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Meetup #18

Wearable Technology: How the Marketplace has changed

#spwearables

• Welcome

• Wearable Technology– Dr. Jayson Parker

• Speaker Q&A

• Break

• Demo Me: Volvox– Yogi Sennik

• Closing Remarks & Networking

Agenda

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TechEntrepreneurs

Business Professionals

Tech Enthusiasts

Industry Leaders

YOU

Community

www.SiliconPeel.com

http://linkd.in/spligroup

@SiliconPeel

Dr. Jayson L. ParkerMedical Biotechnology AnalystMaster of Biotechnology Program, University of Toronto, 2014

New Market Opportunities: Changes in Life Science Software Regulation

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New Market Opportunities: Changes in Life Science Software Regulation

Dr. Jayson L. ParkerMedical Biotechnology Analyst

Master of Biotechnology Program, University of Toronto, 2014

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

Life Science Software has been a Limited Commercial Opportunity

Vertex Pharmaceuticals is a leader in “rational drug design”

Rational Drug Design Software

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.

Medical App Regulation: Potential Model for Wearable Health Regulation

Radiologic viewer - from workstation to smartphone

Cardiac “monitoring” wearable

“Medical” Regulation has Layers - it is Not All or Nothing. Avoid the Core.

“Health”

Low Risk Medical

High Risk Medical

Pacemaker Software

Insulin pump software

Medication reminder software

Product claim strength

Medical Device Risk Stratification

Q-Tip Swab Dental imaging Cardiac stent

Devices are stratified based on risk to the patient

Class I Class II Class III

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 IIIUsually, 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

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)

When does the FDA Views Apps as Medical Devices?

Software is a Medical Device if “intended use” says:

Accessory to a medical deviceDiagnosis (or treatment) of a

conditionMitigation, prevention of

disease *Prism of risk: can software

error harm the patient? Not all medical devices meet this*Exception: iTunes model, homebrew. research use

EKG app on an iPad

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

is above a medical device app?

Discretionary EnforcementTechnically a medical device, and the FDA MAY enforce

regulation.Low risk to patients (Class I)

ExamplesCoaching software: medication reminders, tutorial / how to

informationHealth / medical organizers of patient data for chronic

conditionsApps that help patients communicate / show their own medical

data (MDDS parallel)

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.

The FutureHealth Wearables currently “niche” (beyond traditional medical

devices)Apple “iWatch” may open this marketWearable 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

#spwearables

Break…

#spwearables

Demo Me

Yogi Sennik

Life Band TM

#spwearables

23CONFIDENTIAL

Wrist Worn Health Monitoring Solution

Remote Monitoring | Fitness | Health Tracking

Life Band TM

Life BandTM

24CONFIDENTIAL

Continuous Monitor of Health Vitals

Real Time Data

Heart Rate / ECGRespiration RateBlood Oxygen ContentBlood Pressure (on demand)Skin Temperature / UVMotion Location / BLENon Medical Device(Future ISO 13485)

25CONFIDENTIAL

Life Band TM Quantified self userConsumer demands to know and measure activity & health trends

Aging Population Independent living, mobile and need for security

Life-Style linked diseasesPreventative programs and monitoring

Rising health care costsInternet driven remote diagnostics and monitoring tech.

Other Market driversPatient centric healthcare, Govt. policy, new business models

Life BandTM

26CONFIDENTIAL

Comparatives

FEATURES

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Time of DayStepsDistanceCaloriesSleepHeart RateBlood OxygenSkin Temp Blood PressureRespiration RateHeart Rate VariabilityAltimeterWaterproof

Unit Price ( in US $) 164 60 100 119 100 199 149 129 150 110 130

Life BandTM

27CONFIDENTIAL

Target Markets

Life Band TM Fitness & Health

Chronic

Quantified Self

Seniors

Product Market Segment

Smart Phone

Tablet

Life BandTM

28CONFIDENTIAL

Fitness & Health Chronic Quantified Self Seniors

Life BandTM

29CONFIDENTIAL

Target Markets

Fitness & Health

Chronic

Quantified Self

Seniors

Market Segment

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 family locally39% Seniors Live Alone

>60M in North America

30CONFIDENTIAL

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

Alpha testingIntegration testing

Marketing collateralPrioritize Market

Segment

Aug 2014Oct 2014

Test Board Firmware bug fixes

Hardware RF fixesIndustrial design

Final review of software & hardware

Mar 2014July 2014

Proof of concept

Software architecture

Sensor testingPrototypes

Dec -2013Feb -2014

Life BandTM

Project Status – Next Steps

Beta Units : 50

Crowd Funding

Website

PRSocial Media

Media Advertising

Product Positioning

Channel Partners

#spwearables

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