The Institute of Medicine commissioned my 2011 report on the role of trustworthy software in the context of U.S. medical device regulation. This talk will provide a glimpse into the risks, benefits, and regulatory issues for innovation of trustworthy medical device software. Today, it would be difficult to find medical device technology that does not critically depend on computer software. The technology enables patients to lead more normal and healthy lives. However, medical devices that rely on software (e.g., drug infusion pumps, linear accelerators) continue to injure or kill patients in preventable ways -- despite the lessons learned from the tragic radiation incidents of the Therac-25 era. The lack of trustworthy medical device software leads to shortfalls in properties such as safety, effectiveness, dependability, reliability, usability, security, and privacy.