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Photo courtesy of Kyle Myers
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Interview of Kyle Myers by David Zierler on June 8, 2020,
Niels Bohr Library & Archives, American Institute of Physics,
College Park, MD USA,
For multiple citations, "AIP" is the preferred abbreviation for the location.
Interview with Kyle Myers, Director of the Division of Imaging, Diagnostics, and Software Reliability in the FDA Center for Devices in Radiological Health. Myers recounts her childhood and the many moves her family made in support of her father's career in engineering management for General Electric, and she describes her father's formative influence and encouragement for her to pursue a career in science. She describes her college course work in physics at Occidental and Caltech, and she describes her decision to pursue a degree in optical sciences at the University of Arizona. She describes her work at the Jet Propulsion Lab and how this experience focused her interest on optics. Myers discusses working with her graduate advisor Harry Barrett on human perception and radiological imaging, and the importance of the research support she received from Kodak. She describes her postdoctoral work at Corning developing long-distance optical fibers, and she explains the circumstances leading to her career focus in medical imaging research at the FDA. Myers discusses the administrative evolution of the relevant offices and research centers at the FDA over the course of her career, and she discusses some of the major technological advances and her role in their development, including CT imaging, MRIs, and mammography screening. She describes some of the partnerships in the trade industry and across the federal interagency process that serve as important partners in her work, and she explains the adjudication process when a company is at odds with an FDA review of a given device. At the end of the interview Myers conveys her interest in the future prospects of digital pathology and the benefits it promises in disease detection and treatment.
Okay. This is David Zierler, oral historian for the American Institute of Physics. It is June 8, 2020. It’s my great pleasure to be here with Dr. Kyle Myers. Kyle, thank you so much for being with me today.
You're welcome. It’s my pleasure to speak to you.
Okay. So, to start, please tell me your title and institutional affiliation.
I am the Director of the Division of Imaging, Diagnostics, and Software Reliability in FDA’s Center for Devices in Radiological Health in the Office of Science and Engineering Laboratories, which is the research arm of what we call the Center.
Okay. So, Kyle, let’s take it all the way back to the beginning. Tell me about your family background. Tell me about your parents and where they came from in their professions.
So, my parents are from Wisconsin. My dad grew up on a dairy farm and went to college at University of Wisconsin in EE (electrical engineering) after spending some time in the Army to get on the GI Bill because a dairy farm family couldn't afford that, so kind of a common story for people of that generation. He worked for GE after he graduated. I was born while he was in college, so I was born at the University of Wisconsin hospital—another era thing, right? They had two kids before they were out of college. My mother didn't finish because she had two kids before they got out of college. He was hired by GE, so I’m a little bit like a military kid. If you’ve moved around a lot, you either were a military kid or your father worked for GE. I went to eight schools before I ever went to college, including three high schools, and I always thought that I wanted to be a doctor. That will kind of come back because I didn't really understand what a PhD did and thought that kids that were doing well in school, and including that was my dad’s push, was to be a doctor.
Did your mom ever return to school?
No, she didn't.
Did she return to the workforce?
No, and part of that was the moving around all the time. That’s not something that really is conducive to two jobs, including my parents weren't in this country for some of that time. I spent some time living in Mexico. My parents lived in Mexico for seven years.
Was your father an electrical engineer throughout his career at GE?
He was. Well, he went very early into engineering management for the light program, which just got sold by GE in the last month.
Oh, wow. Oh, wow. So, eight schools growing up, so you were never really in one place that you would call your formative years.
I wasn’t. That’s right. That’s right, we lived all over.
When did you start to develop an interest and a talent in the sciences?
It was there from the beginning. I don't remember not, you know, thinking otherwise. I always loved math especially, and in fact, when my family moved to Mexico it was the beginning of my tenth-grade year. That was a really interesting time in the seventies to be in Mexico. In tenth grade there were seven kids in my class, two girls, five boys, because most of the boys, if they stayed on—this was an American-type school, American style school—but most boys went to a technical school and most girls were getting married and not going on to school. So, my parents figured out pretty quickly that that was not a good place for me.
I was in the last math class as a tenth grader, and so it’s the fall of my sophomore year, as I said—and I won't get into this miracle story, but it was a miracle in my life that I ended up spending my junior and senior year living with a family in Seattle, Washington. That was my last high school place of the three. Ninth grade was Ohio; tenth grade was Mexico; eleventh and twelfth I lived with a couple that my parents didn't meet till I graduated. They each had a PhD from Stanford, and that opened my eyes. It was a very different path through the sciences, and it was a very different kind of marriage to see how they had navigated their lives. So, I’m the beneficiary of the best of both of those situations, my biological family and what I learned from my Seattle family.
Mm-hmm [yes]. Did you connect with your father on a scientific level? Did he share his experiences in electrical engineering with you?
Oh yeah, a lot, and supported me when I was doing schoolwork. He was a plant manager and he would take me on Saturdays and introduce me around. He was very proud of me and proud of what he did and wanted to share that.
And you never got any blocks from teachers or parents or anybody about being a woman interested in science? You never were discouraged in that regard?
Not that I remember. It was something that I think I was just blessed by the time that I was in. Mm-hmm [yes].
Yeah. The degrees from Stanford from the other family—what were they in?
My Seattle dad was a civil engineer and my Seattle mom was a psychologist.
Okay, okay. In high school, were you particularly good at physics?
Yes, I was good at physics. I was better at physics than chemistry, and I hated biology in terms of the process. I always said I could derive things so readily, and memorization is not my thing.
Mm-hmm [yes]. So, were you thinking about science in particular when you were applying to college? Were you already that focused?
I was. I was. I had a Seattle brother who was at Caltech, and I went and spent time with him, stayed in the dorms with him, and was really excited about going to school there. As I walked around, I literally had people come up to me and say, “You must be new here. I’ve never met you before,” because there were so few girls on the campus. That was my senior year of high school. I learned about the 3-2 program with Occidental College and decided that that was a better fit for me because I do love to read and I love to write, so I thought I was going to do the 3-2 program. So, I was taking some classes at Caltech as well as Occidental. I lived at the Caltech dorms in the summer and worked at JPL, and so I really for quite a while thought that that was going to be my path. It was only when I learned about optical sciences at University of Arizona when I took my first optics—you know, full semester of optics—when I said, “This is what I really want to do. Why spend five years in college? I’m going to go to graduate school,” and I just finished up at Oxy and headed to Arizona.
So, you went straight to Arizona from undergraduate.
What was your undergraduate degree in? It was in physics?
I doubled in physics and math.
Okay. So, what exactly was the arrangement between Occidental and Caltech? You did the science and math at Caltech and the humanities at Occidental?
You started off doing the physics at Occidental, and the thing that you could do at Caltech that you couldn't at Occidental was engineering classes. I thought I was going to do a 3-2 engineering because I still had my dad’s sort of model of engineering as something I was going to do, finish up and go be an engineer. Didn't really think I was going to be an astrophysicist or some PhD in physics. It took me a long time to give up on the medical school idea, too. That just came- I just kept thinking about it till about my mid-thirties; thought maybe I would do something related to that. But you know, over time things get more and more narrow and you figure it out.
Right. Right. What were your favorite physics courses at Caltech? What did you gravitate towards?
Well, I actually got to take a class from Richard Feynman, which was really amazing that I got to meet him. I went to undergrad--
Wow! Wow! That must have been towards the later part of his career.
Yeah. My roommate married Ralph- Oh, golly. I’m having a senior moment. Who wrote Surely You're Joking? Ralph Leighton. I was blanking. I was thinking about Liepmann, so I got their names wrong. But yeah, my college roommate married Ralph Leighton who wrote the Surely Your Joking books. Feynman was their best man at their wedding.
Yeah, mm-hmm [yes].
I’ve heard it said of Feynman that even up until the last days of his life he still had- Even though he was frail and he was old, he still had that boyish energy and natural sense of wonder that he was famous for.
Yeah. He was still drumming.
So, did you become close with him, or you just took a class with him?
I took his class but I myself wasn’t close to him. I just get to say, you know, I was very loosely associated with him through my roommate. But I would say—and I’m sure you’ve had more experiences of this than I have—that there are quite a few Nobel Prize winners that I had a chance to at least hear a lecture in person. What an amazing privilege to be able to even say that.
At University of Arizona where I was, Nico Bloembergen was there and Willis Lamb. There were a few that I definitely spent more time with, and that was really special.
So how did you develop the interest in optics? How did that come about?
So, some of it was because my work at JPL was optics-oriented, and I had an officemate there that told me about University of Arizona. I didn't realize until my junior year that you could get a PhD in optics, and it was in my junior year that I was taking the optics semester-long class. I already liked E&M and some of those, you know, Fourier theory and it all just kind of fit. And I started to appreciate also the imaging side of it, medical imaging, so it was all just starting to realize that I could put something together there that connected a lot of the things that were important to me and interesting and that came easily.
What kind of projects did you do at JPL?
I was in the Deep Space Network, but I didn't do space-space. I was doing a lot of energy stuff, including going out to Goldstone and making measurements of buildings to try and make them more energy efficient. A lot of it was thermal and computational modeling. Mm-hmm [yes]. But I was there when we launched Voyager, so just being around at that time was pretty cool.
Why Arizona? Was that the place to be if you wanted to do optics?
There were, at that time, just two places. The University of Rochester has a very storied program called the Institute of Optics that’s been around longer. The University of Arizona program started in the sixties, so it was smaller. It was a little more engineering-oriented than- Rochester was more lens design. Tucson had a tighter connection with the medical school, which mattered to me. And my husband is from El Paso and my parents had moved to El Paso, so some of it was a little bit around family and staying in the Southwest .
In terms of the coursework, how much as a graduate student were you taking physics classes, or was it mostly engineering style classes?
No, it was mostly physics. I took quantum. I took several classes in quantum laser physics. You know, there was a heavy dose of electricity and magnetism.
But there wasn’t a particular professor that you wanted to go with specifically at Arizona; you were just interested in the program.
No. That was a different time. Yeah, I know now people communicate with professors and figure that out in advance, but I’m pre-Internet.
This was 1980 when I headed there.
So, who was your dissertation advisor, and how did you develop that relationship?
So, my dissertation advisor was Harry Barrett, a well-known person in medical imaging.
He was gone on sabbatical the first year I was there taking classes, so I did work one year doing solid state work, thin films for photothermal. But as soon as Harry got back from Germany where he was on sabbatical, I wiggled my way into his group. We stayed friends after I finished and… I mean we talked about writing a book when I was in graduate school, and that developed pretty soon after I left. It got to be a ten-year project for he and I.
Now at what point did you start to think that your area of expertise would be specifically focused on medical issues, human health research, that kind of thing?
Well, as soon as Harry got back to U of A from sabbatical- I mean, I had started to work with some people at the University of Arizona who were collaborators of his while he was gone, but very quickly I decided that that was something that if I could get accepted by him to work with him, that was really what I wanted to do.
So, it’s more about him and not the program. The program itself was not naturally geared towards human health sciences or anything like that.
It wasn’t. It wasn’t. There were just one or two professors working in medical imaging, so it was about if you wanted to do that, you needed to work with these people.
Right, right. How did you go about developing your own dissertation topic?
Harry left that to us. He had all of the students figure that out for themselves. He always had a blackboard full of project ideas, and the group was very interactive and collegial. So, I just started to go to his lab meetings. He had a weekly meeting where all the students that were part of his program shared, and then he had meetings for the sub efforts. I did spend the first, you know, quite a while taking classes and absorbing. He had another book that had already been published in 1980 on radiological imaging—absorbing all of that and starting to figure out the lay of the land and where the gaps were.
To the extent that you thought about these things, what did you feel like your contribution was with your dissertation?
Well, so I was the first in the group to do perception work. And I have to say at the time I didn't like what I was working on in a way. I mean, most of the group was hardware, building modular nuclear medicine cameras and doing signal processing. Back then everybody was doing their own soldering, right, and building, putting things together. But Harry had gone to a conference or two, and I had been able to go along too, where there was this last missing piece. He would say now that our book became the end story for the earlier book that he had written around radiological imaging— the missing piece was around how do you evaluate images, and how do you evaluate them in terms of information transfer from the data to diagnoses? That’s what I ended up working on, which was visual perception applied to medical images.
But at the time I was lonely because I was the only female in the group. There were very few women in the program, and I really felt like it was a soft, girly kind of topic. I had a little bit of my own sense of is it going to measure up? Am I going to get a job, or are people going to just think I couldn't do the hardware? So, there was a little bit of…you know, just a little embarrassment about it. As time went by and the work became much more evidently impactful and picked up by lots of other people, then I got to see that it met standards that I wasn’t sure it would at the time, if that makes sense.
It would seem to me that the issue of visual perception is- I mean, the imaging is only as good as it’s perceived by the person looking at it, right?
Well, it probably seems obvious now, but back then I wasn’t quite sure about how that would all come off and whether or not the work I had done was going to end up being useful to somebody else.
I wonder if your work on the dissertation in terms of visual perception touched on other areas that are related to like sociological issues, like the different ways that different kinds of people might perceive a given image, if that was a part of your research.
It wasn’t. It really was all around thinking about communication theory, some of the really classic works from World War II and imagining the human eye-brain system as a receiver and writing mathematics for that, so it’s much more objective. Just how do you make measurements of what people can see objectively, and how do you set up those kinds of measurements? How do you model it so that you predict human performance? My goal over time has been to develop approaches for evaluating imaging systems with models that are able to be used as replacements for studies involving trained observers because radiologists are expensive. Humans are expensive. It’s timely. They’re variable. How do you do those kinds of measurements in ways where you think about it in terms of the signal and noise of the measurements you made that are of this process of extracting information?
When did you start thinking about where you’d be able to best apply this research in your interests in terms of a career? Were you wide open in terms of industry, a place like the FDA, even university research? What were your options?
I finished my PhD in ’85. My husband needed another year. I brought him with me to Arizona. He got a physics degree at Occidental as well, and so we traveled to Tucson together where I was going to start grad school. He started a PhD a year after me in applied math at Arizona. So, I did a post-doc while I waited for him to finish, and then we were trying to solve the two-body problem. So, we had a lot of different choices that demonstrate the range of options. One of them was he would work for Bell Helicopters in Texas and I had an offer at University of Dallas. Another one was me at UMass in the Worcester area and he was going to work for Pratt Whitney, and we would live somewhere on the border between Massachusetts and Connecticut, and a few things like that. And I had been put through school my last three years by Kodak, and so I had an offer--
Oh, really? Why? How did that happen?
Yeah, yeah. I was selected by the U of A faculty for that. Kodak started a fellowship program at a number of different schools, and they had a really neat setup so that the first year after I was funded, I went to Rochester in the summer with, it was maybe five other grad students from around the country. It was a community that they brought together. This was their plan. I just was cleaning my office and found this picture of that group of students I met at Kodak.
Then the second year, my advisor and I had to arrange to go together because they wanted to pull the advisors into giving feedback on the research labs there. Each of the Kodak fellows was supposed to do that. In my case, Kodak had at that time a pretty strong medical imaging effort. Kodak was well-known for their radiographic film and their characteristics that they would publish of their film to show their competitors and market their products. But they also had, of course, other kinds of optical efforts as well and I was open to any of those possibilities. Then my third summer I had to go and present my dissertation to the program there. I got an offer and so did my husband, to work for Kodak after we graduated. In the end we really liked the offers that we got better from Corning and so I went to work there on fiber optic components and my husband worked on mathematical modeling of fluid flows for Corning. So, I was really open to different job options.
I’m thinking that with just--
And I really appreciate what Corning said, that “You wrote your dissertation in five years. You made yourself an expert. You should be looking at a place that would be willing to let you do that over and over again, and we’re that place.”
Right. I’m just thinking as a matter of history Kodak supported you at a time when people used to buy film for their cameras (laughter).
And that also looks--
Yeah, I got one of their prototypes for this little disk camera that they had with these itty-bitty little pieces of negative around it that would rotate. Do you remember that at all?
Probably before your time.
No, I remember it as a small kid.
But yeah, we’re pretty lucky that we didn't go there!
And now I understand also why Rochester would have had a good optics program that’s probably not coincidental with Kodak also.
Not at all. They were there. You know, there were a lot of different optics companies that were there at the time, mm-hmm [yes].
Right, right. So, the offer at Corning—was your sense that the environment at Corning was a real basic research kind of place where you could pursue your own interests?
No, they had something very specific that they wanted in mind. Corning was well-known for their long-distance fibers, and that was the time where everybody was talking about how do we get fiber to the home? The big barrier to that was fiber optic components, so they used to talk about we need optical plugs. We need the example of an electrical plug that a group in a manhole can put together and make work, robust and all. So, they had a number of different projects to try and create optical connections between fibers. I knew that that’s what I would be working on.
Was this a place where you were able to hone your skills in the harder sciences in terms of your- When you were saying before about your concerns with your dissertation not having more of a hard science component to it?
Yeah. It was that and it was very experimental. We were making things. We were making lens molds and channel arrays, so it was a lot of fun. I actually didn't stay there that long, though. From the time working on my dissertation there was a very close collaborator of my advisor’s that I admired greatly who let me know that there was an opportunity at FDA if I would come. It was a personal invitation and I couldn't turn that down. That was somebody who was working for Roger Schneider in that laboratory, and it just was too much of a tug. So, I left Corning to go do medical imaging work at FDA. I stayed connected to Corning for another couple of years. They were hoping I’d come back although in the end I didn't.
Yeah. So, in some ways the opportunity at FDA was closer to your original interest as a graduate student about medical issues.
It was. It was. It just wasn’t something that was available when I first was looking. I don't know what I would have done if it was, but when it did come around, it was a good time for us.
So how did you manage the two-body problem for FDA?
Yeah, yeah. So, my husband was really supportive of me going, and we both figured that this metropolitan area was going to create some opportunities for him. So, he found something about seven months later, and in between then we just did the drive back and forth every other weekend or so.
Right, right. Okay, so in terms of setting the stage bureaucratically at FDA, what is the office that you initially joined when you started?
It was called the Office of Science and Technology (OST).
Okay. What was your sense of the mandate? What were the big projects that this office was charged with?
So at that time it was very soon after a merger of two bureaus, a Medical Devices Bureau and a Bureau of Radiological Health, and what I joined was the radiological health side of that and still had that culture, which was all around ensuring that exposure of patients to radiation for medical imaging was right-sized, that we were cautious about the use of every photon that we were sending through patients and that our systems had the ability to fully capture the information that was part of the imaging procedure. So, it was about improving image quality and reducing radiation dose. In a nutshell, we thought of imaging efficiency in those terms—you know, information overdose and ways that you would actually quantify those things. So, my work in perception and evaluating information in images fit right in with what they were looking for.
That came in handy!
What were some of the major devices that were issues of concern in terms of patient safety?
Well, CT had just hit the streets. You know, those- It was a golden time. I have ridden a really interesting set of waves because the CT efforts were only then coming to patients. When I was in graduate school, there was no magnetic resonance imaging system at the University of Arizona medical school. That was a brand-new technology, so FDA sent me back to some formal courses on pulse programming and what MR imaging is all about. So, there were those two. We had work in ultrasound and quantitative tissue characterization using ultrasound. Lastly, mammography seems like such a success story today, but there was a time where women—and you’ll get that story from Roger Schneider, and maybe you’ll talk to Bob Jennings—where women were staying away from mammography because the doses were high, and the quality was quite variable. The FDA had an incredible role in changing that in this country.
Right. So, let’s take each of those technologies sort of one by one. So, let’s start with CT. What was the big promise of CT and what were some of the concerns like straightaway as soon as this technology was available to medical practitioners?
So, the promise of CT is that it’s a volumetric or 3D imaging technology, which means that you can essentially open the body up and see information without overlapping tissue. Before that what we had were projection or planar imaging technologies. So, I have a great and sort of a funny slide that I show when I’m talking to young audiences, an image of the head. If you take an x-ray image of the head, especially back then in the seventies and early eighties, you wouldn't see the brain at all. That’s kind of amazing to show this image and say, “What are we missing here?” and then to show even for the early CT images, the beauty of being able to see a brain tumor in soft tissue. That was an incredible thing to be able to diagnose disease so much earlier.
But it comes at the expense of a lot more radiation, so there were people that were really worried about whether or not that radiation dose was going to be problematic. We’ve seen that issue rise and fall so that there was… You know, about ten years ago there was a lot in the papers about some pretty publicized overexposures from CT systems, and they truly were overexposures where there weren't sufficient controls on the control panels and technologists had overexposed patients. Some unfortunate things happened, and some initiatives came out of that to try and keep that from happening. But getting back to the 1980s, that whole challenge of what can you get from a CT image? How can you optimize that to be the most efficient while taking incredible advantage of what CT has to offer?
Now when you say overexposure, does that mean both if people are routinely getting CTs as you're following the progress of a tumor, or can it even be overexposure from one session?
In the case of what happened in 2009 and 2010, it was overexposure in one session, people having their finger on the exposure button too heavily. It was just a couple of cases for which that happened, and you could easily look that up in newspaper files from that time.
Have the concerns about CT exposure borne out epidemiologically? In other words, to the extent that it’s possible to establish causation, have people gotten sick as a result of getting CT scans?
You know, it’s just incredibly difficult to ever show that-
-because the number of CT scans done in the country is high.
Experts largely agree that CT plays a very important and useful role in medical imaging and clinical diagnostics and follow-up and that the benefit outweighs the risk. The number of additional cancers from CT can be calculated based on models that are extrapolated from things like bomb data, and so it’s really hard to show that those are true; they’re just guesses. Then to say are those additional cancers worth it when we’re talking about eighty million people getting a CT scan every year for good reason? So hard to decide which of those you would eliminate.
And you said that even as an early technology CT imaging was very impressive.
It was. It was very impressive, and the rapid improvements in the technology were really exciting to see. So, the first technology was very simple. It was just a pencil beam, so it was one source that ran along a linear detector. It was two boards, basically, and then you rotated it angle by angle. Then they figured out how to do it in a circle, and then … Along came slip ring technology and you could run this thing very fast and then do it helically and things really… And that progression happened very quickly, and the engineering side of it was- It was just putting together the mathematics of CT and image reconstruction. Once those light bulbs went off for the folks that won the Nobel Prize and demonstrated that and the engineers went to work, things moved very fast.
Mm-hmm [yes]. So, let’s now move on to MRI. How well developed was MRI by the time you arrived at FDA?
Not at all. Not at all.
Oh, so that happened after your- When did that happen?
Well, it also was a technology that was coming to the fore in the eighties, so it was not mature. It was definitely behind CT.
What were some of the concerns, because obviously there’s no radiation involved with MRI. So, what are some of the concerns in terms of patient safety?
Well, so at the time people weren't sure what the bioeffects of sitting in a large magnetic field would be, number one, and number two, there is RF heating. We’ve had issues of people having implants that were dislodged in the brain during an MRI scan. We now know that we have to be careful about MR compatibility. You know, first we went to “Don't have an MRI if you’ve got an implant because it might not be MR compatible. It might move or it might heat up.” Both of those things are unhealthy, and now we have the ability to do computational modeling. Some people may not know that when a company brings an implant to the FDA, we’ve made virtual phantoms of people available and software, and they will do- it can be a million simulations of patients of different sizes and shapes and implant locations to get the data to show that the compatibility of the implant is such that it could be labeled that way.
So, your office was involved in determining that nobody was sort of barred from getting an MRI simply because of the kind of implant that they had.
I wouldn't say nobody, but just what are the safety considerations and how do we mitigate those? Then as I said, getting to a place of having modeling and understanding materials and having the ability to model the process. You're modeling the MR coil. You're modeling the imaging sequences. You're modeling patients. You're modeling implants. There’s a lot to that, and there’s a community of science around that now and publications. So, that’s only been in the last ten years.
In terms of establishing a narrative of some of the questions about mammography and the concerns, by the time you entered FDA, where was that national debate about how often and who should get them?
So, it was in the debate process, and it was before the Mammography Quality Standards Act. That was published in the early 1990s. So, when I got to FDA in ’87, that was in the height of the time of appreciating that something needed to be done and that legislation needed to be written. It’s the only area of medical imaging in which the radiologist (in that case the mammographer) has to pass a quality standard, and the imaging environment on top of that, and the technologist. So, there’s a facility certification—rightly so because we would hope that every woman over the age of forty or fifty is impacted by it because those are the screening recommendations.
Right, and I wonder if you talk a little bit more about that. I mean of all of the diagnostic imaging issues, right, why is mammography sort of in its own category in terms of the level of the debate and who is involved and all of these considerations? Why does it seem like it’s mammography and then everything else?
The key word there is screening. A screening technology has a formal definition, but loosely speaking, it’s a technology that we are imposing on patients who have no signs of disease, no symptoms. If you have a reason for imaging that’s related to, in the case of mammography, a lump, a discharge, some sort of an asymmetry or architectural distortion, you go for what’s called a diagnostic exam. But women are recommended to have imaging done who don't have any signs of disease. That’s a screening study. So, we’d better get that right in terms of how much we’re irradiating these women, most of whom will not have breast cancer in their lifetime. So, the lifetime risk is around—what is it?—one in eight (twelve percent). That means most women are being irradiated to find a disease they will never have, and so we need to make sure that we aren’t causing harm by what we’re trying to do to take care of the women that eventually do end up being found to have breast cancer.
And so just so I understand, is that really the only widespread screening that involves radiation for people that are entirely asymptomatic? Is that really what makes it unique?
At that time, it was very much unique. Now we have a few more screening technologies that involve radiation that have been recommended by professional societies and for which there is reimbursement from CMS because the benefit has been shown to outweigh the risks. That includes CT colonography for patients for whom colonoscopy is not recommended because there are issues with scoping them, which can be multifactorial. So then in that case, CT scanning is the thing of choice.
Lung cancer screening using CT has been shown to be effective, and in fact, the clinical trials to show that were stopped early because the benefit was so evident. In that case it’s for high-risk patients, people above a certain age and above a certain smoking pack history. But those are technologies which are still, while you might be at risk—and you can think of the example of breast cancer, where you're at risk if you're a woman—they still are imposing radiation to somebody who most likely doesn't have any sign of disease. The benefit of early cancer detection has been shown to outweigh the radiation risk across all the people who will undergo the screening test.
Remember that my title is medical imaging and diagnostics. There’s a lot of overlap between imaging diagnostics and other diagnostics that involve a test intended for screening. I just wanted to mention that in the area of prostate cancer screening, we also went through in this country a pretty significant debate around the value of prostate cancer screening. You know, what patients for what ages? Did we, by initiating screening, start a prostate cancer epidemic? We’re talking about that a little bit now right around COVID. More testing means you find more disease. So what do you do about that?
You're not saying that the screening causes the disease; it’s that you're finding more disease that maybe could have been left alone and the people would have been fine?
And how do you know? That’s right. Mm-hmm [yes].
Right, right. So, Kyle, I wonder if you could-- Let’s take the mammography debate as one example to give an understanding of the role of your office within that larger debate.
So, does the FDA speak with one voice when there is a debate about who and when and how often? Is that the FDA that’s making that announcement? Is it HHS? Is it your office? How do those things work?
It’s definitely the Center for Devices and Radiological Health, which is one of the centers of FDA, but we’ve learned that on the outside you shouldn't expect people would appreciate the subunits of FDA. So, we speak as the FDA and we definitely partner across the different offices within CDRH. So, my office does research. Everyone in my group also does regulatory review support. They wear those two hats very tightly, and so they are serving on review teams that are making decisions on whether submissions that come from industry for new products should be authorized by FDA for marketing.
So, there’s a really beautiful relationship between the research that the program does, which is driven by the gaps that we see in both public health and especially how do you evaluate technologies? How do you show that something is safe and effective? How do you do that more efficiently in terms of the resources, because of course we don't want to keep patients from having access to a lifesaving or life-improving technology, but we don't want to release things that would not be beneficial. We’re always doing decision making under some uncertainty. We can't have clinical trials as big as you would need to be absolutely sure, so we’re always in a hard place between companies pushing for us to say yes and our really important mandate to protect public health and how to get that right.
In terms of understanding who makes up what part of the debate, is that the essential binary? It’s that the industry and their interests on one side and the FDA and its regulatory and patient safety and efficacy interests on the other side? Is that, in a simplistic way, how to understand the two sides of understanding the issue?
Perhaps, but I guess I wouldn't want to portray industry as being too-
-adversarial with us. We have a really good relationship with the medical imaging industry through the Medical Imaging Technology Alliance and have done a lot of collaborative work with them, including even joint publications and joint standards on these things. They’re aware that it would be- It absolutely is in their best interest to do what they can to get this right, too, or litigation follows, and they need the public trust to buy their products. So, it’s not a huge dichotomy, you know, but there always is a little bit of a gray area. Mm-hmm [yes].
Right, right. So, on that note, I wonder if you could explain a little bit about how the process works in terms of when your center gets involved in an issue, right? So, it must start with a problem. Somebody raises a concern somewhere about some medical device and its limitations in terms of patient efficacy and/or safety. So, my first question is what are the most likely sources to raise that problem? Who’s saying, “I have a concern with this”? Just as like the starting point of what will become a long process—where does that usually start?
Yeah. So, mammography is an area in which… You know, like I said, Kodak was publishing about their film; other companies too. So very early on we and companies were working together on how do you make measurements of system performance? So, there’s the technical side of it, but there are what people call the levels of efficacy of a technology. There’s technical. There’s diagnostic, personal, societal. So, information comes not only from industry, but it comes, of course, from patients and providers, and it may be that- It can come from any of those. As long as- I wasn’t sure if I dropped words. So, in mammography, I’m not exactly sure where all of the information was coming from around…because that definitely was a case where we were getting better and better ability to record images with better film with longer latitude, but there still was the side of the site who was collecting the images and who was reviewing them and understanding the variances around that. So, ensuring quality in all those aspects came out of what was happening at that time.
Fast forwarding to now, I just would want to say that all of our scientists, you know—and at least half of my group is physicists—they publish in the journal Medical Physics and other journals, and they go to conferences. The job of the Research Office is to do our best to ensure the FDA is never surprised when a new technology is going to come to us for regulatory approval. We’d better know about that years in advance because technology is never developed overnight. It starts with prototypes and presentations of concepts and then collecting the first data.
We now have a program that we call the pre-submission process where an innovator, whether or not they’ve been comfortable talking about their innovation in a public sphere depending on where their IP is—if they are so interested, we make ourselves completely available. These meetings are free for an innovator to come talk to us to say, “We have this technology. We think this is what the clinical use case would be, and this is how we are thinking we would validate it. Here’s our study design. Here’s the data that we would collect to show it’s safe and effective. What do you think?” We kind of negotiate around that because we also- Not only do we not want to be surprised by a new technology, we really don't need for people to be spending their time and money in a wasted way on data that we’re not going to be happy with that isn't going to be enough to show that the device is safe or useful for what they were thinking about.
So, by no means does the policy process start just because somebody raises a concern with an existing technology. Your office gets involved on developing technologies as well.
Yeah. So, if you look at all of my research portfolio for our group, it’s predominantly on products that are not on the market—things that are coming or that are kind of in pilot phase. You know, spectral CT so that you're taking advantage of the wavelengths of the CT beam and not making the assumption that it’s monoenergetic when it isn't and having imaging artifacts because of that. Now detectors are coming along that are multi-spectral and fast, and so we can start thinking about taking advantage of a lot of different attributes of every photon that’s being detected in a way that we aren’t now. So, the group is working similarly. As companies we know are working on that, then we’re working on evaluation strategies. So, when I talk to people about working in the group, it’s about explaining to them that we don't compete with industry and we’re not academia. We’re in this interesting place that works on technology evaluation.
Now in those cases when we’re talking about existing technology and somebody does raise that concern, what is the process for this to get to your desk? How does that happen?
So, there are a couple of ways. I mean I certainly can have sidebar conversations at medical meetings—you know, the Radiological Society of North America or something like that—where there are a lot more clinicians than maybe the technology innovators. We also have a number of different ways that FDA collects what we call signals—adverse event reporting requirements. So, we watch for reports that are above what we would have expected to be the baseline since there is no perfect technology.
You know, we’re always going to understand that somebody might have gotten a diagnosis on a CT from one institution that would be different from another. That’s not a surprise. But when we might see too much of that going on or doses being too high as they were in 2009—in that case patients were burned and hurt—those reports. Unfortunately, a radiation burn may not be something that we even know about for weeks or months. It can take a while for a deep fluoro burn to come to the surface. But then that gets reported. It might get reported by the patient and it might get reported by somebody that they go to see about what’s wrong with them. So, then it can come to us and people start moving into action. That’s not a Research Office responsibility by itself. We might get called in as experts to speak to how to do the kind of forensics analysis around what went wrong with the technology on a team with medical officers and compliance officers from other parts of the agency.
And if you can give a sense of the day-to-day, especially on the issue of forensics research and things like that. Does your team do field work? Are they going to the manufacturers or is it all about analyzing the data that you're given?
My group does not go to the manufacturers. There is a group that’s trained in that; that takes some special training to be sensitive about being on site, how to do that in a way that’s professional, what records we can request, and what’s the process for that? What areas of a manufacturing facility might we need to inspect and what’s the process for that? So, my folks can go along in the jump seat just to get that experience on a one-off basis, but it’s not part of our day-to-day life. Our day-to-day is about doing research to address emerging technologies typically more than signal response, and then serving on review teams where our expertise is drawn from to support the evaluations of the newest technologies. So, you have to understand that CDRH (the Center for Devices and Radiological Health) gets like 22,000 submissions from industry every year, pre-market authorization requests. It’s a huge number, and the Research Office is not 200 people.
So, we see a couple thousand of those. We only see the most cutting-edge. There’s a lot of what’s going on that is just gentle technology creep—you know, “me too” devices that are pretty much the same. They don't raise a lot of new questions around the device safety. How do you evaluate performance that’s done on an engineering basis? They don't need the research labs for that. So, our job is to work on what’s the birthing strategy for a new technology? Help get it on the market. Help that pathway. Help it get to be where it gets to be last. It gets to be ho-hum—you know, last decade’s challenge and handed over to the review side because they do it all. Otherwise the research labs never get that ability to move on to the next thing.
So, people in my group are working on things they weren't working on when they got hired years ago. They have to kind of do what we talked about with the dissertation—you know, move on and give older things away. That’s also a little different, right, then in academia where you might… You know, if you think about something like digital breast tomosynthesis, which is 3D mammography, we’ve got four of those systems on the market now. We’re in the process of developing approaches for what we call down-classifying them from our highest risk category to our middle risk category and reducing data requirements for them getting to market and handing over a lot of our responsibility once we’ve developed those kinds of tools so that we can move on to the next challenge. That’s been something we’ve been really busy around since the first system was cleared in 2012. But now here it’s been eight years and now we’ve got four of them. They’re very different takes on how you might get 3D mammograms. We’re not expecting that what comes next is going to be so different that the tools that we’ve already used won't apply to evaluating within what we could define to be digital breast tomosynthesis. So, I don't expect that my group is going to be working in that area, say, three years from now. We always have to be looking ahead.
Now when you say there are 22,000 requests and your office is able to do maybe ten percent of that, does that mean that the other ninety percent are being dealt with at other offices at the FDA or they’re not being dealt with at all?
No, they’re being dealt with by the other parts of the Center for Devices and Radiological Health. So, the Center for Devices and Radiological Health is under 2,000 people. It’s just like I said we’re under 200.
So, we’re about ten percent of the Center, and we do about ten percent of the pre-market review work and then the rest of the Center--
So, what’s the basic threshold for- What’s an easy way to understand the kind of emerging technology that obviously would go to your shop?
You know, it’s a technology that doesn't readily have what we call a predicate, something that it’s substantially equivalent to. We have a formal definition for substantial equivalence, and if it’s not obvious how you would show that it has substantial equivalence to something else that would come to us, then we have to decide what risk category it’s in and develop what we call a pathway. What evidence would show the device is safe and the device is effective? There are formal definitions in the law that establish our work.
So, that might be a short way for understanding roughly how many truly new technologies are hitting the medical device marketplace in any given year.
Absolutely. I think we have two things to look at there. We have what are called the pre-market applications, and we definitely track how many there are and how fast they get through our review process because that definitely is one of the main ways to gauge innovation in our country. Then the other is something newer that we call the De Novo pathway, and it means it’s… It’s not a category 3 risk. It might be only category risk 2. (We have three levels of risk.) But even so, there’s nothing like it that’s on the market, and so we need to come up with some controls for how to make sure that the device is safe and effective and put that out so that that device becomes the beginning of a new tree of devices. It gets its own code and it serves as what we call a predicate for “me too” things that follow that.
Is there ever a case of an emerging technology coming from a startup that’s so green and doesn't understand the regulatory process or maybe doesn't have the best intentions in mind that they try to sort of skirt around the regulatory approval process and you find out about it after the fact? Has that ever happened?
You know, especially, I don't know how much people do that on purpose, and I don't want to be the one to say that because I can't think of any examples. But what I would say is especially now in this world of increasing reliance on digital technology and the Internet of things, we’ve run into companies that just didn't even realize they were a medical device and didn't realize that a digital technology…didn't realize software is a device, can be a medical device.
So, our approach to that is to reach out and to- You know, we have gentle letters that we might send that we refer to as things like an “It has come to our attention” letter-
“-that you are marketing this, and maybe you didn't realize it was a medical device and that you need to come to us if you're going to market it in that way.”
Right, right. So, another issue I wanted to touch on. Roger really impressed upon me that on the whole, you know—and you touched on this as well—that there’s by and large a spirit of partnership between your office and the manufacturers. It’s for the obvious reason: it’s in their interest to work with you because otherwise they’re not going to have a viable product. That intrinsically makes sense, and he even shared with me one technology in the CT world where your office actually helped to improve the technology because as he put it, your physicists were better than their physicists (laughter), which I really enjoyed that story.
I’m curious, though, if there are any, I appreciate, and it’s completely understandable how that would be the general tenor of how things go. But I wonder if there are any—you know, without getting into specifics—if there are any representative issues-- Are there any representative issues of… You know, let’s say you're doing a review of a device or something like that and you come up with a problem and you say, “This is a no-go. This is not going anywhere. We have too many concerns,” and you get strong pushback from a manufacturer. Let’s say it’s this person’s dream. They’ve been working at it for 15 years, or there are venture capitalists and they have millions of dollars on the line or whatever it is. You get really strong pushback that your review is unacceptable. First of all, is there an adjudication process for this? Is it your way or the highway because you're the FDA and there’s no getting around you? How does something like that work when there is this issue where you find a problem and the device maker says, “I’m not going to find a solution. I just reject your findings.” Then what happens?
Yeah. Really good question. I would start by saying that our world is a team environment, and we can have pretty strong disagreements I’ve seen within teams at CDRH. We’ve got people… We’re science-based, but there are value judgments that come into play, of course, always around what is safe enough for what benefit or what risk. So, I wouldn't minimize that. There has to be healthy debate within a place in order for everyone to be heard. I do know of examples where an entire review team might have landed on one side of a decision and they were overruled by their manager or overruled up the line.
You know, my experience has been that the end of the line is our director, Jeff Shuren. He’s the one who takes political heat for the decisions that he makes and has to stand up for that. He is an incredible director, you know, what all he has the finger on within the group, and widely. It’s almost 2,000 people. He just commands incredible respect for just how smart he is, how hard he works, and how much he is able to juggle all the competition around where the decisions land that come both from internal discussion, debate, and sometimes dispute, and outside. So, it pretty much lands on Jeff’s doorstep.
So, your response emphasized intramural debate—in other words, debate within the Center. I’m also curious about the device makers themselves, the manufacturers.
Yeah, and that’s what I’m saying. They may push back at Jeff. He hears from them all the time, phone calls. It used to be in-person meetings, but he’s the one who ends up… You know, when the debate doesn't come to a resolution or it comes to a resolution where industry wants to kick it a level higher, it will end up with him. He’s the one who testifies in front of Congress for why things are where they are.
So that’s where things end up.
So, it ends with Jeff, and then would it be lobbyists? How does it then get to Congress if somebody wants to challenge Jeff’s own decision on something?
So, Congress can hear from lobbyists around and especially societies around things like the medical device tax, but it can often be the heads of companies will be in touch with their Congress person. Those are… You know, the head of Medtronic is plenty able to be heard on his own, so those kinds of folks have no problem picking up the phone and speaking directly to somebody if they can't get through Jeff. But my understanding from two levels down from Jeff is that those conversations happen with Jeff. The industry hears directly from Jeff—industry leads, lobbyists. Jeff is the one who set up the Medical Device Innovation Consortium, which is a way for him to directly talk to industry leaders and develop collaborations. He just has a lot of respect from industry leadership, and if they have heard from him and they haven't gotten anywhere, it’s pretty unusual that they think that they’re going to go to Congress and get something else to happen.
Right, right. So, a positive kind of spin on that question is let’s say your office does find a problem and the manufacturer says, “Great. Thank you for bringing this to our attention. Let’s go about and fix that so that it sails right through next time.” What’s a best-case scenario of how that kind of process plays out?
So, we’ve been doing things like that since Roger’s time. An example that we had was related to reducing dose from some newer what they call iterative reconstruction algorithms. The companies were thinking that we weren't playing fair with each of them around what they each had been able to claim about their product and market it. So, the best thing that happened is they all said, “We’re going to talk to FDA together,” and so all the CT manufacturers arranged to be in the room with us together and we talked about… We heard from them. They heard from us, and out of that launched a couple of task groups to come up with some better practices that we would all agree on. So, it was our physicists working with their physicists and we developed a new imaging phantom. We developed new software. We developed a standardized way to market these products with what we were calling labels and tags, and so at the end of the day everybody felt like we’d gotten to a different place where we weren't yelling. They were yelling at us and at each other, and we got to a different place.
So, I asked before about imaging technologies at the beginning of your career at the FDA. In more recent years, what have been some of the major technologies that have come across your office, that have commanded a lot of attention?
So, the biggie for us right now is… I’ll give you a few. One is digital pathology. All the other imaging technologies have gone digital, but surgical pathology has its own challenges because the microscope has been around for a very long time, and the approach that a pathologist takes to read an image is immersed in a microscope and going up and down through the tissue and at different levels of magnification. How do you collect that data electronically and present it in a way that preserves the information for what truly is the last place for diagnosing a patient? I mean, biopsy is the reference standard for all these other imaging technologies, and so that’s been slow to move to digital and there’s a lot that we still haven't figured out. So, that’s why there’s very little that’s on the market right now. Just two systems that we say are totally locked, meaning they encompass the entire process from the slide to an image from a digital camera, the color management software, the computer, the display—you can't mix and match components like you can in some other imaging technologies. So, the cost of their systems is substantive and there’s no interoperability, and there’s no AI. AI is going to come, but how do you figure out what’s true in those slides that would allow you to validate AI algorithms? So, my group is pretty busy in a number of those different gaps in public health today.
Another one: we have long had a leadership role in image display. Our group was very involved in moving from CRTs to the screen I’m looking at you right now on, on figuring out when a digital technology was appropriate for reading images of different display needs. So, mammography was the most challenging to go digital because again of what was needed in terms of the grayscale range, the number of pixels on the footprint. Digital pathology beats all of that in terms of requirements, but that’s still planar. You, I don't think, will be surprised, though, that my display group has now moved into augmented and virtual or what we call mixed reality. That means not only presenting images, but overlaid information not only for radiology, but for doing slide review or colonoscopy. AR/VR systems are being developed to allow for not just surgical treatment planning, but actual use during surgery, and there’s a lot that we have to get right there so you're coming in the right place and all of that. And AR/VR is being used to develop all kinds of therapies. Or patient tracking for things like concussion disorder and other kinds of mental and brain degenerative diseases. So, my group is working in augmented and virtual reality, just to name a couple.
So, I mentioned to you before we actually started the recording with Roger Schneider and how he said he felt very comfortable in terms of where the future of the office was headed after his tenure. I’m curious from your perspective. In what ways has the mandate of the office changed since your time beginning, and in what ways has it remained the same?
Well, we always have had a public health mandate and a mandate to ensure that technology is safe and effective. When I started in Roger’s office, we had no review responsibility, so what I said about everybody in my group doing about half-time research and half-time review work, that was not true when I started. We were all one hundred percent researchers, and promotion was based on research productivity and evaluation of research impact kinds of metrics, and that’s just not the way it is here today. Now you very much have to be an integral part of the review process as well. It’s a harder place to work.
In what ways is adding the review responsibility to everyone’s portfolio—in what ways is that a benefit and in what ways is that a hindrance to the overall work?
So, you know, it’s tough in that. The review work is always challenging for people because you don't have very much time to respond. Our reviews are mandated by our law to have very tight timelines. You get ninety days for a “me too” product, and they’re never exactly “me too”—and 180 days for something brand new and different. So, they’re very fast turnaround products that we have to contribute to. And it’s not like being in academia where you can plan ahead to be at a conference or plan ahead for grant applications and sort of move your research around to adjust to those deadlines. Instead, these review requests just go boom on your desk and you’ve got a deadline yesterday you didn't know about, and it’s three weeks from now. So, I very much have to hire people who can handle that kind of time crunch. What keeps people here is the mission, the relevance, the knowing things before other people know, being in the frontline, and having that impact of the decision making that something is or isn't ready to go to market, and the relevance.
So, I think this group was largely working in the right area even thirty years ago when I joined, but there definitely were some groups that were not that FDA-ish and have struggled more to have to get in line with what FDA needs and what the public needs. So for us I think it’s just the struggle that a researcher is always a researcher at heart, and while they do the reviews gladly and understand that that helps them choose the right research projects, everybody would always rather have more time to do research, you know?
Of course. Of course.
It’s what Dyson said, infinite in all directions, right?
(Laughter) That’s right. That’s right. So, I’m curious for your own career how… As you have moved up the hierarchy, how have you navigated that personally in terms of how do you remain a working scientist and not somebody who’s managing other scientists?
My collaboration with Harry Barrett continued until…and it still continues, not so much since he retired last summer, but that really was a place where I could be a colleague with somebody. But also, while I don't program anymore myself—I’m the only one in my group that doesn't—I’ve always had the opportunity to participate in projects and mentor the younger scientists and continue to work with them and lead some of our research efforts. So, it’s not as much as maybe I wish, but I’ve appreciated on the other hand trading off the time I’m doing research for the ability to lead an amazing group because it’s really a very dedicated, smart bunch of people and a lot of fun.
Now in terms of the correlation and causation issues and the difficulties it is to really connect a piece of your work with something that actually was good for the public, I wonder, as a broadly retrospective question, if there are any endeavors or research inquiries or projects that you were a part of that you really feel a personal and a professional level of satisfaction that you really furthered the mission and the mandate of your office and you really contributed to those baseline twin pillars of consumer efficacy and safety.
You know, I can't end this conversation without mentioning the book that Harry and I wrote together because while it’s a bit of a tome, it’s something that has influenced not only people in my group and his, but has been something that’s been picked up by just all kinds of folks and won a lot of awards. I’m really proud of how that has created a culture around image science that has just been important to many people, and I hear about that all the time.
I think that our own group has had just a lot of impact in the area of computer-aided diagnosis. We’ve written guidances and very much been in the center of determining the right kinds of studies to bring computer-aided diagnosis to patients. We’ve owned that space for a very long time and have continued to lead it, and it’s really amazing to see where we are today around what AI-enabled medicine is becoming. To be a part of that is something that I just didn't- That I did not see coming when I came to FDA, but the work that I did in evaluating images and how humans perceive images really translated into developing algorithms for interpreting images. So that arc has been really interesting to watch and to just see where others have taken it with computer-aided diagnosis and now what we’re calling AI-enabled medicine.
As I’m sure you know because of coronavirus, people have just not been going to the doctor, right, as they usually do. I’m curious if this is an opening for AI medicine where this is an opportunity to just look for ways not to go to the doctor generally and to see if there are alternatives to that model of going to the doctor’s office.
Oh, for sure. Yeah, yeah. If you look at our emergency use authorizations, we’re doing things related to remote monitoring and telemedicine. It all connects to the work that my group does around how do you have an interaction with your doctor that feels real? Augmented reality has some really amazing tools for that that are almost ready for us, but I don't think we’re going to go back. I think telemedicine, while it’s been with us and it’s been really important for especially remote communities, now we’re realizing that this could work for us, even those of us who live in urban or suburban areas. It’s efficient. It can be effective, so absolutely we’re not going back.
The world will change. We’ll go back some, but it won't be the way it was before.
Looking forward, Kyle, what else do you want to accomplish in your career? What are the things that you're personally excited about doing?
You know, I’m personally excited about just- We’re right now in the process of improving our forecasting for what we’re going to do in the next three or five years, and I really like the fact that we have some things that we’re going to be done doing in three or so years. They are moving our requirements for digital breast homosynthesis to a much lower bar for getting through FDA and seeing AI being brought to 3D mammography because it is absolutely being shown to be so much better than mammography. To have been there for this technology to have been developed, gotten through the FDA, all the different elements of it, and now to look forward to it being down-classified before I leave is something I’m really excited about—and getting to a place where we can uncrack digital pathology and see it being interoperable and commonplace is the other thing that are in my timeline because I’m not expecting to be in FDA any more than another couple of years. I’ve got some family things I’m looking forward to doing as well.
Right, right. So, Kyle, I guess on that note, for my last question it will be a similar one that I posed to Roger, which is together, if you add it all up, what is it? sixty years of institutional memory, something like that, right?
So I wonder, you know, as you now hold the baton, looking forward, first of all it’s so obvious in terms of the record of excellence at the Center that so much depends on where things were and how you’ve sort of carried this tradition forward. So, on that note, looking ahead for the next ten, twenty years, what do you see as some of the greatest challenges that are going to face the Center, either… That can be a question that has… It’s of bureaucratic import. It’s a funding question. It’s a technological question. It’s a how do you attract talent question, that kind of thing. What are the greatest challenges that you see, and then building on the Center’s tradition of excellence and working with industry and advancing the mission of the FDA, how will the Center draw on that legacy to meet those challenges?
Right, right. The good news is we have people in the group that will carry on the tradition that are well-versed in it, dedicated to it, well-recognized around the world. Their leadership brings in talent. It’s definitely the case that when we started… When I started, the group was really well-known in the medical imaging community, but we need to now compete for talent from the Googles and the Facebooks and the Apples who are looking for people in the same areas that we are. That’s new. And the salaries that they can throw at people are twice as much as what we pay. So, what we have learned is we have to get interns in early because when they see what our work environment is like, the collegiality, the kinds of problems that we work on and the mission, that’s what keeps people. We can't compete on the money. And I think the biggest challenge is just…especially in AI, which is where all sensing technologies are going. The pace of innovation is really fast, and our approach to evaluating software where you design it, you study it, you fix it, and we approve it, and then you wait for next year’s update—that’s not the way the world is right now. We need a different approach to looking at the pace of innovation and how we could have a different regulatory approach to that.
Well, Kyle, this has been- I mean, the impetus of this project was, you know, to the outside public, it’s really difficult to know what goes on the inside, and this is like- I couldn't ask for a clearer, more expansive and more eloquent window into understanding how the Center works. So, thank you so much for spending the time with me today.
I’m really glad to be able to include this in the project, so thank you very much.
Thank you. It was fun to talk to you.