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 organ damage expected during CPR process because the worry of causing a break shouldn’t deter people from helping…[Read more]

Last semester in medical device course, I worked on a medical device project called Automated CPR machine and my role was to analyze the risk. The most common risk in this device is bone breakage (sternum, and ribs) and organ damage expected during CPR process because the worry of causing a break shouldn’t deter people from helping someone in…[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 the device or drug meets the standard for safety and efficacy.
Cons- delaying good products into the…[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 health by tracking daily activities. During the day it captures steps, distance walked,…[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 and need to fill out 510K form. But as far fitbit only use as monitoring heart rate and FDA opted not to regulate any…[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 written. “Did you build what I said?” Design validation is intended to tes…[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 contact OCP (Office of Combination product) if you have question about type of information should include in…[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 health and wellness, promote healthy living, and gain access to useful information…[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 to ensure they are clearly understood by team members. There are several skills which are must have in…[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 to ensure they are clearly understood by team members. There are several skills which are must have in…[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 that the customer needs.
According to PMBOK, many devices do not require clinical trials; however, all devices must go…[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 as resources can be used efficiently, products and projects are equally…[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 when it comes to promoting their businesses. Unfortunately, it does not work for healthcare marketing…[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 what role I would be looking for and suit me best throughout this course. Dr simon’s lectures and guidelines were very helpful to me, a…[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 large organization. If employees are not following project management process set by…[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 organization. Supermatrixed employees were…[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 with people you know rather than complete stranger to avoid complication and hesitation. However, in real world situation, this is…[Read more]