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. During when I was interning, they were just starting to test materials. So there would be different groups…[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 we were doing that week and as a result it delayed whatever we were doing the week after. As a result, we had to speed certain things up…[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 of the Gantt chart, the project manager will have to allocate more time for R&D to do further research and figure out the best possible course…[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 would use to conduct the surgery. As an intern, I did not have a major part in the FMEA process, but I got to work on the FMEA for…[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 would use to conduct the surgery. As an intern, I did not have a major part in the FMEA process, but I got to work on the FMEA for…[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 of the skull. We used MRI files and converted that to a 3D model. One of things we have to look into are materials that are…[Read more]

Surprisingly, I am working on my capstone project and am in my critical path weeks. 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 of the skull. We used MRI files and converted that to a 3D model. One of things we have to look into are materials that…[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 DDP, if an issue should arise, some principles from Six Sigma’s DMAIC tool can be used to solve those…[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 wide array of occasions. My Capstone project is studying the effects of TBI’s by measuring brain deformation caused by…[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 does not meet the requirements for a medical device. It does not aid in the diagnosis of a condition. The fitbit is basically a fitness tracker. To…[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 the requirements are fulfilled.

Knowledgeable project manager who is really on top of everyone’s duties. He or she must be able to provide…[Read more]

I think a good team consists of:
Knowledgeable project manager who is really on top of everyone’s duties. He or she must be able to provide the leadership necessary to get the project done on time as well as efficiently. Also, they must foresee any issues and try to mitigate any obstacles.

Subject Matter Expert. This is the person that is very…[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 original post asking what qualifies a “serious risk”. Also what makes something serious as opposed to not serious? What’s interesting is…[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 original post asking what qualifies a “serious risk”. Also what makes something serious as opposed to not serious? I think a “serious” risk…[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, let’s say, can pose a huge risk to a person if it fails. I am sure the business will need a Premarket Approval which is the most…[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 implies that it is aiding the person in a way. The FDA has a very intricate definition for a medical device but, I am going…[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 implies that it is aiding the person in a way. The FDA has a very intricate definition for a medical device but, I am going…[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 implies that it is aiding the person in a way. The FDA has a very intricate definition for a medical device but, I am going…[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 specializes in a particular area is grouped together, they can share…[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, 21 CFR Part 820 of the QSR was the bible in our department. I…[Read more]