Joel Myklebust

Zierler:

Okay, this is David Zierler, oral historian for the American Institute of Physics. It is June 1, 2020. It’s my great pleasure to be here with Dr. Joel Myklebust. Joel, thank you so much for joining me today.

Myklebust:

My pleasure.

Zierler:

To start, please tell me your most recent title and institutional affiliation.

Myklebust:

Most recently, I was the deputy director of the Office of Science and Engineering Laboratories, which is part of the Center for Devices and Radiological Health at the FDA.

Zierler:

And let’s go right back to the beginning. Tell me a little bit about your family background and your early childhood in South Dakota.

Myklebust:

[laughs] Okay. I was born in Sioux Falls, but my family actually moved to Council Bluffs, Iowa when I was about a year old. And there’s a fair amount of family that was — and maybe, to a certain extent, still is — in Sioux Falls, but I grew up in Council Bluffs, Iowa.

Zierler:

Are your parents from South Dakota?

Myklebust:

My mother was from Iowa. She grew up in Humboldt. My dad grew up in southwestern Minnesota: Jasper, a little town in Minnesota. My dad was deaf, so he was actually at the Minnesota State Academy for the Deaf which is in Faribault, Minnesota.

Zierler:

What was your father’s profession?

Myklebust:

He was a linotype operator.

Zierler:

Did you learn to sign with him?

Myklebust:

Yes. Yes. My uncle was a pretty prominent researcher in learning disabilities. He started out working on deafness and ended up in speech and hearing and so forth. And he’s kind of infamous in the deaf community, because he was a big proponent of oralism, that if you don’t learn orally, you don’t do very well. So, he insisted that my parents talk to me. They wanted me to learn to speak before I learned to sign, which of course, [laughs] never would happen.

Zierler:

Right.

Myklebust:

Nowadays, we think it’s great to have kids learn how to sign before they talk, so they can express themselves. But that was his opinion.

Zierler:

And how did your parents communicate? Mostly through sign language?

Myklebust:

Yes. Yes.

Zierler:

Do you have siblings?

Myklebust:

One brother.

Zierler:

Older or younger?

Myklebust:

Younger. He was superintendent of the Arizona State Schools for the Deaf and the Blind [KB1]in Arizona, in Tucson, until he retired. And then after he retired, he spent some time in special education in Tucson.

Zierler:

Oh, wow. Almost the family business.

Myklebust:

Oh, it really is. It really is. One of my dad’s sisters was also deaf, so his other brother became superintendent of the South Dakota School for the Deaf in Sioux Falls. That’s actually where my parents met. She was teaching there, and he was hanging around, I guess, hanging around his brother.

Zierler:

[laughs] Now, did you spend your whole childhood in Iowa through 12th grade?

Myklebust:

Yes.

Zierler:

And are you a product of the public schools?

Myklebust:

Yes.

Zierler:

When did you start to develop a talent for math and science?

Myklebust:

Well, I always liked math and science. That was the direction I was heading. This same uncle that I mentioned was a professor at Northwestern, so the summer between my junior and senior year in high school, he arranged for me to — they have a program, a six-week program, for high-school juniors, rising seniors. So, I spent six weeks there, and it was primarily in the school of engineering. Biomedical engineering was just starting at that time, and that’s when I really decided to become a biomedical engineer, I think.

Zierler:

That early on?

Myklebust:

Yeah.

Zierler:

What captivated you about the field?

Myklebust:

Well, I liked science and engineering and so forth. I think I had some notion that I was going to continue in the family business, and that somehow [laughs] [5:00] I was going to do something related to deafness.

Zierler:

Oh, really?

Myklebust:

Which, of course, I never did until much, much later.

Zierler:

Now, the decision to go to Iowa: I’m assuming it’s a mix of tuition, and it’s close to home, and they had a good program that you were interested in?

Myklebust:

Well, I actually started out at Northwestern. I was there for two years. At that time, they had a program called science engineering, which — they didn’t have biomedical engineering yet, but they had science engineering, which included biomedical, and I think nuclear, and several other things that weren’t really recognized as engineering, and they put them together. [laughs] This was late ’60s kind of time frame, and there was a lot of politics going on in those days.

Zierler:

In Chicago, of all places.

Myklebust:

Well, I had friends at the University of Iowa, and they kind of convinced me to come there and be politically active with them.

Zierler:

Oh, is that right?

Myklebust:

[laughs] Yeah.

Zierler:

Were you at the convention in 1968?

Myklebust:

No, no, no. I was actually — it’s a little hard to admit these days, but I was actually president of the College Republicans at Northwestern for a year, before I headed out to Iowa.

Zierler:

Was that the big motivation for you — your friends convinced you to come out, or you were looking to leave Chicago in any event?

Myklebust:

No, no. It was because I wanted to be with the friends and some ideas that we had at that time.

Zierler:

Political ideas, you mean.

Myklebust:

Yes. Yes.

Zierler:

Like what? What were you interested in?

Myklebust:

Well, I was actually more of a libertarian, and this was the time of the Vietnam War, and we still had a draft. And our position was — we weren’t crazy about the war, but the thing that upset us the most was the draft, that this was one of the more extreme forms of violation of individual rights that you could really have. You know, to coerce people into — you know, it’s interesting. One of the people at that time who was in favor of the volunteer Army was Donald Rumsfeld. It wasn’t until much later that I figured out that his motivation was that he wanted a more efficient Army. [laughs]

Zierler:

Yeah. [laughs] Was the draft a personal concern of yours? Did you have a low number?

Myklebust:

I did have a low number. That really wasn’t the primary motivator. I remember sitting in Iowa City when they had that first draft lottery, and my number was 13.

Zierler:

Yeah, that’s pretty low.

Myklebust:

[laughs] I actually was called in for a physical, which was a pretty interesting experience. Anytime you’re in a line with a whole bunch of naked guys carrying paper from one station to another, it’s kind of an odd experience. But it started out with — we had to take an intelligence test, and a guy got up in front of the room and says, “Okay, you have to take this test. Now, some of you think that, ‘I could fail this test.’ Nobody fails this test.” I had some medical problems. I had a bad knee, which I was reasonably sure was going to keep me out, but they had me — I was carrying my medical papers with me. I went from station to station to station, and finally got to the last guy sitting behind a desk, who somehow had some of the material that we produced at the University of Iowa about the draft [laughs] sitting in front of him. And I handed him my medical stuff, and he says, “Oh. Well, we can’t draft you. Get out of here.” [laughs]

Zierler:

Wow. Wow.

Myklebust:

So, they just wanted to kind of rub my nose in it and make me go through a scary morning.

Zierler:

So, as a libertarian, who was your candidate in 1968?

Myklebust:

I’m not sure that the Libertarian Party had really formed by that time. I don’t quite remember when it started. I think it was a bit after that that it started. [10:00] Yeah, I don’t know that we had anybody that we were [laughs] particularly supporting in 1968, but —

Zierler:

When you transferred over to Iowa, did you stay in the same field of study? Did you transfer that as well?

Myklebust:

Yes. Yes. They also did not have a department of Biomedical Engineering. Very few places had a department of biomedical engineering, but they did have sort of a track. I was in the electrical engineering department and just tried to make sure that I used electives to take biologically related courses, and things like that.

Zierler:

So, you graduate in 1971. Are you thinking at this point about entering industry, or your track was graduate school all the way?

Myklebust:

I was pretty much graduate school all the way. I did interview and things like that. I think I was actually offered one job as a scheduler for the local power utility for repair crews, or something like that. That didn’t sound very appealing. It wasn’t a horrible time, but it was not a great market for going to work at that time. My parents promised me, you know, four years. You get through four years, and then you’re pretty much on your own, because four years after me, my brother came along, and they had to help him. So, I ended up getting a fellowship at the University of Rochester and went out there for a couple of years.

Zierler:

And that was a master’s program. Was it a terminal master’s program, or was it your intention to go on for the Ph.D.?

Myklebust:

I intended to go on for the Ph.D. In fact, I was enrolled in the Ph.D. program, and after I was there for, I think, a little over a year, my advisor looked at me, and he said, “You know, you’ve already satisfied the requirements for a master’s degree. Why don’t you go down to the registrar and pick it up?” [laughs] Which I did. And you know, I was happy that I did, because money — you know, the money was a little tight. The fellowship wasn’t continuing, so I decided I would go to work. I had friends in Milwaukee, the same friends that I had joined in Iowa City. So, I went to Milwaukee and stayed with them for a while and found a job. [laughs] The job was with a company called Seamen Nuclear. They made a device that used basically soundwaves through the Earth to measure what’s underground. You know, it was meant to try to find mineral deposits or things like that. And the guy that hired me said, “Gee, you have this master’s degree. And you know, we have this one product. We think we need to be developing more products and diversify a little bit, so we’d like you to kind of develop new products for us.” So, I said, “Okay.” He said, “But to start with, I want you to work in the repair shop.” I said, “Okay.” I went to work in the repair shop, and then after a while, he said, “Okay. Start designing new products.” “Okay. Where do I sit?” He says, “Oh, maybe over there in the corner.” [laughs] So, I’m sitting over in the corner, with a pad and paper, and you know, trying to sketch out some things. And the owner of the company walks through and says, “Who’s that guy sitting over there in the corner?” [laughs] I figured out pretty fast that this job was not really going to be a long-term solution for me. Just through serendipity, there was an ad in the Milwaukee paper, a want ad, for a biomedical engineer. And I said, “Gee, I think I’m one of those.” So, I called and went for an interview. This was at the Medical College of Wisconsin. The guy who placed the ad was a guy named Anthony Sances, who ended up being my Ph.D. mentor. But in the process of applying for that, I wrote out my resume and went to a copy shop, which was just down the street from where I was working. [15:00] And of course, I made the classic mistake of leaving the original one in the copy machine. [laughs] So, I came in — actually, they waited until the end of a day, you know, at 5:00, and said, “Don’t come back.” [laughs] So, I called up Tony, and I said, “I need to know. If this job isn’t going to come through, I probably have to go back to Council Bluffs and restart, you know, figure out what I’m doing.” And he said, “Well, why don’t you come in and see me?” So, I went back in, and we talked for a while. And he said, “When do you think you could start?” I said, “How about now?” [laughs] And he said, “Why don’t you take a couple days off?” I said, “Okay.”

Zierler:

And what was the work? What were you signing up for?

Myklebust:

It was never particularly clear until later. I thought I was just going to be a biomedical engineer. He headed the neuroscience laboratory at the VA Hospital, and he told me I was going to be working in the neuroscience laboratory. He was a professor at Marquette University, and also at the Medical College of Wisconsin, and had a laboratory at the VA. So, he was one of these guys that you could never really find him, because he was always in some other office somewhere else. So, when he hired me, he said, “Well, go over to the VA and find this guy Paul. He’ll tell you what to do.” So, I said, “Okay.” I went over, found the VA, got in, found Paul. It was kind of an interesting introduction, because I found Paul — actually, his name was Tom. [laughs] Paul — that’s another story. But his name was Tom, and Tom was in this room with four monkeys in Plexiglas chairs, and they were working on a gastric inhibitor project, using electrical stimulation to promote gastric juices that they thought would be useful as a gastric inhibitor. So, I find him, and I said, you know, “I’m here. What do you want me to do?” He hands me the lab book and says, “Here. Take notes.” I said, “Okay.” This goes on for, I don’t know, two or three days, and finally one day, Tom looked at me and he said, “You know, I’m a graduate student. You’re the director of the lab.” [laughs] And that’s when I knew what my job was.

Zierler:

[laughs] Wow. So, what did you do with that news?

Myklebust:

[laughs] Well, I tried to get a little better handle on what was going on in the lab, and I found Tony, and we talked about it a little bit. But it was a good time at that time. He was the director of the biomedical engineering program at Marquette, and he said, “Well, as long as you’re here, why don’t you go back to work on your Ph.D.?” So, it was really the best of all worlds, because I had the laboratory. I was working on all the projects in the lab and going to school, and I could just — and they were paying my tuition, and I could use the projects in the laboratory to write my dissertation. [laughs] So, you know, I was getting paid to go to school and write a dissertation. It was great.

Zierler:

And what was Tony’s overall research project in those years? What was he working on?

Myklebust:

Tony was always involved in a lot of things. His primary partner was a guy named Sanford Larson, Sam Larson, who was the chairman of neurosurgery, and they both came from Northwestern. And so, Tony basically ran the lab and Sam did neurosurgery and came to the lab to do projects. A lot of the work that we did was basically electrophysiology, and that’s what I ended up doing my dissertation on, the somatosensory vocal potential. But both of them were also very interested in head and spine trauma. [20:00] And in fact, Tony became one of the leading experts in the country on car crashes and mechanical trauma. And so, that kind of focused a lot of the research that we did. He also was interested in electrical burn injury, I think mainly because he’d been consulted on some cases or something, so we also developed a major project in electrical burn injury. We had a big generator. And one of the things that we did was to investigate the effects of high voltage electrical contact. We went out to the state of Washington, near a substation, and they bought pigs locally and brought them in, and used a hot stick with several thousand volts and applied it to the pigs to study the kinds of burns that they would get from high voltage electricity. [laughs] I think Tony must have had a case that involved somebody who was wearing a watch when he came into contact with high voltage, because he said, “I need a watch.” I said, “Okay, I’ve got my old Timex here on my wrist. Do you want to use it?” “Sure. Sure.” He takes it, and he puts it on the pig, and there was this great arc. I’m not sure I could lay my hands on it anymore, but there was this great film of it, where it zooms in on the watch. The watch is ticking. It comes back out. The hot stick comes in. There’s a big arc. [makes crashing noise] And then, the camera focuses back in on the watch, and it’s still ticking. So, that’s the old Timex commercial. You know: “It takes a licking and keeps on ticking.”

Zierler:

[laughs] Right. Now, in developing your own dissertation topic, was that a problem that Tony essentially handed to you or you more or less developed your topic on your own?

Myklebust:

It was more or less on my own. We used the somatosensory evoked potential clinically, but then also in research as a way to measure effects of different things on the nervous system and so forth. But one of the questions was: where does it come from? And I developed some experiments to try to figure out where it came from, and I also worked with a neurosurgeon at that time, Joe Cusick, who was also interested in the pathway of the somatosensory evoked potential. A part of the controversy was whether or not the evoked potential was primarily a dorsal column function. You know, was it carried in the dorsal columns? And a lot of people said: no, it’s some combination of spinothalamic and dorsal columns, and there was all this kind of stuff. So, Cusick was the neurosurgeon, and I worked with him on a pretty intricate set of experiments where he — I don’t think you could do these experiments now in monkeys. But we had monkeys, and in one set, he would go in and ablate the dorsal columns. He’d just cut them out over one segment, and then we showed that there was no response going through. And in another experiment, he cut out everything besides the dorsal columns, so just left the spinal cord kind of hanging by a thread, basically, the dorsal columns through that segment, and showed that the evoked potential was intact. And then there were questions about, you know, which nuclei in the brain it went through, and some of those kinds of things, which we spent some time working out. And that was a big part of my dissertation.

Zierler:

Now, when you say that it had a clinical component to it, were you working with patients directly?

Myklebust:

Yes. It was through Dr. Sam Larson. One of the things that they were working on was thalamic ablation for Parkinson’s Disease. This was before L-dopa came along. And there had been work using [25:00] cryogenic methods to ablate the thalamic nuclei that are involved in Parkinson’s Disease. But Tony and Sam used an RF ablation system. So, they put an electrode into the nucleus and then push a button and zap it. My job was two-fold: the way that they knew where they were in the thalamus — I mean, they had stereotaxic frame and Atlas and all this kind of stuff. But this was before significant imaging, so just to be sure they were in the right place, Larson would put a recording electrode into the thalamus, and it would stimulate and record the evoked potential from the thalamus. So, he could locate the VPL — ventralis posterior lateralis — in the thalamus, and then VL, the area he wanted to ablate, would be predictably close to that. So, first he’d find VPL, and then he’d put the ablation electrode into VL, and then my job was to push the button to apply the RF to it. And you know, there again — this was the kind of surgery you’d do when people are awake.

Zierler:

Yeah.

Myklebust:

So, the person would be awake, and with the tremor and so forth, so the procedure was to apply the current for a short period of time and see whether the tremor would go away. And if it did, then you could go back and apply it for a longer period of time to complete the ablation. Over a short period of time, you could stop, and it would recover. But if it was the right place, then you’d ablate the nucleus.

Zierler:

So, in terms of the goals of your dissertation, what would be the best-case scenario in terms of patient outcome, with regard to what it was you were researching?

Myklebust:

That’s an interesting question. I was primarily focused on the characteristics of the evoked potential: you know, what the origins of it were neurologically, and how it was affected by sleep, drugs, and so forth. So, there wasn’t a particular clinical outcome to it. It was more just understanding the nature of it.

Zierler:

Did your research have therapeutic implications, in terms of what you found led to certain ways of dealing with these problems?

Myklebust:

There were certainly clinical uses. For example, one of the things that Joe Cusick, Dr. Cusick was interested in was cervical spondylotic myelopathy. And we were able to show that there was a characteristic evoked potential pattern associated with it, but also that changes in neck position would change the pattern, and you could use this diagnostically. And then he would go in and do a fusion, and then, of course, you’d show that the evoked potential is okay after that was done.

Zierler:

Now, did you essentially have a job lined up straight from your defense on the tenure track line?

Myklebust:

No. I started out just continuing in the lab at the medical college. You know, they gave me academic rank. I started as assistant professor and then became associate professor in neurosurgery at the medical college — involved in writing VA grants, NIH grants, to support the laboratory and support our people.

Zierler:

Did you essentially remain in the same research inquiry?

Myklebust:

At that point, yes, pretty much. The same, but again, we did the electrophysiology. We did trauma biomechanics. We did electrical burn injury. So, we were kind of all over the place.

Zierler:

Joel, I’m curious. In terms of your classical education, the engineering component obviously makes sense, but between biology and chemistry and physics, which of those branches of science did you most [30:00] lean on in terms of your day-to-day?

Myklebust:

That’s an interesting question. I would say it would be between biology and physics. One of the things I kind of figured out was that I think just about every engineer thinks that they’re a scientist, so probably a physicist or something. But at the same time, just about every scientist, physicist, thinks that they’re an engineer.

Zierler:

[laughs] I’ve heard that. Yup.

Myklebust:

It all kind of goes together.

Zierler:

Right. Now, in 1988, you move over to Marquette, or this is the same institution?

Myklebust:

Maybe not surprisingly, Tony and I had a few disagreements over time. I suppose it’s — well, it’s not uncommon, but I think it’s a little bit like growing up and you have to fight with your father a little bit.

Zierler:

Sure.

Myklebust:

So, I went to him and said, “Look, I have to get out of this laboratory.” He was still the chairman of biomedical engineering at Marquette, so I said, you know, “You have an opening at Marquette. Can I go down and fill that?” And he agreed. That’s when I moved to Marquette. Now, at the same time, my wife took over a laboratory at the VA. There was a very well-known woman in gait analysis over the years, Mary Pat Murray, who had a laboratory at the VA, who then unfortunately died. And the medical college and the VA were looking for somebody to take over that laboratory. And it wasn’t — well, it ended up being Barbara, who was just in the process of finishing her Ph.D. at Presbyterian St. Luke’s — Rush University in Chicago. So, I moved my position to Marquette, and I went to work to help her develop her laboratory. So, that’s when I kind of moved more into functional performance biomechanics.

Zierler:

So, what kind of projects did you do in that position?

Myklebust:

We were interested in aging. The idea of the laboratory — well, we wanted to study aging as well as other neurological diseases and things. Not that aging is [laughs] a neurological disease. But what we realized was that in the aging process, people are — there’s a wide range of what people look like in aging. So, we decided that there needed to be more of a baseline to understand: this is what normal aging looks like. So, we developed a project where we looked at a battery of tests, including — we did gait analysis, we did balance, we did postural stability — postural steadiness, basically. We did reflex studies. We did joint compliance studies. Barbara’s dissertation involved — well, let me put that a different way. Her dissertation was on development of stretch reflexes in newborns. But the laboratory where she worked was run by Jerry Gottlieb and Gyan Agarwal [KB2]— was very well known for using a motorized footplate to look at reflexes and joint compliance, stiffness, and so forth, and some reaction-time kinds of things. So, we worked with them to develop a comparable system at our laboratories, so we were able to look at all the joint biomechanics as well as things like nerve conduction. We also used evoked [KB3]potentials. So, the idea was to be able to look at human performance, both macroscopically and microscopically. You know? So, looking at sort of the macroscopic outcomes of the gait and balance: how well do you walk? How well can you stand [35:00] steadily? And then we looked at the components of that, the biomechanics of the joints, how well the nerves are functioning, and so forth. One of the things that we did that was actually a great motivator to get volunteers for the laboratory was that there was a neurologic exam. We got one of the neurologists to do a neurologic exam. So, we had a lot of elderly volunteers, and they [laughs] loved getting that neurologic exam. They also liked coming to the lab, because they’d have somebody to talk to. So, our techs would sit and talk to them for a while, while they’re doing the studies. We published a number of things, but one of the — and we actually ended up publishing this later, but I think it kind of explains a lot about the aging process and changes in all kinds of aging parameters, and that was that looking at the number of neurologic deficits as a function of age, you find that as people get older — first of all, it’s a Poisson distribution for the number of deficits. The Poisson distribution, as you get older, spreads out, becomes a broader distribution, so there’s a wider range of characteristics of people. Young people, it’s a pretty narrow Poisson, and when you get to much older, then it spreads way out. So, it sort of accounts for this — you know, there’s this idea of super aging. You know, so some people have — there’s nothing wrong with them. They run marathons, and they’re in great shape, and then there are other people who are old, frail, feeble. And our goal was to try to be able to say: okay, normal aging is in this range of things. So then, if we look at somebody, and they’re out here, then we say: okay, that’s outside of the normal range. But rather than just saying: the mean is this, the standard deviation [KB4]is this, and if you’re outside of this, then you’re abnormal, because that just doesn’t work for that kind of a population.

Zierler:

It’s quite an ambitious endeavor to try to come up with a standard model for what aging should look like. I’m curious if you put sociological components into the next two — you know, looking at class, and race, and educational background, and things like that.

Myklebust:

That’s actually a good point. We didn’t do that. We did have some questionnaires. There was a depression questionnaire, a quality-of-life kind of questionnaire. But no, we didn’t try to use socioeconomic status as a parameter. That would have been interesting, I think.

Zierler:

And in terms of the findings, who’s the audience that would find value in this research? Would this be like, primary care providers? Would this be pharmaceutical industries? Who’s most interested in this work?

Myklebust:

Actually, I think the gerontologists would be the most interested. You know, just to have a better understanding of their patients and how to look at their status.

Zierler:

Now, during this time, were you teaching? Was this a teaching position also, or this was strictly research?

Myklebust:

I was teaching, both when I was in the neuroscience laboratory with Tony and then also after I moved to Marquette and our performance laboratory. We had a lot of graduate students, so I spent quite a bit of time mentoring graduate students. At Marquette at that time, the normal course load for professors was two a semester. The way that they put it, it was “two, more or less.” You know? [laughs] The idea was supposed to be “more, if you don’t do any research, less if you do some research.”

Zierler:

Right. Sure. And were you publishing a lot during these days? Were you sharing your research at conferences? How well connected were you with the larger academic community in your field?

Myklebust:

Pretty well connected. When I was in the neurosurgery department, we always viewed our sort of bread and butter [40:00] there as being neurosurgery journals, neurosurgery meetings, and so forth. But I was an engineer. Tony was an engineer. So, it’s kind of a standard thing. We would try to a paper [KB5]with the neurosurgeons, publish some part of it in the neurosurgical journals, and then take another part of it and put it into engineering journals. We went to a lot of meetings in those days. We felt we really needed to be out there so people could see us and they knew who we were, because when you send that proposal in, people sitting around the study section, you’d like them to say, “Oh, yeah. I remember that guy.” [laughs]

Zierler:

Right. And then in 1999, you have a big career switch. What happens then?

Myklebust:

Barbara had a big opportunity to move to D.C. George Washington University was starting a new program in physical therapy. Let me give you just a brief background on her, so it kind of fits together.

Zierler:

Sure.

Myklebust:

Her primary degree was in physical therapy from Marquette, a bachelor’s degree. This was in the day when physical therapists got bachelor’s degrees. Nowadays, they’ve all moved on to be DPTs, Doctor of Physical Therapy.

Zierler:

Yeah.

Myklebust:

But George Washington was starting a new — so, Barbara, her first degree was in physical therapy. She did a master’s degree at Marquette when we were both graduate students at Marquette, in biomedical engineering, and then she went on to get a Ph.D. in physiology at Rush University at Presbyterian [KB6]St. Luke’s. So, George Washington wanted to start a new program in physical therapy, and she was selected to be the founding director of the program. So, at that point, we — that was actually in 1997. So, between ’97 and ’99, I was sort of closing down the lab, spending more time teaching at Marquette, and looking for a job in D.C. Actually, in terms of a time for teaching, it was a great couple of years. I had more fun sitting in the lab. I taught the programming course at that time. So, sitting in a lab, helping kids debug their C programs, and driving the TAs nuts. [laughs] “Why is he here?” And one of the reasons that Barbara took the job in D.C. was that we thought that it’s an area where there should be a lot of opportunities. So, I should be able to find something. But you don’t find things instantaneously, so she commuted for a couple of years while I was applying for positions out there.

Zierler:

And then what eventually came through for you?

Myklebust:

I was offered a rotator position at NSF, which I accepted, and then I was called by this agency, the National Institute on Disability and Rehabilitation Research, which at that time was part of the Department of Education, so then I had to call NSF and say, “Gee, I’m sorry.” [laughs] You know? And they always have a hard time filling those rotator positions, so they were kind of upset with me. But this was a permanent job. Actually, a friend of ours, a fellow graduate student at Presbyterian [KB7]St. Luke’s with Barbara, was a guy named Bob Jeager. And he got to NIDRR before I did. Since then — this was after I left there, but they’ve moved it to HHS and added a little bit to the name, so it’s now the National Institute on Disability, Independent Living, Rehabilitation Research: NIDILRR. But the director at that time liked engineers. She wanted more engineering in their portfolio. So, I was offered [45:00] that job and took it. The —

Zierler:

Now, the move to HHS happened during your time there, or that was later on?

Myklebust:

That was later on. That was in the last authorization of the agency, which was a couple of years ago now here. So, this was 1999, the end of one presidential administration, the beginning of another one, which is always an interesting time to go to work. [laughs]

Zierler:

Right.

Myklebust:

But the — although NIDRR at that time — and still, NIDILRR has a major presence in rehabilitation engineering — the primary position that they offered me was to direct the model spinal cord injury program. This is a program — I mean, it’s the top rehab hospitals in the country, and the idea is to show the value of a comprehensive, continuous system of care. So, to be a model system, you know, we had fairly limited budgets. At that time, I think there were maybe 15 of these or something. But you have to show that you have a connection to EMTs, so you get patients at the curbside, through the emergency room, through acute surgery and so forth, and into then long-term rehabilitation, and finally reintegration into society. So, it’s basically an HMO. Sort of a bigger HMO, because it also includes the socio-economic aspects— getting people back to work, getting the homes set up for them, and the whole smash. This program had been around since the late ’70s, and I think it was one of the two drivers that really increased the life expectancy for people with spinal-cord injury. The bigger driver, of course, was the development of EMTs, you know, getting that early care at the curbside. But I think that this also contributed to better quality of life, better life expectancy, and so forth.

Zierler:

In what way? Can you walk me through the process?

Myklebust:

Sure. I mean, certainly, the EMT at the front end — first of all, you’re going to save lives. People aren’t going to die, because you’re there. And two, you’re likely to save levels. So instead of being a C-3 quad, you’re going to be maybe a C-6 quad, or that kind of a thing, where you do somewhat better functionally, and then the — one of the requirements of the system, the program, was that the hospitals that housed the program had to stay in touch with the patients. They had to see them quite regularly. So, there’s the effect of more continuous care, you know, so you know, if you develop a pressure sore at home, and nothing happens for a long time, you have a bad outcome. Whereas here, they’re going to get you in, take care of you much sooner. But also, a lot of other things that were generally part of the programs — so, a lot of peer mentoring for example. You know? So, people that were injured 10 years ago come in and work with somebody who was injured in the last few months, and help them see what they can do, and try to help them move forward. But it was always viewed as a demonstration program. It’s just showing that this is effective. And it had been around for a long time, so there was a lot of pressure. It was coming up for competition right about the time that I got to NIDRR. The whole program turns over in five years. [50:00] And there was a lot of pressure to take the money that was being spent on it and just put it into basic research: we already know this works. Don’t waste more money demonstrating something that we all know works. Put it into more basic research. My approach was to try to pivot the program to become more of a multicenter clinical trial platform, because this is a pretty homogeneous program. Everybody treated people the same way, so it should be a good platform to try new therapies and new things like that. I mean, spinal cord injury is a relatively low incidence, fortunately. I think there’s still something on the order of 10,000 a year, which sounds like a lot, but it’s really not, especially when you consider that that includes people with injuries — you know, high cervical, thoracic, lower lumbar. So, your statistical cell size is small when you start looking at people with injuries at different levels and severities. They’re pretty small. So, trying to use the power of the multicenter platform, where we have all these places that are doing relatively similar treatments, was important. So, the way that our RFAs were done there was through a system they called priorities. They had to put out a priority, and the priority had to be published in the federal register. So, I wrote the priority for the program, which kind of struck a chord. People liked it. And I also took a pretty proactive approach. At that time, I think there were about 16 of these centers, and typically, when they’d run the competition, you know, you’d get the current incumbents, but maybe a couple others. If they had 20 applicants for 16 spots, it would be surprising. But I kind of took the show on the road and marketed it, and said: you know, look. We really need to try to develop this program into this clinical trial platform. And I also — there was a lot of concern among the centers, because they had to maintain this contact with all of their patients, going back 20, 30 years, and it was expensive. And they also — you know, some places had a lot of patients, and some places were newer to the program, and only had a few. But everybody got the same amount of money. So I said at the very beginning that I was going to develop a formula. First of all, I wanted to reduce the number of centers so there would be more money available.

Zierler:

Just as a matter of streamlining bureaucracy.

Myklebust:

Yeah. And I wanted to recognize the actual costs, so all older [KB8]centers, you know, who were trying to follow a thousand, or thousands, of patients, should get more money than somebody who just started in the program who, you know, has a hundred patients to follow, or something. So, we were very, very up-front about it. We were very clear about it. Everybody knew what we were doing. So, we ended up getting 32 applicants for the program, which was —

Zierler:

Oh, wow. What were you expecting?

Myklebust:

I was hoping it would be higher, but that was higher than I thought it would be. And I made a commitment that I would communicate with every center, with every PI, and tell them what the reviews said. And we also had other grant programs, what we called field-initiated, which are the more traditional kinds of things where investigators in the field write a proposal and send it in. So, I promised that I would work with all of the unsuccessful applicants and figure out what part of their proposal would work well as one of these field-initiated proposals— my real goal was just to increase the total amount of spinal cord injury research going on in the agency. [KB9] [55:00] So, get centers doing more, and then get other people putting in more individual proposals, and actually to — even if you were unsuccessful for the center, you could still collaborate with centers to do research and sort of build this whole field that way. There were some difficult phone calls, but [laughs] I did call every single one of them, including one very old important [KB10]center, whose PI liked to communicate with emails in all caps. [laughs] And he was pretty unhappy, because they didn’t make it. They came back into the program later, after they got some things straightened out.

Zierler:

Now, you rose up pretty quickly at NIDRR in terms of your administrative duties.

Myklebust:

We had a couple of positions that I knew were coming up. One of them was — after a lot of effort, we had gotten permission to have a science and technology advisor to the director of the agency, and that was the job I really wanted. And we also had this division director position that was the director for policy planning, budget, and evaluation, which is [laughs] kind of a mouthful of stuff. And that came up first. My idea was that I would apply for that, just to practice interviewing, because I knew it was going to be the same people interviewing. But it came right after a big spinal cord injury meeting in Las Vegas. You know, a lot of spinal cord injury meetings are in Las Vegas, because it’s very accessible, and you can wheel your wheelchair right up to the tables and play. Anyway, I’d just come back from that, and I kind of overshot. I was very excited about stem cells and all the great things we could do, and I guess I kind of went on and on about this in the interview. And the director chose me for the job. [laughs]

Zierler:

[laughs] And what did you see as your mandate for this new position? What were you looking to accomplish?

Myklebust:

Really, a couple of things. One was to get the financial system a little more stable. It was kind of — as an example, there were a number of instances where universities would get the grant money twice in a year, [laughs] you know, and some things like that, which we needed to stop. The other thing, which kind of developed over time — you know, this was the end of the Clinton administration and the beginning of the Bush administration. And one of the things that the Bush administration did was to develop something called the PART: the Program Assessment Review Tool, which they wanted to apply to agencies across the government. And so, somebody from OMB came in and said: okay, we need to go through this PART exercise with you and figure out if you’re actually accomplishing the things that you need to be accomplishing. So, of course, we prepared for this. We had stacks of products. We had papers from all of our programs, and we felt that we had really accomplished quite a few things. And we went into the meeting room with our stacks, and the OMB person was sitting there and said: oh, that’s very nice. Very impressive. But show me your plan. Show me where in the plan — we had a long-range plan, which was actually philosophically very good, and a lot of people liked it, but it wasn’t specific. You know? It didn’t say, “We’re going to develop a floating wheelchair,” or something. So, she said: well, you just have a bunch of stuff. [laughs] you know, I’m not seeing the productivity that you should have. [1:00:00] So, we went back, and I worked with one of the people that worked with me, a very, very good, very strong researcher, but also then very good advisor in our program. And we kind of took a tour of other federal agencies in the area and said, “How are you doing this?” You know?

Zierler:

Did you discover, Joel — was there a lot of overlap, or not that much, when you were going around?

Myklebust:

Not much overlap, no. But there was this, at that time, relatively new idea called the logic model, which is — I don’t know, fairly common now. But we looked at this and said: okay, this will help us be more “planful” — more strategic about our investments. So, we spent a fair amount of time developing this. I don’t know if you’re familiar with the logic model. As an engineer, it’s this thing that sort of makes sense. There’s actually two sides to it: one is the outcome side, and the other is the performance side. And we decided that we weren’t going to worry about hiring people and buying resources and that kind of stuff. We wanted to focus on the outcome side as an agency, and then we would let grantees work on how they were going to accomplish the things that we wanted to lay out for them. The way the logic model works is: at the far right, there’s sort of the ultimate goal of the agency. What’s the real outcome that you’re trying to produce? And in fact, that was — I think one of the problems that we had, and I think a lot of places have, which is that according to our legislation, our objective was to make life better for people with disabilities. So, we’re going to make life better for people with disabilities. But what the heck does that mean? [laughs]

Zierler:

Right. It’s a pretty broad mandate.

Myklebust:

Right. It just means — you know, I used to joke that we would get proposals that would say: oh, it’s very important that we make life better for people with disabilities, and that’s why we need to study the calcium channel in the lamprey, or something like that. [laughs] Wait a minute. What’s the connection? How do you get from that to actually making things better? So, we spent a fair amount of time working on what that outcome — the big outcome area looked like and decided basically that it consisted of: independent living — people needed to be able to live independently; work, so employment outcomes; and that they needed to be healthy. And that as part of making those things happen, we needed to have technology and a few things like that. So, this was our big outcome sphere, which we defined much more specifically than this, but you know, kind of laid out what the real goals are, there. The middle part of the logic model is what you need to do to make that happen. Right? So, to help people live independently or to make sure they can live — they have good health and so forth, you need to have practitioners. You need to have physicians. You need to have social workers. You need to have companies making the right products. You know, there’s this whole middle sphere. And then on the left side of the outcome part of the logic model is the new knowledge production piece. We decided that our niche was that new knowledge production, and that what we needed to do — which we spelled out to a much greater extent — but the real idea is that we would develop this new knowledge, or new methods, new tools, and so on, which would then go into the hands of practitioners who would then use that to make life better in these specified ways. So, rather than us saying: okay, we’re going to do this because it’s going to help these disabled people — no, we’re doing this so that the people [1:05:00] in the middle can accomplish that.

Zierler:

Right.

Myklebust:

I don’t know if you’ve looked at this whole area of outcomes. There’s a whole outcome tracing — all this kind of stuff. And it turns out that it’s — I think it’s basically an ill-posed problem. You know, if you look at the outcomes and say: oh, look. Life is better — let me go back to my college days. I love to use this example. The outcome was the volunteer army. We did away with the draft. You know, so obviously my little group in Iowa City accomplished that. Right? [laughs] No. But it’s fundamentally impossible, I think, to take some major outcome like that and track it back to particular activities or particular developments, and so forth. So, the message for us was that we could count how many papers we write, and so forth, but the real outcome, the real thing we needed to accomplish, was to impact the practitioners, impact people who put things to use and make life better. I see it pop up periodically, looking at some of their things. I don’t know if they’re still using it. But I still see vestiges of it that would have the same major outcome domains on one end, and they still talk about developing tools and methods and so forth. So, I think it’s one of the things that had sort of a lasting impact on the agency.

Zierler:

What do you see as your primary contribution at NIDRR over the course of your six years there?

Myklebust:

I think we got the financial side in much better shape. I worked with a person in the Department of Education budget office. The problem with an agency like that — I mean, it’s the same problem that NSF, NIH, all the grant-making agencies have, which is you’re promising money to people three years or five years from now that haven’t been appropriated yet. Right?

Zierler:

Right.

Myklebust:

So, you have to have a way to keep track of what those commitments are, but then also know how much money you have this year to put out in new grants. And you know, if you — one of the — NSF uses this rotator model, and one of the problems that they have is that I could be a rotator there this year, and I could commit all the money for the next guy for the next five years. And so, he comes in, and he’s got nothing to do. [laughs] So, you have to make sure that you can run new programs, new grants, new programs, but at the same time maintain the old ones. So, we worked in a pretty complicated [laughs] system of making sure that we were able to do that. I felt pretty good about that, and I think — we developed a program review system where — effectively a reverse site visit. We’d have centers come in to us, and we’d get a review panel. We had a formative review and a summative review. You know, in the first year, they would come in and — they’d gotten the grant, but we assemble a team of experts around the table and sort of help them figure out what they’re actually going to do now with these next four or five years. And then close to the end, in the fifth year, we’d have a summative review. We’d bring them in, and a group of people would sit and say: okay, why didn’t you do this? [1:10:00] Why didn’t you do that? That whole system, I thought, was pretty good. It worked pretty well. So, we could really see what the effect of our money — where it was going and how well it was accomplishing the goals that we had. And the logic model was a part of that. That was sort of how we would — the lens that we would look at those things through.

Zierler:

And so then how did the opportunity at the FDA come about?

Myklebust:

That’s actually pretty straightforward. Well, I’ll tell you the story, and then [laughs] when you send me the — I’ll decide whether I’m going to cut it out or not.

Zierler:

You got it.

Myklebust:

[laughs] I had been the — okay, so the director of NIDRR is a political appointment.

Zierler:

Right. And you’re civil service the whole way.

Myklebust:

Right.

Zierler:

Yeah.

Myklebust:

So, the deputy director is a civil service position, and I was the acting deputy — [INTERRUPTION] I had been the acting deputy for some time and applied for the position. I went to see one of the higher officials in the department. This is almost an exact quote. He said, “Well, we’ve decided we want someone who’s not encumbered by the biases that come with substantive knowledge.” [laughs] And I said, “Okay.”

Zierler:

[laughs] That sounds like something right out of Catch-22.

Myklebust:

Yeah. So, I went back to my office, and I dialed up USA Jobs, and there was this FDA job. And I happened to know people there, so I call them up and say — one of the questions you always have to ask in these positions is, “Is this real, or is there somebody sitting over here on the side that you’re going to give it to, and I’m going to waste my time if I apply for it?”

Zierler:

Right.

Myklebust:

So, I called them and said: is this really open? They said: yeah, send us your application. And of course, you’re probably well acquainted with the whole government personnel system.

Zierler:

I sure am.

Myklebust:

[laughs] It took a while, but they finally ended up offering me the job.

Zierler:

Now, did you know people at FDA because of your work, or just from the circles you were in, generally?

Myklebust:

Circles. There was a group of us. One guy from FDA, Bill Herman, Bob Jeager that I knew at NIDRR, but he had moved on to some other things. And there was a guy named Bill Devey [KB12]at NSF who was sort of a paragon there. He finally died in his 90s, I think. But he retired from NSF two or three times. [laughs] He was an amazing guy. He started there coming out of the Navy out of World War II, I think. He was at NSF forever. So, the four of us would get together for lunch once a month or so. We’d rotate around. So, I called the guy from the FDA that was part of this group. He’s the one who told me to go ahead and apply for it.

Zierler:

So, the division and — it’s a bit of a mouthful. What exactly were you the director of? It was the Division of Physics?

Myklebust:

Yes. At that time, we were just the Division of Physics. The office director there at that time was a guy named Larry Kessler, who was kind of a character. But Kessler would [1:15:00] give sort of an overview of his office, and he’d describe each of the divisions, and go through all these things, and then finally he’d get to the end and he’d say, “Now, you’ve noticed that all of our divisions have physics in them, but it doesn’t account for everything, so we have to have a Division of Physics.” [laughs] So, I said, “Okay. We are the Division of Miscellaneous Physics?”

Zierler:

[laughs] There you go. Right. So, what were some of the big programs that were taking place in those days?

Myklebust:

Well, if you take physics as being mechanics, optics, and electricity, we had the optics and electricity part of it. Mechanics was a separate division. We had a big, longstanding program in electromagnetic interference, electromagnetic compatibility. Just as an example of that, this was before I got there, but there was a problem with cell phones interfering with pacemakers. And you know, for a place like FDA, that’s kind of a tough problem, because we regulate pacemakers, but we don’t regulate cellphones. Actually, there’s a little bit of — that radiological health piece of CDRH basically says that CDRH regulates anything that emits energy. [laughs]

Zierler:

Right.

Myklebust:

So, everything from radiation, ultrasound, electrical, and so forth. So, there was some kind of a hook where we could go after cell phones, but that’s primarily FCC’s job, so we work closely with FCC. And it’s kind of tough to go after the pacemakers and say: you have to make yourself immune to these cellphones. And there’s all kinds of issues with cellphones and so forth.

Zierler:

Not to mention the fact that pacemakers precede cellphones. Right?

Myklebust:

Mm hmm.

Zierler:

I would have assumed that would have to be part of it as well. Wouldn’t you think that the new technology would have to conform itself to the existing technology?

Myklebust:

Yeah, but who’s going to make you do that? You know? And in fact, it was a little bit surprising. It sort of came out of the blue. So, the guys in physics tracked down where the problem was coming from and actually helped to develop filters and things to keep it from happening, and then they went to both the cellphone companies and the pacemaker companies and said: here’s where the problem is, and here’s how you can fix it. And they said: oh, great. You solved our problem for us. So, that was kind of an interesting model, and in fact, it’s one of the things that makes, I think, this division of physics — it’s now called biomedical physics — different than other parts of OSEL [KB13]— is this aspect of looking at different kinds of interactions where we regulate one side of it, but not the other, you know, and trying to figure out how to bring some of these kinds of things together. So, electromagnetic compatibility was huge there, and still is. In fact, it’s not entirely true, but I like to say that the new facility out there in White Oak was — the Engineering Physics [KB14]building in White Oak, was built to accommodate the EMC lab, because they had this huge anechoic chamber. And there were actually three chambers in there: anechoic, and one for magnetic, and I forget. The other major operation was optics. And in fact, there were actually three more or less parts to it when I started. One was lasers. Lasers had been big there all along. One was the effect of light — you know, so, infrared or ultraviolet, effects on body and so forth. And then one [1:20:00] which was more incoherent light effects. One of my goals was to try to bring them all together and just say: okay, we’re going to do optics. We don’t have to have — you know, and in fact, my argument was that their position, in terms of trying to ask for budget and things, would be better if they were centralized rather than competing with each other over the nickels and dimes that we were able to come up with. I wasn’t entirely successful with that. I did manage to shrink it into two groups and then got them to, more or less, work together.

Zierler:

What were some of the big regulatory issues with regard to optics during your time there?

Myklebust:

Well, Lasik was always a big issue. Developing standards, developing test methods, for intraocular lenses. Intraocular lenses were also always a big component of it. And one of the guys, who was primarily interested in lasers, used his expertise there to develop a better way to measure the strength of intraocular lenses. There was also always a lot of interest in something — you know, like near-infrared spectroscopy as a way to look at what’s going on in the body. There’ve been — in fact, I think I’ve seen a couple of them advertised lately where devices — that you could put onto the skin and identify whether or not something was cancerous or not. There’s been a growing interest in scopes — you know, scopes to go into the body and do imaging, you know, the pill-cam kinds of stuff, those kinds of things.

Zierler:

Joel, I’m curious in your move over to the FDA — did you consider it a lateral move, and to what extent did your duties change in terms of the mix between science-oriented work and administrative work?

Myklebust:

It was lateral. I was a GS-15 at NIDRR, and then I was a GS-15 division director at FDA. One of the things I like to say, with some truth, is that going from the — although it was at the VA, so it was a government position, but it was still in the laboratory, begging for grants and so forth, and going to NIDRR and giving money away. But it kind of takes you out of that front line. And so, going back to the FDA, I was getting back to the laboratory. What I said was that at least I could see it from my office.

Zierler:

Right. [laughs] And Joel, I wonder if you can give me a sense of where the Division of Physics fit in in the larger constellation in terms of: who are the players who are bringing the issues to your division? What are you doing with the work you’re doing on a day-to-day? And who is the audience for that work? If you could, just give me a sort of larger policy workflow of how all these things are coming together.

Myklebust:

Let me first say that one of the things — when I got there — and I don’t know if you’ve talked to Victor yet.

Zierler:

Just over email so far. I haven’t talked to him. Yeah.

Myklebust:

When I got there, Victor was there already, and he was like the electrophysiology department for us. [laughs] And of course, that’s one of the areas that I was pretty interested in. So, we worked to really grow that whole thing, both in terms of neuro and in terms of cardiovascular. So, we were able to recruit a guy named Rick Gray to come in. He does a lot of cardiac modeling. [1:25:00] Plus, we really pushed the modeling side of things for all of this, but particularly on the electrical side. So, in terms of your question, part of what happened during that time — when I started — we’re the intramural lab. So, the real regulatory work is done in the rest of the center. So, if you submit your application for premarket review or for a 510(k), it’s going to go to the other part of the Center. And typically, the business we tried to grow was that they would come to us and say: we want you to consult on this part of the application. We’d like you to look at this electrical device and see whether it’s going to cause problems for other devices or it’s going to be sensitive other devices and malfunction, and so forth. So, this is called consult. When I started, we did about 200 of those a year. Now, they’re — I think physics, by the time I left — by the time I left the FDA, so just this year, I think they were close to 2,000 or something. It was just a huge growth.

Zierler:

What accounts for a tenfold increase? Is it the proliferation of devices? Are people just reporting more transparently? What is this about?

Myklebust:

When I started, one of the issues — and this, you’ll find, is an issue in most of these intramural kinds of laboratories — we’re a luxury.

Zierler:

Yeah.

Myklebust:

There’s nothing that we do that anybody has to have to make the agency work. So, we worked — not by advertising or soliciting, but we tried to build the networks so reviewers would know to come to us. And so, we kept developing those connections and gradually, over time — and in fact, when we were reviewed by the review system there, a lot of times their complaint would be: so, who are your customers? Who are you doing the reviews for? And they’d say, well, we don’t do that. [laughs] We do science. So, we deliberately set out to increase our connectivity to the center, and that meant doing more consults. And it got to the point where we had to start making distinctions and saying: okay, you’re asking us too much. This one is simple. You should be able to do it. Don’t send us the consult for this one — and turning some of them back. So, as kind of a point of — [laughs] we were too successful at it, basically. But you know, it’s sort of like in academic medicine, you’ve got the clinicians, and then you’ve got the laboratory. And hopefully, you work with the clinicians to find out what the problems are. You know, you listen to them, and then you go back to the laboratory and work on it.

Zierler:

Sure.

Myklebust:

And maybe you get the clinician to come to the laboratory with you, and so on and so forth. And this is the same kind of a thing. If we weren’t connected to the center and didn’t know what devices were being submitted, we didn’t know what the questions were, or what the problems were, then there was no chance that we were going to be relevant. So, we needed to make sure we were connected and understood what they were trying to accomplish.

Zierler:

Right.

Myklebust:

So, that’s one major customer base. For a number of reasons, it’s important for the people in the office to have academic standing outside, you know, so that — to go to meetings and know the people in the field, and so forth. That’s partly for their professional development. We wanted to make sure that they were able to advance their reputation, productivity, and so on and so forth, externally. But if you think about it, it’s a pretty small place. You know, there’s 160, maybe, scientists in the office, and the Center is responsible for everything from tongue depressors to MRI machines. So, there are a lot more issues out there than our staff can work on. So, we came to understand that we needed to be trying to connect with the rest of the academic world, and universities, and so forth. It was hard for us to work with companies, because the conflicts start popping up pretty fast if we’re working with them. But we did. You know, there’s a fair amount of work going on with companies, but it’s very carefully crafted and regulated. But by trying to work with universities, we could try to help them understand what our questions are, what our problems are, and to try to get them to work on our problems. I don’t know if you’ve come across this term of “regulatory science,” and in fact, I said in one place that anytime you have to add the word “science” to what you’re doing, it probably isn’t. [laughs] But in this case, I think it really is. The issue is that the questions that the FDA people have to work on are the questions that are helpful to evaluating the devices that come through: safety, and effectiveness, and so forth. And one kind of trivial example — which I can relate to, because I was [laughs] one of these academics at one point — if I develop a new model for something, a human model, and I get some parameters, I put it together, and I say: okay, here’s this model, and it works. Great. So now, I’ve effectively done like a clinical trial of one. And what you really need is a model that says: okay, here’s how it’s going to work in the population. Here’s how it’s going to work in [KB15]pathological anatomy or physiology, and so forth. Because that’s going to be the real world. You know? It’s not enough just to say: yeah, it’ll work in the 50th percentile male. That doesn’t cut it. And then this pops up in a lot of different ways, and so my claim is that regulatory science is really, first of all, the science of decision-making, and driven more by the kinds of questions you ask than by some particular part of science. And so — it’s a long way around for this — but another part of the customer base for the office is all of the people out in bigger academia, to work with them to work together on scientific questions. You know, we want to do that, but also to help them understand the questions that we really need to have the answers to, so you can focus the research in that way.

Zierler:

Now, in 2010, what kind of a promotion is this? You’re still in the overall same office.

Myklebust:

Mm hmm.

Zierler:

What do you become deputy director of? The entire office of science and engineering laboratories?

Myklebust:

Yes. The guy who had been the deputy retired, and so it was open, and I applied, and they said I could do it.

Zierler:

Now, the mandate for this, I assume — does it go beyond medical devices and optics, or it’s still the same general research area, but you’re just operating at a higher level?

Myklebust:

Well, no. Now it would be — so, the office has a Division of Chemistry, Biology, and Material Science. There’s a Division of Imaging, Diagnostics, and Software Reliability. There’s a Division of Applied Mechanics. They’re unhappy about the acronym. [laughs] And then the Division of Biomedical Physics. So, the responsibility goes across that whole spectrum. When I started, we had two deputies. The other guy was Subhas Malghan. Did I give you his name?

Zierler:

No.

Myklebust:

You might want to talk to Subhas.

Zierler:

Okay.

Myklebust:

He was more of a materials scientist, so we would kind of look across at different parts of the office, in different ways. I should say that one of — [laughs] when you talk to Victor, you can find out whether this is true or not. But one of the things that I decided at this point, when I went from physics to the office, was that I didn’t want to be the guy who was going back to physics all the time, and poking my fingers in, and telling them how to do things. You know? So, I tried to keep it relatively hands-off. You know? I’m happy to give advice. I’m happy to work with you. And part of my job was evaluation and strategic planning and some of those kinds of things, and so we’d work on that. But I’m not going to tell you who to hire. I’m not going to tell you which projects to put money into, and things like that. But yeah, part of what [laughs] — this is another part that we may need to cut out of here.

Zierler:

Say it now, and we’ll figure it out later.

Myklebust:

[laughs] The office directors, during the time that I was the deputy — actually, there were two office directors, and at one point, Kyle Myers was the acting director. And the two permanent directors tended to be sort of one-man-band kind of — they wanted to be the doer of things. In fact, [laughs] I had a conversation with one of them and said: okay, we need to work together, and if you’re going to have a big meeting coming up or something like that, I’ll prepare briefing material for you, and we’ll get this together. And he said: oh, no, no. I do much better on the fly. I don’t want to be encumbered [laughs] by all that other information. So, for me, it was kind of a difficult job, because a lot of the things that — you know, I was the acting deputy at NIDRR for a long time. You know, I had a lot more executive authority at that point.

Zierler:

I mean, it’s also a much smaller organization.

Myklebust:

NIDRR is.

Zierler:

Yeah.

Myklebust:

Yeah. Yeah, NIDRR had about 35 or 40 people, something like that.

Zierler:

So, at that level, were you involved in larger policy questions?

Myklebust:

Yeah, “policy” is a big word. There’s multiple levels to it. So, at one end, there’s this whole thing of guidance documents, where we have the law, we have regulation, but nobody understands what [laughs] all those things mean, so now we’d give you a guidance document to tell you what we really mean. And we were pretty heavily involved in those, especially from a technical standpoint. So, helping to set the policy for how we’re going to look at 3-D printing, for example. Then there’s nuances around review policy and things like that, which we tried to stay out of. We tried to stay away from that, because it’s really the purview of the regulatory group. And then there’s sort of office-level policy, and how we’re going to give out the money, how we’re going to do travel, how we’re going to review the work that’s going on, and so on, and so forth. And that’s the area, I guess, where I would have had more of an impact. I look at policy as sort of object-oriented programming. You know? There’s policy that comes from HHS, and then you come down. And at each level, you get to add the things that are specific to you, as long as they don’t contradict what comes from higher up.

Zierler:

Right.

Myklebust:

And then, you know, it kind of rolls down until you get to you. And the place where you get into problems is in — you know, so travel is a very sensitive — especially now, but [laughs] it was always very sensitive. And you know, we had our own policy, basically, about how we would do travel and how you justify it. But then, at one point, the president put out a thing saying: okay, you have to cut your travel, and then that kind of rolled down. So, by the time I left, nobody could travel unless they wrote a justification for why people had to go to the neuroscience meeting, or something like that, you know, and how many people were going to go, and it turned into kind of a nightmare. But I really kind of think a lot of those kinds of things should be left at the front lines [laughs] of the organization.

Zierler:

Sure. Well, Joel, now that we’ve gotten right up to the present in terms of your most recent position, I want to ask you two broadly retrospective questions about your tenure in the Office of Science and Engineering Laboratories. So, the first is: in terms of the mission there, what were the most important tools that you had at your disposal to advance that mission?

Myklebust:

The mission of the office? The mission of the —

Zierler:

Generally. I mean, both as director of the Division of Physics, and then as deputy director of the overall office. What were those tools? And you can divide that into scientific tools, personnel tools, regulatory tools — how did you see the most — what were the most advantageous things you had at your disposal to do your part to advance that overall mission?

Myklebust:

Particularly as the division director, one of the decisions that I made as that everybody in our division should be promoted. But to get promoted, you have to fulfil the criteria.

Zierler:

Sure.

Myklebust:

So, we met at the beginning of every year, and would say: okay, what are you going to accomplish this year? And we’d go: you know, you should be able to make the next grade. If you’re going to do that, you need to have a couple of papers, and some of this, and some consults. And we’d lay out the requirements. And so, that’s the point where you can have the biggest impact on the longer-term scientific projects that are going on. Say, okay, I think that this project is one that can get you where you need to go and helps contribute to our mission. So, let’s push this along. Part of that decision about everybody needing to be promoted was that I’ve always kind of rebelled against the traditional federal manager kind of thing, where our job is to hold people accountable, you know, hold the reins, and make sure that people perform properly, and so on. I’ve always been more on the professional development side of it, saying: okay, I want everybody to learn and develop. The other big tool, obviously, is the money. There were different approaches at different times, but ultimately, the division director has the discretion over how the money gets spent in the division. You know, it was my job to go to the office director and argue for our annual budget. You know? I need this much money. And then I would get to spend it, basically. Some people basically had the idea that you take that money, and you divide it by the number of people that you have, and everybody gets their $10,000 or something. And that just doesn’t work for me. It has to be focused on, you know: what are you going to accomplish with it?

Zierler:

Yeah.

Myklebust:

How can we — which projects are going to get us where we need to go? So, those are the two big tools that you have, are the evaluation system and money, which you can use to drive — I was talking about improving the networking and things like that. You can do that at the same time. You can say: okay, you need to be connected with — you’re working in this area, which means you need to be connected to this part of, at that time, ODE, the Office of Device Evaluation. So, how are we going to make sure that you’re connected there, so you get some consults, and you know the people, and you learn what their problems are, and so forth?

Zierler:

Right. To flip that question on its head, what were the greatest blockages that you saw to advancing the mission of the office?

Myklebust:

Well, it’s not going to be a big surprise. The biggest problem we had was having enough money.

Zierler:

Even more than the bureaucracy? Just moving things through the bureaucracy? The money was even more of an issue?

Myklebust:

Yes. I mean, well, the bureaucracy part of it, I guess, affected us more in terms of never really having a federal budget and always having to work on continued resolutions, and so forth.

Zierler:

Yeah. Right.

Myklebust:

Physics — I mean, I have — I think I had some bit of a role in this. Victor kind of carried it to a much greater extent, but we had decided that the money that we got from the FDA was never going to be enough for us to do what we needed to do, so we were very proactive about going out and collaborating with universities. They would get the grant, and send us the postdocs, or those kinds of things, and directly trying to get money from places like DARPA and things like that. We always had, I think, the largest chunks of money in the office coming from outside. [laughs] Well, I mean, I had arguments with office directors, but I wouldn’t say it was a major blockage. It was just some [laughs] disagreements about how to manage, and things.

Zierler:

Well, Joel, I think from my last question, it’s a forward-looking question, and I’m thinking about the diversity of your range of research interests over the course of your career. Right? I’m curious. You’re retired now, but to the extent you remain active, either intellectually, in following what’s going on, or in other capacities: of all of the things that you’ve been involved in, what sort of continues to capture your imagination? What are the things that most interest you to continue following? What are you most optimistic about, in terms of perhaps being around to see how some of your research, some of your scholarly work, continues to move the ball forward in the fields that you’ve worked on over the past decades?

Myklebust:

Well — and I have to thank my wife Barbara for this — she follows [laughs] — she sends me links every day about things that are going on out there. I still get things from ResearchGate and academia, and all that kind of stuff. I’m still on the advisory boards for the Catholic University Biomedical Engineering department, and also the VCU Biomedical Engineering Department. I told both of them that I was retiring and that I understood if they wanted to get somebody who was still actively employed. And they were very nice about it and said: no, we’d like you to stay on. So, I continue to do that for the time being. So, I think — yeah, I don’t have a great aspiration to try to go back and work directly in the field, but it’s great to be able to watch it and see how things go. One of the frequent conversations that Barbara [laughs] and I have is, you know, we’ll see some new thing come out and say: oh, yeah. We did that in 1997. What are they doing? [laughs] A lot of it is still going on.

Zierler:

[laughs] Well, Joel, it’s been an absolute pleasure talking with you today. I want to thank you so much for your time.

Myklebust:

Well, thank you. It’s been fun.