By Peter Laird, MD
Innovation in health care devices must pass the scrutiny of the FDA process which is by many accounts arduous and overly expensive. Today, the FDA announced the formation of an ESRD Innovation challenge where medical devices for use in the ESRD population will be undergo and expedited review in the hopes of bringing these devices to the market quickly.
Bringing breakthrough, safe and effective medical devices to patients quickly, safely and efficiently improves lives and health care. To help reach patients with these devices as quickly as possible, the FDA created the Innovation Pathway — a priority program for technologies that address unmet medical needs in disease treatment, diagnosis and health care delivery.
The Innovation Pathway aims to shorten the overall time it takes for the development, assessment, and review of breakthrough medical devices. Some key areas of focus include the development of new decision tools to help the FDA assess and characterize benefits and risks to patients, and new collaborative ways for the FDA and innovators to share ideas about new device concepts. Where applicable, these new approaches, practices, and tools will be used in other pre-market programs.
The question that proceeds from this announcement is why would the FDA introduce such a program if it was not needed by virtue of innovations already in development for years by several companies here in the US and abroad that are now ready for introduction? At this point, there are no public announcements by those who have previously secured venture capital for the development of several new and innovative hemodialysis devices, but perhaps the FDA ESRD challenge is the harbinger foreshadowing the long awaited hemodialysis device entries by several companies known to have active research and development investments. We can only hope but in the least, this is a very intriguing development.