While in some industries verbal agreements can work for small, low risk situations, when it comes to the medical device industry I really don’t think they have any place or credibility due to the strict compliance environment and the severe…   Read more»

I think an agreement starts to become suspicious long before anything blatantly illegal happens. There can sometimes be early warning signs: 1. When the deliverables are vague or unnecessary.If the scope of work is poorly defined (“general advice,” “thought leadership,”…   Read more»

I think clearer numerical standards could help, but they might not fully solve the overlapping problem. Even if the industry set strict limits, for example, a maximum dollar amount for meals or travel, companies would still need to interpret what…   Read more»

I agree that the structure itself isn’t necessarily the issue it’s how communication and expectations are managed within it. One of the biggest “secrets” to making a matrix organization work smoothly is establishing predictable communication pathways and decision rules before…   Read more»

You both make great points about the importance of clearly defining roles and responsibilities to prevent overlap. I would add that another effective approach is implementing a formal priority-setting framework at the organizational level. Instead of relying only on case-by-case…   Read more»

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 numerous “user simulations” with our customer to…   Read more»

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 for optimization for our device only introduced…   Read more»

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 risks manifest, and how they can be…   Read more»

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 streamline marketing projects…   Read more»

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 own business, I would recommend that they take…   Read more»

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 because of the simplicity and independence it…   Read more»

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 their work, but were also passionate…   Read more»

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 having a globally standardized system already exists, but…   Read more»

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 product ultimately reflects their mission…   Read more»

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 promote transparency, not just compliance. This is…   Read more»

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/technicalities behind their work. In my…   Read more»

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, not for the purpose…   Read more»