With all of these I think it depends on the severity of the deviation the failure causes to the original scope of the project. Sometimes losing a vendor or a new regulation might not have a available alternative or work around and the project cannot proceed or must make drastic or time and money consuming changes to continue. In cases where there are alternative solutions like failures with vendors, a company should have backup vendors in mind. Perhaps their first choice was merely the most cost effective and the project can continue using the second best deal. New regulations must be examined for their effect on the project and if the change is minor can most likely be worked into the project without detrimental amounts of delay.

As cs22 had mentioned, the response to a failure depends on the severity of the problem. Throughout the project it is important to meet the requirements that were laid out in the beginning. If failures occur with experiments and with vendors, the reasons why the results were not as expected need to be determined. If a resolution with the vendor cannot be found, then you should look into using other vendors. Regulations must be complied with and customer demands must be met, otherwise you will have no product to sell.

Once the strategic plan is together, there are two critical elements related to project management. One is to identify the projects that are required to ensure success in the execution of each strategy. Another is to develop a prioritization of all these projects to ensure the high priority ones have the proper resourcing to ensure success. This requires a high involvement and commitment on the part of employees to spend the time required on the projects.
The high level of involvement of employees ensures that they understand the strategic plan. It increases their level of commitment to ensure the strategy is successfully executed because they understand how their work and the work they’re completing on the project helps the organization to realize some or all of one of their key strategies.

I think each situation has different repercussions. Failing of experiments is something that should be accounted for during planning. Excessive failure of experiments may show that the project is not as feasible as was thought and should be terminated. I think the other situations listed are slightly less predictable. We saw a similar situation in the MiniSim. A plan was created and deadlines were put in place, however the regulations for what the experiments called for were not properly taken into account. As important as it is to create realistic deadlines and enforce those deadlines, it is equally important to understand that unseen events will be sure to alter those deadlines to some degree.

Failures in medical devices can lead to catastrophic situations. Therefore is it crucial to handle the device related risks when developing medical devices. Focusing on the two steps of the risk management process, i.e. risk identification and risk analysis are crucial. Challenging problems have been found in the risk management process with respect to the definition of the system boundary and system context, the use of scenarios as input to the risk identification and estimation of detectability used during risk assessment.

With failures in projects, it should be kept in mind that they will happen. We need to proceed without panicking and try to overcome the failures. In projects, they are always a setback in deadlines but that is why in the planning phase, we always have a few days extra in case of anything goes wrong. When we have failures in medical devices, it will be referred to the risk analysis that was done previously.

When executing a project, it is important to plan for set backs and failures. This is why the execution phase should be planned out thoroughly to give the group an allotted time to repair errors and compensate for setbacks. The best way to handle situations like these is remain completely calm but remember to work diligently.

There are usually CAPA that are open to address these failures that are managed by the department head and the quality system. If there are failures with regulatory there is not must that can be done except to deal with the consequences per the FDA or which ever regulatory branch that is associated with your device. However, with proper project management the issue should not be failure in the project but rather the standards not being met. Having a close relationship with quality and regulatory it should be possible to stay in compliance and meet the requirement to prevent failures.

In the execution phase when dealing with failure in the experimental phase, the first thing to do is to rerun the experiment but have different individuals perform different tasks to make sure that the tasks are initially completed correctly. Then you can assess and go back to develop a knew experimental plan based on the teams feedback. If the experiment fails it must be dealt with so that your team can provide valuable and reliable data that can be used to prove safety, efficacy, and positive results in animal models so that it can pass the FDA regulations. Failing with vendors is more of a marketing problem, but it is important to keep build close relations and keep close relations with your vendors. If this fails you need to branch to other companies, that do not need to be necessarily close and you must look are regions where your product has high market demand, and what companies are looking to take on new business ventures. New regulations must be meet and the team must address these for the project to work, so this is of significant importance. With customer demands it is important to take surveys and follow up with your customers consistently so as to keep important feedback and allocate a team to deal with the feedback and filter through the useless information.

I think that when it comes to failing with the vendor its important to ask why. Was the product not what they expected, and subsequently lost of interest? Or was the vendor disappointed entirely and pulled its funds. Losing a vendor is tricky if you are relying on it to stay afloat. Finding a new one can be challenging where as losing one of many is not as detrimental to your progress.
Failing regulations is a bit different. I want to say it hold the fate of your product. You need to consider why it failed. If it easily fixed then great, crisis avoided, but if it sets you back then it would be wise to have a back up plan for what to do.
This is why the execution phase is so important, as my colleagues have suggested.

Manufacturing, Designing a Medical device is a complex process and there are many factors to be considered. There would be cases where few things won't go as per plan, I think for each failure there should be different plans to tackle different phases.Failing with experiments is normal and more time should be allocated to that phase so that we are on track with the pace of the project. Failure with vendors I think would be not getting the desired material for a certain part or not getting the part on time so delay in the process in return, for this I feel the track record of the vendor should be seen and if it is not satisfactory we should be on a lookout for different vendor as backup. Regulation failure is something that should be well planned, if there is a failure then we should see why the failure has occurred and come up with more relevant data for approval. Customer demands are never-ending and should be taken and try to implement whatever is possible in the next version of the device.

In the medical field, one should expect that there will always be success and failure. It is the competitive field dealing with human beings and finding a solution to peoples problems. Therefore, it is important that one should always have a backup or plan B regarding the project When executing a project. This is why the execution phase should be planned in detailed thoroughly to give the team an allotted time to manage their position when the project fails.

Failures can occur within the biomedical field through research, development, selling, distributing, and marketing. However, when executing a project, if a failure occurs during research, the team members and PM should evaluate this problem and plan to execute a new plan for the research. Evaluation should be the main key for each problem. Failures with vendors can be for multiple reasons such as problems with stakeholders, money or communication. Vendors should be supportive of the device that is being developed and working together towards the benefits of both parties involved. When dealing with regulation issues this must be reapproved, and there must be documents resubmitted with updated changes fixing the previous problems/issues. With customer demands, businesses should allow for feedback. This allows for them to communicate with there customers and understand the issues that they are having and fixing the failed problems that are occurring. It also allows them to reach out to customers for more ideas, and insight for future projects, or devices being created.