I agree with the above, well-defined roles are crucial to the long-term success of a project team. It is best to allow group members to define their roles themselves if possible so they are personally...

I agree with what has been said above, that determining specs is an extremely important and delicate part of the design process. The specs must be tight enough so that the product can provide its inte...

I agree that the largest challenge that would come with misclassifying a device is stunting your timeline. Additionally, more resources and a deeper budget may be necessary to complete additional test...

I agree that AI-driven medical devices should be even more highly regulated than other devices because of their potential to evolve over time. I think certain guidelines must be put in place to ensure...

Drugs and medical devices are quite different and their general regulatory pathways reflect those differences. A medical device is some sort of mechanical instrument that's purpose is not dependent on...

I'd also agree that inadequate risk management is the most common regulatory pitfall in medical device development. Classification of the device can be a difficulty in the project management process a...

I'm quite surprised by all the previous responses choosing the hands-off approach to project managing, because I think there are a lot of benefits to being more hands-on. I agree with the points that ...

Generally, the most effective communication is early and often. This applies to all walks of life, not just project management. Specifically on a project team, this type of communication could be defi...

I anticipate the biggest risks in medical device project management in the regulatory process. The road to regulatory approval for medical devices in the US is unlike any other products. Devices are m...

An unreasonable location for a sponsored event could be an exotic destination far from the offices of the employees traveling there. Even so, employees in Florida likely cannot have a sponsored event ...

What I think is a major requirement that could be made into a hypothetical international contract law is a mandatory ethical compliance clause. This would require all parties to adhere to universally ...

To maintain a balance between abiding by an NDA and ensuring transparency, companies should draft NDAs that are very specific, clearly outlining what constitutes confidential information. Companies sh...

Upper management requires strategic thinking to see the big picture, set long-term goals, and align organizational objectives. It also is important for upper management to be decisive in making high-s...

Organizational structures significantly impact projects and project management by defining authority, communication, and resource allocation. In afunctional organization, teams work within their depar...

In my time as an intern in the medical device industry, I believe my company worked as a functional organization. The departments mostly worked separately on their own projects with big decisions made...