Medical Device Forum Series, 2021

The College of Engineering and Engineering Technology at Northern Illinois University and the NIU Student Chapter of the Biomedical Engineering Society (BMES) are organizing a series of three virtual forums that will discuss current and emerging trends in medical device technologies, regulations and patient safety, including the impacts resulting from COVID-19. This forum series, which will take place in April, May and June, is dedicated to bringing together key industry professionals and decision-makers, researchers, engineers and scientists for review and discussion of contemporary issues related to medical device technologies, emerging regulations, and healthcare. There is no fee associated with participation in this inaugural event series.

Panel Forum
"New and Emerging Regulations"
April 7, 2021, 9-10:30 a.m. CST via Zoom

This session seeks to provide overviews on the European Union Medical Device Regulations, Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD), as well as new requirements for Risk Management in Medical Devices (i.e., ISO 14971). The medical device industry is continually changing, and emerging regulations reflect the evolution of thinking around patient safety. Evolutionary thinking will originate from keeping current and ahead of the newest requirements on software standards, which is a daunting task.

You will hear a brief presentation from each of our panel members, followed by a Q&A session led by Don Peterson.

Panel Topics and Speakers

James Pink
Risk Management in the New European Medical Device and In-vitro Diagnostic Regulations

James Pink, Senior Director, Health Sciences NSF International

Pat Baird
SaMD vs. SiMD and What's New about the ISO 14971 and ISO/TR 24971 Risk Standards

Pat Baird, Senior Regulatory Specialist and Head of Global Software Standards, Philips

Khaled Moussally
Game Changer! Everything about FDA's Upcoming Guidance on Computer Software Assurance

Khaled Moussally, Executive Vice President for Clients and Regulatory Relations, Compliance Group

Ryan Bauer
Navigating the Complexity of Regulatory Changes on Labeling and Global UDI Requirements

Ryan Bauer, Director, Medical Device and Pharmaceutical Solutions, Siemens Digital Industries Software

Read more about the speakers and their sessions.

Keynote Address
"Current Healthcare Technology Needs and Implementation Constraints"
May 5, 2021, 9-10:30 a.m. CST via Zoom

Jesse Ehrenfeld

Jesse M. Ehrenfeld, M.D., M.P.H., is a Senior Associate Dean, a tenured Professor of Anesthesiology and Director of the "Advancing a Healthier Wisconsin Endowment" at the Medical College of Wisconsin. He also is Professor of Anesthesiology and health policy at Vanderbilt University. He was elected to the American Medical Association Board of Trustees in 2014. Dr. Ehrenfeld divides his time among clinical practice, teaching, research, and directing a $470-million statewide health philanthropy. He also has an appointment as an adjunct professor of surgery at the Uniformed Services University of the Health Sciences in Bethesda, Md., is a consultant to the World Health Organization Digital Health Technical Advisory Group and has served as a special advisor to the 20th U.S. Surgeon General.

Active in the AMA since medical school, Dr. Ehrenfeld has served on the governing councils of both the AMA Resident and Fellow Section and the AMA Young Physicians Section prior to his election to the AMA Board. In addition to his work with the AMA, Dr. Ehrenfeld has served on the governing boards of the American Society of Anesthesiologists Resident Component, the Massachusetts Medical Society, and the Illinois State Medical Society. He also served as speaker of the house of delegates of the Massachusetts Medical Society for six years.

Panel Forum
"Rapid Responsiveness"
June 2, 2021, 9-10:30 a.m. CST via Zoom

This session seeks to provide overviews on advanced manufacturing and simulation and emergency use authorization, as well as perspectives on telemedicine, and includes perspectives on lessons learned from COVID-19.

Panel Members

Dr. Brad Crotty
Telemedicine and Adapting Health Care System and Provider Responses to COVID

Brad Crotty, Chief Digital Engagement Officer for The Froedtert & Medical College of Wisconsin Health System

Alex Rodriguez
Faster, Flexible, Accurate, and Efficient Supply Chain Management

Alex Rodriguez, Management Consultant Business and Technology, SEI

Session Topic: Emergency Use Authorization

Speaker to be announced.