@alexandrabuga I don’t think that this is completely accurate. Depending on the company and how it is structured, sometimes employees wear many hats at once, being the critical members for many, many projects at the same time. This often is the case if there is only one or two people who are the subject matter experts on something and their…[Read more]

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. We already had a base version of the tool that would need to go through the change control process, so every time we found…[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 telling the manager (and other team members for that manner) when they would not be available or if they would not be able…[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 the way the PM may communicate a point or the importance of something may not come across completely to those on the other…[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 bit of a problem. Since that goal was supposed to be achievable, if it is missed the priority becomes finding out why it…[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 done as outlined in the scope of another project? Like mentioned in some other threads, scope creep can be a very real…[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 even misses requirements, then the device is considered to have failed to met the design requirements. This is…[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 involved in discontinuing product codes from being available to be purchased by customers since they were obsolete products. Requestors…[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 the following: If there is a global standard in many countries and some countries decide not to adopt it, is it worth it from…[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 starting point as to where something has gone wrong it makes things easier in solving the problem. What should be done next is…[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 and effectiveness, the prior product will fade to usher in the reign of the new one. Taking the suture market itself as others have, there are so…[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 packaging verification/study for an existing medical device combination kit. This will involve making a change to how the MD is packaged. Because the product itself in…[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 in what capacity. More than that though, the determinations for what processes, verifications, and validations are…[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 do is send documents in a timely manner (at least a week before the DR) for the parties to review. Whether or…[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 already indicate that the device presents the most risk for harm. To add a Class IV would…[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 to recognize it, or worse (depending who you ask), require that you conform to both the country’s regulation…[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 barrier to entry from those regulations. The real question is when this will happen and what will it take in…[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 you would always be having constant communication with several different functional groups. While technical…[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 employee could be part of several projects, reporting to several different person in each project, and then…[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 required to make the change. Some very novel ideas can be delayed for months or years on end if the cost is too high,…[Read more]