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»

It seems as the punishment for missed milestones or a failed project is that the project failed. This can result, as aforementioned, a decrease in bonuses or additional compensation. Also, it is a burden mentally to carry the blame for…   Read more»

The best methods to store information about lessons learned at the end of the project is through a method by which all team members can contribute to their experiences. This can be in the form of a slideshow presentation that…   Read more»

To expand on the points above, I would like to add that decision-making in these high-pressure moments can benefit from a multi-criteria decision analysis (MCDA) approach. MCDA allows teams to compare multiple options by assigning weighted values to different criteria…   Read more»

I personally believe that the planning phase is the most important phase of project management. I believe so because poor planning can doom a project from the start. Without thorough planning, a project will run into too many walls and…   Read more»

In my experience, the best ways to document and share “lessons learned” or other important announcements is through a tool like Microsoft Sharepoint. Sharepoint is a very useful tool that many organizations use to store useful documentation and have it…   Read more»

To ensure a design review meeting is efficient and productive, preparation is key. In my opinion, following a structured guideline both prior to and during the meeting can help to ensure that all required documents and approvals are ready in…   Read more»

I agree that closing a project without evaluating the lessons learned is a significant loss of opportunity. Documenting lessons learned is only valuable if the insights gained are accessible and embedded into future workflows. Finding the best format or platform…   Read more»

I think the Monitoring and Controlling Phase is a significant aspect of any medical device project as it guarantees quality, safety, and compliance with regulations throughout. For highly regulated fields such as healthcare, even small deviations can result in severe…   Read more»