Do you speak fluent CPT®? If not, as a health technology entrepreneur, you likely need to learn more about how a new medical device or procedure fits into the Current Procedural Terminology (CPT) code landscape. That was the topic of a recent American Medical...
The Medical Device Manufacturers Association (MDMA) has been a beacon during the COVID-19 crisis, working closely with the FDA and other key stakeholders to represent the needs of its members and bring innovative devices to patients swiftly but safely. That’s why...
Since there’s nothing more fascinating than a peek behind the curtain, Stanford Biodesign’s most recent “From the Innovator's Workbench” event featuring former FDA commissioner from 2017 to 2019, Scott Gottlieb, MD, was a big draw. More than 400 people attended the...
The show must go on, especially when it is something as important to the industry as the MDMA’s Medical Technology Executive Forum, now in its 13th year. Hosted by MDMA president and CEO Mark Leahey, the virtual event was extremely successful, highlighting how nimble...
Since its inception four years ago, the Fogarty Institute's FDA Fellowship program has blossomed into a successful, ongoing partnership that is being lauded on both sides for enhancing the understanding, communication and collaboration between entrepreneurs and...
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...
Navigating through the Food and Drug Administration’s (FDA) policies, laws, pathways to approval and potential changes to existing regulations can be an intimidating process, especially for new or early-stage medical device startups. However, the organization has done...
As any successful medtech company knows, developing an innovative device is just the first step in improving patient care. Once that idea has come to fruition, regulatory approval begins, which is why medtech startups need an ally who can help walk them through the...
“A truly prosperous American economy is one that is diversified, driven by innovation and works for all people. I believe that to achieve this across the country, we must embrace technology and use it as a vehicle to put people to work. I support advanced American...
Anita Nosratieh, Ph.D., participated in the Institute's 2016 fellowship, part of the FDA/CDRH Innovation program where they learn about the unique challenges faced by startup companies in bringing devices to market. During her time at Fogarty, she was exposed to a...