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 others have mentioned, teams often…   Read more»

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, tasks tied to design verification, validation or supplier lead times could…   Read more»

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, cost estimation should already be included with contingency reserves that…   Read more»

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 integration. Rather than treating the FDA requirements as something…   Read more»

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 quickly before it affects deliverables. Personally, meeting each person…   Read more»

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 the DHF, so managing activities and ensuring compliance occur in…   Read more»

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 to be reopened as well. In medical device…   Read more»

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 section may promote accountability and speed, there…   Read more»

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 influence the verification outcomes, but they would absolutely…   Read more»

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&D, manufactoring and marketing at the same time. The matrix structure…   Read more»

I think overall in any project or mission, it is important to have a balance of the group size and the AMOUNT of groups as well. With that said, I like working in smaller groups due to the communication being…   Read more»

I think the most important responsibility of the FDA is risk based protection for public health across the ENTIRE product lifecycle and not just the initial approval. While the safety and efficacy review before market entry is vital, their ability…   Read more»

In addition to verification/validation and post market surveillance, configuration and changes of management could help in the influence of a medical device’s product life cycle. As time goes on and there is maturation in the device, especially with devices that…   Read more»

For most projects, I prefer a smaller sized team (to me that would be around 4 to 6 people). Communication at this size is faster, the roles are clear and concise, and it is an easier task keeping everyone aligned…   Read more»

To me, it is crucial understanding ones own role because if a team is to work cohesively, everyone needs to play their part from the top down. It can be frustrating having to pick up the slack for someone who…   Read more»

There a lot of points already mentioned in this thread that I agree with, especially the shift of the project manager role once a device enters that post market phase. I think an aspect that has not yet been emphasized…   Read more»

When a conflict between a project manager and a highly skilled member of the team arise, it’s important to understand there isn’t always a one size fits all. In one aspect, it depends on the competence of either member, but…   Read more»

In regards to project management in medical devices, singling out one field as the best fit would be hard. It would be beneficial if some engineer (be it biomedical or other) would be a good fit, but the experience that…   Read more»

When it comes to project managers on medical devices, it is important for them to have good analysis on systems coupled with a strong awareness for risks in the field. Biomedical projects and devices are not necessarily linear and certain…   Read more»

When answering this question, I am tempted to say that the risk should strive for a zero-chance, but that is impossible. Devices and products will always carry some risk, although they will be put to an acceptable level of risk…   Read more»