Maria Ida Iacono, Ph.D.

A Better Model for Safer Devices

Maria Ida Iacono, Ph.D., already had a topic and mentor in mind when she applied to the U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) fellowship program through the Oak Ridge Institute for Science and Education (ORISE).

Iacono received a doctoral degree in bioengineering from Polytechnic of Milan, Milan, Italy, and then she joined the postdoctoral program at the Harvard-MIT Massachusetts General Hospital (MGH) in 2012.

While at MGH, she collaborated on a paper regarding the safety of patients with implanted deep brain stimulation (DBS) with FDA scientist Leonardo Angelone, Ph.D. After completing the paper, both scientists realized that the topic contained unexplored potential, and Angelone encouraged Iacono to apply for an ORISE FDA fellowship at CDRH, so they could continue their research collaboration. Iacono was accepted into the fellowship program. With Angelone as her mentor, Iacono’s research focused on the complex interactions between electromagnetic fields, such as those produced by medical devices and the human body.

Iacono investigated these complex interactions through computational modeling. Her research looked at how implanted medical devices respond to magnetic resonance imaging (MRI) in order to allow use of magnetic resonance conditional devices. These are medical devices which pose no known hazards inside an MRI machine under specific scanning conditions. Because of the powerful electro-magnetic fields, MRI may negatively interact with an implanted medical device, causing the tissue around the device to heat up, malfunction or move if the device itself is ferromagnetic.

Iacono’s research has also improved understanding of the workings of mechanisms of electric brain stimulation. This knowledge can lead to improvements in neurological procedures, better design of stimulation protocol and ultimately better therapy outcomes for patients.

One of her biggest achievements during the ORISE fellowship was generating a high-resolution, three-dimensional model of the human head, known as the MIDA model (multimodal imaging-based detailed anatomical model). It is used in simulating and precisely mapping the electric fields generated by implanted medical devices inside the head.

“The MIDA model can be used in a vast array of computational modeling studies involving anatomically correct models of the human anatomy to support regulatory decision making,” Iacono explained. More than 160 international research groups throughout the world have used the MIDA model, including GE Healthcare, St. Jude Medical, Medtronic, Google, Harvard Medical School, Case Western Reserve University, Cleveland Clinic, ETH Zurich, the Max Planck Institute, the Icahn School of Medicine at Mount Sinai Hospital, the California Institute of Technology, University College London, and the University of Oxford.

Her favorite part of the program was training. “The ORISE program gave me the opportunity to pursue my research goals in a highly stimulating and educational environment. I was, and still am, surrounded by highly qualified scientists who helped me grow and mature professionally and personally,” Iacono said.

During her research period as an ORISE fellow, she strengthened her skills in computational electromagnetic modeling and established productive collaborations.

Iacono’s accomplishments as an ORISE fellow were recognized by her managers, and she was hired as a visiting scientist by the FDA after the completion of her project on the MIDA model. She now serves as a scientist and principal investigator. In addition to conducting research, Iacono also serves as a subject matter expert for MRI safety, medical imaging and computational modeling, and she is a lead reviewer for the CDRH Office of Device Evaluation at the FDA.

The FDA CDRH fellowship program is funded by FDA and administered through the U.S. Department of Energy’s (DOE) Oak Ridge Institute for Science and Education (ORISE). ORISE is managed for DOE by Oak Ridge Associated Universities.