Post on 27-Jun-2015
description
WELCOME
@NimaMirpourian
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
#spwearables
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
#spwearables
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
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
LIFE
BA
ND
LIFE
TRA
K C3
00
MIS
FIT
SHIN
E
AM
IGO
FITB
IT F
LEX
BASI
S
NIK
E FU
ELBA
ND
JAW
BON
E U
P
LARK
LIF
E
POLA
R LO
OP
FITB
IT F
ORC
E
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
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