In my experience, the most effective usability risk strategy is the one that ties real user behavior directly to risk controls. For example, during my capstone experience my team and I went over numer...

I think this is a great question because it is definitely something that isn't talked about often. When working on my capstone project, my team and I definitely had instances were adding improvements ...

First and foremost, it is important to understand that the critical characteristics of the risk profile for a medical device include the key attributes that define how risky the device is, how those r...

As the use of AI becomes more prominent in our society, I think you’re right to frame AI as both an opportunity and a challenge in medical device marketing. In one sense, it has the potential to strea...

In addition to sales meetings and commercial marketing strategies, surgeons can also play a big role in promoting new devices, especially during early market adoption. However, this can sometimes caus...

When it comes to labeling and regulatory submission most companies localize their formatting to the regulations of specific regions, but what about marketing strategy? For example, a patient-monitorin...

This is a great question to ask, especially in today's technologically advanced society where physicians are now able to provide telehealth services. In my opinion, if a physician were to start their ...

I can definitely understand why an LLC would be an appealing choice when considering how to start a business, however, I lean more towards the sole proprietorship approach. The reason for this is beca...

When it comes to experiencing leadership styles in both a corporate and academic setting, I can say that I have been very fortunate to have mentors and supervisors who were not only passionate about t...

I can understand where you're coming from when you mention that the merging of companies can create fragmented quality systems, which in turn slows company progress. However, I think your statement of...

As is the case for any team, communication between members is key to success. When scaled to a larger size, communication between departments is how a company knows its staying on track and that their...

I don’t have any experience with audits, but I like the idea of viewing audits as learning tools rather than check-ins that create more work. However, to shift this culture, leadership needs to promot...

From what I gathered from our week 4 lecture video, it appears that a lot of people in regulatory affairs actually come from a research or lab background, which allows them to understand the science/t...

One example that comes to mind is not exactly a natural outbreak, but the Tuskegee Syphilis Study in the United States. This was a 40 year long study, which targeted black males of a certain criteria,...

Compared to pharmaceuticals, where refinement of a drug is through a fixed and repetitive pipeline, clinical trials for medical devices serve two major purposes. The first being to prove safety and ef...