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