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msc52njit-edu replied to the topic Medical Devices in the forum Project Management Process and Medical Device Development 7 years, 4 months ago
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.