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 nece...

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 wi...

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 ...

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 an...

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 s...

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 m...

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...

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 result...

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 minim...

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 ...

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,...

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). T...

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. Howev...

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 perfo...

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 n...