Planning is one of the important phase like many said. It is basically the game plan if the team does not have a plan, there will chaos because there is no order which they can follow. The team will be…   Read more»

I agree with other stating that it the scope should be clarified in the beginning of the project but also throughout the project because as stated by ks629 someone might want to sell the product oversea. The company needs enough…   Read more»

I agree with everyone that says that the project manager should discuss with each member throughout the duration of the project. In the beginning, Project managers should already have schedules of all members. If there is an emergency, I would…   Read more»

Some problems I feel that project manager can face is the team they choose, time is another problem and communication which everyone mentioned. The team can be a problem because there could be team members that aren’t putting anything on…   Read more»

I think both time and risk are important, but if I had to choose losing a project or getting law suits from harming the public, I would choose increasing testing time because safety is number 1. I could not be…   Read more»

As everyone stated this is very bad because it is a critical part of the device’s function. The first thing I would do is check the deadline because I need to see how much time I have left to see…   Read more»

I think the most effective would first be getting the customer’s needs to draw baseline from there look into competitors in the field with same background in order to create a better device. Looking into competitors will help improve or…   Read more»

Project manager are the head of the project which are responsible in making sure all departments(Regulatory, Marketing, Manufacture, Quality, Clinical, etc.) complete their deliverables. Project manager creates a schedule for everyone to follow and holds meetings where all department come…   Read more»

I agree with others that stated that FDA medical devices are classified by how severe the risk is to the public. The risk classification helps in including addition exams/protocals before release the product if it is class 2/3. Class 1…   Read more»

Interpersonal skill is important for every job. It assist in creating connection with customers, researchers, employees, etc. These connections are important because they keep people focused and drawn to the product or idea you are trying to sell out to…   Read more»

I don’t agree in using unapproved devices because it is a Hail Mary attempt to treat someone. It could cure but there is a high chance that it could cause more pain. Physicians can enlist patients in clinical trials that…   Read more»

I agree with the group that believes validation and verification should be enforce through out the medical design process. During the design process there are documentation and test studies which project manager must hold meeting where all departments must be…   Read more»

Quality plan is very important because as other stated it helps test the quality of the product that is going to be release to the public. There are so many risk that a new product can have and in order…   Read more»

Risk management plan is method to reduce any risk a company can suffer. It is a way that the company can avoid/ minimize being sued or even harming the public. Last year I took medical device development and the way…   Read more»

I would definitely agree on a recall because it will be the company’s fault if one of their product device harms a person. The company is responsible of displaying all warning, healthy issues because the product they released, the public…   Read more»

This is a tough decision but it will all depend on, will it actually work and help the public because there are projects that will not make it to the public due to malfunction and or delays. There must be…   Read more»

I think the ratio should be 60% interpersonal and 40% technical. The reason being is that technical is taught in school. Students are trained how to solve problems and how to do research for their project. However, when it comes…   Read more»

It is very important to pick the right members for a project because they must be able to fulfill their task in order to complete the project. The members chosen must be reliable and have friendly communication skills because the…   Read more»

I think a project manager must have time management and communication skills. The reason being is that for every project there are time limit. Project managements are responsible for meeting all report document deadline from their fellow departments, for example;…   Read more»

I agree with everyone that both written and verbal contract are important and that written contract is more powerful than verbal contract unless it is recorded because they can searched and found as evidence. Written and verbal recordings are documented…   Read more»