I have no experience in the industry, but based on what I know about ECO from Dr. Simon’s course, I would only use an ECO for profits. For example, if there is a major change that needs to occur in the device or protocol, yes by all means submit an ECO. However, one of the main reasons If it was my own product, I would use the ECO if the device or product were going to increase the sales and be more competitive in the market. Since all of the regulations and approvals were vetted, and if a new change will perform the same functions that already exist but also adds something and this results in more business for the company.

Another way I look at ECO, if there is a better way to produce the same product with less cost by changing protocols I would highly consider the use of ECO. I would personally use ECO for these main reasons for better product, better market, better competition.