One important nuance I have always noticed is that it has never been "Nature or Nurture" but rather "Nature vs Nurture." It is not black or white, it is more comparable to grayscale. I think of it as ...

I personally believe that testing in extremes is important. For example, say the labels were only tested for what was deemed "practical application" and tests were never conducted on bottles wet for t...

Fortunately, my group did not seem to run into any issues. However, we did run into a similar situation where everyone seemed to have a slightly different background. I believe it helped us as well. O...

A Design History File (DHF) is essential for regulatory compliance, but a massive part of good project management as well. Any issues with regulatory boards will have drastic implications for the comp...

I believe the best way to handle Design Change Requests is to plan for them in the first place. Obviously no one wants to plan for something to go wrong, but good project management will always plan f...

I think this common practice clearly limits the potential for innovation in the medical field. The most obvious reasons to me are rooted in financial capacity and resources. Innovation and new devices...

Many devices exist in a sort of "grey area" where they could potentially be classified as one class or another, or at the very least experience overlap when it comes to the governing sub-agency of the...

Understanding the differences between these pathways is essential to Project Management since they drastically effect the timelines and requirements for projects that fall under them. Typically, a PMA...

Balancing the values between stakeholders and customers is what I would call being stuck between a rock and a hard place. In a perfect world, all values would align in perfect harmony. However, as any...

I believe there are three keys to effective communication: speed, detail, and situational awareness. Firstly, effective communication must happen as soon as possible. As soon as a need for communicat...

You've certainly nailed the importance of Project Managment! To answer your proposed question, my experience definitely leads me to believe that rules and regulations are by far the biggest hurdle in ...