Being penalized for going over time and more particularly the budget should be punishable only under certain circumstances. What I mean by this is sometimes a project manager, employee, group leader has a vision and is confident enough to see…   Read more»

I agree there should be one place virtually for ideas and notes to be accessed too. Technological advancements through apps such as google drive, Microsoft teams, etc. There are also Gantt charts as Dr. Simon mentioned before and other collaborative…   Read more»

This is an interesting question since an argument could be made for either choice, and I agree with my peers that a balance between both is key and specifically the comment made that “Time is Money.” However, if there’s no…   Read more»

So I currently work with GE Healthcare and their Medical devices and one of the biggest concerns hospitals always have when setting up these devices is patient records/data. Some hospitals prefer to use our data management program called MUSE which…   Read more»

There is no question that slack is necessary because stuff happens, and unexpected hiccups in any project… should be expected. As the professor mentioned accounting for slack in a project’s timeline is important to the success of the project. As…   Read more»

All design controls tie into each other in some way so it’s difficult to single out an “essential” design control. However, since the first 9 design controls serve as a basis whereas the actual content differs from company to company,…   Read more»

I don’t think that Leadership of Nature vs. Nurture but instead a case of Nature AND Nurture. Being “born a leader” obviously isn’t literal but I believe it comes from the nature a leader was bred in. At the same…   Read more»

Whether I am the leader or working with a leader I prefer to work hands-off. One of the biggest things that make most jobs so annoying is the feeling that corporate feeling of “work.” There are enough regulations, design controls,…   Read more»

I agree with some of my peers that depending on the type or environment of work this ratio should be justified. However, I partially disagree with ih37, in that interpersonal skills don’t necessarily mean “talking your way to the top…   Read more»

That’s a very good question I actually had before too and upon taking Dr. Simon’s class from last semester I got the proper response. So essentially Verification is making sure that all the specs were met from the DID which…   Read more»

As many of my peers have mentioned the FDA’s role is to put things in check by ensuring safety. You should definitely have the choice to make a decision when it’s regarding your own life however when others’ safety is…   Read more»

Since every project is different and ranges in sophistication and complications so there will definitely be one phase or process that will outweigh the other when comparing projects. However, it makes sense for the planning and development phase to be…   Read more»

As Dr. Simon mentioned before one of the steps of marketing a new device is analyzing similar devices and being aware of what’s out there in the market. As new as an item may seem there’s always some other product…   Read more»

Well one of the biggest pros of diving the risk management and product management team, as some of our other colleagues have alluded to, is that there wouldn’t be that biased from those who were involved in making the product…   Read more»

For predictive measures, I don’t think a team would decide to log more inputs than necessary. The intentions of the project might be to go above and beyond however at the end of the day it’s a business and you’d…   Read more»

In my experiences with validation and verification in the field, validation is the back and forth we have with customers to try and meet their needs. For example, at the defense company I used to work at, after being presenting…   Read more»

Verification is what ensures the quality of a product and serves as the structure of design controls. Without verification, I don’t think a project can “check out.” It also serves as security to avoid any future problems. With verification, you…   Read more»

Risk management is an integral part if not one of the most pivotal sequences of the planning phase. Not just in medical devices, but in any engineered product that will be used in society. An example Dr. Simon had mentioned…   Read more»

Well, I think the regulation being labeled “As Far as Possible” was meant to be kept as a discrepancy because the limit would vary based on the device and its severity threshold. For example in the company I work at…   Read more»

One of the aspects of my current job is Installing medical equipment for hospitals and typically we keep labels and instructions for certain devices once it is ready for use by the healthcare provider. However, I have never seen anyone…   Read more»