One of the crucial projects going on while I was in my co-op was to manufacture the knee implant. The project manager had broken down in several phases including validation, testing, cleaning, and packaging. This was the first time for us making a knee implant for a specific customer. As we received the material, we first did a prototype lot…[Read more]

During my capstone project, we created a Gantt chart using Microsoft Project to guide us and better visualize the timeline of the project. In the Gantt chart, we divided the project into three parts, thinking, designing, and testing and allocated specific time for each part. During mid-semester, we realized that we missed several milestones and…[Read more]

In my opinion, I believe verification can occur at any phase during a project. It all depends on the kind of project and especially in medical devices, verification is a must step after each operation during manufacturing. Verification can also occur after the project manager creates the Bill of Materials (BOM) and checks to make sure all the…[Read more]

Most of us have experienced a critical path situation during the senior design capstone project. We were designing a product that monitors blood glucose, heart rate and activity that securely transfers data to a remote server. All the data is posted on an UI, which is accessible to family members and doctors. We talked to few professors within…[Read more]

I agree with the above posts that budget cut is very common problem that most project managers deal within a company. In the planning stage of the project, most project managers create a Bill of Materials (BOM) and an estimated labor costs and parts. However, as the project continues, problems arise and the project team needs to review the plans…[Read more]

This is a really interesting topic to discuss as situations like this often happens in the work force. One of the biggest advantage of meeting in person is that one can convey his or her idea without any problems or having to fear who’s coming or not. On the other hand, in virtual meetings, time becomes really important as some team members a…[Read more]

I agree with most of the participants that fitbit is a device made for consumer use. It is NOT a device that doctors recommend to monitor his or her heart rate and activity. It does not harm or pose a risk to a human being if used with the guidelines provided by the company. Since it’s a consumer device, it does not help in treating a c…[Read more]

I agree with most of the participants in these posts on what should be an ideal project team consists of. If I were to be a project manager, communication skills is the number one skill I would look for. Also with communication skills is teamwork, and area of expertise is different areas of the industry.

Communication skill is important to…[Read more]

I agree with Roberts’s opinion that every product has its Life Cycle in which the product undergoes different phase such as Development, Introduction, Growth, Maturity, and Decline. It all depends on how accurately the product satisfies the customer needs and the market. An example of sutures is a great example to show different variation it h…[Read more]

During my experience, I have noticed that most companies have Validation Engineer that performs various tests to validate a machine which is also known as (IQ, OQ, & PQ). There are some specific guidelines set by the FDA that aide the Validation Engineer when carrying out the tests. Furthermore, there are different kinds of validations such as…[Read more]

My experience with design control was with Triangle Manufacturing when I was working as a Quality Engineering co-op. One of my responsibilities was to take part in design meetings and assist the project manager to create BOM (Bill of Materials). I completely agree with the design controls as outlined in this week lecture. Most medical device…[Read more]

In my opinion, I believe that your senior design product would be considered as a mobile medical app. In the week 1 lecture, we learned that Medical Device is anything that cure, prevent, or treat disease in humans. Furthermore, your device aids people with hearing loss and therefore it is considered as “mobile medical app”. After doing fur…[Read more]

First of all, thank you djr32 for putting up this article. It’s very interesting to do research in developing artificial organs from the lab grown biological organs. I completely agree with the above posts that artificial organs would be a Class III device. This would mean getting a Premarket Approval before launching the product in the m…[Read more]

In today’s world of manufacturing, it is essential for a company to have regulatory laws in place. Good Manufacturing Practises (GMP’s) are regulations placed to meet the company’s quality standards and production standards. More importantly, GMP’s regulation sets the company standards higher and also plays a role in the market. For exa…[Read more]