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04/09/2
023
T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
MORPHIN
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1
04/09/2
023
T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
WHAT IS THIS TALK ABOUT, ANYWAY?
What constitutes a medical device?
Historical perspectivesWhere 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 designsTransducers, Power supplies, algorithm development
Morphing a fetal monitor
Challenges
Novel Devices based on mobile platforms
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T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
WHAT CONSTITUTES A MEDICAL DEVICE
Safe for patient and operatorDurable, hospitals are abusive environmentsAcquisition of signals related to vital signsProcessing and manipulation of dataRendering and display of resultsUse in Primary or secondary diagnosis In the United States and some other countries Regulated by the FDA for both design and
manufactureAvailable only with a prescription
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04/09/2
023
T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
REPRESENTATIVE PATIENT MONITORING SYSTEM
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023
T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
PATIENT MONITORS 60S
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Vacuum tube-based, no processing, bouncing ball displaysHeavy, sometimes dangerous to the patient and operator
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T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
MONITORS 80’S AND 90’S
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Siemens Patient monitor early 80’sMotorola 6800 processor CRT displayArrhythmia and vital signs monitoring, 30 Lbs.
Siemens Patient Monitor, 90’s68K processor, Flat panel displays, Arrhythmia and vital signs monitoring, 6 Lbs.
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T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
FETAL MONITOR, EARLY 2000
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Fetal monitor with maternal monitoring
Ultrasound transducer
Toco- Transducer
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T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
User interfacesKeypads, touch screens
DisplaysResolutionColorGray scales
Power Electrical isolationPatient isolationBackup batteries
Transducers Vital parameters such as EKG, BP, etc.
Communications RS 232 (early
devices) USB Internet Wireless
Algorithms
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REQUIREMENTS FOR MEDICAL DEVICES
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T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
EVOLUTION OF MEDICAL DEVICES
1960s•Specialized designs
•Bulky and expensive
•Mostly Analog•No data storage•CRT displays•Patient isolation and safety largely unknown
1970s•Minicomputer based
•Limited storage•RS-232 communications
• Isolated power supplies
•Operational amplifiers and TTL chips
•CRT displays
80’s•8 -16 bit Microprocessor based, some DSP
•RS 232, 10BT• Isolated power supplies
•Larger scale integration (PLDs)
•CRT displays•Switching Power supplies
•Rudimentary wireless
1990’s and 2000’s•16/32 bit microprocessor and DSP based
•10/100BT, USB•ASICs•Lower power•Lower weight
Today and future•Mobile platforms•Communication with transducers using blue tooth/wireless
•3-4G/ WiFi communications
•Local storage (SD cards)
•Remote monitoring
•Smart aps for processing and rendering
•Remote diagnostics
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T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
FETAL MONITORING BASICS
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T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
REPRESENTATIVE ANTE-PARTUM FETAL MONITOR
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04/09/2
023
T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
MORPHING A MOBILE PLATFORM INTO A FETAL MONITOR
Transducers
Ultrasound
Toco
Battery operated
Acquisition and
basebanding
Transducer-platform
communication
Blue tooth
USB
WiFi
Inherent patient
isolation
Data manipulation
apps
signal processing
rendering
Interpretation
alarms
User Interfaces
Operator interface
Displays
Storage
Interactive communicati
on
Novel uses of camera
Remote communicati
on
3G/4G for consultation
WiFi for data transmission
Camera for communicating physical
state
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04/09/2
023
T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
FETAL MONITOR MORPHED INTO A MOBILE PLATFORM
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T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
IS IMITATION THE BEST FORM OF FLATTERYEarly 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
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T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
OTHER NOVEL APPLICATIONS
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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
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T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
CHALLENGES
Application efficiencyFrugality 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!
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04/09/2
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T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
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 security
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T H I RT Y S E V E N T H A S I L O M A R M I C R O C O M P U T E R W O R KS H O P , A S I L O M A R , C A ,
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 paradigms
DeploymentTo countries/area where there is mortality due to inadequate screening
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