The estimation methods you presented provide a fixed schedule of expected task durations. Another approach that should be considered is dynamic scheduling through real-time data integration. By considering ongoing performance data using project tracking tools, scheduling can be continuously updated…   Read more»

One thing to consider with medical devices is that they don’t all carry the same level of risks, hence the classification. Implementing different risk-adaptive techniques for different classifications can speed up the process for Class I medical devices, as they…   Read more»

Some responses already mention ways to increase innovation during a project by using software to communicate throughout the project team effectively or having a change in project structure. Another important factor that can affect the project is the psychological state…   Read more»

Hello everyone! My name is Bryan Xavier, and I’m an undergraduate at NJIT pursuing a BS and MS at NJIT. I can’t wait to connect with everyone! Connect with me here:http://www.linkedin.com/in/bryan-xavier-a680b429a

@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»

@pd493 To add upon your bringing up focusing on high-risk areas, rather than just focusing on one area at a time, they can split up the product in parts. Parts of the product that require strict guidelines can be focused…   Read more»

All the methods listed in this forum are great ways to have flexibility on a DDP, however implementing risk strategies, such as a Risk Register. In a Risk Register, you can lay out all potential project risks from multiple team…   Read more»

Other than updating the DHF as the project progresses, implementing a traceability matrix is another strategy to ensure that the DHF remains well-organized. A traceability matrix visual shows a clear connection between inputs, outputs, verification, and validation. That way during…   Read more»

Some responses already demonstrate how extensively a product that must meet Class III requirements can deter big companies from pursuing new medical treatment methods. However, the FDA does have a program called the “Breakthrough Devices Program,” which was created in…   Read more»

A mix of both would probably be the most advantageous for medical device companies. You would get the best of both worlds: on the one hand, an internal team with an intricate understanding of the product and its development that…   Read more»

Everyone has mentioned that early involvement with the FDA is important to ensure there are no conflicts and delays when approving the distribution of a product. It’s also important for companies to ensure that they get their working product to…   Read more»

As mentioned in this forum already, project managers have to perform risk management preparing them for cases such as this. Besides diversifying their suppliers, project managers can also have a main supplier that they meet with regularly and discuss any issues…   Read more»

@sn64 The length of the project should also be considered, no? If a project’s lifetime is from a week to a few months, there probably wouldn’t be any time to implement the technology anyway, depending on its simplicity. The same…   Read more»