Accepting risk, to a certain extent, should be the case especially when the need is urgent and there are too many factors to consider as individual risks but there can be an overall calculated risk. I...

In reality, there are no 0-risk devices or products on the market in terms of the medical industry. Even devices that may have 100% success rates technically still have some type of risk. For example,...

At some point, there is a tradeoff between mitigating risk and actually increasing the risk through "mitigation techniques or processes." Of course, basic levels of mitigating risk are important to a ...

In general, there is a clear line between neglect and making mistakes. At times, people might change or alter a process and forget to note it down. Although this is also not the correct way of doing t...

At times, things like regulations may seem like barriers. But in reality, they aid in making a more robust device and reduce the chances of adverse effects (lower risk). At times, some regulations may...

Since they are two distinct aspects of the product development process, it is important that both are still completed. Although they do overlap, sometimes more significantly than in other cases, it is...

One issue that would arise is the failure of meeting its intended purpose. Without proper design controls, a product would most likely never make it to its end stages with proper functionality. Produc...

From what I have seen, most feedback can be influential and positive in terms of making a device or product better. Feedback can be in any form, and for the most part it is not a bad thing (if you do ...

I think this is a great question to consider since it is something that most of us, as engineers will eventually face. What is more important, user needs or the business limitations/needs. I think, in...

In my opinion, a single-blind study could work in a majority of the cases since the researchers/investigators do not really have significant effect on the results of the study most of the time. Howeve...

I completely agree that GCP guidelines are done correctly in terms of safety and efficiency. GCP is extremely important in ensuring the validity of a medical device, drugs, etc. Protecting patients is...

I would prefer to be a monitor (clinical research associate) of clinical research because it seems very interesting to do their job. A monitor basically monitors the procedures, data sets, and accurac...

I absolutely believe that the marketing/advertising is targeted towards specific demographics, especially on platforms or TV programs. TV is one of the main ways that advertising is done, basically th...

Personally, I do not see a huge correlation between the colors of devices in terms of medical devices and their branding. Although, you can say that color does have an impact slightly on the marketing...

If I were to change career paths but stay in the same industry, I would definitely go into medical sales. Although marketing is appealing, it is not as interactive in terms of company-consumer interac...