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.

1. Morphing mobile platforms into Medical devices Sreeram (Ram) Dhurjaty, Dhurjaty Electronics Consulting LLC, Rochester, NY <www.dhurjaty.net> 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 1

2. What is this talk about, anyway? What constitutes a medical device? Historical perspectives Where this all this come from? Early devices Our backside is always behind us--- Buckaroo Banzai-- Evolution of systems How did consumer electronic components morph into medical devices Where did one need specialized designs Transducers, Power supplies, algorithm development Morphing a fetal monitor Challenges Novel Devices based on mobile platforms 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 2

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 prescription4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 3

12. Representative patient monitoring system 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 4

13. Patient monitors 60s 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 5 Vacuum tube-based, no processing, bouncing ball displays Heavy, sometimes dangerous to the patient and operator

14. Monitors 80’s and 90’s 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 6 Siemens Patient monitor early 80’s Motorola 6800 processor CRT display Arrhythmia and vital signs monitoring, 30 Lbs. Siemens Patient Monitor, 90’s 68K processor, Flat panel displays, Arrhythmia and vital signs monitoring, 6 Lbs.

15. Fetal Monitor, early 2000 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 7 Toco- Transducer Ultrasound transducer Fetal monitor with maternal monitoring

16. User interfaces Keypads, touch screens Displays Resolution Color Gray scales Power Electrical isolation Patient isolation Backup batteries Transducers Vital parameters such as EKG, BP, etc. Communications RS 232 (early devices) USB Internet Wireless Algorithms 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 8 Requirements for medical devices

17. Evolution of medical devices 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 9

18. Fetal monitoring basics 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 10

19. Representative ante-partum fetal monitor 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 11

20. Morphing a mobile platform into a fetal monitor 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 12

21. Fetal monitor morphed into a mobile platform 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 13

22. Is imitation the best form of flattery Early transformation of technology is based on imitation Early renderings of CT images were multiple static images on a monitor Use of technology leads to surpassing of the imitation Present day CT renderings are dynamic or even 3-D on monitors Fetal monitors on mobile platforms can be transformed Rendering of the Intra Uterine Pressure and Fetal Heart rate can be done dynamically The accelerometers in smart devices can be used to detect uterine contractions The camera can be used to process maternal images in order to extract more information 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 14

23. Other novel applications 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 15 NETRA (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. challenges Application efficiency Frugality and efficiency of code Early systems did a lot with 8-bit processors and limited memory. Portability was an issue between platforms Modern 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! 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 16

25. Challenges (contd.) Regulations Medical devices need a 510K submission (expensive and time consuming) Use and control of the software Version control Coexisting of monitoring software with general purpose apps. Patient privacy and data security 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 17

26. Concluding thoughts and questions Beyond imitation of existing devices What are the characteristics of mobile devices that engender novel uses for each medical domain? Regulations and patient privacy Need to explore workable paradigms Deployment To countries/area where there is mortality due to inadequate screening 4/26/2011 Thirty Seventh Asilomar Microcomputer Workshop, Asilomar, CA, 18