Organizations can balance control and flexibility by implementing a structured yet adaptive change management process. This involves clear criteria for categorizing changes based on risk and impact, ensuring that low-risk modifications undergo a streamlined approval process while high-impact changes receive…   Read more»

Though both are types of verification, scope and design controls verification are quite different. They take place in different project phases and address different things. Scope verification ensures that the project’s defined deliverables meet stakeholder expectations and requirements, confirming formal…   Read more»

In order to ensure that past project insights lead to real improvements, it is important to continuously track and categorize lessons learned. Tracking this throughout a project rather than leaving it until the very end would reduce the chance that…   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»

I think an important motivator for team success is the satisfaction of reaching goals along the way. Thus, a good method for team development during execution is actually done during the planning phase. The project could be set up as…   Read more»

I think it is very important to find the balance between providing enough information to keep stakeholders informed without overwhelming them with excessive updates. To do so, I agree that summarizing updates could be effective. To expand on this point,…   Read more»

During the initiation phase of medical device project management, key inputs include the Project Charter, feasibility data, market analysis, regulatory requirements, and stakeholder expectations. These inputs help define the Project Proposal, Scope Statement, and high-level risk assessment, which guide the…   Read more»

I agree with some of the previous entries that Microsoft Teams can be more efficient than email chains for shorter communication that does not have to be documented. More official, documented messaging across a larger group of people is likely…   Read more»

I think this is a great point because the biomedical industry is highly cross-functional as you’ve mentioned. To ensure alignment among stakeholders in a partnership, project managers need to establish clear communication channels, set shared milestones, and create cross-functional teams….   Read more»

Having slack in a project schedule is quite important to ensure that projects have built-in time for unexpected delays without derailing the entire schedule. I think that consulting the experts is the most important method to ensure that the project…   Read more»

I agree that schedule risks are often the most prevalent and common in medical device projects, but financial risks are the most devastating. As stated earlier, financial risks are very serious and, if things go wrong, could lead to the…   Read more»

I agree that a good strategy for accurate cost estimation of a medical device project is to compare to the cost of a similar past project. However, that information may not be available if the project is very novel or…   Read more»

Many of the past responses include questions like what, when, and where. I think these are important questions to ask, and I’d like to add questions about conditions, reproducibility, and the overall effect. At the start of a root cause…   Read more»

Finding a middle-ground to balance innovation and patient safety in medical device development requires a structured yet flexible risk management approach. One of the most effective strategies is using a risk-based framework to ensure that potential hazards are systematically identified,…   Read more»

Effective risk management in medical device development requires balancing safety, efficiency, and cost. While minimizing risk is essential (especially under ISO 14971 guidelines), overly cautious approaches can delay innovation and inflate costs. It is important to prioritize early-stage risk assessments…   Read more»

I agree that real-time monitoring is the best way an organization can create a culture that embraces the PDCA cycle. As mentioned, regularly scheduled team meeting should incorporate PDCA and a tracking system should be employed to ensure continuous improvement…   Read more»

I agree that it is unwise to jump to design modifications without performing additional tests. It is necessary to pin point where the problem is before trying to solve it. I agree with the above idea that the ethanol wipe…   Read more»

I think it could be necessary to vary testing parameters within regulatory guidelines to come to a favorable outcome after failure. Though it may be difficult to change test parameters if they have already been set and approved, it may…   Read more»

I agree with the above, well-defined roles are crucial to the long-term success of a project team. It is best to allow group members to define their roles themselves if possible so they are personally responsible for their own work…   Read more»

I agree with what has been said above, that determining specs is an extremely important and delicate part of the design process. The specs must be tight enough so that the product can provide its intended function and also loose…   Read more»