Some of our work is in the development of phantoms, or physical models, used to help evaluate medical device effectiveness. Shown above are two examples of a 3-D printed vascular phantom with oximetry map and a multi-layered retinal phantom. Both are used to assess optical imaging devices.
Computational modeling is a tool used extensively in our division. Shown above is an electric field map of a model of a human inside an MRI coil. Models such as these are used to examine the safety of implanted devices during imaging.
Other types of models and simulations can be used to develop disease biomarkers and assess devices and therapies. Shown above is an anatomical simulation of a cardiac pathology, called left bundle branch block, that has a distinct electrocardiography signature.
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The Division of Biomedical Physics (DBP) participates in the Center's mission of protecting and promoting public health by identifying and investigating the biophysical interactions between medical devices and the human body. The division accomplishes this through activities supporting the OSEL mission.
Some examples of research by DBP include investigation of gender-based differences in cardiac resynchronization therapy for pacemakers, development of phantoms (physical models) to assess the measurement of eye disease by optical imaging systems, evaluation and improvement of electrode reliability in neural prosthetics used to control artificial limbs, and computational modeling of active and passive implants to determine if unsafe levels of heating arise during a patient’s exposure to magnetic resonance imaging (MRI) systems. These serve the Center’s mission of advancing regulatory science, facilitating consistent and efficient regulatory pathways, and assuring continued access to safe, effective, and high-quality medical devices.
Specifically, DBP focuses on device issues that involve:
- biomedical and tissue optics,
- biophysics and electrophysiology,
- electrical engineering,
- functional device performance and human factors, and
- wireless communication and electromagnetic interference and compatibility.
DBP has expertise in the diagnostic and therapeutic applications of biomedical optics; biophysics, including cardiac electrophysiology, neuroscience, and functional MRI; computational models; tissue phantoms; electrical engineering, including embedded microprocessor and electronics design, failure analysis, data, signal, and image acquisition and processing; electromagnetics, including MRI implant and electromagnetic compatibility; and functional device performance, encompassing physical medicine, biomechanics, additive manufacturing, and human performance factors.
DBP is charged with developing and evaluating models and methodology to minimize or optimize clinical testing and other types of human exposure to medical devices, developing laboratory test platforms, measurement methods and clinical endpoints, device instrumentation, calibration capabilities, and analytical procedures to characterize and evaluate devices and products in support of the Center’s pre-market and post-market activities.
The technical disciplines of DBP staff include physics, mathematics, biophysics, neuroscience, optics, biomedical engineering, electrical engineering, mechanical engineering, and systems and general engineering.
The following represent three division areas in DBP, each containing research programs:
- Electromagnetic Compatibility (EMC)
- Electromagnetic Dosimetry
- Electromagnetic Modeling
- Functional Magnetic Resonance Imaging and Quantitative Electroencephalography (fMRI/qEEG)
- Magnetic Resonance Imaging (MRI) Safety
- Medical Device Electrical Safety
- Medical Device Interoperability
- Wireless Coexistence