In the planning phase of a medical device, some more aspects that should be discussed are: stakeholders, roles and responsibilities, scope, schedule and cost, management plan, staffing plan, quality and risk. These are some very important terms to discuss in…   Read more»

Delays in a project can be a major factor for the failure of it. There are multiple solutions around this however. The solutions are specific to what the time delays are caused by. But in general, most unexpected delays can…   Read more»

If a manager or team member has a personal connection to the project, and that project looks like it will not succeed, it can be very challenging to pull it off. If a risk management team decides that a project…   Read more»

I believe the most effective method for resolving an experiment failure is more testing. This gives you the opportunity to try out different parameters and see their interactions. It will become clear down the line which ones have the highest…   Read more»

I believe that in the case of prioritizing projects, a company shouldn’t move everyone from one project to the next according to prioritization. But they should decrease the number of employees working on a low priority project. The projects themselves…   Read more»

I think the best way to get fast approval from the committee at the design review meetings is to present the proper material and hold them at the right times. For example, a design review should occur with each step…   Read more»

I would personally pick matrix organization. This is because it incorporates more of the team aspect. Teams get a bigger say in the project and the outcome than managers and functional heads. The problem with matrix organization is that it…   Read more»

Writing a successful project proposal can be very tedious. This is because, you have to deliver something that might seem ingenious to you to others and have them see the same thing you see. To do so, I believe you…   Read more»

I first want to emphasize what the difference between verification and validation is. Verification is intended to check if the product meets the design specifications. Validation is intended to ensure that the product meets the operational needs of the user….   Read more»

Part of the FDA requirements is that labels and markings have to be correctly placed on the device. They have to be visible and clear for the user. If they’re not, then they’re breaking FDA compliance and must order a…   Read more»

If I had to pick one skill a manager has to have to be successful, I would pick interpersonal skills. I’ve dealt with plenty of managers over the years. Only one stood out. This one is in the company I…   Read more»

I used to work in a the Department of Veterans Affairs in a group called War Related Illness and Injury Study Center (WRIISC). This group has a couple of biomedical engineers that make medical devices and test them on veterans….   Read more»

I believe that technical knowledge in many cases is useless without interpersonal skills. For example, we have a saying at work that says, “A well performed analysis poorly communicated is a failure.” This means that no matter how much knowledge…   Read more»

When you go to write an essay, the introduction is the hardest part. But the introduction is literally the most important part because it will present a layout for the rest of the essay. Initiating a project idea is like…   Read more»

A flaw in any design process can be detrimental. It could hold up work to be done for months or even worse, produce wrong results. To prevent this from happening, companies must test their devices repeatedly using different parameters to…   Read more»