The word “risk” itself tends to imply a negative result or red flag that the team should get away from. However, risk management is very beneficial to any project in order to evaluates all potential risks. Risk management file does…   Read more»

I think the most ideal solution in this case is to set up phase review meetings after each phase in order to review all documents and make sure that everything looks good with no mistakes that might delays things in…   Read more»

In most companies, this should not be a problem. In the beginning of the project, it is much easier to face this issue than the end, since the due dates are more tight towards the end of the project. Usually…   Read more»

Setting timelines is very important to any project, since it determines the launch date of the product that is being developed or modified. Based on my experience, with the current technology most companies in the industries use excel to have…   Read more»

Nowadays with COVID-19, this is a very common issue. Not getting a hold of someone is definitely possible since it is not that easy anymore to just stop by someone’s desk for 15min and get the answer to question. The…   Read more»

I agree that all phases are very important to ensure the success of the project and that often times the initiation or planning phases are argued to be the most important since a good foundation will ensure the success of…   Read more»

Deciding on how long a task will take can be very tricky, but also very typical. Any project has a timeline and some milestones that have to get communicated to the business in order to decide on a launch or…   Read more»

Everything classified as a medical device would require a 510(k), unless they are exempt. Bandages are considered as class I medical devices used to cover and protect wounds, to hold together the skin edges of a wound, to support an…   Read more»

With the technology getting better and better everyday, of course some products will decline by time and won’t have a need anymore, however, that does not mean that low volumes devices cannot be used anymore or are not needed. One…   Read more»

I wouldn’t think such issue or failure would require a recall. Recall is defined by the FDA as when when a medical device is defective, when it could be a risk to health, or when it is both defective and a…   Read more»

So it really depends on the product. Most of the products functional testing are per ISO and ASTM standards, which are international standards that most of the international health authorities require. Sometimes there are extra standards to be followed besides…   Read more»

There is nothing guaranteed when it comes to design verification and validations, and especially when it comes to new product development. For sustaining projects, usually design verification should be very straight forward; since the product is already an existing product…   Read more»

Having the same regulations worldwide seems to be an easy solution to launch one product across all regions/countries without spending extra time trying to meet all those different regulations, however, it is not that easy of a solution. Every region/country…   Read more»

I believe that there still can be an ideal PM. I feel like soft skills are the key for success of any project manager; problem solving, communication, and time organization are the most important soft skills that are a must…   Read more»

Even though engineering and design plays a huge role in coming up with a new project/product, the business need is far more important. Before presenting a project, a market research has to be done to determine the need of the…   Read more»

Any project within the medical device industry requires some sort of design verification and validation work in order to ensure that the product is safe and effective. Timing can be very critical to the project since launching date is directly…   Read more»

I agree, it is been really hard lately communicating things between team members due to the lack of face-to-face communication. Everything works best when you have the opportunity to just stop by someone’s desk and discuss something for 15min rather…   Read more»

Repeated mistakes happen all the time due to associates leaving the company or moving to another position within the company without sharing their previous experience with the rest of their project team or function. Projects are never useless, even if…   Read more»

Strict policies are always a good routine to follow, to have a successful company so everything would run smoothly. I mean it is kind of understandable that you can only get a gift for the physician that is related to…   Read more»