Alumna Heather Agler has channeled her dual interests in engineering and medicine into a career with the Food and Drug Administration (FDA) spanning 20 years. In that time, she has used her unique combination of skillsets in engineering, chemistry, medicine and technology to advance policy surrounding medical devices critical to public health.
Agler earned her bachelor’s degree in chemical engineering from the University of South Carolina in 1995 and her Ph.D. in biomedical engineering from Johns Hopkins University in 2004. Although she entered USC as a civil engineering major, her love of chemistry prompted a change before the end of her freshman year. Shortly afterward, she began to consider a career in medicine.
“My mom worked in hospital labs,” Agler says. “I loved chemical engineering, but I also had this interest in medicine that I don’t think I acknowledged when I was younger. It grew from watching my mom’s career and having grandparents who experienced medical issues.”
Agler’s professors at USC and internship experiences further guided her decision to pursue her graduate degree in biomedical engineering.
“I attended USC’s Honors College, which gave me the benefit of a small school experience in a large school environment. My professors were incredibly helpful and guided me in the decision-making process,” she says.
One of those professors was Michael Amiridis, now president of the university.
“I was just a girl in his class, but Dr. Amiridis took me under his wing and helped me get lab work experience,” Agler says. “He helped me tremendously in my decision to attend graduate school.”
During her undergraduate studies, Agler observed an autopsy through an internship at Geisinger Medical Center in Danville, Pennsylvania. She was fascinated by the devices present in the patient’s body, such as a knee replacement and heart valve. Agler also participated in a fellowship with Washington Internships for Students of Engineering, a nine-week summer program where students conduct research on public policy issues. She chose the FDA approval process for medical devices as her focal topic.
At Johns Hopkins University in Baltimore, Agler attended a presentation by a graduate of her biomedical engineering program about working with the FDA. It piqued her interest as an opportunity to work with science and policy, while staying true to her technology and engineering roots. This motivated her to apply for and accept a position in the FDA’s Interventional Cardiovascular Devices Group in 2005.
“The device side was a natural fit because of my engineering background,” Agler says. “I was working in the structural testing of devices, using basic engineering concepts that I learned in undergrad.”
Since then, Agler has held a number of positions within the FDA. She served as senior science health advisor in the Division of All Hazard Preparedness Response. As lead of the division’s Medical Countermeasure Innovation Program, she worked alongside agencies, academia and industry to reduce the regulatory hurdles that often accompany bringing new medical countermeasure technology to market.
“We never change the bar for safety and effectiveness because that is most important, but we look at how we can get through the regulatory process in the most efficient and transparent way,” she says.
Agler’s work in medical countermeasures included a role in the FDA’s response to COVID-19. At the beginning of the pandemic in 2020, she worked on methods to increase accessibility of ventilators and improve the emergency use authorization process to combat the new, unforeseen demands and resulting supply chain challenges. Her department developed new methods to increase production of ventilators and other personal protective equipment supplies.
Agler has also been involved in digital health topics, such as medical mobile applications, interoperability of medical devices, and policies pertaining to wireless technology of medical devices. This work included automation of medical devices for the military, such as advancing automation tools to help care for soldiers when certain medical personnel is not available. This includes closed-loop control of ventilation using sensors to monitor a patient’s breathing, control algorithms, and actuators to automatically adjust a patient’s ventilator parameters.
“I love working with the military,” Agler says. “My father was in the military for 30 years, and advancing the availability of medical devices that can be used against threats facing the warfighter was an important initiative for me.”
Agler has provided numerous contributions to policy surrounding medical devices and countermeasures during her 20 years with the FDA. Earlier this month, she was promoted to deputy office director of surgical and infection control devices. In her new role, she is responsible for the review and regulation of devices such as personal protective equipment, and disinfection and reprocessing devices.
Linda Ricci, deputy director of the FDA’s Office of Strategic Partnerships and Technology Innovation, has worked with Agler throughout much of her career with the agency.
“Heather consistently demonstrates high scientific and professional standards,” Ricci says. “She has worked in a variety of areas across the Center for Devices and Radiological Health. This includes work on digital health, emergency preparedness, cardiovascular devices, and prevention and mitigation of shortages for critical medical devices. She is a strong supporter of public health and has made significant contributions throughout her career at the FDA.”