Remote Patient Monitoring How are medical devices changing for home health care?

K A B L O O E D E S I G N + P D T

March 3, 2015

WHO WE ARE

Tom KraMer President & CEO, Kablooe Design

Mark Schwartz CEO, Product Development Technologies

Realizing a better way

Research Ideation Design

Engineering Prototyping Production

Product Development Technologies (PDT) is a global,

full-service product design and development firm.

O U R E X P E R T I S E :

Strategy

Scouting

Design Research

Industrial Design

User Experience Development

Mechanical Engineering

Electrical Engineering

Software Development

Sourcing

A W A R D S :

Consumer Vital Tracking and Clinical Grade Devices Are Converging

Consumer Vital Tracking and Clinical Grade Devices Are Converging

Consumer Vital Tracking and Clinical Grade Devices Are Converging

Home healthcare and patient empowerment is driving this trend

Consumer Vital Tracking and Clinical Grade Devices Are Converging

Home healthcare and patient empowerment is driving this trend

How do we do this while allowing communication with your primary care physician or other caregivers/patients?

1. HIPPA

2. Security

9 Issues to Tackle WHEN CONVERTING CONSUMER DEVICES TO MEDICAL DEVICES

1. HIPPA

2. Security

3. Simplified for patient / Sophisticated for caregiver

9 Issues to Tackle WHEN CONVERTING CONSUMER DEVICES TO MEDICAL DEVICES

9 Issues to Tackle WHEN CONVERTING CONSUMER DEVICES TO MEDICAL DEVICES

1. HIPPA

2. Security

3. Simplified for patient / Sophisticated for caregiver

4. Manpower to screen data, who gets alerted when?

9 Issues to Tackle WHEN CONVERTING CONSUMER DEVICES TO MEDICAL DEVICES

1. HIPPA

2. Security

3. Simplified for patient / Sophisticated for caregiver

4. Manpower to screen data, who gets alerted when?

5. Overwhelming of physician

9 Issues to Tackle WHEN CONVERTING CONSUMER DEVICES TO MEDICAL DEVICES

1. HIPPA

2. Security

3. Simplified for patient / Sophisticated for caregiver

4. Manpower to screen data, who gets alerted when?

5. Overwhelming of physician

6. With high risk seniors, nurses are not paid to react all day long

9 Issues to Tackle WHEN CONVERTING CONSUMER DEVICES TO MEDICAL DEVICES

1. HIPPA

2. Security

3. Simplified for patient / Sophisticated for caregiver

4. Manpower to screen data, who gets alerted when?

5. Overwhelming of physician

6. With high risk seniors, nurses are not paid to react all day long

7. Devices are expensive, apps are cheap

9 Issues to Tackle WHEN CONVERTING CONSUMER DEVICES TO MEDICAL DEVICES

1. HIPPA

2. Security

3. Simplified for patient / Sophisticated for caregiver

4. Manpower to screen data, who gets alerted when?

5. Overwhelming of physician

6. With high risk seniors, nurses are not paid to react all day long

7. Devices are expensive, apps are cheap

8. Common information formats

9 Issues to Tackle WHEN CONVERTING CONSUMER DEVICES TO MEDICAL DEVICES

1. HIPPA

2. Security

3. Simplified for patient / Sophisticated for caregiver

4. Manpower to screen data, who gets alerted when?

5. Overwhelming of physician

6. With high risk seniors, nurses are not paid to react all day long

7. Devices are expensive, apps are cheap

8. Common information formats

9. Making it usable and well understood by seniors

THE INVERSE RULE:

“ The more likely you are to

need technology, the less likely

you are to be savvy with it.”

Deloitte University Press 2014

Consumer Vital Tracking and Clinical Grade Devices Are Converging

Home healthcare and patient empowerment is driving this trend

How do we do this while allowing communication with your primary care physician or other caregivers/patients?

If we do not address this need with innovative design solutions, patients will begin to use consumer level vital tracking

systems for self-diagnosis.

SYMPTOM-BASED

“The nature of web searches makes critical diagnoses seem much more prevalent when the user is

searching for information online. Most websites use mathematical model that’s based on page views

when determining what order in which to rank pages in search responses, and articles about cancer

might get more hits or page views than articles written about eye strain or fatigue. ” Markovsky Health and research consultancy Kelton, FierceHealthIT reports, September 11, 2013

Probability of Mention of Cause Given Symptom

Consumer Vital Tracking and Clinical Grade Devices Are Converging

Home healthcare and patient empowerment is driving this trend

How do we do this while allowing communication with your primary care physician or other caregivers/patients?

If we do not address this need with innovative design solutions, patients will begin to use consumer level vital tracking

systems for self-diagnosis.

Consumer Vital Tracking and Clinical Grade Devices Are Converging

Home healthcare and patient empowerment is driving this trend

How do we do this while allowing communication with your primary care physician or other caregivers/patients?

If we do not address this need with innovative design solutions, patients will begin to use consumer level vital tracking

systems for self-diagnosis.

never talk to their

doctor about it 50%

Consumer Vital Tracking and Clinical Grade Devices Are Converging

Home healthcare and patient empowerment is driving this trend

How do we do this while allowing communication with your primary care physician or other caregivers/patients?

If we do not address this need with innovative design solutions, patients will begin to use consumer level vital tracking

systems for self-diagnosis.

PROS AND CONS:

1. Over diagnosing self can flood the system

2. Self diagnosing can be pro-active and preventative

Consumer Vital Tracking and Clinical Grade Devices Are Converging

Home healthcare and patient empowerment is driving this trend

How do we do this while allowing communication with your primary care physician or other caregivers/patients?

If we do not address this need with innovative design solutions, patients will begin to use consumer level vital tracking

systems for self-diagnosis.

DATA-BASED

Consumer Vital Tracking and Clinical Grade Devices Are Converging

Home healthcare and patient empowerment is driving this trend

How do we do this while allowing communication with your primary care physician or other caregivers/patients?

If we do not address this need with innovative design solutions, patients will begin to use consumer level vital tracking

systems for self-diagnosis.

“ “

Scanadu’s device sounds useful, but only if the

results are accurate.” Ki Chon, Professor, Biomedical Engineering, Worcester Polytechnic Institute

We now certainly have the benefit of hindsight, with

that hindsight, it is clear we underestimated the

level of difficulty in developing ... Initial test units

had a persistent accuracy problem ” Scanadu CEO Walter DeBrouwer

Focal points for design engineering:

1. Accuracy of sensors

2. Difficult/poor sensor placement

3. User error

The Dichotomy That Exists Between Clinicians and Manufacturers Is Complex

Manufacturers are developing more expensive, high tech, connected devices, hoping hospitals will pay more to keep

patients from coming back in less than 30 days.

Clinicians will want to spend less on all devices as reimbursement will not go up, and they are getting paid less per

patients with population health care.

This will result in hospitals becoming the buyers of our new devices that are related to ACO readmissions, not

necessarily the clinicians, technicians or physicians of the past.

CONNECTIVITY: A WHOLISTIC VIEW

Learnings from the evolution of the cell phone are instrumental in telehealth and remote patient monitoring. Additionally, solutions from

other industries, like defense and consumer electronics can be leveraged for novel ideas.

HOW DO DEVICES COMMUNICATE?

We divided connected and mobile health solutions into four levels of complexity:

1 2 3 4 Smartphone app Smartphone

+ wireless device

Smartphone

+ hard wired device

Medical device

ecosystem

HOW DO DEVICES COMMUNICATE?

We divided connected and mobile health solutions into four levels of complexity:

1 2 3 4 Smartphone app Smartphone

+ wireless device

Smartphone

+ hard wired device

Medical device

ecosystem

EXAMPLE

Weight Watchers app enables users to input personal data and track eating and exercise habits

S M A R T P H O N E A P P

Pros:

Great solution for monitoring and scheduling

Good avenue for compiling data from different devices

Lowest cost of development

Can be a teaser to bigger and better things (i.e. user being

enticed to buy hardware)

S M A R T P H O N E A P P

WHY

Cons:

Not good for use in mission critical/life sustaining equipment

and data

Relies on reliability of phone

Not secure enough for sensitive medical data

Crowded space due to low barrier to entry

Users hesitant to pay for applications

Limited to sensors within the phone or entering manual data

such as calorie intake, etc.

Accelerometer

Compass

Barometer (iPhone 6)

Gyroscope

Camera

Heart rate monitor (Samsung Galaxy S5)

DEVELOPMENT CHALLENGES S M A R T P H O N E A P P

Choosing the right mobile platform

Info security

Usability: is it making processes easier rather than more difficult or complex?

Source: http://www.sitepoint.com/mobile-platforms-watch-2014/

Android & iOS have a combined marketshare of 85-95%

Android vs. iOS: How do you go about an app?

1. Choose one platform and debug first

+ Allows for user feedback

+ Can work out bugs in advance

- Second app is delayed

2. Design parallel in both platform

+ Both apps are released at the same time

- Time consuming

HOW DO DEVICES COMMUNICATE?

We divided connected and mobile health solutions into four levels of complexity:

1 2 3 4 Smartphone app Smartphone

+ wireless device

Smartphone

+ hard wired device

Medical device

ecosystem

EXAMPLE

Nike+ Fuelband wirelessly connects a wearable with app to fitness activity

S M A R T P H O N E + W I R E L E S S D E V I C E

WHY

Good for use when the smart phone can be used as the primary user interface. Often on mission

critical systems, the UI function is good to be isolated from the control operation.

Can use many different smart phone devices to meet an acceptable solution for UI without

having to do the hardware development.

S M A R T P H O N E + W I R E L E S S D E V I C E

WHY S M A R T P H O N E + W I R E L E S S D E V I C E

Pros:

Able to communicate and obtain data not possible with a

smartphone alone

Wireless interface can be selected which may be

compatible with other wireless devices (Bluetooth, etc.)

Cons:

Wireless devices require their own pour source

Depending on interface, pairing the smartphone to the

wireless device may be required

DEVELOPMENT CHALLENGES

Designing wearables for the rigors of everyday use

Connectivity: Bluetooth, ANT+, NFC

Sensor reliability / accuracy

Two batteries must be maintained

One device may run out of battery power before another

S M A R T P H O N E + W I R E L E S S D E V I C E

DEVELOPMENT CHALLENGES

Bluetooth

Available in nearly all smartphones/tablets

Low power (esp. with BLE-Bluetooth Low Energy)

More vendor offerings compared to ANT+

Requires pairing process

Low data rate (3Mbit/s classic, 1Mbit/s BLE)

BLE devices don’t interoperate with classical Bluetooth

devices (however dual-mode devices are available)

Low power, low data rate applications

Point-to-point communication

ANT+

Simpler protocol than BLE

Low power

Multiple topologies supported (point-to-point star, tree, mesh)

Low data rate (1Mbit/s)

Not as many vendor offerings as Bluetooth

Low power, low data rate applications

Sports and fitness fields

Performance and health monitoring

NFC

Simple setup – doesn’t require pairing

Extremely low power

Short communication range (<20 cm)

Low data rate (106kbit/s to 424 kbit/s)

NFC can be used to setup more capable wireless

connections such as Bluetooth or WiFi Direct

Mobile payments

Patient confirmation/data

WiFi

High speed data transfer (over 1Gbit/s)

Longer communication distance (~100m)

High power consumption

Relatively expensive implementation

Internet access

Pros Cons Best Application

S M A R T P H O N E + W I R E L E S S D E V I C E

HOW DO DEVICES COMMUNICATE?

We divided connected and mobile health solutions into four levels of complexity:

1 2 3 4 Smartphone app Smartphone

+ wireless device

Smartphone

+ hard wired device

Medical device

ecosystem

EXAMPLE

Satellite communications APPcessory device

S M A R T P H O N E + H A R D W I R E D D E V I C E

WHY

The ability to afford home healthcare has changed with new laws.

The creation of ACO’s mean in-home caregivers are getting paid less, so less experienced caregivers are in the home.

APPcessories leverage the familiar, intuitive interface of the smartphone.

S M A R T P H O N E + H A R D W I R E D D E V I C E

WHY S M A R T P H O N E + H A R D W I R E D D E V I C E

Pros:

Ability to charge the smartphone with docking device

Opportunity for high-speed communication through wired

connection

Cons:

Wired connections interfaces can vary widely across

software and devices

DEVELOPMENT CHALLENGES

Would be difficult to be able to use multiple

smartphone versions and vendors

Every year new versions come out with different form

factors, connectors, etc.

Software updates

Heavily relying on the smartphone’s reliability

Smartphone battery – will it last?

Ties up your phone while in the device

S M A R T P H O N E + H A R D W I R E D D E V I C E

S M A R T P H O N E + H A R D W I R E D D E V I C E

DEVELOPMENT CHALLENGES

The ability to afford home healthcare has changed with new laws.

The creation of ACO’s mean in-home caregivers are getting paid less, so less experienced caregivers are in the home.

APPcessories leverage the familiar, intuitive interface of the smartphone.

Lightning connector for Apple

Micro USB for Android

DEVELOPMENT CHALLENGES

Lightning connector (Apple)

Able to provide or draw power from the Apple device

High data transfer speeds through USB 2.0 (480 Mbits/s).

Cable provides reliable connection

Reversible connection

Need to be physically connected to phone

Need to meet the Mfi (Made For iDevice) requirements

High cost of connector (requires MFI chip)

Large amounts of data transfer

Charging iPhone while docked on accessory.

Micro USB

Able to provide or draw power from the smartphone

High data transfer speeds through USB 2.0 (480 Mbits/s)

Available on almost all smartphones (except Apple)

Need to be physically connected to phone

Large amounts of data transfer

Charging smartphone while docked on accessory

Headphone Jack

Nearly universal across smartphones

Very minimal power can be harvested from port

Likely need external power source for accessory

Low data throughput

Very low power, low data rate communication

Credit card readers

Pros Cons Best Application

S M A R T P H O N E + H A R D W I R E D D E V I C E

S M A R T P H O N E + H A R D W I R E D D E V I C E

DEVELOPMENT CHALLENGES

Square connects through the headphone jack

HOW DO DEVICES COMMUNICATE?

We divided connected and mobile health solutions into four levels of complexity:

1 2 3 4 Smartphone app Smartphone

+ wireless device

Smartphone

+ hard wired device

Medical device

ecosystem

EXAMPLE

Diabetes management system: fully touchscreen management device + Bluetooth insulin delivery pump

M E D I C A L D E V I C E E C O S Y S T E M

WHY

Provides a substantial custom-hardware component to facilitate proprietary sensors and other hardware protocols not found

in a smartphone

Provide a very application-specific solution

Gives you ability to create all of the solutions needed for the use case

Potential for a stronger IP position

M E D I C A L D E V I C E E C O S Y S T E M

WHY M E D I C A L D E V I C E E C O S Y S T E M

Pros:

Designer has control over all devices in ecosystem

Can be designed for longer field life which is very desirable

for medical devices (not dependent on smartphone which

will be upgraded in 1-2 years)

Cons:

Longer development time

If cellular network is used, device must have its own SIM

card and data plan instead of using smartphone for this

function.

Generally high cost for development

Long development cycle

More to test and more regulatory hurdles because each

component has to pass

More complex, more variables, more testing required

M E D I C A L D E V I C E E C O S Y S T E M

DEVELOPMENT CHALLENGES

If one component fails, the others could be rendered useless or

not effective

Patient risk is higher

User interface development is a challenge due to varied levels of

user comfort and familiarity with technology

HOW TO DECIDE W H I C H O F T H E 4 D I R E C T I O N S I S A P P R O P R I A T E F O R Y O U R A P P L I C A T I O N ?

Consider the following:

Who will be using your solution and what stakeholders will need what information? In what form?

How much time do you have to develop the solution?

Does it have to work with existing components?

What does your IP cover?

Do you need automated input to verify compliance?

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