As mentioned above, collaborations between companies become necessary when one company lacks money, resources, time, or experience to complete a project on its own. What hasn't been mentioned, however...

I think an important motivator for team success is the satisfaction of reaching goals along the way. Thus, a good method for team development during execution is actually done during the planning phas...

I think it is very important to find the balance between providing enough information to keep stakeholders informed without overwhelming them with excessive updates. To do so, I agree that summarizing...

During the initiation phase of medical device project management, key inputs include the Project Charter, feasibility data, market analysis, regulatory requirements, and stakeholder expectations. Thes...

I agree with some of the previous entries that Microsoft Teams can be more efficient than email chains for shorter communication that does not have to be documented. More official, documented messagin...

I think this is a great point because the biomedical industry is highly cross-functional as you've mentioned. To ensure alignment among stakeholders in a partnership, project managers need to establis...

Having slack in a project schedule is quite important to ensure that projects have built-in time for unexpected delays without derailing the entire schedule. I think that consulting the experts is the...

I agree that schedule risks are often the most prevalent and common in medical device projects, but financial risks are the most devastating. As stated earlier, financial risks are very serious and, i...

I agree that a good strategy for accurate cost estimation of a medical device project is to compare to the cost of a similar past project. However, that information may not be available if the project...

Many of the past responses include questions like what, when, and where. I think these are important questions to ask, and I'd like to add questions about conditions, reproducibility, and the overall ...

Finding a middle-ground to balance innovation and patient safety in medical device development requires a structured yet flexible risk management approach. One of the most effective strategies is usin...

Effective risk management in medical device development requires balancing safety, efficiency, and cost. While minimizing risk is essential (especially under ISO 14971 guidelines), overly cautious app...

I agree that real-time monitoring is the best way an organization can create a culture that embraces the PDCA cycle. As mentioned, regularly scheduled team meeting should incorporate PDCA and a tracki...

I agree that it is unwise to jump to design modifications without performing additional tests. It is necessary to pin point where the problem is before trying to solve it. I agree with the above idea ...

I think it could be necessary to vary testing parameters within regulatory guidelines to come to a favorable outcome after failure. Though it may be difficult to change test parameters if they have al...