This is one of the main reasons I left a previous job, there was poor Human Resource Management. Sometimes there would be insane deadlines put on project deliverables and even if the employee worked extremely hard and did a good…   Read more»

I completely agree with your point that using a supplier as a backup to itself doesn’t make much sense. The point of having a dual source is to ensure complete independence assuming there are any problems with one of them….   Read more»

I have had to source vendors several times at my work for different equipment and material needs. Sometimes all it starts with is a good old google search to get it going and find all the different suppliers. Usually you…   Read more»

While project processes and design controls are not directly related, it is pretty standard that verification will be achieved through the executing phase of the large-scale project. Since verification will certainly be done through a series of testing protocols, it…   Read more»

In the medical device industry there are countless things which need to be documented according to the FDA which may seem monotonous but are all the same mandatory. My company was audited by the FDA for several weeks and they…   Read more»

There are many obstacles to consider when attempting to ramp up something from prototype to mass production. Usually a Performance or Process Qualification protocol will need to be completed to prove there is long-term stability and quality built in to…   Read more»

Money is one of the main driving factors for any project. Many people including investing stakeholders, upper management, and customers are all concerned with how much money the project is consuming. Planned Value and Earned Value can be compared to…   Read more»

Going with the category of mobile applications, food intake trackers would be considered general wellness products. Apps like MyFitnessPal allow you to log what you are eating and drinking in order to determine how many calories you consume daily. This…   Read more»

I think project managers are like a lot of different professions in that you are very specialized in certain types of projects. There are some universal principles such as the initiate, plan, execute, monitor/control, and close phase cycle. These are…   Read more»

While some products age different than others, i think this results from how much innovation is possible. Sutures are very simple in that it is basically just nylon wire. There is not much that can be improved on this. In…   Read more»

The FDA classification system seems fine for the most part. There have been previous issues with the “predicate device” exemption when companies try to base this off something that was developed more than 15 years ago. Technology has improved so…   Read more»

As someone who has witnessed some design review meetings succeed and fail, there are some things you can do to ensure success. As @vcf3 mentioned, the attendees of the meeting have a high chance of ignoring you completely and showing…   Read more»

Dr.Simon has mentioned multiple times the importance of this in his lectures. It is part of the project manager’s responsibility to create a log of some sorts which details everything that worked and everything that failed during the course of…   Read more»

I currently work in the manufacturing department of a medical device company. A lot of the principles from this class tie into what goes on in an everyday basis, but perhaps on a smaller scale. Not everybody is responsible for…   Read more»

I sort of had a similar experience in Capstone as my group had to keep a detailed log of everything that was working out for us and more important what was not working. Our advisor let us find out for…   Read more»

I can see how this could be a common problem in industry, especially when Project Managers get requests from stakeholders not directly involved in planning or executing the project. One day you are on track, have a budget established, and…   Read more»

There are many reasons why a certain product or process will require changes during its life cycle. One example could be cost. To attain certain tight tolerances, material purity, or other favorable physical characteristics, companies may have to pay a…   Read more»

There are plenty sources of input to pool from when developing the Design Input Document (DID). Other than the marketing department you should be collecting information from external such as consumers and doctors. Consumers can be useful by supplying knowledge…   Read more»

I do not think this is a problem as there have probably been hundreds of medical devices approved using predicate devices and which have probably benefited society due to the faster track of class 2 devices. just because it has…   Read more»

I currently work as a manufacturing engineering co-op for a medical device company which is most like a functional organization. Each department has their own managers (Manufacturing, Quality, Purchasing, R&D) and they usually conduct work independently on projects concerning the…   Read more»