morphing mobile platforms into medical devices dhurjaty

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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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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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REPRESENTATIVE PATIENT MONITORING SYSTEM

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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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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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FETAL MONITOR, EARLY 2000

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Fetal monitor with maternal monitoring

Ultrasound transducer

Toco- Transducer

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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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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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FETAL MONITORING BASICS

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REPRESENTATIVE ANTE-PARTUM FETAL MONITOR

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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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FETAL MONITOR MORPHED INTO A MOBILE PLATFORM

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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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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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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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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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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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morphing mobile platforms into medical devices dhurjaty

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