Earlier this year, acting FDA Commissioner Andrew von Eschenbach unveiled the Medical Device Initiative Innovation. This proposed plan is designed to overhaul the process of examination and, perhaps more significantly, to adjust the role of the FDA.

As a medical device company, Rimon is encouraged by the awareness of the FDA that, as technology grows and the quantity of device-based treatments increases, adjustments are required within the regulating body to facilitate the movement from research to standard of practice.

Our primary product, the MI-Sorb™ dressing, is a Class I Device and is now in its first clinical trial. The prospect of assistance from the FDA to navigate through the paperwork, to improve communication, and to streamline the process is welcomed. There is the awareness that such alterations do not manifest themselves overnight. The proposed changes will be a long time in coming, with some believing that they might not come at all.

Criticism has come, not necessarily for the measures proposed, but for the likelihood of their implementation. As MD&DI has noted, as long as von Eschenbach is an "acting" director, it is unlikely that the working body of the FDA will embrace the changes and begin restructuring itself.

Implementation of the proposed changes or not, Rimon's key product will continue to benefit from the shorter timelines, and therefore, reduced developmental costs, compared to those of pharmaceutical products.

“Over the next decade, medical technology innovations will fundamentally transform health care and delivery systems, providing new solutions with medical devices that will challenge existing paradigms and revolutionize the way treatments are administered.”

The FDA’s announcement in May of this year outlined its intentions to implement ground-breaking alterations in the way the FDA operates and to its place in the development of new treatments. In addition, as demonstrated in the quote above from its official web site, the FDA acknowledges that medical treatment is changing and development of medical devices is leading the way into a new era.

Rimon is part of what the FDA refers to as the “unfolding pattern of ‘smart’ technologies that integrate engineering and biological approaches” that enable “precise clinical interventions”. In the treatment of wound care, Rimon’s primary product, the MI-Sorb™dressing (now in clinical trials), is on the front line of this development. Rather than acting as a passive dressing, providing protection and absorption of exudates, the MI-Sorb™ dressing actively works to counter the damaging effect of matrix metalloproteinases (MMPs) produced by the body, and by doing so, allows for healing to occur.

As a Class I device, MI-Sorb™ operates with drug-like margins, but benefits from the shorter device timelines. The announcement by the FDA to implement changes intended to facilitates the movement of “smart” devices from research to market could further reduce the timeline for MI-Sorb™ to be introduced to patient care and the costs involved in doing so.