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G7 PRE-ECLAMPSIA DIAGNOSTIC DEVICE - DEVELOPMENT
AND IP COST.
Signed & Approved byCEO- Vinie Varkie
General Manager- Shrishti Jain.
Chief Business Strategist- Igwe Daniels
Chief Scientific Officer- Helena Gwani
Operating Manager- Priyesh Waghmare
Marketing Manager- Ayo Awosusi.
Contento Introduction
o Company Profile
o Salary Distribution
o Gantt Chart
o Quality Control
o IP status
o Internal Management Systems policy
o Registration for ISO 13485
o CE marking 7rocessNow is the future… lol.
IntroductionPre- Eclampsia
Globally,
• 10% of all pregnancies
• 12% of maternal deaths
• 1/3rd of pre mature births
Causes:
• Damage to the blood vessels
• Insufficient blood flow to the uterus
Symptoms:
• Rising High blood pressure
• High protein levels in the urine
• Severe headache
• Visual Disturbances
G7 DIAGNOSTICS
Market need
12% of maternal deaths
Our market research reveals:There is no clinically useful screening test to predict the development of preeclampsia in either low-risk or high-
risk populations.
Global prevalence of pre-eclampsia
G7 DIAGNOSTICS
Company profile
Research and Development
• Chief Scientific Officer
• Scientists (PhD, B.Sc)
Operations(Process Development)
• Scientists (PhD, B.Sc)
• General Manager
• Assistant
Business Development
• Market Research analyst
• Business development analyst
Administration and Finance
• Chief Executive Officer
• Finance Manager
Quality Systems• Quality
Assurance engineer
• Quality Control engineer
• Documentation specialist
• Validation engineer
Salary Distribution (pre-clinical trials)Role Number Work Status Salary (GBP p.a.)
1.DevelopmentChief Scientific Officer 1 1 day/ week 15,000Scientists (PhD) 2 Full-time 30,000
2. Operations (Process Development)Scientists (PhD) same as above _ _Scientists (B.Sc) 1 Full-time 25,000General Manager 1 Full-time 60,000
3. Business DevelopmentBusiness Development analyst 1 2 days/ week 30,000Market Research analyst 1 2days/ week 12,000
4. Administration and FinanceChief Executive Officer 1 1 day/week 18,000Finance Manager 1 1 day/week 12,000
5. Quality SystemsQuality Assurance engineer Scientist (B.Sc.) _ _Quality Control engineer 1 1 day/ week 17,500Documentation specialist 1 1 day/ week 12,500Validation engineer 1 1 day/ week 15,000
PRODUCT DEVELOPMENT - GANTT CHART
Planning
ManufacturingSpecification
Process designProduct design
Production of 2040 stripsProduction of 50 meters
Quality ControlVerification
ValidationFeedback
Legal
20-Jan-11 11-Mar-11 30-Apr-11 19-Jun-11 08-Aug-11 27-Sep-11 16-Nov-11 05-Jan-12
30
30
60
60
30
30
20
30
30
365
File Patent PCT
Development phase: Gantt chart
G7 DIAGNOSTICS
S.No. Tasks Start Date Duration (days) End Date Cost involved (£'000) 1 Planning 20/01/2011 30 19/02/2011 10 2 Manufacturing Specification 20/02/2011 30 22/03/2011
350 Process design 23/03/2011 60 22/05/2011 Product design 23/05/2011 60 22/07/2011 86 Production of 2040 strips 13/10/2011 30 12/11/2011 51 Production of 50 meters 13/11/2011 30 13/12/2011 400 3 Quality Control Verification 22/07/2011 20 11/08/2011
80 Validation 12/08/2011 30 11/09/2011 Feedback 12/09/2011 30 12/10/2011 4 Legal 20/01/2011 365 20/01/2012 80 filing a patent licencing liability
therapeutical consequences reliability of results 5 Salary 247 Total 1,304
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
Quality Control System(Validation and Verification)
G7 DIAGNOSTICS.COM
Selectivity 95%
Specificity 95%
Reproducibility 91%
Storage conditions 20°C
Heat stability 15°C – 30°C
Being spot-on at quality is always an issue at G7…
IP StatusPatent No. Title Inventor Applicant
GB 2464222 Analysis method and device.
Bolbot, J. A. (2010)
Inverness Medical Switzerland Gmbh
EP 1175940 Diagnostic devices and apparatus for the controlled movement of reagents without membranes.
Beuchler, K. A. (2002)
Biosite Diagnostics Inc.
G7 DIAGNOSTICS.COM
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.”
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
CE Marking Process
G7 pre-Eclampsia strip and meter
Full quality assurance system (Annex II)
The notifying body will assess and monitor our quality system
“ … 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) operates…”
Technical file
• Intended use of the test: early detection of pre-eclempsia
• Indication for use: Week 12 and week 19 of gestation period
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
Technical file: Equipment specification1- Power Button
2- LCD (liquid crystal display)
3- Thermal Printer
4- Printer Cover
5- Diagnostic Device Insertion Point
6- Power Supply Connection
7- Data Connection
8- Printer
9- Battery Cover
10- Code Chip Port
Meter specifications Physical
Size Diameter 8.5" , Weight 6.25", Height 2.75"
Weight1.5 pounds without batteries; 1.6 lbs with batteries
Keypad 12 numeric keys, 10 function keys
Electrical 6 volt DC @ 1 amp.
AC / DC converter or 4 AA batteries
Printer Panasonic Thermal Printer
Interface RS-232 Computer Serial Port
Environmental
Temp 15 C - 30 C
Humidity 10% - 85%
Location Dry, flat, horizontal surface away from direct sunlight
Optical
Laser Laser Diode - 1 milliwatt
Detector Silicone Photodiode
Memory capacity
User ID's 600
Patient Diagnostics 750
ZONES SPECIFICATIONS
Main Body
1. Sample addition zone
2. Sample addition Reservoir
3. Sample-reaction barrier
4. Reaction chamber
5. Time gate
6. Fluid control means
7. Diagnostic element
8. Used reagent reservoir •.
12
45
3
6
7
8
Technical file: Strip specification
Plastic material: length 10cm, width 3cm.
Round shape
•Open trough. •Filter – PA 66, Polyamide ( mesh count: 93mesh/inch, diameter 0.10nm, thickness 0.18mm).
•Narrow capillary: diameter 0.05mm
•Depth 5mm, width 0.3mm.•Nanoparticle based antibody with fluorophore: powder 1.4nm, fluorophore: Alexa488.
•Polystyrene latex: diameter 2µm, length 1mm. •Binding component: Bovine serum albumin.
•Trapezoid shaped gap.
•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
Risk management
Will the end user be harmed at any point?
YES
NO
What necessary steps to be taken to minimize risk?
Implementation of corrective
actions
Continue monitoring
• Careful sample collection,
labeling and storage
• Storage of strips at proper
temperature• Periodic
(monthly) calibration of
meter• Bar code
validation
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. Production.
THANK YOU FOR LISTENING