The industry and academia is an interesting Venn diagram in the realm of biomedical engineering. In terms of the qualities that one must have to possess, the center of the Venn diagram must include passion. Additionally, one must have the…   Read more»

The claim that one wants to perform research that has immediate effects and benefits seems to be somewhat flawed. The immediate benefits of a laboratory study is decided by the results of the study. If the results disprove the hypothesis…   Read more»

Meeting minutes are one facet of the diamond I like to call personal responsibility in the workplace. It may seem tedious and unnecessary, but taking notes for every meeting or call is absolutely necessary. This is in addition to taking…   Read more»

From my work experience with a biomedical device that utilizes software, software validation is integral to the success of the device in the field. One issue with software that I have seen be dealt with is cybersecurity concerns. There have…   Read more»

I believe there needs to be clarification over the design control requirements by the FDA for class I, II, and III devices. The initial post in this thread states that design controls are mandated by the FDA for low risk…   Read more»

In my experience in the industry, I have seen the the importance and effects of both verification and validation. The first step in the journey of the product is that it is verified to match safety and functionality according to…   Read more»

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»