Missing a milestone is seen often as a setback, but it can also serve as an important indicator that the project timeline did not accurately reflect the work that was listed for a given project. I have noticed in my…   Read more»

@devdesai Hi there! You made a great point about how it is important to incorporate slack into a project’s timeline. Slack helps account for expected delays like vacation and unexpected issues that might arise. Having extra time as a buffer…   Read more»

Hi everyone! My name is Tiffany Magno, and I am pursuing both my BS and MS in BME at NJIT. A fun fact about me is I am also in the military!  Tiffany Magno | LinkedIn I look forward to…   Read more»

An organization’s culture and available resources significantly influence project execution by shaping how efficiently and effectively a project can be managed. For instance, a culture that embraces agility and innovation can expedite decision-making and foster a collaborative environment, leading to…   Read more»

Balancing rigorous design controls with the flexibility required for innovation is crucial in regulated industries like medical devices. Strict design controls, while adding complexity, ensure accountability and product safety by requiring thorough documentation and formal review meetings. However, they can…   Read more»

Balancing risk versus reward in medical device development is indeed a critical challenge. While adhering to ISO 14971 guidelines ensures systematic risk management, it’s essential to strike a balance between minimizing risks and maintaining development speed. Prioritizing early-stage risk assessments…   Read more»

Stakeholders’ engagement is needed to contribute to project success and customer satisfaction from the start to the end of the project; it helps to enable success in each phase. The design Development Plan (DDP) lays out the project proposal and…   Read more»

Slack is an essential component of project planning because it allows for flexibility when unexpected delays occur. It helps ensure the project still finishes on time even if unexpected issues come up. Once the project exceeds its slack time, the…   Read more»

I agree with @gdecarvalho22 above that the FDA indirectly approves the tests as long as the final design and design process shows to comply with FDA standards. If the test parameters are not within what the company claims for either…   Read more»

A WBS not only breaks down the total scope of work into manageable tasks but also offers flexibility and adaptability in project planning. By decomposing the project into work packages, it becomes easier to identify dependencies and potential risks at…   Read more»

Scope management, time, and cost management are deeply interconnected, especially in complex projects like medical device development. When scope changes, it forces a reevaluation of the timeline and budget. One effective approach is using tools like Earned Value Management (EVM)…   Read more»

In the initiation phase of medical device project management, key inputs such as the Project Charter, feasibility studies, regulatory landscape assessments, and stakeholder analyses are critical. The Project Charter formally defines the project’s purpose, high-level objectives, and authorizes the commitment…   Read more»

Hypothetically, if the bottles are meant to be stored in 37C due to its contents, then we can’t change the testing parameters. The bottles’ labels must be able to stay adhered to the bottle at 37C. In this case, we’d…   Read more»

One thing to consider with the testing of worst-case scenarios is the resources that get used within this verification process. Worst-case scenarios can involve a multitude of possibilities without specification, and in turn need a large amount of equipment and…   Read more»

The FDA should have some indirect impact on verification and validation tests. Ideally, these would be guidelines for companies should follow, but should not be strict standards. Regulatory requirements already have a strong impact on medical devices, especially smaller startups…   Read more»

When Verification tests fail, I think that the best approach is to first evaluate whether the model still fills the need of the customer. The testing parameters could’ve been set incorrectly because they excluded a large amount of customers. In…   Read more»