Biomedical and Chemical Engineering Ph.D. Research Seminar - Dr. Kyle J. Myers

BMECHE Research Seminar

March 26

12:30 p.m.

Institute Hall - INS-1140

Kyle J. Myers, Ph.D.

Puente Solutions LLC
Fellow, Hagler Institute for Advanced Study at Texas A&M University

So you want to be a medical (imaging) device innovator:
Regulatory pathways, recent authorizations, and ways academic investigators can have a major impact

Abstract
Medical imaging offers a dazzling array of approaches for acquiring information that supports disease detection, staging, treatment selection, and follow up. In this presentation you will learn about the various routes for bringing a new medical imaging product (hardware or software) to the US market, including regulatory pathways and pitfalls, with examples. You will also learn about ways that academic investigators can accelerate device innovation and translation through FDA programs specifically designed to leverage their research outputs, including computational models, imaging phantoms, novel study designs for imaging clinical trials, and DATA.

Biography

Dr Kyle J. Myers earned a doctorate in Optical Sciences from the University of Arizona. For over 30 years she worked for the US FDA’s Center for Devices and Radiological Health, where she served as the Director of the Division of Imaging, Diagnostics and Software Reliability. She is best known for the development of analytical and regulatory science methods for assessing the safety and effectiveness of medical imaging devices. Her work established next-generation study designs and evaluation methods for novel medical imaging and diagnostics products including digital mammography, 3D breast imaging, low-dose CT for lung cancer screening, and whole-slide digital pathology.

Myers belongs to the National Academy of Engineering. In addition to being a Fellow of the Hagler Institute for Advanced Study at Texas A&M University, she is a fellow of the American Association of Physicists in Medicine (AAPM), the American Institute for Medical and Biological Engineering (AIMBE), the International Society for Optics and Photonics (SPIE), and Optica. She served on SPIE’s Board of Directors from 2018 through 2023. She is currently SPIE Vice President, part of the SPIE Presidential Chain.

Her honors include the Joseph W. Goodman Book Writing Award, jointly awarded by SPIE and Optica, the SPIE Community Champion Award, and the SPIE H.H. Barrett Medical Imaging Award. Myers has coauthored two books, 3 book chapters, and over 90 peer-reviewed articles.

As founder and principal of Puente Solutions LLC, she now works as an independent research collaborator and consultant to med-tech companies.