Going back to Devarshi’s original point, I think it is actually good that sometimes a user’s needs are a bit vague. This allows the engineer to be a bit more creative catering to the needs of the user. For example,…   Read more»

The Gantt Chart is actually really great for any sort of project management but especially helpful for the medical device field because it allows for projects to be seen visually by all members of the team. Since in the medical…   Read more»

Everything is about risk — as everyone above me has stated, its all about whether the good will outweigh what might possibly go wrong. Therefore, a good PM must be able to analyse and handle the risk in the most…   Read more»

According to the PMBOK, standard process groups can be created and applied (and edited as needed) for companies. Most companies have a dynamic way of doing their projects and if they are able to pin down the exact way they…   Read more»

Ethically speaking, one cannot skip over any regulations, regardless of what the situation might be, monetarily. The main aspect of the situation must be that the device follows all regulations and protocols as written. In actuality, it might, at first,…   Read more»

What I find to be actually pretty interesting now is that we’re in the age of Kickstarter. Scientists and engineer who have innovative ideas are actually able to bypass much of the needed fundraising by simply setting up pages, displaying…   Read more»

According to the FDA, the medical devices are characterized into three categories based on a few factors. According to them, “The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their…   Read more»

As you guys have mentioned, the project proposal is the heart of the initial project. It is meant to be a short, insightful look into what the device will be about, its cost, and why it should be created. Its…   Read more»

I think that the process of V&V, with the many years of re-evaluating, has become a lot more streamlined than it was previously. Although it can be cumbersome and add on time if issues come up, it is still in…   Read more»

I think that the process of V& V, with the many years of re-evaluating, has become a lot more streamlined than it was previously. Although it can be cumbersome and add on time if issues come up, it is still…   Read more»

I agree with krp67 — the question of why is very important when it comes to any sort of development. Why is something being created? Why must it go through quality? Why did other companies fail at certain points? That…   Read more»

It makes sense that the customers for medical device companies would be hospitals/doctors and not actual patients. Companies need to sell their products in bulk and that isn’t really a possibility when it comes to single patients (just how many…   Read more»

Reply to: ap962 Its interesting that the FDA is so much more stringent with medical devices in comparison with other countries. However, there are aspects to these fields in which other countries were more stringent. For instance, no cosmetic brands…   Read more»

I agree with wms7 — the pill’s primary function is to cause changes in the body biologically and therefore, it would be assigned to the CDER. The sensor does not make actual changes to the body and therefore, is a…   Read more»

The ideal version of a project manager would allow the person to be able to work across the board of industries, regardless of their technical knowledge. PMI is the sort of organization that helps to create these types of PMs….   Read more»

At my previous jobs, which were not in the medical device industry, the lines of communication were relatively open but not always utilised to the fullest. * What sorts of project management software or systems does your company have? We…   Read more»

If there were more coatings then there might be more options to what the clear choice may have been. Perhaps coating C could have garnered quicker results, such as coating A, but without the stress deaths, such as coating B….   Read more»

I agree with smk45 — technical skills, for a student, are a bit more important than they are for the average professional. As a student, its hard to get your foot in the door because you need to show that…   Read more»