wearable technologies confidential building …€¦ · flextronics medical technology initiatives...
TRANSCRIPT
Wearable Technologies
Building blocks for a future medical device Lior Shtram July 22nd, 2013
CONFIDENTIAL
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Agenda:
• First Generation: SmartPatch
• ECG demo
• Purpose of the project
• Product use case
• Development process
• Technology toolbox
• Next Generation: Wearable Medical Sensors for the Young
• Case study: children cardiac arrest
• System Architecture
• Concept
• Technology toolbox
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Subject Title
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SmartPatch Project
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SmartPatch initiative
Flextronics Medical technology
initiatives
Work to mature new technologies to
eventually provide Flextronics
Medical customers with a tool box for
the creation of new products
Flextronics Medical involvement in e-
Monitors was driven by the interest in
upcoming technologies and solutions
in wearable electronics as well as
interest in key technologies for home
monitoring and telemedicine
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Building blocks of a wearable product
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Product Use Case
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SmartPatch Research
In the vast panorama of medicine, we
carried out desktop research and a
number of interviews, and identified
the branch of Cardiology as an
interesting and important field to
investigate further.
Cardiology
Diabetes
Gynaecology
Oncology
Obesity
Respiratory Diseases
We researched the context and market, and identified
products and services for monitoring of Cardiology patients.
We found numerous activities based around the
development of sensors and systems for the monitoring of
patient ECGs.
BUT:
- Already in-use systems and under development systems
are closed, tied to specific devices and Companies. They
are not ‘open platforms’;
- Most of them focus on collecting data from only 1 device
at a time, and the data is sent manually after each reading;
- None of them offer continuous monitoring.
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Smart Patch - Interviews and observational work
Cardiac
Insufficiency
Arrhythmia
Ischemia & ACS
In order to understand the Cardiology context and appreciate its complexity, we conducted a
set of interviews with care givers (Cardiologists, Cardiology nurses and Family Doctors)
“When the patient wears
the Holster, he/she doesn’t
move ... If the patient
doesn’t have a normal life
the Holster is useless”.
N. Caffarelli
“It is very difficult for the
patient to wear the Holster
for an entire week... It is
extremely uncomfortable.”
D. Stangalini
“When the patient is
monitored from home
he/she feels much safer.”
N. Caffarelli
“Having someone’s vital signs
under constant observation
cannot anticipate what will
happen to them, but it definitely
helps them feel better.”
G. Occhi
“Before the patients are enrolled
onto the home telemonitoring
programme, it must be explained
to them how it works...
Otherwise it can get out of
hand..”
N. Caffarelli
“It is better to have a soft
monitoring system so that
patients can move and leave
their beds and recover more
quickly.”
M. Borchini
“We are continuously
pressured to send our
patients home as soon
as possible.”
G. Occhi
We understood which
are the three main
cardiac diseases and
which are the main vital
parameters doctors need
to monitor.
Analyzing the interview outcomes, we were able to identify diverse
opportunities for the successful application of an open platform
telemonitoring system.
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SmartPatch - User Analysis
In order to understand our target user and his/her needs, we carried out a number of
interviews towards patients and their family members.
! ! !
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QUICKENED DISMISSAL FROM HOSPITAL
The patient can return home sooner and
complete the rehabilitation process in the
comfort of his/her home.
While exercising, his/her ECG is monitored
continuously from the Call Centre.
MONITORING OF ALL VITAL SIGNS
The patient is reminded through the HUB to
measure certain vital signs, such as blood
pressure. The reading is sent automatically
through the HUB to the Call Centre who can
intervene if necessary.
EMOTIONAL SUPPORT
The patient is free to leave his/her home,
even for long periods, in order to do what
pleases him/her thus returning to a normal
healthy life, always knowing that someone
is keeping an eye on him/her.
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SmartPatch - Initial User Scenario
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SmartPatch - Scenario development
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Development Process
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SmartPatch Body Area Network development
• Preliminary form factor
• ID / EE concept proposals
• Initial architectural
component assessment
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SmartPatch initial prototyping
Personal eMonitors
ECG smartpatch
• Form development
• Usability tests of concepts
• Analysis of participatory
observations
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Prototypes Making
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Patch Assembly Disassembly
1 2 1
1 2 3 1 2
SmartPatch - Summary Assembly & Disassembly
Conductive Tape
Preformed Window
Rivet 1 1
1 2 1
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3
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Technology Toolbox
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Printed Display
Survey of multiple companies and technologies
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Flexible Batteries
Survey of multiple companies and technologies
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Sensium ANT+ BodyLAN MICS
Data Rate 50kbps 1Mbps 1Mbps 16kbps
Power consumption ~4.5mA @ 1.08V 11-17 mA @ 3V N/A 7.5 mA RX
25mA TX
Frequency 868/915 MHz 2.4 GHz 2.4 GHz 405/405 MHz
Transmission Distance 10 m N/A Few m 10 m
Additional Features •Reconfigurable Sensor Interface
•Digital Block based on 8051 •Simple to complex network coonfig
•FDA's Medical Implantable
Communications Systems and ULP-AMI
Compliant
Already Used
In many fitness/healthcare products
MICS BLE
Low Power Wireless solutions
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Soft Electronics encapsulation
Survey of multiple materials and processes
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Complete SmartPatch Overview
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1st Generation SmartPatch
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Smart Patch | Exploded view
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2nd Generation SmartPatch
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2nd Generation SmartPatch
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2nd Generation SmartPatch testing
The last development of the e-monitor
is currently undergoing field testing in
"Oasi San Gerardo" - House for the
elderly.
The aim is to fine tune engineering
parameters as well as gather feedback
from a hands-on experience.
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The 3rd Generation -
Catering for the young
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Cardiac Arrest in Children - A Real Concern
Over 16,000 American children suffer from cardiac arrest each year. When the event happens, just a
fraction of the children survive the event without severe neurological complications .
A large portion of these events can happen to infants that arrive to hospitals following traumas,
respiratory disorders and other critical conditions. Survival rates without further complications in a
hospital environment are better than outside, but nevertheless, as a head of a children hospital put it:
"I don’t want any child to die or suffer neurological damage from a cardiac arrest we can
predict and prevent " in a hospital environment
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Cardiac Arrest common causes
Traumas: Results from any bodily wound or shock produced by sudden physical injury. The patient is
susceptible to secondary complications like the cardiac arrest.
Poisoning: Due to accidental causes, poisons can cause several complications one of them the
cardiac arrest.
Respiratory Disorders: Respiratory conditions can quickly deteriorate into respiratory failure and
cardiopulmonary failure, and may subsequently lead to cardiac arrest
In fact the cardiac arrest can be predicted by specific vital signs that can be identified under the
correct monitoring and, most important, can be prevented in order to save the patients life.
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Near ICU class monitoring for every hospitalized child
Enable wireless near-
continuous monitoring of key
vital parameters:
• Heart Rate / ECG
• Respiratory Rate
• Pulse Oximetry
+ =
Bring DOWN cost
of consumables to
near dressing
level
Apply to every child that
enters an hospital a cardiac
arrest prevention system
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Predictable Factors
Pre-arrest symptoms start 90 min before
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Predictable Factors
Typical changes in vital signs values and patterns
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System Architecture
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Oximetry
HUB
HR / ECG
+
Respiratory
Rate Patch
Proposed System Architecture
The patient's hub communictes with the hospital network via WIFI. Data is processed by the main
server and warnings issued to the wards in case of emergencies.
Through-Body
patch-hub
communication
Hospital
WIFI Hospital
sys. server /
data
processing
Ward arrest
signals display
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System Architecture – Hospital deployment
With all the patients connected through the hospital wireless network one single person can monitor
several patients rather than check each one individually. At the same time different floors or sections
can communicate those dates.
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Product Concept – our vision
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Introducing the Flextronics "My ❤! Patch"
Flextronic's vision of
how Wearable
Technology could help
children too.
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Introducing the Flextronics "My ❤! Patch"
single-use / disposable
My ❤! Patch kit
Reusable / Sterylized
components kit
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Concept application to infants
disposable kit
reusable kit
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Concept application to infants
disposable kit
reusable kit
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Concept application to infants
disposable kit
reusable kit
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Concept application to infants
disposable kit
reusable kit
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Concept application to infants
disposable kit
reusable kit
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Concept application to infants
disposable kit
reusable kit
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Concept application to infants
disposable kit
reusable kit
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Concept application to infants
disposable kit
reusable kit
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Concept application to infants
disposable kit
reusable kit
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Concept application to infants
disposable kit
reusable kit
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Concept application to infants
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"My ❤! Patch"
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Technology Toolbox
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Existing Technology Blocks
ECG Patch Flexible PCB,
Flexible Battery
Ultra low power
wireless technology
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New Technology Blocks To Be Developed
Pulse Ox patch:
Printed
electronics on
flexible
substrates
Through-body
communication:
connect ECG
to wrist hub
Respiratory
rate
monitoring
added
to ECG patch
Mobile M2M
Hub:
connecting
medical
devices to the
cloud
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•ECG patch + wrist Hub communicate
through the body
• Capacitive coupling to the body.
•Wireless, antenna free communication
•Secure communication
•Low power (coin cell battery)
•Small size technology fitting child
wearable
Through-body Communication
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•Printed Electronics
• Photo detector
• Light source (RED and IR)
• Supporting circuitry
•Bandage-like material
• Fully flexible & stretchable
• Sticks to baby/child – low
sensitivity to movements
• Cost structure for one time
disposable
Printed Electronics Pulse Oximetry
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• HR \ RR sensors combined with
ECG patch
• Sharing same electrodes
• Combination of printed
electronics and flexible PCB
•Split durable and disposable
components
Heart Rate \ Respiratory Rate Patch
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•Connects medical devices to the
hospital server
•Communication:
• Pulse Ox – wired
• ECG/Respiratory patch -
through-body
• Hospital servers – WiFI
•Small size (child wrist)
•Lightweight (child mobility)
•Mobile, Low power (battery
operated)
Wrist Hub: Mobile M2M device
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"My ❤! Patch"
Questions?