G7 Pre-eclampsia Diagnostic device - Development and IP costPresentation Transcript
Signed & Approved by CEO- Vinie Varkie General Manager- Shrishti Jain.Chief Business Strategist- Igwe Daniels Chief Scientific Officer- Helena GwaniOperating Manager- Priyesh Waghmare Marketing Manager- Ayo Awosusi.
Content o 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 Now is the o CE marking 7rocess future… lol.
Introduction Pre- EclampsiaGlobally, Causes: Symptoms:•10% of all •Damage to the blood •Rising High bloodpregnancies vessels pressure •Insufficient blood flow •High protein levels in•12% of maternal to the uterus the urinedeaths •Severe headache•1/3rd of pre maturebirths •Visual Disturbances G7 DIAGNOSTICS
Market need12% of maternal deaths Global prevalence of pre-eclampsiaOur market research reveals: There is no clinically useful screening test to predict the development of preeclampsia in either low-risk or high- risk populations. G7 DIAGNOSTICS
Company profileResearch and Operations Business Administration and Quality SystemsDevelopment (Process Development Finance •Quality Development) Assurance•Chief Scientific •Chief Executive engineerOfficer •Scientists (PhD, •Market Officer B.Sc) Research analyst •Quality Control•Scientists (PhD, •Finance Manager engineerB.Sc) •General Manager •Business development •Documentation •Assistant analyst 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 30,0002. Operations (Process Development)Scientists (PhD) same as above _ _Scientists (B.Sc) 1 Full-time 25,000General Manager 1 Full-time 60,0003. Business DevelopmentBusiness Development analyst 1 2 days/ week 30,000Market Research analyst 1 2days/ week 12,0004. Administration and FinanceChief Executive Officer 1 1 day/week 18,000Finance Manager 1 1 day/week 12,0005. 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 20-Jan-11 11-Mar-11 30-Apr-11 19-Jun-11 08-Aug-11 27-Sep-11 16-Nov-11 05-Jan-12 Planning 30 Manufacturing Specification 30 Process design 60 Product design 60 Production of 2040 strips 30 Production of 50 meters 30 Quality Control Verification 20 Validation 30 Feedback 30 Legal 365 File Patent PCT
Development phase: Gantt chartS.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 Validation 12/08/2011 30 11/09/2011 80 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 G7 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 registeredG7 DIAGNOSTICS
Quality Control System(Validation and Verification) Selectivity 95% Being spot-on Specificity 95% at Reproducibility 91% quality is Storage conditions 20°C always an issue Heat stability 15°C – 30°C at G7… G7 DIAGNOSTICS.COM
IP Status Patent No. Title Inventor Applicant GB 2464222 Analysis method and Bolbot, J. A. Inverness Medical device. (2010) Switzerland Gmbh EP 1175940 Diagnostic devices Beuchler, K. Biosite Diagnostics Inc. and apparatus for the A. (2002) controlled movement of reagents without membranes.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 13485Review 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 Full quality assurance systemG7 pre-Eclampsia (Annex II) strip and meter 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 specification 1- 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 specificationsPhysicalSize Diameter 8.5" , Weight 6.25", Height 2.75" 1.5 pounds without batteries; 1.6 lbs withWeight batteriesKeypad 12 numeric keys, 10 function keys Environmental 6 volt DC @ 1 amp.Electrical Temp 15 C - 30 C AC / DC converter or 4 AA batteriesPrinter Humidity Panasonic Thermal Printer 85% 10% - OpticalInterface RS-232 Computer Serial Port Laser Laser Diode - 1 milliwatt Detector Silicone Photodiode Location Dry, flat, horizontal surface away from direct sunlight Memory capacity User IDs 600 Patient Diagnostics 750
Technical file: Strip specification ZONES SPECIFICATIONS Main Body Plastic material: length 10cm, width 3cm.1 1. Sample addition zone Round shape2 •Open trough.3 2. Sample addition Reservoir •Filter – PA 66, Polyamide ( mesh count: 93mesh/inch, diameter 0.10nm, thickness 0.18mm).45 3. Sample-reaction barrier •Narrow capillary: diameter 0.05mm •Depth 5mm, width 0.3mm.6 4. Reaction chamber •Nanoparticle based antibody with fluorophore: powder 1.4nm, fluorophore: Alexa488. 5. Time gate •Polystyrene latex: diameter 2µm, length 1mm. •Binding component: Bovine serum albumin.7 6. Fluid control means •Trapezoid shaped gap. 7. Diagnostic element •Two opposing surfaces a capillary distance apart •Antibodies array: •Soluble fms-like tyrosine kinase (sflt) •Soluble Endoglin (sEng) •Placental growth factor (PlGF) antibodies. 8. Used reagent reservoir •. •Nitrocellulose material.8 •Capillary space: width 2mm, depth 1mm. •Capillary grooves: depth 0.3mm, density 40 grooves/cm
Risk management •Careful sample collection, labeling and storage •Storage of strips at YES What necessary proper temperature Implementation steps to be taken •Periodic (monthly) of corrective to minimize risk? calibration of meter actions •Bar codeWill the end user be harmed validation at any point? Continue monitoring NO
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
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