As a sales rep for a company, following up on cold calls and inquiries by customers about the products of the customers becomes essential for the company to acquire a sale and make a profit. Creating this bond of trust…   Read more»

Financially, companies wouldn’t go about developing medical devices if they didn’t see profit in the near future, but there are ways companies develop these devices even though they aren’t profitable. There are devices similar to drugs, better known as orphan…   Read more»

Going into business becomes a difficult process for one individual. The way I would do it is to get business partners on a product, like a start-up, and my partners would also invest in a common investment. The other side…   Read more»

In the company I worked for, they weren’t a very big company and were rather small, so I was boxed into one particular field while working there. My position had to do with different parts of manufacturing, such as planned…   Read more»

The Form 483 reminds me of this one case study I learned about, which had to deal with Harvard and some medical tests they were doing. The case study was based on the fact that Harvard was conducting clinical trials…   Read more»

Manufacturing safety becomes a second thought often during manufacturing because many companies are concerned with profit and how much they can make. Having the safety-approved equipment becomes less important because there isn’t a disaster or worst-case scenario where companies aren’t…   Read more»

Quality assurance and quality control serve different purposes within the medical device field, where each complements the other. My background is in quality control, not in medical devices, but in lab testing, which is the hands-on experience of testing the…   Read more»

Switching from the engineering role to a regulatory role has always interested me because of the perks of the job that other jobs do not have. More and more regulatory roles are becoming remote due to the nature of the…   Read more»

Handling a pandemic is of course going to be messy, no matter which government agency handles it, and the way the FDA handled the vaccine rollout was probably the best that could’ve happened. The vaccine was developed rather quickly due…   Read more»

The main impact on the project is product development as opposed to post-market management because of the nature of the project. In any project, most of the work is done during product development, but because this is regulatory work, most…   Read more»

Considering the fact that a pre-clinical study and/or clinical study consist of several tasks, this would constitute a project, so a project manager would be necessary in this case. The project manager is tying all the personnel that are involved…   Read more»

The guideline I found most important to this would be “requirement of due care,” which encompasses the animals, the study, as well as those outside the study. The guidelines previously mentioned cover certain requirements for the FDA as well as…   Read more»

Stability testing is done in order to maintain the function as well as to make sure the product is safe to use, such as the use of IV needles, which need to be sterilized. These types of products in the…   Read more»

Putting academia and industry side by side in terms of project management I tend to find many similarities in what I have experienced in both fields. In terms of academic research, making a Gnatt chart becomes unclear in some instances…   Read more»

When managing a project, the first few questions before beginning a project are ultimately what the subject of the project is and what can be allocated to certain resources. In my experience, the project needed to be approved based on…   Read more»

Implementing AI into project management seems like a good idea and seems like a very different approach to project management. I think applying AI to project management can happen in today’s society because of the immense amount of data the…   Read more»

Going into the industry with a bachelor’s degree shows the employer that you went to college and are capable of doing work at the entry level. There are other jobs that require only a high school education but pay significantly…   Read more»

Most industry jobs require a bachelor’s degree, and in some cases, a higher degree would open more doors. At the same time, when recruiters screen through the applicants, they consider the GPA to be one of the deciding factors in…   Read more»

Working remotely from home as opposed to the office has been a topic that I have considered multiple times in my industry as well as academic life. With the transition during COVID during my academic BS of my undergrad, I…   Read more»