@ppp23: if you are asking about what it is, it stated on that document that “Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design…   Read more»

I agree with previous comments about the need of HF. I came across this interesting situation where it seems like validation could be a bit flexible. There’s this article from Arena Solutions giving an example about Band-Aid products as a…   Read more»

To add in @ao242 comment about ASEAN Medical Device Regulations, Vietnam is one of the countries that import a lot of medical devices. In the past (before the end of 2016), there were 2 distinct bodies of legislation—one for medical…   Read more»

It’s important to have clinical trials. I agree with Mark and @reshamn on this point. I also want to point out that before going on clinical trials. The drug and medical devices being tested must have been tested intensively in…   Read more»

I agree with @srg36 that placebos are very important. The expectation is a very powerful thing. Similar to the example Dr. Simon mentioned in the lecture, sometimes, when people call to make an appointment with a doctor/therapist, they already feel…   Read more»

I think having a clinical background is a great advantage. It may not be a necessity depending on your roles. After college, I was working in a clinical research lab in a hospital as a Research Assistant (RA) for two…   Read more»

References:
1. https://www.fastcompany.com/3060123/the-career-limitations-of-emotional-intelligence
2. https://brandongaille.com/12-pros-and-cons-of-emotional-intelligence/ (I only agree with a few points taken from this article, stated in the post).

I agreed with previous posts (from @aaq2 & @ppp23 …) about the definition of EI, the importance of EI in marketing and Kidwell’s paper. I also think that EI is essential in marketing However, I would like to add a…   Read more»

I think “persuading” is “maniplulating” in some extent. As Dr. Simon mentioned in one of the lecture about the fact that when you try to sell something, you try to change the person’s mind about it. However, it doesn’t mean…   Read more»

**I couldn’t post the reference for some reason I have came across these grand strategies including market growth, product development, turnaround and liquidation. Market growth centralizes on expanding the market for present product. Product development relies on creating new products….   Read more»

Thank you for bringing up the topic! I came across these 5 most common ways to pierce a corporate veil: 1. The existence of fraud, wrongdoing, or injustice to third parties. 2. Failure to maintain the separate identities of the…   Read more»

I agree with @bb254 and @asimbana about the INC choice over LLC and would like to add more on the CONS. The biggest drawback is the double taxation (C Corp). Also, shareholders that control and own a significant amount, or…   Read more»

I would prefer a limited partnership corp. because being a limited partner puts a limitation on liability with respect both to potential lawsuits and money; the limited partner is only going to be liable for the amount of capital it…   Read more»

I did some research on Regeneron, these were my findings: Gross Profit Margin: 91.68% Net Profit Margin: 18.43% ROE: 22.10% Current Ratio:3.75 ROC: 35.21% Gross profit margin is a very high number. It almost gets to 1. It means that…   Read more»

I agree with @srg36 about the nuances when it comes to quality control. Quality assurance process and quality control processes are crucial for any company/organization. In fact, it’s so important that it should be paid attention carefully and fully invested…   Read more»

I agree with @aaq2 and @myton‘s opinions. I would like to summarize a few main points and add a few more points to the ideas for improving quality control: 1. Define processses, streamline processes as @aaq2 has mentioned: By doing…   Read more»

I agree that once a product is in widespread use, unforeseen problems can sometimes lead to a recall and sometimes, it takes a while for the issue to surface so that it could lead to a recall. Furthermore, sometimes, when…   Read more»

1. I found Dexcom as the only FDA-approved Continous Glucose Monitoring System that does not require pricking the fingers. As of Dec 20, 2016, the FDA “expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow…   Read more»

As of now, the FDA has finalized a rule that extends its regulatory authority to all tobacco products, including e-cigarettes, cigars, and hookah and pipe tobacco. So yes, they do (including cigarettes effective August 8, 2016 (fda.gov). In terms of…   Read more»

I agree with others about ISO10993. I would also like to add a few points. Before a new biomaterial product is going into clinical practice, a few special considerations should be examined: 1. Product characterization: component-cellular, noncellular, combination … 2….   Read more»