Spotlight: Mark Leahey, MDMA CEO and Fogarty Institute Board Member

Every industry needs a “voice” standing up for it, and the entrepreneurial sector of the medical device industry is fortunate to have Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), as its advocate on Capitol Hill.

Mark has spearheaded MDMA since 2001, when the organization was just him, an assistant and 80 members who were largely small, family-run companies. But Mark saw limitless opportunity and applied his vision and relentless passion to help the industry grow its stature through a continued focus on innovation and patient care, along with improvements to the regulatory and reimbursement landscapes.

Today, MDMA boasts nearly 300-member companies, including many of the most innovative, research-driven medtech startups in the nation. It continues its focus on working with Congress, the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and other federal and state agencies in efforts to advance the healthcare industry, while educating members about policy impacting their companies.

A chance encounter leads to the ideal position

Although Mark earned his JD from Georgetown University Law Center and his MBA from Georgetown University McDonough School of Business, he decided not to pursue a traditional law office job. Instead, he began his career as a clerk in the DA and Attorney General’s office in Massachusetts and then worked on the Hill for a member of Congress in his home district.

By chance, he ran into the chief of staff for a member of Congress who had just been recruited to act as executive director of the MDMA and was in need of someone who could help on policy. That was nearly 18 years ago — and Mark has never looked back. “I can’t imagine working outside of this industry,” he says. “It’s fascinating to be surrounded by the sharpest minds, who are constantly seeking new ways to solve healthcare problems.”

Using his position to make a difference

Mark is proud of his role as an advocate, which proves the many different ways that people can make a contribution to an industry like medtech. That’s because entrepreneurs need someone championing them, and MDMA takes seriously its duty of examining policy issues from the vantage point of improving patient care and accelerating innovation.

MDMA has spearheaded a number of successes, and Mark points to two of which he is particularly proud. The first came early in his career when the organization was able to successfully advocate for reduced FDA user fees and free premarket approval (PMA) for smaller, earlier-stage companies, allowing them to preserve capital as they got started.

The second, which he considers a career highlight, was the path that culminated in the 2012 reauthorization of the Medical Device User Fee Act (MDUFMA). “This was thanks to the collective work of organizations such as Stanford Biodesign, the National Venture Capital Association, MDMA and prominent industry leaders like Josh Makower and others who all worked together to collect data and provide evidence of the negative effect the FDA was having on U.S. medical device innovation at the time,” said Mark. “Since this legislation was enacted in 2013, FDA processes have improved dramatically, which has led to greater economic growth and innovation — and ultimately, better patient care.”

The organization is now aiming to replicate this success to policies that will apply the same consistency and predictability to address patient reimbursement, which has been identified as a top challenge.

To that end, MDMA is working with CMS and private insurance companies to narrow the gap between FDA approval and reimbursement to establish a more timely, transparent and efficient system.

Bringing his expertise to the Fogarty Institute

Throughout his tenure with MDMA, Mark has had the opportunity to interact with Dr. Fogarty and the seasoned entrepreneurs on the Fogarty Institute board, and he is delighted to join the organization.

“I’ve always been inspired by Dr. Fogarty’s passion for the industry and the patients, and the culture he has built around mentoring the future generation of entrepreneurs,” Mark says. “I am looking forward to joining this extraordinary board and leadership team that has such a wealth of experience and is so dedicate to patient care and innovation.”

And, he notes that the challenges in policy are more easily addressed when diverse industry members partner and focus their efforts, ultimately smoothing the path to allow companies to be more creative and more dollars to be invested – resulting in more options for patients and clinicians.

When not focused on his work with the MDMA, Mark likes to spend time with his wife and two daughters, ages 10 and 12, playing golf or skiing, two of the favorite activities they share.

START TYPING AND PRESS ENTER TO SEARCH