I agree with the points everyone has made so far. However, one thing I noticed is that everyone is assuming that falsification is happening intentionally. In a real-life situation, with capable leaders and team members, falsification may happen quietly and…   Read more»

Most of the discussion so far has been about avoidance, but I want to bring into question whether avoidance is actually the dominant strategy in medical device development. Avoiding risk sounds ideal in theory, but in reality, many medical devices…   Read more»

I also agree that this qualifies as a major change in the device. If the EMA is questioning whether the current method to sterilize is safe and whether it changes the surface of the product, which you claimed is very…   Read more»

What I deduced from this week’s lecture is that slack is calculated flexibility that comes from understanding ES, EF, LS, and LF. Slack will be strategic if the PM understands how early and late times are derived from the network…   Read more»

I love the examples that everyone has given so far! I want to build on this by directly connecting to project management tasks and seeing the FS and SF relations in play. I think your confusion comes from how both…   Read more»

I think this question highlights how uncomfortable the reality is that if a project is technically feasible and can actually help the market in a specific clinical area, it does not immediately seem that the project has commercial viability. If…   Read more»

What stood out to me from this week’s lecture slides is how different project management phases are from design control phases. In project management, the lecture discussed how phases can overlap and blend together, so there is no concrete, clear…   Read more»

I think one issue that has not been discussed enough is how developmental life cycles influence team behavior and risk tolerance, along with the timelines and documentation. The life cycles affect the humans who are bound by them. Teams often…   Read more»

  I agree with how business needs and customer satisfaction are treated as separate priorities and should be intertwined when creating a plan. I think they should be embedded in the project proposal from the beginning. When customer needs are…   Read more»

If I were the PM in this situation, I would take the results from the pre-clinical trials and definitely change the plan to address the situation. Continuing without making adjustments to the plan would be irresponsible. The first step I…   Read more»

I think the optimal project management software should have intelligent automation and predictive analytics that all members of the team can use to see where the project is going, and also not have to waste time and energy on tasks…   Read more»

I agree with how separating design controls and management can lead to issues with verification and validation. I think rushing these processes takes away the main point of verification, which is to make sure that the product itself works with…   Read more»

  I think design reviews and design changes are most important during the Check and Act phases of the PDCA cycle. The Check phase is important because it connects all the other phases of the design process together. With Check,…   Read more»

One way to reduce “project myopia” is to connect the project lifecycle to the higher-ups at multiple points in the timeline. This ensures that the project is aligned with company goals and policies. In the lecture, it was discussed that…   Read more»

You bring up good points about the submersion and drying times of the bottle label, since the timing is important for adhesion and how strong the adhesion is. With more time, more bonds can be made, allowing for a stronger…   Read more»

The key theme across all these responses is that challenges in the regulatory section of project management must be addressed pre-emptively. Any issues must be predicted and prevented as opposed to reacting to the problems as they come up in…   Read more»

I think you make a good point about planning for uncertainty, since it is almost never possible for a best-case timeline for sure. This is especially applicable for Class II and III devices. One thing I would add is the…   Read more»

  I currently work in a neuroscience lab that deals with the Protecadherin gene in the brain. This gene codes for the “molecular barcode” of each neuron, and this barcode is used to ensure that neurons make proper connections between…   Read more»

I myself have not worked in industry yet, but I asked some family members who do about your question. PERT and CPM are used more implicitly in practice than their textbook form that you have mentioned above. A lot of…   Read more»

I like how it is very clear that continuous compliance is the main point regarding FDA “licensure.” From the standpoint of project management, this moves the focus from one approval milestone to continuous coordination across the company. Regulatory and project…   Read more»