The way a company sells, brands, and markets a device can be as or more important for selling the devices. For a medical device that is reasonably competitive in the market, its quality is likely comp...

Personally, I believe that privately owned companies (with the exception of those acquired by private-equity) are the most likely to stay aligned with their initial vision and goal for the company. Wh...

When discussing the standard and risk owners and executives should hold in the medical device industry, I believe it is important to consider what it looks likes for those in comparable industries. A ...

I agree there are many tradeoffs made when deciding whether to outsource aspects of a business or complete them in house. These decisions are situation specific, so it is difficult to say one way is b...

I agree that alignment between QA and QC is crucial efficiency and effectiveness of quality processes. Strategies to help ensure alignment between these divisions can include the following: Continuit...

  In this context, I believe the QA professional should make the final decision. This is because the QA professional often understands additional context that the AI does not. For instance, the Q...

I believe "The Cost of Quality" is an especially relevant topic in todays engineering atmosphere. One of the most influential figures in engineering and tech today is Elon Musk, who - among many notab...

  I would argue that the regulatory affairs department does not set out to protect the patients, but to protect their company. As mentioned in the lecture, the regulatory affairs department acts ...

I believe the 501(k) process does limit innovation. From the perspective of the medical device company, if I can make a device that is equivalent to a predicate device, why would I invest resources in...

As we learned in this weeks lecture, all new products that are not substantially equivalent to a predicate device are categorized in Class 3 until proven to belong to a lower class. From a safety pers...

I tend to agree that industry is more set up to push ideas into executed research trials. Although the pressures to work within a budget and timeline can compromise some aspects the study, those same ...

In this weeks presentation, Professor Simon listen 3 different ways to handle performing pre-clinical research: In-house, in an academic lab, in a contract lab As with all engineering decisions, there...

When determining whether a company should use an established material or risk using a new one, there are some questions a developer or manager must consider. These questions may include but are not li...

As many have discussed previously, the relationship between the manager and engineer is paramount to the success of the project. A manager that is knowledgeable, respectful, and open in communication ...

I agree many companies and project teams can rush through the initiating phase, which certainly can lead to problems later in the project execution phase. As presented in lecture, consequences can inc...