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 – it’s 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