I agree that the Project Planning Phase is extremely important and crucial for any project’s success. A project must be planned well. Planning is required as it helps in identifying the desired goals, reducing the risks, avoiding the deadlines, and able to deliver the agreed product on the scheduled time. Planning is the base of the project s…[Read more]

The phrase – “Everything is about risk” means that the entire project is dependent on whether the reward of continuing the project will outweigh the risk. A project manager must analyze all the possible options and their outcomes before taking the risk. The method to go about is as follow: Identify the risk, Analyze the risk, Evaluate or rank the…[Read more]

For effective project management, accurate time estimation is crucial. The team member and their logs must be updated at each and every milestone for clarity and proper completion of the project. In order to achieve that goal, all team members of the group should meet up and discuss their time estimations for each step and their reasons.…[Read more]

As you have mentioned, Schedule variance specifies project whether how much ahead or behind the schedule. Some factors that can affect the project schedule variance are unexpected changes to the design of the project. These changes bring the new request on the project which causes the timeline of the project to change most likely increases extra…[Read more]

Logging work is the most important phase in the project or either in work place. For me, keeping a detailed log of work helps you to produce an intended result in any projects by keeping track of what you have done, the amount of time that it took to do it, and anything that came up in the process of work. It can also give you an idea of…[Read more]

In the medical field, one should expect that there will always be success and failure. It is the competitive field dealing with human beings and finding a solution to peoples problems. Therefore, it is important that one should always have a backup or plan B regarding the project When executing a project. This is why the execution phase should be…[Read more]

It is already half of the semester, and till now we have been studying all different methods and documents that support in managing the project. According to me, the best way to meet the deadlines in this scenario is to give the planning phase of the project manager to consider and devote as much time possible to research. When developing a…[Read more]

As @mb698 have mentioned, every phase is important in project management however, initiating the project, planning on how to divide into segments and executing that plan is the most crucial part of a project. These are an important phase as it will help you understand whether your project will be a success or failure. A project management plan is…[Read more]

Design Validation is a powerful tool to achieve a highly effective product. For medical devices, it is crucial to conduct a human factor study to be precisely making sure that the device, equipment or process fits well to the human body. A company does validation to make sure that the company is putting out a quality product that follows the…[Read more]

According to me, logging at work has proven to be very effective and save the struggle when any issue occurs. For me, keeping a detailed log of work helps you to produce an intended result in any projects by keeping track of what you have done, the amount of time that it took to do it, and anything that came up in the process of work. It can also…[Read more]

For any project to succeed does not matter what field it is from, communication and collaboration is the key. It is every team members responsibility to inform the project manager of their possible holiday/vacation time. Based on that, the manager will schedule the deliverable. Also, when an emergency situation occurs, it is a member and manager…[Read more]

In the field of project management, things do go wrong and unexpected changes are always there. So, including a time buffer as a line item in the schedule is a way to account for unknown changes in the schedule. Also, I think this is a better way to avoid an extension of the project in order to protect the critical path from further delay instead…[Read more]

According to me, every milestone is important for any project. Therefore, any missed milestone will have an impact on a project. The only difference is whether the missed milestone falls under either of these two categories: major or minor. Minor milestone will not impact much on the project as much as major one. The datelines will change which…[Read more]

Design input document states what the product objective and its purpose. Besides the marketing team compiling the document, the whole team, sponsor, and customers also give their input, since the Design input document gives the necessary desires for the products based on the market and customers input. Also, another department that provides…[Read more]

According to me, to help track the status of the project, one must establish goals and milestone and in order to keep track of this milestone, the manager must hold team minute meetings which provides detail on the project with any encountered issues. Furthermore, each milestone must have deadlines as well. Also, the famous Microsoft project tool,…[Read more]

As you have mentioned already, combination products are combined drugs, devices, and/or biological products with one another, and are a growing and important category of therapeutic and diagnostic products. Similar to medical devices classification, combination products are also classified into 9 different types. Regarding the review, combination…[Read more]

When it comes to an ideal project team, I believe the project manager must choose the project and its team members wisely. In order to have a successful project, it requires a sponsor, whose project the team is going to be dealing with, then knowledgeable team who has experience in the field with outside knowledge which will benefit the team, also…[Read more]

In my opinion, I don’t think it is necessary to have a separate classification for the device as the function of the device is already known in the market or FDA database. If the FDA finds the devices with more risks than normal it would lead them to classify differently. Therefore, I think it is based on the risk of the device that it can be…[Read more]

Design Reviews are designed to be checkpoints during medical device product development to ensure the product design is safe, effective, and progressing. In order to have a proper meeting for the design review and a project to move as swiftly as possible, I agree with Dr. Simon’s suggestion by sending the documents ahead of time in order to get…[Read more]

The core of the successful project manager revolved around the interactions of the team and their communications. As a project manager, one needs to communicate with everyone from a team member, to different departments, to physicians, to hospitals administration in an effective way. Also, the ability to lead individuals on the team based on team…[Read more]