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When Worlds Collide:
Medical Devices Meet
Consumer Technology
William (Bill) Betten
Vice President of Business Solutions
Medical/Life Sciences
Logic PD

1

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Agenda
•
•
•
•

Overview
Remote Monitoring and Connected Devices
Consumer Impact on Medical
Conclusions

2

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Who is Logic PD?
• We are the most complete product innovation and product realization
company for connected devices in the world’s most demanding markets.
• Our promise to our customers:
– We help you launch products that accelerate growth.

• Logic PD integrated process:

3

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Consumer Industry vs. Medical Industry

Source: IBM Institute for Business Value
Copyright 2013 Logic PD, Inc. All Rights Reserved.

4
Trends Driving Convergence
• Growth and acceptance of
technology in new applications

• Aging population and chronic
disease increase

5

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Smartphone Growth
Worldwide smartphone shipments from 2010 to 2016 (in million units)

Source: Worldwide, IDC
Copyright 2013 Logic PD, Inc. All Rights Reserved.

6
Tablet Growth
Forecast for global sales of tablets, notebooks and desktop PCs from 2010 to
2015 (in million units)

Source: IDC, Morgan Stanley 7
Copyright 2013 Logic PD, Inc. All Rights Reserved.
Chronic Disease Impact
• Caused 60% of deaths in 2005.
• Accounts for twice as many deaths as all communicable diseases, maternal and
perinatal conditions, and nutritional deficiencies combined.

• Aging population means will lead to an increase in chronic disease cases

Source: World Health Organization: “Global Surveillance,
Prevention and Control of Chronic Respiratory Diseases”
Copyright 2013 Logic PD, Inc. All Rights Reserved.

9
Chronic Disease Attributes
• Can take decades to become fully established
• Prevention opportunities
• Multiple diseases per patient
• Long-term and systematic approach required
• Integral part of health services

Source: World Health Organization: “Global Surveillance,
Prevention and Control of Chronic Respiratory Diseases”
Copyright 2013 Logic PD, Inc. All Rights Reserved.

10
The Shift in Healthcare

Quality Of
Life

100%

Healthy,
Independent Living

Community
Clinic

Chronic Disease
Management

Doctor’s
Office

HOME CARE

Assisted Living

RESIDENTIAL
CARE

Skilled
Nursing Facility

ACUTE CARE

Specialty Clinic

ICU

Community Hospital

0%

$1

$10

$100

$1,000

$10,000

Source: Intel Corp., Center for Aging

Cost Of Care / Day
Services Technologies (CAST)
Copyright 2013 Logic PD, Inc. All Rights Reserved.

11
Chronic Disease Management
• Home health care drivers
– Improved efficiency
– Lower health care cost
– Improved patient results

• Home health medical equipment needs
– Small and portable
– Easy to use
– Low cost
– Connected

12

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Medical Trends: Remote Monitoring

13

Copyright 2013 Logic PD, Inc. All Rights Reserved.
FDA and Mobile Apps
Proposed scope for oversight.

FDA Scope

“mobile
medical apps”
Enforcement
Discretion

No regulatory
requirements.

Other mobile apps
that meet “device”
definition

Not considered “mobile medical
apps”

14

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Medical Device Trends - 2012
Statistics – Number of Devices Added

Connection Type

Cardiac Monitoring

69

Connects to Smart Device

147

Health and Fitness Monitoring

63

Connects to Gateway/Smart Device

37

Glucose Level Monitoring

31

Gateway

35

Weight Monitoring

17

Embedded

34

Blood Pressure Monitoring

15

Health and Fitness Monitoring

12

Blood Oxygen Monitoring

12

Air Flow Monitoring

9

Sleep Monitoring

8

Baby Monitoring

8

Medication Compliance Monitoring

5

Coagulation Monitoring

1
Source: GSMA mHealth Device Listing

Copyright 2013 Logic PD, Inc. All Rights Reserved.

15
Medical Device Trends
Global mobile health market opportunity by service categories.
Monitoring - 65%
Diagnosis - 15%
Independent
aging – 71%

Chronic disease
management
and post acute
care – 29%

Estimated Worldwide opportunity of $23 Billion in 2017
Copyright 2013 Logic PD, Inc. All Rights Reserved.

Treatment - 10%
Health Practitioner
Support - 5%
Wellness - 3%
Administration - 1%
Prevention - 1%

Source: PwC analysis

16
Medical Device Trends: Health Apps
Types of Health Apps

% of Health App Users

Exercise, fitness, pedometer or heart rate monitoring

38%

Diet, food, calorie counter

31%

Weight

12%

Period or menstrual cycle

7%

Blood pressure

5%

WebMD

4%

Pregnancy

3%

Blood sugar or diabetes

2%

Medication management

2%

Mood

< 1%

Sleep

< 1%

Other

14%
Source: Pew Internet/CHCF Health Survey,
August 7-September 6, 2012

Copyright 2013 Logic PD, Inc. All Rights Reserved.

17
Medical Device Trends: “Other Health Apps”

18

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Medical and Consumer Convergence

Consumer

Hybrid
Device

Medical
19

Copyright 2013 Logic PD, Inc. All Rights Reserved.
The 3 Stages of Convergence
1. Wired or wireless connection
2. Physically joined together
3. Integrated

CoPilot GPS for Laptop

Navman GPS Sleeve

iPhone with GPS

20

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Examples of Medical Device Smartphone Convergence
Airstrip Patient
Monitoring
Withings Blood
Pressure Monitor
Sanofi Aventis iBGStar
Blood Glucose Monitor

iStethoscope
Expert

AliveCor ECG Sleeve
21

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Ultrasound
Mobisante

Future

Past
Current

22

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Tandem Diabetes Care®: t:slim Pump

23

Copyright 2013 Logic PD, Inc. All Rights Reserved.
t:slim Pump: Consumer Influences
Color touch screen
Rechargeable
batteries
Compact size
Intuitive

Durable, waterproof
24

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Consumer vs. Medical Device Development
Attribute

Consumer Devices

Medical Devices

Time to Market

Rapid (< 1 year)

Slow (3 – 5 years)

Product Longevity

Short (2 years)

Long (7 – 15 years)

Hardware

Latest and greatest

Available and stable

Software

Open source

Differentiator

User interface

Simple

Specialized

Price

Low

High

Reliability

Moderate

Vital

25

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Consumer vs. Medical Device Development
Attribute

Consumer Devices

Medical Devices

Regulatory

UL, FCC

Ul, FCC, FDA, ISO13485

Information Security

Moderate

High (HIPAA)

Volume

Millions to 100’s of millions

Thousands to a million

Efficacy

Limited

Clinical trials

Interoperability

Common

Limited

Intellectual Property

Aggressive

Incremental Innovation

26

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Consumer Industry vs. Medical Industry

Source: IBM Institute for Business Value
Copyright 2013 Logic PD, Inc. All Rights Reserved.

27
Who Will Win?
Consumer Electronic
Companies
Branding and product loyalty



Bringing innovative products to market quickly



Consumer/user expectations

Medical Device
Companies



Healthcare distribution channels



Reimbursement and regulatory



Industry credibility



Industry insights



28

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Who Will Win?

Source: IBM Institute for Business Value
Copyright 2013 Logic PD, Inc. All Rights Reserved.

29
The Future
Consumer health and wellness applications for smart phones:
– 360% growth from May 2011 to January 2013
• May 2011: 16,400 Healthcare & Fitness and Medical apps for iOS
• January 2013: 37,263 Healthcare & Fitness and Medical apps for iOS (55% / 45%)
• January 2013: 21,634 Healthcare & Fitness and Medical apps for Android (69% / 31%)

• Mobile applications for medical diagnostics (84% at MD&M West)
• Increase in body-worn sensors
• FDA mobile application guidance in the US:
– Used as an accessory to an FDA-regulated medical device
– Transform a mobile platform into a regulated medical device

Sources: 148Apps.biz; appbrain.com; MD&M West 2012
Copyright 2013 Logic PD, Inc. All Rights Reserved.

30
The Future?
• Qualcomm Tricorder XPRIZE - $10 Million
− Imagine a portable, wireless device in the palm of
your hand that monitors and diagnoses your health
conditions.
• Nokia Sensing Xchallenge - $2.25 Million
− Envision a future where everyone has access to
affordable, personalized healthcare through
sophisticated sensing technologies and a whole new
level of personalized, digital health information.

31

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Internet of Everything/M2M/Connected Devices

H2H

M2H

M2M
32

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Take Aways
• Management of chronic diseases is driving a fundamental change in health
care.
• The convergence between consumer electronics and medical devices is
changing both worlds.
• The challenge is to understand the complexities of managing and developing
innovative products in these very different environments.
• The world is becoming connected; the key is identifying value.

33

Copyright 2013 Logic PD, Inc. All Rights Reserved.
Questions?
Bill Betten, Logic PD
• Email: bill.betten@logicpd.com
• Website: www.logicpd.com

34

Copyright 2013 Logic PD, Inc. All Rights Reserved.

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The integration of mobile and medical technologies

  • 1. When Worlds Collide: Medical Devices Meet Consumer Technology William (Bill) Betten Vice President of Business Solutions Medical/Life Sciences Logic PD 1 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 2. Agenda • • • • Overview Remote Monitoring and Connected Devices Consumer Impact on Medical Conclusions 2 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 3. Who is Logic PD? • We are the most complete product innovation and product realization company for connected devices in the world’s most demanding markets. • Our promise to our customers: – We help you launch products that accelerate growth. • Logic PD integrated process: 3 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 4. Consumer Industry vs. Medical Industry Source: IBM Institute for Business Value Copyright 2013 Logic PD, Inc. All Rights Reserved. 4
  • 5. Trends Driving Convergence • Growth and acceptance of technology in new applications • Aging population and chronic disease increase 5 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 6. Smartphone Growth Worldwide smartphone shipments from 2010 to 2016 (in million units) Source: Worldwide, IDC Copyright 2013 Logic PD, Inc. All Rights Reserved. 6
  • 7. Tablet Growth Forecast for global sales of tablets, notebooks and desktop PCs from 2010 to 2015 (in million units) Source: IDC, Morgan Stanley 7 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 8. Chronic Disease Impact • Caused 60% of deaths in 2005. • Accounts for twice as many deaths as all communicable diseases, maternal and perinatal conditions, and nutritional deficiencies combined. • Aging population means will lead to an increase in chronic disease cases Source: World Health Organization: “Global Surveillance, Prevention and Control of Chronic Respiratory Diseases” Copyright 2013 Logic PD, Inc. All Rights Reserved. 9
  • 9. Chronic Disease Attributes • Can take decades to become fully established • Prevention opportunities • Multiple diseases per patient • Long-term and systematic approach required • Integral part of health services Source: World Health Organization: “Global Surveillance, Prevention and Control of Chronic Respiratory Diseases” Copyright 2013 Logic PD, Inc. All Rights Reserved. 10
  • 10. The Shift in Healthcare Quality Of Life 100% Healthy, Independent Living Community Clinic Chronic Disease Management Doctor’s Office HOME CARE Assisted Living RESIDENTIAL CARE Skilled Nursing Facility ACUTE CARE Specialty Clinic ICU Community Hospital 0% $1 $10 $100 $1,000 $10,000 Source: Intel Corp., Center for Aging Cost Of Care / Day Services Technologies (CAST) Copyright 2013 Logic PD, Inc. All Rights Reserved. 11
  • 11. Chronic Disease Management • Home health care drivers – Improved efficiency – Lower health care cost – Improved patient results • Home health medical equipment needs – Small and portable – Easy to use – Low cost – Connected 12 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 12. Medical Trends: Remote Monitoring 13 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 13. FDA and Mobile Apps Proposed scope for oversight. FDA Scope “mobile medical apps” Enforcement Discretion No regulatory requirements. Other mobile apps that meet “device” definition Not considered “mobile medical apps” 14 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 14. Medical Device Trends - 2012 Statistics – Number of Devices Added Connection Type Cardiac Monitoring 69 Connects to Smart Device 147 Health and Fitness Monitoring 63 Connects to Gateway/Smart Device 37 Glucose Level Monitoring 31 Gateway 35 Weight Monitoring 17 Embedded 34 Blood Pressure Monitoring 15 Health and Fitness Monitoring 12 Blood Oxygen Monitoring 12 Air Flow Monitoring 9 Sleep Monitoring 8 Baby Monitoring 8 Medication Compliance Monitoring 5 Coagulation Monitoring 1 Source: GSMA mHealth Device Listing Copyright 2013 Logic PD, Inc. All Rights Reserved. 15
  • 15. Medical Device Trends Global mobile health market opportunity by service categories. Monitoring - 65% Diagnosis - 15% Independent aging – 71% Chronic disease management and post acute care – 29% Estimated Worldwide opportunity of $23 Billion in 2017 Copyright 2013 Logic PD, Inc. All Rights Reserved. Treatment - 10% Health Practitioner Support - 5% Wellness - 3% Administration - 1% Prevention - 1% Source: PwC analysis 16
  • 16. Medical Device Trends: Health Apps Types of Health Apps % of Health App Users Exercise, fitness, pedometer or heart rate monitoring 38% Diet, food, calorie counter 31% Weight 12% Period or menstrual cycle 7% Blood pressure 5% WebMD 4% Pregnancy 3% Blood sugar or diabetes 2% Medication management 2% Mood < 1% Sleep < 1% Other 14% Source: Pew Internet/CHCF Health Survey, August 7-September 6, 2012 Copyright 2013 Logic PD, Inc. All Rights Reserved. 17
  • 17. Medical Device Trends: “Other Health Apps” 18 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 18. Medical and Consumer Convergence Consumer Hybrid Device Medical 19 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 19. The 3 Stages of Convergence 1. Wired or wireless connection 2. Physically joined together 3. Integrated CoPilot GPS for Laptop Navman GPS Sleeve iPhone with GPS 20 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 20. Examples of Medical Device Smartphone Convergence Airstrip Patient Monitoring Withings Blood Pressure Monitor Sanofi Aventis iBGStar Blood Glucose Monitor iStethoscope Expert AliveCor ECG Sleeve 21 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 22. Tandem Diabetes Care®: t:slim Pump 23 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 23. t:slim Pump: Consumer Influences Color touch screen Rechargeable batteries Compact size Intuitive Durable, waterproof 24 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 24. Consumer vs. Medical Device Development Attribute Consumer Devices Medical Devices Time to Market Rapid (< 1 year) Slow (3 – 5 years) Product Longevity Short (2 years) Long (7 – 15 years) Hardware Latest and greatest Available and stable Software Open source Differentiator User interface Simple Specialized Price Low High Reliability Moderate Vital 25 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 25. Consumer vs. Medical Device Development Attribute Consumer Devices Medical Devices Regulatory UL, FCC Ul, FCC, FDA, ISO13485 Information Security Moderate High (HIPAA) Volume Millions to 100’s of millions Thousands to a million Efficacy Limited Clinical trials Interoperability Common Limited Intellectual Property Aggressive Incremental Innovation 26 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 26. Consumer Industry vs. Medical Industry Source: IBM Institute for Business Value Copyright 2013 Logic PD, Inc. All Rights Reserved. 27
  • 27. Who Will Win? Consumer Electronic Companies Branding and product loyalty  Bringing innovative products to market quickly  Consumer/user expectations Medical Device Companies  Healthcare distribution channels  Reimbursement and regulatory  Industry credibility  Industry insights  28 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 28. Who Will Win? Source: IBM Institute for Business Value Copyright 2013 Logic PD, Inc. All Rights Reserved. 29
  • 29. The Future Consumer health and wellness applications for smart phones: – 360% growth from May 2011 to January 2013 • May 2011: 16,400 Healthcare & Fitness and Medical apps for iOS • January 2013: 37,263 Healthcare & Fitness and Medical apps for iOS (55% / 45%) • January 2013: 21,634 Healthcare & Fitness and Medical apps for Android (69% / 31%) • Mobile applications for medical diagnostics (84% at MD&M West) • Increase in body-worn sensors • FDA mobile application guidance in the US: – Used as an accessory to an FDA-regulated medical device – Transform a mobile platform into a regulated medical device Sources: 148Apps.biz; appbrain.com; MD&M West 2012 Copyright 2013 Logic PD, Inc. All Rights Reserved. 30
  • 30. The Future? • Qualcomm Tricorder XPRIZE - $10 Million − Imagine a portable, wireless device in the palm of your hand that monitors and diagnoses your health conditions. • Nokia Sensing Xchallenge - $2.25 Million − Envision a future where everyone has access to affordable, personalized healthcare through sophisticated sensing technologies and a whole new level of personalized, digital health information. 31 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 31. Internet of Everything/M2M/Connected Devices H2H M2H M2M 32 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 32. Take Aways • Management of chronic diseases is driving a fundamental change in health care. • The convergence between consumer electronics and medical devices is changing both worlds. • The challenge is to understand the complexities of managing and developing innovative products in these very different environments. • The world is becoming connected; the key is identifying value. 33 Copyright 2013 Logic PD, Inc. All Rights Reserved.
  • 33. Questions? Bill Betten, Logic PD • Email: bill.betten@logicpd.com • Website: www.logicpd.com 34 Copyright 2013 Logic PD, Inc. All Rights Reserved.