I think another important aspect during design transfer is making sure the manufacturing team really understands the product and how it is supposed to be built. During development the engineers usuall...

If this were to happen in the middle of validation, I think the first step would be to immediately document and record the defects and contact the vendor in order to start a root cause investigation i...

A lot of points listed here I agree with, especially with increasing project risk just to shorten the schedule could be a dangerous path, especially in medical device development. In the miniSim examp...

While I think transparency is important, one practical reason finances might not necessarily be fully disclosed to a PM is that the budgets are often tied to a larger portfolio of projects and upper m...

I believe early stage risk assessments should be prioritized because they help identify major hazards before significant time and resources are invested into development. I hear my self mimicking this...

In real world projects, I think these line of phase processes act more as a framework rather than a strict sequence of steps, but alternatively they should still be linear in some fashion. As several ...

A lot of great points raised, especially between padding tasks and building structured buffers. Slack management should also be aligned with regulatory risk and verification cycles. As an example, tas...

Budget cuts indeed cause an impact on cost estimation, but I would say they also expose weaknesses in the original estimating process. In medical device development, especially with regulated products...

I agree with the emphasis on the prioritization of safety and regulatory compliance, although I believe there are other important balancing tools for the PM to utilize such as regulatory strategy inte...

There are a lot of points I agree with, especially those regarding neutrality, early intervention and structured conversations. A good approach would also be starting with an address to the issue quic...

The PM's role does not fully shift from taskmanagement to compliance, but in medical device development, the two could become inseparable. Every task should generate objective evidence that feeds into...

There is an appreciation to what is being said about having an emphasis on humility, documentation and risk management. I agree in regards that emotional intelligence is important when a phase needs t...

Understanding hiow the work is divided in a group project is crucial to ensuring both the efficiency and cohesion in the final version of the product. While assigning each individual person a separate...

I agree that in the real world, with a regulated environment in medical device development, there has to be a clear separation between roles while still maintain collaboration. The PM should not influ...

I personally lean towards the matrix organization, but with an emphasis on a balanced matrix. In biomedical and medical device structures, projects would require input from the regulatory, quality, R&...