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Sweet sensors
1. Sweet Sensors
Glucose Monitor: We have developed a
novel technology to use
• Widely available any glucose monitor
• Cheap without modifications to
• Quantitative detect a wide range of
information non-glucose targets at
• $10 billion market very low concentrations
(such as diseases (e.g.,
However, it can detect TB), heavy metal ions
only one target: glucose (e.g., Pb, Hg), organic
and at very high toxins, bacteria, viruses
concentrations and cancers)
Yu Xiang and Yi Lu, Nature Chem. 3, 697-703 (2011).
2. Business Model Canvas #2
Yi Lu, Tian Lan
Sweet Sensors Neil Kane
Chris Sorensen
Conferences
Product R&D
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
Cheaper
KOL
More frequent Retailers (Walgreen)
IPs
Personnel Better indicator of Online vendors (Amazon)
health (diabetic
management) Direct sales
Reagents
Manufacture
Disposable test kit (used repeatedly
Licensing on a regular basis)
FDA approval for in
vitro diagnostics
3. Missions accomplished
- VC/patient in China
- Juanzuo Zhou, manager in diagnostic product
distribution in a Chinese biotech firm
- Steve Mayor, M.D., ex-Abbott researcher
- Dr. Lisa Freeman, Veterinarian, Northern Illinois
Univ.
- Research on the FDA approval procedure
4. Key findings
From Steve Mayer:
1. Systematically examination of a range of targets
and pick a test that has NOT been done yet.
2. Skeptical about going after a large volume market
first; instead, should look at niche market with high
value and establish dominance.
3. Idea of IMMEDIACY.
The result of the test should induce a immediate action, e.g.,
food safety related and security related targets.
hinted us to add an additional value proposition
“immediacy” and the hypothetical customers
5. Key findings
From VC/patient (in China):
4. Confirms the value of the test
5. Concern of high cost to capture the market
From Lisa Freeman and Juanzuo Zhou:
6. Opportunity for targets relate to food safety, such
as melamine detection in raw milk and bacteria
detection in farm or animal products
6. Key findings: FDA approval
Same
characteristics as
the predicate
Same intentioned
use as the predicate Has different
Substantial equivalence technology
test: as safe and as effective characteristics 510(k) fast
comparing to an existing and information track
device submitted to
Our FDA
device
Not substantial 510(k) approval Does not raise
equivalent process new questions of
safety and
effectiveness; as
1. 510(k): 5M and 1 year safe and as
2. 510(k) fast track: 50K and 6 months effective
7. 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
Manufacture
Disposable test kit (used repeatedly
Licensing on a regular basis)
FDA approval for in
vitro diagnostics
8. People we are talking to later this
week
1. Natalie Solomon, Senior Scientist, Abbott Labs
2. Peter Saravis, CEO, eVive Health
3. Norbert Riedel, Chief Scientific Officer, Baxter
4. Harlee Sorkin, entrepreneur with medical device
expertise
5. Dr. Dan Derman, CEO of Northwestern Medical
Physician's Group at Northeastern Hospital.
6. Diabetes patients support groups at Urbana Champaign
7. Karen Chapman-Novakofski, Professor@UIUC
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
– E.g., melamine in raw milk (in China), bacteria in food,
etc…
Hinweis der Redaktion
Team introduction, glucose meter for detection of targets other than glucose
In the past week, our effort was focus on validating our customer segments. Is the diabetes market valid?
The conversation with Steve Mayer hinted us that there is some other attractive market with a new value proposition, IMMEDIACY.
The easy way is prove substantial equivalence, 50K, 6 months and can be carried out by a third party. If not, normal 510(k) process.