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.