Abstract
This paper discusses foundation for component-based design and integration, development and quality assurance, and certification of medical devices and systems. In addition to medical devices used in hospitals and clinics by professionals, we also need to be concerned with assistive devices, which are used by naïve users in and out of homes. Examples include medicine dispensers that can help to ensure correctness and enforce compliance of medication schedules, and monitors that can record and process vital-sign signals, detect irregularities, and send notifications. The division between assistive and medical devices is often blurry and future medical care and health delivery system will contain both. The paper first discusses needed information technologies (IT) and sciences for each of the topics listed above. The roadmap at end of the paper suggests a plan to acquire them.