I have not worked in industry, but project management in academic labs is somewhat similar. I think the best project managers are those who set solid plans while leaving room for error and potential delays. I don’t think it is…   Read more»

Combination devices (if not proven to be substantially equivalent to other products on the market) often require multiple levels of testing and validation before they can be approved by the FDA and given to the public. In terms of managing…   Read more»

In addition to the soft skills mentioned, I believe a good project manager should be up to date with technology and equipping the team with relevant software or recent technology. A big set-back to completing a project may be lack…   Read more»

During my senior design project, which involved building a low-cost scanning acoustic microscope, one obstacle we encountered was the fact that no one had experience in LabView programming. This was a major hurdle for the team, since the professor (the…   Read more»

Milestone been missed can either be a success to the project or a failure to the project depending on what kind of project is involved and how huge of a milestone was missed in the process. This is where the…   Read more»

I believe a great challenge in being a project manager in medical devices as opposed to being a project manager in building a skyscraper is the fact that the medical device industry is very susceptible to pandemics and new diseases….   Read more»

In general, all phases in the project life cycle are important and must be done properly.I think that the initiating, planning, and closing phases are repeatable. It is more like copying from past project because the headlines at these phases…   Read more»

The most challenging part for combination device is to know to what FDA Department it will be classified under (CBER, CDER and CDRH). As each one of these department has it is own rules for reviewing the product. Depending on…   Read more»

Project Objectives should also be S.M.A.R.T : Specific, Measurable, Achievable, Relevant and Time-Related. To have objectives to the project but the most important part is to get the Right Objectives. Its good to learn from previous projects experiences to build…   Read more»

I agree with what had been said, Good project manager should have a lot of different soft skills with good experience. In my opinion, if a person have 15 years experience in the industry with no leadership or good soft…   Read more»

I also do not have much experience within the industry and am only speaking from an academia perspective in terms of project management, however, I believe there are a few commonly overlooked attributes in identifying a good project manager. The…   Read more»

I have not had the opportunity to work on a project where there were multiple project managers, although depending on the size of the project, I do think this method could be more efficient in some cases. Having multiple project…   Read more»

While working on my Capstone Design Project with a team of six, it was very difficult to find time outside of class for everyone to meet. The focus of our project was to prototype a functional near-infrared spectroscopy (f-NIRS) cap…   Read more»

I agree but I also think a good project manager needs a few critical characteristics. One would be able to organize the scope, cost, schedule and resources. Being able to create a plan of the critical project elements and be…   Read more»

I think project management of medical devices has some few unique aspects in relation to other types of projects. i would like to discuss three areas; product complexity, uncertainty and risk/product liability. Medical devices are becoming more complex with regards…   Read more»

My experience working in the industry is that the projects are goal-oriented. The project team works together to complete these goals and meet the desired specifications. I think the most rewarding benefit of working in industry is getting to view…   Read more»

Speeding up the approval of medical devices certainly has its benefits. The COVID-19 pandemic has created a dire need for devices such as vaccines and respirators. The dilemma of COVID-19 devices taking precedent over other “direly needed” devices is quite…   Read more»