I believe the planning phase is really important for a project to be successful. Like in the example, problems are unavoidable which may require members of the group or the project manager to go back and figure out other ways…   Read more»

I agree that logging work is important especially when there are new employees at work as well as when there are audits going on. When I used to work at a research lab, there were different notebooks used for different…   Read more»

I agree that the entire team is needed to determine the duration of the project and each task because those who work on those tasks will know how long they will take and what will be involved in the task….   Read more»

It’s important to have multiple overlapping tasks in different categories because in different departments, tasks can be completed early on and at the same time as other tasks which can speed up the timeline and give more time for validation…   Read more»

I do agree that the marketing team is a good group of people to figure out the specifications of the device, but I also believe that engineering and regulatory should be involved in the specifications. The marketing team knows what…   Read more»

For a project, there should be effective communication within everyone in the group. If people are working by themselves and don’t tell other people on their progress, there can be delays in the project timeline which would push back trials…   Read more»

During the planning phase of the project, I do agree that the user needs should be considered in a vague aspect. The customers are the ones who are going to be using the device/product so that should be one of…   Read more»

Communication is definitely a big factor in projects because without it, you aren’t able to talk to vendors, other team members, your manager, or the customers. I also believe you need to be a good listener and approachable because when…   Read more»

The best time for validation and verification is when all the deliverables and specifications of the project are figured out and then it’s time to manufacture and test out the actual product. You must make sure that the product looks…   Read more»

If this was a real industry project with a team, there would be more face to face interactions. There would be meetings and discussions with different people in the team to discuss how to go about the issue in the…   Read more»

I do agree that sutures do not seem to have decline  in the different phases of the product life cycle but potentially in the future it might. Currently sutures are used in hospital settings as well as clinics to fix…   Read more»

The hardest part of the project development is initiating an idea because many devices and projects already exist. There are different testing that each project requires and if it does not make a revenue for the company, many of the…   Read more»

While currently working in the industry, I had a chance to be apart of the Design Changes and a little bit of the verification and validation part of the design controls steps. I would definitely like to be more involved…   Read more»

I do agree that many of the lower priority projects go on hold or get cancelled because of the lack of resources as well as the lack of interest and benefit of the project. Resources can impact a project timeline…   Read more»

With the different regulatory systems including FDA and the Europe’s new system, there can be a globalization of regulatory procedures, but I don’t think it would be any time soon. There are many products that can be used in the…   Read more»

With the different regulation requirements for medical devices and drugs individually, I do believe that when a combination of the two is at play, that both regulation requirements need to be done to have the product be approved by the…   Read more»

I do believe Project Management has its similarities and differences in different types of industries. It all pertains to the type of project people are working for. Each project manager will have to work with different types of team members…   Read more»

For a project team, it would be dependent on how many people are needed for the project and what kind of project it is. For a project that requires a lot of team work, I would want people who can…   Read more»

Interpersonal Skills are important skills to have when working with coworkers and managers in a industry or academic setting. A Project manager must be able to communicate with their team and other managers to convey what is needed in the…   Read more»

The difference between or verbal and written agreements is that written agreements definitely easier to find and use as proof if something goes wrong or to show the other person what’s in the fine print when there is a disagreement….   Read more»