Following up on what bnb6 said, I think that we should also discuss metal-on-metal (MoM) hip replacements and the special risks they carry. In terms of risk management, they are far less likely to be used now because the risks of use are much higher than the average hip replacement.
For example, additional risks include:
1. General…[Read more]

Hey,
I also think that information that is discovered once the verification is over should also be discussed. This could lead to additional or updated reports that would be necessary, especially if discrepancies are discovered. Sometimes, the verification process might miss something vital and therefore, even though it might have technically…[Read more]

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, if a user is especially specific “I need a blank stent of blank length made of blank material coated in blank” then that narrows down…[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 device field, so many people work hand-in-hand to complete one project, it makes it easy to cater to a larger realm of…[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 efficient way possible:
1. Identify the risk: What is it? Where is it coming from?
2. Analyze the risk: What exactly does the risk…[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 initiate, execute, and finish, they should be able to create the following archetypes that may be edited as needed:
1.…[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, seem reasonable to cut a few corners and then cover them as time moves forward. However, with…[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 the ideas behind their devices, and having strangers fund them on the criteria that the funders would gain…[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 risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I dev…[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 important for the proposal to be succinct — it cannot be lengthy or overly drawn out because all that will do is force the people you are…[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 the best interest of the consumer (and companies) that it is followed. For instance, according to Bryan Larson, president of Toltec Ventures…[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 the best interest of the consumer (and companies) that it is followed. For instance, according to Bryan Larson, president of Toltec…[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 why allows the project manager to understand what must be dealt with and in what way.

For example, the FDA just released a new…[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 hip replacements does a person really get in one lifetime?). Therefore, it really doesn’t make sense to…[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 used to be able to sell things in China unless animal testing had been done on them, something…[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 secondary feature.

Although I think its a really interesting concept, I was actually really interested in two concepts that the…[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. However, just I doubt that there is an ideal PM because it is difficult to lead a project if a person doesn’t have even…[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 primarily used email or face-to-face communication, which was not always for the best. Often, people were left…[Read more]