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»

From my own understanding and experience, too many regulations or rules in quality control testing can definitely slow down progress. In my previous experience, I worked in industrial chemical engineering, where it is not as rigorous for testing the products,…   Read more»

I think that regulations are extremely important for public transparency and risk reduction. They set a baseline of what needs to be done at minimum to allow for a product to go out onto the market, which is important for…   Read more»

I think the biggest aspect of the safe vs unsafe aspects of any medical device or product depends on the testing done, the science behind it, the public knowledge of it (papers or studies done on it), and then your…   Read more»

I think this is a great question, especially since there are new technologies being made that might not be able to be classified as easily. I do believe that the class I, II, and III system is outdated but also…   Read more»

I would definitely say from a researcher’s perspective, navigating the organizational and approval process is the more challenging part of pre-clinical development. If you think about a researcher prior to joining a lab or committing to doing research, they will…   Read more»

From what I have learned and from the experiences I have heard from other people, animal variety can have significant effects on reproducibility, on both sides of the spectrum. For example, having different types of animals in a study for…   Read more»

I would definitely prefer industry when it comes to research for medical device development. The first reason is because of the availability of direct impact and visibility of the direct impact on patients. For example, companies that make MRI machines…   Read more»

In my opinion, missing a milestone is not directly a failure, although it does sound like one. For example, companies miss milestones all the time, but the impact the milestone has on the overall project makes it a failure or…   Read more»

In my opinion, a project manager needs to have 1 main quality: openness. The manager needs to be open to ideas, open to the team, open to change, etc. When taking on a project, there are hundreds of factors that…   Read more»