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 the table which the project manager has advised them to do. Project manager should look in to the people before…[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 able to reduce the time because quantity is not everything, but quality is. The product needs to be done the right way because someone can…[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 what I can do. For starter find other test that would be able to reduce and replace other test that was scheduled so that the team can go back to R&D to…[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 better the device input. Next, to me would be working with regulatory and quality control department. Regulatory…[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 together and to verify and validate the document they…[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 is the class that has the lowest risk while the other two classes requires additional regulation/special controls.

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 them. Everyone needs to be able to socialize because it is form to establish a friendly…[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 are testing FDA unapproved medical device/drug. However, before being part of the trial the physician must information all…[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 aware on what each department’s task are, they must go over all plans and result before…[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 to avoid causing harm to their customer and their reputation. They must layout all possible risk. The first step that the quality department must…[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 we dealt in starting our risk management plan is by shooting any risk idea that happen and from there we would solve them. If any new…[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 might have a little to no information. For example, if their is a new drug to relieve headaches faster,…[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 a full through research done on the project. However, as other mentioned, the market gap should also be researched because you cannot produce a…[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 to presenting, some students freeze. Interpersonal as most said cannot be taught, there are mental block which the…[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 project cannot be completed if one is not handing the require documents on time or if one is having problems. It is a…[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; regulatory, quality, marketing. Project manager must create schedules for meeting…[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 and stored in files that state an agreement between two individuals or groups. I believe any…[Read more]

This is good course for getting experience in the start development of medical devices. This course shows how each department work in the development process of devices and what documents are required. Prior to this class I did not know what group were involve. I really enjoyed this course because the final project helps show how the group…[Read more]

The difference between NDA and Patents is that NDA keeps a secret between to people and or companies, while patent provide ownership of the device product. I feel that if you are developing a device you can’t patent it on the spot, it will take process before it is full developed. So on the meanwhile, NDA is required so others cannot use your idea…[Read more]

The way I would create my project group is picking people who I know that will work with well with a team. If I don’t know them, I will look for people that have a high communication skills because communication is important for project and that are interested in the project topic. After choosing I would have group meetings just to interact with…[Read more]