Within a Design and Development Plan (DDP), sub-planning planning involves breaking down the overall design and development process into discrete elements, each of which needs a customized strategy. For instance, within a software development project, specialized sub-plans may be created…   Read more»

I think hands off is definitely the best way to go. But, obviously, it might not be the best way to go for all employees. Some employees might be really good in a hands-off style but at some point, if…   Read more»

This is a good question because as a Ph.D. student, I always have a concern about the privileges that I may have in the future as a part of a project member. Generally, I believe that individuals with advanced degrees…   Read more»

The PDCA cycle is an essential aspect of successful biomedical engineering projects. While each respective department may have its own PDCA cycle, the “check” aspect can involve members of different specialties. For instance, in a pharmaceutical company, clinical trial protocols…   Read more»

I think the culture is very important. There are different ways of managing this dilemma and at the end of the day, it just depends on the company you are in. For me, I would focus on a more continuous…   Read more»

Project sub-plans play a crucial role in the successful execution and completion of a project in project management. From my perspective, resource allocation and risk management are two important components. Resource allocation is essential for effective project management. By creating…   Read more»

I think at the end of the day, they will both have different perspectives. However, they are both going to have to learn a lot of stuff, either way, if they both want to do their job well. I do…   Read more»

I don’t think I am too aligned with your assessment. As a project manager, your job is to manage the project. I do not believe it is our responsibility to make sure that everyone has an equal contribution to the…   Read more»

Sub plans are important in project management, especially in cases where specific details of a specific aspect of a project need to be expanded. For instance, a project management plan usually includes an executive summary, a Gantt Chart, a risk…   Read more»

Verification and validation are similar processes but with different goals. Verification relies on testing the design requirements/specifications to ensure that the product is built/functions as designed. Validation is testing to ensure that the customer’s requirements or needs are met. For…   Read more»

Good question. A project manager manages a project. He is the king of that project. As you said a project manager can have a ph.D. degree or experience to support clinical or market knowledge.  In my opinion, it depends on…   Read more»

well, its a good question. However, I can tell you an easy way to understand it. All the inputs have an output. Each output is verified in verification. Tests are done here to check the output. Additionally, it is observed…   Read more»

@mt644  Thank you for the new information. I’d like to bring up a concern that has been on my mind throughout my career in the field of medical equipment. One of these concerns relates to the fast cycle you mentioned….   Read more»

@sa2847  It is indeed an interesting idea, but it should be noted that there are very complicated and cumbersome regulations from the FDA for third-party companies. In fact, for most hospital managers, dealing with these types of companies is perceived…   Read more»

@ma2726  Thank you for your response, and I apologize for the delayed reply. Let me add the following to your response: Collaborative Research: The idea is to increase synergy among all the components involved in a medical device. By creating…   Read more»

I agree with the above posts by various members on educating oneself. It is essential to build a knowledgeable and multi talented team. This is possible when the project has been broken down sufficiently in steps to understand the various…   Read more»

In functional organizations, communication is observed mainly in functional departments. Managers overseeing the project go through a particular hierarchy to convey the information. In Weak Matrix, managers directly convey the information to the team members. Project manager has more influence…   Read more»

The different organizations mentioned in the lecture were also interesting to me because I tried to compare them to the teams i have worked on in the industry and feel like my company has had situations of all organizations. Currently,…   Read more»