leader, a lot of problems form due to miscommunication, misunderstanding, or the lack of communication between team members. As a team member, it is crucial…   Read more»

As many users of this post have said, biotechnology companies tend to look at the rewards more than the risks. I do think that there are some companies that actually do take into account the risks, but they only take…   Read more»