As someone still learning the ins and outs of project scheduling, i found it really helpful to see how early start and late finish are connected to the critical Path method and influenced by things like resource availability and task…   Read more»

Reading this thread, I’ve found it really interested to see how tools like SV and CV aren’t always telling the full story, especially in complex fields like medical device development. From what I’ve studied, one of the biggest takeaways is…   Read more»

I’m still a student without industry experience yet, but I’ve come across similar ideas while working on team-based projects in classes. In lab work, I’ve seen how small changes in procedures can affect results, especially in bio related tests. So…   Read more»

While I don’t have industry experience yet, I’ve worked in team settings like capstone projects where communication was just as critical to keeping things on track. What worked best for us was a combination of weekly team meetings and informal…   Read more»

All the frameworks mentioned highlight how important it is to slow down and really understand the problem before making a decision under pressure. I think one key takeaway is that it’s not just about choosing the technically correct fix, but…   Read more»

I agree with the points raised about the long-term consequences of rushing through experimentation, especially when it comes to medical devices where safety and effectiveness are importanst. Cutting corners in the short term can easily backfire if the data isn’t…   Read more»

These are some really insightful suggestions, especially the emphasis on stakeholder engagement and using living checklists to stay on track. One preparation step Ihave observed being really helpful is holding informal team syncs or pre-review discussions a few days before…   Read more»

Regarding the points about incentives, I think they can play a role, but they need to be carefully structured. Bonuses work but other things like public recognition or additional responsibility might work just as effectively. And I’d say that they…   Read more»

One thing I think can be added to this conversatuion is that incorporating regular risk assessments throughout the process is important. As the previous reply mentioned, using a risk register can be a proactive way to anticipate potential problems, assess…   Read more»

From what i’ve understood, I would emphasize that both processes are crucial in ensuring the safety and efficacy of a medical device, but they operate in different contexts. Verification focuses more on internal consistency, making sure that the design outputs…   Read more»

I think the balance between providing access to potentially life-saving treatments and ensuring patient safety is the biiggest challenge with the HDE program. While it’s undeniable that HDE facilitates faster access to treatments for rare diseases, the limited clinical evidence…   Read more»

I agree that the main difference between project and program managers lies in the scope and level of responsibility. The strategic thinking required for program managers makes their role a bit more complex, especially when it comes to managing risks…   Read more»

For smaller, short-term projects where quick decision-making and flexibility are needed, I think a project-based organization works really well because it allows the team to focus solely on the task at hand without getting bogged down by a complex hierarchy….   Read more»

Good idea to take some time and reflect on what worked with our teams- it was definitely interesting how we all approached problemsolving from different angles. In my team, I took the lead on organizing the project by setting up…   Read more»

I completely agree with the importance of balancing testing for worst-case scenarios with real-world usage conditions. It’s clear that a product should be able to withstand extreme conditions that may occur under rare circumstances, but I also think it’s crucial…   Read more»

Based on the replies on this thread, while the FDA doesn’t directly approve the specific procedures for verification and validation, it certainly plays a critical role in ensuring that the end results meet safety and efficacy standards. The FDA’s oversight…   Read more»

I don’t have direct/industry experience in this area yet but I think the balance between meeting timelines and ensuring quality is a tough challenge. Because, its clear from the discussion that the FDA’s role is critical in ensuring safety and…   Read more»

While I don’t have industry experience yet I can see how EEFS would play a significant role in project delays, especiallywith external factors like supply chain issues or internal factors like organizational culture. From what I’ve read and learned, addressing…   Read more»

Iff we had the option to modify the DSD, the approach would shift for sure. I do think that changing the verification test alone is a more straightforward and cost-effective route, but altering the DSD opens up possibilities for addressing…   Read more»

Having a clear plan in place definitely seems like a responsible step for any business owner to ensure smooth operations during unexpected situations. Without something mapped out, I can imagine it would create confusion and potentially harm the business. Choosing…   Read more»