There are various factors that are asked when the task is to find the root cause. Root cause analysis can be likened to a never ending nested doll stack, where one doll is opened to find another. When the engineering…   Read more»

I don’t believe it is wrong to state that there should always be a leader in the group. As life, and many novels and stories will tell us, groups tend to fall apart if there is no leader. Having a…   Read more»

Based on my experience in the biomedical industry so far, every change in the product should be traceable. Even in basic or routine analysis or documentation, traceability and having a path to demonstrate how a change occurred is necessary. It…   Read more»

While I understand the viewpoint that budget changes should be expected in a project plan, if the DSD is well specified, large shifts should not be highly expected. Shifts in budget usually occur for products that unexpectedly fail testing and…   Read more»

Flexibility and balance are needed in every aspect of life, and the same goes for companies and managers allowing both in person and remote work. Both methods of working have benefits, and too much of one method can create unhappiness….   Read more»

There are many things to do in order to ensure that proper communication takes place in the workplace. Although the following step may seem to be counterintuitive, it is extremely important and effective. This step is to listen. The wisest…   Read more»

Although I myself have not worked as a project manager, my work experience has allowed me to be extremely familiar with the work of a project manager. I worked with some project managers over the course of my career so…   Read more»

From my work experience, project management is an essential part of any successful working experience. Project management skills of cooperation, team work, conflict resolution, and being approachable are skills everyone should have. For project managers, they are skills they must…   Read more»

I believe leadership qualities are a combination of innate characteristics and learned characteristics. However, the greater portion belongs to learned behavior. If we are speaking with regards to children, a child may learn from anyone they have met how to…   Read more»

There are several differences and similarities between medical devices and pharmaceutical drugs. Now, whether a pharmaceutical product is a medical device (drug delivery systems) is a separate conversation. Medical devices are usually closely associated with implants and materials that are…   Read more»

Based on my experience working in the field, I prefer to work in small teams. This allows for everyone to get to know each other quickly and easily, while recognizing different strengths and weaknesses. Working in large teams can go…   Read more»

From my experience of working in the biomedical industry, conflicts between team members can be the reason a team becomes stronger or weaker. For example, if a team overcomes an internal conflict, then it senses invincibility and can conquer any…   Read more»

It is clear that the main priority of the stakeholders is profit and reaching finance goals, while the customers value product safety and affordability. While there are some times where the values of these two groups overlap, there is a…   Read more»

There are several obvious things that companies would agree to keep confidential with a consulting firm. These include parts pertaining to intellectual property, client information, financial data, and any other type of information that the company desires. The agreement should…   Read more»

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»