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Interview of Brian Beard by David Zierler on May 15, 2020,
Niels Bohr Library & Archives, American Institute of Physics,
College Park, MD USA,
For multiple citations, "AIP" is the preferred abbreviation for the location.
Brian Beard, Deputy Director of the Division of Biomedical Physics at the FDA, is interviewed by David Zierler. Beard recounts his childhood in Pennsylvania Dutch country and describes his early interest in robots and science fiction. He discusses his education at the Air Force Academy, where he double majored in electrical engineering and physics, and his service as a pilot in the Vietnam War. Beard describes his work as an F4 flight instructor at MacDill AFB, as a senior electronics engineer at Eglin AFB, and as technical director at Fort Walton Beach. He discusses his research in millimeter wave radars and activity monitor microprocessors, and his work for the White Sands Missile Range. Beard explains his decision to leave the Air Force and pursue a Ph.D. at Vanderbilt in biomedical engineering. He describes his work in signal processing and electrical aspects of biomedical devices, and he explains the findings in his dissertation measuring post-operative left ventricular function using non-imaging radionuclide techniques. Beard discusses the events leading to his job offer at the FDA, where he started as a biomedical engineer in the Electro-physics Branch. He describes his many responsibilities at the FDA over the past decades, including his research on catheters and mechanical scanning systems, and he explains the sequencing process that gets medical devices approved for use. Beard explains the interagency approval mechanism on issues including regulating wireless coexistence, and cell phone safety. At the end of the interview, Beard describes the unique public health impact that can be attained in a career at the FDA.
OK, this is David Zierler, oral historian for the American Institute of Physics. It is May 15th, 2020. It's my great pleasure to be here with Dr. Brian Beard. Brian, thank you so much for being with me today.
All right. So to start, please tell me your title and institutional affiliation.
So I am currently the deputy director of the Division of Biomedical Physics in the Office of Science and Engineering Laboratories in the Center for Devices and Radiological Health [at the U.S. Food and Drug Administration].
OK. All right. Great. So now let's take it right back to the beginning. Tell me a little bit about your family background and your childhood.
Oh, my. Well, I came from a very blue-collar family. I was the first one in my entire extended family ever to attend college.
What did your parents do for a living?
My mother was a housewife most of her life. And my father worked in the local newspaper.
Oh, yeah. What did he do?
He was a Linotypist.
And where did you grow up? Where were you born?
In Southeastern Pennsylvania. In more or less, the Pennsylvania Dutch area.
And were your parents from that region as well?
Yes. My entire extended family had probably not gone more than a few hundred miles on vacation ever. [Laughs]
And did you go to public schools throughout childhood?
And when did you start exhibiting an interest in science?
Oh, probably in junior high.
In what ways? Were you interested in nature, were there particular classes that you gravitated towards?
I was very interested in science fiction. Robots. I was interested in paleontology as well. And biology at that time, if you remember back then and you probably don't, you're too young. But it was the height of the Cold War and the Sputnik scare. And there was a big drive on to move science education down to the lowest [grade school class] level possible.
And I was involved in the BSCS Blue biology series back in junior high. And the same with physics and mathematics.
I'm not familiar with that biology series. What was that?
It was a biology series that was put together to boost the country's basic education in biology.
Mm hmm. And you had the good physics and chemistry classes as well?
How big was your high school?
My graduating class was one hundred and eighty-three, I think.
OK. And were you a particularly strong student in science?
Yes, I got the graduation award for science.
Oh, wow. What is that, like the highest G.P.A. in science classes?
Yes, I guess.
Now, being the first in your family, even extended family, to go to college. I'm curious what you thought your opportunities and options were when you graduated high school.
Well, I had applied for a scholarship at the United States Air Force Academy. And by the time I graduated, I knew I had gotten it.
What was it about the Air Force that attracted you?
Oh, the possibility of flying and the high tech involved with the Air Force.
Now what year did you graduate high school?
OK, so the Vietnam War was very much on your radar at that point.
So did you expect to serve in Vietnam upon entering the Air Force?
Yes, and I did.
So tell me a little bit about your experiences. Just to just to flesh out the story a little bit. So you graduate high school and then then where do you go?
Two weeks after high school I reported to basic training in Colorado at the academy. And was there until the 6th of June, 1973, when I graduated. And then I went to navigator training in California at Mather Air Force Base. My eyes were not good enough to be a pilot. And from navigator training in California, I went to F-4 Flight School in Homestead, Florida. So, then I flew in the back seat of F-4s. You're familiar with F-4s? Know anything about fighters? OK. It's sort of like if you saw Top Gun, you know, maverick and goose, I was goose.
Now you're four years at the academy. What kind of academic training did you get there?
I was a double major in electrical engineering and physics.
Oh, OK. And between the two, what did you think you were going to pursue more closely as a career?
So, a double major. Was that common for people to do a double major? That was your own initiative?
That was my own initiative. It was not common at all.
And was your sense? I mean, you know, you didn't have a perspective of going to a nonmilitary school, but was your sense that those majors had a particular military focus to them? In other words, were you doing electrical engineering as it would be geared toward military or national security applications?
No, the curriculum was not aimed particularly at military applications although electrical engineering certainly had applicability to a lot of the missions in the Air Force.
OK. And so you graduated from the academy in 1973.
And then where did you go?
Well, like I said, I went to the Navigator training at Mather Air Force Base California, followed by F-4 Flight School at Homestead. And then I was stationed that Udon Thani Royal Thai Air Force Base. Which is in Thailand, of course. And I was there for the last year of the Vietnam War, which included, I don't know, you probably are not familiar with it, the Mayaguez incident.
I know about it. Yeah.
The Cambodians seized a U.S. cargo ship.
We flew down there and strafed and bombed them. And the evacuation of Saigon, I was there for that, too.
Oh, my goodness. Wow. Where were you during the evacuation? You were right in Saigon?
No, since we were stationed in Thailand, we were flying cover above Saigon to make sure that if the North Vietnamese came down with any MiGs or aircraft and tried to disturb anything, that we would fight them off. Which would have been quite foolish of them because we were leaving, so why interfere? [Laughs]
Right, right. And was there interference? Did you experience any interference from the North Vietnamese?
No. They left the evacuation pretty much alone. Like I said, they were intelligent about that since we were headed out. They just let us.
OK, and so then when did you, when did your time over, you know, Vietnamese airspace, when did that come to an end?
Oh, heavens. It was very shortly after the evacuation of Saigon, the squadron moved to Clark Air Force Base in the Philippines.
OK. And now you were in the Air Force until 1979. So what were you doing for those last four years?
After Southeast Asia, I spent two years in Europe at RAF Bentwaters. And we were a NATO Mobility squadron. So, we deployed all over Europe, different NATO bases: Aviano, Italy, [Torrejón], Spain, Aalborg, Denmark, Bodo, Norway, and a couple of places in the U.K. as well. So, probably out of the two years there, I spent one year away.
OK. OK. And if you can reflect broadly, in what ways did you have opportunity to apply your academic experience with electrical engineering and physics during your career in the Air Force?
Well, as the back seater in an F-4, I was technically what is known as a weapons systems operator. I had all the radar controls there, and Radar was actually one of the graduate courses I took at the academy. And the use of the radar was very important for air to air intercept, ground mapping, all weather bombing, things like that.
Now you say you took graduate courses while you were at the academy as well?
I did take one graduate course in radar. Yes.
Interesting. Was that, was that your own interest or a professor suggested that you take that opportunity?
A professor suggested I do it. He was interested in teaching it and he had to recruit enough students to do it. There were three of us in the class, which was very nice. It's the smallest class I've ever been in.
Right. Right. OK. So then in 1977, you joined the U.S. Air Force Armament Laboratory?
No. The Vietnam War ended in 1975. Then I spent the next two years in Europe.
And then I back to the United States at MacDill Air Force Base in Tampa, Florida.
And I was an instructor for F4 training.
OK, I'm just going off of your CV here. It says from 79 to 81, you were in the armament laboratory at Eglin Air Force Base.
Right. And from 77 to 79, I was at MacDill, as an instructor for Air Force training. Then in 1979, I got out of the Air Force and went to work for the Air Force as a civilian at Eglin Air Force Base.
I see. I see. What was your title in your civilian capacity?
I was his senior electronics engineer.
OK, so you were a civilian employee of the Air Force. You were not a contractor.
That is correct.
Mm hmm. And so what were your duties in that capacity? What were you working on?
I actually, I changed jobs while I was there, I was in the weapons development section for a while where we worked on the AMRAAM missile, an air to air, sort of fire and forget missile. And then I transitioned to the 3246 Test Wing, which basically conducted weapons tests there at Eglin Air Force Base, which next to Nellis is the largest air force base, I think, in the continental United States, huge ranges there, almost bigger than counties.
Yeah. Yeah. Now, I'm curious, during this time, what was your sense of, was most of your work and the work of your colleagues? Was it mostly geared toward containing the Soviet threat or was there a sort of broader national security mission that defined your activities?
I think that is really a question that was sort of, as they say in the federal service, above my pay grade. The strategy for containing the Soviet threat and communism was decided at a much higher level. We had specific projects to work on and we did that. Also, while I was at MacDill before moving up to Eglin Air Force Base, I started taking graduate courses in electrical and electronic engineering at the University of South Florida, it's in Tampa. And then I continued at the extension campus of the University of Florida at Eglin Air Force Base.
Was your intention when you first started to think about going back to school to go all the way for the PhD, or were you looking just to take classes and to gain more knowledge and expertise?
Initially, just to gain more knowledge. I took a lot of mathematics courses at Tampa, and some communications courses. Then I took a lot of radar courses and signal processing courses at Eglin. And I started thinking about getting a master's in double-E [Electrical Engineering] at that point. Only to discover that, because it was graduate school, that the University of Florida system would not allow me to transfer credits from Tampa to the other school. I could use the credits from Eglin Air Force Base or from Tampa, but I couldn't put them together into one curriculum.
Mm hmm. Mm hmm.
Oh, that was disappointing.
Now we're there. Did you have colleagues or superiors in the Air Force who encouraged you to continue taking classes? This is mostly your own, your own interest.
There was a general encouragement to seek higher education. Nothing specific aimed at me. But I was interested in it. After I discovered that I couldn't combine the engineering credits from South Florida with the University of Florida. I started working on an MBA from the University of West Florida, which is in Pensacola.
Why did you want to pursue an MBA?
Because I was working on the side doing electronic design for some local companies and was interested in the business aspects of that.
Oh, OK. What did you envision? Did you think about starting your own company?
Possibly. I do have my own Web site where, as you saw on my resumé, I write articles. [Zierler: Yeah.] For electronic magazines and stuff like that. So, I have a small web presence selling kits and doing electronic programing and things like that.
Now, in 1985, you moved to Fort Walton Beach in Florida. According to your resumé, you were a technical director there from 1981 to 1985.
Right. That's. That's the business I was talking about. That I work for. I worked for them part time and then I worked for them full time doing electronic design mostly for oil drilling instrumentation.
Oh, wow. And it says here you designed a risk worn battery powered microprocessor based on biomedical data for the U.S. Army Medical Corporation. That sounds like some pretty advanced stuff for the early 1980s.
It was. It was leading edge at that point in time.
What were some of the objectives for having this kind of system?
It was what is known as an activity monitor. And there was an RFP that came out of Walter Reed for small businesses to look at the design of this system that would be used to be worn on the wrists or ankles of soldiers and track their activities. So we had a, at this time, this is before laser gyros and stuff like that. So we built our own three axis accelerometer system out of small piezo strips with weights attached to the end of them. That was tied into a microprocessor, which was a Motorola 705, that would record the data and then it could be read back out later at a computer station.
It sounds a little like a very early version of a Fitbit. Would that be a fair comparison?
Probably fair, yeah.
Did you have any idea that that kind of technology would be so widely adopted 30 years later?
Oh, I don't think anybody saw all the change coming in memory density and cost of microelectronics. You know, how the density went up and the cost went down. I mean it made our whole world today possible.
Right, right. And then in 1985, you were a senior engineer at the test wing at Eglin Air Force Base.
What were you doing there?
I mostly worked in millimeter wave radars.
What does that mean, millimeter wave radar?
It means above 20 gigahertz, 20 gigahertz to 100 gigahertz is where we worked mostly.
And so just for further the broader audience that will be listening to this, can you explain what that what application that's useful for?
Well, nowadays, the upper frequencies in 5G cell phones are in the millimeter wave bands, so it's useful for communication. At that point in time though, millimeter wave sources were extremely expensive and very limited in power.
Why were they so expensive?
because it was a new field. Just getting sources to operate at gigahertz frequencies was tough. There were really only two sources which were Varian and Hughes. And Varian made a tube source and Hughes made solid-state sources, and they were all in the tens of thousands of dollars each.
And what particular advantages did this system serve in a national security context?
Well, it just…As it does for 5G cell phones today, the available bandwidth is enormous up there. You think about the distance between, say, 60 gigahertz and 65 gigahertz. You know, that's five gigahertz bandwidth. And that's the same as it is from DC [Direct Current or 0 Hz] current to five gigahertz now, which encompasses all TV and radio and 3G cell phones, they are all within five gigahertz. When you get above 20 gigahertz or so, there's just so much bandwidth available.
Plus, there's also a lot of unique applications that are available there. Around 60 gigahertz, there is a, I forget if it's oxygen or water right now, but there's a high absorption band in the atmosphere. So, you can do tactical communications, that's a military application, that have a very limited range which makes intercept by the enemy very difficult because it attenuates so fast. It's also quite useful for satellites. Satellite to satellite communication. It won't penetrate into the atmosphere. So that satellite-to-satellite communication can't be picked up from the earth. It's secure.
Oh, interesting. Interesting. Now, the work you were doing, was it specifically for the White Sands Missile Range or it had broader applications than that?
Well, the White Sands I mentioned my resumé was one specific application that we were doing with weapons seekers and guidance for things like bombs. We did cooperate with the White Sands Missile Range, which is the army. And I did design a radar tracker, a range only radar tracker, at ninety-four gigahertz for them. They have, or had, I don't know what they have at the moment, but they had the optical tracking systems that they used on their missile range, and they required at least three to get, you know, the exact position in space when they were tracking a missile. And it's often difficult to pick up these high-speed rockets and missiles with three trackers at once. So if they could get a range on it with the trackers, that would give them the position with just one tracker.
And so what, the activities that were going on in White Sands, were they unique in the military landscape, or that was just representative of what was going on and a lot of places?
Well, it was fairly representative of what was going on at Eglin and White Sands. Eglin was doing a lot of the same sort of things for Air Force systems that White Sands was doing for Army.
I see. I see. Now, in 1990, you move on to Vanderbilt in Nashville.
Yeah, I decided it was time to finally go back and get my PhD.
Now, did you leave the Air Force at this point, or did you go on limited duty or something like that?
Well, remember, I was a civilian employee of the Air Force, right? I quit my job and went back to school full time.
Oh, wow. OK. And so what were, what were your motivations? Why do you want to get your PhD?
I had always wanted to get a PhD, and it seemed like the best time to do it. I had saved up enough money that I could afford to do it. Plus, Vanderbilt had offered me essentially a full scholarship to come back and work on my PhD.
Now what, what programs were you looking at specifically? Were you looking at electrical engineering programs?
I was looking at electrical engineering and biomedical engineering, which, back at that time, biomedical engineering was the new kid on the block
And if you know about biomedical engineering, it's essentially the intersection of medicine and technology. So, it's, it's very broad.
My concentration was primarily in the signal processing and electrical aspects of biomedical engineering.
So what program did you settle on at Vanderbilt? Was it biomedical engineering?
And were they known to have a particularly strong program in biomedical engineering? Was it just getting started at that point?
It had been in existence for four years, but it was well recognized in the nation and it still is.
OK, so tell me a little bit about the curriculum. How much how many courses did you take in the first years? Was there lab work? What kind of field work was there?
Oh, heavens. I can't remember exactly. I do remember, though, that that first year was quite challenging, after having been in the working world for quite a few years, getting back to being a full-time student was particularly challenging.
I'm curious if you were older than most of your classmates, or the program was sort of geared toward mid-career professionals.
No, I was older than most of my classmates. I was older than most of my advisers on my PhD committee.
Yeah, and that first year was tough. I took some of the toughest courses that year, just to make sure that I could hack it. I took advanced image processing, which involved an awful lot of math and getting back into the heavy mathematics was difficult.
Now you say how biomedical engineering is really the intersection between biology and technology. So, I'm curious in the courses, was there roughly an equal emphasis in the two disciplines?
There was, I guess you could say it was an equal emphasis. All the biomedical engineering graduate majors; we all took a couple of courses at the medical school, physiology. So, that was a year at the medical school. Plus, cellular biology.
What were some of the most exciting technologies on the horizon during your time at Vanderbilt? What were some of the devices that held the most promise for really advancing human health and research?
Oh, my. Well, I do remember that the chairman of the department was very involved in research and ARDS, which today is a very big subject.
I'm sorry, what is that? ARDS.
Adult Respiratory Distress Syndrome. Which is what is killing most people from COVID.
I was not personally involved in the research they were doing on that. I was involved in signal processing for cardiac dynamics.
What is that useful for?
We worked primarily with transplant and bypass patients. Computer timed out again. [Laughs]
That's fine. So you are interfacing directly with patients or you are interfacing with medical doctors, who was who is your point of contact in terms of, you know, working in a clinical environment?
It was medical doctors, so I worked with medical doctors in the cardiac and thoracic surgery department at the Vanderbilt University Hospital. And we did do a clinical trial on the instrumentation that I developed. Well, in conjunction with the surgeons there, of course. And I did have to go out and recruit the patients into that study and shepherd them around the hospital and to the cardiac catheterization lab, which is where we actually did studies.
So, I'm curious, in terms of the instrumentation, how much were you tinkering and improving existing technology and how much were you building things, you know, from scratch?
We didn't develop anything that would require an I.D.E. Investigational Device Exemption. Now that I work for the FDA and I'm more familiar with that sort of stuff.
And what why do you need an I.D.E.? Why is that significant?
An I.D.E. for a new type of device. And you want to do a trial on it. You have to come to the FDA and say - here's my new device and this is why I think it's safe and efficacious, and I have to do a clinical trial. And then the FDA gives you an I.D.E. which allows you to conduct that clinical trial.
When I was at Vanderbilt, we used approved medical devices, but basically we integrated the data from several approved medical devices together in a unique way.
Now, I'm curious, you know, in working with medical doctors, how did those conversations play out in the most productive way where you knew what you needed to do in terms of instrumentation and technology? Would they communicate things to you like, you know, this patient needs this and we don't have this available, so can you put something together? Is that the way that those collaborations went about? Were they patient specific? Or was it more generalized in terms of here's the kinds of things that we're seeing and these are the kinds of needs that we have.
It was more general and the primary surgeon that I worked with was looking for a way to monitor patients after major cardiac surgery and to look at their ejection fraction and cardiac dynamics and make sure that they didn't have any sudden relapses. And to be able to predict sudden relapses if they were about to occur.
Right. Right now, as you mentioned, you know, biomedical really took off in the 1990s. I think, you know, the NIH budget, I think it doubled or something like that during those years. And so I'm curious how well, I mean, you're in Vanderbilt, you're in Nashville, obviously. But I'm curious how well integrated you are in sort of national trends and what in terms of what's going on biometrically. Are you attending conferences? Are you working with colleagues in other institutions? Or is your world really, you know, sort of centrally focused within the confines of Vanderbilt.
I would say from my first few years there, it was very centrally focused. It was getting back into school and doing the courses and learning. You know, the medical jargon and getting more into the medical area, transitioning from engineering. But the last year, year and a half, there, obviously I was starting to look for a job and I went out to a couple of conferences. So, fairly typical course for graduate student.
Now, how did you go about developing your dissertation topic?
It was in conjunction with the surgeons that I was working with.
And what was your topic, what did you work on?
Oh, heavens. Hold on a second here, I'll pull it out. It was real time measurement of post-operative left ventricular function using non imaging radionuclide techniques.
OK. Would you please translate that for us? [Laughs] What does that mean, essentially?
Well. Real time, so it's tries to give information to the surgeons and nurses as close to instantaneously as possible. Post-operative, though, as I said, the surgeons were interested in monitoring patients that had bypass or organ transplant, cardiac organ transplant. Left ventricular function, so that's the major pumping chamber of the heart, the one that supplies the body. Using radionuclide techniques, the major instrument that we used was a radiation scintillator, that sat over the heart and could measure the decay of a nuclide. We used a tagging agent from Mallinckrodt that bonded to hemoglobin. So as the left ventricle filled, you got more nuclear counts, and then as it contracted and squeezed out the blood, you got less nuclear counts. So getting that scintillator positioned correctly above the heart was a major portion of my work when I worked with patients.
Was this the kind of work that was suitable to be patented?
Not really. As I said, it was mostly an integration of existing stuff. The scintillator was an existing product from a company in New Jersey and was actually one of the companies I interviewed with when I graduated. And then we use pressure monitoring systems and indwelling catheters to get other data, but they were all marketed devices. It's just the way we put the data together and displayed it in the computer that was unique.
Now I want to ask. Oh, yeah, please.
There's an example of the display.
This is what's called a pressure volume loop. It's the pressure in the left ventricle versus the volume in the left ventricle over one heartbeat.
Interesting. So, I'm curious, again, that same question about the blended approach. At the conclusion of graduate school, do you feel like you came out with a better understanding on the on the bio side or the electrical engineering side? Or was it really a blend of the both in terms of how you felt like your knowledge was advanced?
It was a bit of both. Because it had been several years since I had any graduate courses in engineering. So I sort of got back up to speed there and the entire medical portion of my education was entirely new. Yeah, so it was very good.
I'm curious if you ever thought, even for a half a second, about pursuing a medical degree.
I did. Although I did not want to practice, if I had gotten the medical degree, I would have gone into research. But, looking around and talking with other people, most of the medical research that is done, is done by biomedical engineers.
And since patients are involved, obviously there's an M.D. But the majority of the research is actually done by biomedical engineers and not M.D.s.
Right. And you think that's basically the way it should be or there is a need for more M.D.s working in that capacity?
No, I think that's the way it should be. They're obviously necessary to work with the patients, both legally and morally.
But that's interesting, what do you what do you mean morally, what's that what are the considerations there?
Well, like I said, I recruited patients in the studies and stuff, and they're always concerned that they didn't want an engineer poking around in them. They want to make sure that it was somebody that really knew what they were doing. And there's a lot of faith in doctors and I guess not as much in engineers. [Laughs]
Fair enough. So, Brian, when you graduated, when you got your PhD, what were some of the opportunities that you were looking at? Did you specifically, were you specifically looking to join the FDA? Were you thinking about teaching, joining a university, maybe going into industry? What were your general options and ambitions at that time?
My options were all of the above. I did interview for a department to actually chair a technology department at a college. Like I said earlier, I interviewed with the company that manufactured the nuclear scintillator I'd been working with. I interviewed with another company as well and you may remember the internet was just starting to pick up at that time.
And I was a student member of the IEEE and checked the IEEE job site and found the advertisement from the FDA there. And since I had the previous government time, it seemed like it might be worthwhile getting back into the government so that I could add to my government time.
Right. Right. And now this goes back when the FDA was in Rockville, correct?
And the position that you saw on the IEEE, that was for the biomedical engineer position in the electro physics branch?
And what was your sense when you first got there, when you interviewed, how well developed was the electro-physics branch? What was what was the history behind it? Where did it come from? How well developed was it?
It seemed very well developed. As the biomedical physics branch now, it was a fairly diverse group with electrophysiologists, electrical engineers, physicists, and chemists all working together. Where it came from, I don't know. I can't be complete on that because obviously I wasn't with the FDA before that. I do know that, I think it was 1976, when the Medical Device Amendment Act was passed, which merged the FDA and the Bureau of Radiological Health. And it was a consequence of them merging that the Center for Devices and Radiological Health came about and the substructure underneath that.
And from your interview or from touring the office, what was attractive about what the electro-physics branch had to offer for you and what you might have had to offer them?
They were interested in someone that was familiar with cardiac instrumentation because they were interested in moving more into cardiac instrumentation, and, also, as everybody at the FDA does, in reviewing submissions for medical devices to be marketed in the United States.
So just to give a sense, I mean, this is a unique opportunity for, you know, to sort of peer inside the inner workings of the FDA, right? So, I'm curious, just like, you know, when you started there, what is an average day look like? Is it mostly desk work? Are you working in labs? Are you in the field? What is what is it? What does an average day look like for you?
Well, back then, before I was a manager, a lot of it was in the laboratory. And on average, I'd say probably four days in the laboratory and one day per week reviewing submissions.
And the laboratory means what? What does the laboratory look like? What are the kinds of instruments in there? And what are you doing with them?
Oh, heavens. Well, my first work, as you can see in my papers, when I got here, the FDA was looking at catheters and the safety of catheters for oblation and placemaking. I was doing a lot of work with those, looking at specific absorption rate. That involves a lot of instrumentation, looking at small temperature changes, very tiny temperature changes. So I had to learn a great deal about thermistors. I Also developed the mechanical scanning systems that went with doing that, to do the mechanical scanning of sensors.
And I'm curious in terms of the kinds of things that you were doing, how did it work in terms of issues that were brought to the FDA as attention? In other words, a manufacturer had come up with a new device and that's how you came to it? And how much of it was the FDA going out and being aware of what was being done and then, you know, reaching out and getting those get getting that information itself? How did that work in terms of the kinds of issues and the kinds of products that you were working with?
Well, when medical device reports come in, which we call MDR, and that system has been in existence for a long time, it reports all fatalities and major incidents with medical devices.
And who creates the MDR? Where does it come from?
It can income from consumers and manufacturers as well, but mostly it comes from health care professionals.
OK. And what's the most important information that you're looking for in an MDR?
Trends. So, you know, isolated incidents pop up all the time, but if you start seeing a particular medical device showing up a lot or a particular procedure showing up a lot. Then, that's what we typically call, at least now, a signal, and requires further investigation.
So, if there's a medical device or a procedure that's coming across your desk at this point, obviously at some point earlier in the process, there must have been some kind of regulatory approval for that product to be on the market or for that procedure to be done. And so my question is, when you see a signal, is that to suggest that there was some problem with the initial approval or that there might have been something that had gone out of whack, that had not been present at the original time of approval? How does that work in terms of when you are finding a signal and how does that define how you're approaching the problem?
Huh. Well, first of all, let me say for the most part, for the vast majority of cases, the manufacturers are entirely honest and very conscientious. When something happens, you know, it's unexpected, on our part and by the manufacturers. So, yeah, I mean, we're all people and we're all humans, we miss things and it's unfortunate.
But things happen that are that are unexpected. I mean, it's what's called the twiddler's syndrome. And, it's when a pacemaker gets implanted in the chest, you know, above the ribs and under the muscle there, in the pectorals, and there's excess lead that goes from the pacemaker to the heart. And usually that's just coiled up and put there with the pacemaker. But patients would tend to, you know, feel this thing here and just sort of play with it, and it would spin the pacemaker and wrap up the wires, and we call it twiddler's syndrome.
You mean like it's like a nervous tick? They would just do that.
Well, either that or it itched or something. You know, nobody thought that once you put the pacemaker there, the patient would spin it around and wrap up all the wires and get them tight and twist things.
I mean, things like that happen.
Yeah, that's a great example to illustrate the point you were making. And so, I'm curious, you know, when you have twiddler's syndrome, right, and there's an MDR that's created, right. That MDR, you're saying that the originator of that MDR can be the patients themselves, it can be the doctors who are seeing this or it can be the manufacturer who's saying, you know we've got this thing that people are doing and we need a way to deal with it? You're saying that the MDRs can come from any one of those groups?
That is correct.
What, in your experience, what have been the most efficacious MDRs? What's the group that's producing and the MDRs that are most useful for you to, you know, to positively improve the product and the process?
Nurses. Why nurses?
Because they're the ones that deal with the devices more than the doctors.
Right. Right. The doctors just swoop in for 15 minutes and then they're out of there, right?
So, what's the process? A nurse sees this issue, first of all, how does a nurse, I mean, I'm not in the field, so I'm just learning about MDRs as I'm talking to you. How do nurses even know that an MDR exists and that they're empowered to create one? Where in their training are they aware that this is an option available to them?
I can't really say I'm not that familiar with the training that nurses go through. But they obviously are, because a lot of MDRs come from nurses.
Right. Right. And I wonder, that would warrant further investigation, but obviously, I would imagine somewhere in the FDA there's an office charged with making sure that people know that there's this process available to them.
There probably is.
But the FDA is a big organization, and I can't speak for the whole organization.
Of course. Now, I wonder, in terms of your work reviewing regulatory documents, were you working with attorneys? Are you learning this stuff on your own? How are you interfacing with regulatory documents during this time?
There is, there wasn't when I first started, but there is now training for all new employees called the reviewers certification program that walks them through the legal requirements, the internal documentation that we use for tracking documents and the timelines that are required by the legislation for reviewing certain types of documents and how to do it, how to document what you're doing. I'm saying documenting a lot, and documenting is very important in the FDA. [Laughs]
And as I said, this reviewer certification program is now in existence. It wasn't when I first started and frankly, I have to say that the FDA has improved a lot since I came on board, not only in the internal training of the people involved, but in their interface with external groups and legislators. So, I've definitely seen a big improvement in the FDA, and I think the FDA's stock, as it were, with legislators and consumers has risen.
That's very good to know now. Now, in April of 2004, I'm curious, it seems to be that there's two moves. So, first of all, when first do you move to Silver Spring? When is that big move from Rockville to Silver Spring? When does that happen? Does that happen right around that time?
I think we moved in 2007.
Oh, OK. OK. So 2007 you move. But in 2004, you are now in the Center for Devices and Radiological Health, Office of Science and Engineering Laboratories. Is that a substantive change or is that more an administrative change to the same basic work that you were doing in the electro-physics branch?
It was a reorganization of the office.
So it changed from OST to OSEL. And OST had the office, divisions, and branches. So I had been in the Office of Science and Technology Division of Physical Sciences, the Electro-physics Branch.
And when we moved to OSEL, we made a flatter structure so it was just the office and divisions, no branches.
And what were some of the objectives in this reorganization?
Again, to make a flatter structure, to get less siloing. To get people to collaborate more with their colleagues.
Would you say that's been successful to remove the soloing effect?
To some extent. Some people, you know, tend to isolate themselves and stay silent anyway.
Right, right. Sure.
But, for the most part, I think the larger organizations have helped to get better collaboration and more exposure to what your colleagues are doing.
And what was your career trajectory in this transition? Did this involve a promotion for you?
Not really a promotion, but it involved a change from research to management.
OK. So, you were more managing the people doing the job than you had previously done? Is that fair to say?
Yes. Now when we reorganized, the division of physics, which then became the division of biomedical physics, was composed of the electro-physics branch and the electro-optics branch. So, they took the branch chief from the electro-optics branch and they wanted the deputy for the new division to come from the electro-physics branch, and they asked me to do it.
OK. And this was you perceive this to be a good opportunity? It was a good thing to go for?
And how did your day to day change? In terms of, were you, obviously you were not in the lab as much as you had previously been, I assume.
That is correct.
So what were you doing instead? What kind of work were you doing if you were not in the lab as much?
The things that all managers do. I work on timesheets and promotions and awards, on justifying why our research programs are doing certain things, on budget, on purchasing. Yeah. [Laughs] I finally...
I'm sorry, I missed that, you finally what?
With my MBA work.
Oh, I see, right. Brian I'm curious, what are some of the most important partnerships that your organization has? You know, broadly conceived partnerships with other federal agencies, partnerships with health institutions, partnerships with device manufacturers. If you could just give a sort of overview on, you know, the kinds of institutions and organizations that are most vital for you to achieve your mission.
OK, let's run through those one at a time. What was the first one you said again?
So, federal agencies and offices that are that are really important for you to do your work.
OK. We work with a lot of other federal agencies. In the particular area where I supervise people, the FCC [Federal Communications Commission] is probably the biggest one.
We work with electromagnetic compatibility and wireless coexistence.
So what would be an example of wireless coexistence and compatibility in so far as the FCC is concerned and the kinds of issues and devices you deal with?
Well, one example, the FCC received a request for an exemption or higher power on a medical device, and we didn't know anything about it. And we would not have known anything about it until the application came in for marketing.
Now, why would the exemption have gone to the FCC and not you if it's a medical device? Wouldn't that be in your bailiwick?
No, it's a matter of legislated missions. The FCC is responsible for the civilian use of the spectrum. You know, send and receive at what frequencies and how much power they can put out at those frequencies. That's the primary concern of the FCC.
So, at the FDA, we're just interested in safety and efficacy. We don't really care how much something would transmit as long as it's safe.
So, to transmit over the established power limit at a certain frequency, a company has to go to the FCC, not us.
What about some other government agencies and institutes?
Oh. We have worked with, oh my heavens, the Army, their telemedicine people. We've worked with the Air Force, the Air Force Research Lab. We worked with the FAA on oxygen concentrators in airplanes. We've worked with the State Department on the safety of security scanners in association with medical devices like pacemakers and other implants passing through them and things like that. Homeland security on their airport scanners and the safety of those. Heavens, we work with the NIH all the time on different matters. National Science Foundation, we have a grant program. I wouldn't actually call it grant, but it's called the National Science Foundation Scholar in Residence Program. It's not just with the FDA, they have it with other institutions as well, but we are one of the participants in that. That lets us do research collaborations, that are funded by the NSF, with academic institutions. Oh. So, there's probably some I've missed, but we have a lot of. Oh! NIST [National Institute of Standards and Technology]. We do a lot of work with NIST as well.
How interesting. What would be an example of a collaboration with NIST?
Oh, well, we have one that's going on now, looking at the use of Wi-Fi routers to detect respiratory rate of patients.
So, it's. There have been some investigations done in universities out there, but we're trying to find out, you know, how reliable it is. What are the parameters involved? How do they affect accuracy? What's the maximum theoretical limits on these things? And NIST is involved because it's a good opportunity. You know they're a part in the Department of Commerce.
So their charter is to promote companies and the use of technology. So, they're interested in getting it out there as a usable technology.
Now, I'm curious, with all of these with all of these partnerships and collaborations within the federal infrastructure, what's the initial point of contact? Are most of these agencies getting in touch with you because there's this specific issue that they run across and they need your assistance? Or is it more that you're generally aware of what's going on and you become aware of these issues and insert yourself into the policy process? How does that point of contact, how is that usually initially made?
It's usually made at a lower level as opposed to a higher level.
So there are some exceptions. There's a big effort going on within NIBIB here at NIH and that's being pushed at the top levels to establish some ongoing collaborations and information exchange. But for the most part, it's usually at the lower levels. You know, if we've got a problem, say, for instance, with this wireless router that I was just talking about and we realize that another government agency has the resources or the knowledge that we need to actually reach an answer, we'll just go talk to him. There are a lot of people that we know from conferences, from IEEE, from school, whatever. So, there's often just personal contact as the initial point or just, you know, go to their website and find out who's working in that area. And it's not just us going to them, it's them coming us often, because if there's a medical issue involved or a safety issue involved, we're often consulted on it.
But OSHA [Occupational Safety and Health Administration]. We have worked with OSHA quite a bit too.
So the next on that list in terms of the most important partners in collaborations for your work would be health institutions. I'm curious what kind of partnerships you have either with, I don't know, insurance companies or, you know, university hospitals or medical associations. What are some good examples of partnerships in the private healthcare world?
Nothing that I'm aware of with insurance companies.
I do know that we have a lot of people that are collaborating in investigations with different university and state hospital systems. Massachusetts General, which is also associated with Harvard. University of Texas Medical School, University of Maryland Hospital, Johns Hopkins. We have people collaborating with all of those.
And what how did those collaborations generally get started? Is it issue specific? Are these ongoing relationships where items come up regularly? Had how does that usually work?
They're pretty much issue specific.
What's an example that comes to mind with a hospital that would raise to your level?
I know we have an effort going on with University of Maryland looking at breast implants. And looking at magnetic resonance imaging, scanning breast implants and comparing the different scan modalities that are possible in an MR machine. And determining which one is the best predictor of ruptures and the best detector of ruptures in breast implants.
And then the next on that list would be device manufacturers and industry in general. What kind of partnerships do you have in that realm?
We have quite a few, actually. There are two primary mechanisms that we use in that. One's called a CRADA, which you may be familiar with, a co-operative research and development agreement. And that is, that is used when money changes hands. Usually it comes to FDA. The FDA really doesn't have the resources to fund a lot of external research.
We had two big CRADAs that I was involved in. And again, I'm speaking from the perspective of what I've done here in the division of biomedical physics, and we've got other divisions in OSEL chemistry and material science. And they probably have research efforts and collaborations going on with groups that I'm unaware of.
So, this is not an exhaustive list that I'm giving.
Of course, of course. It's only your perspective. That's understood.
Right. So, where was I? I was talking about CRADAs, yes. I did a big CRADA with the, and they've changed names now, but it was the medical, pardon me, the Manufacturers Forum for Cell Phones. That's not the exact title anymore, but we're doing research on dosimetry measurement of radio frequency exposure from cell phones. This was back in the late 90s when there was no established method to measure the exposure from cell phones. So, we worked with the IEEE and this other group to come up with the methods and techniques to do cell phone dosimetry. And then we've got another one ongoing at the moment with a company in Switzerland called ITIS that is doing modeling of neurons in human models and whether particular electromagnetic stimulations will actually trigger neurons causing nerve firing, which is an issue in MR and a lot of other procedures that use electromagnetic radiation.
OK. So, Brian, I think now that we've gotten sort of present day in terms of the narrative, I want to ask a few questions that are sort of, you know, broadly retrospective of your career at the FDA. The first is, you know, the idea that, you know, fundamentally the FDA is about safety and efficacy. I wonder if your involvement in a few specific issues really stand out as being particularly satisfying or successful in terms of, you know, here's the mission of your work, this is what your office is designed to do, here's an issue that came up and here's how your involvement or your office's involvement really ensured that, you know, the mission of improving safety and efficacy was really achieved. If there are a few, you know, representative stand out issues that you can think of over your past decades at the FDA that you might want to share with me as, you know, really satisfying or successful stories.
Well, for myself, I think the biggest one involved with, it's not actually medical devices, per say. It is the one we're just talking about, looking at exposure from cell phones. Because back in the 90s, there was an interest in this because there wasn't a standard. There was a lot of pressure from consumers and from Congress on the FDA to come up with a way to safely measure the exposure from cell phones. So, finally getting that done and getting an IEEE standard established on how to make those measurements was a very important thing. You know, not because it was a medical device, because it involved radiation safety. Which is part of CDRH. I mean, it's also radiological health. That's the R.H. at the end.
Another question is just going back to the kinds of things you were considering when you completed your PhD. You know, you could have gone into industry, you could have gone into teaching. And I'm curious, obviously, one of the reasons why you get into this field is to make a difference in and improve people's lives, right? And so, I'm curious, in what ways do you think the FDA has been particularly good in terms of allowing you to achieve your own personal objectives in your career of, you know, putting your expertise to the best possible use? How has the FDA been a place for you to, you know, realize those ideals or objectives?
Well, first of all, I think it has been a place where I can do that and, you know, even had I gone to industry and helped in the development of a particular medical device or something like that, my individual contribution to that would have been just one of many. And here at the FDA, when you review a device coming in, your contribution is just one of many. But I think the review is really worthwhile. We often pick up things that are potentially hazardous, sometimes downright hazardous. And it's always nice to get our correspondence back from the manufacturer that says, "Oh, yeah. We hadn't thought of that. Thank you." And that's happened several times. [Laughs]
I'm sure that's a great feeling.
Yes, it is. So, you know, I have a very minor touch, but on a lot of things.
Right. Right. So that's a that's a big impact when you when you put it all together.
So another question. And this might either take you back to your textbooks, even from high school or maybe at the academy or maybe at Vanderbilt, but I'm curious if there are concepts or laws either in electrical engineering or physics that have stayed close with you, that, you know, there's something that you learned from however many decades ago and whatever class you were taking that you always come back to that are really, they either shaped the way that you pursue your science, they either shaped the way that you approach a particular issue. Anything from physics or an electrical engineering in an academic sense that is really useful to you on the on the day-to-day basis.
Yeah, having gone through all this education and actually accumulated five degrees on the way, I've got to say that I've probably forgotten a great deal of what it is I learned.
But I think the basics really stick with you. I'm constantly referring back to the basics in most of these fields, including trigonometry. I mean, trigonometry never seems to go away.
And the question, of course, that's on everyone's mind right now in the present day, I'm curious where, if at all, your office has a role to play in getting us out of our current crisis with regard to COVID-19.
We have been very involved in emergency use authorizations for ventilators and non-contact thermometers, specifically our office.
What is a non-contact thermometer. What does that mean? What does that look like?
I don't know if you visited any facilities where they took your temperature in the last month.
OK. I have. But it's sort of like a little gun thing, they just point your forehead and it is an infrared measurement of your temperature.
They're not allowed to stick anything in your mouth.
Right. And so your office has been involved in fast tracking that approval.
Yes. They're called emergency use authorizations and they're nothing new. I mean, they've been done for SARS and for the swine flu, pardon me not the swine flu, the Hong Kong flu, all that, and Ebola when those emergencies happen. And basically, it's permission to use these devices for the duration of the emergency, because there is a shortage because of the emergency. And obviously, the Center for Biologics is heavily involved in vaccines, in the trial vaccines for COVID, and the Center for Drugs on Treatments.
So now I'll ask and again to emphasize, this is purely your own perspective, not representative of anything from an institutional basis. But what are your personal feelings about our prospects for getting out of this? What do you think the best course forward is?
Oh boy. [Laughs] Given our current situation where a lot of states are releasing controls, are releasing stay at home orders. And they're doing that presumably because the infection rates are coming down. But if you look at the normal distribution, that means we've gone to the peak number of infected and they're starting to decline. But the total number is still very high, higher than it was down here at the start of the curve. So, if you release controls completely at that point, you have a larger number. So your initial condition now is much worse than it was back when we started. So the potential for a resurgence is much higher. So, I think we're going to see a lot of resurgences.
You'll note my question was, how do we get out of this, not how we get back into it? [Laughs]
Well, yeah, I think the death toll is going to continue to go up and we won't get out of it until a vaccine is developed.
Are you more optimistic about the development of a vaccine or effective therapies?
Given the multi-system attack that COVID does, I think it's more likely that a vaccine will be the solution rather than effective treatments.
So, Brian, for my last question, it's going to be a forward-looking question, and that is, either for you personally or in your capacity for what you do at the FDA, what are you most excited about in terms of making the greatest impact going forward? What are some emerging technologies or scientific discoveries or regulatory improvements? What are the kinds of things that, you know, looking ahead in your own career or sort of a long-term planning view of your office, what are some things to be excited about or optimistic about in the future?
Well, the one that I'm probably most familiar with and most involved with is an increase in communications capabilities and processing power. Just the ability to deal with a large number of data inputs, I think is very promising epidemiologically. Being able to find trends, being able to parse out small trends from large numbers of inputs. So, I think that's a big help potentially. And just the increase in the ability to move that data around to get it to where it's needed, I think is going to be really helpful. If the public health officials are going to be allowed to do it and to act on it.
And you think that's an actual, that's a legitimate concern given the current environment?
And so, what you're saying is, right now, there's just more data than the computational ability to deal with it all? Is that the current state of play as you see it? Or is it a matter of harnessing the available computer resources to those ends?
Well, I think the cloud and the ability to get data into the system is the big issue. So, processing power, I guess, won't go up that much more. But the communications and the spread of the communication capability across the country and across the world is really going to allow for the collection of more data. Now, obviously, there are factors working against that. A lot of people see that as privacy issues. But, from a public health perspective, collecting that data is invaluable.
And what would be a good example of your office benefiting from a more powerful or useful analysis of that data, given what you're envisioning could happen?
My office specifically, it's not deeply involved in public health issues, other than our contribution to individual submissions and standards and things like that. So, but, you know, getting back to, I think it will be helpful in the COVID emergency and future emergencies that might pop up. And just trends in in general health issues, you know.
Right. OK. Well, Brian, this has been terrific. I want to thank you so much for your time today.