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what we're doing in this paper is examining the approach that the FDA takes to medical device regulation and
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asking the question is it optimal or how close to optimal is it there's a raging
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debate about whether the FDA is too difficult on medical device regulation whether it's too hard for device
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manufacturers to get their device through the regulatory process or whether they're two lakhs and let too
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many potentially harmful devices through the process and so our research asked the question how much information does
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the FDA regulatory process generate for the market to use in deciding what to device to use in a given patient and
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should they require more information or less information and that's what our
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paper seeks to address what we did is we compared the behavior of devices in the US which has a much
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more difficult and rigorous regulatory standard to the European Union which has a much less informational requirements
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to get their devices through the approval process so we compared how the devices that were common in both markets
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how their market share evolved over time and we compare that to devices that were
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only offered in the EU which is what typically happens since the you market is much easier to answer there's many
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more devices and we examined how those market shares evolved over time and use that information to make inferences
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about the information that was being generated by the regulatory process and and then translate that into real
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consumer welfare measures what we found is that the US FDA regulatory process for the devices we
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looked at which were second generation stents cardiac stents was pretty close to optimal and while the EU which has
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very lacks regulatory standards was 22 lacks in that if they were to implement more rigorous informational requirements
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for getting devices through to the market they would improve consumer welfare and that surprises us that
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surprised us that the u.s. was so close to optimal given the calls for reforms at the FDA we kind of expected the FDA
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to be mean to too difficult to get through the trade off the regulator the regulator has to make is to if you
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require more information you delay the introduction of the device and make it more difficult for devices to enter the
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market raise the entry cost so the trade-off is that the regulator is making is the increased informational
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content of increasingly clinical trials for example in the benefits of that information so that's the kind of the
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benefit side the cost is that you delay entry and you and that's a real cost you
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have less access to device so there's a real access versus information trade-off
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here so one of the things we looked at is how could we improve the process and what we
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found is if we could make the post market informational generation process more informative that would generate a
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lot of welfare because then we could even relax the pre market requirements more and then more devices would get to
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market quicker and so that's the one thing that I think the takeaway is that
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there's a lot to be gained from increasing post market surveillance of medical devices
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hopefully this research will dispel the notion that the FDA is really way too difficult for particularly second
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generation devices I think our research pretty in my view pretty convincingly shows that they actually may be close to
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doing the right thing well there really is no other kind of similar analysis out there that's been
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able to credibly identify the causal relationship between regulatory regimes and this information content and the
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benefits that patients get from these devices so I we think our research is kind of one of a kind and there's some
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older research thats related to but we think ours is pretty unique and in that sense
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so what's next is you know it's we want to see kind of what market forces are at
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play that would allow medical device and cause medical device manufacturers to run their own clinical trials and
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provide this information on their own and not through you know requirements of the FDA and kind of providing
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information to the market and so that's kind of where we're next going with this
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research you