I cannot speak in terms of me finding a job position as a consultant after graduation but if I were a client or any other departments’ employee that would directly receive the consult, I would not prefer a new grad…   Read more»

First off, as the name of the NDA says, I would suggest to make sure that you are clear of what must be kept confidential. If there is any case you can think of but not sure how to handle…   Read more»

I think it is important that there is presence of a neutral third party that witness the verbal contract. I think with the technology and how we use it nowadays, it is a good practice to record the meeting no…   Read more»

I would prefer the matrix structure given that it blends the strengths of both functional and project-based setups. It allows team members to benefit from specialized expertise within functional departments while also working dynamically on specific projects. I love how…   Read more»

Medical device companies can adopt several organizational development strategies to align with the growing demand for value-based healthcare. One idea is that they can invest in data analytics and digital health tools to demonstrate the clinical and economic value of…   Read more»

Interesting question. Let’s put it this way: the advantage is decision made by only one person, the disadvantage is decisions made by only that person. Why is it kept the way it is until now? It’s probably because the advantage…   Read more»

I do not think this is necessary to be discuss: would anyone want a product without any precautions or want it when they know the product is not tested for any risk? Or let’s talk about a drug: would you…   Read more»

I think I can tell one situation from my personal experience. It was during COVID time and my undergraduate research work involves with studying the virus. The vaccine was not vastly applied at such time so the live virus is…   Read more»

First off, I totally agree with someone above that it would be better to have subscription mechanism for citing all these regulations. Honestly, I think that these organization should be supported by the government because it is for everybody’s good…   Read more»

I would think of it as a multifunctional device. Usually, you would not expect a vacuum robot that is small and can also mop the floor to be as good in vaccuming the floor like a simple vacuum cleaner. Same,…   Read more»

To me, insufficient design control basically means that you are not foreseeing enough problems that can incur during the development of the product. That basically means that you do not have enough “test case” to plan to test your product…   Read more»

To my experience, meeting minutes are ver very important. They are brief but has important information in them. We can track how the project progress through the minute and is a great resource to keep track or look up something….   Read more»

Design control is indeed a big help to mitigate risks in medical device development. It is basically the framework of standards and tests required for the development of such project to ensure it meets all the requirement to eventually get…   Read more»

I do not think of it as input-output relationship, especially for design purpose. Therefore, I don’t think we need an output in this case. For design control, I think of input as standard and bullet points of what are considered…   Read more»

For trial periods, drugs are conducted in four phases (I,II,II and IV). The first three trials test for safety, effectiveness, dosage, and side effects, which are carried out so that the drug can be approved by FDA. Phase IV is…   Read more»

I believe the placebo effect will vary a lot within the group of test patients who are have placebo treatment. This can be one sign because as said in the lecture, it really depends on the patients’ expectancy and I…   Read more»

There are a lot of things that the clinical trials cannot show that I believe are important as well but you cannot start modifying and improving the drug until it reaches more patients so clinical trials are the best we…   Read more»

This is a very interesting prompt to start with. However, I do not think the drug, if it is truely a placebo, will be approved by the FDA. It will involve ethic issues since most of the clinical trials, if…   Read more»

I think I would definitely try it out if I ever have a chance. It must be harder for something changing from sale to engineer role because of the technical background, which counts as hard knowledge. On the other hand,…   Read more»

I think personalize the experience is the way to go. There are a lot of membership programs that offer people great deals at first for them to join, exploit preferences information about the customers themselves like which types of products…   Read more»