One of the big projects going on around the time I was interning was this change from one method of sterilization technique to a new method of sterilization technique. The project manager had broken down the schedule into different phases….   Read more»

For my capstone project, I had to follow a schedule I made on microsoft project. We had allocated a certain amount of time for a specific part of the project. The week before we ran into an issue with whatever…   Read more»

I think this would be a critical part of the entire scheduling for the project. The balloon did not do what it was supposed to and as a result, whatever comes after in the schedule will be delayed. In terms…   Read more»

At Zimmer, I was involved with a project where the Case Development team was designing and launching a new case for a product. The case was for a total knee replacement and had compartments for all the tools a surgeon…   Read more»

Surprisingly, I actually ran into this last semester during my capstone project. I am trying to make a transparent skull to study the effects of traumatic brain injuries and in order to do that I have to get proper geometry…   Read more»

I agree that the Six Sigma tool has some applications with the Project Planning Process. We looked at the PPP in terms of initiating, planning, executing, and closing. In all of those steps, monitoring and controlling is involved. During the…   Read more»

I think helmets could be considered a general wellness device. Helmets are used to provide support to your head and lower the risk of injury. It provides the basic necessities to reduce the risk of traumatic brain injuries to a…   Read more»

I agree with the majority of the people in that fitbit is not a medical device. It does not pose a risk to the user. It is intended for use in the diagnosis of disease or other conditions. The fitbit…   Read more»

I think a good team consists of: A sponsor. At the end of the day, you need to submit your project. The project sponsor is the person that reviews the results of your project and checks and makes sure that…   Read more»

I agree with the above post but, I think the criteria in general have to be further explained. If you look at the requirements from the site all of them say “serious risk”. This brings up the question in the…   Read more»

I would agree with the above posts that an artificial organ would be a class III device. Class III devices are typically the ones that pose the greatest risk to a patient and as you can imagine an artificial heart,…   Read more»

I agree with pretty much everyone on this post regarding the fact that your device would be considered a mobile medical app. The fact that your capstone project actually served as a method to TRAIN users to hear auditory cues…   Read more»

After working at Zimmer-Biomet and Stryker, I realized that they were both functional organizations. This means that that organization is divided into groups for different specialized functions (IT, R&D, Quality, Manufacturing, etc.). The advantage of this is because everyone who…   Read more»

Current Good Manufacturing Practices (cGMP) are systems in place that ensure that a product is being made according to current regulations. This means that it meets quality standards, production standards, and regulatory standards. While working in quality engineering at Zimmer-Biomet,…   Read more»

Overall, I believe that project management ultimately depends on the way you look at the project, whether it is the same industry or within several industries. While all projects follow the same PDCA cycle as mentioned by someone in an…   Read more»