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»

These are all really good insights, it makes sense that having clear deliverables and timelines in agreements would help avoid confusion. I also like the idea of adding periodic reviews to keep things adaptable as projects evolve. For NDAs, making…   Read more»

In medical device consulting agreements, arbitration and mediation are common because they’re quicker and less expensive than litigation. Setting clear jurisdiction clauses or using neutral venues can help avoid bias. Simplifying conflicts often involves including dispute escalation steps, like mandatory…   Read more»

It’s really interesting to see how different organizational structures can benefit various industries and even specific types of companies within those industries. For the medical device sector, I agree that size, maturity, and the company’s focus (like R&D vs. manufacturing)…   Read more»

These are all great perspectives and I agree that both Gantt charts and network diagrams serve important, complementary roles in project planning and management. The Gantt chart provides a detailed view of tasks, timelines, and resource allocation, which is essential…   Read more»

These are all insightful points and I agree that organizational change is about more than just structural adjustments, it’s also about fostering adaptability and aligning employees with the company’s vision. I find the emphasis on clear communication and employee involvement…   Read more»

These are good suggestions, I really like the idea of using tools like Trello or Miro for virtual collaboration, especially when in-person meetings aren’t feasible. I don’t have much experience with facilitating risk management meetings, but I agree that preparation…   Read more»

I really enjoyed reading everyone’s experiences—it’s fascinating to see how CAPAs and risk management play out in different settings. I don’t have audit experience myself, but it’s interesting to hear how findings can drive major improvements, like revamping entire calibration…   Read more»