This topic is very interesting. I think this is the most common problem while working in team. I have experienced this situation many times due to lack of communication, delay in replying and most important when the team members rely…   Read more»

I agree with jvv6, it completely depends on the project if someone has previous experience with similar project can start with minimal information about new project with confident. However, if the project is new then required lot of research and…   Read more»

sorry i posted on wrong place

Last semester in medical device course, I worked on a medical device project called Automated Chest compression machine and my role was to analyze the risk. The most common risk in this device is bone breakage (sternum, and ribs) and…   Read more»

I want to add some pros and cons of FDA regulations Pros-increase public awareness and education regarding the dangers and misuse and over prescribing drugs, FDA plays a “gate keeper” role for consumers, and overall public safety by checking that…   Read more»

Many people want to change their unhealthy lifestyle, especially college students who do not have time for exercise and eat without counting calories. There is general wellness device called Withings pulse Ox can help someone be more active and improve…   Read more»

I agreed with above posts that fitbit should not consider for FDA approval unless if fitbit claims to treat or diagnose other specific diseases then definitely need a FDA approval and I believe it considers as a class II device…   Read more»

Design verification and validation are the procedure to check during medical device development process that the product meets the specific requirements and error free. Design verification is testing that the design output meets the design input and requirements you have…   Read more»

First of all, person/company needs to find out if this product even required RFD because not all product required RFD submission. The necessary step to take before submitting RFD with a better understanding of how the product works and then…   Read more»

Hello, I think during capstone project the application your team developed is considered to be mobile medical app because it allows people to retain their auditory stimuli. Furthermore, mobile medical application is something that can help people manage their own…   Read more»

To be a good project manager, I think project manager should have certain skills in order to be effective and successful. I agreed with above posts that communication skill is very important to transfer information relate to any changes and…   Read more»

Design validation is required to verify if user needs and intended uses are met; it can improve the launch success and reduce the chances of product recalls. In simple words, Validation is to check that you have made the device…   Read more»

Hello, I would like to work in a matrix type organization. Matrix organization is a mixture of functional and projectized organization structure which helps employees to perform well, allows enhanced growth and career development. Matrix organization has some advantages such…   Read more»

Hey Roberto, The topic is very interesting. Lamiaa has a good example why it is necessary. I understand, it is very competitive to bring something new in the market, and it makes sense that owners or company considered every angle…   Read more»

Before taking this course, I had hard time figuring out what I could do as a biomedical engineers when I will be looking for industry based jobs. I have gained bit of knowledge now to know how industry works and…   Read more»

Very interesting question. To be successful in the project, culture organization has a huge impact on your success rate. Your organization structure can help or hurt project success, it is easier to change organization structure than culture organization for a…   Read more»

Hello, There is a recent Gallup survey article about revisiting the matrix organization published on January 2016 which involved 4000 US employees highlighted some benefits in matrix organization. Survey categorized as matrixed, slightly matrixed, non-matrixed, supermatrixed employees working in such…   Read more»

While forming a project team, mistakes I would try to avoid are not been cooperative, lack of communication and effort. I think I would like to work with people who I am familiar with, it is always easy to communicate…   Read more»

I agreed with above discussions. I think it is very important for doctors, surgeons or who else is involve in using that device to have a training or at least instructions have been read before using any new medical device…   Read more»

Design transfer is the process in which the device design is translated into production, distribution, and installation specification. Some of the common problem during Design transfer include • Product developers do not have a finalized design. • Manufacturing processes have…   Read more»