Morphing Mobile Platforms Into Medical Devices Dhurjaty
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This document discusses how mobile platforms can be morphed into medical devices. It provides a brief history of how consumer electronics components evolved into specialized medical devices like fetal monitors. It then describes how a fetal monitor could be morphed onto a mobile platform by using the phone's sensors and camera to dynamically monitor the fetus. However, challenges like meeting regulatory requirements, privacy concerns, and ensuring software quality would need to be addressed for such mobile medical devices. The document concludes by questioning how mobile characteristics could enable novel medical applications and how such devices could be deployed in areas lacking healthcare infrastructure.
Morphing Mobile Platforms Into Medical Devices Dhurjaty
- 1. Morphing mobile platforms into Medical devicesSreeram (Ram) Dhurjaty, Dhurjaty Electronics Consulting LLC, Rochester, NY <www.dhurjaty.net>4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 1
- 2. What is this talk about, anyway?What constitutes a medical device?Historical perspectivesWhere this all this come from? Early devicesOur backside is always behind us--- Buckaroo Banzai--Evolution of systemsHow did consumer electronic components morph into medical devicesWhere did one need specialized designsTransducers, Power supplies, algorithm developmentMorphing a fetal monitor ChallengesNovel Devices based on mobile platforms4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 2
- 3. What constitutes a medical deviceSafe for patient and operator
- 4. Durable, hospitals are abusive environments
- 5. Acquisition of signals related to vital signs
- 6. Processing and manipulation of data
- 7. Rendering and display of results
- 8. Use in Primary or secondary diagnosis
- 9. In the United States and some other countries
- 10. Regulated by the FDA for both design and manufacture
- 11. Available only with a prescription4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 3
- 12. Representative patient monitoring system4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 4
- 13. Patient monitors 60s4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 5Vacuum tube-based, no processing, bouncing ball displaysHeavy, sometimes dangerous to the patient and operator
- 14. Monitors 80s and 90s4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 6Siemens Patient monitor early 80sMotorola 6800 processor CRT displayArrhythmia and vital signs monitoring, 30 Lbs.Siemens Patient Monitor, 90s68K processor, Flat panel displays, Arrhythmia and vital signs monitoring, 6 Lbs.
- 15. Fetal Monitor, early 20004/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 7Toco- TransducerUltrasound transducerFetal monitor with maternal monitoring
- 16. User interfacesKeypads, touch screensDisplaysResolutionColorGray scalesPower Electrical isolationPatient isolationBackup batteries TransducersVital parameters such as EKG, BP, etc.CommunicationsRS 232 (early devices)USBInternetWirelessAlgorithms4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 8Requirements for medical devices
- 17. Evolution of medical devices4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 9
- 18. Fetal monitoring basics4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 10
- 19. Representative ante-partum fetal monitor4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 11
- 20. Morphing a mobile platform into a fetal monitor 4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 12
- 21. Fetal monitor morphed into a mobile platform4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 13
- 22. Is imitation the best form of flatteryEarly transformation of technology is based on imitationEarly renderings of CT images were multiple static images on a monitorUse of technology leads to surpassing of the imitationPresent day CT renderings are dynamic or even 3-D on monitorsFetal monitors on mobile platforms can be transformedRendering of the Intra Uterine Pressure and Fetal Heart rate can be done dynamicallyThe accelerometers in smart devices can be used to detect uterine contractionsThe camera can be used to process maternal images in order to extract more information4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 14
- 23. Other novel applications4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 15NETRA (Near-Eye Tool for Refractive Assessment). The user places the device to the eye and, using phone's keypad, aligns patterns in the viewfinder. These alignments provide the data needed to determine a prescription. Courtesy: MIT
- 24. challengesApplication efficiencyFrugality and efficiency of codeEarly systems did a lot with 8-bit processors and limited memory. Portability was an issue between platformsModern systems can use some of the tricks developed in the past A fetal monitor that I designed in 1982 achieved adequate performance using a 4 MHz 8088!4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 16
- 25. Challenges (contd.)RegulationsMedical devices need a 510K submission (expensive and time consuming)Use and control of the softwareVersion controlCoexisting of monitoring software with general purpose apps.Patient privacy and data security4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 17
- 26. Concluding thoughts and questionsBeyond imitation of existing devicesWhat are the characteristics of mobile devices that engender novel uses for each medical domain?Regulations and patient privacyNeed to explore workable paradigmsDeploymentTo countries/area where there is mortality due to inadequate screening4/26/2011Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 18