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.