The document outlines the agenda for Meetup #18 on wearable technology. It includes welcome remarks, a presentation from Dr. Jayson Parker on changes in life science software regulation, a Q&A session, a break, a product demo of the Volvox wearable by Yogi Sennik, and closing remarks. Dr. Parker's presentation discusses how regulation has created new opportunities in wearables and the importance of understanding regulatory pathways. It covers different regulatory classifications and exemptions for low-risk wellness apps and software. The demo introduces the Life Band wearable for health monitoring and its target markets in fitness, chronic conditions, the quantified self, and seniors.

2. WELCOME
Meetup #18
Wearable Technology: How the
Marketplace has changed
#spwearables
@NimaMirpourian

3. • Welcome
• Wearable Technology
– Dr. Jayson Parker
• Speaker Q&A
• Break
• Demo Me: Volvox
– Yogi Sennik
• Closing Remarks & Networking
Agenda
#spwearables

4. www.http://linkd.@SiliconPeel

5. New Market Opportunities: Changes
in Life Science Software Regulation
Dr. Jayson L. Parker
Medical Biotechnology Analyst
Master of Biotechnology Program, University
of Toronto, 2014
#spwearables

6. New Market Opportunities:
Changes in Life Science
Software Regulation
Dr. Jayson L. Parker
Medical Biotechnology Analyst
Master of Biotechnology Program, University of
Toronto, 2014

7. Monetizing Opportunity: Hardware is only
the Gateway. Analytics is the Endgame.

8. Life Science Software has been a
Limited Commercial Opportunity

9. Why is Product Regulation
Relevant?
Cost. Time to market.
Cost. Testing requirements for product validation.
Market size. Limitations on the kinds of customers you can target.
Value Proposition. Limitations on the kind of product claims you can
make.
Opportunity. Recent changes in regulation have created new wearable
opportunities.
In my experience - no management team can can be taken seriously who
does not understand the regulatory path for their product.

10. Medical App Regulation: Potential
Model for Wearable Health Regulation
Radiologic viewer - from
workstation to
smartphone
Cardiac “monitoring”
wearable

11. “Medical” Regulation has Layers - it is
Not All or Nothing. Avoid the Core.
“Health”
Low Risk
Medical
High Risk
Medical
Medication reminder
software
Insulin pump software
Pacemaker Software
Product claim strength

12. Medical Device Risk
Stratification
Class I Class II Class III
Devices are stratified based on risk to the patient

13. US FDA Regulatory Path: Accessory
Rule Exemption for Apps
FDA Regulated medical Mobile apps can be
(as with any medical device): Class I, Class
II, Class III
Usually, software meets the same
requirement of the device connected to
for regulatory control. This known as
the “accessory rule”
Exception: the accessory rule is not
applied to mobile apps as this is
deemed to burdensome.
If the app adds functionality, then
requirements should reflect that
functionality

14. Apps that are not regulated as
Medical Devices: “Health” vs.
“Medical”
“apps” that have medical content that the FDA does not consider a “medical”
app include:
Mobile apps that are electronic “copies” of medical textbooks, teaching
aids or reference materials, or are solely used to provide clinicians with
training or reinforce training previously received. These types of apps do not
contain any patient-specific information
(other examples dropped from final guidance)

15. When does the FDA Views
Apps as Medical Devices?
Software is a Medical Device if
“intended use” says:
Accessory to a medical device
Diagnosis (or treatment) of a
condition
Mitigation, prevention of disease *
Prism of risk: can software error
harm the patient? Not all medical
devices meet this*
Exception: iTunes model,
homebrew. research use

16. Getting “Cute” & Avoiding Intended
Use Claims that Require Regulation

17. Discretionary Enforcement
Technically a medical device, and the FDA MAY enforce regulation.
Low risk to patients (Class I)
Examples
Coaching software: medication reminders, tutorial / how to information
Health / medical organizers of patient data for chronic conditions
Apps that help patients communicate / show their own medical data
(MDDS parallel)

18. Wearables Crossing the Line:
Screening (FYI) vs. Diagnosis
(Promise)
Product Claim 1: Will give
early warning of heart attack.
Customer: Recent heart
attack.
Product Claim 2: Will track work
out intensity (which is known to
be a predictor of heart attack)
Product Claim 3: Will help
prevent heart attacks caused by
exertion.

19. The Future
Health Wearables currently “niche” (beyond traditional medical devices)
Apple “iWatch” may open this market
Wearable to track food consumption
Wearables need to stick to “health”, low cost and avoid “diagnosis”
Apps / software that are a part of a wearable will have different
regulatory frameworks
Rise of Big Data in Health (not medical)
Advanced pattern recognition / “data” scientists

20. #spwearables

21. Break…
#spwearables

22. Demo Me
Life Band TM
Yogi Sennik
#spwearables

23. Wrist Worn Health Monitoring
Solution
Remote Monitoring | Fitness | Health Tracking
CONFIDENTIAL 23
Life Band TM

24. Life BandTM
Continuous Monitor of Health Vitals
Real Time Data
Heart Rate / ECG
Respiration Rate
Blood Oxygen Content
Blood Pressure (on
demand)
Skin Temperature / UV
Motion
Location / BLE
Non Medical Device
(Future ISO 13485)
CONFIDENTIAL 24

25. Life Band TM
Quantified self user
Consumer demands to know and measure activity & health trends
Aging Population
Independent living, mobile and need for security
Life-Style linked diseases
Preventative programs and monitoring
Rising health care costs
Internet driven remote diagnostics and monitoring tech.
Other Market drivers
Patient centric healthcare, Govt. policy, new business models
CONFIDENTIAL 25

26. Life BandTM
Comparatives
CONFIDENTIAL 26
FEATURES
LIFE BAND
LIFETRAK C300
MISFIT SHINE
AMIGO
FITBIT FLEX
BASIS
NIKE FUELBAND
JAWBONE UP
LARK LIFE
POLAR LOOP
FITBIT FORCE
Time of Day
Steps
Distance
Calories
Sleep
Heart Rate
Blood Oxygen
Skin Temp
Blood Pressure
Respiration Rate
Heart Rate Variability
Altimeter
Waterproof
Unit Price ( in US $) 164 60 100 119 100 199 149 129 150 110 130

27. Life BandTM
Target Markets
Product Market Segment
Life Band TM Fitness & Health
Chronic
Quantified Self
Seniors
Smart Phone
Tablet
CONFIDENTIAL 27

28. Life BandTM
Fitness & Health Chronic Quantified Self Seniors
CONFIDENTIAL 28

29. Life BandTM
Target Markets
>60M in North
America
CONFIDENTIAL 29
Market Segment
Fitness & Health
Chronic
Quantified Self
Seniors
2013 Fitness Trackers
Sales $330M
Asthma / COPD / Heart
Disease / Dementia
2014 Q1 F Trackers
Sales $200M
70 M in North America
840 M combined World
> 1.3B World Wide – 50%
Increase by 2030
48% do not have
39% Seniors Live Alone family locally

30. CONFIDENTIAL 30
Life Band TM
Patent pending software for PPG, respiration,
Blood pressure calculation and automatic sleep
detection.
Multiple sensors – temperature, optical,
motion, gyro and proprietary software to
derive sleep, motion and fall detection events.
Free RTOS OS based and open to third party
innovation

31. Aug 2014
Oct 2014
Alpha testing
Integration
testing
Marketing
collateral
Prioritize
Market
Segment
Production
planning
Launch
Mar 2014
July 2014
Test Board
Firmware bug
fixes
Hardware RF
fixes
Industrial
design
Final review of
software &
hardware
Life BandTM
Dec -2013
Feb -2014
Proof of
concept
Software
architecture
Sensor testing
Prototypes
Project Status – Next Steps
Beta Units : 50
Crowd Funding
Website
PR
Social Media
Media Advertising
Product Positioning
Channel Partners

32. #spwearables

34. Next Meetup #19
“Women in Technology”
Date: Sept 25, 2014
Time: 7:00pm-9:30pm
Location: Xerox Research Centre of Canada
Address: 2660 Speakman Drive, Mississauga ON
Registration via Eventbrite.com or Meetup.com