Ross Segan, MD, to Become FDA CDRH’s Office Director, Product Evaluation & Quality

Life Science Partner has recruited Ross (Rusty) Segan, MD, formerly Chief Medical Officer of Olympus and Integrated Leader, Pre-Clinical, Clinical, and Medical Affairs at DuPuy Synthes, to the FDA to become Director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health (CDRH).

Segan’s New Role and Responsibilities at the FDA

In this role, Dr. Segan is responsible for setting the strategy and overseeing Device-Specific Offices, the Office of Clinical Evidence and Analysis, and the Office of Regulatory Programs. His leadership ensures quality end-to-end device evaluation and consistent interpretation and application of regulatory policy and guidance.

Career Highlights and Contributions to the Medical Device Industry

Before joining the FDA, Dr. Segan held several prominent positions in the medical device industry. As Chief Medical Officer of Olympus, he was pivotal in driving the company’s medical safety initiatives and fostering innovation across the global portfolio. At Johnson & Johnson’s DuPuy Synthes, he led Pre-Clinical, Clinical, and Medical Affairs for the $9 billion orthopedic and medical device division.

His career also includes leadership roles at Covidien, overseeing a diverse portfolio of clinical studies, healthcare economics, and reimbursement strategies. Across these roles, Dr. Segan consistently demonstrated his ability to integrate business strategy with scientific excellence, driving transformation in medical technologies that improved patient care worldwide.

“Rusty brings a wealth of experience in science, medicine, and, most importantly, organizational leadership,” said Thomas Callaway, MD, Founder of Life Science Partner.  His former colleagues widely praised his management skills, an asset that will help him succeed in leading the teams and infrastructure within the FDA’s CDRH. 

Dr. Segan’s educational background complements his extensive career in the medical technology industry. He earned his Medical Doctor degree from UMDNJ-Robert Wood Johnson Medical School and holds a Master of Business Administration with specializations in Entrepreneurship, Innovation, and Leadership from New York University’s Stern School of Business.

Before his medical education, Dr. Segan earned a Bachelor of Science from Salisbury State University and a Master of Science in Athletic Training from West Virginia University. 

His clinical training includes general surgery residencies at Thomas Jefferson University Hospital and Cooper Hospital/University Medical Center and a clinical fellowship in minimally invasive surgery at the University of Maryland.

This diverse academic background has equipped Dr. Segan with a unique combination of medical, business, and leadership expertise, enabling him to excel in advancing healthcare technology and regulatory practices globally.

Read More About Life Science Partner’s Recruitment for the FDA

Here are some of featured Press Releases that describe our executive placements and involvement with the FDA: