Verbal contracts seem like a tricky part of the legal processes. There are several ways to ensure that verbal agreements are kept, though it may be difficult. There can be witnesses present at the initiation of the verbal agreement. This…   Read more»

It seems absolutely necessary to have arrangements for how operations if something unfortunate were to happen to me as the owner or CEO of the company. Unless there is a company policy, prior agreement, or legal issue, I see no…   Read more»

Unfortunately, in this organizational structure, there seems to be several issues. From the favoritism to the lack of concern for quality and regulatory needs, there needs to be a re evaluation of how that department or team is run. The…   Read more»

Upper management and middle management often fall into the blame game when it comes to the state of a company, especially a biomedical device company. As other posts have mentioned, upper management is visionary and seeks relevance in the market…   Read more»

The original post in this thread raises an important point, but I believe there is a simple answer. While assembling a project team, it is important to have people with a variety of skills, strong knowledge, and good team work…   Read more»

Whether for a certain class or for personal research, I have certainly read some research papers, which after I read, I said “that should not have been released”. One of the reasons why I might have thought that statement to…   Read more»

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»