It can be easily argued that a change notice is required for every proposed change to any document. It is a good practice for several reasons. It ensures that everyone is dealing with changes in the same way, and allows…   Read more»

I think that design controls “force” the company to be responsible for having a product that works and does not harm anyone. At the end of the day, biomedical device companies are businesses, so the main motivator is the monetary…   Read more»

This is an interesting prompt. I seriously question if this product will be able to be brought to market. One of the requirements of a product is that it must solve a problem and is effective. In this case, it…   Read more»

In clinical studies, it is extremely evident that diversity is necessary in order to properly represent the possible effects of the product or drug on all peoples. If diversity is needed in the results, the diversity is needed in the…   Read more»

I have always been fascinated by the concept of placebo. The fact that it is possible for the brain to allow suffering of healing, based on itself, is almost mind boggling. There are attempts to minimize the effects of placebo,…   Read more»

The first impression of a logo or office space is often the color. Colors and design must make sense to the product or theme that is trying to be sold. For example, a product geared towards kids must not be…   Read more»

I think it is clear that different types of healthcare products and biomedical devices require different types of marketing. For example, pharmaceutical drugs and devices, such as a new pill or patch, benefits greatly from interacting with the average consumer….   Read more»

Based on the project managers and managers I’ve interacted with at my workplace, a business degree is extremely helpful. At the end of the day, any biomedical engineering company sells a product(s). Therefore, sales is what drives the business and…   Read more»

A partnership has several positive characteristics, especially when there is a unified goal, mission, and method of completing tasks. Additionally, there could be less financial risk and burden. However, as in any partnership in life, each partner needs to be…   Read more»

The benefits of an MBA are obvious. The education and the connections are extremely valuable. However, there is not such thing as required. A MBA is not required to start a business, and one can perform their own research and…   Read more»

The core of this issue is asking if the person starting the business is capable of doing it. Entrepreneurial skills vary and are required. A person can be zealous, then quickly realize that they are not equipped financially, emotionally, or…   Read more»

A quality control engineer must have extensive knowledge of the product, the theories that make the product work, and the specifications of the product and its components. For example, in the case of a non conforming material, the engineer must…   Read more»

Based on what I have seen, many companies are still shy of using AI. The efficiency and ease of AI is a double edged sword. It can take away jobs, and there are still inquisitions about accuracy. A side question…   Read more»

Quality assurance is the internal FDA of a medical device company. It is the first step in preventing complaints from returning from the field. For example, if a non conforming material is found on the manufacturing floor, a future complaint…   Read more»

I have recently switched from an engineering role to a regulatory role, and there are obviously pros and cons to it. Roles in regulatory or compliance usually provide more flexibility to work from home, which some people prefer. Engineering and…   Read more»

As someone who works for a medical device company, I have had my fair share of unique experiences in and outside of the office. Yes, people have different types of accents, different backgrounds, different styles of thinking and approaching matters….   Read more»

From an external point of view, the FDA has the role of dictating the balance between innovation and safety. Between the three different levels of devices, there are guidelines that are already set in place. Additionally, past experience with products…   Read more»

There are similarities and differences in the desired qualities of an engineer in the industry versus a researcher in academia. Both fields require expertise in knowledge, however, academia prefers graduate level education. One can work in the industry with just…   Read more»

It seems as there are mainly students participating in this, that most are speaking from personal experience, as will I. I have had professors who are research lab leads and are conducting innovating research in their on campus labs. The…   Read more»

As one of the professors in the biomedical engineering department at NJIT once said, “biocompatibility is not a real word”. Obviously, it is a real word. He was trying to explain to his students that the human body will always…   Read more»