Some common aspects touched upon for recruiting underrepresented communities for clinical trials were building trust, making the process more accessible, and ensuring the message has some form of relatability and clarity. However, one aspect that is often overlooked is the…   Read more»

The original poster brings up a good point about the marketing engineer role, especially in the medical device industry, as this career path blends technical expertise with the need of strong interpersonal skills and the ability to sell complex ideas….   Read more»

@tamanna While I agree with you that working in a smaller company can offer valuable exposure to multiple areas, I would also like to make note of the downside that being spread too thin across multiple departments can limit the…   Read more»

Having volunteered at a tissue bank before, I see that non profit tissue banks are playing a critical role in public health by focusing on service rather than profit. My favorite aspect about non profits is that generally, their goal…   Read more»

After working with a couple medical device companies, I believe my top requirements do not depend on the notion of public or private, but rather the entirety of benefits offered to me. First, I personally flourish in a place of…   Read more»

I appreciate that the original topic starter had mentioned thinking from the patient’s point of view. I believe this is a highly important notion for the medical device industry. There are standards such as ISO 14971 that allow for risks…   Read more»

@fh28 I agree with your perspective on the importance of diversity as well as varied expertise on an FDA expert panel! This is crucial as each member brings a different background to the evaluation, as every side of a product’s…   Read more»

The most common problem I face as a quality engineer intern are challenges due to document control. In other words, updating procedures, specifications, and records among different teams and ensuring that the correct standards are being followed. This issue also…   Read more»

@dmf2 I respectfully disagree with the notion that the primary responsibility for addressing a damaged label should fall on the store. In my point of view, I believe that the manufacturer is 100% responsible for ensuring their product is properly…   Read more»

Although it is tempting for me to say that post-market management is where the issues arise, I would argue that product development is the single most critical phase in determining a project’s success or failure, as this is where the…   Read more»

@sn64 In addition to these categories, an important comment I would like to make is that  “Voluntary Action Indicated” (VAI) should be taken seriously. They may not lead to recalls but rather they reflect areas where compliance could worsen if…   Read more»

I believe the extent of a professor’s passions in academia and research depends on the individual professor, but often professors have a mix of these motivations. I have had professors who have been deeply passionate about the subject they teach,…   Read more»

I have been working as an intern in industry research for the last couple months and what I can gather is that it is generally heavily regulated by agencies like the Food and Drug Administration (FDA), which adheres to strict…   Read more»

There are many hurdles that companies face when attempting to align themselves with ISO 10993’s biocompatibility principles. First, medical devices are often made with complex materials to enhance their performance in the human body. In this respect, it may be…   Read more»

Being over qualified for a job can be both a blessing and a curse. As many have mentioned, the choice between over qualification and under qualification depends on one’s goals at work as well as desire for growth. Let us…   Read more»

On a scale from 1 to 10, where the viewpoint presented rates grades as a 1, I would personally place the importance of attaining good grades at around 5. Grades are not the sole determining factor of success, however, they…   Read more»

I believe it is unlikely that Artificial Intelligence will “control” the medical industry, however, it will play an increasingly important role. One example used today is IBM’s Watson artificial intelligence model. Watson has been used in oncology to analyze medical…   Read more»

I have to disagree with most of these posts that immediately view missing a milestone as a failure. In my opinion, it depends on the circumstances present. While working in Capstone I and II, I noticed that missing deadlines also…   Read more»

Hi Jafar, I absolutely agree that having FDA Regulatory Consultant in medical device projects is essential. Medical devices are subject to strict regulations due to their requirements regarding patient health and safety. This is especially important for ensuring that devices…   Read more»

Out of the qualities listed, I believe that personal organization is the most essential feature for a project manager. As the previous posts expressed, communication and negotiation are critical however personal organization ensures that a manager can effectively lead all…   Read more»