Hey everyone my name Jacob Chabuel and I am a thesis option Biomedical engineering student at NJIT. My undergraduate degree was also in BME with concentration in biomaterials. Here’s my LinkedIn profile: http://www.linkedin.com/in/jacob-chabuel-0950a1299Looking forward to connecting with others in and out…   Read more»

One thing that I think is worth mentioning and I haven’t really seen brought up yet is the fact that product life cycles can really be influenced by technical debt. For example, companies may have invested so much money and…   Read more»

I was a bit confused on the wording of this post but I’m assuming you meant making modifications to a previously existing medical device. From my understanding, the FDA does not require a total re-evaluation of a device in that…   Read more»

I think the best project management software ideally would integrate scheduling tools, have some form of traceability, or be able to reference deliverables such as important documents or design files. That being said, I do not think there is one…   Read more»

Pulling from my experience as a Resident assistant, a big part of our job as a leader is to deal with conflict resolution or handling certain situations. A big thing that I try to do in these scenarios where conflict…   Read more»

I agree with Vansh to some extent in that the Regulatory Affairs Specialist is the team member that more closely works with the FDA and creates the legal strategy when dealing with them. That said, it is still the PMs…   Read more»

I think the thing that makes the project management role so interesting is that you do not necessarily need to have a deep level of understanding in one particular field or discipline. I find that the best project managers are…   Read more»

Taking away from my personal experience, I think there are several different ways to ensure that communication is properly established amongst a team. Drawing from my experience as an RA, the best communication occurred within our teams when we were…   Read more»

Going based on of the question proposed in the title of this post, Risk assessments are absolutely necessary for medical devices. Risk analysis or assessments are required not only in the US by the FDA, but also in the EU…   Read more»

As was already said before me, I think it is virtually impossible to completely eliminate risk. Even using a medical device in perfect conditions and following intended use protocols to a tee, there is still a possibility for risk to…   Read more»

I believe that in most scenarios it is ideal for the risk management team to be made up with members of the project team and those that belong to the risk management department. The individuals that are on the project…   Read more»

To answer your question, I do not believe it possible to entirely predict all real world failures of medical devices. The core problem of design controls is that they are created with what the designers or creators anticipate to occur…   Read more»

In reference to the title of the question, I do not think that there should necessarily a winner in regards to whether user needs or engineering viability are more important. The teams should instead come together and collaborate discussing what…   Read more»

I believe that you make a great point that the constant updating of the documents contents can become very confusing or lead to an overload of information as you say. The most important thing to do in this instance to…   Read more»