Wearable Technologies CONFIDENTIAL Building …€¦ · Flextronics Medical technology initiatives...

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

Pocket

Rivet 1 1

1 2 1

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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?