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.