#361: Speaking the Language of IVD

Most discussions around medical device quality stop at commercial launch. Once a product ships, teams tend to celebrate and move on to the next development cycle. However, the real engineering work often begins the moment a device leaves the manufacturing floor. In this episode o ...  Show more

Navigating the regulatory landscape for combination products requires understanding how primary modes of action (PMOA) dictate oversight pathways. In this episode, host Etienne Nichols sits down with Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), ...  Show more

Dr. Katherine Rubino, intellectual property lawyer, from Caldwell Intellectual Property Law talks about intersections of technology and health care, including artificial intelligence, biotechnology, and patient privacy. This episode is part of a Health IT series by the AMA-MSS Co ...  Show more

In this episode, Dr. Aaron Carroll talks with Hugh Lee, associate professor of biomedical engineering and director of the Center for Implantable Devices at Purdue University. They discuss how research translates into new implantable medical devices, including a device Lee is work ...  Show more

Our guest Ritu Agarwal, PhD, and Robert H. Smith Dean’s Chair of Information Systems and founding director of the school’s Center for Health Information and Decision Systems (CHIDS) discusses using digital technology, analytics, and AI to educate the next generation of health IT ...  Show more

Today's guest is Urvashi Tyagi, Advisor and Former CTO at ResMed. Urvashi joins us on today's podcast with Emerj Senior Matthew DeMello to discuss the unique challenges healthcare leaders face in driving software development efficiencies for medical devices and customer-facing ...