Project execution is rarely static, especially in fields like medical device development where shifting regulations, sudden roadblocks, and changing priorities are the norm. Adaptability isn’t just a nice to have it’s essential. Teams need the flexibility to shift roles, rebalance…   Read more»

I personally feel as in person meetings are essential to success. Emails simply cannot get important information across. We live in an age where many young people barely check their email, and when they do they skim it as it…   Read more»

Effective planning can be very essential for the managing of various complex demands in medical device development. This can include but not be limited to including meeting deadlines, staying within budget of the project, as well as tending to regulatory…   Read more»

Although I worked for a company before with a Team, I don’t have experience Initiating and Managing a Project. I think that as an Engineer becomes more experienced with managing many projects in their career, every process in the project…   Read more»

Thorough planning is vital to the proper management of all issues related to medical device development, ranging from meeting deadlines and staying within budget to complying with regulatory standards. Poorly structured planning may result in delays, increased work scope, and…   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»

Ensuring compliance with regulations is essential for the innovation of medical devices, as it ensures that new technologies are safe, effective, and ready to be captured in the marketplace. Absent of a robust compliance strategy, even the most spectacular innovations…   Read more»

For the successful completion of medical device projects, strong team development is key. In this case, collaboration across functions, adhering to regulations, and technical creativity need to fuse. A well-organized team enhances efficiency, problem-solving, and risk management which results in…   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»

Project execution is inherently dynamic, and adaptability in project management is key to ensuring success, especially in industries like medical device development where shifting priorities, regulatory updates, and unforeseen challenges are common. A strong project team must be built with…   Read more»