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 job, there was no acknowledgement of that effort. There was also a reluctance to allow people to do fulfill the roles…[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. There a multitude of events which can occur that would mean suppliers can’t fulfill their contracts. This includes natural…[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 will then get in contact with a salesperson who can find the exact product you are looking for and get you an official quote for…[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 is conceivable that the writing of the protocols could be done in the planning…[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 were asking for all sorts of different documents and justification evidence for certain decisions. If you do not have these…[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 the process. Each part needs to have acceptance criteria with upper and lower control limits…[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 see whether or not projects are over or under budget and that comparison has the power to derail…[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 would definitely be promoting a healthy lifestyle with and helping to reduce the risk or impact…[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 the basic ways to complete any type of project and generally be successful if you utilize them.…[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 the future someone could create a suture string which is coated with a healing agent but besides that we have reached an…[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 much in that time that it is hard to compare new products to such seemingly archaic products. But…[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 up to the meeting clueless as to what you are trying to accomplish. Once you get to know these people more, you…[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 the project. This should be done during the closing phase of the project and stored in the Design History…[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 every part of every project phase. For example the R&D department in my company is in the process of bringing a new device…[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 ourselves instead of telling us when she knew something would fail and so we went through many design changes throughout the project. In the end we…[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 have a product on its way towards being released. Then upper management all of a sudden makes a request which…[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 lot more money. If it is able to be determined that the acceptability criteria can be changed to…[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 in the form of surveys and focus groups to see what types of features in a device they…[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 a lower risk rating does not mean it is simply thrown into the market without proper justification of safety and…[Read more]