Risk mitigation and continuous improvement are critical components of effective project management, particularly in medical device development, where failures can have regulatory and safety implications. Conducting a Failure Modes and Effects Analysis (FMEA) early in the design phase allows teams…   Read more»

Label adhesion failure during water submersion testing presents a multifaceted challenge that requires a structured root cause analysis before considering design modifications. A key factor to investigate is the material compatibility—is the label adhesive specifically formulated for prolonged water exposure,…   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»

@sn64 Hi sn64! I recently learned about a tool used at work to facilitate analysis regarding regulatory classification. The company one of my professors work for uses an AI-powered regulatory decision matrix for this process. The tool streamlines analysis by…   Read more»

@amm7 I agree that finding the right balance between tight and loos specification is very important however I would also like to note that beyond functionality is the impact on long term performance and regulatory compliance. What do I mean…   Read more»

@archishak Hi there! While project management skills can be beneficial in many fields, I would actually argue against your post that a deep understanding of project management is not always necessary to contribute effectively to a project’s success. Many professionals…   Read more»

Applying lessons from verification failures to strengthen future strategies involves a systematic approach to risk management and continuous improvement. Conducting a Failure Modes and Effects Analysis (FMEA) early in the design phase helps identify and prioritize potential risks, allowing teams…   Read more»

To navigate stakeholder expectations while staying within the project’s defined scope, project teams can employ several strategies. First, clear and consistent communication is essential to keep stakeholders informed about progress and any potential issues. Regular updates and meetings can help…   Read more»

Verification failures, like label adhesion issues during water submersion testing, highlight the need for a structured problem-solving approach. Conducting a root cause analysis using methods like the 5 Whys or Fishbone Diagram can help identify whether the problem lies in…   Read more»

During verification testing, it is quite common to encounter unanticipated issues (like adhesive failure in water) that drive budget increases for additional experiments. One way to mitigate this is to incorporate contingency funds into the initial project budget. For example,…   Read more»

I believe the differences between project managers and program managers extend into both technical focus and soft skills. Project managers concentrate on the detailed execution of individual projects (managing schedules, budgets, risks, and quality control through hands-on use of tools…   Read more»

When determining the correct product code and regulation number, I think it’s important to develop a detailed comparison. This tool helps align your device’s key attributes (such as intended use, material composition, and technological features) with those of potential predicate…   Read more»

A Design History File (DHF) is essential for regulatory compliance, but a massive part of good project management as well. Any issues with regulatory boards will have drastic implications for the company in question. One of the best ways I…   Read more»

I believe the best way to handle Design Change Requests is to plan for them in the first place. Obviously no one wants to plan for something to go wrong, but good project management will always plan for setbacks and…   Read more»

In my personal experience, I had to jump into a role working with a team in a functional organization, not yet knowing how organizations worked and the meaning of the tasks I was doing. Know that I know how projects…   Read more»