1. Current & Future States of Medical Device Systems PastPresentFuture Medical Device Systems Paul L. Jones Senior Systems/Software Engineer Office of Science and Engineering Laboratories pxj@cdrh.fda.gov

2. Medical Device Systems Discrete Systems Discrete Hybrid Systems Discrete Integrated Hybrid Systems Networked Hybrid Systems Distributed Hybrid Systems Pervasive Hybrid Systems PastPresentFuture

3. Past State Discrete system properties Analog / digital based Proprietary hardware / software Relatively simple design Relatively long life span Competent human intervention

4. Present State Discrete hybrid system properties COTS hardware / software Design complexity increasing Life spans shrinking Competent human intervention e.g. Imaging systems

5. Present State Discrete integrated hybrid system properties Accessory to a device Proprietary interfaces Human in the loop e.g. Imaging/TPS/Linac systems

6. Future State Networked hybrid system properties Networked device systems Standardized interfaces Closed loop systems Centralized e.g. HIS and PnP

7. Future State Distributed hybrid system properties Distributed resources Decentralized e.g. Telemedicine, Remote Surgery

8. Future State Pervasive hybrid system properties Autonomous Omni-present Biomedical e.g. Star Trek

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