November 16, 2018

MDIC Computer Modeling and Simulation (CM&S) project FDA Principal Investigator discusses the future impacts of 3D data rich methods on regulatory science.

Kyle Myers, a physicist with a Ph.D. in optical sciences, is a member of MDIC’s Computational Modeling and Simulation Steering Committee. She is Director of the Division of Imaging, Diagnostics, and Software Reliability in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). In February, Myers was elected to membership in the National Academy of Engineers, one of the profession’s highest distinctions. The Academy recognized Myers’ development of analytical and regulatory science methods for accuracy and safety of medical imaging devices. Myers leads a team of scientists studying how next-generation screening and diagnostic devices using three-dimensional (3-D) imaging — like that used in video games and movies — can/may help detect and diagnose cancers, particularly early stage breast cancer.


MDIC: How do you view MDIC’S modeling and simulation work in terms of aligning with the FDA’s strategic priorities?

Myers: MDIC’s modeling and simulation project is completely aligned with the FDA’s priorities, particularly the science involved with assessing FDA-regulated products. Through MDIC, scientists from FDA/CDRH, industry and nonprofits are able to collaborate on developing new modeling and simulation tools and the design of new devices, as well as new approaches for the regulatory decision-making process. Of course, it’s the FDA’s responsibility to determine when a model or simulation technique is regulatory grade, but MDIC’s work will make modeling tools more widely available. This provides the FDA with valuable input on their applicability and reliability as evidence of device safety and effectiveness.

MDIC: Can you describe the 3-D imaging work you have been leading at the FDA?

Myers: Studies are under way to introduce imaging technologies that offer a three-dimensional view of the breast tissue and allow for improved visualization of suspicious abnormalities. The research conducted at the Division of Imaging, Diagnostics and Software Reliability (DIDSR) is aimed at supporting the development of better 3-D breast imaging systems. These systems offer improved performance over traditional two-dimensional (2-D) screening methods such as mammography. The 3-D imaging technologies include 3-D breast tomosynthesis, 3-D ultrasound and breast computerized tomography (CT). Methods for evaluating these systems in the laboratory reduces the need for expensive clinical studies, which in some cases deliver additional radiation dose/doses to the study population.

MDIC: When do you expect these new technologies to be widely available?

Myers: Digital breast tomosynthesis is already available at many facilities across the U.S. and in January of this year the FDA approved the first dedicated breast CT system. Prior to this, in September 2012, the FDA approved the first ultrasound imaging system for automated screening of women with dense breast tissue and a negative mammogram. Then in June 2014, they approved the GE Invenia Automated Breast Ultrasound system. The increasing awareness of breast density as a risk factor for breast cancer and the additional information available from these ultrasound systems will likely increase the utilization of this modality in the coming years, although we don’t know exactly by how much.

MDIC: Is there a potential benefit of using 3-D display technologies developed for other markets, including gaming and entertainment sectors, to better visualize 3-D breast images?

Myers: Scientists in DIDSR are currently conducting research comparing different technologies for stereoscopic presentation. In this case, the work consists of developing measurement methods for 3-D image quality. This will combine physical laboratory measurements with in silico (computer-based) models of image interpretation, and it has the potential to complement or replace expensive reader studies in the premarket evaluation of new 3-D imaging devices.

MDIC: What are the advantages of modeling and simulation and how have your experiences thus far validated the importance of the field?

Myers: Our lab is a world leader in providing software tools that enable groups around the globe to model breast imaging systems. These tools allow developers to test system designs on virtual patients and perform virtual clinical trials. Poor design choices can be eliminated, tradeoffs can be evaluated and improved system options can be selected for further development. FDA makes these modeling tools available to speed innovation externally and to facilitate the development of test methods for characterizing systems after they’re built.

Researchers in CDRH and DIDSR also develop and make available software for designing and analyzing clinical trials for imaging systems. The goal is to make such code widely available. This will facilitate imaging trials that appropriately account for the sources of variability that exist in a study of an imaging system. CDRH and DIDSR researchers are world renown for their expertise in imaging clinical trials methodologies. We make statistics packages available freely over the web so all involved in the imaging clinical trial enterprise have a level playing field for designing and analyzing their imaging studies. In the end, this leads to better trial designs and better information regarding the trial results once completed.

MDIC: As an instrumental member of FDA’s collaboration with MDIC, how do you view the importance of public-private partnerships in advancing regulatory science now and looking toward the future?

Myers: Advancing regulatory science needs to be collaborative, involving scientists and thought leaders in government, industry and academia to leverage the best minds and available resources across the medical device landscape. However, only since the establishment of MDIC has there been a recognized home for and leadership of these public-private partnerships specific to medical devices.

MDIC: What does being elected to the National Academy of Engineers mean to you?

Myers: It’s an unbelievable honor. It is recognition of not just my work but of all of the great work going on in my group and the impact of the group in the imaging community. I lead a fantastic organization of motivated and passionate people who are making a difference. It’s a really great thing to be able to contribute with them to the innovation of devices in the research space in which we operate and see them brought to patients. I hope that as more scientists in industry collaborate with FDA through MDIC, more people will find that we have highly trained scientists at CDRH preparing the way for new technologies to get to the U.S. market.