I believe that marketing should never oversell a device onto the public. It simply cannot be on the providers to justify a devices long term safety. Physicians are not trained to fully understand the FDA regulations and what tests and…   Read more»

The best selling product is surely not always the best product. I have worked in hospitals and in medical offices for years and have noticed physicians usually will go with companies that they are most familiar with rather than exploring…   Read more»

In present day many surgeons do serve as Key opinion leaders for medical devices and run clinical trials, so I do feel that having prominent physicians can be a huge asset to a company. While the physicians will be the…   Read more»

Hi I deeply agree that all STEM majors especially engineers should take more business related courses. While being an engineer and understanding the principles and skillsets to translate a concept to device are important, the skills to get said device…   Read more»

Hi I think this is a great question which ultimately depends on the companies trajectory and long term goals. While being either public or private comes with their pros and cons, knowing your brand and what would be the best…   Read more»

I also agree that an MBA would not be necessary for an engineer who has aspirations of going into business. While an MBA can be an amazing tool if used properly, many of the skills and content can be learned…   Read more»

Hi, yes it may seem that the cost of quality can be a hassle to deal but in the long run for companies that would like to continue to perform and survive they are absolutely vital. They serve as a…   Read more»

I can definitely understand the perspective that QC can slow down innovation, but I feel that with all of the pieces that work together. Without QC innovation would possibly be more chaotic in my opinion as there is no proper…   Read more»

I believe that the AI is a decent tool to use while performing QA, but I don’t feel that it should override Human judgement from actual experts. QA experts have experience in the real world and can properly and accurately…   Read more»

I feel that AI based devices may need to be approached differently than how regulations has handled medical devices traditionally. There just has been a surge in recent years with the applications towards device advancements that it definitely makes it…   Read more»

I too didn’t realize how important regulatory affairs were in the grand scheme of device progression and maintaining it beyond it being in the market! I recall from earlier modules with Dr.Simon stating that companies are eager to hire individuals…   Read more»

I agree that it may be difficult for smaller start ups to navigate and afford to go through all of the regulatory processes. Yet, I see that there is a need for this because of the concerns of safety for…   Read more»

I feel that cutting corners in research in industry is necessary but while corners may be cut to meet the demanding deadlines the integrity of the research must still be intact. While many times projects aren’t the most perfect outcome…   Read more»

I feel that there should be a healthy balance as to knowing when to apply either methods of playing it safe or being risky. When I say this I do agree that companies to stay competitive have to be willing…   Read more»

Hi I think that is a very interesting question that you’ve presented about pre clinical research and which is more appealing. I would also agree with you on the stance of favoring research in the industry realm. Although I am…   Read more»

I think the qualities of a project manager really make or break a projects execution. They are essentially the coach that has to push, guide, and communicate with their team to win or in this case complete projects in the…   Read more»

I believe that missing a milestone in the process of a project most often not would be considered a failure or shortcoming. With biomedical devices there are many moving pieces that must work together for the objective to be accomplished….   Read more»

I agree as well that planning is extremely vital for the success of any project or mission, when done properly. As discussed in the module for this week not planning means you plan to fail but it all must stay…   Read more»

Hi I would agree that the BME degree is fairly broad degree as there are so many different skillsets that you learn over the span of the degree. At NJIT there seems to be a lot of flexibility given that…   Read more»

Hi I do feel they are both highly impactful with their contributions to society and work together. From my experiences in schooling academia has given an abundant amount of opportunities to be at the cutting edge of science and to…   Read more»