Kim Kontson, Ph.D., a mentor for the Oak Ridge Institute for Science and Education (ORISE) U.S. Food and Drug Administration (FDA) Research Participation Program, said her parents played a significant role in her developing a curiosity for science, math and biomechanics.
“My parents taught me to be curious and ask questions,” she said. “It didn’t take long for me to realize I loved science and math, but also enjoyed working with patients and people. Even in high school, I had an interest in neuroscience, biomechanics and prosthetic devices. A degree in biomedical engineering seemed like the perfect way to merge my desire to interact with patients with my technological curiosities.”
While pursuing her doctorate in biomedical engineering at the University of Maryland, Kontson became interested in the ORISE program at the FDA. She began as a fellow in 2011 and transitioned to become a mentor in 2016.
The ORISE Research Participation Program at the FDA is an educational and training program designed to provide college students, recent graduates and university faculty opportunities to connect with the unique resources of the FDA.
“The ORISE program helped me obtain the government position I hold today,” she said. “During my transition from an ORISE postdoctoral fellow to a full-time employee at the FDA, I was learning from my mentor, Dr. Gene Civillico, and others around me how to successfully navigate the ORISE mentorship. When my ORISE mentor left the FDA, I needed to take what I had learned and step up to push these research projects forward and help guide the research fellows. I was excited to be given the responsibility and privilege of being an ORISE mentor so that I might pass these great opportunities on to passionate, motivated students wishing to begin carving out their own career paths.”
Currently, Kontson mentors four graduate students pursuing their Ph.D.s along with two post-baccalaureate research fellows. “All of my mentees have contributed significantly to advancing our research in clinical outcome assessment development for advanced limb prosthetic devices, population variability of non-invasive electrophysiological measurements and human performance and ergonomic evaluation during the use of augmented reality (AR) and virtual reality (VR) devices.”
Although her research focuses on several different types of devices and applications, Kontson’s goal within the FDA is to facilitate the review of emerging medical technologies. Her and her mentees’ research efforts at the FDA will result in “valid, scientifically robust assessment methods to evaluate the effectiveness and benefits of medical devices,” Kontson said.
Kontson’s research at the FDA is three-fold and involves developing more subjective, quantitative ways to assess prosthetic upper limb function to better facilitate evaluation of advanced prosthetic devices. She also oversees the development of quality assurance metrics for electroencephalogram (EEG)-based devices and works with colleagues on the development of fit-for-purpose test methods of usability for augmented reality/virtual reality (AR/VR) medical devices.
“There are significant advancements in upper limb prosthetic technology that aim to provide more dexterous control of robotic limbs and incorporate sensory feedback through electrodes implanted in the peripheral nerves,” Kontson said. “These advancements have the potential to bring substantial benefits to prosthetic users, but also bring additional risks with implanted components. With this additional risk comes greater regulatory scrutiny, elevating the importance of metrics that can be used to evaluate these new technologies.”
Neurodiagnostic devices that use EEG systems, which measure brain electrical signals from the scalp, can be used to assist clinicians in the diagnosis of medical conditions and used as tools in pharmaceutical clinical trials to assess drug safety and efficacy. Kontson and her mentees aim to develop metrics of EEG quality assurance to enhance the review process of EEG-based devices and provide a tool for companies and academia in research and development to determine artifacts contributing to poor signal quality.
The final facet of Kontson’s research is an interdisciplinary collaborative project in AR/VR. “Advances in computing have enabled a recent surge in low-cost AR/VR hardware and software, and clinical researchers and medical device developers have begun to leverage this nascent technology for both diagnostics and therapeutics,” she said. “These technologies have the potential to revolutionize healthcare with their adoption for diagnosis, surgery and various areas of care management including autism and depression therapy, pain treatment, cancer therapy, and rehabilitation. An understanding of how these devices impact the cognitive, physical and visual loads of the user would aid in the FDA’s evaluation of the potential benefit and effectiveness of AR/VR medical devices.”
As a mentor, Kontson values the ability to be involved in multiple projects simultaneously. “That kind of diversity in my research efforts makes each day exciting and new,” she said.