One approach that some projects use to manage scope creep and task delays is the Event Chain Methodology or ECM. ECM identifies potential event chains that can kickstart due to unexpected events and c...

Instead of having one fixed critical path over the entire project, breaking the work into smaller pieces and having multiple critical paths for each phase allows for some leeway to reassess the next c...

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 consid...

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...

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 im...

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: www.linkedin.com/in/bryan-xavier-a6...

@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 such ...

@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 t...

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 e...

@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 guide...

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 proje...

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 ...

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 pro...

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 prod...

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 e...