U S Department of Health and Human Services

U. S. Department of Health and Human Services Center for Devices and Radiological Health Component Composition Medical Device Regulatory Challenges Paul L. Jones Senior Systems/Software Engineer Division of Electrical and Software Engineering Office of Science and Engineering Laboratories Dec 3, 2007

Medical Devices Containing Software Center for Devices and Radiological Health Application specific calculator U. S. Blood Bank System 2

Digital Thermometer Center for Devices and Radiological Health Proton Beam Therapy System The Gantries: Resembling giant ferris wheels can rotate around the patient and direct the proton beam to a precise point. Each gantry weights about 90 tons and stands 3 stories tall. It supports the bending and focusing magnets to direct the beam. The Injector: Protons are stripped out of the nucleus of hydrogen atoms and sent to the accelerator. 3 Synchrotron: (Accelerator) A ring of magnets, 20 ft. in diameter, through which protons circulate in a vacuum tube. Steel-reinforced concrete walls are up to 15 feet thick. Beam Transport System: Carries the beam from the accelerator to one of four treatment rooms. This system consists of several bending and focusing magnets which guide the beam around corners and focus it to the desired location.

Medical Device Systems Past t t t Present Center for Devices and Radiological Health Future Discrete Systems Discrete Hybrid* Systems Discrete Integrated Hybrid Systems Networked Hybrid Systems Distributed Hybrid Systems Pervasive Hybrid Systems *Hybrid – something of mixed origin or combination (AHD) 4

Past State Discrete system properties t Analog / digital based t Proprietary hardware / software t Relatively simple design t Relatively long product life span t Competent human intervention 5 Center for Devices and Radiological Health

Present State Center for Devices and Radiological Health Discrete hybrid system properties t COTS / SOUP hardware / software t Design complexity increasing t Product life spans shrinking t Competent human intervention (main RCM) e. g. Imaging systems 6

Present State Center for Devices and Radiological Health Discrete integrated hybrid system properties t Accessory to a device t Proprietary interfaces t Human becoming part of the loop t Competent human intervention (main RCM) e. g. Imaging used by TPS used by Linac systems 7

Future State Networked hybrid system properties t Networked device systems t Standardized interfaces t Closed loop systems t Centralized e. g. HIS and Pn. P 8 Center for Devices and Radiological Health

Future State Distributed hybrid system properties t Distributed resources t Decentralized e. g. Telemedicine, Remote Surgery 9 Center for Devices and Radiological Health

Future State Pervasive hybrid system properties t Autonomous t Omni-present t Biomedical e. g. Star Trek 10 Center for Devices and Radiological Health