In this context, I believe the QA professional should make…   Read more»

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 notable companies – founded the biotech company…   Read more»

  I would argue that the regulatory affairs department does not set out to protect the patients,…   Read more»

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 into developing a novel device that…   Read more»

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 pressures also ensure that the…   Read more»

When determining whether a company should use an established material…   Read more»

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 with their engineers can lead to an environment and dynamic…   Read more»

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 include scope creep, underbudgeting, and unachievable deadlines. A thorough…   Read more»

[quote data-userid=”55586″ data-postid=”23978″] When a technical or regulatory problem arises in medical device development, how should project managers weigh the importance of deadlines for a project’s completion against patient safety? While some industries may put pressure on project managers to…   Read more»

For many posts on this thread the common consensus seem to be that due to the multidisciplinary nature of biomedical engineering, students often feel like generalists. While the coursework may be broad and touch a variety of subjects, I don’t…   Read more»

I think there are limitations to the control AI will have in the medical device industry, especially in highest regulated class of devices. Many of these devices are implantable and stay with patients their entire lives since they only go…   Read more»

For many posts on this thread the common consensus seem to be that due to the multidisciplinary nature of biomedical engineering, students often feel like generalists. While the coursework may be broad and touch a variety of subjects, I don’t…   Read more»

When comparing academia and industry, I believe fulfillment comes down to the timescale on which you see your impact. For instance in academia you may spend months doing research and writing a paper that may not directly cause a notable…   Read more»