About UCI Applied Innovation: UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market. About the Cove @ UCI: To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts. Follow us on social media: Facebook: @UCICove Twitter: @UCICove Instagram: @UCICove LinkedIn: @UCIAppliedInnovation For more information: cove@uci.edu http://innovation.uci.edu/

1. UC Irvine Applied Innovation Center
Lunch-n-Learn Presentation @ The COVE
Friday August 4, 2017
“Defining a Commercially Viable Product”
A Case Study: Phase – 0 to Phase 2
Manas Kanungo
Int’l Medical Marketing (IMM) USA, LLC
I love a challenging role – where I can learn and create innovative, sustainable global
solutions that enhance health outcomes.
Manas Kanungo Confidential 1

2. Career Summary
Define, Plan, Execute Innovative Solutions - Enter & Grow Int’l Markets
Manas Kanungo Confidential 2
 15+ Yrs in Hospital, Lab, POL, POC Medical Device, Diagnostic industry
 Small - Large companies: Start-ups, BioTek, Quidel, Roche, Bayer, Abbott
 Built, coached, supervised, led direct, in-direct, matrixed teams
 Define, Develop, Execute market entries, growth, product & brand launches, exits
 Multi-country, multi-segment VOC qual/quant market, ethnography research
 Unique ability to cross boundaries between diseases, therapies, technologies,
providers, payers, patients for impactful, competitively sustainable solutions
 Lived, worked out of 3, traveled in 50+ countries
 US citizen with work visas for Brazil and India
 Native English w/business fluency in Portuguese, Hindi, Oriya; basic Spanish
 Int’l Sales, Distribution, Product, Marketing, JV, Commercial Leadership Roles
 Strong Strategic Upstream Planning, Downstream Execution – Products, Markets

3. Academic Achievements
Degrees
HealthCare Executive MBA: UC Irvine
MS Bioengineering & MS Electrical Engineering: West Virginia University
BS Electrical Engineering: National Institute of Technology, India
Continuing Education
Omics, Bioscience, BioPharma, Life Science Trends & Strategies: UC Berkeley
Cloud Computing: Stanford University
Mobile Medical: UC Santa Clara
High Impact Leadership: UC Berkeley
Global Leadership: Thunderbird
Recognitions, Publications, Patent
Honorary Diploma, Association of Hospital Engineers, Spain
SBIR Grants, MS Thesis, VT State Award, ISO/ASTM for Ventilator Tester
Published in Electrophysiology area; White Papers; Patent applied for.
Manas Kanungo Confidential 3

4. New Product Development & Commercialization Process
Phase - 0 Phase - 1A Phase – 1A Phase – 1B
Manas Kanungo Confidential 4
Phase - 2 Phase - 3 Phase - 4 Phase - 5
Idea – Hypothesis - Proposal
Prelim. Interests, Potential
Qualitative – Assessment
Observe, Probe, Analyze, SWOT
Market, Competition, Customer
Qualitative - Proposal
Build, Test Mock Demos
Unspoken, Unmet Needs
Quantitative Definition
Build, Test Working Prototype
Product, Workflow, Targets
Road-map, Business Proposal
Product, Market Development
Mfg Eng., Build, Validate, Costs
Marketing, Sales, Target Plans
Pre-Launch, Market Access
Clinicals -> FDA/CE -> Reimb.
Buildup Forecasts, 7Ps, Teams
Launch Product, Services
Staged Roll-out, Alliances
Media, Marcom, Partnerships
Post-Launch
Monitor, Lifecycle, Exit
Portfolio Extensions, NextGen
7P’s: Product, Price, Placement, Promotion, People, Process, Physical Evidence

5. Phase – 0: Idea, Hypothesis, Proposal
Manas Kanungo Confidential 5

6. Page 6
Big Gap b/w high-end ‘connected’ monitoring systems &
low-end BGM meters
• Suitable for high-end networked hospitals
• Facilitates accreditation and QC related needs
• Cost to use is relatively higher than SMBG meters
• Currently many hospitals use only a few functions
that are being offered in this category
• Does not require IT infrastructure in the hospitals
• Manual methods for accreditation and QC needs
• Offers very limited functionality
• Ease of use and low cost are primary drivers
10:23pm 08/03/2011
Test Menu
Control Test
Patient Test
Main Menu
XP Hospital
• A middle level meter that does not require
elaborate IT infrastructure and resources
• Helps meet accreditation and QC needs
• Easy to use functions for multi-patient, multi-
user, small-mid sized hospital environment
• Broad range of functions with ability to
customize for local needs
Cost&ITsophisticationlevel
High
Low
ABT-PxP Roche-Inform Nova-Stat Strip

7. Industry Trends, External Forces
• Push to Implement New Point-of-Care Standards
– With better performance: + 10-15% accuracy with no
interference from drugs or other health conditions
– Prevent cross-contamination: multi-patient / user
• More hospitals world-wide wanting to adopt
ISO, POC Standards for Accreditation
– To be equal to their peers, be a global player
– Command higher reimbursement, fees
• New Entrants Challenging BGM Market Leaders
MK 2014 Manas Kanungo Confidential 7

8. Page 8
• To develop a cost-effective, multi-patient, multi-user,
“middle meter” w/new technology platform in development.
• To fill an important gap in the portfolio, by meeting the
needs of hospitals motivated for QA or Accreditation, but
w/o budget or infrastructure for IT or high-end systems.
Opportunity
• A meter positioned towards ‘aspiring’ hospitals in emerging
economies with a broad range of relevant features and
offered at a price point close to existing SMBGs commonly
used in hospitals by leveraging the new platform.
• Additional potential for US, CND, EU
Strategic
Intent
• Hospitals that need compliance with QA, QC, audit,
Accreditation and Regulatory requirements for multi-
patient, multi-user POC blood glucose testing without
additional investment in IT infrastructure and resources
Target
Market
PROJECT OVERVIEW – Initial Proposal

9. Phase – 1A: Qualitative Assessment
Observe, Probe, Analyze, SWOT
Market, Competition, Customer
Manas Kanungo Confidential 9

10. Page 10
Amongst Top BGM Manufacturers, LifeScan [ J&J ] was the only known
competitor developing a “middle meter” for emerging hospital markets.
OneTouch Verio PRO; 1st Generation meter
(H1:12 Asia Pac)
• Uses OneTouch Verio test strip (0.4 µL, 5
sec), no-coding, POC hospital accuracy
• Verio test strip is NOT approved for
neonatal use at this time; venous, capillary,
and arterial testing only
• Expected 1st gen meter features:
•Test Strip ejector
• Color Screen, use in low light
• New industrial design, created
specifically for the hospital segment
(can withstand rigorous cleaning/
disinfection, durable, etc.)
• NO Connectivity, NO Ketones
2nd Generation Verio PRO (currently in
early development stage, est 2013 - 2014 )
• Same meter chassis and test strip
• Enhanced software functionality:
• Connectivity, data transfer
• Multi-patient capability with ability to
validate results recorded
• QA/QC
While Roche and Bayer did not appear to have internal
“middle-meter” hospital products in development,
select Asia Pacific based secondary players (Sanwa,
Arkray, Terumo) have shown hospital focused meters
for Japan with strip ejectors.

11. Page 11
Developing economies present a significant opportunity ….
LA $98
EMEA
$197
APAC
$187
2010 2017
LA $98
EMEA
$211
APAC
$213
< 100
OUS Market Size - $ 535 M
Expected growth in market size by region1
Per capita expenditure on health by country2
1 Based on BBC WWB Data 2010; 2. Based on WHO estimates
Market Drivers:
• 7% growth expected over next 5
years among inpatient hospital
strip business in developing
economies – BBC report
• China likely to add at least 300
county-level hospitals and
1,000 town-level health centers
– Ministry of Health of China
• High growth expected in hospital
beds fueled by strong demand
from medical tourism in India,
Thailand, Taiwan and Malaysia
• Increase in number of beds in
Singapore due to ageing
population – Frost and Sullivan
• Moderate growth expected in
Australia with nearly 50% of
patients treated by private
hospitals in the future (presently
40%) - Australian Institute of
Health & Welfare
>4kPer capita expenditure on health ($)
<0%
> 30%
Growth(05-10)
India
Thailand
UK
Argentina
Australia
Brazil
Chile
China
France
Germany
ItalyMalaysia
Mexico
Singapore

12. Manas Kanungo Confidential 12
8 Countries: USA, CND, Brz, UK, Fr, Ger, Chn, Jap

13. Manas Kanungo Confidential 13
22 Hospitals; 500+ HCPs

14. Manas Kanungo Confidential 14

15. Manas Kanungo Confidential 15

16. Manas Kanungo Confidential 16

17. Manas Kanungo Confidential 17

18. Manas Kanungo Confidential 18

19. Phase – 1A: Qualitative Proposal
Build, Test Mock Demos – Alpha Units
Validate Unspoken, Unmet Needs
Manas Kanungo Confidential 19

20. Manas Kanungo Confidential 20

21. Insights gained from research feeds concept development

22. MK 2014 Manas Kanungo Confidential 22

23. Phase – 1B: Quantitative Definition
Fine-tune Product – Beta Units
Define Workflow, Target Market/s
Strategic Road-map, Business Proposal
Manas Kanungo Confidential 23

24. Page 24
Market Research: Phase 0 - 1B: 8 Countries, 44 Hospitals, 500+ HCPs
COUNTRIES Phase-0 Qualitative
7 Countries,24 Hospitals,126 HCPs
Phase-1A Qualitative
4 Countries, 20 Hospitals,64 HCPs
Phase-1A Quantitative
227 Online Participants:
Decision Makers &
Influencers
Phase-1B: 82 HCPs
Sept GUI: 3 Countries
Sept Feedbacks: 5 Countries
UK: Nov GUI, Dec Formative
In Field: 13 mths May – July ‘2010 Nov ’10 – Jan ‘11 May – June ‘11 Sept– Dec ‘11
UK
• Frimley Hospital
• Barnet Hospital
• Kings Cross College
• Royal Free Hosp * Chlesea/ Westmr
• North Middlesex * Kings College
• Royal London Hosp * Homerton NHS
126
Admins, Purchasers;
Nurses, POCCs, Lab,
Endos, Diabetologists
• Feedbacks:
Sept 19 – 20 (3 POCCs)
• GUI & Formative: 12 + 12 HCPs
Nov 1-3; Dec 13-15
Germany • Charite Berlin * Martin-Luther
• Vivantes * Diab Clinic Berlin
France
• CHU Nantes
• La Pitie Salpetriere
• Ambroise Pare
• Le Havre Hospital
• Reims Hospital
• Bichat Hospital
• Feedbacks: Sept 22 – 23
(7HCPs)
China
• Peking UniversityHospital
• Shanghai Huashan
• Shanghai No. 6 Hospital
• Feedbacks& GUI: Sept 26 – 30
(17 HCPs)
Japan
• Japanese Red Cross Medical Center
• Eiju General Hospital
• Fukushima Medical UniversityHosp
• Feedbacks: Oct 4-6
(12 HCPs)
Brazil
• Santa Casa de Misericordia
• Hospital Nipo Brasileiro
• Hospital Clinicas
• Hospital Alemao Oswaldo Cruz
• Albert Einstein Hospital
• Hospital Beneficia Portuguesa
• Darcy Vargas * Hospital Pasteur
• Lefort
• Sabara
• Santa Paula
• Pro-Cardiaco
• HCN - Niteroi
101
Admins, Purchasers;
Nurses, POCCs, Lab,
Endos, Diabetologists
• Feedbacks& GUI: Sept 26 – 30
(16 HCPs)
Canada • St. Mary’s Hospital Centre Montreal
• Verdun Hospital Centre Montreal
• San Francisco: Dry Run
Sept 1 (3 HCPs)
USA
• RUSH Hospital Chicago
• Montefiore, Bronx NY
• MUSC, Charleston, SC
• VA Hospital, Madison

25. Page 25
Regulatory Compliance:
(Internal or External)
 QA Enforcement
or
 Accreditation
Motivation
Hospital Budget & Infrastructure – IT and POCC
(Automation, EMR, LIS, HIS, Wireless)
Low
XP-H Pegasus
P2-H
Enabled by New Precision Hospital Strip
“Aspiring” Middle Market “Networked” Market
“Status-Quo” Market
High
Low High
“Low Compliance” Market
or
XP-H will fill an important gap, by meeting the needs of “Aspiring” Hospitals
motivated for QA or Accreditation, but without budget or infrastructure
Hospital Portfolio Map
There are more # of
“Aspiring” middle-
market hospitals than
large hospitals.

26. Page 26
“Networked” “Aspiring” “Status-Quo”
Meter System that meets needs PXPw + PWeb XP-H P2-H
Hospital
Hospitals with sufficient budget
and infrastructure for IT and
POCCs
Hospitals with less budget and
no infrastructure for IT or POCCs
Any Hospital
Lab Role, and status of
Enforcement of QA/QC
Procedures
High degree of lab control of
quality and training.
QA/QC SOPs for POC glucose
testing throughout hospital are
highly coordinated.
Emerging lab control for quality
and training.
Emerging coordination & SOPs
for hospital wide QA/QC of POC
glucose monitoring systems
Little or no lab control of quality
and training.
Little or no QA/QC SOPs for
hospital wide POC glucose
monitoring systems
Meter role in certification
Hospital certification relies
heavily on automated meter
features & software to integrate
with networks, processes, and
procedures
Hospital certification is a
combination of policies,
procedures, and manual
processes, aided by meter
features
Hospital certification depends on
manual process to meet minimal
requirements
Purchase Decision Making
Process
Hospital-wide meter selection
process.
Individuals external to the point
of use have primary influence
(purchasing, lab, hospital
administrator)
Moving towards hospital-wide
selection process, may have
some departments coordinated.
Endos, nurses, and some times
labs have influence on meter
decision making.
Purchase Decisions made by
point-of-use department or ward.
Endos and nurses are primary
decision makers for meter
selection.
Characteristics of “Aspiring” middle-market Hospitals

27. Page 27
Users, Influencers, Decision Makers – “Personas”
Specialties Features Used
Hospital
Administration
• Administrators
• Department Managers
• Audit Managers
• Risk Managers
• All consolidated hospital-wide and location reports
• Exception reports
• Results Traceability – Patients, Hypo/Hyper, QC,
• Benchmark performance
• Operator Training Compliance
• Strip inventory / usage summary stats, trend graph
Physicians
• Endos
• Diabetologists
• Patient results on meter, reports, with IDs
• Hypo/Hyper alerts, readings, guidance for next steps
Laboratory
• Lab Managers & Technicians
• POCCs
• Meter set up
• QC: readings, reminders, lockout, exception reports
• Operator Training Compliance
• Data export, consolidation, reports
Nurses
• Head Nurse
• Floor / Ward Nurse
• Diabetes Specialist Nurses (DSN)
• Nurse / Health Care Assistants
• Perform patient tests, use results for therapy
• Perform QC tests
• Patient results w/traceability to record, act on
• Operator Training Compliance
• Guidance messages for next steps

28. Page 28
Meeting Accreditation and Standards Requirements
.. 4 Relevant Areas Across 9 US & Int’l Standards
Patient Care Standards How to Meet This Requirement
• Accurately Identify Patients • Match patient with a number, name, and/or birth date
• Record Results for the right Patient • Enter and confirm Patient ID before testing
• Retrieve Patients’ Results • Search and retrieve patient results using IDs
• Define Critical Results & Guidelines,
follow Protocols for Clinical Care
• Method to identify and alert out-of-range patient
results, and provide guidelines for next steps
• Evaluate Patient data to Improve Care • Consolidate data, generate statistical & trend reports
*Joint Commission Int’l (JCI); ClinicalPathology Accrdn; CPA-POCT Addendum; Canadian Int’l Lab & Blood, BiomedicalLab, POCT; Brazil RDC & ONA; China POCT
 No Standard requires a “networked” system ….any device can be used for this process
 There are 4 main areas relevant to bedside testing, across 9 Int’l Standards …
…. Where streamlining the process to meet these requirements will make a difference…
Operator Standards How to Meet This Requirement
• Evaluate Operator Performance,
Training
• Consolidate data, generate statistical & trend
reports
• Identify Operator when test is
performed
• Enter Operator ID before a patient or QC test
Quality Control (QC) Standards How to Meet This Requirement
• Regularly test/calibrate devices,
reagents
• Perform, record regular QC tests on devices,
reagents
• Implement & record corrective
actions
• Prevent patient testing if QC fails; record &
report data
• Evaluate data, improve quality of
process
• Consolidate data, generate statistical & trend
reports
Data Management
Standards
How to Meet This
Requirement
• Data readily available
in format to promote
monitoring and
traceability
• Ability to filter, sort, search,
and report data in ways
relevant to use areas
• Prevent loss or
tampering of data
• Administrative access to,
prevent editing of, records
• Implement inventory
control system
• Monitor and report strip
usage

29. POC Lab Accuracy
Shazam H
Positioning &
Differentiation
XXXXXXXXX

30. Page 30
40%
37%
30%
20%
+3%
+7%
+10%
Hypo/Hyper Alerts Patient Results Traceability Glucose and Ketone Strip
Testing
Training Compliance
Prioritized Features w/Purchase Intent “TURF” Analysis
Order of Focus for Maximum Reach
Cumulative
Reach
48%
45%
40%
32%
+3%
+5%
+8%
Hypo/Hyper Alerts Training Compliance Glucose and Ketone Strip
Testing
Individually Foil Wrapped
Strips
Training Compliance is
interchangeable with:
1..Quality Control 41%
2. Strip Usage: 40%
3. Audit Performance: 39%
"Total Unduplicated Reach and Frequency"

31. Page 31
Product Overview – Key FeaturesA cost-effective, easy to use touch screen hospital meter to ensure compliance with Regulatory & Accreditation
requirements; enforce QA Procedures; Audit Performance & Manage Strip Inventory; and to Improve Quality of Care in a
multi-patient testing environment that requires minimal IT investment
Performs Meter QC
Hypo Hyper Alerts
Multi-patient usability
Nurse ID Record
Foil wrapped strips
• Performs Meter QC with options for
 Alerts
 Lock-outs to ensure QA Compliance
• Hypo / Hyper Alerts with
 User customizable messages for next steps
• Multi-patient results tracking to reduce transcription errors with
 Customized length of numeric characters (up to 12 digits) to record patient ID
 Option to sync with PC app to download patient data on meter
• Ability to record Nurse ID to aid compliance documentation with
 Customized reporting for better inventory management &
 Enforce QA protocol in the hospital setting
• Foil wrapped Glucose & Ketone strips with
 New ISO accuracy &
 5-sec test time

32. Page 32
Data ReviewSettings
Test Menu
Main Menu
BETA UNITS, MENU OPERATION
CLIA Waived, FDA Class-II, POC System for Hospitals, Clinics, POLs

33. Page 33
Work-flow: Patient Testing GUI

34. Page 34
Work-flow: QC Testing - GUI

35. Page 35
Patient & QC Reports via PC App

36. Page 36
PROJECTIONS
Estimated
Launch Countries
Estimated
approval
time
(months) Risks
Chile 0
Launch could be delayed if Chile
regulation changes and decides
to regulate medical devices
Colombia 2
France 1
Germany 1
Hong Kong 0
Regulation expected to change.
Launch could be delayed if Hong
Kong regulation changes by the
launch time
Italy 1
Malasya 0
Regulation expected to change
by Q4/14. If project gets
delayed, this product will require
longer time for approval and
launch
Spain 1
Thailand 1
UK 1
Q1/14 India 7 to 10
Argentina 9 to 13
Mexico 10 to 13
S.Korea 8 to 12
Australia 13
Singapore 13 to 16
Brazil 25 to 30?
Taiwan 16 to 24
Q2/15 China 22
Q4/13
Q2/14
Q3/14
Q1/15
Total
2010 2011 2012 2013 Program
OPS / QA FTE - - - - -
Outside Spend - - 0.1 - 0.1 Capital Equipment Setup
Total OPS / QA - - 0.1 - 0.1
R&D FTE - 0.5 2.6 2.6 5.7 R&D, Ops/QA and NPI Proj Leadership HC
Outside Spend - 0.5 3.2 2.0 5.6 See Detail Below
Total R&D - 1.0 5.8 4.6 11.3
GSM FTE - 0.5 0.5 0.5 1.5
Outside Spend 0.6 0.2 0.3 1.2 2.3 Market Research, Toolkit Development
Total GSM 0.6 0.7 0.8 1.7 3.8
Legal FTE - - 0.1 0.1 0.2
Outside Spend - - 0.3 - 0.3 FTO / Patent Landscape
Total Legal - - 0.4 0.1 0.5
Total FTE - 1.0 3.2 3.2 7.4
Expenses Outside Spend 0.6 0.7 3.9 3.2 8.3
Total P2 Expenses 0.6 1.7 7.1 6.4 15.7
Capital Expense 2010 2011 2012 2013 Total
Product Molds - - 0.5 - 0.5
R&D Detail ($MM) 2012
Software & SWQA $1.5
Design and Testing 1.2
Materials and Parts 0.1
Human Factors 0.1
Clinical Trials (Approval) 0.4
Total R&D Outside Spend $3.2
Costs INCREMENTAL (Fully Burdened) P&L
2012 2013 2014 2015 2016 2017
Sales - 15.6 21.4 39.3 41.4 43.6
COGS - 4.5 5.1 10.1 11.5 11.7
Prod Mgn - 11.1 16.3 29.2 29.8 31.9
% of NS n/a 71% 76% 74% 72% 73%
Distribution Mgn (0.1) 9.5 14.2 25.2 25.7 27.5
% of NS n/a 61% 66% 64% 62% 63%
R&D 5.8 4.6 1.3 2.4 2.5 2.6
% of NS n/a 30% 6% 6% 6% 6%
SG&A 1.2 1.8 7.3 13.5 14.2 15.0
% of NS n/a 12% 34% 34% 34% 34%
Division Margin (7.1) 3.1 5.5 9.3 9.0 9.9
% of NS n/a 20% 26% 24% 22% 23%
CASH FLOW
2012 2013 2014 2015 2016 2017
Net Income After Tax (4.4) 1.9 3.4 5.8 5.6 6.1
Capital Expense (0.5) - - - - -
Working Capital 0.9 (3.1) (0.6) (2.6) (0.5) (0.2)
Net Cash Flow (4.0) (1.2) 2.9 3.2 5.1 5.9
NPV $6.6
IRR 42%
Financials Regulatory Approvals & Launch

37. STRATEGIC ROAD-MAP