In one of my previous positions, I and a team of other people had to create a tool that would basically verify Bill of Material data and compare it to new product code Bill of Material data, all done semi-automatically….   Read more»

Experience in the industry validates quite a bit of what was said here: communication definitely is key in leading a project and in working with team members. What I have seen is this: team members would often be proactive in…   Read more»

I quite agree with the point made about communication being a big challenge that PM’s have to face. If the team you are working with is one that is global, the language barrier becomes a huge obstacle to overcome. Sometimes…   Read more»

Like some other people have mentioned here I think that the answer is really it depends. Of course, if a milestone that has been properly set (takes into account what is possible/resources to achieve) is missed then there is a…   Read more»

One of the most important things to take into account when dealing with a change in a project is what importance of the change is. Is it something that MUST happen (FDA regulation, critical business reason,etc.) or can it be…   Read more»

Design validation is important in Project Management because it basically answers the question “Does this device do what it is supposed to do?”. If after testing is done the device is found to not perform at the requested level or…   Read more»

Scope creep can often be a problem faced in the medical device industry. How much noise it creates can differ however depending on who is being affected by the drift. In one of my experiences, part of my team was…   Read more»

Should there be a global standard created, and countries conform to it, there will be those countries that will decide not to conform to it and go with their own standards. I would be interested in hearing some thoughts on…   Read more»

As another person said, it is important to step back and look at what has happened. Formulating theories on why something has not gone correctly is the first step to remediating the situation. When you can have at least a…   Read more»

I agree with this point, I think that at some point, there will be a decline in a certain product: it is only a matter of time of when that is. When something replaces the product in having better use…   Read more»

While I haven’t been part of Design Control process yet as I am new in my current role, I do know that in a few weeks I will be part of a project that will be involved in creating a…   Read more»

The best time to do to do validation and verification is most naturally towards the end of a project/process. At this point, the roles and responsibilities of these tasks have been determined, meaning who will do what in what place…   Read more»

In the part of the company that I’m in, my group is mainly responsible for heading DR’s and sending out the required documentations for the respective parties to review. In my and other co-worker’s experience, sometimes the best you can…   Read more»

I strongly agree with RyanRattazzi’s point about adding more tiers to the medical device classification system: it would be an unhelpful and unneccesesary addition to add something like a class IV device. From a risk indication perspective, Class III devices…   Read more»

One interesting point to mention however: will every country adopt this global standard (assuming you believe a global standard will occur)? I feel it is likely that even if there is a global standard created, some countries will decide not…   Read more»

I think that regulation of medical devices is approaching a global standard. As mentioned in our class discussion, much of the world’s regulating bodies are catching up with each other in terms of how stringent regulations may be and the…   Read more»

Interestingly enough I have had experience on both sides of the spectrum within engineering in terms of what skills were needed to succeed. In my time on the supply chain side, having interpersonal skills were crucial to doing well, as…   Read more»

Through my experience at the company that I work at, I see that it has clearly adapted a project based structure. There are various project groups with their own hierarchies and reporting structures, each working towards a certain goal. One…   Read more»

In the line of work that I am in, there are hundreds of potential projects that could be picked up. Oftentimes however, these projects are prioritized mainly according to how much it would cost/net the company and if they are…   Read more»

Echoing points made earlier, it is absolutely crucial do understand what exactly you are agreeing to when signing an agreement. It is very easy to simply sign without reading through the agreement, since it may take some time and some…   Read more»