I agree with all the posts above explaining the value of metrics, but I do think there can reach a point where a company can over-track metrics to a point that it becomes burdensome on the project. If having good…   Read more»

Many of the posts above mentioned that often rather than killing a project, it is just placed on hold until circumstances permit it to continue, and I think this is very true, but I also liked how that hm243 and…   Read more»

From my experience in industry I have seen several product failures, and one of them was particularly interesting. The product was a spinal implant with unique fixation features. During development of the product, there was a lot of excitement because…   Read more»

One of the biggest hurdles my company has overcome in order to drive more innovation was similar to the point Dr. Simon mentioned in his lecture, about how companies often try to drive their innovation projects with their current operations….   Read more»

I wouldn’t necessarily say they are the most important parts of the entire project, but I would agree that these are very important aspects of the executing phase of a project. Having poor communication, selecting the wrong suppliers, or not…   Read more»

I think those were very good points mentioned by cs22 and msc52njit-edu. Although I do agree that it can be more beneficial in the long run to delay the project in order to fully resolve an issue, I do think…   Read more»

In addition to the factors mentioned by msc52njit-edu that can negatively impact the SV of a project, from my experience working on medical device projects one of the factors which often had a negative impact on SV was supplier delays….   Read more»

In my company, there are 2 main categories for our testing deviations: deviating from a standard, or deviating from the protocol. For testing our implants we follow ASTM standards for our testing procedures, but there are certain tests where we…   Read more»

I think the best strategy is to get the disagreeing parties together in a room and have a face to face meeting so that everyone can understand the full picture and determine a strategy for moving forward. A very important…   Read more»

A good way to prevent scope creep is to gather inputs from the customer early on in the project and lock down the scope as early as possible. I agree with cdj24 that in some cases scope creep can be…   Read more»

In my company, the first step in performing a change is to submit a change request via our Windchill software. This request goes to the change administrator who either approves or reworks the change request. Once approved, a request goes…   Read more»

I agree with the posts above that state that it is important that medical device companies have both a proactive and reactive risk management system in place. Although I agree that being proactive and trying to prevent failures from happening…   Read more»

I agree with the 6 steps outlined by moniquet07. I would just like to elaborate on the importance of the PM developing the the task scheduling with input and feedback from the resources who will be executing the tasks. The…   Read more»

I have experienced this situation several times in projects, and I believe that often it is due to a lack of understanding of these seemingly simple parts of the project that may take much more time than is budgeted for….   Read more»

Similar to Viraj D, I’m familiar with FDA regulations from my experience in industry, but I really didn’t understand EU regulations until I took this class, so I found it very interesting to learn about the differences and similarities between…   Read more»

In my company our process validations include machining validations, welding validations, validation of assembly fixtures, and finishing validations, such as electropolish validations. One of the validations that we always struggle with is welding validation, and this is mainly due to…   Read more»

Although proper use of project management tools can definitely mitigate the risk of pitfalls, as wms7 mentioned, even in relatively simple projects, the unexpected will almost always happen. However, when you use these tools effectively, they can be very useful…   Read more»

From my experience with working on projects in industry, I would agree with the above posts that often during a project, it is necessary to go back to the planning phase to re-evaluate the project based on the current situation….   Read more»

I did my undergraduate degree at NJIT in ME, and I thought that I got a decent amount of exposure to technical writing, especially in the form of lab reports. Although it may not be the same as design control…   Read more»

I agree with the posts above that the inputs for the DID should be gotten directly from the end user or customer. In my company the marketing department is responsible for gathering VOC (voice of customer) inputs and using this…   Read more»