Medical Device Courses | Giang | Activity

Giang replied to the topic "Benefits of Consulting Experience as a Recent Graduate" -

Mon, 02 Dec 2024 03:24:19 -0500

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»

Giang replied to the topic "Advice before signing an NDA" -

Mon, 02 Dec 2024 03:16:35 -0500

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»

Giang replied to the topic "Verbal Contracts" -

Mon, 02 Dec 2024 03:08:03 -0500

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»

Giang replied to the topic "Your Organizational prference; but why?" -

Mon, 25 Nov 2024 03:58:31 -0500

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»

Giang replied to the topic "Value-based healthcare: "Dos and Don'ts"" -

Mon, 25 Nov 2024 03:06:58 -0500

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»

Giang replied to the topic "Desicion made by one person" -

Sun, 24 Nov 2024 21:38:16 -0500

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»

Giang replied to the topic "To risk manage or not to risk manage?" -

Mon, 18 Nov 2024 03:09:05 -0500

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»

Giang replied to the topic "Hazard, Hazardous, Harm" -

Mon, 18 Nov 2024 02:42:11 -0500

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»

Giang replied to the topic "Expense of Regulations" -

Mon, 18 Nov 2024 02:37:34 -0500

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»

Giang replied to the topic "Design "Overvalidation"?" -

Sun, 10 Nov 2024 23:50:47 -0500

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»

Giang replied to the topic "Consequences Of Insufficient Design Controls" -

Sun, 10 Nov 2024 23:43:53 -0500

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»

Giang replied to the topic "Minutes for meetings" -

Sun, 10 Nov 2024 23:04:31 -0500

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»

Giang replied to the topic "Design control and risk management" -

Mon, 04 Nov 2024 02:59:46 -0500

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»

Giang replied to the topic "Design Output" -

Mon, 04 Nov 2024 02:55:36 -0500

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»

Giang replied to the topic "Medical Device Clinical Trials vs Drug Trials" -

Mon, 04 Nov 2024 02:50:51 -0500

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»

Giang replied to the topic "Placebo's Impact on Pain-related Clinical Research" -

Mon, 28 Oct 2024 02:11:05 -0400

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»

Giang replied to the topic "What is not seen in Clinical Trials?" -

Mon, 28 Oct 2024 01:53:55 -0400

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»

Giang replied to the topic "What if I told you..." -

Mon, 28 Oct 2024 01:00:49 -0400

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»

Giang replied to the topic "Transition from Engineering to sales or marketing?" -

Mon, 21 Oct 2024 00:42:10 -0400

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»

Giang replied to the topic "Long-term customer relationships in the face of increasing competition" -

Mon, 21 Oct 2024 00:29:20 -0400

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»

Giang replied to the topic "Digital Marketing" -

Mon, 21 Oct 2024 00:24:14 -0400

I think it is obvious to everyone that the internet has drastically changed the marketing strategies of almost every company in the past years. Now, without hiring people to distribute flyer or hosting big event every time for a launch… Read more»

Giang replied to the topic "Factors going into Buisness" -

Mon, 14 Oct 2024 02:06:25 -0400

If I were to start a business, I would define my business to be a small one because I would like to manage it on my own given that I do not have any background in business management. If the… Read more»

Giang replied to the topic "Business Courses for Engineering Students?" -

Mon, 14 Oct 2024 02:01:08 -0400

I think it can be an optional course counted toward the degree, not a mandatory course though because each person has his/her own path and not that everyone will need or willing to take that course enjoyably. With that being… Read more»

Giang replied to the topic "First Job: What type of company to choose?" -

Mon, 14 Oct 2024 01:56:59 -0400

I think that it is up to your own preference. I always believe that if you consider fresh-out-of-school employment to be the time to learn and pick up several skills, start up is the way to go because most of… Read more»

Giang replied to the topic "organizational skills for QC" -

Mon, 07 Oct 2024 02:30:03 -0400

I think the best QC can do is keep double checking everything occasionally make “tests” to assess the project. This can be in many forms, like just some questions that express our concerns about the product, or asking about a… Read more»

Giang replied to the topic "Job Skills in Quality - Root Cause Analysis" -

Mon, 07 Oct 2024 02:25:16 -0400

One interesting thing I can relate to myself about the root cause analysis is during my time coding undergraduate for CS major. When I was in lower classes, I ran into a bug and just tried to fix the lines… Read more»

Giang replied to the topic "Discussion Topic: Quality Assurance vs. Quality Control" -

Mon, 07 Oct 2024 02:20:38 -0400

Here are things that I understand about the difference in QA and QC. QA is process-oriented, aiming to build quality into the product from the start, whereas QC is product-oriented, ensuring the finished product meets the required standards. QA takes… Read more»

Giang replied to the topic "Drugs banned in US but not in other countries" -

Mon, 30 Sep 2024 03:18:34 -0400

I guess it’s just the matter of perfectionsim. I think different countries have different amount of “risk” that they can accept in exchange of treatment that can save and ease their lives, which makes perfect sense because we as human,… Read more»

Giang replied to the topic "Switching to a Regulatory Career" -

Mon, 30 Sep 2024 03:03:45 -0400

Switching to such career is a recent idea in my mind. I think what attracts me the most to it is the fact that more and more of those positions are becoming remote due to its nature of leaning toward… Read more»

Giang posted a new topic "How to start career in regulatory area (no industry exp yet)" -

Mon, 30 Sep 2024 02:52:10 -0400

It appeared very interesting to me on the first lecture that positions in regulatory is in demand. Just want to ask for insights from those who are in it or know more information: how do you actually start a career… Read more»

Giang replied to the topic "Skills to get into research" -

Mon, 23 Sep 2024 02:34:17 -0400

Regarding industry only, I think you need to master a specific skill to fulfill a position’s requirement. As I applied for jobs, I tend to see and hear that people hire those with a specific skill that they look for…. Read more»

Giang replied to the topic "Animals used for research and for food" -

Mon, 23 Sep 2024 02:28:01 -0400

My thinking is pretty straight forward. Human are carnivores so we eat animals anyway. The fact that animals dies from human act not because of food source reason but rather to serve the purpose of enhancing human civilization should not… Read more»

Giang replied to the topic "Key factors to consider while selecting appropriate animal models for pre-clinical research to develop therapies for neurological disorders." -

Mon, 23 Sep 2024 01:39:45 -0400

The most important factor I believe must be how similar their neurological function and structure are to the human neurological system. No matter what the moral behind using each species is, at the end of the day, it all comes… Read more»

Giang replied to the topic "Which feature is the most important for a project manager?" -

Sun, 15 Sep 2024 20:35:28 -0400

I strongly believe that good communication skill is a must for good project manager. To my understanding, the PM is the one the represents client in front of the working team, and represents the team in front of the client…. Read more»

Giang replied to the topic "PM cycle" -

Wed, 11 Sep 2024 20:25:33 -0400

I really think that the starting phase is the most important, either if it is initiation where you talk about desired final product or the first few executing and feedback because if they get your project’s “style” and “vibe”, it… Read more»

Giang posted a new topic "PM requirement (education wise)" -

Wed, 11 Sep 2024 20:17:19 -0400

I know that many PM positions in software dev field do not really require background in computer-related degrees. But a lot of them run over from other fields but are still doing PM after really short boot camp of basic… Read more»

Giang replied to the topic "Academia or Industry Preference?" -

Wed, 11 Sep 2024 13:44:25 -0400

I’m doing PhD now and I still hope there is a position such that you can get the industry salary but do not have to do the job of “begging for funding” like in the academia. That’s pretty much the… Read more»

Giang replied to the topic "How to get prepare for the industry job during Ph.D. ?" -

Wed, 11 Sep 2024 13:44:24 -0400

The thing that I have observed (that I still haven’t got a chance to do) is that people started out more smoothly if they have intern experience. I also really wonder what will happen to me later when I got… Read more»

Giang replied to the topic "Onsite or Remote (Work)" -

Wed, 11 Sep 2024 13:44:24 -0400

I would always prefers the flexibility in the working mode. My boyfriend (working as a software engineer, I know that it’s very different in terms of working-remotely-possibility but still, …) has to come to office at least 5 days a… Read more»