@cs22 I fully agree with you—jeopardizing the integrity of experimental data can lead to much graver outcomes than merely delaying a project. I noticed that if inadequate experimentation results in unnoticed design defects, the problem might not emerge until significantly…   Read more»

@sa2847 In root cause analysis (RCA), defining the issue, setting timeframes, and identifying locations are crucial, but I believe that this method is sometimes overly strict and fails to encompass the full depth of an effective RCA. In my experience…   Read more»

Apart from quality assurance we need quality Control (QC) in medical device development. It focuses on identifying defects in the final products or during production to ensure that only high-quality products are released to the market. These processes involve inspecting…   Read more»

Collaborations, like the one between BoneFix and FactoSet, are beneficial when a company lacks the resources or expertise to develop a product independently, or when partnering can speed up development and reduce costs. These agreements typically involve detailed negotiations to…   Read more»

Improving QA processes in the medical device industry requires a multifaceted approach that includes rigorous pre-market testing, comprehensive post-market surveillance, and a culture of continuous improvement. One effective strategy is to implement robust post-market surveillance systems that actively monitor device…   Read more»

In the context of business collaborations like the one between BoneFix and FactoSet, companies often choose to collaborate when they lack the necessary capabilities or resources to develop a product independently, or when partnering can accelerate product development and reduce…   Read more»

Maintaining detailed project documentation is critical to ensuring a smooth execution phase. A well-organized log of risks, actions, issues, and decisions (RAID log) helps project managers track key aspects that can impact project success. One challenge many teams face is…   Read more»

Altering or omitting sequence activities can lead to significant project risks, including scope creep and timeline disruptions. If tasks are not performed in the correct order, dependencies may be overlooked, causing rework, inefficiencies, or even project failure. One example is…   Read more»

The project initiation phase is crucial in setting the foundation for success, but it also presents several challenges. One major challenge is securing stakeholder alignment because of differing priorities or unclear expectations, which can lead to miscommunication and scope disagreements….   Read more»

Strategic and business management are very important skills because they help project managers ensure their projects are aligned with the greater goals of the company. It’s not just about getting work done on time, but making sure the project is bringing value to the company. Additionally, it helps project managers understand the market and make…[Read more]

I do not have much industry experience either in addressing project planning, however in what projects I have seen and participated in there have been common factors. Before the initiation of any work such as data gathering, a key detail…   Read more»

I definitely believe that Task scheduling plays a very important role in almost every important in any sort of project, whether small or big, which includes balancing the scope, time, and resources of the project.  Prioritization of tasks according to their dependency and risk potential is also one approach that could…   Read more»

This is an amazing definition of the concept of project initiation. Keeping in mind all the objectives of project initiation, I’m curious about what complications can arise within the medical device industry. A business case typically includes a summary of…   Read more»

In my opinion, Microsoft Teams simplifies sending direct messages, group chats, and file sharing via one interface.  For day-to-day communication, Teams is what I would prefer because it is faster and more convenient for quick questions or team chat, and also it reduces the clutter in my email inbox by handling most informal communication….   [Read more]