WBS does have its pros and cons. However, I feel that the biggest pitfall in this case could be having to do with multiple task all at once.The goal is to break down all tasks so that you can compete the project easily. However like we have learned, other priorities come in the way, the problem is that the your coworkers could end up spending a…[Read more]

I think HR plays a huge role. This department is responsible for find the correct candidate for the desired position. In terms with medical device, they typically look for someone who as a similarity of the process in the medical device industry. The role of HR determines policies how individual employees can to increase their performance. They…[Read more]

I’ve also experience something similar with my capstone project. We had multiple components or call them sensors, in order to finish our final project. Our project’s goal was to measure three different biometrics data (blood glucose, blood oxygen, and activity). The biometric data will then be transmitted to a UI. We distributed the task eve…[Read more]

I had the same experience with my capstone project. We were really confused on what class it would be considered. On the other hand we had so many different components, that we had to do research for each one separately. Our project was a medical device that was able to measure blood oxygen level, heart rate and blood glucose levels. Ultimately,…[Read more]

As people have stated the professor mentioned this in the lecture. In my case, during our weekly meetings we go over the weekly metrics. Overall, I believe project management metrics, can help teams especially project managers keep track and have better control over the project, so it can succeed. It can show the project manager’s where the team…[Read more]

Like many, we had to create a gantt chart for our capstone project. There were many couple of times where we missed a great milestone in our project. Our project consisted of using several different sensors, that will be uploaded data to the web. Our first issues was getting defective parts from Europe. We fell behind schedule, because it took…[Read more]

I remember during my internship, I had an opportunity to sit down in a design review meeting. All the head department members were at the meeting. These meeting were taken very seriously and it was mandatory for all member to attend. As the meeting progressed, they discussed certain small changes that were recommended. This was a fairly quick…[Read more]

I believe having a strong baseline schedule is really important. Scheduling seems to be easy but it is never hundred percent accurate. There will always be unexpected events that can throw a team off schedule. For example, one of my coworkers was having trouble for one of his projects, the quality department was taking to long and signing off…[Read more]

Yes the executing phase is very important, this were the project is done. However I don’t think it’s the most important. In my opinion planning phase is the most important. You would have to establish roles and responsibilities, make sure you have a strong schedule, and need to set a budget for the entire project, etc. Before you start any p…[Read more]

There are some methods to avoid scope creep. One method is to understand the clients or customers vision of the project. What does the client require? As we learned we need to clarify the goals and objectives in the initial planning phase. The team should set a high level schedule and a list of deliverables for each task. These should be broken…[Read more]

This will definitely delay the project. Both sides can be at fault, Dr. Malekai should have presented his information earlier. This simulation showed that there is miscommunication within the project team. The research was basically condense and gave a higher risk potential. I understand that in this situation can be stressful but as professionals…[Read more]

Design Validation is basically, did the project team design the right device? In the medical device industry the design validation used to create device within a specific requirement, like design outputs. The goal is to accomplish all the users needs. I don’t believe compromising is a solution unless the one of the requirements is impossible to a…[Read more]

Anything that is unethical will end up causing problems in the end. I believe any medical device companies will try their best to avoid anything unethical, or they will eventually have to deal with the FDA. PM’s need to set boundaries and should oversee all work. Have meeting with the team and see how you can be more complaint. Come up with a c…[Read more]

The planning phase is the foundation of the entire project. It really is how you will execute. If you don’t plan a head, you are bound to fail at some point during the project. The planning phase will determine how the project can end up. There are many things to consider like you stated budget and completion dates, etc. Remember a lot of money g…[Read more]

During my capstone project unfortunately we had many critical path situations. Our project was a monitoring device, using a blood oxygen sensor, and accelerometer that can transfer data to a secure UI. Our goal was to make this monitoring device compatible and with one another. The issue was the sensors were not able to transmit data to our UI…[Read more]

A lot of companies use gantt charts, and it is a very useful tool. I believe using gantt charts for medical devices helps see the overall picture from the initiating phase to the end phase. It is helpful tool to see the complexity of the project and to see the milestones achieved. This tool helps organize different tasks that need to be completed…[Read more]

Like many have stated, some pitfall will occur. Things like holidays and days off could slow a team down. That is why many teams and companies use gantt charts, to organize their tasks. I believe as a team or an organization, we need to be better prepared. There will be times when coworkers will could cause a delay in a project, but as a team we…[Read more]

I remember during my undergraduate capstone class, we had to create a budget for a grant we received. We list all the materials we needed for this project. The biggest problem was we needed sensors and that came from europe. We had an issue with some of the sensors because they did not work. It took three months to ship and and another three…[Read more]

I also agree with the others, the capstone class is a great example and experience of monitoring and controlling. During my project, there were many times were we fell behind schedule mainly because of our code and electrical components did not cooperate with one another. As required by the class we created a high level schedule and made…[Read more]

Risk analysis is crucial for medical device companies. Medical device companies has to be safe and service efficiently. I do not think there is a specific ratio, because the less risk companies have or more awareness the companies know about the risk, the more beneficial. I think medical device companies that have class III devices have to be more…[Read more]