I agreed with others about the differences between a patent and an NDA and how a patent gives you a legal proof of idea ownership. I would like to add to the idea of using NDA to protect ideas and inventions:
NDA can be helpful to protect certain ideas and concepts which are not patentable or easily protected by other intellectual property…[Read more]

hi @merzkrashed, there are a few important points of information that if I were to sign an NDA form, I would definitely want to know in details: what information is considered confidential (definitions and boundaries), obligations/responsibilities or what might considered a breach and lastly, as you have mentioned: time periods. A time period is…[Read more]

Thank you for teaching this course. What I love most about it was the information-rich lessons and flexibility. The lessons were organized in separate topics and videos for each week so they are very easy to digest. I love the fact that I can watch this when I have time and can rewatch the videos. I found all the templates very helpful. Thank you…[Read more]

Although I agree with @Adrian and many others about the matrix organization, I actually work in a small collaborating environment that use the project-based organization well. We were managed by a manager who reports to the boss. We report directly and remotely to the manager who is from a different organization (the communication was really great…[Read more]

I personally perfer upper management because I tend to look at things in a big picture and for long term processes and I agree with @dag56 and @scott that to be a upper manager, you should have to have certain experience in middle management. Also, I have read the article that @kak33 posted and actually agree with the opinion stated in the article…[Read more]

I was in a Matrix Organization where I had 2 direct bosses. The organization was not as clear as in the lecture that each project has a functional manager and a project manager. We typically work in various projects managed by a functional manager or a senior and a project manager (study coordinator). In most cases, everything ran quite smoothly…[Read more]

I agree with other about the ISO 14971 and Yiming Chen about the key terms. I would like to elaborate on the major phases of the risk management process aligning with ISO 14971 standard (Adding on to @jtl27‘s comment). Major phases: risk analysis, risk evaluation, risk control, residual risk evaluation, risk/benefit analysis, evaluation of overall…[Read more]

I would like elaborate @merzkrashed‘s point about the FDA article “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”.
When determining risk, the FDA assessing the severity, type, frequency, and length of harmful events. In addition, the FDA will also evaluate other…[Read more]

I agree with Mark about the formality, necessity, and process of a risk and with @dag56 about profit/risk scale. I think it would also be beneficial to have prior smaller meeting building up to this big scale meeting that Mark has mentioned. For examples, a meeting between all the engineers and scientist and PM to draw up the risks before all the…[Read more]

In my opinion, I don’t agree with the previous comment If I understand correctly about numerous trials. Instead, a company/manufacturer should have an established procedures with a defined operating conditions (units, lots, time etc) like @markabdelshahed has mentioned. First of all, conducting too many trials could be a waste of time/money if you…[Read more]

HI, @Scott, I haven’t done any protocols for medical devices but in the past working in clinical settings, we have planned different protocols, proposals. We mostly used Gpower analysis to determine the amount of subjects (samples) needed for a protocol (power around 80%) in order for the data to be reliable. And with the confidence level, we used…[Read more]

I agree with @gaberuiz13 that the tests have to make sense. Specifically, some products already have a set of “gold-standard” validation protocols to follow, such as blood pressure cuff. There are myriads of different kinds of blood pressure cuffs in the market right now. Internationally, these BP products are validated based on protocols…[Read more]

@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 output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling,…[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 Class I device.

If the band-aid did not meet the product requirement stated in the document, the company…[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 devices manufactured in Vietnam and the other for imported ones. All domestically manufactured medical devices had t…[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 many different models in vivo, vitro to assure the safeness and efficacy.
I think the point of clinical trials is to…[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 better even before they see the doctor/therapist. Another point I want to point out is that in most…[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 years. I came in without any experience in clinical research. Since it was a very busy lab with lost of simultaneous research…[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 few points about the “cons” of EI that haven’t been mentioned. I believe these points are not “negative” but they are something worth…[Read more]