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Regulatory Feasibility Analysis for a New Atrial Fibrillation Ablator in Selected Countries

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Regulatory Feasibility Analysis for a New Atrial Fibrillation Ablator in Selected Countries MQP – FRH – FHO2 Regulatory Feasibility Analysis for a New Atrial Fibrillation Ablator in Selected Countries A Major Qualifying Project Report Submitted to the Faculty of the Worcester Polytechnic Institute in partial fulfillment of the requirements for the Degree of Bachelor of Science in Management by ______________________ Matthew Hammond Approved: _______________________ _______________________ Martin Sklar, President and CEO Frank Hoy, Ph.D. AblaCor Medical Corporation Paul R. Beeswick Professor of Project Sponsor Innovation and Entrepreneurship Project Advisor _______________________ Jerome Schaufeld, Ph.D. Professor of Practice Project Co-Advisor 1 | P a g e Abstract Medical device registration for class three devices, such as a catheter ablator, can be a long and difficult process. The regulatory requirements can vary greatly by country, overlap and benefit one another, or require repeating a certification depending on the country in question. Determining the order in which to enter specific countries greatly depends on the size of the potential market and the costs and time needed for regulatory approval. Prior approval on major facets such as clinical trials may greatly reduce the costs of entering a particular country if the data from an outside source is deemed acceptable. This creates a complex problem where start- ups who cannot afford to pursue regulatory approval in all major markets simultaneously must carefully chose and enter individual markets a few at a time. The paper will evaluate the regulatory pathways of ten select countries. This regulatory analysis, combined with a market analysis on these same countries by the other three members of the project, will form a basis from which we can create a suggested order of entry. 2 | P a g e Table of Contents Abstract ......................................................................................................................................................... 2 Table of Contents .......................................................................................................................................... 3 Acknowledgements ....................................................................................................................................... 5 Background ................................................................................................................................................... 6 Project Purpose ............................................................................................................................................. 8 Methods ........................................................................................................................................................ 9 European CE Marking Process .................................................................................................................. 9 Regulatory Approval Process in the United States ................................................................................. 10 Table 1 ................................................................................................................................................. 11 Regulatory Approval Process in Japan .................................................................................................... 11 Cost of Regulatory Approval between the US, EU, and Japan ............................................................ 12 Table 2 ................................................................................................................................................. 13 Regulatory Approval outside of the Top Three Markets ........................................................................ 13 Australia .............................................................................................................................................. 14 Brazil ................................................................................................................................................... 14 Canada................................................................................................................................................. 15 China ................................................................................................................................................... 15 India .................................................................................................................................................... 16 South Korea ........................................................................................................................................ 17 Russia .................................................................................................................................................. 17 Results ......................................................................................................................................................... 18 Sizing Up Markets and Difficulty of Regulatory Access .................................................................... 18 Easy Access ........................................................................................................................................ 19 Following International Standards ...................................................................................................... 19 Discussion.................................................................................................................................................... 21 Conclusions ................................................................................................................................................. 22 Sources ........................................................................................................................................................ 25 General Regulatory Information ............................................................................................................. 25 3 | P a g e Europe ..................................................................................................................................................... 25 United States ........................................................................................................................................... 26 Japan ....................................................................................................................................................... 27 Australia .................................................................................................................................................. 27 Brazil ........................................................................................................................................................ 27 Canada .................................................................................................................................................... 27 China ....................................................................................................................................................... 27 India ........................................................................................................................................................ 28 South Korea ............................................................................................................................................. 28 Russia ...................................................................................................................................................... 28 Appendix ..................................................................................................................................................... 29 Glossary of Terms.................................................................................................................................... 29 Selected Market Data ............................................................................................................................. 30 Regulatory Costs and Timetables ............................................................................................................ 31 Historic and Country Specific European Information ................................................................................. 32 Five Year Rise in Arrhythmia in European Nations ............................................................................. 32 Number of Atrial Fibrillation Ablations and Performing EPs in Europe in 2012 by Country .............. 32 4 | P a g e Acknowledgements I would like to thank Martin Sklar for his expertise and continued interest in the success of our project for AblaCor. His experience and input was critical in determining the scope of this project. I would also like to thank my advisors Professor Frank Hoy and Professor Jerry Schaufeld for all their guidance and feedback. They were critical in helping us find relevant sources and contacts crucial to the research of this project. Finally, I would like to thank my team, Kyle Cayabyab, Meagan Ward, and Jameel Galloway for all their help and research on the project. They were a great help in compiling the massive amounts of data we ended up going through. I wish them the best in the coming semester. 5 | P a g e Background Atrial Fibrillation (AF) is the most common form of arrhythmia, accounting for approximately 40% of all cases of arrhythmia. Arrhythmia is defined as an irregular heart rhythm caused by electrical
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