Quality Management is not simply a legal box to check; it is integral to the thoughtful design and development of a medical device. It protects patients by ensuring that products are safe, effective, and consistently align with the design and…   Read more»

Design review meetings play a big role in keeping projects on track, especially in the medical device space where documentation and compliance are so important. Even though I haven’t been directly involved in one yet, I’ve learned that solid preparation…   Read more»

You make a great point about how important those early estimates are when it comes to using SV and CV effectively. I haven’t used these metrics myself yet, but it makes sense that if the original plan is off, like…   Read more»

I agree with the previous posts that sometimes project delays and exceeding the budget is not always expected or at the fault of any team member. Rather, I would prefer delays and going over the budget over poor quality and…   Read more»

When it comes to project management, communication skills are a must. This helps the project manager facilitate collaboration, prevent conflicts, define goals & expectations, and allows for decision-making in the project to occur. Communication within a project is what allows…   Read more»

I haven’t had any hands-on experience with EVM yet, but from what I’ve learned, it’s a valuable project management approach. One of EVM’s biggest strengths is how it combines scope, cost, and schedule into one system, making it easier to…   Read more»

Lessons learned can also be used to include things discovered during experimentation that can be improved or modified to achieve better or different results. These can lead way to interesting ideas that can be a whole project to study itself….   Read more»

These cases highlight the importance of keeping up-to-date with newer regulations. As more research is done, certain things are found to be harmful or dangerous. The FDA is always updating their policies. Additionally, many small changes to a device after…   Read more»

As you mentioned, EVM is a good tool for identifying if a project is behind schedule by using EV and PV. One additional benefit of EVM is its ability to detect scope creep before it happens. Projects that have requirements…   Read more»

I think this is a great point. For bigger projects that have a larger impact or cover something new (new line of medical devices for the company or international product), it is very important to document risks and lessons learned…   Read more»

Budgets can be high with animal experiments. This has to do with how time and labor intensive the studies are, resources needed for animal care, long-term nature of the studies (if applicable), material and equipment costs, and compliance with regulations….   Read more»

Sending multiple samples to be tested will help in managing variability, but the optimal method would be testing multiple random samples from different batches. This will ensure that the concerns such as process variables and formulation consistency are being dealt…   Read more»

I really appreciate how this discussion emphasizes the importance of long-term responsibility in medical device management. One thing that stands out to me is how quickly science, society, and patient expectations change. What worked well a few years ago might…   Read more»

I believe that finding a balance between these two alternatives is dependent on understanding the roles of different team members within a project and the complexity of the information being communicated. Different team members have different roles, and a way…   Read more»

There’s a lot of great insight here, especially around how SV and CV can be distorted in the complex and evolving landscape of medical device development. One thing that’s helped in projects I’ve been part of is blending traditional Earned…   Read more»

These are all great insights, and I agree that preparation sets the stage for a smooth and productive design review. One thing that I think also helps a lot in building a regulatory readiness checklist that mirrors specific requirements, like…   Read more»

Rather than using negative reinforcement, it might be better to reward excellent behavior. This would prevent team members from becoming hesitant of helping others with their work or resort to a “he said, she said” situation. Projects are team efforts…   Read more»

Capturing lessons learned by using a slideshow presentation or using software like sharepoint is a good idea, but making these efforts to capture the project lessons without working off of them could defeat the purpose of doing so in the…   Read more»

I can definitely relate to having my definition of a stakeholder changed. What changed for me the most was that a stakeholder technically does not even have to be a person. I always thought of a stakeholder as a single…   Read more»

The main key aspects of the preparation for a design review were covered previously, however one critical step for preparation is engaging with stakeholders prior to the design review meetings. Stakeholders can provide valuable insights that may have been overlooked…   Read more»