This is a really interesting topic. Gene therapies have great potential but face sustainability challenges, especially with a finite patient pool and high development costs. I agree that valuebased pr...

I agree with the importance of early cross-functional meetings to address potential issues before they become significant roadblocks. To address challenges in the initiation phase, conducting thorough...

I agree with the points raised about the importance of communication and stakeholder engagement in scope verification. One additional challenge could be managing regulatory changes during the project ...

The FDA ensures companies disclose both positive and negative data through regulations like GLP, but issues like data manipulation can still occur, as seen with Ranbaxy mentioned earlier. While indepe...

i agree that both email and teams have their place depending on the context. For quick check-ins/updates Teams is good, it’s more conversational and less formal, which helps keep momentum going. But f...

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 li...

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 ...

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 affe...

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 combi...

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 ...

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 c...

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 i...

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 ...

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...

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 ...