Project manager faces many challenges in medical device industry compared to project manager involved in construction of a school or skyscraper. Project manager in medical device industry faces increased clinical and regulatory standards that are being FDA regulated. Project manager will have to keep up with FDA in regards to more clinical data and longer process time for 510K (PMA or IDE) approval. This results into higher expense to support R&D and clinical data. Project manager will also have to plan for the cost of innovation. Another challenge that we see in medical device industry is being innovative with the goal of saving life. Medical device has to constantly keep up with the upcoming opportunities and technology to evolve and continually help saving lives. Project manager involved in construction will have to plan and manage contractors, schedule, budget and risk but they don’t have to keep up with FDA regulations or innovation.