Are you involved in the development and introduction of hardware technology products to the market? Would you like to understand how to assess a product’s feasibility for moving into development? During this session, Micah Bongberg, the President of Annuvia and his development partners will share their experiences in determining the feasibility of Annuvia’s innovative new “Beacon” product. Learn how they figured out that the product was NOT classified as a medical device, even though it attached to a Class III Automated Electronic Defibrillator (AED). Find out how they navigated a technological “pivot”, after the team discovered an optimal sensing methodology that was more reliable and scalable than originally planned.

1. Product Realization Group
Webinar Series
Product Feasibility
…. Annuvia case study, understanding product readiness
Michael Keer
Founder and CEO
Product Realization Group
mkeer@productrealizationgroup.com
408.427.4645
©Product Realization Group, Inc., 2012 Pg 1

2. Where does Feasibility Fit?
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Product Lifecycle
Follows a product from concept to end-of-life
Feasibility is a subset of the product lifecycle, and
focuses on understanding the readiness to
move a product into development
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3. Impact of Feasibility in the
Product Lifecycle
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4. Importance of Feasibility in the Product Lifecycle
Escalator Effect
2500
$$$$
2000
# of Units
1500
$$$
#
1000
$$
$
500
0
NPI Proto I
Feasibility NPI Proto II Pilot Vol. Prod.
Do it right from the start -
The leverage is HUGE!
©Product Realization Group, Inc., 2012 Pg 4

5. Speakers
Micah Bongberg
Is the President and CEO of Annuvia. Annuvia is
one of the leading health, safety, emergency
preparedness, and emergency response
organizations in the United States.
Michael Keer
Is the Founder and CEO of Product Realization
Group. The PRG enables rapid and cost effective
introduction of products to the market, regulatory
compliance, manufacturing, service, and lifecycle
support.
©Product Realization Group, Inc., 2013 Pg 5

6. Speakers
Mark Brinkerhoff, PE
Is the President of Fusion Design. Fusion
provides mechanical development services
for medical, industrial, recreational and
many other product applications
Walt Maclay
Is the President of Voler Systems. Voler
provides electronic design and software
services for medical, industrial, aerospace
and instrumentation applications
applications.
©Product Realization Group, Inc., 2013 Pg 6

7. Feasibility Tips
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Identify risks early (regulatory,
technology, manufacturing, etc.)
Evaluate multiple solutions
Use known & easily available
y
technology
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8. Feasibility Tips
y p
Consider emerging technologies & markets
Weigh evolutionary vs. revolutionary
Choose scalable solutions
Technology
gy
Manufacturing
©Product Realization Group, Inc., 2013 Pg 8

9. BEACON PRODUCT FEASIBILITY:
CASE STUDY
©Product Realization Group, Inc., 20112

10. AED Industry Background
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Sudden Cardiac Arrest (SCA) is the leading cause
of death in the United States
Automated External Defibrillator (AED) units
provide a therapy that can save the majority of
victims (+70%)
Time is of the essence: Victim loses a 10%
chance of survival for every minute that passes
©Product Realization Group, Inc., 2013 Pg 10

11. Arch Software: What Does it Do?
Maintains records for AED owners, distributors,
and manufacturers
Registers units with local EMS or 911 dispatch
Oversee records by a licensed MD
Send AED owners reminders to update equipment
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12. The Beacon Product Concept
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Integrates with Arch
Turns our “static” database “dynamic”
Live Feedback
Automatically “reads” an AED’s status
Accurate AED location/placement data
Notification Instant AED is opened
Additional features (remote
updates)
Voice to connect rescuer with 911 operator
Temperature monitoring
©Product Realization Group, Inc., 2013 Pg 12

13. Now What?
Toe the
T th market opportunity while testing
k t t it hil t ti
feasibility
Understand all risks and expenses (to
build, produce,
build produce and operate)
Does the market opportunity exceed the
costs? How soon will we break even?
©Product Realization Group, Inc., 2013 Pg 13

14. Is it Feasible?
Regulatory Environment
l
Technology
Time-to-Market
Manufacturability
Costs
C t
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15. Regulatory Environment
g y
What class medical device would it be?
AED is class III, most highly regulated
Extra cost of developing a medical device
can easily double the cost
Quality system
Regulatory paperwork
FDA filing
Waiting for FDA response
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16. Determining Regulatory Status
g g y
Getting FDA to give definitive advice
before a product is developed is very
difficult
PRG regulatory partner has experience
working with FDA staff
g
Was able to get an email stating the
proposed product would not be a medical
device
Huge savings in time and money
©Product Realization Group, Inc., 2013 Pg 16

17. Technology: Feasibility Approach
gy y pp
Define key methods of detection
Design a test set up
Build
Test and submit results
Update test set up per feedback
Test
Report f
R t feasibility fi di
ibilit findings
Update Product Requirements
Document ( (PRD) )
©Product Realization Group, Inc., 2013 Pg 17

18. Technology Feasibility
Product Requirements
Sense a message on LCD display
g p y
Photosensor with LED illumination is simple, low cost detector
Wide range in ambient light – dark to full sun
Can t
Can’t obstruct view of
LCD display
Wireless data transmission
Low power consumption
Quickly open and replaced
electronics
Mechanical alignment
©Product Realization Group, Inc., 2013 Pg 18

19. Technology Feasibility - V1
gy y
Built simple circuit & mechanical mock-up to test
detection of warning
Tested in direct sunlight
Tested in full darkness
2-3 weeks to design, build, and test
Test results
Could sense error symbol in all light levels
Difficulty with reflected light
Obstructed view of display
©Product Realization Group, Inc., 2013 Pg 19

20. Technology Feasibility - V2
gy y
Pivot and design change
Camera chip sends image of LCD display
Easier to handle reflected light
Transmit entire image
Heavily compressed image
Large amount of data still makes detection easier
Technical challenges
Reflected light / proper illumination
Transmit entire image with low power consumption
What type of wireless transmission?
©Product Realization Group, Inc., 2013 Pg 20

21. Mechanical Feasibility: V1 vs. V2
y
LED Method Camera Method
VS
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22. Technology Feasibility - V2
gy y
Built and tested mock-up (2 – 3 weeks)
mock up
Built circuit from development boards (off the shelf)
Mechanical fixturing (board and light mount/shroud)
Test
T t results
lt
Detection worked in all light conditions
Display obstruction satisfactory
p y y
Determined housing could support solution
Cellular service met requirements best
Available h
A il bl where AED are located
AEDs l t d
Simple installation, no repeaters required
Low monthly cost
©Product Realization Group, Inc., 2013 Pg 22

23. Technology Feasibility V2
gy y
Integrated Camera System
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24. Product Feasibility
Conclusions
Regulatory impact
Knew what regulatory path was required
Lower cost and lower risk
Impact of feasibility technical work
I t ff ibilit t h i l k
Avoided designing a product that didn’t work
Saved two months and 10% of Dev. Cost
Lowered project risk – remainder of project had little
uncertainty
Product Requirements Document complete
Design schedule and cost accurately estimated
Ready to begin the design
y g g
©Product Realization Group, Inc., 2013 Pg 24

25. Feasibility Tips (summary): Q&A
y p ( y) Q
Identify risks early (regulatory
(regulatory,
technology, manufacturing, etc.)
Evaluate multiple solutions
Use known & easily available technology
Consider emerging technologies & markets
Weigh evolutionary vs. revolutionary
Choose scalable solutions
Technology
Manufacturing
©Product Realization Group, Inc., 2013 Pg 25

26. Product Realization Group
Webinar Series
Product Feasibility
…. Annuvia case study, understanding product readiness
Michael Keer
Founder and CEO
Product Realization Group
mkeer@productrealizationgroup.com
408.427.4645
©Product Realization Group, Inc., 2012 Pg 26