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 ob...

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 ...

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 outp...

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 th...

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...

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...

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 help...

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...

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 an...

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 o...

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 o...

If I was running a risk management meeting, the first thing I would do is ask the team to review IS0 14971, because it is basically the bread and butter for risk analysis for medical devices. I would...

There are many risk management plans for different backgrounds. In the medical device industry we base our risk management plans on ISO 14971. Every time we mention risk management I think of ISO 1497...

In my current company it all depends on which department you work for. The department I work for is a functional organization. I know most engineers in other departments are assigned to a project. In ...

That’s really interesting, because I believe it all depends on the company. The question can arise, why should customers and funders buy and fund your products? In my opinion, if the company has a pro...