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. In all cases, risk should…   Read more»

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, 1,000,000 people may have used…   Read more»

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 device, since in doing so you prevent any mishaps…   Read more»

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 things, especially when…   Read more»

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 seem too much and may cause…   Read more»

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 important to perform both because they both still…   Read more»

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. Product recalls, risks, and general non-compliance would occur…   Read more»

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…   Read more»

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 a consumer-seller relationship, the seller…   Read more»

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. However, this may not be true sometimes…   Read more»

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 the number 1 responsibility of a clinical trial,…   Read more»

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 accuracy of the experiments that occur. This is similar…   Read more»

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 the most common one at least up until the 2010s. The…   Read more»

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. For example, more neutral colors…   Read more»

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 interactions and I believe, from what I…   Read more»

In my opinion, your career in a sense starts in college. Although it is not the end all be all, internships/research positions are where your individual experiences start and they are a great place to figure out where your interests…   Read more»

I believe it depends on the person’s background, their interests, and also the depth the course takes. For example, I completed my undergraduate degree in biomedical engineering with a minor in business. I took classes in management, marketing, corporate finance,…   Read more»

I would say that you do not necessarily need an MBA or a business-related degree to start a business, it could be something just learned purely from experience or just speaking with lots of different entrepreneurs who have their own…   Read more»

Specifically focusing on AI, it could greatly impact the jobs of QA individuals and aid them in making more effective SOPs, validation documents, etc. Utilizing AI to help improve certain processes and making better validation methods could help not only…   Read more»

At the end of the day, both QC and QA are crucial to the success of a product line and a company in general. If a device is not properly prepared, manufactured, and then tested, it will be a failure…   Read more»