Recently, I encountered my first experience not meeting a deadline in industry due to underestimating the time needed to complete the task. The task was to obsolete a product line which should have taken around a week for me to complete. However, my project manager and I did not take into account the time needed for the document to get approved…[Read more]

The process to perform quality assurance includes both inputs and outputs. A couple of examples of quality assurance responsibilities in terms of inputs are process improvement plan, work performance and quality management plan. Quality management plan is within the DDP, while process improvement plan is based on the companies approach on work…[Read more]

One issue that all project managers face is being able to keep communication between different departments or people. Information distribution such as sending emails and phone calls to people to get updates on certain assignments is a big task. Sometimes, people do not get along in a project team therefore they do not communicate with one…[Read more]

For our online simulation a project manager will have to priorities time management. Since the assignment is given a time limit of a week a project manager would have to take into account the team members work/ school schedule and the time it takes for Dr.Simon to respond to rounds. The project manager should be able to understand what the…[Read more]

Missing milestones creates setbacks a lot of the time which can be harmful to a company rather than beneficial. I understand when you say that it might be beneficial to a company because your working on perfecting the device before it gets marketed. However, missed milestone in a company can lead to loss of money. My dad is a supervisor in New…[Read more]

Since starting at Maquet I never actually knew what I would be doing as a manufacturing engineer in industry. I heard about the FDA maybe once or twice as an undergraduate.This course taught me so much about working as an engineer in industry compared to a majority of other courses I have taken in my undergraduate career. The first weeks lecture…[Read more]

When a test on whether the balloon system pops after 10 days fails for a device such as ReShape Integrated Dual Balloon System it creates a stir in the office. I would like to share my experience on when a test fails in the medical industry for a different device. I work in company that is known for their product of IABs (intra-aortic balloons). I…[Read more]

For my capstone project to build a robotic arm control we had to use the work breakdown structure to outline the hierarchy of tasks. In order to build our controller we divided the responsibilities into mechanical, electrical and software. All of these three categories each had their own subcategories such as testing, evaluating and creating.…[Read more]

This week’s lesson speaks volumes to my experience with highlighting the critical path. So during my senior design course I encountered numerous obstacles which affected our critical path. I and my two friends were supposed to design a controller using a RS232 shield which would control a robotic arm called an iARM. In order to outline our e…[Read more]

A budget cut will affect the cost estimation of a project because if in development stages of a product the budget is cut the project team has to reanalyze the scope of the project. Project managers will need to remain calm so that the project team does not panic. Then they need to present the project to the business to show how the project fits…[Read more]

When working on the creation of a seven degree of freedom impedance controller for an iARM my project team encountered many delays due to a critical path. The controller was initially expected to be controlled using an RS232 shield with an Arduino Mega which would communicate between the iARM and the controller. This was not considered a critical…[Read more]

I would classify the Zoll Lifevest as a class 3 device because it has really high risk and it is used to help sustain life. The lifevest device begins to apply high energy shock during life threatening scenarios of ventricular tachycardia or ventricular fibrillation. However, this device will send electric shocks when it detects an abnormal…[Read more]

A lot of college students undergo a large amount of stress and are always trying to find ways to get more sleep. The sound + sleep product promotes “relaxation, renewal and deeper sleep.” It is a general wellness product because it has very low risk. It plays natural music which calms individuals down and allows for people to enter a more rel…[Read more]

Center of device & radiological health (CDRH) definition of a general wellness products as
“Products that are intended for only general wellness use and present a low risk to the safety of the user.”
Based on this definition, I do not believe that the fitbit is required to have FDA approval because it is used to track your heart rate as a wel…[Read more]

The beginning stages of a project are always the most critical and research focused. It is viewed as the hardest section out of the nine design controls because you only have an idea of what you want. It is crucial to figure out within this stage:

Who you are marketing to?
What characters of your product fill a market gap?
Figuring out the major…[Read more]

Within my senior capstone course I utilized many of the design control requirements without even realizing it. My capstone team developed a seven degree of freedom impedance controller for an intelligent assistive rehabilitation manipulator (iARM). We had to create a proposal on the idea we had which was supported by lots of research. We had our…[Read more]