-
dfn3 replied to the topic Types of Corporations in the forum Business 101 6 years, 11 months ago
I would want to be part of a Limited Liability Corporation. I agree there is a limited risk among the owners. This is one of the only companies where the owners do not have total liability. It is also easier to get loans and shares can be sold to raise money. One important advantage is that the taxes are uncomplicated taxes. It is lots of…[Read more]
-
dfn3 replied to the topic Public vs. Private Companies in the forum Business 101 6 years, 11 months ago
The main difference between public and private companies are that private companies are owned by a 100 individuals and are not traded publicly. Public companies are traded and have zillions of shareholders. Public companies also are responsible to the Securities and Exchange Commission whereas private companies are not. Private companies are not…[Read more]
-
dfn3 replied to the topic Good Quality Control or Quality Assurance Department in the forum Quality Control and Quality Assurance 6 years, 11 months ago
Since you were able to get both sides as in at one job QA had no issue but the second job QA had some issue. I would like to know how the jobs differed. Like maybe something was done differently and thats why one worked and other did not.
-
dfn3 replied to the topic Experience in Quality Assurance and Quality Control in the forum Quality Control and Quality Assurance 6 years, 11 months ago
To add to this question I would like to know how the tests helped the project or company as a whole? What happened after you tested it? Did it fail or pass and what were the steps that happened after?
-
dfn3 replied to the topic Discussion Topic: The cost of Quality in the forum Quality Control and Quality Assurance 6 years, 11 months ago
I can understand why it would be a burden. Especially since you have to spend money on a quality engineer but it would be smarter to spend the money earlier than having to deal with it later and possible having to give up your company because of all the money you will have to spend if something goes wrong. It would be more beneficial to spend the…[Read more]
-
dfn3 replied to the topic Delay in Recall. in the forum Regulatory Basics for Medical Devices 6 years, 11 months ago
This is a great question. I also do not understand why they take so long to make recalls. I know some of my friends whose cars got recalled like years after they bought it. Why would they not have verified it before it was sold to millions of people. There has to be better ways for this to be avoided. Especially in the beginning before they are…[Read more]
-
dfn3 replied to the topic The people we shall encounter in the field in the forum Regulatory Basics for Medical Devices 6 years, 11 months ago
I believe that human differences will be a very helpful when the group works as a whole. While working on a project you will get so many different ideas from all the different backgrounds. Having people from different backgrounds can help make a more diverse device because the group members can give us the distinct characteristics from each…[Read more]
-
dfn3 replied to the topic Precision and Accuracy in the forum Regulatory Basics for Medical Devices 6 years, 11 months ago
I agree that accuracy and precision are so important to the FDA. They cannot have a drug or device not pass those regulations because they will be used for the general population. If they do not follow the the FDA regulations it could be harmful to the general public. Ofcourse there will never be a device or drug that is perfect but they want to…[Read more]
-
dfn3 replied to the topic Ethics of Animal Testing in the forum Pre-clinical Device Development 6 years, 11 months ago
I understand as to why testing animals is unethical. But at the moment it is the only option that has been successful. If there were other options I feel like they would have been used already. If there is an alternative to testing on animals we just need to do our research into finding out what exactly that is. Maybe there are some companies now…[Read more]
-
dfn3 replied to the topic Academia vs. Industry Research in the forum Pre-clinical Device Development 6 years, 11 months ago
That is very interesting but what does happen if that proper structure does not work or is interrupted? Would the project not be successful? The flow in the industry can be interrupted if lets say someone does not finish their part on time or has a problem with their side of the project? I feel like there are still flaws even with the proper…[Read more]
-
dfn3 replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 6 years, 11 months ago
The tests used to determine biocompatibility of a material are used in regards to ISO 10993. These tests can include cytotoxicity, genotoxicity and irritation. These test if the material is poisonous to the cells or genes. They even test if the material will irritate the skin or body and if it destroys blood cells. The tests will differ depending…[Read more]
-
dfn3 replied to the topic Due Diligence in the forum Intro to Project Management 6 years, 11 months ago
I agree that an important part of the project is who should be involved. The project manager needs to involve the right people who understand the specifications of the project and can accomplish them. I also agree with the continuation of the project. If you start a project that cannot be improved on and it does not do much maybe making it is not…[Read more]
-
dfn3 replied to the topic Due Diligence in the forum Intro to Project Management 6 years, 11 months ago
I agree that these questions are so important to the development of the project. Before making a device we need to make sure that we can sell it. Why waste money on a project that we will not make money from. Also need to understand the objectives of the device because if they are not realistic we will put ourselves in a situation where the…[Read more]
-
dfn3 replied to the topic Discussion Topic: Project Management in a medical device setting in the forum Intro to Project Management 6 years, 11 months ago
The first challenge that comes to mind would be the FDA guidelines. But other challenges could be that each project has different specifications. Project managers for medical devices have to make sure the device works for every type of person that could be using that device. They have to make sure it is adjustable to every body type whereas a…[Read more]
-
dfn3 replied to the topic Discussion Topic: Practical vs. Informational courses in the forum Introduction to Medical Device Development 7 years ago
Until this course I had no idea what I would be doing in the real world because I was not told about professions in industry. I only knew about academic jobs and that was never an option for me. I believe this course and courses like it are very helpful for student especially ones like myself who don’t see themselves as teachers or researchers.…[Read more]
-
dfn3 replied to the topic Discussion Topic: Practical vs. Informational courses in the forum Introduction to Medical Device Development 7 years ago
I do not agree. I think once we are in our masters we should take more practical courses. We do still need academic courses but we need more than 3 practical courses. Once in the real world, practical courses may be more useful than academic courses. You may know all the knowledge behind biology, chemistry and physiology but if you do not know how…[Read more]
-
dfn3 replied to the topic Discussion Topic: Academia vs. Industry in the forum Introduction to Medical Device Development 7 years ago
I agree with the arguments you have presented. But you have to remember that when it comes to academia it may not be as time flexible as you believe. A profession in academia can be becoming a professor and with that you have to be at school at certain hours. Being a professor also comes with the advantage of having tenure, basically amazing job…[Read more]
-
dfn3 became a registered member 7 years ago