William Betten, Vice President of Business Solutions, Logic PD

1. Copyright 2014 Logic PD, Inc. All Rights Reserved.
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Copyright 2014 Logic PD, Inc. All Rights Reserved.
The Integration of Mobile
and Medical Technologies
William (Bill) Betten
Vice President of Business Solutions, Medical/Life Sciences
Logic PD

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Agenda
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• Overview
• Why Mobile?
• Consumer Impact on Medical
• Regulatory View of Mobile Apps
• Conclusions

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Who is Logic PD?:
We help you launch
products that
accelerate growth.
3

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• Growth and acceptance of
technology in new applications
• Aging population
• Chronic disease increase
• 55 million Americans over age 65
by 2020
Trends Driving Convergence

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Worldwide smartphone shipments from 2010 to 2016 (in million units)
Source: Worldwide, IDC
Smartphone Growth

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Source: IDC Worldwide Mobile Phone Tracker, September 4, 2013
Smartphone Growth
0
0.5
1
1.5
2
2.5
Mobile Phones Smartphones
2013
2017
InBillionsofUnits

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Source: IDC Worldwide Mobile Phone Tracker, September 4, 2013
Smartphone OS
2013 Market
Share
2017 Market
Share
Android 75.3% 68.3%
iOS 16.9% 17.9%
Windows Phone 3.9% 10.2%
BlackBerry OS 2.7% 1.7%
Others 1.2% 1.9%
Totals 100.0% 100.0%
Top Smartphone Operating Systems, Forecast Market Share and CAGR, 2013–2017
Growth of Smart Phone Operating Systems

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$1 $10 $100 $1,000 $10,000
0%
100%
Healthy,
Independent Living
Chronic Disease
Management
Doctor’s
Office
Community
Clinic
HOME CARE Assisted Living
RESIDENTIAL
CARE
Community Hospital
ICUSpecialty Clinic
ACUTE CARE
Cost Of Care / Day
QualityOf
Life
Skilled
Nursing Facility
Source: Intel Corp., Center for Aging
Services Technologies (CAST)
The Shift in Healthcare

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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

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10Methodology: Representative sample of 12,000 adults ages 18 and older.
Intel Healthcare Innovation Barometer (Dec. 2013)
Yes
No
Optimistic about healthcare
innovation/technology
Yes
No
Hospital obsolescence
Yes
No
Willing to share info for reduced
healthcare costs
Yes
No
Willing to use home monitors
80%
80%
50%+
70%

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Medical Trends: Remote Monitoring

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Adoption of mHealth initiatives and phases, globally
Source: World Health Organization 2009 Member Survey
Smartphones and Medical Devices

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13Source: PricewaterhouseCoopers’ HRI Physician Survey 2010
Do physicians want to track patients at home?

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14Source: PricewaterhouseCoopers’ HRI Physician Survey 2010
What do patients want from mobile technology?
51%
I would not buy mobile
health technology
20%
Monitor fitness/
wellbeing
18%
Have doctor monitor
condition from afar
11%
Monitor previous
condition

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Medical Device Trends
Global mobile health market opportunity by service categories.
Monitoring - 65%
Diagnosis - 15%
Treatment - 10%
Health Practitioner
Support - 5%
Wellness - 3%
Administration - 1%
Prevention - 1%
Chronic disease
management
and post acute
care – 29%
Independent
aging – 71%
Source: PwC analysisEstimated Worldwide opportunity of $23 Billion in 2017

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FDA Regulation of Mobile Platforms and Apps
• “Mobile platforms” - commercial off-the-shelf (COTS) computing platforms, with or
without wireless connectivity, that are handheld in nature.
• “Mobile app” - software executed on a mobile platform or web-based software that is
tailored to a mobile platform but is executed on a server.
• “Mobile medical app” - used as an accessory to a regulated medical device; or to
transform a mobile platform into a regulated medical device.
• “Mobile medical device” - When the intended use of a mobile app is for the diagnosis of
disease or other conditions, or the cure, mitigation, treatment, or prevention of
disease, or is intended to affect the structure or any function of the body of man.

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FDA and Mobile Apps
Proposed scope for oversight.
“mobile
medical apps”
Other mobile apps
that meet “device”
definition
Not considered “mobile medical
apps”
No regulatory
requirements.
Enforcement
Discretion
FDA Scope

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FDA Regulation of Mobile Apps
Note:
• First app approved in 1997.
• Total of 103 by 2013.

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Medical Device Trends: Health Apps
Source: Pew Internet/CHCF Health Survey,
August 7-September 6, 2012
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%

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Medical Device Trends: “Other Health Apps”

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MedicalConsumer
Hybrid
Device
Medical and Consumer Convergence

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Navman GPS SleeveCoPilot GPS for Laptop iPhone with GPS
The Three Stages of Convergence
1.Wired or wireless connection
2.Physically joined together
3.Integrated

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Sanofi Aventis iBGStar
Blood Glucose Monitor
Withings Blood
Pressure Monitor
AliveCor ECG Sleeve
iStethoscope
Expert
Examples of Medical Device Smartphone Convergence
Airstrip Patient
Monitoring

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Tandem Diabetes Care®: t:slim Pump

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Consumer Industry vs. Medical Industry
Source: IBM Institute for Business Value

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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

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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.

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Qualcomm Life Example
• Introduced the 2netTM Platform and Hub, which are designed to link medical
devices to service providers via the “cloud.”

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Internet of Everything/M2M/Connected Devices

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Mobile and Medical Concluding Thoughts
• Patients would like to have a single device that does everything.
• According to HRI research, at least 18 companies from the
telecommunications and consumer electronics sectors have entered the
medtech space.
• The value of devices is no longer only in the actual product itself.
• Don’t deliver data; deliver information.

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Bridge the Chasm
Relative%ofphonenumbers
Time
Customers want
technology and
performance
Customers want solutions and convenience
Innovators,
enthusiasts
Early adopters,
visionaries
Early majority,
pragmatists
Late majority,
conservatives
Laggards, skeptics

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Questions?
Bill Betten, Logic PD
• Email: bill.betten@logicpd.com
• Phone: 612.436.9771
• Website: www.logicpd.com