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 MonicaGoncalves mentioned that another option to Go, Kill or Hold is to change the scope of the project so that it better aligns with…[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 of the novelty of the device, and it was predicted to do very well once it launched. After launch…[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. We were trying to create innovative products, but we were boxed in by our procedures and often had to…[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 maintaining a good relationship with your suppliers are all things that can definitely derail or sink a…[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 that in some scenarios where the company is developing a new technology and speed to market is critical to the success of the project, a…[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. Since we outsource all our manufacturing, we depend quite heavily on our suppliers to develop their own timeline…[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 always have to deviate from the standard by creating custom fixtures for testing. For testing our…[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 thing for a project manager to remember is to avoid finger pointing and try to reduce finger pointing among team members, as…[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 unavoidable, especially considering that the medical device market is very dynamic and the scope may have to be adjusted in order for the product that…[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 out to all the managers of each department asking them to assign a person from their department to join the…[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 is definitely preferred over having to deal with failures, it is inevitable that no matter how much due…[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 PM often does not understand the specifics of what exactly is required for task completion, and therefore they will not be…[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. From my experience, this often happens with processes related to our Tier 2 suppliers. For example, our suppliers may outsource…[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 the US and EU medical device regulations. I am sure that I will come across EU regulations sometime in my…[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 the fact that our weld validation procedures are confusing,…[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 in managing unexpected events that do occur. If you keep your Gantt chart updated, it…[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. Although the project management process is broken up into distinct phases, in the real world, some of these phases may…[Read more]