In a public company, there is more pressure to deliver short-term financial results to reach quarterly goals set by shareholders. To meet these goals, management may place more constraints on engineers  spending for R&D, quality, and other operational costs. This…   Read more»

Many of the above responses focus on growing the company and attracting investors, so they choose an INC. Personally, a mid-size company making moderate revenue would be safer operating as an LLC. An LLC provides strong legal protection by separating…   Read more»

I never really thought of taking a business course at NJIT until this week’s lecture. This past lecture has enlightened me that knowing the ins and outs of the business world could be helpful before starting a job in industry….   Read more»

Ensuring the safety and efficacy of medical devices through QC and QA takes quite the balancing act between technological advancements and regulatory requirements. Key challenges include keeping up with evolving standards from regulatory bodies like the FDA and ISO, ensuring…   Read more»

I agree with several of the replies above, that continuous involvement with projects can improve relations between Quality and R&D. I do not yet work in industry, but internship experience has shown me the underlying tension between the Quality department…   Read more»

I agree that the quality department is one of the most important in a medical device company. I view QA/QC as a mini FDA within a company that is continuously evaluating products and processes to prepare the company for audits…   Read more»

The FDA’s goal is to ensure medical devices are completely safe for the public, but in reality a 100% safe device is probably not going to exist past a class I. Unless if we’re talking about band-aids and tongue depressors,…   Read more»

When it comes to the FDA, I think strict is a positive. It is of utmost importance that the FDA is strict, unbiased, and efficient to keep American people safe. If we have to choose to lie on one side…   Read more»

Though the 510K process requirement of connecting current devices to those manufactured in 1976 may seem nonsensical, it is important to note that direct comparisons are not always necessary. This means that a chain of similar devices can be compared…   Read more»

It is difficult to say whether research for the future or the present is more important, both are necessary for the advancement of medical knowledge in society. I would make the argument that research for the future can have pitfalls where it…   Read more»

I’m actually quite surprised that no responses have brought up bioreactors yet. Yes, it is true that the Institutional Animal Care and Use Committee (IUCUC) have set up a system to make animal testing the most ethical it can be,…   Read more»

Extensive in vitro and in vivo testing is required to solidify the biocompatibility of a medical device throughout its entire lifecycle. Depending on the device, its life cycle within the human body could be varied from a few days to…   Read more»

I really like this question as I am an athlete myself. I have learned the value of teamwork and the makeup of a good team throughout my years as a basketball player and I think that the lessons learned there…   Read more»

Avoiding scope creep can be quite the challenge in the engineering industry when you are dealing with such active thinkers and creative minds. However, scope creep can debilitate a project if it gets out of hand. For this reason, the…   Read more»

It is important to begin considering quality and risk management for a project as early as the planning phase to ensure the project remains on course. The planning phase should outline a specific quality management plan including applicable testing procedures…   Read more»

Regulatory Affairs is an extremely important industry when it comes to developing new medical devices. FDA approval is necessary to ensure that products on the market are safe for people to use. If a product was introduced to the market…   Read more»

Dr. Simon touched on this comparison in this week’s lectures. Academia can have positives if you are looking to do a lot of research and traveling with your profession. It also can’t hurt if you have any passions for teaching….   Read more»

As AI technology advances, it is almost a given that there will be changes affecting the medical industry. AI completely controlling the medical industry, however, I think is unlikely. AI will definitely be implemented more into data analysis and automating…   Read more»