I have more than 30 years of experience in the manufacturing field with a focus on medical product development including equipment design and process development. I have spent the last 4 years working as a consultant doing both medical device product design as well as designing automated assembly and test equipment. For the medical device design, a major portion of the work involved identifying and qualifying manufacturing partners that would be used and then implementing manufacturing procedures and processes as required. I would work with the vendors to identify cost effective plans for startup manufacturing and develop prototypes that allowed us to verify design intent as well as test and verify production methods and procedures. I also worked with the vendors to establish a longer term ramp plan as quantities to be produced increase. My consulting work also included designing and building several pieces of semi-automated assembly and test equipment for use in clean rooms by medical device manufacturers.