In general, estimates of budgets are usually obtained from thorough market research. Even if a product is not exactly the same as previous products, a rough estimate can be obtained by looking at fact...

I recently worked on a Capstone Project where we had to design and construct a medical device. After completing the project, the biggest lesson I learned was to be more proactive. Instead of waiting f...

In my experience, poor project planning leads to 2 issues: oversights and delays. When a project is not properly organized from the onset, work is often not delegated properly. Because of this, delays...

In general, I do not think there is a major difference between a project manager with an academic background and one with more professional experience. An individual can develop expertise on a given s...

Some individuals are born or inherit traits that are favorable to being a leader. However, not all of these individuals use these traits to lead. Sometimes you meet an individual who is a strong commu...

As stated in previous posts, I believe there are pros and cons to both in-person and online project management. While it is more convenient and cheaper to have an online project manager, communication...

The PDCA cycle is an essential aspect of successful biomedical engineering projects. While each respective department may have its own PDCA cycle, the "check" aspect can involve members of different s...

Sub plans are important in project management, especially in cases where specific details of a specific aspect of a project need to be expanded. For instance, a project management plan usually include...

Verification and validation are similar processes but with different goals. Verification relies on testing the design requirements/specifications to ensure that the product is built/functions as desig...

I do believe there is some ambiguity in the classification of medical devices, especially when considering combination products. However, I'd make the argument that it is better to "overclassify" than...

Misclassifying a medical device will shift the project's overall timeline as different testing or steps would be necessary. For instance, if a Class II device is reclassified as a Class III device, a ...

Reclassification can happen if there are changes made after undergoing testing. For instance, imagine that a traditional hip implant is being tested. During this testing, the researchers note that the...

A lack of funding is not a positive sign when proposing a new project. While the project may have patent potential, you need to ask yourself why there has not been funding for the project. Is the proj...

I think the size of a given project team is highly dependent on the scale of the project being worked on. However, in terms of medical devices and biomedical engineering products, I do believe that th...

@afshinsadri Thank you for your explanation of both preventative maintenance and preserve maintenance, as I had never heard of these terms before. This aspect of project management seems especially im...