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zha7 replied to the topic Drugs banned in US but not in other countries in the forum Regulatory Basics for Medical Devices 7 years, 3 months ago
Interesting topic and replies. In my research on this topic, I was surprised that India is one of the countries that still use, sell, buy many medicines that are banned in other countries due to safety and regulation issues. Japan and UAE were the two countries that are very strict in allowing random medicines to enter their countries. I was not…[Read more]
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zha7 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 7 years, 3 months ago
In this discussion, we can refer back to our last discussion regarding the challenges in the medical devices industry, in which most replies stated that FDA approval and regulations are the most challenging step in developing a new medical device or medical drug. I wouldn’t agree with saying that FDA is too tough and strict. Going over their…[Read more]
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zha7 replied to the topic Discussion Topic: Beyond experimental design issues in the forum Pre-clinical Device Development 7 years, 4 months ago
First, I would go over the manual that came with the new biomaterial and research about it, discover the chemical name, the formulation data/report, the manufacturing info, the sterilization compatibility, etc. and inquire the manufacturer if there is any unclear info. Depending on the biomaterial and the medical device category, further checks…[Read more]
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zha7 replied to the topic Ethics of Animal Testing in the forum Pre-clinical Device Development 7 years, 4 months ago
Testing animals are the pathway for medical researchers and scientist to explore and test a medical device efficiency, a therapeutic drug effectiveness for a specific disease, or particular surgical techniques (ex. hip replacement, kidney transplant, heart transplant, etc.). As it is unethical and impossible to test these aspects on humans due to…[Read more]
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zha7 replied to the topic Academia vs. Industry Research in the forum Pre-clinical Device Development 7 years, 4 months ago
I agree with the above replies, as research in academia is more likely open-ended in a way or another, managed by a Professor. While in Industry research takes a slightly different path in which the research goal is set clearly, with a well-designed and studied timeline, and with a most likely expected outcome. The fund in both depends on the…[Read more]
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zha7 replied to the topic Multiple Project Managers for one project in the forum Intro to Project Management 7 years, 4 months ago
I never worked on a project under multiple managers, but I would imagine that it would be harder than having one main manager. Although is all depends on the project and managing environment, things may get a little complicated, as multiple managers may have different commitment and responsibilities which would hinder the project flow and the…[Read more]
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zha7 replied to the topic Obstacles while working on a project in the forum Intro to Project Management 7 years, 4 months ago
Many obstacles would encounter any group project. For me, I experienced a group noncooperation issue in which some group members were ignoring their assigned tasks and depending on the other members to do them. This was really frustrating for me as a group leader, because I was restricted by due dates which I can’t miss. My project manager…[Read more]
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zha7 replied to the topic Discussion Topic: Project Management in a medical device setting in the forum Intro to Project Management 7 years, 4 months ago
I found the above replies interesting as most people mentioned that the Regulatory compliance (FDA approval, etc.) which must guarantee the medical product safety is the main challenge in the medical device industry compared to other industries and that would cost millions of dollars. Infiniti Research website stated on their website that the…[Read more]
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zha7 replied to the topic Advice for Biomedical Engineering Students in the forum Introduction to Medical Device Development 7 years, 4 months ago
I agree with you, Karen. As a BME graduate student who is still looking for an internship, I started doing research since my 3rd year in my undergrad instead of wasting my time waiting for that intern/coop as it was harder for me to get Because I am an international student who needs sponsorship. However, this doesn’t mean that I gave up, I am…[Read more]
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zha7 replied to the topic Discussion Topic: Academia vs. Industry in the forum Introduction to Medical Device Development 7 years, 4 months ago
A Life Sciences Salary Survey affirmed that scientists in the US, Canada, and Europe who worked in the industry made around 30% higher than those in academia per the the-scientist website. Another disadvantage of working in academia is that in most research cases the work may be open-ended, and may not be completed in a due date, while in the…[Read more]
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zha7 replied to the topic Discussion Topic: Academia vs. Industry in the forum Introduction to Medical Device Development 7 years, 4 months ago
I think it depends first on the person mindest whether it is academic or industry. However, being a scientist researcher in the industry may have many advantages over being a researcher in academia, not only income-wise but also in lifestyle and scientific outcome-wise. As a graduate researcher, I can tell that being in a lab, working all day…[Read more]
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ZAHRAA replied to the topic Discussion Topic: Practical vs. Informational courses in the forum Introduction to Medical Device Development 7 years, 4 months ago
It is hard to say that is a good ratio for me, because I graduated from my undergrad BME with no practical course credit, in which I was lost after graduation. Our goal was only to maintain a high GPA with all that stress and homework & exams load. Having a practical part in each course would be an ideal option for graduate students, especially…[Read more]