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

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

3. Center for Devices and Radiological Health 3 The Injector: Protons are stripped out of the nucleus of hydrogen atoms and sent to the accelerator. Synchrotron: (Accelerator) A ring of magnets, 20 ft. in diameter, through which protons circulate in a vacuum tube. 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. 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. Steel-reinforced concrete walls are up to 15 feet thick. Digital Thermometer Proton Beam Therapy System

4. Center for Devices and Radiological Health 4 Medical Device Systems  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) PastPresentFuture

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

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

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

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

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

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