G7 Pre-eclampsia Diagnostic device Development and IP cost.

Signed & Approved by

CEO- Vinie Varkie

Click to edit Master subtitle style

General Manager- Shrishti Jain.

Chief Business Strategist- Igwe Daniels Chief Scientific Officer- Helena Gwani Operating Manager- Priyesh Waghmare Marketing Manager- Ayo Awosusi.

12/26/12

a G7 Diagnostics Inc.

Content
o

Introduction Company Profile Salary Distribution Gantt Chart Quality Control IP status Internal Management Systems policy

o Registration for ISO 13485 12/26/12 a G7 Diagnostics Inc.

Now is the future lol.

Introduction
Pre- Eclampsia
Globally, of all pregnancies

Causes: Damage to the blood vessels

Symptoms: Rising High blood pressure

10%

deaths

12% of maternal 1/3rd of pre

Insufficient blood flow to the uterus

High protein levels in the urine

Severe headache Visual Disturbances

mature births
G7 12/26/12 DIAGNOSTICS

a G7 Diagnostics Inc.

Market need

12% of maternal deaths

Global prevalence of pre-eclampsia

Our market research reveals:

There is no clinically useful screening test to predict the development of preeclampsia in either low-risk or highrisk populations.
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G7

a G7 Diagnostics Inc.

Company profile

Research and Development Chief Scientific Officer

Operations (Process Development) Scientists (PhD, B.Sc)

Business Development Market Research analyst

Administration and Finance Chief Executive Officer

Quality Systems Quality Assurance engineer Quality Control engineer

Scientists (PhD, B.Sc)

General Manager Assistant

Business development analyst

Finance Manager

Documentation specialist

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a G7 Diagnostics Inc.

Validation engineer

Salary Distribution (pre-clinical trials)

Role Number 1 2 Work Status 1 day/ week Full-time 1.Development Chief Scientific Officer Scientists (PhD)

Salary (GBP p.a.) 15,000 30,000

2. Operations (Process Development) Scientists (PhD) Scientists (B.Sc) General Manager

same as above 1 1

_ Full-time Full-time

_ 25,000 60,000

3. Business Development Business Development analyst Market Research analyst

1 1

2 days/ week 2days/ week

30,000 12,000

4. Administration and Finance Chief Executive Officer Finance Manager

1 1

1 day/week 1 day/week

18,000 12,000

5. Quality Systems

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a G7 Diagnostics Inc.

PRODUCT DEVELOPMENT - GANTT CHART

40563 40613 40663 40713 40763 40813 40863 40913

File Patent

PCT

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a G7 Diagnostics Inc.

Development phase: Gantt chart

S.No. 1 2 3 4 5 Tasks Planning Manufacturing Specification Process design Product design Production of 2040 strips Production of 50 meters Quality Control Verification Validation Feedback Legal filing a patent licencing liability therapeutical consequences reliability of results Salary Total Start Date 20/01/2011 20/02/2011 23/03/2011 23/05/2011 13/10/2011 13/11/2011 22/07/2011 12/08/2011 12/09/2011 20/01/2011 Duration (days) 30 30 60 60 30 30 20 30 30 365 End Date 19/02/2011 22/03/2011 22/05/2011 22/07/2011 12/11/2011 13/12/2011 11/08/2011 11/09/2011 12/10/2011 20/01/2012 Cost involved ('000) 10 350 86 51 400 80 80 247 1,304

G7 12/26/12

a G7 Diagnostics Inc.

Gantt chart

The research phase is not considered Production of equipment and strips subcontracted The respective subcontractors follow standard procedures and are ISO13485 registered

G7 DIAGNOSTICS

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a G7 Diagnostics Inc.

Quality Control System (Validation and Verification)

Selectivity Specificity Reproducibility Storage conditions Heat stability 95% 95% 91% 20C 15C 30C

Being spot-on at quality is always an issue at G7

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G7

a G7 Diagnostics Inc.

IP Status
Patent No. GB 2464222 Title Analysis method and device. Inventor Applicant Bolbot, J. A. Inverness Medical (2010) Switzerland Gmbh

EP 1175940

Diagnostic devices Beuchler, and apparatus for K. A. the controlled (2002) movement of reagents without membranes.

Biosite Diagnostics Inc.

G7

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a G7 Diagnostics Inc.

G7 Diagnostics internal management system policy

policy shows the commitment of the company as it encompasses quality, environmental management and safety measures which the company holds in high esteem.
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Registration for ISO 13485

Review of Internal Quality Management system policy

Hold meetings within Quality System team:

Objectives of ISO 13485 Medical Device regulations Coach members across functional departments

Conduct internal audits and spot checks

Audit by (external) notified body

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a G7 Diagnostics Inc.

CE Marking Process
Full quality assurance system (Annex II) The notifying body will assess and monitor our quality system

G7 preEclampsia strip and meter

12/26/12

acquisition of the CE Marking is very important in boosting our chances of increasing sales especially considering the stringent rules by which hospitals (our target market) a G7 operates Diagnostics Inc.

Technical file

Intended use of the test: early detection of pre-eclempsia Indication for use: Week 12 and week 19 of gestation period

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a G7 Diagnostics Inc.

Quality Management Systems certification

Product Classification: Annex II List B (non-self testing) Declaration of conformity (Annex III) Aiming at European Market Acceptance:

ISO 13485 CE marking

a G7 Diagnostics Inc.

12/26/12

Technical file: Equipment specification

1- Power Button 3- Thermal Printer 4- Printer Cover

2- LCD (liquid crystal display)

5- Diagnostic Device Insertion Point 6- Power Supply Connection 7- Data Connection 8- Printer 9- Battery Cover 10- Code Chip Port

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a G7 Diagnostics Inc.

Meter specifications
Physical Size Weight Keypad Electrical Printer Interface Diameter 8.5" , Weight 6.25", Height 2.75" 1.5 pounds without batteries; 1.6 lbs with batteries 12 numeric keys, 10 function keys Environmental 6 volt DC @ 1 amp. Temp 15 C - 30 C AC / DC converter or 4 AA batteries Humidity 10% - 85% Panasonic Thermal Printer Optical RS-232 ComputerLaser Port Serial Location

Laser Diode - 1 milliwatt

Dry, flat, horizontal Silicone Photodiode surface away from Detector direct sunlight Memory capacity User ID's Patient Diagnostics 600 750

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a G7 Diagnostics Inc.

Technical file: Strip specification

ZONES SPECIFICATIONS
Main Body

1 2 3

Plastic material: length 10cm, width 3cm. Round shape Open trough. Filter PA 66, Polyamide ( mesh count: 93mesh/inch, diameter 0.10nm, thickness 0.18mm).

1. Sample addition zone 2. Sample addition Reservoir 3. Sample-reaction barrier 4. Reaction chamber 5. Time gate

4
5 6

Narrow capillary: diameter 0.05mm

Depth 5mm, width 0.3mm. Nanoparticle based antibody with fluorophore: powder 1.4nm, fluorophore: Alexa488.

Polystyrene latex: diameter 2m, length 1mm. Binding component: Bovine serum albumin.

6. Fluid control means 7. Diagnostic element

Trapezoid shaped gap.

8. Used reagent reservoir

Two opposing surfaces a capillary distance apart Antibodies array: Soluble fms-like tyrosine kinase (sflt) Soluble Endoglin (sEng) Placental growth factor (PlGF) antibodies. Nitrocellulose material. Capillary space: width 2mm, depth 1mm. Capillary grooves: depth 0.3mm, density 40 grooves/cm

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a G7 Diagnostics Inc.

Risk management
YES
What necessary steps to be taken to minimize risk?
Careful sample collection, labeling and storage Storage of strips at proper temperature Periodic (monthly) calibration of meter Bar code validation

Implementation of corrective actions

Will the end user be harmed at any point?

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Continue monitoring

NO

a G7 Diagnostics Inc.

Summary:

Detailed description of Gantt Chart Time period for Product development estimated as ~ 1 year Conclusion: Long term vision- G7 as global company Immediate goal: to attain the ISO 13485 and fulfill regulatory requirements a G7 Diagnostics Inc.

12/26/12

THANK YOU FOR LISTENING

12/26/12

a G7 Diagnostics Inc.