Balancing FDA Regulation With Technology Innovation

Simon D. Murray, MD: Part of that is regulatory too, I think the FDA doesn’t allow drug companies to re-use old studies, you have to redo the wheel every time.

Eric Daimler, PhD, MS: We, as a society, need to have a conversation about what we want the FDA to be. It’s not for me to say, it’s not for any one person to say. But if what we determine as a society is that any failures are intolerable, than that falls out a whole bunch of other regulatory processes. But on the other hand if we can accept a certain amount of error in a certain context, then that allows for a different level of experimentation.

One of the difficulties about all of these issues is the degree of innovation that takes place in general in healthcare. Fresh out of medical school you’re taught the latest procedures. You might think of yourself as the most innovative, but you’re not the most experienced. Maybe ten years in, you’re experienced, you’re appropriately seasoned, but you’re no longer the most innovative. It’s a tension between those two.

The regulatory regime we have set up isn’t rewarding innovation. It rewards practicing to the standard of care. So we have, reasonably, come to these conclusions, and set up everything including our health insurance to accommodate these societal conclusions. But we don’t have the larger conversations that society needs to have about the totality of the system, what that means for the outcome.

SM: What do you think about the FDA’s recommendations about robotic surgery, particularly with invasive, as it relates to cancer surgery?

ED: I think this goes to the point about what the FDA should be doing, about how much they should be regulating. I think in these issues I am deeply suspicious of the possibility for misinterpretation on what we even mean by surgical robotics, and how that may be misapplied.

I think when we go down these paths people often think of robots as being fully automated. They don’t think of robots as being augmentations, little assistance robots.

SM: Co-bots.

ED: Yeah, co-bots, collaborative robots. When I had the good fortune of working in the Obama administration we were looking for the future of robotic research for the federal government. I was privileged to be among the best minds at the table, we came up with the idea that these collaborative robots would be ubiquitous. That’s the best thinking we have. Rather recently. These co-robots would be all around us. And they’re going to be augmenting us. So I was working with one surgical robot that would allow my shaky hand to be completely smooth.

That’s a robot. And it’s augmenting me. And I not being an expert as a regulator, would say that’s pretty easy to argue that that’s going to help my efficacy.

SM: Yet it didn’t. Many of the studies showed that the robotic surgeries were no more effective than conventional surgeries, yet they were more expensive. Which surprised me. Am I correct in saying that?

ED: I think in the totality of these technologies and the totality of this environment, what we might see is perhaps the outcomes are no different but the surgeon is less fatigued, maybe the outcomes are no different but there’s a lessened likelihood of catastrophic outcomes for example. Then we might say, they’re worse because the surgeons ignored them, didn’t follow the directions. So I don’t know. I would say the jury’s out on that and the robot I saw a year ago could be very different than it is today.

Transcript edited for clarity.