Keeping all these details in mind, I think a balance of both perspectives can be valid depending on the product and the function of that product. Mimicking worst case scenarios helps combat Murphy’s law as much as possible. It is…   Read more»

A key way to strengthen verification strategies after a failure is to establish a structured feedback loop where testing outcomes directly inform future design and risk management processes. When a failure occurs, such as a label detaching during water submersion,…   Read more»

Keeping the Design Input Document (DID) and Design Specification Document (DSD) separate helps ensure a smooth development process by allowing flexibility and better organization. The DID acts as a foundation, outlining what the product needs to achieve, such as a…   Read more»

A key strategy for managing stakeholder expectations while staying within the project’s scope is to establish clear project boundaries from the beginning. When verification failures occur, it’s crucial to assess whether the issue can be resolved within the existing scope…   Read more»

I don’t believe it is wrong to state that there should always be a leader in the group. As life, and many novels and stories will tell us, groups tend to fall apart if there is no leader. Having a…   Read more»

Based on my experience in the biomedical industry so far, every change in the product should be traceable. Even in basic or routine analysis or documentation, traceability and having a path to demonstrate how a change occurred is necessary. It…   Read more»

While I understand the viewpoint that budget changes should be expected in a project plan, if the DSD is well specified, large shifts should not be highly expected. Shifts in budget usually occur for products that unexpectedly fail testing and…   Read more»

Risk assessment and scenario planning could also serve as additional tools for stakeholder alignment. When verification failures occur, project teams can proactively manage stakeholder expectations by conducting impact assessments. These would evaluate the cost, risk, and timeline changes related to…   Read more»

Great points! I also think that a hybrid approach could be a strong alternative that could maintain the clarity of separate documents while still improving efficiency. Instead of two entirely different documents, companies could use a linked document system where…   Read more»

Below are the reasons or purpose not to combine two documents ( DID and DSD ) to make a single document.  1)Progressive Detailing: The DID serves as a high-level foundation, capturing user needs, regulatory requirements, and functional expectations. The DSD…   Read more»

@amm7 To add on to your potential test, it may be better to test if the label does better on a flat surface or a curved surface. If the testing is done on a curved surface, it may cause problems…   Read more»

@ms3548 Adding to your point, its important to have the project teams and stakeholder have multiple ways to determine how to stay in scope with the project. Stuff like a simple cost-benefit analysis to decide whether a feature should be…   Read more»

One thing that may help when considering changing test parameters or even mitigating failures can be consulting experts in fields that deal with the potential failure that are trying to avoided. For example, with the case of label adhesion failure…   Read more»

Yes, before recommending design modifications, additional testing should be performed to validate the root cause of the verification failure. This helps ensure that any design changes are based on data rather than assumptions. Recommended Steps: Conduct Root Cause Analysis Use…   Read more»

I think having a basic understanding of project management is valuable, even if someone isn’t planning to pursue it as a career. In industries like medical devices, where projects are highly regulated and involve multiple teams, knowing how project management…   Read more»

When dealing with verification failures in a project, I always find that a structured problem-solving approach is the best way forward. In the case of label adhesion failure during water submersion testing, the first step should be a thorough root…   Read more»

f we’re running verification tests to check the specs, inputs, and outputs from the DSD, the probability of needing a budget change depends largely on how well the initial planning and risk assessment were conducted. Thorough upfront validation can reduce…   Read more»

I consider that the most complex aspect of managing a project for a medical device is the interplay between challenges in compliance and technology. These two factors tend to reinforce and aggravate each other, presenting major problems for project managers….   Read more»