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»

In my experience, ensuring product quality starts well before a device or test reaches the market—QA isn’t just about final products but also about refining processes during the R&D phase. Our work employs multiple strategies to ensure that preprocessed samples…   Read more»

In my experience, the best way to communicate really depends on the size and nature of the team. I worked on a small project with just two or three other people, all of us being technical professionals or scientists. We…   Read more»

An important factor to consider which is equally important as pre-market approval is post-market surveillance of medical devices. A rigorous and well-made pre-market portion of a medical device project is essential for the approval and success of the device. An…   Read more»

In order for project managers to strike the right balance between keeping stakeholders informed and avoiding overwhelming them, there are many strategies that can be employed. Customizing the information flow between stakeholders is a great start. Project managers can segment…   Read more»

Balancing innovation with regulatory compliance requires a proactive approach that integrates compliance into each stage of product development. By not addressing it early, companies set themselves up for delays, regulatory setbacks, and high costs. Implementing a Regulatory Affairs and Quality…   Read more»

Balancing effective communication and productive work time is very important in project management. Instead of looking at meetings and emails as opposing forces, I think project managers can implement tiered communication strategies. These would be based on different factors such…   Read more»

Both email and Teams come with their advantages and disadvantages. Also, they are not direct substitutes for one another since they are completely different tools for different purposes. On Microsoft Outlook, there are amazing methods in organizing one’s inbox and…   Read more»

As the original post mentions, email can be an effective method for communicating without setting up time consuming meetings. This type of discernment is needed by the project manager in order to maximize working time, while at the same time…   Read more»

I think a great approach to fix the potential problems from each extreme side is to incorporate two ways of communicating informational updates. For information that does not require questions and in depth talks, it can just be put into…   Read more»

Validation is crucial in assessing test results. In a fast-paced world where immediate answers are required, there is a temptation to prioritize technological innovation to deliver rapid results, often bypassing essential protocols for quality control, verification, and validation. I work…   Read more»

The work breakdown structure (WBS) should be developed alongside scope verification. Together, these two processes enhance the effectiveness of delivering inputs and outputs before moving on to quality assurance. In creating a work breakdown structure, the scope statement serves as…   Read more»

There are many effective strategies present in fostering team development during execution. Establishing team culture can help in team development. Team culture is a set of shared attitudes, values, goals, and practices that characterizes an institution or organization. Company culture…   Read more»

Beforehand, in a project team, there will be interdependence in the different phases of the project, during which, in its development, there will be dynamic circumstances. Hence, one strategy is to establish at the beginning of the project roles and…   Read more»

Planning is indeed a critical phase in project management, and I appreciate the insights shared regarding structured techniques like work breakdown structures (WBS), risk assessments, and iterative planning approaches. In both academic and industry settings, the balance between detailed upfront…   Read more»

Patient-reported outcome measures (PROMs) can significantly enhance QA by providing real-world insights into device performance and usability. Digital platforms, such as EHR integrations and mobile applications, streamline PROM data collection, allowing patients to report issues in real time. These tools…   Read more»

As mentioned above, collaborations between companies become necessary when one company lacks money, resources, time, or experience to complete a project on its own. What hasn’t been mentioned, however, is how this decision is almost purely a financial one. To…   Read more»