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 engineer...

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 ...

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 s...

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 wi...

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 sho...

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 prep...

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...

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...

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 mea...

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...

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...

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 c...

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 learne...

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 ...

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 qual...