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I am the Branch Chief of the Epidemiology Branch in the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health, in the Food and Drug Administration. Previously, I have been in small animal practice, the state veterinarian for a greyhound racetrack, and taught at Purdue University, School of Veterinary Medicine, after receiving my Ph.D. in epidemiology and public health. Although I love infectious and zoonotic diseases, medical device epidemiology is a great challenge. The challenges are two-fold. First, medical device epidemiology is a newly growing field. Although much can be learned from pharmacoepidemiology, new methodologies and analyses have to be developed. Additional sources of data have to be identified and evaluated for usefulness. Finally, the area of medical devices is broad and diverse. Products range from life-sustaining to diagnostic and surgical to products used by consumers everyday.