1. Sweet Sensors
Glucose Monitor: We have developed a novel
technology to use any
• Widely available glucose monitor without
• Cheap modifications to detect a
• Quantitative wide range of non-glucose
information targets at very low
concentrations
However, it can detect (such as disease markers,
only one target: glucose drugs, heavy metals, toxins,
and at very high bacteria and viruses)
concentrations
Yu Xiang and Yi Lu, Nature Chem. 3, 697-703 (2011).

2. Business Model Canvas #3
Yi Lu, Tian Lan
Sweet Sensors Neil Kane 10-18-2011
Chris Sorensen
Conferences
Product R&D Immediacy?
Glucose monitor At home Diabetics
QC Product supports
manufacturers
Clinicians (in rural area)
Marketing Convenient Patient
Kit manufacturers network/community Triage nurses
FDA approval for in Less exposure to
Reagent suppliers vitro diagnostics infectious diseases Pre-diabetics
in the hospital
Food safety and
Cheaper security related
KOL
More frequent Retailers (Walgreen)
IPs
Personnel Better indicator of Online vendors (Amazon)
health (diabetic
management) Direct sales
Reagents Disposable test kit (used repeatedly
on a regular basis)
Manufacture
Licensing
FDA approval for in
vitro diagnostics

3. Meetings/Conversations From the Past Week
• Ned Devine, Underwriter Lab
FDA • Dr. Anand Akerkar, CEO of MDI consultants
regulation
• Harlee Sorkin, med. device entrepreneur
• Patient group at Christie Clinic@Champaign
Customer/ 6 patients + 2 nurses
value prop
• Professor Karen Chapman-Novakofski
• David Rosenthal, CEO of ConcernTrak
Customer • Principal scientist at Abbott Molecular
/Partner • People from a major Pharma company

4. Key findings: Customers
• From the Christie Clinic’s diabetes support
group:
1. All A1C tests are administered in the clinic with a blood test
2. Bayer A1CNOW+ home test kit is not accurate
Our product will be valuable if it’s accurate enough (+/- 0.1 %)
3. Test performed quarterly for patient with > 7.5 % HbA1c; good
management means lower frequency for HbA1c testing
4. Some patients lack confidence of performing their own HbA1c testing by
themselves
• Prof. Chapman-Novakofski:
1. Lipid profiling along with HbA1c in the blood test, but it’s an annual test
2. Home test kit can reduce the clinic visit to annually
3. Opinion of the nurse can influence doctor’s decision
4. LDL is one other marker that diabetes patients check regularly, yet no
home test is available

5. Key findings: Partners and Others
• Principal scientist at Abbott Molecular
1. Abbott sells a glucometer now
2. Potential partner, but also an 800 lb. competitor?
3. We are waiting to hear back from them
• Reimbursement strategy (Harlee Sorkin)
1. It’s as crucial as the product for medical devices
2. Insurance/Medicare/Medicaid coverage
- CMS codes available for reimbursement (Yes good; No, takes 5 years or
more to apply for one)
• Monitoring prescription drugs in patients
1. A major pharmaceutical company has expressed interest in using our
technology for patients to use glucose meter to monitor drugs they sell to the
patients (this application is very close to blood glucose monitoring by
diabetics in terms of regular use and immediacy (they need to take actions
based on the results)
2. The company is willing to provide R&D support if they decide to proceed

6. Business Model Canvas #4
Yi Lu, Tian Lan
Sweet Sensors Neil Kane 10-25-2011
Chris Sorensen
Conferences
Product R&D Immediacy
Glucose monitor Out of clinic Diabetics
QC Marketing Product support
manufacturers
- Abbott? Clinicians (in rural area)
FDA approval for in Convenient Patient
vitro diagnostics network/community
Pre-diabetics
Kit manufacturers
Food safety and
Reagent suppliers security related
Cheaper
Drug monitoring
KOL More frequent Retailers (Walgreen)
IP Personnel Medical Products Distributors
Pharmaceutical Cos
Disposable test kit (used repeatedly
Reagents Licensing on a regular basis)
Manufacturing FDA approval for in Reimbursement strategy
vitro diagnostics
Licensing Sponsored development or JDA

7. Decision point
HbA1c market (diabetes) or other Ensuring compliance of patented
consumer markets pharmaceuticals
Results: Mixed results from customer Results: Clear demand & support from big
development activities pharmaceutical company
Actions: Actions:
• Talk to people more intensively • Probe for similar demand from other
• Find the more valuable market segment pharmaceutical companies
or continue with HbA1c market • Confirm that exclusivity is limited to
• Continue on the business model canvas their patented drugs only
• Investigate cardiac markers • Talking to pharmaceutical companies
and pursue partnership
From the standpoint of the curriculum, pursuing the HbA1c market route is more
straightforward. Partnership with big pharmaceutical companies may be more
appropriate in reality but hard to see how it will be conclusive by December.

8. Key findings: FDA approval
1. 510(k): 5M and 1 year
2. 510(k) fast track: 50K and 6 months (?)
• UL can perform the testing for $8,500 in 6 months, but can NOT help to craft the 510 (k) application
• Dr. Akerkar suggested the WHOLE process would take 12-18 months and $500K-$600K (including
his consulting fees, ~$180K)
Same
characteristics as
the predicate
Same intentioned
use as the predicate Has different
Substantial equivalence technology
test: as safe and as effective characteristics Special
comparing to an existing and information 510(k)
device submitted to
Our FDA
device
Not substantial Traditional 510(k) Does not raise
equivalent approval new questions of
safety and
effectiveness; as
safe and as
effective

9. Critical Success Factors
• Validation of the need
• Validation of the customer segmentation
• Evidence of market accessibility
• FDA regulation for in vitro diagnostics
– Other applications that do not require FDA approval
• Other options that meet the immediacy criteria
– Food safety/regulation, e.g., melamine in raw milk (in
China), bacteria in food, etc…