United States. Food and Drug Administration

In this interview, David Zierler, Oral Historian for AIP, interviews Dr. Joel Myklebust, former deputy director of the Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, at the FDA. Myklebust recounts his childhood in Iowa and his libertarian politics as a college student in Chicago. He describes his graduate work at the Medical College of Wisconsin-Milwaukee where he conducted research on neuroscience from a physics perspective. Myklebust explains his work in biomedical engineering at Marquette where he studied neurological issues relating to aging. Myklebust describes the circumstances leading to his tenure at the National Institute on Disability and Rehabilitation Research, where he worked on rehabilitation engineering, and he describes his work in CDRH over the past twenty years. He provides a broad overview of the development of biomedical physics at the FDA, and he discusses the various technological and regulatory issues surrounding the Agency’s mission to ensure device efficacy and safety.

In this interview, Ilko Ilev, discusses his career as a Senior Biomedical Research Service Scientist within the U.S. Health and Human Services Department. He details getting his PhD from the Technical University of Sofia in laser physics, where his thesis was focused on the development of alternative effective laser designs with direct lens-free optical fiber outputs and their implementations towards nonlinear broadband frequency conversions in optical fibers. Ilev details his experience as a Senior Assistant Professor at the Technical University of Sofia where he taught courses on general physics, quantum electronics, and fiber optics. He discusses the relationship between the FDA and medical device manufacturers. He describes the FDA’s longstanding collaboration with the Uniformed Service University of the Health Sciences, which has resulted in the development of a new field, Photobiomodulation Therapeutics. Lastly, Ilev discusses the various ways in which physics is directly applicable to his work.

Interview with Kyle Myers, Director of the Division of Imaging, Diagnostics, and Software Reliability in the FDA Center for Devices in Radiological Health. Myers recounts her childhood and the many moves her family made in support of her father's career in engineering management for General Electric, and she describes her father's formative influence and encouragement for her to pursue a career in science. She describes her college course work in physics at Occidental and Caltech, and she describes her decision to pursue a degree in optical sciences at the University of Arizona. She describes her work at the Jet Propulsion Lab and how this experience focused her interest on optics. Myers discusses working with her graduate advisor Harry Barrett on human perception and radiological imaging, and the importance of the research support she received from Kodak. She describes her postdoctoral work at Corning developing long-distance optical fibers, and she explains the circumstances leading to her career focus in medical imaging research at the FDA. Myers discusses the administrative evolution of the relevant offices and research centers at the FDA over the course of her career, and she discusses some of the major technological advances and her role in their development, including CT imaging, MRIs, and mammography screening. She describes some of the partnerships in the trade industry and across the federal interagency process that serve as important partners in her work, and she explains the adjudication process when a company is at odds with an FDA review of a given device. At the end of the interview Myers conveys her interest in the future prospects of digital pathology and the benefits it promises in disease detection and treatment.

Interview with Robert Jennings, retired since 2018 from the FDA’s Center for Devices and Radiological Health, where he was a research physicist. He recounts his childhood in Southern California and the formative influence of Sputnik on his physics education. Jennings discusses his undergraduate experience at Occidental and his master’s work at UCLA, and he describes his postgraduate work at the NASA Ames Research Center where he worked on optical detectors. He explains his decision to pursue a PhD at Dartmouth where he studied under John Merrill and worked on Tonks-Dattner resonances. Jennings describes the circumstances leading to his postdoctoral research in Brazil at the Institute of Atomic Energy, where he worked on medical radiation in the Division of Solid-State Physics. He discusses his subsequent research with John Cameron at the University of Wisconsin’s Medical Physics section to develop spectroscopy systems. Jennings explains that the expertise he developed in radiation and modeling in Wisconsin served as his entrée to the FDA ,which excited him as the place where the most impactful research was happening at the time. He surveys the major projects he was involved with over his career, including human visual signal detection, quality assessment of medical devices, improving mammography diagnostics, tomosynthesis, and CT scanners. At the end of the interview, Jennings surveys the fundamental developments that have advanced over the course of his forty-plus year career at FDA, his major contributions in tissue simulation science, and why he believes AI will become increasingly central to advances in medical imaging. 

Interview with Zane Arp, director for Biomedical Physics at the FDA. Arp provides an organizational overview of where his office sits within the FDA and its key institutional partners throughout and beyond the federal government. He recounts his childhood in Texas and his undergraduate experience at Angelo State where he majored in chemistry. Arp explains his decision to pursue a PhD in physical chemistry at Texas A&M with a focus on quantum chemistry through spectroscopy, and he describes his postgraduate work at Los Alamos on laser-induced breakdown spectroscopy. He discusses his subsequent work at Wye Laboratories and Johnson Space Controls in support of the International Space Station. Arp describes his next job at GlaxoSmithKline to work on pharmaceutical development and where he grew into management leadership roles. He describes the opportunities that led to him joining the FDA and he describes his game plan for improving the biomedical device research and regulatory process. Arp explains why this is a long-term proposition and he describes how COVID has, and has not changed FDA’s regulatory environment. At the end of the interview, he reflects on what shifts he been able to put in place so far at the FDA and why his office truly benefits from having a mission statement.

This is an interview with Howard Bassen, Research Engineer in the FDA’s Center for Devices and Radiological Health, Division of Biomedical and Physical Sciences. Bassen recounts his childhood in Rochester and then suburban Washington DC. He describes his early interests in science and electronics, and discusses the impact of Sputnik on his undergraduate degree in electrical engineering at the University of Maryland. Bassen describes his post-college work at Harry Diamond Labs, where he designed radio frequency transmitters, and he explains how his opposition to the Vietnam War compelled him to move to the U.S. Postal Research Labs in Rockville, where he worked on surveillance and package security with X-ray systems. Bassen discusses his first encounter with the Bureau of Radiological Health and his first job in the Microwave Radiation Branch, where his main project was testing home microwave ovens for radiation levels. He describes his work measuring radiation and tissue implantable probes in the human body, and he explains his motivation for taking a job as branch chief of the Microwave Research Branch at Walter Reed, where he studied the effects of very high power microwaves emanating from missile-jamming technology. Bassen explains the absorption of the Bureau of Radiological Health by the FDA, and he describes his decision to return to work on electromagnetic compatibility and cell phone safety. He explains the importance of ensuring electromagnetic compatibility of medical devices so that, for example, an implanted pacemaker does not malfunction when exposed to a cell phone or an MRI machine. At the end of the interview Bassen reflects on his career and singles out his work in determining the safety of electromagnetic fields as the most impactful aspect of his career. 

Donald Witters recently retired as a Senior Review Scientist from the FDA, Center for Devices and Radiological Health. In this interview, Witters recounts his childhood in suburban Washington DC, and his decision to pursue a physical sciences degree at the University of Maryland. He describes meeting Howard Bassen and the opportunity to join the FDA and he explains the overall mission of the FDA’s work on technology regulation for public health, including the regulation of microwave ovens, X-rays, and electric and radio fields. Witters explains how regulatory questions reached his office, and how he and his colleagues transmitted information as part of the process of regulatory policy. He discusses the role of the FDA in regulatory medical devices and the research that demonstrated that cell phones did not produce a hazardous level of radiation. Witters describes the many challenges associated with RFID and avoiding interference with medical devices such as pacemakers. At the end of interview, Witters surveys the regulatory work that will be needed for the wireless 5G network, and he describes the value in completing a graduate program at Georgetown in biomedical engineering.

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.

In this interview, David Zierler, Oral Historian for AIP, interviews Ksenia Blinova, acting assistant division director, Office of Science and Engineering Laboratories, Division of Biomedical Physics at the FDA. Blinova recounts her childhood in Tula, Soviet Union, and she describes the “physics” and “lyrics” educational scheme that splits school children into either a science or humanities focus. She describes her education at Moscow State University, where she became interested in physics and where Victor Yuzhakov and Svetlana Patsaeva were her graduate thesis mentors and where she developed her expertise in fluorescence intensity. Blinova discusses her postdoctoral work at the NIH where she was mentored by Robert Balaban in the Cardiac Energetics Laboratory. She describes the fellowship opportunities stemming from NIH-FDA collaborations that led to her initial work at the FDA, where she learned both biostatistics and took training in regulatory issues. Blinova discusses her subsequent work in electrophysiology and induced pluripotent stem cells, and she describes some of the challenges in ensuring that medical devices are certain to be safe and effective for patients. She describes how physics is applied in her division, particularly in computer modeling, and she describes her interest in developing human cell research as an alternative to animal testing. At the end of the interview, Blinova describes how she plans to remain close to the research as her administrative responsibilities increase, and she explains the promise of her current work on cardiac ablation for patients suffering from atrial fibrillation.

Family background; grows up in California; early interest in electronics. Undergraduate and graduate studies at Caltech. Strong interest in history of science as undergraduate. Ph.D. in physics, 1932. University of California at Berkeley, 1932-1934. MIT from 1934; founder of the Radioactivity Center. Starts first course designated "nuclear physics," January 1935. Strong interest in study of radium poisoning; radium tolerance in humans, cancer research. World War II work, postwar work; establishment of Laboratory for Nuclear Science and Engineering. Markle Foundation supplies funds for the Radioactivity Center's Cyclotron; the 1940 Conference on Applied Nuclear Physics (sponsored by the American Institute of Physics and MIT); World War II work at the Radioactivity Center at MIT; radium dial paint studies; radium and plutonium safety regulations (Glenn Seaborg); work relations with the Manhattan Project; the MAMI (marked mine) project reveals indication of German plutonium project. Also prominently mentioned are: Carl David Anderson, Joe Aub, Joe Boyce, Vannevar Bush, Evan Byers, John Cockcroft, Robert Colenko, Arthur Holly Compton, Karl Taylor Compton, Enrico Fermi, Horace Ford, Ralph Howard Fowler, George Gamow, Newell Gingrich, Clark Goodman, Leslie Richard Groves, George Harrison, Hobart, Elmer Hutchisson, Ray Keating, Arthur Kip, Pinkie Klein, Rudolf Ladenburg, Charles Christian Lauritsen, Thomas Lauritsen, Ernest Orlando Lawrence, Gilbert Newton Lewis, Willard Frank Libby, Milton Stanley Livingston, Leonard Benedict Loeb, Sam Lynd, Edwin Mattison McMillan, Robert Andrews Millikan, J. Robert Oppenheimer, Elmer Robinson, Ernest Rutherford, John Clarke Slater, Sorensen, Robert Jamison Van de Graaff, Ernest Thomas Sinton Walton, Martin Wittenberg, Jerrold Reinach Zacharias; American Institute of Physics; American Cancer Society, Bausch and Lomb Co., National Research Council, Radiation Standards Committee, United States Federal Cancer Commission, United States Food and Drug Administration, United States National Bureau of Standards, United States Navy, University of Rochester, University of Utah Salt Lake City Project, Wesleyan University, World War I, and World War II.