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Aversion Mission Statement Rev1 04Oct2016

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Niamh Lynch
Niamh Lynch

Aversion Ltd aims to design safer medical devices through shared risk information and improved risk management tools. Their solution, RISKie, is a free-to-use online risk management tool including FMEA, FTA, and HAZOP that allows users to access a global database of known hazards. This centralized system addresses current issues like lack of shared information between companies and inadequate risk management tools. The founder has over 25 years of experience in life sciences and developed a risk management system for Johnson & Johnson. Aversion sees an opportunity to provide an easy-to-use software solution where paper-based and costly systems currently dominate.

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What is Aversion? Aversion Ltd http://www.aversionltd.com/
Mission Statement Design and Develop Safer Medical Devices Use Big Data to Share Hazard Information and Improve Risk Management tools globally whilst ensuring compliance to ISO 14971:2012, Risk Management Standard for Medical Devices & Life Sciences. Our Value is the Risk / Hazard Information we Provide
The Founder Founder & Principal Engineer: Niamh Lynch (nee St John), BSc(Hons), MSc. MScSED & NUIG TechInnovate Fellow http://techinnovate.org/ https://ie.linkedin.com/in/niamhstjohnlynch Developed State of the Art Risk Management System for Johnson & Johnson and presented with Encore Award for same in 2014. Expert in Quality Risk Management with experience in Boston Scientific, Beckman Coulter, J&J, Merit Medical, & Mylan. +25 Years Experience in IT & Life Sciences (Pharmaceutical, BioTechnology and Medical Devices)
Problem Worth Solving Medical Device Recalls Doubled in a Decade Why? Lack of Shared Information; companies do not share known hazards Lack of appropriate Risk Management Tools Risk Management Tools in existence (primarily FMEA) rarely provide adequate Closed Loop Feedback from Complaints and those that do work retrospectively Inadequate Predictive Capability Lack of Knowledge on Risk Methodologies Continued Confusion from recent updates to ISO EN 14971:2012 following EU Content Deviations cited under : Focus on Compliance not Safety REFERENCES: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ St John, N. (2016). Risk Management Risk Management within Life Science Industry: Meeting the needs and requirements of ISO 13485: 2016 and ISO EN 14971: 2012, NUIG Library. http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en
Solution RISKie : Free-to-Use Risk Management Tool includes FMEA, FTA, HAZAOP, etc. Medical Device Engineer uses On-line Web-based Risk Management Tool centrally controlled by Aversion Ltd. Big Data Shared Global System of all known Hazards Aversion provide own research on products & materials and update known hazards to provide State of the Art Risk Management Solution Benefits: RM Tool is Free & Compliant to Standards with Free Reporting of Own Data free to register per user Risk Reports of all known hazards to be downloaded for a fee or monthly / yearly registration to service Proprietary information not available Known Hazards only. Centrally controlled Severity Rankings by Approved Medical Practitioner avoid need for in-house assessment Government Agencies have a central database to advise on risks for a fee Patients have a system to view Risk Reports on given products considering for use
Business Concept Big Data NoSQL Database using NEO4j Graph Database Technology FMEAArchitecture designed & published under St John, N. (2016). Risk Management (RM) within Life Science Industry: Meeting the needs and requirements of ISO 13485: 2016 and ISO EN 14971: 2012, NUIG Library. The value is in the data, the freemium RM tool makes it easy to be compliant. It can help save lives, your business and the bottom line.
Opportunities Currently paper-based systems predominantly used including MS Word and MS Excel to support Risk Management Market ready for easy-to-use software that provides same functionality (e.g. FMEA tool) that works within requirements FMEA Tools available at a cost customers not biting its a risk! Refer to research performed under MScSED Thesis in support of statements made: St John, N. (2016). Risk Management Risk Management within Life Science Industry: Meeting the needs and requirements of ISO 13485: 2016 and ISO EN 14971: 2012, NUIG Library
Competition Manual Systems (MS Word & MS Excel) people ready for change. Quality Management Systems with Risk Management included people not ready to change entire Quality Management Systems / Too Costly FMEA solutions cost and no significant cost/benefit Our Value is the Risk Information we Provide currently research done by google and through text books, FDA websites, etc.
Risks and Rewards RISKS: Must meet existing requirements within companies Must be EASY-TO-USE. Must provide more than existing paper-based systems REWARDS: SAFER Products Support in meeting Risk Management Requirements to MDSAP Global Standards, FDA, EU, etc. Irish Company providing Global Solution Ability to expand to other markets where risk management is required

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Aversion Mission Statement Rev1 04Oct2016

  • 1. What is Aversion? Aversion Ltd http://www.aversionltd.com/
  • 2. Mission Statement Design and Develop Safer Medical Devices Use Big Data to Share Hazard Information and Improve Risk Management tools globally whilst ensuring compliance to ISO 14971:2012, Risk Management Standard for Medical Devices & Life Sciences. Our Value is the Risk / Hazard Information we Provide
  • 3. The Founder Founder & Principal Engineer: Niamh Lynch (nee St John), BSc(Hons), MSc. MScSED & NUIG TechInnovate Fellow http://techinnovate.org/ https://ie.linkedin.com/in/niamhstjohnlynch Developed State of the Art Risk Management System for Johnson & Johnson and presented with Encore Award for same in 2014. Expert in Quality Risk Management with experience in Boston Scientific, Beckman Coulter, J&J, Merit Medical, & Mylan. +25 Years Experience in IT & Life Sciences (Pharmaceutical, BioTechnology and Medical Devices)
  • 4. Problem Worth Solving Medical Device Recalls Doubled in a Decade Why? Lack of Shared Information; companies do not share known hazards Lack of appropriate Risk Management Tools Risk Management Tools in existence (primarily FMEA) rarely provide adequate Closed Loop Feedback from Complaints and those that do work retrospectively Inadequate Predictive Capability Lack of Knowledge on Risk Methodologies Continued Confusion from recent updates to ISO EN 14971:2012 following EU Content Deviations cited under : Focus on Compliance not Safety REFERENCES: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ St John, N. (2016). Risk Management Risk Management within Life Science Industry: Meeting the needs and requirements of ISO 13485: 2016 and ISO EN 14971: 2012, NUIG Library. http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en
  • 5. Solution RISKie : Free-to-Use Risk Management Tool includes FMEA, FTA, HAZAOP, etc. Medical Device Engineer uses On-line Web-based Risk Management Tool centrally controlled by Aversion Ltd. Big Data Shared Global System of all known Hazards Aversion provide own research on products & materials and update known hazards to provide State of the Art Risk Management Solution Benefits: RM Tool is Free & Compliant to Standards with Free Reporting of Own Data free to register per user Risk Reports of all known hazards to be downloaded for a fee or monthly / yearly registration to service Proprietary information not available Known Hazards only. Centrally controlled Severity Rankings by Approved Medical Practitioner avoid need for in-house assessment Government Agencies have a central database to advise on risks for a fee Patients have a system to view Risk Reports on given products considering for use
  • 6. Business Concept Big Data NoSQL Database using NEO4j Graph Database Technology FMEAArchitecture designed & published under St John, N. (2016). Risk Management (RM) within Life Science Industry: Meeting the needs and requirements of ISO 13485: 2016 and ISO EN 14971: 2012, NUIG Library. The value is in the data, the freemium RM tool makes it easy to be compliant. It can help save lives, your business and the bottom line.
  • 7. Opportunities Currently paper-based systems predominantly used including MS Word and MS Excel to support Risk Management Market ready for easy-to-use software that provides same functionality (e.g. FMEA tool) that works within requirements FMEA Tools available at a cost customers not biting its a risk! Refer to research performed under MScSED Thesis in support of statements made: St John, N. (2016). Risk Management Risk Management within Life Science Industry: Meeting the needs and requirements of ISO 13485: 2016 and ISO EN 14971: 2012, NUIG Library
  • 8. Competition Manual Systems (MS Word & MS Excel) people ready for change. Quality Management Systems with Risk Management included people not ready to change entire Quality Management Systems / Too Costly FMEA solutions cost and no significant cost/benefit Our Value is the Risk Information we Provide currently research done by google and through text books, FDA websites, etc.
  • 9. Risks and Rewards RISKS: Must meet existing requirements within companies Must be EASY-TO-USE. Must provide more than existing paper-based systems REWARDS: SAFER Products Support in meeting Risk Management Requirements to MDSAP Global Standards, FDA, EU, etc. Irish Company providing Global Solution Ability to expand to other markets where risk management is required